Integration of force isolation elements into steerable elongated members

Abstract

The device includes an elongate body and a tendon assembly. The elongate body includes a sidewall comprising a flexible material, a proximal portion, and a distal portion. The tendon assembly is operable to drive deflection of a portion of the elongate body away from a central longitudinal axis. The tendon assembly includes a tendon housing and a tendon. The tendon extends through the sidewall. The tendon housing has a distal end fixed in a longitudinal position along the elongate body. The tendon is slidably disposed within the tendon housing. The tendon has a distal portion extending distally from the distal end of the tendon housing. The distal portion of the tendon is rigidly fixed relative to the elongate body.

Description

[Technical Field]

[0001] (Priority) This application claims the benefit of U.S. patent application Ser. No. 18 / 536,621, filed December 12, 2023, entitled "Integration of Force Isolation Elements into Steerable Elongate Member," which in turn claims priority to U.S. patent application Ser. No. 63 / 436,194, filed December 30, 2022, entitled "Integration of Force Isolation Elements into Steerable Elongate Member," the disclosure of which is incorporated herein by reference. [Background technology]

[0002] Various surgical instruments include end effectors for use in medical treatments and procedures performed by medical personnel, including applications in robotic-assisted surgery. In robotic-assisted surgery, a surgeon can operate a master controller to remotely control the movement of such surgical instruments at the surgical site. The controller may be located a significant distance from the patient (e.g., on the other side of the operating room, in a different room, or in a completely different building from the patient) or in close proximity to the patient in the operating room. The controller may include one or more hand input devices (e.g., joysticks, exoskeleton gloves, master manipulators, etc.) coupled to the surgical instruments by servo mechanisms. In one example, servo motors move manipulators supporting the surgical instruments based on the surgeon's manipulation of the hand input devices. During surgery, the surgeon may use a variety of surgical instruments via the robotic surgical system, including ultrasonic blades, surgical staplers, tissue graspers, needle holders, electrosurgical cautery probes, etc. Each of these structures performs a function for the surgeon, such as cutting tissue, coagulating tissue, manipulating a needle, grasping a blood vessel, dissecting tissue, or cauterizing tissue. Robotically controlled instruments can be introduced into the patient through an incision, through a naturally occurring orifice, or otherwise.

[0003] While several robotic surgical systems and related components have been made and used, it is believed that no one prior to the present inventors has made or used the invention as set forth in the appended claims. [Brief explanation of the drawings]

[0004] While this specification concludes with claims particularly pointing out and distinctly claiming the present technology, the present technology will be better understood from the following description of specific embodiments taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which: [Figure 1] FIG. 1 illustrates a top view of an example of a robotic surgical system being used in a urological procedure. [Figure 2] 2 shows a schematic diagram of various components of the robotic surgical system of FIG. 1. [Figure 3] 10A-B show enlarged views of other components of the robotic surgical system of FIG. 1, including the distal portion of the ureteroscope. [Figure 4] 2A-2C show schematic diagrams of examples of articulating elongate members that may be used with the robotic surgical system of FIG. 1. [Figure 5] 5 illustrates a cross-sectional side view of the elongated member of FIG. 4 taken along line 5-5 of FIG. 4. [Figure 6] 6 illustrates a cross-sectional end view of the elongate member of FIG. 5 taken along line 6-6 of FIG. 5. [Figure 7] 7 illustrates a cross-sectional end view of the elongated member of FIG. 5 taken along line 7-7 of FIG. 5. [Figure 8] 8 illustrates a cross-sectional end view of the elongated member of FIG. 5 taken along line 8-8 of FIG. 5. [Figure 9] 9 illustrates a cross-sectional end view of the elongated member of FIG. 5 taken along line 9-9 of FIG. 5. [Figure 10] 1A-1C show perspective views of components of a device that may be used to manufacture an elongate member having a braided structure. [Figure 11] 11 shows an example of a mandrel set that can be used in a variation of the apparatus of FIG. 10 to manufacture the elongate member of FIG. 5. [Figure 12] 12 shows a cross-sectional end view of the mandrel set of FIG. 11 taken along line 12-12 of FIG. 11. [Figure 13A] 12 shows a cross-sectional end view of the mandrel set of FIG. 11 taken along line 12-12 of FIG. 11 as the mandrel set is being used in a first portion of the process of manufacturing the elongated member of FIG. 5. [Figure 13B] 12 shows a cross-sectional end view of the mandrel set of FIG. 11 taken along line 12-12 of FIG. 11 as the mandrel set is being used in a second portion of the process of manufacturing the elongated member of FIG. 5. [Figure 13C]12 shows a cross-sectional end view of the mandrel set of FIG. 11 taken along line 12-12 of FIG. 11 as the mandrel set is used in a third portion of the process of manufacturing the elongated member of FIG. 5. [Figure 13D] 12 illustrates a cross-sectional end view of a portion of the elongated member of FIG. 5 after the remaining mandrels of the mandrel set of FIG. 11 have been removed during the process of manufacturing the elongated member of FIG. 5. [Figure 14] 6 shows a schematic diagram of example components and steps that may be used to carry out the process of manufacturing the elongate member of FIG. 5.

[0005] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the technology may be embodied in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings, which are incorporated in and form a part of this specification, illustrate several aspects of the technology and, together with the description, serve to explain the principles of the technology, although it is understood that the technology is not limited to the precise arrangements shown. DETAILED DESCRIPTION OF THE INVENTION

[0006] The following description of specific examples of the present technology should not be used to limit its scope. Other examples, features, aspects, embodiments, and advantages of the present technology will become apparent to those skilled in the art from the following description, which is, by way of example, one of the best modes contemplated for carrying out the technology. It will be understood that the technology described herein is capable of other different and obvious aspects, all without departing from the technology. Therefore, the drawings and descriptions should be regarded as illustrative in nature, and not restrictive.

[0007] It is further understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein can be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Therefore, the teachings, expressions, embodiments, examples, etc. described below should not be considered in isolation from one another. Various suitable ways in which the teachings herein can be combined will be readily apparent to those skilled in the art in light of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

[0008] For clarity of this disclosure, the terms "proximal" and "distal" are defined herein relative to a human or robotic surgical instrument operator. The term "proximal" refers to the location of an element closer to a human or robotic surgical instrument operator and further from the surgical end effector of the surgical instrument. The term "distal" refers to the location of an element closer to a surgical end effector of the surgical instrument and further from the human or robotic surgical instrument operator. It will also be further recognized that for convenience and clarity, spatial terms such as "to the side," "upward," and "downward" are used herein to refer to relative positions and orientations. Such terms are used hereinafter with reference to the illustrated figures for clarity and are not intended to limit the invention described herein.

[0009] Aspects of the present embodiments described herein may be integrated into robotic-enabled medical systems, including robotic surgical systems, capable of performing a variety of medical procedures, including both minimally invasive procedures such as laparoscopy and non-invasive procedures such as endoscopic procedures. The robotic-enabled medical systems may be capable of performing bronchoscopy, ureteroscopy, gastroscopy, among other endoscopic procedures.

[0010] In addition to performing a wide range of procedures, robotic-enabled medical systems may offer further advantages, such as enhanced imaging and guidance to assist medical personnel. Additionally, robotic-enabled medical systems may provide medical personnel with the ability to perform procedures from an ergonomic position without requiring awkward arm movements or postures. Still further, robotic-enabled medical systems may provide medical personnel with the ability to perform procedures with improved ease of use, such that one or more instruments of the robotic-enabled medical system may be controlled by a single operator.

[0011] I. Examples of robot-enabled medical systems FIG. 1 illustrates an exemplary medical system 100 for performing various medical procedures in accordance with aspects of the present disclosure. The medical system 100 may be used, for example, in endoscopic (e.g., ureteroscopic) procedures. Certain ureteroscopic procedures involve the treatment / removal of kidney stones. While the system 100 of FIG. 1 is presented in the context of a ureteroscopic procedure, it should be understood that the principles disclosed herein may be implemented in any type of endoscopic (e.g., bronchial, gastrointestinal, etc.) and / or percutaneous procedure.

[0012] The medical system 100 of this example includes a robotic system 10 (e.g., a mobile robotic cart) configured to engage and / or control one or more medical instruments (e.g., a ureteroscope 40, a basket system 30, etc.) via one or more robotic arms 12 to perform a direct access procedure on a patient 7. In some variations, the robotic system 10 and / or control system 50 are configured to receive from a scope 40 and / or display images and / or image data representative of the internal anatomy of the patient 7, i.e., the urinary system with respect to the particular depiction of FIG. 1 .

[0013] It should be understood that the direct entry instruments operated via the systems 10, 50 may include any type of medical instrument or combination of instruments, including an endoscope (e.g., ureteroscope 40), a catheter (e.g., steerable or non-steerable catheter), a nephroscope, a laparoscope, a basket system 30, and / or other types of medical instruments. The various scope-type instruments disclosed herein, such as the scope 40 of the system 100, may be configured to navigate within the human anatomy, such as within a natural orifice or lumen of the human anatomy. The terms "scope" and "endoscope" are used herein in accordance with their broad and ordinary meanings and may refer to any type of elongated medical instrument having imaging, viewing, and / or capture capabilities and configured to be introduced into any type of organ, cavity, duct, chamber, or space in the body. Scopes may include, for example, ureteroscopes (e.g., for accessing the urinary tract), laparoscopes, nephroscopes (e.g., for accessing the kidneys), bronchoscopes (e.g., for accessing the airways such as the bronchi), colonoscopes (e.g., for accessing the colon), arthroscopes (e.g., for accessing the joints), cystoscopes (e.g., for accessing the bladder), colonoscopes (e.g., for accessing the colon and / or rectum), borescopes, etc. Scopes / endoscopes may, in some cases, comprise rigid or flexible tubes and may be sized to be passed within an outer sheath, catheter, introducer, or other luminal device, or may be used without such a device.

