Tools for robotic endoluminal systems

Abstract

Robotic endoscope apparatuses including endoscope tool drivers as well as endoscope tools adapted for use with robotic systems, including robotic systems that are nested, rigidizing and endoluminal. These apparatuses and methods may provide precise and efficient control of endoscope tools for an endoscope procedure. A wide range of tools may be used. Also described herein are shields for preventing contamination of a tool, including but not limited to the tools described herein.

Description

TOOLS FOR ROBOTIC ENDOLUMINAL SYSTEMSCLAIM OF PRIORITY

[0001] This patent application claims priority to U.S. provisional patent application no. 63 / 686,162, filed on August 22, 2024, titled “TOOLS FOR ROBOTIC ENDOLUMINAL SYSTEMS,” and U.S. provisional patent application no. 63 / 744,836, filed on January 13, 2025, titled “TOOLS FOR ROBOTIC ENDOLUMINAL SYSTEMS,” each of which is herein incorporated by reference in its entirety.BACKGROUND

[0002] Robotic systems may reduce patient recovery time, costs and side effects while increasing patient comfort. Of particular interest are rigidizing medical robots, including nested rigidizing robots, such as those described, e.g., in US 11135398, US 11478608, US 11554248, US 11724065, US 11937778, US patent application no. US20220323166, PCTUS2021024582, PCTUS2021034292, PCTUS2021049165, PCTUS2022014497, PCTUS2022019711, PCTUS2022082300 and PCTUS2023067072. Any of these robotic systems may be used with one or more tools. In particular, tools for such apparatuses may be used with to examine, excise, and otherwise operate on tissue, particularly when the robot is positioned near a target tissue. The rigidizing nature of these apparatuses provides numerous advantages when using tools, including improved support and access to such tools, but challenges remain.

[0003] To perform procedures, the operator (e.g., a surgeon, endoscopist, etc.) passes tools to an internal surgical site and manipulates them from outside the body. In particular, these devices may be elongated surgical tools that must pass through the external or internal working channels of a scope included as part of the robot or used with the robot (see, e.g., US 11793392, PCTUS2023067072 and US patent application no. 18235719). The tools must be controllable by the operator, to control both the position of the tool relative to the body, as well as to actuate a distal end effector on the tool, e.g., jaws, energy applicator, etc. Ideally such tools could be manually and / or robotically controlled. Tools may have one or more axes that are robotically controlled.

[0004] Tools for use with robotic systems may be expensive and difficult to clean. It would also be beneficial to provide methods and apparatuses that may allow more economical and easier re-use of endoscope tools.

[0005] Described herein are apparatuses and methods adapted for use with a robotic endoscope system, including (but not limited to) nested, rigidizing robotic endoscope- 1 -SG Docket No.: 13668-740.600systems. Also described herein are apparatuses and methods for enhancing cleaning and / or reuse of robotic endoscope tools.SUMMARY OF THE DISCLOSURE

[0006] Described herein are robotic endoscope apparatuses configured to allow automatic or semi-automatic (e.g., robotically assisted) operation of the endoscope tools. Any of these robotic endoscope apparatuses may include an endoscope tool driver or may be configured to operate with an endoscope tool driver. In generate these endoscope tool drivers may be operated with any endoscope tool, including in particular the tools described herein. Also described herein are endoscope tools, including those adapted specifically for use with an endoscope tool driver as described herein. The endoscope tool drivers and / or the endoscope tools described herein may be adapted specifically for use with a robotic endoscope system, including in particular a robotic, rigidizing endoluminal apparatus that may rigidize to form a stable platform within the body (e.g., within a natural or artificial body lumen, vessel, etc.). The robotic endoscope apparatuses described herein may be configured to control and / or coordinate operation of endoscope tools.

[0007] As will be described in greater detail below, the endoscope tool drivers described herein (which may also be referred to as endoscope auxiliary axis (EAA) drivers, EAA device, or simply EAA), may generally be configured to secure to a proximal end region of an endoscope tool and to advance or withdraw the endoscope tool relative to a working channel of the endoscope. For example, the endoscope tool driver comprises a base and a seating region movably coupled to the base, wherein the seating region is configured to secure a proximal end region of the endoscope tool. The endoscope tool driver may comprise a securement configured to secure over the seating region and to secure the proximal end region within the seating region.

[0008] The robotic endoscope apparatuses may incorporate any of the endoscope tool drivers described herein. The robotic endoscope apparatuses themselves may generally be configured to robotic operate an endoscope assembly. The endoscope assembly may include an endoscope and / or may be a nested system including an overtube and an endoscope. In some, nonlimiting, examples the robotic endoscope apparatus is configured to operate a rigidizing endoscope assembly (e.g., a rigidizing overtube and / or a rigidizing descope, including endoscopes adapted to be rigidizing by coupling to a rigidizing sleeve). The methods and apparatuses described herein may be configured to including one or more control inputs (e.g., keypads, keyboard, buttons, knobs, sliders, dials, touchscreens, handles / joy sticks, trackballs, etc.) for controlling the movement of the endoscope assembly - 2 -SG Docket No.: 13668-740.600and / or movement(s) of the endoscope tool. The endoscope driver and the endoscope tool driver may be controlled automatically and / or by user input (manually and / or through the one or more control inputs).

[0009] In general, the endoscope tool drivers described herein may be configured to control axial movement (e.g., distal / proximal movement) of the endoscope tool. In any of these endoscope tool drivers, the endoscope tool driver may be configured to control roll of the endoscope tool. In particular, the endoscope tool drivers described herein may control roll of the tool end effector. Thus, the endoscope tool drivers may drive roll of all or a portion of the endoscope tool in order to rotate the end effector of the tool (or the entire length of the tool) relative to the long axis of the tool. In some cases roll may be achieved by engaging and rolling (e.g. rotating) an inner member of the tool (e.g., sleeve, wire, tendon, etc.) relative to an outer member (e.g., sleeve, tube, channel, etc.).

[0010] For convenience herein an endoscope tool may be referred to simply as a “tool”.

[0011] In some cases the endoscope tools described herein may be robotic traction tools. For example, these tools may provide 0.2N or more of traction force. In some cases these apparatuses may be adapted for use as a diagnostic endoscopy apparatus and / or a therapeutic endoscopy apparatus.

[0012] The robotic endoscope apparatuses and / or endoscope tools described herein may be used with any appropriate procedure, including interventional procedures. Interventional endoscopy involves minimally invasive procedures performed using an endoscope to diagnose and / or treat conditions within the gastrointestinal tract. Examples of interventional endoscopy procedures that may use one or more of the tools, methods and devices for operating / controlling them may include, but are not limited to, diagnostic procedures (e.g., esophagogastroduodenoscopy (EGD), colonoscopy, endoscopic ultrasound (EUS), etc.), therapeutic procedures (e.g., polypectomy, endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), endoscopic retrograde cholangiopancreatography (ERCP, sphincterotomy, stone extraction, stent placement, endoscopic balloon dilation, endoscopic variceal ligation (EVL), endoscopic sleeve gastroplasty (ESG), endoscopic full-thickness resection (EFTR), endoscopic suturing, endoscopic management of gastroesophageal reflux disease (GERD), endoscopic placement of feeding tubes, percutaneous endoscopic gastrostomy (PEG), percutaneous endoscopic jejunostomy (PEJ, peroral endoscopic myotomy (POEM), treatment for achalasia by cutting the muscles at the lower end of the esophagus, natural orifice translumenal endoscopic surgery (NOTES), etc.), ablative procedures (e.g., radiofrequency ablation (RFA), cryotherapy, argon plasma coagulation (APC), etc.), palliative procedures (e.g., stent placement, gastrostomy tube placement, etc.).- 3 -SG Docket No.: 13668-740.600These methods and apparatuses described herein may provide easy-to-control traction for these procedures in contrast to existing approaches that are laborious and inaccurate. As used herein, good traction may include traction that is decoupled from endoscope motion, easy to use, sufficiently high in force (e.g., greater than or equal to about 0.2 N), and positionable / re- postionable. One particular advantage of the methods and apparatuses described herein is the ability to dynamically adjust the traction force, direction and point of application, which may be referred to herein as ‘dynamic traction’.

[0013] Although referred to herein for convenience as “endoscope” tools and “robotic endoscope apparatuses,” it should be understood that the robotic endoscope apparatuses and / or endoscope tools and methods of operating, making and using them described herein may be used with any scope, including but not limited to endoscopes. An endoscope as described herein may be refer to any appropriate type of scope. Examples of endoscopes may include, but are not limited to colonoscopes, arthroscopes, bronchoscopes, cystoscopes, hysteroscope, enteroscopes, esophagogastroduodenoscopes, hysteroscopes, neuroendoscopes, sinuscopes, laparoscopes, laryngoscopes, mediastinoscopes, sigmoidoscopes, nasopharyngoscopes, thoracoscopes, ureteroscopes, etc. Endoscopes are typically long compared to their diameter, are typically either rigid or flexible, and are configured for inserting into a body.

[0014] In general, described herein are robotic endoscope apparatuses and endoscope tools as well as methods and apparatuses for controlling the tools, either or both manually and / or robotically, using an endoscope tool driver which may be part of a robotic endoscope apparatus or may be configured for use with a robotic endoscope apparatus (or separately). In particular, the methods and apparatuses described herein may be used with or as part of a robotic system (including by not limited to a nested rigidizing robotic system) and may allow the user to choose between robotically controlling the tool or manually controlling the tool. The tools described herein may have one or more axes that are robotically controlled and one or more axes that are manually controlled. These tools may work with a system that is stable within the body. These tools may work with a system that may be removed from the body, and then reinserted, including through the use of a nested member that is stable within the body. These systems may be rigidizing or dual rigidizing.

[0015] For example, described herein are robotic endoscope apparatuses that may include: an endoscope driver comprising a robotic assembly configured to engage an endoscope assembly, and to move an endoscope of the endoscope assembly; an endoscope tool driver coupled to the endoscope driver, wherein the endoscope tool driver is configured to secure to a proximal end region of an endoscope tool and to advance or withdraw the- 4 -SG Docket No.: 13668-740.600endoscope tool relative to a working channel of the endoscope; one or more control inputs; and a controller receiving input from the one or more control inputs and configured to control operation of the robotic assembly to drive insertion, withdrawal and steering of the endoscope and to control advancing and / or withdrawal of the endoscope tool.

[0016] Any of these endoscope tool drivers may be configured to roll the endoscope tool, and in particular to roll a distal end effector of the endoscope tool. Any of these endoscope tool drivers may be configured to actuate a distal end effector of the endoscope tool. For example, these apparatuses may be configured to open / close jaws, extend / retract a loop / snare / lariat / hook, apply energy (e.g., electrical energy, thermal energy, optical energy, etc.), steer the end effector (e.g., probe, pick, knife, etc.), capture / cut / incise tissue, apply fluid, etc.

[0017] As will be described and shown in examples below, an endoscope tool driver may comprise a base and a seating region movably coupled to the base, wherein the seating region is configured to secure a proximal end region of the endoscope tool. The endoscope tool driver may comprises a securement (e.g., cover, lid, clamp, arm, belt, etc.) configured to secure over the seating region and to secure a proximal end region of the tool within the seating region. In some cases a separate (and / or moveable) engagement region may engage an actuator control on the endoscope tool driver, such as the distal-most end region of the tool, a button, lever, switch, etc. on the tool, etc.

[0018] The endoscope tool driver may include a drive coupled to the seating region and configured to drive the seating region in a liner path to insert and retract the endoscope tool. The drive may be configured as a linear drive (e.g., moving the tool shaft and therefore the tool proximally distally). Alternatively, the drive may be configured as a rotary drive, and the endoscope tool driver may be configured to convert a rotational movement of the drive into the linear movement of the endoscope tool. For example the endoscope tool driver may be configured to include one or more gears, linkages, racks, pinions, etc. to cover rotational movement of the drive into linear movement of the tool.

[0019] As mentioned, the robotic assembly may include any appropriate robotic assembly. For example, the robotic assembly may include one or more links and an endoscope mount(s) configured to engage the endoscope assembly. For example, the endoscope driver may be configured to drive a nested endoscope assembly comprising an endoscope and an overtube, and the robotic assembly may be configured to separately mount to (e.g., couple with) the overtube and endoscope (in some cases, and endoscope covered by a sleeve or shield, including a rigidizing shield). The endoscope drive may be a traditional robotic arm; e.g., the robotic assembly may comprise an arm assembly comprising two or- 5 -SG Docket No.: 13668-740.600more pivotally joined links. Alternatively or additionally, the robotic assembly may comprise a telescoping robotic assembly comprising two or more telescoping links (e.g., 3 or more links, 4 or more links, etc.) that are configured to move axially to advance or retract the endoscope assembly. When the endoscope assembly is a nested endoscope assembly, the endoscope driver may be configured to separately and / or jointly move the different nested components, e.g., overtube and endoscope.

[0020] In any of these apparatuses the endoscope driver may be configured to engage a rigidizing endoscope and / or rigidizing overtube. For example, an endoscope driver may include sensors and or sources of positive and / or negative pressure (or ports for positive and / or negative pressure), force sensors, pressure sensors, etc., to coordinate and / or control the rigidization state of the endoscope assembly (e.g., in some cases an overtube and / or and endoscope).

[0021] As mentioned, any appropriate control inputs may be used. The one or more control inputs may comprise a first input control configured to receive user inputs to advance or retract the endoscope tool coupled to the endoscope tool driver and a second input control configured to receive user inputs to move the endoscope. Examples of control inputs that may control (separately or jointly) the endoscope driver and / or the endoscope tool driver) may include physical control interfaces, such as: buttonsjoysticks, dials, knobs, pedals (e.g., foot pedals), sliders, touchscreens, trackballs, rotary encoders, switches, etc., including combinations of these (e.g., having multiple controls on a hand-held control input). Any of these control inputs may be digital or software-based inputs, including graphical user interfaces (GUIs), voice command systems, gesture recognition systems, haptic devices, keyboards, etc. In any of these apparatuses the one or more control inputs may be a gamestyle controller.

[0022] For example, described herein are robotic endoscope apparatuses comprising: an endoscope driver comprising a robotic assembly comprising one or more links and an endoscope mount configured to engage an endoscope assembly comprising an elongate flexible endoscope having one or more working channels, and to move the elongate flexible endoscope of the endoscope assembly; an endoscope tool driver coupled to the endoscope driver, wherein the endoscope tool driver is configured to secure to a proximal end region of an endoscope tool and to advance or withdraw the endoscope tool relative to a working channel of the elongate flexible endoscope; one or more control inputs; and a controller receiving input from the one or more control inputs and configured to control operation of the robotic assembly to drive insertion, withdrawal and steering of the elongate flexible endoscope and to control advancing and / or withdrawal of the endoscope tool.- 6 -SG Docket No.: 13668-740.600

[0023] Although many of the examples of endoscope tools described herein are shown as graspers (e.g., jaws for grasping and / or manipulating tissue), any of the apparatuses and techniques described herein may be used with and / or adapted for use with any appropriate endoscope tool (e.g., having any end effector), including (but not limited to) clamping, e.g., forceps, graspers, etc., cutting / dissecting / ablating tools (e.g., mechanical cutting, thermal cutting, thermal / cryoablation, radiofrequency ablation, radiofrequency cutting, laser cutting, laser ablation, etc. including knives), needle / suture passers, snares, nets, retrieval basket, staples, dilators (e.g., balloon dilators), stents, probes, needles, biopsy tools, imaging tools (e.g., optical cameras, electrodes, etc.), sampler (e.g., cytology brush), waterjet tools, suction tools, etc. In some cases, described herein are traction tools, such as graspers, manipulators, etc. Traction may be particularly important for robotic endoscope tools.