[0014] The medical system 100 of this embodiment further includes a control system 50, a table 15, and an electromagnetic (EM) field generator 18. The table 15 is configured to support a patient 7. The EM field generator 18 may be held by one or more of the robotic arms 12 of the robotic system 10 or may be a stand-alone device. As shown in FIGS. 1-2 , the control system 50 includes various input / output (I / O) components 258 configured to assist a physician 5 or others in performing a medical procedure. For example, the I / O components 258 may be configured to allow user input to control / navigate the scope 40 and / or basket system 30 within the patient 7. The I / O components 258 of this embodiment include a controller 55 configured to receive user input from an operator and a display 56 configured to present specific information to assist the operator. The controller (55) may take any suitable form, including, but not limited to, one or more buttons, keys, joysticks, handheld controllers (e.g., video game-style controllers), computer mice, trackpads, trackballs, control pads, and / or sensors that capture hand and finger gestures (e.g., motion sensors or cameras), touchscreens, etc.

[0015] As also shown in FIG. 2 , the control system 50 of this embodiment includes a communication interface 254 operable to provide a communication interface between the control system 50 and the robotic system 10, the basket system 30, the scope 40, and / or other components. Communication via the communication interface 254 may include data, commands, power, and / or other forms of communication. The communication interface 254 may also be configured to provide communication via wired, wireless, and / or other modalities. The control system 50 also includes a power interface 259, which may receive power to operate the control system 50 via wires, batteries, and / or any other suitable type of power source. The control circuitry 251 of the control system 50 may provide signal processing and execute control algorithms to achieve the functions of the medical system 100 as described herein.

[0016] The control system 50 may also communicate with the robotic system 10 to receive position data from the robotic system 10 regarding the position of the distal end of the scope 40, the access sheath 90, or the basket device 30. Such position data regarding the position of the scope 40, the access sheath 90, or the basket device 30 may be derived using one or more electromagnetic sensors associated with the respective components. Additionally, in some variations, the control system 50 may communicate with the table 15 to position the table 15 in a particular orientation or otherwise control the table 15. The control system 50 may communicate with the EM field generator 18 to control the generation of an EM field in the area surrounding the patient 7.

[0017] As described above and shown in FIGS. 1-2, the robotic system 10 includes robotic arms 12 configured to engage with and / or control a scope 40 and / or basket system 30 to perform one or more aspects of a procedure. It should be understood that the robotic arms 12 may be coupled to instruments different from those shown in FIG. 1 , and in some scenarios, one or more of the robotic arms 12 may not be utilized or coupled to a medical instrument. Each robotic arm 12 includes multiple arm segments 23 coupled to joints 24 that may provide multiple degrees of movement / freedom. In the example of FIG. 1 , the robotic system 10 is positioned adjacent a patient's leg, and the robotic arms 12 are operable to engage and position the scope 40 for access into an access opening, such as the urethra 65, of the patient 7. Once the robotic system 10 is properly positioned, the scope 40 can be inserted into the patient 7 robotically using the robotic arms 12, manually by the physician 5, or a combination thereof. A scope-driver instrument interface 11 (i.e., an instrument device manipulator (IDM)) can be attached to the distal portion of one of the arms 12b to facilitate robotic control / advancement of the scope 40. Another of the arms 12c can include an instrument interface / manipulator 19 configured to facilitate advancement and manipulation of the basket device 30. The scope 40 can include one or more working channels through which additional tools, such as a lithotriptor, basket device, forceps, etc., can be introduced into the treatment site.

[0018] The robotic system 10 may be coupled to any component of the medical system 100, such as the control system 50, the table 15, the EM field generator 18, the scope 40, the basket system 30, and / or any type of percutaneous access device (e.g., needle, catheter, nephroscope, etc.). As described above, the robotic system 10 may be communicatively coupled to the control system 50 via communications interfaces 214, 254. The robotic system 10 also includes a power interface 219, which may receive power for operating the robotic system 10 via wires, batteries, and / or any other suitable type of power source. Additionally, the robotic system 10 of this example includes various input / output (I / O) components 218 configured to assist the physician 5 or others in performing a medical procedure. Such I / O components 218 may include any of the various types of I / O components 258 described herein in the context of control system 50. Additionally, or alternatively, I / O components 218 of robotic system 10 may take any suitable form (or may be omitted entirely).

[0019] The robotic system 10 of this example generally includes a column 14, a base 25, and a console 13 at the top of the column 14. The column 14 may include one or more arm supports 17 (also referred to as "carriages") to support the deployment of one or more robotic arms 12 (three are shown in FIG. 2). The arm supports 17 may include individually configurable arm mounts that rotate along a vertical axis to adjust the base of the robotic arms 12 for desired positioning relative to the patient. In some variations, the arm supports 17 may be connected to the column 14 through slots 20 positioned on either side of the column 14 to guide vertical translation of the arm supports 17 along the column 14. The robotic arm 12 of this example generally includes a robotic arm base 21 and an end effector 22 separated by a series of articulated arm segments 23 connected by a series of joints 24, each joint including one or more independent actuators 217. Each actuator 217 may include an independently controllable motor. I / O components 218 may be located at the top of the column 14. The console 13 also includes a handle 27 to assist in steering and stabilizing the robotic system 10.

[0020] Each end effector (213) of the robotic arm (12) may include an instrument device manipulator (IDM) that may be attached using a mechanism changer interface (MCI). In some variations, the IDMs (213) may be removed and replaced with different types of IDMs (213), e.g., a first type (11) of IDMs (213) may operate a scope (40), while a second type (19) of IDMs (213) may operate a basket system (30). Another type of IDM (213) may be configured to hold an electromagnetic field generator (18). The MCI may provide a power and control interface (e.g., a connector) to transmit pneumatic, power, electrical, and / or optical signals from the robotic arm (12) to the IDM (213). The IDM (213) may be configured to operate a medical instrument (e.g., a surgical tool / instrument) such as a scope (40) using technologies including, for example, direct drive, harmonic drive, gear drive, belt and pulley drive, magnetic drive, etc.

[0021] The system 100 may include specific control circuitry configured to perform specific functions described herein, including the control circuitry 211 of the robotic system 10 and the control circuitry 251 of the control system 50. That is, the control circuitry of the system 100 may be part of the robotic system 10, the control system 50, or some combination thereof. The term "control circuitry" is used herein according to its broad and ordinary meaning and may refer to any collection of processors, processing circuits, processing modules / units, chips, dies (e.g., semiconductor dies containing one or more active and / or passive devices and / or connectivity circuits), microprocessors, microcontrollers, digital signal processors, microcomputers, central processing units, field programmable gate arrays, programmable logic devices, state machines (e.g., hardware state machines), logic circuits, analog circuits, digital circuits, and / or any devices that manipulate signals (analog and / or digital) based on hard-coded and / or operational instructions in the circuitry. The control circuitry referred to herein may further include one or more circuit boards (e.g., printed circuit boards), conductive traces and vias, and / or mounting pads, connectors, and / or components. The control circuitry referred to herein may further include one or more storage devices, which may be embodied in a single memory device, multiple memory devices, and / or embedded circuitry of a device. Such data storage devices may include read-only memory, random access memory, volatile memory, non-volatile memory, static memory, dynamic memory, flash memory, cache memory, data storage registers, and / or any device that stores digital information. It should be noted that in variations in which the control circuitry includes hardware and / or software state machines, analog circuits, digital circuits, and / or logic circuits, the data storage devices / registers that store any associated operating instructions may be embedded within or external to the circuitry including the state machines, analog circuits, digital circuits, and / or logic circuits.

[0022] The control circuitry (211, 251) may include computer-readable media that store and / or are configured to store hard-coded instructions and / or operational instructions corresponding to at least some of the steps and / or functions illustrated in one or more of the present figures and / or described herein. Such computer-readable media may, in some cases, be included in an article of manufacture. The control circuitry (211, 251) may be maintained / located entirely locally or may be at least partially remotely located (e.g., indirectly communicatively coupled via a local area network and / or wide area network).

[0023] In some variations, for example, the physician 5 can provide input to the control system 50 and / or the robotic system 10, and in response to such input, control signals can be sent to the robotic system 10 to operate the scope 40 and / or the catheter basket system 30. The control system 50 can include one or more display devices 56 to provide various information related to the procedure. For example, the display 56 can provide information related to the scope 40 and / or the basket system 30. The control system 50 can receive real-time images captured by the scope 40 and display the real-time images via the display 56.

[0024] As shown in FIG. 2 , the basket device 30 of this example includes a basket 35 formed from one or more wire tines 36 disposed along its length within a basket sheath 37, with the tines protruding from the distal end of the sheath 37 to form the basket 35. The tines 36 further extend from the proximal end of the sheath 37 and are slidable within the basket sheath 37. The tines 36 and sheath 37 may be coupled to respective actuators 75 of the basket cartridge component 32. The basket cartridge 32 may be physically and / or communicatively coupled to a handle portion / component 31 of the basket system 30. The handle component 31 may be configured to be used to assist in basket control, either manually or through robotic control. Basket system 30 may be powered through power interface 39 and / or controlled through control interface 38, each or both of which may interface with a robotic arm / component of robotic system 10. Basket system 30 may further include one or more sensors 72, such as pressure and / or other force reading sensors, which may be configured to generate signals indicative of forces experienced at / by one or more of actuators 75 and / or other couplings of basket system 30.

[0025] In an example use case, if a patient 7 has a kidney stone 80 located in a kidney 70, a physician may perform a procedure to remove the stone 80 through the ureter 65, 60, 63. Specifically, as shown in FIG. 1 , the physician may operate the medical system 100 to achieve direct entry of the scope 40 into the ureter 65, 60, 63 of the patient 7 via the urethra 65. The physician 5 may interact with the control system 50 and / or the robotic system 10 to control the robotic system 10 to advance and navigate the scope 40 from the urethra 65, through the bladder 60, up the ureter 63, and into the renal pelvis 71 and / or calyx omentum of the kidney 70, where the stone 80 is located. The physician 5 may further interact with the control system 50 and / or the robotic system 10 to advance / control the basket device 30 through the working channel of the scope 40, the basket device 30 being configured to facilitate capture and removal of kidney stones. The control system 50 may provide information associated with the medical instrument 40 and / or other instruments of the system 100, such as real-time endoscopic images captured by the medical instrument 40, via the display 56 to assist the physician 5 in navigating / controlling such instruments.

[0026] In this embodiment, a ureteral access sheath 90 is positioned within the ureter 65, 60, 63 to the region near the kidney 70. A scope 40 may be passed through the ureteral access sheath 90 to access the internal anatomical structures of the kidney 70, as shown. Upon reaching the site of the kidney stone 80 (e.g., within the target calyx 73 of the kidney 70 where the stone 80 is accessible), the scope 40 may be used to guide / direct the basket device 30 to the target location. Once the stone 80 is captured within the distal basket portion 35 of the basket device 30, the kidney stone 80 may be extracted from the patient 7 using the utilized ureteral access pathway.

[0027] FIG. 3 illustrates one embodiment of a scope 440 that can be used as the scope 40 described above. The scope 440 of this embodiment includes a working channel 444 for deploying medical instruments (e.g., a lithotriptor, basket system 30, forceps, etc.), irrigation, and / or suction to a working region at the distal end of the scope 440. The scope 440 can be articulated, such as relative to at least a distal portion of the scope 440, so that the scope 440 can be maneuvered within the human anatomy. In some variations, the scope 440 is configured to articulate with five degrees of freedom, including, for example, X, Y, and Z coordinate movement, as well as pitch and yaw. In some variations, the scope 440 provides six degrees of freedom, including X, Y, and Z ordinate positions, as well as pitch, roll, and yaw. The position sensors of the scope 440 can similarly have similar degrees of freedom for the position information they generate / provide. As shown in FIG. 3, the tip (442) of the scope (440) can be oriented with zero deflection relative to its longitudinal axis (406) (also referred to as the "roll axis").

[0028] In this embodiment, the scope 440 may house an optical assembly, which may include an imaging device 448, such as an optical camera, and wires and / or optical fibers for transmitting signals to / from the distal end 442 of the scope 440. The imaging device 448 may be used to capture images of an internal anatomical space, such as the target cup / papilla of the kidney 70. The scope 440 may be further configured to house optical fibers for carrying light from a proximally located light source, such as a light-emitting diode, to the distal end 442 of the scope 440. The distal end 442 of the scope 440 may include a port for a light source to illuminate the anatomical space when the imaging device 448 is in use. The imaging device 448 may include optical fibers, a fiber array, and / or lenses, or light-emitting diodes at the distal end 442. The optical components of the imaging device (448) move with the distal end (442) of the scope (440) such that movement of the distal end (442) of the scope (440) results in changes in the image captured by the imaging device (448).

[0029] To capture images at different orientations of the tip 442, the robotic system 10 may be configured to deflect the tip 442 on the positive yaw axis 402, the negative yaw axis 403, the positive pitch axis 404, the negative pitch axis 405, or the roll axis 406. The tip 442 or the body 445 of the scope 442 may extend or translate in the longitudinal axis 406, the x-axis 408, or the y-axis 409. The scope 440 may include a reference structure (not shown) for calibrating the position of the scope 440. For example, the robotic system 10 and / or the control system 50 may measure the deflection of the scope 440 relative to the reference structure. The reference structure may be located on the proximal end of the endoscope 440 and may include, for example, a key, slot, or flange.

[0030] The robotic arm 12 of the robotic system 10 may be configured / configurable to manipulate the scope 440 as described above. Such manipulation may be performed by actuating one or more elongated members, such as one or more pull wires (e.g., pull wires or push wires), cables, fibers, and / or flexible shafts. For example, the robotic arm 12 may be configured to actuate multiple pull wires (not shown) coupled to the scope 440 to deflect the tip 442 of the scope 440. The pull wires may comprise any suitable or desirable material, such as metallic and non-metallic materials, such as stainless steel, aramid fiber, tungsten, carbon fiber, and the like. In some variations, the scope 440 is configured to exhibit nonlinear behavior in response to forces applied by the elongated movement members. The nonlinear behavior may be based on the stiffness and compressibility of the scope 440 and the variability in sag or stiffness between different elongated movement members.

[0031] In some variations, the scope 440 includes at least one sensor configured to generate and / or transmit sensor position data to another device. The sensor position data can indicate the position and / or orientation of the scope 440 (e.g., its distal end 442) and / or can be used to determine / estimate the position / or orientation of the scope 440. For example, the sensor (sometimes referred to as a "position sensor") can include an electromagnetic (EM) sensor having a coil of conductive material or other form of antenna. In some variations, the position sensor is located on the distal end 442 of the scope 440, while in other embodiments, the sensor is located elsewhere on the scope 440.

[0032] As shown in FIG. 3 , the EM field generator 18 is configured to broadcast an alternating current EM field 90 that is detected by the EM position sensor of the scope 440. The alternating magnetic field (MF) can induce small currents in the coils of the EM position sensor, which can be analyzed to determine the distance and / or angle / orientation between the EM position sensor and the EM field generator 18. It should be understood that the scope 440 may include other types of sensors, such as shape-sensing fibers, accelerometers, gyroscopes, satellite-based positioning sensors (e.g., global positioning system (GPS) sensors), radio frequency transceivers, etc. In this example, the EM position sensor of the scope 440 provides sensor data to the control system 50, which is then used to determine the position and / or orientation of the scope 440.

[0033] In some variations, any of the above-described features and aspects may be implemented using techniques described in U.S. Patent No. 11,737,663, entitled "Target Anatomical Feature Localization," published on August 29, 2023, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent Application Publication No. 2021 / 0369384, entitled "Stuck Instrument Management," published on December 2, 2021, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent Application Publication No. 2021 / 0401527, entitled "Robotic Medical Systems Including User Interfaces with Graphical Representations of User Input Devices," published on December 30, 2021, the disclosure of which is incorporated herein by reference in its entirety; and / or U.S. Patent Application Publication No. 2021 / 0401527, entitled "Robotic Medical Systems Including User Interfaces with Graphical Representations of User Input Devices," published on March 31, 2022, the disclosure of which is incorporated herein by reference in its entirety. The present invention may be constructed and operable in accordance with at least some of the teachings of U.S. Patent Application Publication No. 2022 / 0096183, entitled "Ultra-High Performance Computing System for Detecting and Resolving Signals Using a Microcontroller," the disclosure of which is incorporated herein by reference in its entirety.

[0034] II. Examples of Integration of Force Separation Elements into Steerable Elongated Members As mentioned above, it may be desirable to provide an elongate member (e.g., the shaft of the scope (440)) with one or more articulating sections, which may enable active steering of the elongate member along tortuous anatomical structures, provide a movable field of view from a camera at the distal end of the elongate member, facilitate access to a target anatomical structure using another instrument slidably disposed within the elongate member, and / or other purposes. To the extent that pull wires and / or other tensioning elements are used to achieve such articulation, it may be further desirable to prevent longitudinal compression in one or more regions of the elongate member if the elongate member is formed from a longitudinally compressible material. Similarly, it may be desirable to prevent longitudinal elongation in one or more regions of the elongate member if the elongate member is formed from a longitudinally extensible material. Otherwise, unwanted longitudinal elongation or compression within the elongate member may result in undesired articulation of the elongate member. In scenarios where an articulation drive element (e.g., a tendon) may tend to cause undesired longitudinal stretching or compression within the elongate member in the first longitudinal region while intentionally driving articulation in the second longitudinal region, it may be beneficial to include a force isolation element that prevents such undesired longitudinal stretching or compression within the elongate member in the first longitudinal region.