[0024] The apparatuses described herein may provide robotic endoscope apparatuses and robotically controlled endoscope tools that may be particularly well suited for use with rigidizing endoscope assemblies, including nested systems. In some cases these tools may have 1, 2, 3, 4, 5, 6, 7, 8 or more DoF (Degree of Freedom), and may include robotic endoluminal graspers. These higher DoF tools may be difficult to manually control but may be more easily robotically manipulated.

[0025] For example, a endoscope tool for a nested rigidizing apparatus may include: an elongate body having a first distal region configured to bend in a single or dual planes and a second distal region proximal to the first distal region configured to bend in two or more planes; a distal end effector extending distally from the fist distal end region comprising a pair of graspers; wherein the distal end effector is configured to be moved to apply 0.2 N or force or greater to lift a tissue when extended from a distal end of a working channel of the nested rigidizing apparatus.

[0026] The first distal region may be configured to be articulated by a first pair of cables. The second distal region may be configured to be articulated by two or more pairs of cables. Any of these tools may include a first distal region that comprises a hypotube cut into an interlocking pivot flex section oriented to pivot in one direction. Alternatively or additionally, any of these tools may include pivot links (which may be, e.g., machined or Metal Injection Molded); pivot links may provide indeterminate or determinant movement. In some cases the links may be used with one or more sensors to create feedback loops enhancing tool control.

[0027] In any of these apparatuses the outer surface of the tool may be particularly well adapted for insertion through a working channel, including an expandable working channel. For example, the elongate body may be covered by an angulation mesh configured to provide a low-friction exterior.- 7 -SG Docket No.: 13668-740.600

[0028] In some cases the distal end of the tool may be a grasper, and the grasper may comprise a rat-tooth grasper, or any other appropriate type of grasper. The first distal region may be separated from the second distal region by a first flex interface region including a cable termination region the first pair of cables.

[0029] In any of these examples, the second distal region may comprise a hypotube cut into an interlocking pivot flex section oriented to pivot in two or more directions. The elongate body may comprise a plurality of eyelets within the elongate body for stabilizing the first pair of cables and the second two or more pairs of cables. The first distal region may be any appropriate length, such as between about 1 cm and 15 cm (e.g., between about 2 cm and 10 cm, between about 2 cm and 8 cm, etc.), and the second distal region may be any appropriate length, such as between about 1 cm and 15 cm (e.g., between about 2 cm and 10 cm, between about 2 cm and 8 cm, etc.). In some cases the first distal region may be shorter than the second distal region. Alternatively in some cases the second distal region may be shorter than the first distal region.

[0030] Also described herein are methods of operating an endoscope tool for a nested rigidizing apparatus. For example, a method may include: inserting the endoscope tool through a working channel of a nested rigidizing apparatus, wherein the working channel is external an outer rigidizing member of the nested rigidizing apparatus; extending the distal end region of the endoscope tool distally from the working channel; navigating the endoscope tool to a tissue region by: advancing and / or retracting the endoscope tool longitudinally; bending a first distal end region of the endoscope tool in a first plane; bending a second distal end region of the endoscope tool, proximal to the first distal end region, in two or more planes; and rotating the endoscope tool relative to the working channel; grasping a tissue of the tissue region with a distal grasper and applying 0.2 N of force or more to pull the tissue.

[0031] In any of these methods inserting may comprise inserting the endoscope tool through a tool liner within the working channel. The liner may comprise a spiral -cut hypotube. In any of the apparatuses and methods described herein, a liner may be an elastomer and wire reinforced tube. The liner may be flexible / collapsable over the majority of the length but may be more rigid at the distal end region. In any of these examples, applying 0.2 N of force may comprise applying the force against the overtube. Applying 0.2 N of force may comprise moving the distal grasper at least 1 cm of travel relative to the tissue region. The liner may have an eccentrically mounted wire that is used to make it steerable.

[0032] In any of these examples, navigating the endoscope tool may comprise moving the distal grasper within the field of view of an imaging sub-assembly of the nested rigidizing apparatus. Grasping the tissue may comprise grasping a polyp.- 8 -SG Docket No.: 13668-740.600

[0033] In any of the methods described herein each of the steps of bending the first distal end region, bending the second distal end region, rotating the endoscope tool and grasping the tissue may be separately controlled. In any of these examples, each of the steps of bending the first distal end region, bending the second distal end region, rotating the endoscope tool and grasping the tissue may be controlled by a tool driver coupled to the endoscope tool.

[0034] Navigating the endoscope tool to the tissue region may comprise navigating the endoscope tool when the outer rigidizing member is in a rigid configuration. Any of these methods may include removing the endoscope tool from the working channel.

[0035] Also described herein are shields for protecting an endoscope tool, e.g., to prevent or limit contamination, and / or to prevent or limit damage. Optionally, but not necessarily, these shields may maintain sterility of the tool. The shield may be applied before inserting the tool into the robot and / or into the body. The shield may be tested before, during or after use to confirm patency of the shield (e.g., confirming that a rip or tear that may breach the contamination barrier has not occurred). In some cases, these shields may be applied while inflating (e.g., applying positive pressure, e.g., using a fluid such as air, saline, etc.) to make them easier to apply. The tool shields described herein (which may be referred to as “shields”) may enable multiple uses of highly complex tools, thereby lowering the per-use cost and reducing waste. These shields may protect the underlying elements and may reduce or eliminate the need for cleaning, which is expensive, cumbersome, time-consuming, skillbased, logistically difficult, requires facility space, noxious chemicals, PPE, and is error prone. Cleaning with an autoclave requires specialized materials that can withstand high temperatures. Further, autoclaving does not guarantee that the tools is clean, as the tool may still be full of debris that, even if they are sterile, can interfere with operation (e.g., movement) of the tool. Debris may be released during subsequent clinical use, which could cause a pyrogrenic response.

[0036] In general, the shield may be adapted to protect the entire tool, including the distal end region, while still permitting it to operate without significantly disrupting the function. In some cases the shield may include an adapter that may be electrically and / or optically and / or thermally transparent (e.g., for use with an energy cutting / sensing / treating endoscope tool). In some cases the distal end regio of the shield may include a flexible and glove-like region that may be adapted to increase the contact with the tissue as compared with other regions of the shield.

[0037] For example, a shield for an endoscope tool may include: an elongate shield body comprising a flexible layer of fluid-impermeable material; a distal glove region configured to fit over the distal region of the endoscope tool. For example, the distal region of the tool may - 9 -SG Docket No.: 13668-740.600be a clamping actuator, wherein the distal glove region comprises a first jaw covering configured and a second jaw covering; and a first textured region on the first jaw covering and a second textured region on the second jaw covering, wherein the first and second textured regions are configured to extend over a tissue contacting surface of the clamping actuator when the shield is worn over the endoscope tool.

[0038] The elongate shield body may be formed of any appropriate material. In some cases the elongate shield body may comprise a polymeric or elastomeric material. The distal glove region may be formed of the same material as the elongate shield body, or a different material. The shaft may be a reinforced elastomeric structure. Any appropriate material may be used, including biocompatible polymers such as: polystyrene (PS), polypropylene (PP), polyvinyl chloride (PVC), polyethylene (PE), polyurethane (PU), polycarbonate (PC), polyethylene terephthalate (PET), polyetheretherketone (PEEK), etc. The distal glove region may be formed with (e.g., as a unitary structure) the elongate shield body. In some cases the distal glove region may be separately formed and sealed to the elongate shield body.

[0039] Any of these shields may include a securement at a distal end region of the shield, proximal to the distal glove region, that is configured to secure the shield to an outer surface of the endoscope tool. The securement may comprise an elastic securement. In some cases the securement may be an interference fit. In some cases the securement may be an elastic band, clip, etc.

[0040] The distal glove region may be reinforced relative to the elongate shield body. In some cases the distal glove region may be formed of a different material, a different thickness, or an additional (e.g., reinforcing) material.

[0041] Any of these shields may include a proximal seal configured to seal the proximal end of the shield over the endoscope tool. Any of these shields may include an inflation port configured to apply pressure between the shield and the endoscope tool to detect leaks within the shield. The first and second textured region may comprise a gripping surface.

[0042] Also described herein are methods operating a endoscope tool for a nested rigidizing apparatus, the method comprising: inserting a clamping actuator of the endoscope tool into a distal glove region of a shield, so that a first jaw of the clamping actuator is within a first jaw covering and a second jaw of the clamping actuator is within a second jaw covering; extending an elongate shield body of the shield over a length of the endoscope tool from the clamping actuator to a proximal region of the endoscope tool; and inserting the endoscope tool covered by the shield though a working channel.

[0043] Any of these methods may include gasping tissue between the first and second jaws so that the tissue contacts a gripping surface of the first jaw covering and a gripping- 10 -SG Docket No.: 13668-740.600surface of the second jaw covering. Extending the elongate shield body of the shield over the length of the endoscope tool may comprise securing the elongate shield body to an outer surface of the endoscope tool at one or more discrete regions.

[0044] In any of these methods, securing the elongate shield body may comprise securing the elongate shield body so that a region of material forming the elongate shield comprises an excess of length of the elongate shield body to prevent binding of the endoscope tool by the shield body when bending the endoscope tool. Any of these methods may include sealing a proximal end of the shield over the endoscope tool. For example, any of these methods may include testing the shield for leaks. For example, the method may include applying positive or negative pressure between the shield and the endoscope tool (and identifying a pressure leak). Testing may be performed before, during and / or after a procedure. Should the unit be pressurized and not leak, that would confirm that the shield remains hermetically intact, such that the underlying tool is not contaminated. Thus, the tool could subsequently be sterilized, without the need for manual cleaning and without the concern about debris contamination. Alternatively, the tool could simply be used again with another shield. Shields can be packaged sterile, with multiple sterilization methods possible, including EtO sterilized, E- beam, gamma, or with chlorine gas. The shield may be pressure-tested as an individual entity, or as part of a system with the tool installed.

[0045] An endoscope tool driver device may include: a base; a tool handle receiver extending from the base and having a receiving surface configured to engage with a tool handle of a tool; a tool end effector actuator extending from the base and configured to engage a proximal end of the tool and to rotate the proximal end of the tool; and a linear drive coupled to the tool end effector actuator and configured to move the tool end effector actuator proximally and distally relative to the tool handle receiver; wherein the base is configured to be mounted to a link of a robotic driver to insert and retract the flexible elongate tool.

[0046] The tool handle receiver may comprise a dock configured to receive a projection extending from the tool handle. The tool handle receiver may comprise a seating region. The seating region may comprise an elastomeric material configured to conform to the tool handle.

[0047] Any of these devices may include a sensor configured to detect that a tool handle is engaged with the tool handle receiver. Any of these devices may include a lock configured to lock a tool handle to the tool handle receiver. Any of these devices may include a rotatable tool shaft grip rotatably coupled to the tool end effector actuator configured to engage the proximal end of the tool and to rotate the proximal end of the tool handle.- 11 -SG Docket No.: 13668-740.600

[0048] The tool end effector actuator may be configured to rotate the proximal end of the tool handle relative to the tool handle. The tool end effector actuator may comprise a friction wheel configured to drive rotation of the proximal end of the tool. The linear drive may be embedded within the base.

[0049] For example, an endoscope tool driver device may include: a base; a tool handle receiver comprising a dock having a receiving surface configured to engage with a projection from a tool handle of a tool; a rotatable tool shaft grip rotatably coupled to a tool end effector actuator configured to engage a proximal end of the tool and to rotate the proximal end of the tool handle relative to the tool handle; and a linear drive coupled to the tool end effector actuator and configured to move the tool end effector actuator proximally and distally relative to the tool handle receiver; wherein the base is configured to be mounted to a link of a robotic driver to insert and retract the flexible elongate tool.

[0050] Also described herein are methods of controlling operation of a flexible tool for use with an endoscope, the method comprising: inserting the flexible tool through a working channel of the endoscope; securing a handle region of the flexible tool in a tool handle receiver of an endoscope tool driver and a proximal end of the flexible tool in a tool end effector actuator; and activating a linear driver of the endoscope tool driver to advance and / or retract the proximal end of the flexible tool relative to the handle region to steer and / or actuate a distal end effector of the tool.

[0051] Any of these methods may include activating a rotary driver of the endoscope tool driver to rotate the proximal end of the flexible tool relative to the handle region steer and / or actuate the distal end effector of the tool.

[0052] Inserting the flexible endoscope tool through the working channel may comprise inserting the flexible endoscope tool through an external working channel. Inserting the flexible endoscope tool through the working channel may comprise inserting the flexible endoscope tool through an internal working channel of the endoscope. Securing the handle region of the flexible tool in the tool handle receiver may comprise inserting a tool engagement projection on the tool handle into a tool handle dock.

[0053] Any of these methods may include locking the handle region of the flexible tool in the tool handle receiver.

[0054] For example, a method of controlling operation of a flexible tool for use with an endoscope may include: inserting the flexible tool through a working channel of the endoscope; securing a handle region of the flexible tool in a tool handle receiver of an endoscope tool driver and a proximal end of the flexible tool in a tool end effector actuator; and- 12 -SG Docket No.: 13668-740.600activating a linear driver of the endoscope tool driver to advance and / or retract the proximal end of the flexible tool relative to the handle region to steer and / or actuate a distal end effector of the tool; and activating a rotary driver of the endoscope tool driver to rotate the proximal end of the flexible tool relative to the handle region steer and / or actuate the distal end effector of the tool.

[0055] All of the methods and apparatuses described herein, in any combination, are herein contemplated and can be used to achieve the benefits as described herein.BRIEF DESCRIPTION OF THE DRAWINGS

[0056] A better understanding of the features and advantages of the methods and apparatuses described herein will be obtained by reference to the following detailed description that sets forth illustrative embodiments, and the accompanying drawings of which:

[0057] FIGS. 1 A-1D illustrate one example of a nested robotic scope device that may be used with any of the apparatuses (e.g., tools) and methods described herein. The elongate medical instrument in this example is an endoscope (e.g., in some examples, a colonoscope) having a nested inner member and an outer member that are both selectively rigidizing.

[0058] FIGS. 2A-2B illustrate another example of a system as described herein, including a multi-lumen extensible external working channel and a tool liner tube.

[0059] FIG. 3 A is a section through an elongate rigidizable device (e.g., rigidizing overtube) that may be rigidized by the application of negative pressure.

[0060] FIG. 3B is an enlarged view showing one example of the arrangement of layers within the elongate rigidizable device of FIG. 3 A.

[0061] FIG. 3C is a section through an elongate rigidizable device (e.g., rigidizing overtube) that may be rigidized by the application of positive pressure.

[0062] FIG. 3D is an alternative sectional view showing one example of the arrangement of layers within the elongate rigidizing device of FIG. 3C.

[0063] FIGS. 4A-4B schematically illustrate rigidizing of a pressure-actuated rigidizable device.

[0064] FIG. 5 A shows an example of a rigidizable device (e.g., rigidizing overtube) including a knit rigidizing layer, shown with the knit rigidizing layer exposed.

[0065] FIG. 5B shows an example of a rigidizable device (e.g., rigidizing overtube) such as the one shown in FIG. 5 A with the outer layer(s) covering the knit rigidizing layer.

[0066] FIG. 5C is an enlarged view of one example of a knit.- 13 -SG Docket No.: 13668-740.600

[0067] FIG. 5D shows a section view through an example of a knit over an inner tubular member.

[0068] FIG. 6A shows an example of a weft knit.