[0035] In some cases, one section of the elongate member body (e.g., the proximal section) may be formed of an incompressible / inextensible material (e.g., steel tubing, etc.), while another section of the elongate member body (e.g., the distal section) is formed of a compressible / extensible material (e.g., a polymer, braid, etc.). However, using such different materials may complicate the process of manufacturing the elongate member, add cost, and / or have other undesirable consequences. Therefore, it may be desirable to provide an elongate member having a body formed from a material that provides a degree of compressibility / extensibility that is substantially uniform along the length of the body, while also varying along the length of the body. It may also be desirable to provide an elongate member having an articulation control element (e.g., a tendon) that does not encroach into the working channel of the elongate member or adversely affect the cross-sectional efficiency of the elongate member.

[0036] 4-5 illustrate an example of an articulating elongate member 500 that may provide one or more of the beneficial features and functions mentioned above. The articulating elongate member 500 may be used with the robotic surgical system 10. By way of example only, the elongate member 500 may represent a variation of the scope 40, the access sheath 90, or the scope 440. Alternatively, the elongate member 500 may take the form of a catheter and / or any other suitable type of elongate instrument. The elongate member 500 of this example includes a body 502 having a proximal portion 510, an intermediate portion 512, and a distal portion 514. In this embodiment, the intermediate portion 512 and the distal portion 514 are each operable to articulate such that the distal end 504 of the elongate member 500 can deflect laterally away from and toward a central longitudinal axis (LA) (e.g., defined by the proximal portion 510). In some variations, the elongate member 500 is operable to articulate in only one region along the length of the elongate member 500, or in three or more different regions. For example, the distal portion 514 may include one or more articulation sections, the intermediate portion 512 may include one or more articulation sections, and / or the proximal portion 510 may include one or more articulation sections.

[0037] The proximal portion 510 is coupled to an instrument coupling 11 of the robotic surgical system 10 such that the robotic surgical system 10 is operable to drive the elongated member 500 via the instrument coupling 11. By way of example only, the robotic surgical system 10 may be operable to drive translation along the central longitudinal axis LA, rotation (e.g., spinning about the central longitudinal axis LA), articulation, and / or other forms of movement of / by the elongated member 500.

[0038] The distal end (504) of this embodiment may include one or more openings through which one or more additional instruments may exit into a surgical space or other anatomical region within a patient. The distal end (504) may also include one or more imaging devices, such as an imaging device (448), which may take the form of one or more cameras, one or more optical fibers with corresponding lenses, or the like. The distal end (504) may also include one or more illumination elements, such as one or more integrated light-emitting diodes, one or more lenses optically coupled to corresponding optical fibers, or the like. In some variations, the distal end (504) includes an end effector operable to perform one or more actions on tissue, such as grasping, cutting, suturing, sealing (e.g., with radiofrequency or ultrasonic energy), stapling, etc. In this embodiment, the distal end (504) includes a control ring (504) securely secured to the body (502). The control ring (504) is configured to provide a distal fixation point for tendons (524, 534), as described in more detail below. To the extent that other components (e.g., imaging devices, lighting elements, end effectors, etc.) are positioned at the distal end (504), such additional components may be positioned distal to the control ring (504).

[0039] As shown in FIGS. 5-8, the body (502) of this embodiment defines an inner lumen (542) and an array of angularly spaced tendon assembly lumens (508). The inner lumen (542) is configured to receive other components. In this embodiment, the inner lumen receives a working channel (546), which may contain a braided shaft and / or any other suitable components. The working channel (546) defines a lumen (548). The working channel (546) is shown in FIGS. 6-8 but is omitted from FIG. 5 for clarity. In some variations, the lumen (548) slidably receives other instruments. By way of example only, the basket (35) and basket sheath (37) of the basket device (30) can be advanced distally through the lumen (548) of the working channel (546). By way of further example only, a laser fiber or other instrument may be disposed in the lumen 548 of the working channel 546. Alternatively, a fluid (e.g., liquid, suction, etc.) may be communicated through the lumen 548 of the working channel 546. The inner lumen 542 and working channel 546 may extend all the way to the distal end 504, and the inner lumen 542 may terminate in a distal opening that allows an instrument disposed in the working channel 546 to exit distally from the elongate member 500. In this embodiment, the inner lumen 542 includes a liner 540 configured to reduce friction, thereby promoting slidability through the inner lumen 542. By way of example only, the liner 540 may include polytetrafluoroethylene (PTFE), polyimide, and / or any other suitable type of material. Although not shown, other features, such as electrical wires, optical fibers, flex circuits, etc., may extend outside of the working channel (546) along at least a portion of the length of the inner lumen (542).

[0040] In this embodiment, the tendon assembly lumens (508) are positioned approximately 90 degrees apart from one another about the central longitudinal axis (LA). In the views shown in Figures 6-8, tendon lumen (508a) is at the 12 o'clock position, tendon lumen (508b) is at the 6 o'clock position, tendon lumen (508c) is at the 3 o'clock position, and tendon lumen (508d) is at the 9 o'clock position. In this embodiment, the tendon lumens (508) extend along the entire length of the body (502). Each tendon assembly lumen (508) houses a corresponding tendon assembly (520, 530). Specifically, tendon assembly 520a is positioned within tendon lumen 508a at the 12 o'clock position, tendon assembly 520b is positioned within tendon lumen 508b at the 6 o'clock position, tendon assembly 530a is positioned within tendon lumen 508c at the 3 o'clock position, and tendon assembly 530b is positioned within tendon lumen 508d at the 9 o'clock position. It should be understood that the number of tendon assembly lumens 508 and the angular positions of the tendon assembly lumens 508 described above are merely examples. Other variations may have any other suitable number of tendon assembly lumens 508 at any other suitable angular positions.

[0041] Each tendon assembly (520, 530) includes a housing (522, 532) and a tendon (524, 534) slidably disposed within the housing (522, 532). The housing (522, 532) is configured to bend laterally away from a central longitudinal axis (LA) without being compressed longitudinally. By way of example only, the housing (522, 532) may be configured as a coil pipe formed of round or square steel wire. As another example, the housing (522, 532) may include several adjacent helically wound wires. As yet another example, the housing (522, 532) may comprise a tubular structure formed of steel, high-strength plastic, and / or any other suitable material (including combinations thereof). In some variations, the housing (522, 532) comprises a stainless steel hypotube. Alternatively, the housing (522, 532) may take any other suitable form. In some variations, the housings (522, 532) include a low-friction (e.g., polytetrafluoroethylene (PTFE), polyimide, etc.) lining within the lumen in which the tendons (524, 534) are positioned. The housings (522, 532) may also include a lubricious interface on the exterior of the housings (522, 532), thereby facilitating sliding of the housings (522, 532) within the tendon assembly lumen (508).

[0042] Similarly, instead of using laser-cut hypotubes to form the housings (522, 532), the housings (522, 532) may comprise coilpipes. Such coilpipes may be longitudinally stretched along a distal region of the coilpipe to plastically deform the coils, effectively opening the coils along the distal region of the coilpipe. Such plastically deformed distal regions may be positioned along the articulating distal region of the elongate member (500), similar to the laser-cut regions of the hypotubes described above. Such plastically deformed distal regions may provide a desired amount of compression along the distal portion (514) of the elongate member (500).

[0043] As shown in FIGS. 5 and 6, housings (522, 532) all extend along the entire length of proximal portion (510). As shown in FIGS. 5 and 7, housing (522) continues to extend through intermediate portion (512), while housing (532) terminates distally at intermediate portion (512). Bonding is provided within tendon assembly lumen (508) to secure the distal portion of housing (532) within intermediate portion (512) relative to body (502). By way of example only, this bonding may be provided via a separate adhesive applied within tendon assembly lumen (508). By way of further example only, this bonding may be provided by reflowing the material forming body (502), reflowing the material forming housing (532), and / or providing some other form of thermal bonding process. Alternatively, bonding may be formed between the distal portion of housing (532) and body (502) in any other suitable manner. It should also be understood that the bond may be isolated only at the distal end of housing (532), or may extend proximally along housing (532) from the distal end to any suitable extent.

[0044] As shown in FIGS. 5 and 8 , the housing (522) terminates distally at the distal portion (514). An adhesive (526) is provided within the tendon assembly lumen (508) to securely fasten the distal portion of the housing (522) to the body (502) within the distal portion (514). By way of example only, this adhesive (526) may be provided via a separate adhesive applied within the tendon assembly lumen (508). By way of further example only, this adhesive (526) may be provided by reflowing the material forming the body (502), reflowing the material forming the housing (522), and / or providing some other form of thermal bonding process. Alternatively, the adhesive (526) may be formed between the distal portion of the housing (522) and the body (502) in any other suitable manner. It should also be understood that adhesive (526) may be isolated only at the distal end of housing (522), or may extend proximally along housing (522) from the distal end to any suitable extent.

[0045] In some variations, housing (532) terminates distally at distal portion (514), in addition to housing (522) terminating distally at distal portion (514). In some such variations in which housing (522, 532) comprises stainless steel hypotubes, the distal regions of housing (522, 532) can be laser cut to create a compression spring (i.e., the spring portion of housing (522, 532)). Housing (532) can be securely secured (e.g., via thermal bonding, etc.) to body (502) and / or braid assembly (550) immediately proximal to distal portion (514). The spring portion of housing (522, 532) extending along distal portion (514) can provide the compression necessary for articulation of distal portion (514). The pitch of the spring portions of the housings (522, 532) can be adjusted as needed to provide variable stiffness / allowable compression (before the spring portions are fully stacked). This may allow for better tailoring of the articulation geometry as desired. Additionally, this arrangement may allow the braid assembly (550) to have a fixed lumen size throughout its entire length without concern for excessive clearance / deformability in the articulation section (between the inner lumen 542 and the tendon assemblies (520, 530)).