[0069] FIG. 6B shows an example of a warp knit.

[0070] FIG. 6C shows an example of a knit material formed of a single continuous filament.

[0071] FIG. 7A is an example of a woven rigidizing layer formed of filament; this woven rigidizing layer may be used as part of a rigidizable device (e.g., rigidizing overtube) as described herein.

[0072] FIG. 7B is an example of a woven rigidizing material formed of monofilaments that are woven together; this woven rigidizing layer may be used as part of a rigidizable device (e.g., rigidizing overtube) as described herein.

[0073] FIG. 7C shows another example of a woven material.

[0074] FIGS. 8 A and 8B show examples of braided material that may be used as (or as part of) a rigidizing layer of a rigidizable device (e.g., rigidizing overtube) as described herein. FIG. 8B shows a braided layer that is discontinuous.

[0075] FIG. 9 illustrates one example of a robotic system for performing any of the methods described herein.

[0076] FIG. 10A illustrates one example of an endoscope tool for use with a robot as described herein.

[0077] FIG. 10B shows a section view through the endoscope tool of FIG. 10 A.

[0078] FIG. 11 schematically illustrates one example of an elongate tool as described herein.

[0079] FIG. 12 is perspective view of an example of an endoscope tool for use with a robot as described herein.

[0080] FIGS. 13A-13C illustrate examples of a distal end region of an endoscope tool for use with a robot similar to that shown in FIG. 12.

[0081] FIGS. 14A-14C illustrate another example of an endoscope tool for use with a robot (FIG. 14A), including detailed views of a proximal interface region (FIGS. 14B-14C).

[0082] FIGS. 15A-15B illustrate the tool of FIG. 14A (shown in FIG. 15 A), including details of the proximal -to-distal interface region (FIG. 15B).

[0083] FIG. 16A illustrates an example of an endoscope tool for use with a robot as described herein, extending distally from a working channel of a nested rigidizing device.

[0084] FIGS. 16B and 16C show examples of the tool of FIG. 16A further deployed from the distal end region of the nested device.- 14 -SG Docket No.: 13668-740.600

[0085] FIG. 17 schematically illustrates one example of an endoscope tool for use with a robot as described herein deployed and controlled by a tool driver.

[0086] FIG. 18 illustrates an example of a tool liner for an endoscope tool for use with a robot as described herein.

[0087] FIG. 19 shows an example of a tool driver interfacing with an example of an endoscope tool for use with a robot.

[0088] FIGS. 20A-20D illustrate an endoscope tool having a distal bend region and a proximal bend region in various states, including unbent (FIG. 20A), unbent with the distal actuator, e.g., grasper / jaws, being deployed (FIG. 20B) and proximally bent to a maximum angle of approximately 150 degrees (FIG. 20C) and distally bent to a maximum angle of approximately 105 degrees.

[0089] FIG. 21 schematically illustrates an example of deployment of an endoscope tool relative to a distal end of an outer nested member of a rigidizing robotic device.

[0090] FIG. 22 illustrates another example of a rigidizing traction tool as described herein.

[0091] FIGS. 23 A-23D illustrate the operation of a rigidizing traction tool similar to that shown in FIG. 22.

[0092] FIGS. 24A-24D show an example of the operation of a rigidizing tool similar to that shown in FIG. 22.

[0093] FIGS. 25 schematically illustrates one example of a method of deploying an apparatus as described herein.

[0094] FIGS. 26A-26C illustrate an example of an endoscope tool for a rigidizing apparatus as described herein, in which the robotic tool is configured to be assisted in deployment by the inner nested rigidizing member including a tether or loop.

[0095] FIGS. 27A-27C illustrate an example of an endoscope tool for a rigidizing apparatus as described herein, in which the endoscope tool is configured to be assisted in deployment by the inner nested rigidizing member including an expandable member, such as a balloon.

[0096] FIG. 28 illustrate an example of an endoscope tool for a rigidizing apparatus as described herein, in which the endoscope tool is assisted in deployment by a magnetic / electromagnetic coupling on the inner nested rigidizing member.

[0097] FIGS. 29A-29C illustrate an example of an endoscope tool for a rigidizing apparatus as described herein, in which the endoscope tool is configured to rigidize.- 15 -SG Docket No.: 13668-740.600

[0098] FIG. 30 illustrate an example of an endoscope tool for a rigi dizing apparatus as described herein, similar to that shown in FIGS. 10A-10B, in which the tool includes multiple planes of bending that may be controlled by a cable / tendon.

[0099] FIGS. 31A-31B illustrate operation of an endoscope tool for a rigidizing apparatus similar to that shown in FIG. 30.

[0100] FIGS. 32A-32C illustrate an example of a robotic tool for a rigidizing apparatus as described herein, in which the endoscope tool is itself nested and includes an articulating inner member and a passive rigidizing outer member.

[0101] FIG. 33 illustrates the operation of an articulating endoscope tool as described herein.

[0102] FIGS. 34A-34C illustrates an example of operation of an endoscope tool having a distal articulating portion.

[0103] FIGS. 35A-35B illustrate an example of an endoscope tool having a proximal three (3) DoF section and a distal two (2) DoF section.

[0104] FIG. 36 illustrates an example of a seven DoF endoscope tool as described herein.

[0105] FIGS. 37A-37B illustrate an example of an endoscope tool configured for compound motion with the grasper and the bending.

[0106] FIGS. 38A-38B illustrate one example of a motor chassis for use with an endoscope tool for a rigidizing apparatus.

[0107] FIGS. 39A-39B illustrate an example of a linear mount for an endoscope tool as described herein.

[0108] FIGS. 40A-40B schematically illustrate one example of an endoscope auxiliary axis driver (EAA), e.g., endoscope tool driver, as described herein.

[0109] FIG. 40C illustrates one example of a telescoping robotic driver that includes an endoscope auxiliary axis driver.

[0110] FIGS. 40D-40E show an example of an endoscope tool driver.[OHl] FIG. 40F illustrates an example of operation of an endoscope tool driver.

[0112] FIGS. 41A-41D illustrate an example of a multi-axis endoscope auxiliary axis driver as described herein. FIGS. 41 A and 41D show alternate views of one example of a multi-axis endoscope auxiliary axis driver. FIGS. 41B-41C schematically illustrate operation of a multi-axis endoscope tool driver similar to the one shown in FIG. 41 A and 41D.

[0113] FIG. 4 IE illustrates an example of operation of a multi -axis endoscope tool driver.

[0114] FIGS. 42A-42C illustrate an example of a polypectomy tool having multiple axis of control. For example, the shaft can be moved. For example, the jaw may be actuated. For- 16 -SG Docket No.: 13668-740.600example, the distal region may be deflected. These motions can be controlled by a multi -axis endoscope auxiliary axis driver.

[0115] FIGS. 43A-43C illustrate an example of a snare tool having multiple axis of control (e.g., jaw actuating and jaw deflection) that may be controlled by a multi-axis endoscope auxiliary axis driver.

[0116] FIG. 44 illustrates a packaging / packing, storing and dispensing of a tool that may be used with any of the tools described herein.

[0117] FIGS. 45A-45C illustrate one example of a disposable shield for use with any of the endoscope tools described herein.

[0118] FIGS. 46A-46B illustrate an example of a distal end region of a disposable shield for an endoscope tool similar to that shown in FIGS. 46A-46C.

[0119] FIGS. 47A-47C illustrate another example of an apparatus including a disposable shield portion including a disposable end effector that may releasably couple to a reusable tool portion. FIGS. 47 A show the components, including the reusable tool shaft and proximal end, and the disposable shield and end effector. FIG. 47B shows the disposable end effector coupled to the reusable shaft portion. FIG. 47C shows the operation of the tool with the shield.

[0120] FIGS. 48A-48B schematically illustrates the operation of another example of a tool, configured as a suturing tool (needle) having a high torquability.

[0121] FIGS. 49A-49D illustrate an example of an endoscope tool driver apparatuses configured to roll the body of the endoscope.

[0122] FIGS. 50A-50C illustrate an example of an endoscope tool driver.

[0123] FIGS. 51A-51E illustrate an example of an endoscope tool driver.

[0124] FIGS. 52A-52C illustrate an example of an endoscope tool driver.

[0125] FIGS. 53A-53B illustrate an example of an endoscope tool driver.

[0126] FIGS. 54A-54C illustrate an example of an endoscope tool driver.

[0127] FIGS. 55A-55C illustrate an example of an endoscope tool driver.

[0128] FIGS. 56A-56C illustrate an example of an endoscope tool driver.

[0129] FIGS. 57A-57E illustrate an example of an endoscope tool driver.

[0130] FIGS. 58A-58B illustrate an example of an endoscope tool driver.

[0131] FIG. 59A shows an example of a robotic driver including telescoping links having an integrated endoscope tool driver coupled to the third link.

[0132] FIG. 59B schematically illustrates the third link of the telescoping link assembly for the robotic driver shown in FIG. 59A.- 17 -SG Docket No.: 13668-740.600

[0133] FIGS. 60A-60C illustrate an example of an endoscope tool driver or controlling an external tool as described herein.

[0134] FIGS. 61 A-61C illustrate an example of an endoscope tool driver or controlling an external tool as described herein.

[0135] FIG. 62A-62B illustrate an example of a tool handle region of a tool that may be used with an endoscope tool driver such as the endoscope tool driver shown in FIGS. 60 A- 60C or 61A-61C.

[0136] FIGS. 63 A-63B illustrate an example of a tool handle region of a tool that may be used with an endoscope tool driver such as the endoscope tool driver shown in FIGS. 60 A- 60C or 61A-61C.

[0137] FIGS. 64A-64F illustrate examples of tool handles for various tools configured for used with the endoscope auxiliary axis drivers described herein. FIG. 64A shows an example of a tool handle for a snare / net tool. FIG. 64B shows an example of a tool handle for an ablating snare tool. FIG. 64C shows an example of a tool handle for a hemostatic clip tool. FIG. 64D shows an example of a tool handle for a coagulation grasper tool. FIG. 64E shows an example of a tool handle for a biopsy forceps tool. FIG. 64F shows an example of a tool handle for an injection knife tool.

[0138] FIGS. 65A-65B show an example of an endoscope tool driver coupling to robotic endoscope apparatus including an RFID chip.

[0139] FIG. 66 shows an example of an endoscope tool driver configured to couple to an endoscope tool including a hinged clamp for securing the distal end region of an endoscope tool.

[0140] FIG. 67 shows another example of an endoscope tool driver configured to couple to an endoscope tool including a collet-type clamp for securing the distal end region of an endoscope tool.DETAILED DESCRIPTION

[0141] Described herein are endoscope tools, as well as drivers for controlling operation of the tools, that may be used with robotic apparatuses. In some cases, the robotic apparatus may be, but is not limited to, a rigidizing robotic apparatus (e.g., a nested rigidizing robotic apparatus). For example, the tools described herein may be adapted specifically for use with robotic endoscope systems, including (but not limited to) robotic, and nested rigidizing endoluminal apparatuses. In some cases the robotic apparatus is not rigidizing. Also described herein are methods of making and using any of these tools driver and apparatuses including them.- 18 -SG Docket No.: 13668-740.600

[0142] For example, described herein are endoscope tools that may be operated manually and / or robotically. In some cases these tools may include multiple serially-arranged bending regions providing specified degrees of freedom (e.g., directions of bending) and / or may control the actuation of tool to provide multiple controlled degrees of freedom. These tools may be configured for use with an external or internal working channel and may be particularly well suited (though not limited to) use with a nested robotic rigidizing system, as they may permit reliable operation even when outside of the field of view of the endoscope.

[0143] Also described herein are tools that are configured and adapted for use with a driver (e.g., an endoscope tool driver), and particularly a multi-axis endoscope tool driver. The endoscope tool driver may be configured to engage with the proximal end region of the tool that is arranged with control s / actuators for controlling one or more of bending / steering the distal end region of the tool, actuating the distal end effector of the tool, etc. The proximal control s / actuators are typically arranged in series along the distal end region and may be independently actuated (e.g., by moving in / out, rotating, etc.). Any of the endoscope tools described or referenced herein may be adapted for use with the drivers (e.g., muti-axis endoscope tool driver) described.

[0144] Also described herein are tool shields that may be configured for use with any of the tools described herein, including manually operated tools as well as tools adapted for use with a driver such as an endoscope tool driver, including a multi-axis endoscope tool driver.

[0145] FIGS. 1-10, described below, illustrate examples of nested robotic rigidizing systems that may rigidize to form a stable platform within the body (e.g., within a natural or artificial body lumen, vessel, etc.). The endoscope tools and accessories (e.g., shields) described herein may be particularly well adapted for use with these systems but are not limited to such systems.

[0146] The endoscope tools described herein may be traction tools. For example, these tools may be configured to provide 0.2N or more of traction force. The endoscope tools described herein are not limited to traction tubes. Although many of the examples of endoscope tools described herein are shown a graspers (e.g., jaws for grasping and / or manipulating tissue), any of the apparatuses and techniques described herein may be used with and / or adapted for use with any appropriate endoscope device, including clamping endoscope devices (e.g., forceps, graspers, etc.), cutting / dissecting tools (e.g., mechanical cutting, thermal cutting, RF cutting, laser cutting, etc.), needle / suture passers, imaging tools (e.g., optical cameras, electrodes, etc.), etc.

[0147] As mentioned, aspects of the present disclosure may be integrated into a robotically-enabled medical system capable of performing a variety of medical procedures,- 19 -SG Docket No.: 13668-740.600including both minimally invasive procedures - such as laparoscopy - and non-invasive procedures - such as endoscopy. Among endoscopy procedures, the system may be capable of performing colonoscopy, enteroscopy, bronchoscopy, ureteroscopy, gastroscopy, etc.Examples of endoscopes may include, but are not limited to colonoscopes, arthroscopes, bronchoscopes, cystoscopes, hysteroscope, enteroscopes, esophagogastroduodenoscopes, hysteroscopes, neuroendoscopes, sinuscopes, laparoscopes, laryngoscopes, mediastinoscopes, sigmoidoscopes, nasopharyngoscopes, thoracoscopes, ureteroscopes, etc.

[0148] In addition to performing the breadth of procedures, the system may provide additional benefits, such as enhanced imaging and guidance to assist the physician.Additionally, the system may provide the physician with the ability to perform the procedure from an ergonomic position without the need for awkward arm motions and positions. As described in greater detail below, these methods and apparatuses may permit the streamlined control of the tool (through an internal working channel, external working channel, or in free space, without a working channel) from the proximal end region of the tool. Still further, the system may provide the physician with the ability to perform the procedure with improved ease of use such that one or more of the instruments of the system can be controlled by a single user. An apparatus (e.g., a system, devices, etc.) for operating and / or dispensing a robotic scope may be configured extend (distally) and / or retract (proximally) to control operation of the flexible tubular member.

[0149] In general, these apparatuses may be used to deliver a flexible tubular member, including in particular, a nested endoscope that include both an outer “overtube” coupled with an inner endoscope that may be moved proximally / distally relative to each other and may each be rigidized to guide and / or steer the device through the patient’s body. These apparatuses may include a telescoping set of links, and in particular vertically-arranged links. For example, the apparatuses (device, systems, etc.) described herein may be configured as a portion of a robotic system for delivery of a pair of a nested endoscope device, including an inner endoscope and an outer overtube, that are each capable of relatively high and low levels of compliance.

[0150] The apparatuses described herein may have a generally linear form factor and may therefore provide a linear kinematic system for delivery of devices. The primary linear axis that may position the apparatus (e.g., the overtube of the endoscope) into the patient includes a telescoping mechanism formed of a link assembly. The bidirectional telescoping action of this link assembly may allow the relatively long linear axis to be relatively short when its full extension is not needed, which addresses room size limitations in some facilities. In examples including flexible tubular member systems with both inner and outer members, the position - 20 -SG Docket No.: 13668-740.600of the inner endoscope relative to the outer overtube may be controlled by an independent linear axis. Although these apparatuses may be used with virtually any flexible tubular member, they may be particularly helpful when using a nested, and in particular rigidizing, endoscope, such as a dual rigidizing endoscope.

[0151] For example, FIGS. 1 A-1D illustrate one example of a robotic scope configured as a dual rigidizing endoscope. In FIGS. 1A-1D, the dual rigidizing endoscope 100 is configured as a nested system including a rigidizable (e.g., rigidizing) outer member 112 and a rigidizable inner member 110. In FIG. 1A, the steerable inner rigidizing member 110 is positioned within the outer rigidizing member 112 such that the distal end of the inner rigidizing member 110 extends outside of the outer rigidizing member. In some cases the inner rigidizing member may be fully withdrawn and removed from the outer member. In some cases it may be subsequently re-inserted through the outer member, or another inner member may be inserted through the outer member. In some cases the inner rigidizing member 110 may be fully retracted into the outer rigidizing member 112. FIG. IB shows the distal end of the inner rigidizing member 112 is bent slightly in a desired direction / orientation (e.g., via steering cables or other steering mechanism) and then rigidized (e.g., using positive or negative pressure). 112 may also be bent because it was in the flexible state as it followed the curvature of 110, and then was subsequently rigidized. In FIG. 1C, the outer rigidizing member 112 (in the flexible configuration) is advanced over the rigidized inner rigidizing member 110 (including over the bending distal section). Once the distal end of the outer rigidizing member 100 is sufficiently advanced over the distal end of the inner rigidizing member 110, then the outer rigidizing member 112 can be rigidized (e.g., using positive or negative pressure as described herein). In FIG. ID, the inner rigidizing member 110 can then be transitioned to the flexible state (e.g., by removing the positive or negative pressure in some examples, and by allowing the steering cables to go slack such that tip can move easily) and can be advanced and directed / oriented / steered as desired. Alternately, in FIG. ID, the inner rigidizing member 110 can be actively steered (either manually or via computational control) as it emerges such that is minimizes the load on the rigidized outer tube. Minimizing the load on the outer rigidizing member may make it easier for this tube to hold the rigidized shape. Once the inner rigidizing member 110 is rigidized, the outer rigidizing member 112 can be transitioned to the flexible state and advanced thereover. The process can then be repeated to navigate through even more tortious anatomies. However, it may be particularly difficult to coordinate the movement of the inner and outer members, including advancing / retracting and selectively rigidizing either the inner or outer or both, making a robotically controlled system particularly advantageous. The repeated process can result in- 21 -SG Docket No.: 13668-740.600“shape copying,” whereby the inner and outer rigidizing members, while in a flexible configuration, may continuously conform to (or copy) the shape of whichever member is in the rigid configuration.

[0152] The example of a robotic scope shown in FIGS. 1 A-1D illustrate the operation of just one type of medical instrument that may be used with the methods and apparatuses described herein. Furthermore, these apparatuses may be configured so as to function as endoscopes, including one or more of imaging, irrigation, lighting, steering channels for removing or applying materials, etc. For example, the robotic scope 100 may be a “navigation” device comprising a camera, lighting and a distal steering section. The navigation device (scope or portion of a scope) may be well sealed such that it is easy to clean between procedures. In some examples it does not need to be cleaned because it is fully sheathed, including both on the outside and through the working channels. In some examples a second inner device may then be placed inside the rigidized outer member and advanced past the distal end of the outer member. The second inner member may be a “therapeutic” tube comprising such elements as a camera, lights, water, suction and various tools. The “therapeutic” device may not have a steering section or the ability to rigidize, thereby giving additional room in the body of the therapeutic tube for the inclusion of other features, for example, tools for performing therapies. Once in place, the tools on the “therapeutic” tube may be used to perform a therapy in the body, such as, for example, a mucosal resection or dissection in the human GI tract.

[0153] In general, the endoscope tools described herein may be particularly well adapted for use with medical robots including working channels. Working channels may be internal working channel or channels, or an external working channel or channels. For example, FIGS. 2A-2B illustrate an example of a robotic system 1600 including an outer elongate medical device 1646 onto which a plurality of external working channels 1644, 1644’, 1644” have been formed as part of a tube 1603 (e.g., working channel tube). An inner medical device 1645 (e.g., endoscope) is shown inserted through the outer medical device. The tube or shield 1603 is coupled distally to the distal end region of the medical device 1646 and the proximal end is coupled to a proximal end region of the medical device including an introducer region 1616 that provides access into each of the collapsed or partially collapsed external working channels (shown as color coded in this example). In examples including an endoscope 1645 that may visualize the distal end region of the apparatus, the endoscope 1645 may detect when the tool or a liner insert tube 1604 exits by correlating which color and / or marking 1688 indicates where the tool 1607 was inserted or introduced into the working channel. FIG. 2C shows another example of the same system as in FIGS. 2A-2B but with a - 22 -SG Docket No.: 13668-740.600second tool 1607’ inserted into a second channel of the elongate tube. FIG. 2D shows an enlarged view of the distal end region of the robotic system including an outer elongate medical device 1646 (configured as a mother or overtube), an inner elongate medical device 1645 (configured as a child, shown as an endoscope) and a tool 1607, configured as a suction tube. In some examples a liner insert tool may be used (not shown).

[0154] FIG. 2B also illustrates an example of an inner internal working channel 1692 through which any of the tools described herein may be operated. The methods and apparatuses (e.g., tools, drivers, etc.) described herein may be used with an internal working channel and are not limited to external working channels. In FIG. 2B a single internal working channel 1692 is shown. In some case a scope (e.g., endoscope) may include multiple (e.g., two) internal working channels. Any of the tools described herein may be sized and dimensioned for use within an internal working channel of an endoscope.

[0155] The rigidizing devices described herein (including the robotic, nested rigidizing devices as well as rigidizing version of any of the tools described herein) may include an elongate rigidizing body formed of a plurality of different layers; pressure may be applied (either positive and / or negative pressure and / or both positive and negative pressure simultaneously or intermittently) to set the flexibly / rigidity of the elongate body. For example, that elongate body of the rigidizing apparatus may include a support layer (e.g., a cylindrical / tubular support layer that may be reinforced, e.g., by a wire coil or otherwise), a rigidizing layer (which may be formed of multiple lengths of overlapping strands, fibers, filaments, etc., e.g., a knitted, woven, braided, etc. cylindrical layer), and a compression layer (e.g., a bladder layer) that may be compressed by the application of positive and / or negative pressure against the rigidizing layer. In the more flexible configurations of the elongate body, the multiple lengths of strands of the rigidizing layer may slide against each other freely or with little friction. The compression layer may be driven against the lengths of strands of the rigidizing layer to restrict their relative movement (e.g., sliding) which results in an increase stiffness. In general, the greater the pressure applied by the compression layer, which may be function of the applied pressure, the greater the stiffness (e.g., the lower the flexibility) of the rigidizing layer, and therefore the elongate body. Examples of alternative configuration for rigidizing and controlling the stiffness / rigidity are provided below, e.g., in reference to FIGS. 3A-3B, 3C-3D, 5A-5D, 6A-6C, 7A-7C and 8A-8B.

[0156] The rigidizable apparatuses and methods described herein may be part of a medical access system (e.g., robot) for diagnosing and treating regions of the body that are otherwise hard to access and operate within, particularly during minimally or non-invasive procedures. In particular, these methods and apparatuses may be used in highly tortuous - 23 -SG Docket No.: 13668-740.600and / or unsupported regions of the body. These methods and apparatuses may be used in combination with, and / or may modify and improve the rigidizable devices and methods of using them described in U.S. patent no. 11,135,398 (titled “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES”), U.S. patent application no. 17 / 604,203 (also titled “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES”), PCTUS2021024582 (titled “LAYERED WALLS FOR RIGIDIZING DEVICES”), PCTUS2021034292 (titled “RIGIDIZING DEVICES”), PCTUS2022014497, titled “DEVICES AND METHODS TO PREVENT INADVERTENT MOTION OF DYNAMICALLY RIGIDIZING DEVICES,” PCTUS2022019711, titled “CONTROL OF ROBOTIC DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES,” U.S. provisional patent application 63 / 265,934, “METHODS AND APPARATUSES FOR REDUCING CURVATURE OF A COLON,” U.S. provisional patent application 63 / 296,478, titled “RECONFIGURABLE STRUCTURES,”

[0157] U.S. provisional patent application 63 / 308,044, “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES,” U.S. provisional patent application 63 / 324,011, “METHODS AND APPARATUSES FOR NAVIGATING USING A PAIR OF RIGIDIZING DEVICES, U.S. provisional patent application 63 / 342,618, “EXTERNAL WORKING CHANNELS FOR ENDOSCOPIC DEVICES,” U.S. provisional patent application 63 / 335,720, “HYGIENIC DRAPING FOR ROBOTIC ENDOSCOPY,” and U.S. provisional patent application 63 / 332,686, “MANAGING AND MANIPULATING A LONG LENGTH ROBOTIC ENDOSCOPE,” each of which is herein incorporated by reference in its entirety.

[0158] Rigidizing apparatuses as described herein may be configured to rigidize when negative pressure and / or positive pressure is applied. These rigidizing apparatuses as described herein may be used in conjunction with other rigidizing devices that rigidize with other methods, including those that do not rely upon the application of positive or negative pressure. For example, a rigidizing device may be configured to include multiple layers arranged into an elongate catheter-like body. The device may include a handle or other manipulator and may include a connection to one or more pressure sources. Applying pressure from the pressure source may be controlled by multiple methods, including operation of a handle or an electronically controlled device. Control may result in a pressure differential that causes the device to transition between a highly flexible configuration, allowing the tubular body to readily bend, when steered or otherwise guided (e.g., over a guidewire, etc.), and one or more (e.g., a continuum) of rigid configurations. In some examples, particularly (but not exclusively) in reference to apparatuses that rigidize based on the application of positive pressure, the rigidity of the elongate body is proportional to the- 24 -SG Docket No.: 13668-740.600applied pressure differential, so that the greater the pressure differential, the more rigid the device may become over at least a range of pressure differential values.

[0159] In general, these apparatuses may include multiple layers, including a rigidizing layer and at least one of an outer or inner layer. Many of these examples also include a compression layer that may engage with the rigidizing layer, and in some examples the apparatus may include a combined rigidizing layer / compression layer. Described herein are rigidizing layers that may be particularly well suited to rapid and precise actuation over a variety of pressures, including in particular positive pressures (e.g., high positive pressures, i.e., atm of about 2 or more, 4 or more, 6 or more, 8 or more, 10 or more, 15 or more, 20 or more, 30 or more, etc.). Any of these apparatuses may also be configured so that at least some of the inner and / or outer layers making up the rigidizable device have different durometers on the inner and outer portion of either the inner or outer layers. Also described herein are apparatuses and methods including nested sets of rigidizable apparatuses, which may include any of these rigidizable devices. Any of these apparatuses may include one or more torsional enhancing layers for improving torsional control, particularly when included as part of a nested pair of rigidizable devices (e.g., as part of the inner, or child, device).

[0160] FIG. 3 A illustrates an example of a transverse section through an elongate rigidizing device, showing the arrangements of the many layers that may be included. In this example the rigidizable device 100 is configured to be actuated by the application of a negative pressure (e.g., vacuum). The device 100 shown includes an inner layer (115) that may be reinforced (e.g., by including one or more reinforming members, such as a helically arranged strip, ribbon or wire), an optional slip layer (113), a gap (111), a rigidizing layer (109), configured in this example as a braid layer, a second gap (107) and an outer layer (101). In some examples a vacuum may be applied between the outer layer and the inner layer to rigidize. For example, a port configured to couple to the source of negative pressure may be located at the proximal end of the device and may be in fluid communication with the gap region 107 between the flexible outer layer 101 and the rigidizing layer 109, e.g., braided layer. Thus, in this example the outer layer may act as a compression layer. FIG. 3B shows a section through one wall region B of the cylindrical-shaped body of the device. Applying suction may allow the outer layer 101 to be drawn onto the rigidizing layer, causing it to rigidize, limiting or preventing bending of the device.

[0161] Another example of a rigidizable device is shown in FIGS. 3C-3D. In this example the device may also be an elongate, e.g., catheter or tubular-shaped device similar to that in FIGS. 3A-3B but may be rigidized by the application of positive pressure. For example, FIG. 3C shows a section transverse to the long axis of an elongate rigidizable- 25 -SG Docket No.: 13668-740.600device. In this example, the layers forming the device are arranged so that an inner reinforced layer 2115 is the most radially-inward layer and may be reinforced, e.g., by a helically wound ribbon, strip, cable, etc. The device may also include an optional slip layer 2113 which may reduce the friction between the inner layer and the more radially-outward layers. The slip layer may be a powder, or it may be a lubricious layer or a layer of lubricious material. A first gap 2112 layer is shown separating the inner layer 2115 and / or the slip layer 2113 from a compression layer, configured in this example as a bladder layer 2121. A second (or intermediate) gap layer 2111 spaces the bladder layer from the rigi dizing layer 2109, shown in this example as a braid layer. A third gap layer 2107 is positioned between the rigidizing layer and an outer layer 2101. The outer layer in this example (similar to the inner layer 2115) is reinforced, for example, by a helically wound filament, wire, fiber, band, etc. Although not shown, when actuated by the application of positive pressure between the compression (e.g., bladder) layer and the inner layer, the bladder layer may push the braid layer into the outer layer to rigidize the rigidizing layer.

[0162] Both examples of a devices shown in FIGS. 3A-3B and 3C-3D may include additional optional layers or components. Further, the compositions of the rigidizing layers may be modified in order to improve performance. In particular the rigidizing layer may be modified to include structures (e.g., knits, wovens, braids, scales, plates, arrays of filaments, granules, and combinations thereof, etc.) that may enhance or improve performance. Rigidizing elements may be used as one type alone, or in conjunction with other rigidizing elements. In some examples the inner and / or outer layers may be modified to enhance or improve performance, including the addition of torsional control components, and / or modulating the durometer of the inner and outer regions of these layers.

[0163] Further, any of the rigidizable devices described herein may be configured as nested apparatuses that may be nested to provide enhanced performance. For example, a nested apparatus (system) may include an outer rigidizable device (e.g., rigidizing overtube) and an inner rigidizable device (e.g., rigidizing endoscope). The inner rigidizing device (e.g., scope) can be, for example, configured to receive pressure (positive and / or negative pressure) to rigidize from a more flexible to a less flexible configuration. Any of these rigidizing devices may include an air / water channel and a working channel that can extend with the inner rigidizing device.Knit Rigidizing Layers

[0164] In any of the rigidizable devices described herein (and any nested systems or methods including them) may include a rigidizing layer formed of a knit material or knit layer (e.g., knit tube). The knit rigidizing layer, which may be referred to herein equivalently- 26 -SG Docket No.: 13668-740.600as a knit rigidizing layer or a knitted rigidizing layer, may be formed of a single fiber or may be knitted from multiple fibers. The fiber forming the knit may be a yam, a filament, a monofilament, a plurality of filaments, a strand, a thread, a wire, etc. The fiber may be made of a natural or synthetic material, including polymeric materials, metals and metal alloys, and a composite or a combinations thereof. In some cases the knit is formed of a polymeric material. The fiber may be continuous, in which each of the filament lengths forming the rigidizing layer are part of a single fiber, or they may be broken up into multiple filament lengths. For example, the knit material may be single fiber that is broken / cut at regular or irregular lengths.