[0046] Returning to this example, as shown in FIGS. 5-9 , each tendon (524, 534) extends along the entire length of the body (502), with the distal end of the tendon (524, 534) fixedly secured to the control ring (506), which in turn is fixedly secured to the distal end of the body (502). By way of example only, each tendon (524, 534) may include a pull wire, a drive band, a single-strand cable, a multi-strand cable, one or more metals, one or more fibers, and / or any other suitable component operable to transmit tension along the length of the elongated member (500), thereby providing articulation of the elongated member (500) without substantial stretching. Such tendons (524, 534) may also be coupled to the instrument interface (11) of the robotic surgical system (10) such that the robotic surgical system (10) is operable to drive the tendons (524, 534) via the instrument interface (11).

[0047] As noted above, the housing (532) terminates distally at the intermediate region (512), while the housing (522) terminates distally at the distal region (514). Also as noted above, the housing (532) is configured to resist longitudinal compression. Thus, when tension is applied to any of the tendons (524), the region of the distal portion (514) distal to the distal end of the corresponding housing (522) will articulate. Meanwhile, the housing (522) provides compression isolation along the entire length of the body (502) proximal to the distal end of the housing (522). In other words, the region of the body (502) proximal to the distal end of the housing (522) will not deform in response to tension applied to the corresponding tendon (524). Similarly, when tension is applied to any of the tendons (534), the distal portion (514) and the region of the intermediate portion (512) distal to the distal end of the corresponding housing (532) articulate. Meanwhile, the housing (532) provides isolation against compressive forces along the entire length of the body (502) proximal to the distal end of the housing (532). In other words, the region of the body (502) proximal to the distal end of the housing (532) does not deform in response to tension applied to the corresponding tendon (534). From the foregoing, it should be understood that the tendon assemblies (520, 530) can be configured and operable like a Bowden cable assembly.

[0048] In some variations, the housings (522, 532) do not terminate distally at the locations described above and shown in FIG. 5 . Some such variations may include additional housing structures used solely for adhesive termination, such as plugs made from similar materials (e.g., metals or polymers, composites, etc.) as described above. For example, a short section made of the housings (522, 532) may be placed within and bonded to the tendon assembly lumen (508). This may thus form a subassembly. The remaining length of the housings (522, 532) may abut this subassembly and need not be bonded to the tendon assembly lumen (508).

[0049] In this embodiment, tendon assemblies (520, 530) extend along respective linear paths parallel to the central longitudinal axis (LA) along the entire length of elongate member (500). In some other variations, tendon assemblies (520, 530) may extend along helical paths along at least a portion of the length of elongate member (500). As shown in FIGS. 6-8, tendon (524) is positioned along a first plane extending along the central longitudinal axis (LA) (i.e., a vertical plane in the views of FIGS. 6-8). Meanwhile, tendon (534) is positioned along a first plane extending along the central longitudinal axis (LA) (i.e., a horizontal plane in the views of FIGS. 6-8). Thus, tendon (524) is operable to drive articulation along a plane orthogonal to the plane in which tendon (534) is operable to drive articulation. In this embodiment, tendons (532, 534) may be independently actuated. Thus, the distal portion (514) can be articulated in a first direction while the intermediate portion (512) is articulated in a second direction. It should be understood that any other suitable number of tendon assemblies can be provided at any other suitable angular positions about the central longitudinal axis (LA), and that any alternative tendon assembly can have a housing that terminates distally with an attachment at any suitable position along the length of the body (502). Such variations in angular positions and variations in housing distal end attachment positions can be selected and combined to provide a particular desired articulation profile.

[0050] In some variations, the proximal ends of housings (522, 532) are rigidly fixed relative to instrument coupling (11) (or to a handle or other structure), but are not fixed relative to the proximal end of body (502). In some such variations, the entire length of each housing (522, 532) proximal to bonds (526, 536) may slide longitudinally relative to body (502). In other words, the proximal end of each housing (522, 532) may be configured to translate longitudinally relative to the region of body (502) proximal to bonds (526, 536). In some such variations, such slidability of the proximal ends of the housings (522, 532) relative to the body (502) may allow the proximal portion (510) of the elongate member (500) to bend laterally (e.g., traverse tortuous anatomy) without causing undesired articulation of the intermediate portion (512) or distal portion (514) of the elongate member (500). To facilitate such slidability, the exterior regions of the housings (522, 532) and / or the interior region of the tendon assembly lumen (508) may include a lubricious material (e.g., polytetrafluoroethylene, etc.).

[0051] As also shown in Figures 6-8, the elongated member 500 of this embodiment includes a braid assembly 550. The braid assembly 550 is wrapped around the liner 540 and embedded within the body 502. The braid assembly 550 includes multiple wire strands 552 wound to form an elongated braided structure extending along the length of the liner 540 and the body 502. The tendon assemblies 520, 530 are effectively intertwined within the braid assembly 550 such that each tendon assembly 520, 530 is disposed within a space 554 defined by the wire strands 552. As described in more detail below, in some variations, the tendon assemblies 520, 530 may be effectively trapped between the braid assembly 550 and the liner 540. Meanwhile, in other variations, tendon assemblies (520, 530) may be effectively integrated into braid assembly (550) by being interwoven with strands (552).

[0052] The body 502 in this embodiment is formed around the exterior of the braid assembly 550. By way of example only, the body 502 may be formed around the exterior of the braid assembly 550 by a reflow process and / or any other suitable process. The body 502 may include a reflow material such as polyether block amide (PEBA) and / or any other suitable type of material. At least a portion of the material used to form the region of the body 502 outside the braid assembly 550 may also reach the region between the braid assembly 550 and the liner 540, as shown in FIGS. 6-8. In scenarios where either of the tendon assemblies (520, 530) tends to exert an outward / outward force on the body (520) (e.g., during bending of the elongate member (500), especially during actuated articulation), the braid assembly (550) can effectively absorb such forces, thereby protecting the body (502) from damage that may be caused to the body (502) by the tendon assemblies (520, 530). Thus, the braid assembly (550) provides structural reinforcement to the body (502). However, the braid assembly (550) still allows the body (502) to flexibly deflect laterally, such as during traversal of tortuous anatomical structures and / or during actively actuated articulation.

[0053] III. EXEMPLARY APPARATUS AND METHODS FOR MANUFACTURING STEERABLE ELONGATED MEMBERS HAVING INTEGRAL FORCE ISOLATION ELEMENTS FIG. 10 illustrates an example of an apparatus 600 that may be used in a process for manufacturing at least a portion of an elongate member including a braided structure. Specifically, FIG. 10 illustrates a head 610 at the distal end of a shaft 612, with a mandrel 620 disposed within a central opening 614 defined by the head 610. The head 610, in this example, has a rounded, generally conical shape. The proximal end of the shaft 612 may be coupled to a motor (not shown), which may be operable to rotate the shaft 612 and head 610 about a central longitudinal axis shared by the shaft 612 and mandrel 620. An actuator (not shown) may be coupled to the mandrel 620 to drive the mandrel 620 longitudinally relative to the shaft 612. Alternatively, the actuator may be coupled to the shaft (612) to drive the shaft (612) and head (610) longitudinally relative to the mandrel (620).

[0054] During longitudinal translation of the mandrel 620 relative to the head 610 (or during longitudinal translation of the head 610 relative to the mandrel 620), regardless of whether the head 610 rotates relative to the mandrel 620, the multiple braided strands 602 may be wrapped around the mandrel 620 (or onto a structure pre-placed on the mandrel 620), thereby forming a braid around the mandrel 620 (and around any structure pre-placed on the mandrel 620). Such braid wrapping of the strands 602 may be performed by coordinated movement of various spools, etc., from which the strands 602 are supplied, using known components and techniques. The rounded, generally conical shape of head (610) can support strands (602) and thereby help guide strands (602) into position along mandrel (620) (or on a structure pre-positioned on mandrel (620)) as strands (602) are wound to form braid (604).

[0055] As discussed above, it may be desirable to form the elongate member (500) with the tendon assemblies (520, 530) effectively intertwined within the braid assembly (550) such that each tendon assembly (520, 530) is positioned within the space (554) defined by the wire strands (552). Figures 11-12 show an example of a mandrel set (700) that may be used with a variation of the apparatus (600) during the process of manufacturing the elongate member (500). The mandrel set (700) in this example includes a central mandrel (702) and an array of outer mandrels (704) angularly spaced about the central mandrel (702). The central mandrel (702) may effectively function as the mandrel (620) described above, such that the central mandrel (702) is longitudinally translatable through the central opening (614) in the head (610). The diameter of the central mandrel (702) corresponds to the diameter of the inner lumen (542).