[0165] FIGS. 5A and 5B illustrate an example of a rigidizable device 500 including a knit rigidizing layer (e.g., tube) 505. In FIG. 5 A the outermost layer (outer layer 515) is removed for clarity; FIG. 5B shows the rigidizable device with the outer layer 515 covering the other layers. This outer layer may be a reinforced outer layer, such as an outer coil-wound tube. In FIG. 5A the rigidizable device includes the knit rigidizing layer 505 extending over the elongate body of the device, including over a compression layer 507 (e.g., bladder) and an inner layer 509. The inner layer and the outer layer 515 may both be reinforced. This example, which is similar to the configuration shown in FIGS. 3C-3D (with the rigidizing layer 2109 configured as a knit layer 505), may be rigidized by the application of positive pressure between the compression layer 507 and the inner layer 509, which may drive the compression layer radially outward against the outer layer 515. Any of the other layers shown in FIGS. 3C-3D may be optionally included, including the gap regions / layer and the optional slip layer (which may not be necessary). This configuration may alternatively be actuated by the application of negative pressure, e.g., between the outer layer and the compression layer (including the region of the knit), which may draw the compression layer against the knit layer by the vacuum, rigidizing the layer.

[0166] A rigidizable device such as that shown in FIGS. 5A-5B may alternatively be configured so that positive pressure is applied between a compression layer (e.g., bladder) and the outer layer 515 (outer reinforced layer). In some examples the compression layer may be positioned between the outer layer and the knit rigidizing layer, so that positive pressure applied between the outer layer and the compression layer may rigidize the knit layer by driving the compression layer against the knit layer into the inner (reinforced) layer. As in the configuration shown in FIGS. 5A-5B, the device may alternatively be actuated by the application of negative pressure, e.g., between the inner layer and the compression layer (including the region of the knit).- 27 -SG Docket No.: 13668-740.600

[0167] Alternatively, the rigidizable device including a knit rigidizing layer may be configured as shown in FIGS. 3A-3B and may be actuated by the application of negative pressure. In some examples the outer layer or the inner layer may be configured to as the compression layer (e.g., bladder) and may engage with the knit rigidizing layer when vacuum is applied. Examples of these alternative arrangements are described in FIGS. 20A-20N, below, and may include a knit rigidizing layer.

[0168] FIG. 5C illustrates one example of a portion of a knit layer 505 formed of a single filament 518 that forms interlocking loops. In the example shown in FIG. 5C the knit includes a plurality of stich loops each having a length, y, and a curved head and foot region having a length x. The stitch pattern shown in FIG. 5C is a weft knit pattern, but other knit patterns may be used. FIG. 5D shows an example of a transverse section through a knit layer positioned adjacent to a compression layer 507. In this example the knit layer is a tube having 28 strand segments that are formed of the same strand into loops (e.g., 14 loops that are arranged with the wale of the knit in parallel with the long axis of the device). The knit tube has a diameter, z, and the spacing between adjacent loops, n, is approximately equal around the circumference of the knit tube. The spacing between the stitch width, p, and the spacing, n, may vary along the length of the knit tube. The dimensions are illustrative only.

[0169] FIGS. 6A-6B illustrate two different examples of knits 600, 600’ that may be used. FIG. 6A shows a weft knit, similar to that shown in FIG. 5C. In this example the knit is formed of one or more strands (which may be continuous or broken / cut), forming stitch loops 602 that each include a head region 604, a pair of legs 606 and a first and second foot 608 where each foot engages with the head of a stitch loop in a course above or below the original stitch loop course. The connection between the feet of adjacent stitch loops may be referred to as the sinker (the sinker may also correspond to a head when the knit is rotated 180 degrees). In FIG. 6A the wale direct 612 extends up / down, and the course 610 extends right to left. Typically, a wale is a column of loops running lengthwise, corresponding to the warp of woven fabric in FIG. 6 A. The course is a crosswise row of loops, corresponding to the filling of the resulting knit.

[0170] FIG. 6B illustrates an example of a warp knit 600’. In this example the warp knit also has a course 610’ and wale 612’ direction but the feet of each loop engage with the head region of a knit loop in a row (in the course direction) that is offset, as shown, forming a pattern of overlap 612 and underlap 614 lengths. The knit rigidizing layers described herein may use any appropriate pattern and may arrange the direction (course or wale direction) relative to the elongate axis (length) of the device. For example, the knit structure (the knit rigidizing layer) may be configured so that a wale direction of the knit extends in a long axis - 28 -SG Docket No.: 13668-740.600of the flexible tube. Alternatively, the knit structure may be configured so that a wale direction of the knit structure is perpendicular to a long axis of the flexible tube. Depending on the stitch length (y) relative to the loop diameter (p) and / or the spacing between loops (n), which may be related, it may be beneficial to arrange the knit rigidizing layer so that that either the wale or the course is arranged in parallel or perpendicular to the long axis of the elongate body of the rigidizable device. In any of the examples described herein, the knit structure may comprise an average loop length that is longer than the loop width. For example, the loop length may be two times or greater (e.g., 3x, 4x, 5x, 6x, 7x, 8x, 9x, lOx, 20x, 40x, 60x, 80x, lOOx or more) than an average loop width. Because knits (including knit tubes) may be stretched and compressed in bending without buckling or wrinkling, they may be particularly useful in the rigidizable devices described herein.

[0171] As shown in FIG. 6C a knit rigidizing layer 600” may be formed of a single knitted fiber 618. As mentioned above the fiber may be formed of a single filament (monofilament) or a bundle of filaments (multi-filament). The pattern shown therefore includes a plurality of lengths of filaments (e.g., an array of filament lengths) that cross each other in the knit pattern. In FIG. 6C the plurality of lengths of filaments that cross over and under each other are all part of the same fiber or strand. In some examples the knitted fiber or strand may be cut or divided into multiple separate filament lengths. The knit material (e.g., the fiber) may be formed of any appropriate material, such as a metal, metal alloy, polymeric material, natural fiber, etc.Woven and Braided Rigidizing Layers

[0172] In any of the rigidizable devices described herein (and any nested systems or methods including them) may include a rigidizing layer that is woven. FIGS. 7A-7C illustrate an example of a woven a rigidizing layer 705 that may be used as the rigidizing layer of the rigidizable device and may be arranged as shown in FIGS. 3A-3B, 3C-3D or 20A-20N. In FIG. 7A the weave includes a plurality of parallel fibers that form a set of intersecting fibers; in FIG. 7A the fibers intersect with each other at 90 degree angles, but this angle may vary (e.g., between about 30 degrees and 150 degrees, 45 degrees and 135 degrees, 50 degrees and 130 degrees, 70 degrees and 110 degrees, 80 degrees and 100 degrees, etc.). The pattern of intersecting filament lengths (e.g., the array of filament lengths) includes individual filament lengths that cross over and under each other as shown; a first filament length 718 crosses over a second filament length 728 and under a third filament length 725. In this example, the pattern shown in an under-over pattern, but this pattern may be different for other examples of rigidizing layers; in FIG. 7A the pattern is one over, one under. In some examples the pattern may be two over two under, or two over and one under, etc. Any appropriate fiber- 29 -SG Docket No.: 13668-740.600(e.g., strand) may be used to form the rigidizing layer, a mentioned for knit rigidizing layers above. In the woven rigidizing layer shown in FIG. 7A the fiber is a muti-filament fiber including a bundle of multiple filaments forming each strand. FIG. 7B shows an example of a woven rigidizing layer 705’ formed of a monofilament, also arranged with parallel strands 718’, 728’ arranged in a woven pattern similar to that shown in FIG. 7 A. The woven pattern may be any desired tightness (e.g., pore size). In general, as shown in FIG. 7C, multiple different lengths of fibers 718”, 728” are used to form the woven pattern 705”.

[0173] FIGS. 8A and 8B illustrate examples of braided rigidizing layers. In FIG. 8A. In FIG. 8 A the braid 800 is formed of a plurality of fibers 818, 828 that are arranged in an over- and-under pattern having a braid angle relative to the long axis (e.g., the long axis of the device when included as the rigidizing layer). In general, the braid angle (relative to the centerline along the central axis) of the braided rigidizing layer (tube) may be 45 degrees or less (e.g. less than 45 degrees, 40 degrees or less, less than 40 degrees, 35 degrees or less, less than 35 degrees, 30 degrees or less, 20 degrees or less, less than 20 degrees, etc. In FIG. 8 A the different filaments forming the braid layer are continuous and unbroken. However in some examples it may be beneficial to include breaks or cuts, as illustrated in FIG. 8B. In this example, the material includes a plurality of breaks or cuts 838 in the braided strands.Although such an arrangement may be undesirable in a fabric or even in a braid used as part of a medical device, this disrupted (e.g., broken or cut) arrangement may be beneficial in the context of a rigidizing layer. Thus, in FIG. 8B the braided pattern 800’ forming the rigidizing layer (e.g., rigidizing tube) may enhance flexibility in the un-rigidized configuration, while permitting a high degree of rigidizing in the actuated state. Thus, in FIG. 8 the strands 818, 828’ cross over and under each other in the braid pattern shown but are cut 838 periodically along their lengths. The number or density of the cuts may be varied; in some examples the fibers may be cut after every crossing over or under another fiber, while in other examples the fibers may be cut after every 2 (or 3, or 4, or 5, or more) crossings. The cut pattern may be non-uniform. In some examples it may be beneficial to have the cuts or breaks distributed at a density of between about one cut / break for every third crossing, etc. (e.g., between every second and every 25thcrossing, every third and every 20thcrossing, etc.).

[0174] Other rigidizing layers (e.g., knit, woven, etc.) may also include breaks or cuts. These breaks or cuts may be formed during fabrication by laser cutting, mechanical cutting, or any other appropriate cutting technique.- 30 -SG Docket No.: 13668-740.600Pressure-driven Rigidization

[0175] As mentioned above, in general, these apparatuses may be configured to be rigidized by the application of pressure. This is illustrated schematically in FIGS. 3A-3D and 4A-4B for a generic rigidizing layer. In this example the device is shown in longitudinal cross-section through a portion of the length of the device. The layers forming the device are arranged as concentric tubes. In FIG. 4A the device is shown without the application of pressure, and includes an inner layer (tube) 954, an outer layer (tube) 948 and a compression layer (e.g., bladder) 950 and a rigidizing layer 952. The particular configuration shown illustrates the rigidizing layer 952 between the inner layer 954 and the compression layer 950. A first gap layer 956 is present between the outer layer 948 and the rigidizing layer 952. A port (not shown) may be present at an end (e.g., a proximal end region) of the device to couple to the source of pressure (e.g., positive pressure). A second gap layer may be present between the compression layer 950 and the rigidizing layer 952, and / or between the rigidizing layer 952 and the inner layer 954. In the configuration shown in FIG. 4A the device may be flexible as each of these layers may slide relative to each other when bending the device. In particular, the rigidizing layer may flex and slide relative to the inner layer 954 and the compression layer 950.

[0176] FIG. 4B illustrates the device of FIG. 4A when positive pressure 960 is applied between the outer layer 948 and the compression layer 950. Alternatively the compression layer may be a bladder into which the positive pressure is applied. In FIG. 4B, as positive pressure is applied the compression layer 950 is driven 961 against the rigidizing layer 952, so that is compressed between the compression layer 950 and the inner layer 954 (and / or any intervening layers). Compressing the rigidizing layer 952 rigidizes the device. Any bends or curves are preserved without changing the shape.

[0177] In the example shown in FIGS. 4A and 4B, any appropriate rigidizing layer 952 may be used, including knit compression layers, woven, braided, granules, scales, etc.

[0178] In some examples, particularly those having elastic (e.g., elastomeric) compression layers and rigidizing layers formed of filament lengths that cross over and under each other, the compression layer may deform into the rigidizing layer, which may enhance the rigidity of the device. For example, as pressure is applied, the compression layer (e.g., bladder) may apply force directly to the rigidizing layer. Depending on the bladder type, the bladder may deform, depress, or interdigitate into the space around and between the elements (e.g., filaments, wires, etc.) of the rigidizing layer. Conforming to the overlapping (over-and- under) fiber or filament lengths may help lock the rigidizing layer relative to the inner layer (or in some examples outer layer) to which it is being compressed. The application of positive - 31 -SG Docket No.: 13668-740.600pressure in this manner may therefore increase rigidization as positive pressure is increased even beyond what is otherwise expected. Thus a rigidizing layer comprising a plurality of filament lengths crossing over and under each may be generally configured so that, in the flexible configuration, the filament (e.g., fiber) lengths may shear relative to each other. However, when positive pressure is applied, the deformable compression layer may be pushed against the rigidizing layer so that the compression layer may conform to or deform into or between the plurality of filament lengths to prevent shear of the plurality of filament lengths relative to each other.Robotic apparatuses

[0179] As mentioned above, any of the methods and apparatuses described herein may be part of a robotic method / system. For example, the rigidizing apparatuses (e.g., rigidizing overtube) described herein may be configured as part of a robotic system or for use with robotic apparatuses. In some cases the other components (e.g., steerable redirector, endoscope, etc.) may also or alternatively be part of the robotic system and the movements of these components may also be robotically controlled and / or implemented. Thus, any of these methods may be performed by a robotic apparatus. In some examples the rigidizing apparatus may be configured as an outer tubular member (overtube) that is robotically controlled, e.g., configured as a robotically controlled overtube and / or endoscope assembly. FIG. 9 shows an exemplary apparatus 3100, including a rigidizing device configured as an overtube 3112; the system may optionally include the steerable redirector 3110. The overtube and steerable redirector can be separately or collectively be robotically controlled or manipulated (e.g., steering, movement, rotation, etc. including in some examples, rigidizing). The overtube and inner endoscope may be configured as illustrated in any of the examples described above, and may have the same general construction, or may be of different constructions. As shown in FIG. 9, the rigidizing overtube 3112 and the steerable redirector 3110 may be terminated together into a common structure, such as a cassette 3157, or two separate cassettes may be used. In some cases a single controller may coordinate movement of the one or more cassettes. The rigidizing overtube 3100 can be movable with respect to the steerable redirector 3110 by rotation of a driver mounted to the cassette 3157. The system may include actuators 3171a, 3171b that may connect to cables 3163a, b respectively, to steer (e.g., bend or deflect) the steerable region of the steerable redirector 3110 (and / or in some examples the rigidizing overtube 3112). Other steering mechanisms (e.g., pneumatics, hydraulics, shape memory alloys, EAP (electro-active polymers), or motors) are also possible. The cassette 3157 can further include bellows 3103a, 3103b that may connect to the pressure inlet of the rigidizing overtube 3112, to drive fluid through pressure lines 3105z, in some variations for- 32 -SG Docket No.: 13668-740.600rigi dizing the overtube. As shown in this example, the cassette 3157 can include eccentric cams 3174a, b to control bellows 3103a, b. Alternatively, one or more linear actuators can be configured to actuate the bellows. As another alternative, the rigidizing overtube (and / or in some examples the steerable redirector) can be rigidized and de-rigidized through one or more pumps or pressure sources (e.g., via pressure line 3105z).Endoscope tools

[0180] The apparatuses and methods described herein may be used with any appropriate endoscope tools, and in particular elongate including endoscope tools configured for inserting through a working channel of an endoscope and / or through an external working channel such as those described above in FIGS. 2A-2B. These endoscope tools may include a flexible, or in some cases rigidizing, elongate body having a distal end and a proximal end. The distal end may include a distal end effector that may be configured to manipulate and / or sense one or more properties of the tissue. The tools may be referred to by their distal end effector. For example, the tools described herein may include distal end effectors comprising graspers, lariats, or clamps (e.g., traction tools) having one or two movable jaws, fixation tools (e.g., suture passers, staplers, etc.), sensing tools (e.g., optical sensors, thermal sensors, ultrasound sensors, electrical sensors), cutters (e.g., mechanical cutters / blades, electro surgical cutters, thermal cutters, etc.), thermal applicators (e.g., electrocautery applicator, cryoapplicator, etc.), suction applicators, irrigators, etc.