[0056] In some variations, the outer mandrel (704) is pre-positioned in a fixed manner in the position shown in FIG. 12 . In some such variations, the outer mandrel (704) mates with the central mandrel (702) through a central opening in the head (610). This may allow the outer mandrel (704) to be effectively captured within the braid assembly (550) relative to the liner (540) without necessarily interweaving between the strands (552). In some other variations, the outer mandrel (704) is laterally flexible, and the strands (552) are fed along the mandrel (702) as guided by the head (610). This may facilitate interweaving of the mandrel (704) between the strands (552) so that the mandrel (704) cooperates with the strands (552) to effectively integrate into the braid assembly (550).

[0057] The position and diameter of outer mandrel 704a will ultimately correspond to the position and diameter of tendon assembly lumen 508a. The position and diameter of outer mandrel 704b will ultimately correspond to the position and diameter of tendon assembly lumen 508b. The position and diameter of outer mandrel 704c will ultimately correspond to the position and diameter of tendon assembly lumen 508c. The position and diameter of outer mandrel 704d will ultimately correspond to the position and diameter of tendon assembly lumen 508d.

[0058] 13A-13D and 14 illustrate examples of materials and processes that may be used to manufacture elongate member 500 using variations of apparatus 600 including mandrel set 700. In particular, FIG. 14 illustrates the use of a low-friction material 802 (e.g., polytetrafluoroethylene, polyimide, etc.) to form liner 540, a material 804 (e.g., stainless steel, aramid fiber, etc.) to form strands 552 that ultimately form braid assembly 550, one or more materials 806 (e.g., steel and / or polymer) used to form mandrels 702, 704, and a material 810 (e.g., polyether bromine, etc.) to form body 502. Illustrated is a set of components (800) including a material (816) for forming the housings (522, 532) (e.g., steel wire coil pipe, steel hypotube, incompressible but laterally flexible polymer structure, etc.), a material (820) for forming the tendons (524, 534) (e.g., stainless steel, aramid fiber, tungsten, carbon fiber, etc.), and a material (824) for forming the control ring (506) (e.g., stainless steel, rigid polymer, etc.).

[0059] At the beginning of the manufacturing process, a lubricant may be applied to at least the outer mandrel (704) and, optionally, the central mandrel (702). Then, as shown in FIG. 13A, the liner (540) is positioned around the central mandrel (702). Next, as shown in FIG. 13B, the strands (552) are wound with (or around) the outer mandrel (704) and the central mandrel (702) while the liner (540) is positioned on the central mandrel, such that a braid assembly (550) is formed around the liner (540). This braid-forming process is also represented by block (808) in FIG. 14. As mentioned above, in some variations of this braid-forming process, the outer mandrel (704) is guided by the head (610), and the strands (552) are fed / wrapped around the liner (540) and the central mandrel (702). In such a variation, the outer mandrel (704) is interwoven with the strands (552) so as to be effectively integrated into the braid assembly (550).

[0060] Regardless of whether the outer mandrel 704 is effectively captured between the braid assembly 550 and the liner 540 or cooperates with the strands 552 to effectively integrate the braid assembly 550, the material 810 used to form the body 502 may then be applied around the braid assembly 550 and the mandrel set 700, as represented by block 812 in FIG. 14 . As mentioned above, this process may include a reflow process, a molding process, an extrusion process, and / or any other suitable process for forming the body 502. In either case, the resulting formation may appear as shown in FIG. 13C . It should be understood that the braid assembly 550 is coextensive with the body 502 in this example, such that the braid assembly 550 extends along the entire length of the body 502, and vice versa.

[0061] Once the body 502 is formed, the mandrel assembly 700 is removed, as represented by block 814 in Figure 14. As mentioned above, a lubricant may be applied to at least the outer mandrel 704, so that the lubricant can facilitate removal of the mandrel 704 from the body 502 and braid assembly 550. In either case, the resulting formation may appear as shown in Figure 13D.

[0062] As shown in FIG. 13D , the tendon assembly lumens (508) are formed at this stage and ready to receive the corresponding tendon assemblies (520, 530). The material (816) forming the housings (522, 532) is then inserted into the corresponding tendon assembly lumens (508) and secured in the appropriate longitudinal position via adhesives (526, 536), as represented by block (818) in FIG. 14 . The inner diameter of the tendon assembly lumens (508) may be sufficiently larger than the outer diameter of the housings (522, 532), such that lubrication may not be necessary to facilitate insertion of the housings (522, 532) into the corresponding tendon assembly lumens (508). By way of example only, the inner diameter of the tendon assembly lumens (508) may be at least approximately 0.002 inches larger than the outer diameter of the housings (522, 532).

[0063] In variations in which the bonds (526, 536) are formed by thermal bonding, heat can be concentrated in longitudinal regions of the body (502) corresponding to the distal portions of the housings (522, 532) and / or anywhere else along the length of the body (502) where it may be desired to form bonds (526, 536). To the extent that some of the heat reaches regions of the lumens (508) that do not include the housings (522, 532), the heat may tend to slightly reduce the inner diameter of such lumens (508) without necessarily effectively collapsing such lumens onto the tendons (524, 534). In some variations, the housings (522, 532) include an outer polymer layer (not shown) along the distal regions where the bonds (526, 536) are formed. Such an outer polymer layer may tend to increase the adhesive strength of the bonds (526, 536).

[0064] In this example, the material (820) forming the tendons (524, 534) is pre-disposed within the housings (522, 532), such that the process does not involve the additional step of feeding the tendons (524, 534) into the corresponding housings (522, 532). However, some variations of the process may include such a feeding step. Another optional step may include stripping a coating from the distal ends of the tendons (524, 534), as represented by block (822) in FIG. 14, to facilitate bonding of the tendons (524, 534) to the control ring (506), as described below. However, this step may be omitted in some variations (e.g., based on the existing configuration of the tendons (524, 534), such as those lacking a coating). Regardless of whether a delaminating step (822) is used, the distal ends of the tendons (524, 534) may be securely fastened to the control ring (506), as represented by block (826) in Figure 14. By way of example only, this step (826) may include laser welding, soldering, adhesive bonding, or any other suitable technique (and / or fastening components).

[0065] With the tendon assemblies (520, 530) secured within the corresponding tendon assembly lumens (508) and the distal ends of the tendons (524, 534) secured to the control ring (506), the control ring (506) is then secured to the distal end of the body (502). This is represented by block (828) in FIG. 14. At this stage, the manufacturing process for the elongate member (500) may be considered complete, as represented by block (830) in FIG. 14. This may be particularly true if the elongate member (500) functions as a guide sheath or guide catheter. In some other variations, for example, when elongate member 500 functions as a variation of scope 400, one or more imaging devices (e.g., imaging device 448), one or more illumination elements (e.g., one or more integrated light emitting diodes, one or more lenses optically coupled with corresponding optical fibers, etc.), and / or other features may be secured to or near control ring 506. Alternatively, an end effector (e.g., basket 35 or other feature operable to perform one or more actions on tissue, such as grasping, cutting, suturing, sealing, stapling, etc.) may be secured to or near control ring 506. Other suitable steps that may be performed after completing the process illustrated in FIGS. 13A-13D and 14 will be apparent to those skilled in the art in view of the teachings herein.

[0066] IV. Combination Examples The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to limit the scope of any claims that may be presented at any time in this application or any subsequent application thereto. No disclaimer is intended. The following examples are provided merely for illustrative purposes. It is contemplated that the various teachings herein may be configured and applied in many other ways. It is also contemplated that some variations may omit certain features referred to in the following examples. Accordingly, none of the aspects or features referred to below should be deemed critical unless later expressly indicated otherwise by the inventors or their successors. If a claim presented in this application or any subsequent application related thereto includes additional features other than those referred to below, those additional features should not be deemed added for any reasons of patentability. [Example]

[0067] 1. A device comprising: (a) an elongate body defining a central longitudinal axis, the elongate body including: (i) a sidewall including a flexible material; (ii) a proximal portion; and (iii) a distal portion terminating at a distal end; and (b) a first tendon assembly operable to drive deflection of a portion of the elongate body away from the central longitudinal axis, the first tendon assembly including: (i) a first tendon housing extending through the sidewall at a first angular position about the central longitudinal axis, the first tendon housing having a distal end fixed at a first longitudinal position along the elongate body; and (ii) a first tendon slidably disposed within the first tendon housing, the first tendon having a distal portion extending distally from the distal end of the first tendon housing, the distal portion of the first tendon being rigidly fixed relative to the elongate body. [Example]

[0068] 2. The device of example 1, wherein the flexible material is one or both of longitudinally extensible and longitudinally compressible. [Example]

[0069] 3. The device of any of Examples 1-2, wherein the flexible material comprises a polyether block amide. [Example]

[0070] 4. The device of any of Examples 1-3, wherein the first tendon housing is longitudinally incompressible. [Example]

[0071] The apparatus of any one of Examples 1-4, wherein the first tendon housing comprises a coil pipe. [Example]

[0072] The device of any one of Examples 1 to 5, wherein the first tendon comprises a pull wire. [Example]

[0073] 7. The apparatus of any one of Examples 1-6, wherein the first tendon assembly forms a Bowden cable assembly. [Example]

[0074] The device of any of Examples 1-7, wherein the first longitudinal position is proximal to a distal end of the distal portion of the elongate body. [Example]

[0075] The device of any of Examples 1-8, further comprising a fixation element at a distal end of the distal portion of the elongate body. [Example]

[0076] 10. The device of Example 9, wherein the distal portion of the first tendon is securely secured to the fixation element. [Example]