[0181] In some cases these tools may be steerable in one or more directions (e.g. planes). For example, the distal end region of the endoscope tools described herein may be configured to be bent or curved (steered) by pulling and / or pushing a wire, tendon, cable, or the like. Multiple steerable regions, which may be arranged in tandem along the distal end region and may have different maximum bending angles may be used.

[0182] The proximal ends of any of the tools described herein may be adapted to engage with a tool driver (e.g., an endoscope tool driver, as shown in FIGS. 43A-43C and 44A-44C, described in detail below, that may interface with the robotic system and permit automatic or semi-automatic control of the tool. In some cases the actuators for actuating the distal end effector may be located on a proximal end region and may be configured for engaging the driver (e.g., endoscope tool driver). Actuating the distal end effector may refer to one or more of operating a mechanical components, delivering energy to drive an electrical or electromechanical output, and / or receiving input (e.g., from one or more sensors). The actuators for steering the tool may also be arranged in series on the proximal end of the device, e.g., in series with each other and in series with the actuator(s) for the distal end- 33 -SG Docket No.: 13668-740.600effectors. The tools described herein may also be configured to be inserted / retracted / actuated by the endoscope tool driver and / or to be rotated (e.g., rolled) by the endoscope tool driver.

[0183] FIGS. 10A-10B show one example of an endoscope tool. In some cases, this tool may be adapted for use with a driver that may be incorporated as part of a robotic system described herein or may be configured for manual operation. The example tool shown in FIG. 10A is configured as a grasper tool for including a distal pair of jaw 1045 and a distal end region 1008 that is configured to bend when actuate by a tendon / pull wire. The tools shown in FIG. 10A has six degrees of freedom (DOF), including axial insertion / retraction 1006, rotation 1004, bending at the distal end in vertical plane, movement of the grasping jaw, and flexion in two additional planes. The flexible distal end region may be formed, for example, by a laser cut hypotube that may be actuated by a Bowden cable. A section (B-B’) through the proximal end region of the tool is shown in FIG. 10B. In this example the section shows an outer tool body surrounding a plurality of coil pipes 1016 surrounding cables (e.g., push- pull cables 1018, tendons 1020 to bend the body in a first or second plane) surrounded by the tool body 1022. The dimensions shown are not intended to be limiting but are mere examples. Other dimensions may be used.

[0184] FIG. 11 schematically illustrates another example of a tool 1100 that may be used with any of these apparatuses. In FIG. 11, the tool includes a tool body 1011, a proximal tool segment 1009, a distal tool segment 1008 and an end effector 1045 (which is shown in this example as a forceps or pair of jaws). Other end effectors may be used, including loops / lariats, electrosurgical / electrocautery element, aspirator, etc. As mentioned, virtually any tool effector may be used. Each of the segments is separated by a region configured to flex (“body flex interface” 1013 and proximal -distal flex interface 1015) to allow the tool to bend in a predictable and limited manner.

[0185] FIG 12 shows another example of a tool 1200 similar to that shown in FIG. 11 that also include an end effector comprising a pair of grasping jaws 1245. In this example the tool include a body formed of a laser-cut hypotube 1212 (e.g., spiral cut), a proximal region 1209 comprising pairs of interlocking pivoting links (bending in two planes) and a distal region 1208 formed of interlocking members that allow bending in one plane. The device may include one or more cables actuating bending (not shown) in the various planes as well as actuating the end effector (e.g., grasper in FIG. 12). The cables / tendons may couple to the distal ends at a termination region 1214 of the first 1209 and a termination region 1215 of the second 1208 bending sections . In some examples the distal actuator may be retractable into the distal end of the tool and extended for use.- 34 -SG Docket No.: 13668-740.600

[0186] FIGS. 13A-13C illustrate one example of a distal end effector 1345 for a tool. In this example the tool shown is a pair of graspers (jaws) that extend distally from the elongate body of the tool. In some examples he tool distal end may be independently rotatable relative to the elongate body of the tool. Alternatively or additionally, the entire tool shaft may be sufficiently torqueable to allow rotation during use. The different connecting regions, e.g., between the end effector and distal end region 1330, between the distal end region and the proximal end region 1331, etc. may be reinforced or in some cases may be flexible. For example, FIGS. 14A-14C illustrate a joint region and regions to which the tendons may be attached to articulate the tool, The tool 1400 shown in FIG. 14A is similar to that shown in FIGS. 11 and 12, and includes a distal end effector configured as a grasping set of jaws 1445. This example has two bending regions that may be articulated by internal tendons / cables. In FIG. 14A the proximal bending region may extend 1460 from the flexible elongate body within the external working channel. FIG. 14B shows a reinforced region to which one or more tendons may be attached. FIG. 14C shows the joint region 1433 between the proximal end of the tool shaft and the intermediate region of the distal end region of one example of a tool. FIGS. 15A and 15B show the region 1433 between the intermediate region and the distal end region of the tool shaft, which may also be reinforced, and may attach to a pair of pull wires for articulating the region proximal to this joint.

[0187] In general, the tools described herein may be inserted through a robotic apparatus that includes an inner working channel or an outer tool channel, in which the robotic apparatus includes a nested pair of rigidizing devices, as described above. Thus these tools may be adapted for use with an eternal (and in some cases expandable) working channel. FIG. 16A shows the tool 1600 exiting an external working channel 1603 having an adapter 1605 to hold the working channel open at the distal end of the device.

[0188] One particular challenge for these tools is the nested nature of the robotic system, particularly when the tool is riding on the outside of the of the rigidizing device (e.g., the rigidizing overtube and / or endoscope) since the inner member, often an endoscope, may be independently extendable and retractable relative to the outer (e.g., overtube). In addition, the inner and outer member may transition between rigid and relaxed configurations, which may make it difficult to navigate the tool and to visualize the tool. The methods and apparatuses described herein may take advantage of the rigidizing nature of the overtube / endoscope in order to leverage support, particularly as the tool exits the distal end region.

[0189] For example, FIGS. 16A-16B illustrate the combination of the tool 1601, overtube with an external working channel and adapter at the distal end of the overtube holding the working channel open, as well as in inner endoscope. In this example, the endoscope may not- 35 -SG Docket No.: 13668-740.600be able to visualize the tool as it exits the endoscope, but the tool may be steered so that it may operate within the field of view of the endoscope, shown in FIG. 16C.

[0190] FIG. 17 illustrates an example of a system including a nested pair of rigi dizing tools 1704 (overtube and inner rigi dizing endoscope) with an external working channel on the overtube and a proximal robotic subsystem driving the nested overtube / endoscope. The proximal subsystem also include a tool driver 1760 that may operate (e.g., advance / withdraw) the tool as part of the system controls (e.g., robotic controls). The tool shown in FIG. 17 is also an example of a grasper having a pair of movable jaws 1645.

[0191] In any of these tools, the external working channel may include or may be used with a shield and / or liner. For example a tool liner may be attached to the ends of the overtube and driver (e.g., tool chassis) This may reduce hysteresis in the system and help ensure that the axial motion is transmitted down the overtube. In some cases the liner may be formed of a hypotube. The hypotube may include spiral cuts to permit easy bending but may prevent collapse of the external working channel from applying too much drag on the tool.

[0192] FIGS. 18 and 19 shows an example of a driver 1880 for driving operation of a specifically adapted tool 1900. The tool may be inserted through the external working channel of the robotic device, as shown, and the posterior end of the tool can be inserted into the driver apparatus. In this example the driver includes a plurality of tendon controls for holding and manipulating the push / pull cables (tendons) to steer the tool and / or to operate the end effector. Driver also includes a sled portion that moves forward (distal) and backwards (proximal) for insertion / withdrawal of the tool relative to the robot.

[0193] In some examples the tool may be configured to include one, two, three or more bending sections. The bending sections may have different planes of bending. The different bending sections may be arranged along the longitudinal length, typically but not necessarily at the distal end region. Each bending section may have a different maximum flexion. For example, FIGS. 20A-20D illustrate one example of a tool having two bending sections, a distal-most bending section 2008 and a more proximal bending section 2009, both on the distal end region of the tool. FIG 20A shows the tool in the unbent configuration, which may be ‘relaxed’ (e.g., allowed to freely bend as the nested robotic device bends and moves. In FIG. 20A the end effector (jaws, in this example) is shown closed. FIG. 20B also shows the tool in the unbent configuration, with the end effector (jaws) opened. FIG. 20C shows the tool with the more proximal bending section bent to a maximum flexion (e.g., approximately 150 degrees). In some cases the maximum flexion may be between 80 degrees and 180 degrees (e.g., between 90 degrees and 170 degrees, between 95 degrees and 160 degrees, etc.). FIG. 20D shows the tool with the distal bending section bent to a maximum flexion- 36 -SG Docket No.: 13668-740.600(e.g., approximately 105 degrees). In some cases the maximum flexion may be between 60 degrees and 180 degrees (e.g., between 70 degrees and 160 degrees, between 80 degrees and 150 degrees, between 90 degrees and 140 degrees, etc.). In general the distal bending section may have a lower maximum flexion than the proximal bending section. Alternatively, in some cases the proximal bending section may have a lower maximum flexion than the distal bending section. In this example the distal bending section bends in only one plane, and the proximal bending section bends in multiple (e.g., two or more) planes.

[0194] FIG. 21 illustrates an example of a tool 2100 such as the tool shown in FIGS. 20A-20D inserted into an external working channel 2103 of a nested robotic device including an overtube 2128 and an inner endoscope 2129. Both the overtube and the inner endoscope may be rigidizing. The tool is shown extending distally from the overtube distal end, and may extend and be manipulated (steered, etc.) proximal to the distal end of the inner (endoscope) nested member. Alternatively, the tool may be extended distal to the distal end of the endoscope (inner nested member) and may be visualized by the endoscope. In some examples the tool may include a sensor, such as a position sensor (e.g., magnetic position sensor) to indicate where in space the end of the tool is, particularly when it is not within the field of view of the endoscope. In addition, the robotic apparatus may calculate (and display) the relative distal positions of the tool and nested robot and / or surrounding anatomy, as the length of the tool is fixed, and the shape of the tool for the region distal to the overtube may be estimated based on the bending applied to the tool and / or any position / shape sensors on the tool and / or the nested robot.

[0195] Any of the tools described herein may be themselves rigidizing over all or a portion of their length, including rigidizing by the application of pressure (e.g., positive pressure). FIG. 22 schematically illustrates another example of a tool that may be used with a nested robot as described herein that includes a rigidizing proximal shaft region. The rigidizing proximal shaft 2211 region may be rigidizable over the entire proximal length and may have a structure as described above. The distal end region may include one or more bend regions 2213. In FIG. 22 a single bend region is shown (e.g., configured to bend in a single axis). This bend region may be flexible in a relaxed configuration but may be articulated to bend in a single plane. The distal bend region and distal end effector, shown as a pair of jaws in FIG. 22, may be non-rigidizing. Any end effector may be used.

[0196] FIGS. 23 A-23D illustrate an example of the use of a rigidizing tool similar to that shown in FIG. 22 with a nested rigidizing robot including an overtube 2328 (OT) with an external working channel 2323 (EWT) and an inner endoscope 2329 (scope). Both the overtube and endoscope may be rigidizing. In FIG. 23 A the nested robot may be navigated to - 37 -SG Docket No.: 13668-740.600the treatment site, using a combination of steering the distal end region of the endoscope and using shape copying. For example, the overtube may be held rigid while the endoscope is flexible, advanced and steered, then the endoscope may be rigidized and the overtube de- rigidized and advanced over the endoscope. The overtube may then be rigidized, copying the shape, and allowing the process to be repeated by the endoscope. Advancing the overtube may also potion the external working channel near the treatment site, as shown in FIG. 23B. The tool may then be inserted through the external working channel (in this case, with a liner) and extended distally out of the external working channel, as shown in FIG. 23C. Int this example the tool (e.g., the rigi dizing proximal end 2311) may be rigidized to provide stability and leverage for the distal end region 2313 and distal effector regardless of the longitudinal position of the overtube and / or endoscope.

[0197] FIGS. 24A-24D illustrate another example of the use of a rigi dizing tool. In general, the rigidizing tool 2463 may copy the shape of the robot once it rigidizes. The tool may therefore hold the shape once rigidized, even as the nested robot is withdrawn proximally. For example, in FIG. 24A the robot is advanced to a lesion site, in this case by steering the endoscope, rigidizing, then advancing the overtube 2428 over the rigid endoscope 2429 to position the external working channel (and therefore the tool) near the lesion, as shown in FIG. 24B and 24C. The tool may be rigidized and the de-rigidized robot may then be withdrawn proximally, allowing broader visualization by the endoscope, which can be moved over the set shape of the tool to adjust the field of view and / or the application of material / removal of material through the internal working channels of the endoscope, as shown in FIG. 24D. In some examples the tool may be rigidized, and the articulation section (the bending distal end region) may be adjacent to the endoscope tip and positioned within the field of view; the overtube may be retracted over the rigid tool, leaving the tool adjacent to the endoscope tip, which may be manipulated to control the end effector and treat tissue.

[0198] In general, the tools described herein may be used as part of a procedure. FIG. 25 schematically illustrates one example of a method of operating a tool with a rigidizing, nested robot. In FIG. 22 the example shown in for treating a polyp, e.g., as part of a colonoscopy procedure. In this example, the overtube may be positioned relative to the endoscope and the tool may be advanced through the working channel (e.g., external working channel) until it reaches the end of the tube. The tool may then be advanced beyond the overtube until it enters the field of view of the camera on the endoscope, and the tool may then be controlled and moved to a position where it can reach the polyp; the nested robot (e.g., the overtube) may be rigidized to improve access and stability for the tool, particularly as it extends distal to the endoscope. In some cases the tool may be coupled to both the overtube and the- 38 -SG Docket No.: 13668-740.600endoscope; in some cases the tool may be coupled just to the overtube (e.g., through the external working channel). Once in position, the tool may engage with the tissue (e.g. polyp), including applying force (e.g., to grasp, cut, etc.) the tissue. The tool may be manipulated, and in some cases may release the tissue prior to removal of the tool. Finally, the tool may be retracted from the visual field and ultimately back into the external working channel.

[0199] FIGS. 26A-26C illustrate an example of an apparatus in which the tool 2600 is coupled to both the outer nested member (e.g. overtube 2623) via an external working channel 2628 and the internal nested member (e.g., endoscope 2629). In this example the endoscope is adapted to include an engager (e.g., a tool engagement member shown as a loop 2691 in FIGS. 26A-26C) for contacting and assisting in steering the tool. The tool may be advanced or retracted relative to the endoscope, but the engager on the endoscope helps direct the tool into the field of view of the endoscope, which may be steered to the tissue to be treated, as shown in FIG. 26C. Thus, the tool may “piggyback” onto the inner nested member (endoscope) as shown. In some cases the tool may decouple from the inner nested member, e.g., by withdrawing from the engager, allowing it to be moved and / or manipulated independently of the endoscope. The engager shown in FIGS. 26A-26C is a loop, which may be expanded or contracted, e.g. from the proximal end of the robotic apparatus.