[0077] The device of any of Examples 9-10, wherein the fixation element comprises a control ring. [Example]

[0078] 12. The device of any of Examples 1-11, wherein the first tendon assembly is operable to drive deflection of the distal portion of the elongate body away from the central longitudinal axis. [Example]

[0079] The device of any one of Examples 1 to 12, wherein the elongate body further defines an inner lumen. [Example]

[0080] The device of Example 13, wherein the inner lumen is coaxial with the central longitudinal axis. [Example]

[0081] The device of any of Examples 13-14, further comprising a liner within the inner lumen, the liner being radially interposed between the sidewall and the inner lumen. [Example]

[0082] 16. The device of example 15, wherein the liner comprises polytetrafluoroethylene or polyimide. [Example]

[0083] The device of any one of Examples 1-16, further comprising a braid assembly. [Example]

[0084] 18. The device of Example 17, wherein the braid assembly is positioned within the sidewall. [Example]

[0085] A device described in any of Examples 17-18, wherein the braided assembly includes strands and the first tendon assembly is interwoven with the strands so that the first tendon assembly is integrated into the braided assembly. [Example]

[0086] The device of any of Examples 1-19, further comprising a second tendon assembly operable to drive deflection of a portion of the elongate body away from the central longitudinal axis, the second tendon assembly comprising: (i) a second tendon housing extending through the side wall at a second angular position about the central longitudinal axis, the second tendon housing having a distal end fixed to the elongate body; and (ii) a second tendon slidably disposed within the second tendon housing, the second tendon having a distal portion extending distally from the distal end of the second tendon housing, the distal portion of the second tendon being rigidly fixed relative to the elongate body. [Example]

[0087] 21. The apparatus of example 20, wherein the second angular position is angularly offset from the first angular position by about 90 degrees. [Example]

[0088] 21. The apparatus of example 20, wherein the second angular position is angularly offset from the first angular position by about 180 degrees. [Example]

[0089] A device described in any of Examples 20-22, wherein the distal end of the second tendon housing is fixed to the elongate body at a second longitudinal position along the elongate body. [Example]

[0090] 24. The device of Example 23, wherein the second longitudinal position is more proximal than the first longitudinal position. [Example]

[0091] The device of Example 24, wherein the elongate body further includes an intermediate portion between the proximal portion and the distal portion, and wherein the first tendon assembly is operable to drive deflection of the distal portion of the elongate body away from the central longitudinal axis, and the second tendon assembly is operable to drive deflection of the intermediate portion of the elongate body away from the central longitudinal axis. [Example]

[0092] A device described in any of Examples 20 to 25, wherein the first tendon assembly is operable to drive deflection of the distal portion of the elongate body away from the central longitudinal axis along a first joint plane, and the second tendon assembly is operable to drive deflection of the distal portion of the elongate body away from the central longitudinal axis along a second joint plane. [Example]

[0093] 27. The device of Example 26, wherein the second joint plane is orthogonal to the first joint plane. [Example]

[0094] A device comprising: (a) an elongate body defining a central longitudinal axis, the elongate body including: (i) a sidewall including a flexible material; (ii) a proximal portion; and (iii) a distal portion terminating at a distal end; (b) a tendon assembly extending through the sidewall, the tendon assembly operable to drive deflection of a portion of the elongate body away from the central longitudinal axis; and (c) a braid assembly positioned within the sidewall, the braid assembly including strands, the tendon assembly being interwoven with the strands such that the tendon assembly is integrated into the braid assembly. [Example]

[0095] The device of Example 28, wherein the tendon assembly includes: (i) a tendon housing extending through the side wall, the tendon housing having a distal end fixed in a longitudinal position along the elongate body; and (ii) a tendon slidably disposed within the tendon housing, the tendon having a distal portion extending distally from the distal end of the tendon housing, the distal portion of the tendon being firmly fixed relative to the elongate body. [Example]

[0096] 1. A device comprising: (a) an elongate body defining a central longitudinal axis, the elongate body including: (i) a sidewall comprising a flexible material; (ii) a proximal portion; (iii) a distal portion terminating at a distal end; and (iv) an intermediate portion between the proximal and distal portions; (b) a first Bowden cable assembly extending through the sidewall, the first Bowden cable assembly operable to drive deflection of the distal portion of the elongate body away from the central longitudinal axis; and (c) a second Bowden cable assembly extending through the sidewall, the second Bowden cable assembly operable to drive deflection of the intermediate portion of the elongate body away from the central longitudinal axis. [Example]

[0097] 31. The device of Example 30, wherein the first Bowden cable assembly includes a first housing having a distal end fixed at a first longitudinal position along the elongate body, and the second Bowden cable assembly includes a second housing having a distal end fixed at a second longitudinal position along the elongate body, the second longitudinal position being proximal to the first longitudinal position. [Example]

[0098] 1. A device comprising: (a) an elongate body defining a central longitudinal axis, the elongate body including: (i) a sidewall comprising a flexible material; (ii) a proximal portion; (iii) a distal portion terminating at a distal end; and (iv) an intermediate portion between the proximal and distal portions; (b) a first Bowden cable assembly extending through the sidewall, the first Bowden cable assembly operable to drive deflection of a portion of the elongate body away from the central longitudinal axis and positioned at a first angular position about the central longitudinal axis; and (c) a second Bowden cable assembly extending through the sidewall, the second Bowden cable assembly operable to drive deflection of a portion of the elongate body away from the central longitudinal axis and positioned at a second angular position about the central longitudinal axis. [Example]

[0099] 33. The device of Example 32, wherein the first Bowden cable assembly is operable to drive deflection of the distal portion of the elongate body away from the central longitudinal axis in a first direction, and the second Bowden cable assembly is operable to drive deflection of the distal portion of the elongate body away from the central longitudinal axis in a second direction. [Example]

[0100] A method comprising: (a) translating a central mandrel relative to a head; (b) positioning a plurality of outer mandrels around the central mandrel; and (c) wrapping a plurality of strands around the central mandrel and the outer mandrels to form a braided assembly while the central mandrel translates relative to the head. [Example]

[0101] 35. The method of example 34, further comprising positioning the liner around the central mandrel such that the braid assembly is formed around the liner. [Example]

[0102] 36. The method of claim 35, wherein the liner comprises polytetrafluoroethylene or polyimide. [Example]

[0103] A method according to any of Examples 34 to 36, wherein positioning the multiple outer mandrels around the central lumen includes guiding the outer mandrels along the head while the central mandrel translates relative to the head, and the multiple outer mandrels also translate relative to the head while the central mandrel translates relative to the head. [Example]

[0104] The method of any of Examples 34-37, wherein wrapping the plurality of strands around the central mandrel and the outer mandrel to form the braided assembly further comprises interweaving the plurality of mandrels with the plurality of strands, thereby incorporating the plurality of strands into the braided assembly. [Example]

[0105] The method of any of Examples 34-38, further comprising forming an elongate body around the braid assembly, wherein the central mandrel and the plurality of outer mandrels remain within the braid assembly while forming the elongate body around the braid assembly. [Example]

[0106] 40. The method of example 39, wherein forming the elongate body comprises one or more of a reflow process, an overmolding process, or an extrusion process. [Example]

[0107] The method of any of Examples 39-40, further comprising removing the central mandrel and the plurality of outer mandrels from the combination of the elongate body and the braid assembly, wherein removal of the central mandrel forms an inner lumen along the combination of the elongate body and the braid assembly, and removal of the plurality of outer mandrels forms a plurality of tendon assembly lumens. [Example]

[0108] 42. The method of example 41, further comprising inserting tendon assemblies into the tendon assembly lumens, each tendon assembly comprising a tendon housing and a tendon. [Example]

[0109] 43. The method of example 42, further comprising securely fastening a distal portion of each tendon housing to the elongate body. [Example]

[0110] The method of any of Examples 42-43, further comprising firmly securing a distal end of each tendon to the elongate body. [Example]

[0111] The method of Example 44, further comprising: (a) securely securing a distal end of each tendon to a fixation member; and (b) securely securing the fixation member to a distal end of the elongate body.

[0112] V. Other It should be understood that all or part of any patent, publication, or other disclosure referred to herein as being incorporated by reference is incorporated herein only to the extent that the incorporated material does not contradict current definitions, views, or other disclosure material set forth in this disclosure. Therefore, where necessary, the disclosure explicitly set forth herein shall prevail over any conflicting material incorporated herein by reference. Any material, or portion thereof, referred to herein as being incorporated by reference but that contradicts current definitions, views, or other disclosure material set forth herein shall be incorporated only to the extent that no conflict arises between the incorporated material and the current disclosure material.

[0113] The above-described variations may be designed to be disposed of after a single use, or they may be designed to be used multiple times. In either or both cases, the variations may be reconditioned for reuse after at least one use. Reconditioning may include any combination of the steps of disassembly of the system, device, and / or portions thereof, followed by cleaning or replacement of particular parts, and subsequent reassembly. Specifically, some variations of the system, device, and / or portions thereof may be disassembled, and any number of particular parts or components of the system, device, and / or portions thereof may be selectively replaced or removed in any combination. Upon cleaning and / or replacement of particular parts, some variations of the system, device, and / or portions thereof may be reassembled for subsequent use either at a reconditioning facility or by an operator immediately prior to a procedure. Those skilled in the art will recognize that a variety of techniques for disassembly, cleaning / replacement, and reassembly may be utilized to recondition systems, devices, and / or portions thereof. The use of such techniques, and the resulting reconditioned systems, devices, and / or portions thereof, are all within the scope of the present application.

[0114] By way of example only, the variations described herein may be sterilized before and / or after treatment. In one sterilization technique, the system, instruments, and / or portions thereof are placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and the system, instruments, and / or portions thereof may then be placed in a field of radiation that can penetrate the container, such as gamma rays, X-rays, or high-energy electrons. The radiation may kill bacteria within the system, instruments, and / or portions thereof, as well as the container. The sterilized system, instruments, and / or portions thereof may then be stored in the sterile container for later use. The system, instruments, and / or portions thereof may also be sterilized using any other technique known in the art, including, but not limited to, beta or gamma radiation, ethylene oxide, or steam.

[0115] While various embodiments of the present invention have been illustrated and described, further adaptations of the methods and systems described herein may be achieved by appropriate modifications by those skilled in the art without departing from the scope of the present invention. While some of such possible modifications have been mentioned, other modifications will be apparent to those skilled in the art. For example, the examples, embodiments, geometries, materials, dimensions, proportions, steps, etc. discussed above are illustrative and not required. Accordingly, it will be understood that the scope of the present invention should be considered in terms of the following claims, and is not limited to the details of construction and operation shown and described in the specification and drawings.

[0116] [Embodiment] (1) A device comprising: (a) an elongate body defining a central longitudinal axis; (i) a sidewall comprising a flexible material; (ii) a proximal portion; (iii) a distal portion terminating at a distal end; and (b) a first tendon assembly operable to drive deflection of a portion of the elongate body away from the central longitudinal axis; (i) a first tendon housing extending through the sidewall at a first angular position about the central longitudinal axis, the first tendon housing having a distal end fixed at a first longitudinal position along the elongate body; (ii) a first tendon assembly including: a first tendon slidably disposed within the first tendon housing, the first tendon having a distal portion extending distally from the distal end of the first tendon housing, the distal portion of the first tendon being fixedly secured to the elongate body. (2) The device of embodiment 1, wherein the flexible material is either longitudinally extensible or longitudinally compressible, or both. (3) The device of claim 1, wherein the flexible material comprises a polyether block amide. (4) The device described in embodiment 1, wherein the first tendon housing is longitudinally incompressible. (5) The device of embodiment 1, wherein the first tendon housing comprises a coil pipe.

[0117] (6) The device of embodiment 1, wherein the first tendon comprises a pull wire. (7) The device of embodiment 1, wherein the first tendon assembly forms a Bowden cable assembly. (8) The device of embodiment 1, wherein the first longitudinal position is proximal to the distal end of the distal portion of the elongate body. (9) The device of embodiment 1, further comprising a fixation element at the distal end of the distal portion of the elongate body. (10) The device of embodiment 1, wherein the first tendon assembly is operable to drive deflection of the distal portion of the elongate body away from the central longitudinal axis.

[0118] (11) The device of embodiment 1, wherein the elongate body further defines an inner lumen. (12) The device of embodiment 1, further comprising a braid assembly. (13) The method further comprising: a second tendon assembly operable to drive deflection of a portion of the elongate body away from the central longitudinal axis; the second tendon assembly comprising: (i) a second tendon housing extending through the side wall at a second angular position about the central longitudinal axis, the second tendon housing having a distal end fixed to the elongate body; (ii) a second tendon slidably disposed within the second tendon housing, the second tendon having a distal portion extending distally from the distal end of the second tendon housing, the distal portion of the second tendon being fixedly secured to the elongate body. (14) The device of embodiment 13, wherein the second angular position is offset from the first angular position by approximately 90 degrees. (15) The device of embodiment 13, wherein the second angular position is offset from the first angular position by approximately 180 degrees.

[0119] (16) An apparatus comprising: (a) an elongate body defining a central longitudinal axis; (i) a sidewall comprising a flexible material; (ii) a proximal portion; (iii) a distal portion terminating at a distal end; and (b) a tendon assembly extending through the sidewall, the tendon assembly operable to drive deflection of a portion of the elongate body away from the central longitudinal axis; (c) a braid assembly positioned within the side wall, the braid assembly including strands, the tendon assembly being interwoven with the strands such that the tendon assembly is integrated into the braid assembly. (17) The tendon assembly includes: (i) a tendon housing extending through the side wall, the tendon housing having a distal end fixed at a longitudinal position along the elongate body; (ii) a tendon slidably disposed within the tendon housing, the tendon having a distal portion extending distally from the distal end of the tendon housing, the distal portion of the tendon being fixedly secured to the elongate body. (18) A method comprising: (a) translating a central mandrel relative to the head; (b) positioning a plurality of outer mandrels around the central mandrel; (c) wrapping a plurality of strands around the central mandrel and the outer mandrel to form a braid assembly while the central mandrel translates relative to the head. 19. The method of claim 18, further comprising positioning the liner around the central mandrel such that the braid assembly is formed around the liner. (20) The method of embodiment 18, wherein positioning the plurality of outer mandrels about the central lumen includes guiding the outer mandrels along the head while the central mandrel translates relative to the head, and the plurality of outer mandrels also translate relative to the head while the central mandrel translates relative to the head.

Claims

1. 1. An apparatus comprising: (a) an elongate body defining a central longitudinal axis; (i) a sidewall comprising a flexible material; (ii) a proximal portion; and (iii) an elongate body including a distal portion terminating at a distal end; (b) a first tendon assembly operable to drive deflection of a portion of the elongate body away from the central longitudinal axis; (i) a first tendon housing extending through the sidewall at a first angular position about the central longitudinal axis, the first tendon housing having a distal end fixed at a first longitudinal position along the elongate body; (ii) a first tendon assembly including: a first tendon slidably disposed within the first tendon housing, the first tendon having a distal portion extending distally from the distal end of the first tendon housing, the distal portion of the first tendon being fixedly secured to the elongate body.

2. 10. The device of claim 1, wherein the flexible material is one or both of longitudinally extensible and longitudinally compressible.

3. The device of claim 1 , wherein the flexible material comprises a polyether block amide.

4. The device of claim 1 , wherein the first tendon housing is longitudinally incompressible.

5. The device of claim 1 , wherein the first tendon housing comprises a coil pipe.

6. The device of claim 1 , wherein the first tendon comprises a pull wire.

7. The device of claim 1 , wherein the first tendon assembly forms a Bowden cable assembly.

8. The device of claim 1 , wherein the first longitudinal position is proximal to the distal end of the distal portion of the elongate body.

9. The device of claim 1 , further comprising a fixation element at the distal end of the distal portion of the elongate body.

10. The device of claim 1 , wherein the first tendon assembly is operable to drive deflection of the distal portion of the elongate body away from the central longitudinal axis.

11. The device of claim 1 , wherein the elongate body further defines an inner lumen.

12. The device of claim 1 further comprising a braid assembly.

13. and a second tendon assembly operable to drive deflection of a portion of the elongate body away from the central longitudinal axis, the second tendon assembly comprising: (i) a second tendon housing extending through the side wall at a second angular position about the central longitudinal axis, the second tendon housing having a distal end fixed to the elongate body; 10. The device of claim 1, comprising: (ii) a second tendon slidably disposed within the second tendon housing, the second tendon having a distal portion extending distally from the distal end of the second tendon housing, the distal portion of the second tendon being fixedly secured relative to the elongate body.

14. 14. The apparatus of claim 13, wherein the second angular position is angularly offset from the first angular position by approximately 90 degrees.

15. 14. The apparatus of claim 13, wherein the second angular position is angularly offset from the first angular position by approximately 180 degrees.

16. 1. An apparatus comprising: (a) an elongate body defining a central longitudinal axis; (i) a sidewall comprising a flexible material; (ii) a proximal portion; and (iii) an elongate body including a distal portion terminating at a distal end; (b) a tendon assembly extending through the sidewall, the tendon assembly operable to drive deflection of a portion of the elongate body away from the central longitudinal axis; (c) a braid assembly positioned within the side wall, the braid assembly including strands, the tendon assembly being interwoven with the strands such that the tendon assembly is integrated into the braid assembly.

17. The tendon assembly includes: (i) a tendon housing extending through the side wall, the tendon housing having a distal end fixed at a longitudinal position along the elongate body; 17. The device of claim 16, comprising: (ii) a tendon slidably disposed within the tendon housing, the tendon having a distal portion extending distally from the distal end of the tendon housing, the distal portion of the tendon being fixedly secured relative to the elongate body.

18. 1. A method comprising: (a) translating a central mandrel relative to a head; (b) positioning a plurality of outer mandrels around the central mandrel; (c) wrapping a plurality of strands around the central mandrel and the outer mandrel to form a braid assembly while the central mandrel translates relative to the head.

19. The method of claim 18 , further comprising positioning the liner around the central mandrel such that the braid assembly is formed around the liner.

20. 20. The method of claim 18, wherein positioning the plurality of outer mandrels about the central lumen includes guiding the outer mandrels along the head while the central mandrel translates relative to the head, and wherein the plurality of outer mandrels also translate relative to the head while the central mandrel translates relative to the head.

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