[0200] FIGS. 27A-27C illustrate another example of an apparatus in which the tool 2700 may be assisted in positioning by an engager 2723 on the endoscope 2729. In this case the engager is an inflatable / deflateable balloon that may be used to adjust the relative position and / or support the tool distal end region. Other engagers may be used, including magnetic engagers 2891 (as shown in FIG. 28). The system also includes an overtube 2723 and external working channel 2728.

[0201] FIGS. 29-29C illustrate another example of a tool 2900 including a rigi dizing elongate body. In this example the tool may be selectively coupled and de-coupled from the endoscope 2929 (e.g., using an engager as discussed above). Thus, with the tool engaged to the endoscope, the endoscope may be steered and manipulated to position the tool; once in place, as shown in FIG. 29A, the tool may be rigidized, as shown in FIG. 29B, and decoupled from the engager and therefor the endoscope. As mentioned, an engager may be mechanical (e.g., a loop, clamp, clasp, etc.), inflatable (balloon), magnetic / electromagnetic, etc. Once decoupled from the endoscope, the endoscope may be moved, leaving the tool in position and stabilized by its rigid proximal end, so that it can manipulate the tissue while the endoscope is free to move relative to the tool.

[0202] In some cases the tool 3000 may be configured to have multiple degrees of freedom, as shown in FIG. 30. In this case the tool has a three DOF region proximal to the - 39 -SG Docket No.: 13668-740.600distal-most steerable region, and the distal-most steerable region may have a single plane DOF, as shown. The tool may also be rotated (e.g., torqued). FIGS. 31A-31B illustrate one method for operating a tool similar to that shown in FIG. 30. As described above for the rigidizing tool, in some cases the tool may be selectively coupled / decoupled from the inner rigidizing member (e.g., endoscope 3123) of the nested robot. For example, in FIG. 31 A the tool is coupled with the endoscope and positioned so that the distal end effector (shown as graspers in this example) may interact with the tissue. The tool may then be decoupled from the endoscope, as shown in FIG. 3 IB, and the distal end of the endoscope moved independently of the tool. In some cases this may allow for a steeper approach for the endoscope relative to the tissue, which may improve access and visualization.

[0203] In any of these apparatuses the tool may also be a nested apparatus. For example, also described herein are tools that include a rigidizing outer tube 3298 and an articulating inner tube. In this example, shown in FIGS. 32A-32C, the tool 3200 includes an inner member 3299 that is axially moved relative to the inner, steerable (at least at its distal end region) tube to which the end effector is coupled. The inner and outer tubes forming the tool may be moved together, as shown in FIG. 32A, allowing positioning of the tool. With the outer tube of the tool in the flexible configuration the tool may be steered by steering the inner tube of the tool. Once in position near the tissue to be treated, the outer tube may be rigidized, as shown in FIG. 32B, and the inner tube advanced distally to engage with the tissue; the inner tube of the tool may be steered independently of the rigid outer tube. The entire tool (inner and outer tubes) may be manipulated, e.g., to rotate or move the tool, as shown in FIG. 32C. In examples such as that shown in FIGS. 32A-32C, the end effector (jaws of the grasper) may apply traction to the tissue while supported by the rigid outer tube of the tool.

[0204] In any of these apparatuses and methods the tool may be configured to be aligned with the endoscope and / or overtube. In particular, the tool may be configured to maintain an alignment (e.g., rotational position) relative to the endoscope; in some cases the tool may be configured to indicate, by optical, audible, haptic or other output. For example, the tool may be engaged with the overtube and / or endoscope to indicate and / or maintain the rotational position of the tool in a known configuration with the endoscope. For example, FIG. 33 shows a tool 3300 having a three DOF articulation section 3397 that matches the endoscope 3323 shape. The distal portion of the tool may be configured to bend in a plane, which may be preferably a vertical plane relative to the endoscope. For example, the tool may be configured to held so that this distal-most bending region is arranged relative to the endoscope (or ‘click’ or lock into this position) so that the distal bending is in the vertical - 40 -SG Docket No.: 13668-740.600plane, as shown. This may provide a highly predictable movement for the tool, even when it is out of the field of view of the endoscope.

[0205] Any of these apparatuses may be configured so that movements of the tool may be compounded together to enhance ease of use. For example, actuating the end effector may also adjust the bend angle and / or longitudinal position of the tool. FIGS. 34A-34C illustrate an example in which actuating the end effector, shown as a set of grasping jaws 3445 in this example, and moving the distal end region “up” (e.g., pulling away from the tissue once the tissue is grasped) are compound movements. In FIG. 34A the tool 3400 is positioned near the tissue so that the end effector can grasp the tissue. Once in position (which may be seen by the endoscope), the tool is actuated so that the end effector is activated, shown in FIG. 34B, grasping the tissue; after the tool has actuated (e.g. once the graspers are closed onto the tissue) the distal end region may be moved vertically, away from the tissue, pulling the tissue taut, as shown in FIG. 34C. These two motions may occur sequentially.

[0206] As mentioned above, in some cases the end effector may be rotatable relative to the elongate body of the tool, this may allow rotation of the end effector elements (e.g., jaws, loop, etc.), independent of the rotational position of the body, which may be advantageous for positioning the end effector relative to the tissue.

[0207] In some cases the tool may include two bending regions that are positioned in series, in which both bending regions may move in two or more planes. This is shown in FIGS. 35A (showing a side view of the tool 3500) and 35B (showing a top view of the tool 3500). In this example the tool may be more maneuverable in operation.

[0208] In some cases the tool may be a nested inner and outer tubular members that are both steerable, as shown in FIG. 36. In FIG. 36 the inner and outer tubes forming the tool 3600 are nested and longitudinally movable and both the inner and outer tubes are steerable at their distal ends in one or more directions. For example, both the inner and outer tubes may have three DOF articulate distal sections and a distal end effector (shown as a grasper 3645 in FIG. 36).

[0209] As discussed above in relation to FIGS. 34A-34C, the tool may be configured for compound action of the end effector and the articulation or movement of the tool body. This compound action may be programed (by software or firmware) and / or it may be part of the hardware for the tool, as illustrated in FIGS. 37A-37B. In this example the sequence of actuation of the end effector (e.g., in some cases opening / closing the jaws when the end effector is a grasper) may be coordinated with the bending of the distal end region of the tool. In FIG. 37A the grasper is opened and the tool may be rotated. In FIG. 37B the grasper is closed and can be bent.- 41 -SG Docket No.: 13668-740.600Drivers

[0210] Also described herein are drivers that may assist the user in controlling the operation of a tool. These drivers may be referred to as endoscope tool drivers as they may control the tool (auxiliary) axis associated with the robotic device, including the endoscope. FIGS. 38A-38B show an example of a driver that may be used with some of the tools described above, including multiple cable drivers for steering the distal end region of the tool. The driver may interface with the distal end of the tool to engage with one or more cables within the tools and provide steering. This is illustrated in FIGS. 39A-39B. In this example the tool is passed through a shield and through the external working channel on the overtube. The proximal end of the tube is coupled to the driver which may interface with the push / pull cables steering the device. FIG. 39B shows an alternative example of a driver. In both cases the driver also includes a sliding stage for inserting / withdrawing the tool into / out of the external working channel. The proximal end region of the tool may be stiffer than the more distal regions to more easily insert / withdraw the tool.

[0211] In some examples the driver may be a single axis endoscope tool driver in which the driver is configured for advancing / retracing the tool. In some cases actuation of the end effector may be separately (and / or manually) controlled. In some cases steering and / or roll of all or a part of the tool may be separately and / or manually controlled. Also described herein are multi-axis endoscope tool drivers that may have two or more (e.g., two, three, four, five, etc.) axes. These methods and apparatuses may use one or more semi -custom tools with the endoscope tool driver. In any of these cases, the tool may engage at its proximal end region with the driver to control insertion and removal (e.g. longitudinal movement). Additional axes may be used so that actuators on the proximal end can create other motions, such as operation of a distal end effector. For example, FIGS. 40A-40B schematically illustrate an example of a single-axis endoscope tool driver 4000, that includes a track 4060 onto which the movable base 4005 may be advanced / retracted in a linear motion 4035. In this example the track show is long; shorter tracks may be used. As shown in FIG. 40B, a tool 4001 may engage with a tool receiver (e.g. seating region) 4015 on the sliding / moving movable base 4005. The receiver 1015 may include an endoscope tool driver securement (e.g., lid, clamp, holder, lock, etc.) that may hold the tool fixed to the base so that movement of the base is translated into movement of the tool, in Some examples the receiver may also engage with an actuator to actuate the end effector. For example, the receiver may include an actuator the engages with a cable (e.g., wire, push / pull tendon, etc.) to pull / push the cable to actuate the end effector. The actuator may be specific to the end effector, e.g., an electrosurgical end effector may couple to a source of electrical energy, etc.- 42 -SG Docket No.: 13668-740.600

[0212] The driver (e.g., endoscope tool driver) may be mounted to or integrate with the robotic driver, including a telescoping robotic driver, as shown in FIG. 40C, including a link assembly 301, for positioning the nest rigidizing robot. In this example, the vertically arranged link assembly 301 includes a first link 305 (e.g., outer link), a second link 307 (e.g., middle link) and a third link 309 (e.g., inner link) that are vertically arranged relative to each other and are separated by shuttles (e.g., first shuttle 319 and second shuttle 318), that may be coupled with one or more bands and / or belts to permit them to coordinate extending and retracting. The first link 305 may be coupled with a base (directly or indirectly) of the positioning apparatus, and the third link 309 may be coupled with a mount assembly (including one or more mounts). The tool driver 4000 may be positioned on or integrated with the tool second mount 331, as shown in FIG. 40C.

[0213] In general, the tool drivers described herein may be used with off-the-shelf tools directly, without requiring modification. For example, single-axis endoscope tool driver 4000 may engage with a proximal end region of a tool (e.g., may lock over and frictionally engage the outer surface of the tool) and may control insertion / withdrawal of the tool in a precisely controlled manner. Thus, the endoscope tool driver may include a friction clamp for securing onto a device shaft. As described in detail below, other driver apparatuses, including in particular, multi-axis endoscope tool drivers, may be customized to engage with one or more interfaces created on the proximal end regions of the tools that may interface with the robot and / or with the multi-axis endoscope tool driver. Thus, the apparatus may advantageously be used with a large number of tools both custom and non-custom.

[0214] The link assembly 301 includes a mount assembly including a first mount 323 (e.g., overtube mount) and a separately actuating second mount 333 (e.g., inner tube mount).

[0215] The mounts 323, 333 of the mount assembly are configured to operate together, to provide relative motion between the first and second mounts. The mounts may be directly or indirectly coupled together. For example, both the first mount 323 and the second mount 333 forming the mount assembly are coupled with the third link 309 (e.g., inner link). The first mount 323, e.g., for the overtube, may be rigidly (e.g., fixedly) coupled with the third link 309. The first mount 323 may include an overtube driver (e.g., overtube roll motor) to drive roll of the overtube in the clockwise and / or counterclockwise direction. The second mount 333 (e.g., for the inner tube) is proximal to the first mount 323 and is configured to moved distally / proximally along an endoscope inserting track. In some examples, the track includes a slot within the side of the third link 309. In some examples, the track includes a bracket (e.g., that is part of or coupled to) the side of the link 309. As mentioned, the second mount- 43 -SG Docket No.: 13668-740.600333 may include the driver (e.g., endoscope tool driver) for operating various aspects of the tool.

[0216] The driver 4000 shown in FIG. 40C is also shown in greater detail in FIGS. 40D and 40E. In any of these apparatuses the driver 4000 may move (e.g., proximally / distally 4035) relative to a base portion of the driver that may be rigidly mounted to the second mount 331 of the robotic driver. In this example the endoscope tool driver 4000 may be configured to have a relatively small axial (e.g., distal to proximal) throw distance, but this distance may be sufficient to actuate the tool, e.g., to insert / withdraw the tool and / or to open / close jaws in a grasper end effector. FIGS. 40D-40E illustrate an example of an endoscope tool driver 4000, similar to that shown in FIG. 40C, that may connect to and control the operation of the tool. In FIG. 40D the driver 4000 includes a driver receiver 4015 the rigidly couples to the proximal end of the tool so that the tool can be advanced proximally and distally by the driver receiver. In some examples the driver may also include an actuator that may engage with a pullwire or other control in the tool to acuate the end effector (not shown). In operation the endoscope tool driver may be secured over the proximal end of the tool, as shown in FIG. 40E, in which a clamshell-like cover (e.g., lid) closes over the tool to secure it to the base 4005. The driver receiver may be configured to secure the tool therein. In some cases the driver receiver may include a material that is configured to engage with the tool’s outer surface, such as a grip region. The grip region may be a low-durometer material (e.g. 70 ShoreA or less, 60 ShoreA, 50 ShoreA, 40 ShoreA, 30 ShoreA, etc.) the grip region may be formed of a polymer. The grip region may be compressible. The grip region may be texturized. In general, the grip region may be configured to hold the outer tubular body of the tool secured within so that the tool does not slide relative to the driver. Any of these apparatuses may include a lock to lock (e.g., releasably lock) the tool within the driver. For example, in FIGS. 40D and 40E the lid includes magnets that may engage when the lid / cover is closed, to secure the tool shaft within the tool. In some variations the tool driver (e.g., endoscope tool driver) may include one or more sensors for sensing when the tool is engaged and / or when the tool is secured by the device. For example, the endoscope tool driver may include a mechanical sensor, a force sensor, optical sensor, a magnetic sensor, etc. In some cases the sensor may detect when the lid is closed (and / or locked). Any of the endoscope tool drivers described herein may be configured to detect or determine position, e.g., position of the endoscope tool driver, which may indicate how inserted / retract the tool and / or deployment state of the end effector of the tool.

[0217] In the example shown in FIGS. 40D-40E, the driver frictionally clamps or engages by means of shear geometry, onto a tool without the need for modifications to the tool.- 44 -SG Docket No.: 13668-740.600Multiple engagement methods could be utilized. In some cases the tool may be configured to include one or more features that engage features on the driver. For example, a tool may include software, hardware and / or firmware (e.g., a readable chip) that may identify the tool, or one or more characteristics of the tool (e.g., tool identity, operating parameters, number of uses, etc.) and / or may uniquely identify the tool and / or confirm it is appropriate for use with the driver and / or scope.

[0218] The endoscope tool driver and / or the second mount 331 may be configured to allow a user to manually access and operate the tool, including in some cases, actuating the end effector on the tool, and / or steering the tool. For example the endoscope tool driver may be positioned on the second mount 331 so that there is room for a user to access one or more controls on the proximal end region of the tool to control other operations that may not be fully controlled by the endoscope tool driver.

[0219] FIG. 40F shows an example of an operator operating a driver to remotely control the operation of a tool using a user interface (e.g., joystick, panel, etc.). Thus, the user may be physically remote from the tool that is inserted through the back of an endoscope. This creates ergonomic, staffing, and workflow advantages. The driver, including the driver control may allow very precise control of the tool, including locking the position and / or orientation of the tool and / or end effector. In FIG. 40F, the endoscope tool driver may be similar to that shown in FIG. 40C and may be remotely controlled via a controller 4080 that may communicate wirelessly or via a wired connection to the endoscope tool driver 4000 in order to advance and / or retract the tool in a linear movement 4035, as shown. The control may include a consolejoystick, keypad, keyboard, foot petal, etc.

[0220] Any of these tool drivers may be configured to control multiple actions of the tool, which may be referred to as multiple axes. For example, described herein are multi -axis tools. The tool driver shown in FIGS. 40A-40B may be operated in a single axis (e.g., moving the tool in / out relative to the nested robotic device (e.g., in / out of the external working channel). In some cases the tool may also include an actuator for actuating the end effector, as described above. The actuator may also be controlled by moving linearly (e.g., in / out) as in a pull / push wire to open / close the jaws of an end effector configured as a grasper. Additional tool controls may include bending / flexing the distal end region of the tool, as described above. In some cases these bending / flexing controls may be configured to be controlled by linear movement of a portion of the tool accessible at the proximal end. Thus, also described herein are multi-axis endoscope tool drivers that may control two or more linear movement controls (actuators) for operating the tool. Any of the endoscope tool drivers described herein may also control rotational position of the tool.- 45 -SG Docket No.: 13668-740.600

[0221] FIGS. 41A-41D illustrate an example of a multi-axis endoscope tool driver 4100 as described herein. In this example the endoscope tool driver includes three sliding bases that each move linearly in / out along a track 4111 to control one or more aspects of the tool. For example, a first base 4105 may include a first receiver 4115 to engage with the elongate body of a tool 4101 (as shown in FIG. 41C), and slide 4135 the entire tool body distal / proximal. A second base 4107 on the same track as the first base may include a second receiver 4117 configured to engage with and actuate a control on tool proximal to the elongate body that may be, e.g., coupled to a pull / push cable for actuating bending of the distal end region of the tool. Linear movement 4137 of the second base may therefore bend / unbend the distal end region. A third base 4109 may be connected to the same track 4111 adjacent to the first and third bases and may include a third receiver 4119 to couple to another control (e.g., push / pull cable) on the tool to actuate the tool. In the example shown in FIGS. 41 A-41D the tool includes a cable for actuating the end effector (e.g., jaws 4145’) to open / close the jaws. Thus, the third base may be moved linearly 4139 to open / close the jaws of the tool in this example.

[0222] The second and third sliding bases may be coupled to the first sliding base so that movement of the first sliding base also moves the second and third sliding base, but the second and third sliding base may be moved independently of the first. The tool driver may also include a roll axis drive (not shown) to roll the tool. In any of these apparatuses the driver may include software, hardware and / or firmware to recognize and / or log the tool. In some cases the tool driver may require verification that the tool is correct (and / or is correctly seated) and is unused, before it may drive the tool. In some cases the driver may include a reader (optical, magnetic, etc.) to confirm the identity of the tool.

[0223] In some cases the tool may include a read-only chip or a read / write chip. The chip may include data related to the tool, including tool operating parameters (e.g., steering axes, tool type, end effector type, throw lengths, etc.), number of uses, identification reference (e.g., alphanumeric identification codes), or the like. In some cases this information may be printed on the tool for reading by the driver and / or robot (e.g., without requiring the use of a ‘chip’). In some cases the chip may be a read / write chip onto which parameters, error codes, uses (duration of use, number of use, etc.) may be stored for subsequent reference. Thus, any of the drivers described herein may be configured to read data (and optionally in some variations, record data) from a tool (and optionally back onto the tool).

[0224] In general, these tool divers may include one or more motors to drive movements, and one or more processors to control operation of the driver. The processor(s) may receive input from the robotic system to coordinate movement of the robot with operation of the tool.- 46 -SG Docket No.: 13668-740.600The same controller used for operating the robot may be used with the driver for the tool. The tool driver may be configured for remote operation (e.g., telemetry) and / or for local operation.

[0225] An of these tool drivers may be configured to clutch (e.g., to stay firmly in one spot), and to provide precise motion control. The user may set motion control parameters, for example, driving motion of x (e.g., scaling factor) for a given input (e.g., O.Olx, O.lx, 0.5x, lx, 1.5x, 2x, 5x, lOx, lOOx, etc.). The system may be configured to remember user preferences, including for specific types of tools being used. In any of these cases the tool driver may be configured to include one or more sensors. Sensor may sense the operation of the tool and / or for sensing one or more parameters in contact with the tool (e.g., conductance, impedance, temperature, force, etc.).

[0226] The endoscope tool driver apparatuses described herein may be side loaded by the tool (e.g., rather than inserting from a proximal end and / or a distal end). This is shown in FIGS. 40A-40F for a single-axis endoscope tool driver. Multi-axis endoscope tool driver devices may also be configured for side loading. For example FIGS. 49-58 show examples of endoscope tool drivers that may be side loaded and may control operation of one or more axes (e.g., multi-axis endoscope tool driver). FIG. 49A shows the distal end with an example of an end effector (shown as a jaw in this example). FIGS. 49B-49D show an example of a proximal end of a tool including an interface for an endoscope tool driver 4981. Any tool (including off-the-shelf tools) may be adapted by replacing the traditional handle / controls at the proximal end with the proximal interface such as that shown in FIGS. 49B-46D, which is configured to engage with an endoscope tool driver 4981. In FIG. 49B, the proximal end interface includes a telescoping cylindrical construction that may be engaged with inner control elements (e.g., tendons, wires, etc.) to actuate one or more bending regions and / or an end effector actuator. The proximal end interface 4980 may have an outer diameter that is similar to the outer diameter of the tool shaft, or slightly larger (e.g., less than 4x the outer diameter of the tool shaft, less than 3x the outer diameter of the tool shaft, less than 2x the outer diameter of the tool shaft, less than 1.5 x the outer diameter of the tool shaft, etc.). The outer diameter of this region may be geared 4983 or may otherwise include structures to engage with the seating region 4981, 4981’ of the endoscope tool driver. In FIG. 49C the seating region of the endoscope tool driver is configured as a clamp that may secure around the cylindrical proximal end interface. The gearing 4983 on the outer surface may allow rotation (torque) of this region or may prevent rotation relative to the inner region 4985 which may be manually manipulated or may engage with another portion of the endoscope tool driver. The distal end region 4981 of the tool may be configured to actuate the end- 47 -SG Docket No.: 13668-740.600effector and may be manually manipulated or may engage with another portion of the endoscope tool driver.

[0227] The cylindrical proximal end interface may be engaged with one or more sideloading bases, that may engage with a portion of the proximal end interface. In some examples the side-loading base(s) may be y-shaped or channels, shown in FIG. 49C, that may engage around the cylindrical outer body of the proximal end interface. A similar example is shown in FIGS. 50A-50B. In some cases one or more gears or rollers may be included within the seating portion of the base(s) to allow control of roll of the proximal end interface and therefore the tool. As mentioned here, the shaft of the tool may be configured to transmit torque, while allowing flexibility, e.g., by using a laser-cut hypotube and / or a reinforcing wire mesh.

[0228] FIGS. 50A-50C and 51A-51E shows another example of a proximal end interface 5080 that may be part of an endoscope tool, including different control regions that may be rolled and / or moved axially once engaged with seating region 5081 of different bases of the endoscope tool driver. The endoscope tool drive may include one or more sensor to sense when the endoscope tool driver is engaged with a tool, as shown in FIG. 50B, including a sensor 5088 that is depressed when a tool is seated in the endoscope tool driver. The seating region 5081 may also include a torque driver 5089 that may engage with an outer torquable surface 5083, 5083’ of the proximal end interface 5080 of the tool, as shown in FIG. 50A. Similar features are show in FIGS. 51A-51E, however the seating region of the endoscope tool drive shown in FIG. 51 may include engagement regions 5186, 5186’ at both ends, as shown.

[0229] FIGS. 52A-52C, 53A-53B and 54A-54C illustrate examples of construction of the proximal end interfaces 5280, 5380, 5480 that may be used as described herein, including regions corresponding to different control for the tool, e.g., different tendons, actuators, etc. For example, FIGS. 52A-52C show an example in which the proximal end interface of the tool is configured to include different torquable regions 5283, 5283’, 5283”. Each region may be internally coupled to different elements within the proximal end interface to control the tool, as shown in FIGS. 52B and 52C; rotation of these different regions may result in control of tool bending / articulation, and / or actuation of the tool. Similarly, different longitudinal region of the proximal end interface may control different aspects of the tool, as shown in FIG. 53 A, in which different telescoping regions of the proximal end interface 5380 may correspond to different control regions of the proximal end interfaces and therefore the operation of the tool. For example, moving one region proximally or distally may steer the distal end region (e.g., distal end effector) and / or actuating the distal end effector. FIG. 53B- 48 -SG Docket No.: 13668-740.600shows an example of an internal structure that may correspond. In FIGS. 54A-54C the proximal end interface is configured to control different aspects of the distal end effector (e.g., an example of which is shown in FIG. 54A) in parallel rather than in series, as in FIGS. 52A-52C and 53A-53B. In this case, different regions may be torqued based on rolling different controls on the proximal end interface 5480.

[0230] Alternative constructions of the proximal end interfaces are shown in FIGS. 55A- 55C, 56A-56C, 57A-57E and 58A-58B. In some cases a manual interface may also be used to engage with the proximal end interface and operate the tool manually, rather than requiring an endoscope tool driver. For example, FIGS. 55A-55C illustrate an example in which the outer body of the proximal end interface is not cylindrical but is box-shaded and includes a projecting region that may be used to register and secure the proximal end interface. In this example, rotation of a control 5557 on the proximal end interface may advance / withdraw the distal end effector, as shown in FIG. 5C.

[0231] In any of these apparatuses described herein, tool (e.g., the proximal end interfaces of the tool) may include manual controls in addition to controls that are operated by the endoscope tool. For example, in FIG. 56C, the proximal end interface includes controls on the outer surface for roll 5663, end effector actuation 5664, and distal deflection (in two planes 5665, 5666). An example of the end effector is shown in FIG. 56A. FIG. 57A- 57C shows a similar example with controls for controlling roll 5763, end effector actuation (e.g., open / close jaws) 5764, and deflection in various directions 5765, 5766, 5766’. In some cases the toll may include a proximal end region (e.g., proximal end interface) that is configured to communicate and allow control via an electronic interface, as shown in FIGS. 58A-58B. For example, in some cases the proximal end interface may make electrical connections with the endoscope tool driver and may communicate with a user interface (shown in FIG. 58B) that include manual controls, such as sliders 5856, 5856’ or other controls 5857 that man manipulate various controls on the tool.

[0232] In general, the endoscope tool drivers described herein may be adapted for use with a variety of different tools, even tools having different actuators for controlling the different end effectors. These endoscope tool drivers may allow precise control of movement (and non-movement, e.g., locking) and may scale to allow control of different sensitivities, forces, etc.) for actuating different apparatuses.ENDOSCOPE TOOL EXAMPLES

[0233] FIGS. 42A-42C illustrates an example of a tool that may be used with the driver (multi-axis driver) of FIGS. 41 A-41D. In this example the tool is configured as a polypectomy device 4201 that includes an end effector comprising a pair of jaws 4245. The - 49 -SG Docket No.: 13668-740.600tool includes an elongate body 4215 having distal end region 4240 that is deflectable / bendable. In addition, the jaws may be opened / closed. The proximal end of the tool includes three connectors; the first connector (distal-most connector) 4222 is coupled to the elongate body and is configured to be locked onto the first sliding base of the tool driver shown in FIG. 41 A. The second connector 4220 is coupled to a pull / push wire or cable for controlling the jaws and may connect to the second sliding base. As shown in FIG. 42B, moving the second connector 4220’ proximally relative to the first connector may open the jaws 4215’, and moving the second connector distally may return the jaws to the closed position. A third connector 4218 may be configured to actuate bending of the deflectable distal end region 4242, as shown in FIG. 42C. This third connector may couple to the third base of the driver. The third slider may also be connected to a cable to cause deflection of the distal end region.

[0234] Although the tools described herein may be operated with a driver that may be mounted to a robotic system (e.g., robot or robotic driver) as described above and shown in FIGS. 40A-40E and 41 A-41D, any of these tools may be either manually controlled and positioned and / or used with an unmounted driver instead. For example, the motion / position of the tool and any end effector can be controlled by a controller that is mobile. Thus, a user does not need to insert the tools at the end of the endoscope or at the end of the robot. In some cases the tools and / or driver may be held directly by the operator who may be located in any desired position.

[0235] In any of these methods and apparatuses, the tool may be locked in position during use. For example in some cases the robotic control of the tool and / or driver may be configured to scale the motion applied, to allow more precision. For example, the driver may be configured to adjust the motion scaling, so that for a given input the tool may move a scaled distance and not necessarily 1 : 1 (e.g., by a scaling factor of between about 0.1 to 100). Robotically controlled tools may ‘clutch,’ so that they stay in the same place when released. In general, the use of a driver and / or a robotic control operating the driver may reduce the need for additional staff.

[0236] In particular, the methods and apparatuses (tools, drivers, etc.) described herein may be configured to include a lock to maintain the position of the end effector, particularly in examples, such as a net, grasper, etc. where the end effector may be engaged with the tissue or with another tool. For example, if the tools includes a capture member (e.g., a net) at the distal end region, the tool may be configured so that the end effector may be locked in position from the proximal end, to allow removal or other manipulation of the tool without disruption the engagement of the end effector. Thus, if the tool (particularly after engaging - 50 -SG Docket No.: 13668-740.600tissue) is too big to remove through the working channel for removal, the entire scope could be removed while the overtube stays in place. In this case, the tool may be removed from the tool driver and an end effector lock, which may be configured to releasably secure the relative position of the cable operating the end effector, for example, may held in position relative to the elongate body of the tool, locking the end effector in position, including when engaged with tissue.

[0237] As mentioned, any of these apparatuses may be remotely operated. For example, FIG. 4 IE shows an apparatus including a multi-axis endoscope tool driver 4100 that may be similar to those shown in FIGS. 41 A-41D, and that may engage with approximal end of a tool 4181 that is inserted through a working channel (in this example, an inner working channel of an endoscope, though any of these may be external working channels instead). The tool is inserted into a nested robotic device including an inner (rigi dizing) endoscope 4183 and an outer (rigi dizing) overtube 4185. The multi -axis endoscope tool driver 4100 may be remotely operated by a user operating a control 4180. As mentioned, the control may be wired or wirelessly connected to the multi-axis endoscope tool driver and / or may be part of the controls for the robot (e.g., the link assembly 301 driving the nested, rigidizing robot). The control may be any user control (keyboard, keypad, touchscreen, consolejoystick, etc.).

[0238] FIGS. 43 A-43C illustrates another example of a tool that may be used with the driver (multi-axis driver) of FIGS. 41 A-41D. In this example the tool is configured as a snare device 4301 that includes an end effector comprising a loop or snare 4347. The tool includes an elongate body 4315 having distal end region 4340 that is deflectable / bendable. In addition, the snare diameter may be increased or decreased, by pulling it into or extending it out of the distal end of the tool. The proximal end of the tool includes three connectors; the first connector (distal-most connector) 4322 is coupled to the elongate body and is configured to be locked onto the first sliding base of the tool driver shown in FIG. 41 A. The second connector 4320 is coupled to a pull / push wire or cable for controlling the snare. As shown in FIG. 43B, moving the second connector 4320’ proximally relative to the first connector may tighten / reduce the diameter of the snare 4347’ . A third connector 4318 may be configured to actuate bending of the deflectable distal end region 4342, as shown in FIG. 43C. This third connector may couple to the third base of the driver. The third slider may also be connected to a cable to cause deflection of the distal end region.

[0239] In any of these configurations, force measurements may be included. Force feedback may be provided to the user, in multiple forms, as data on a screen, as force that is feedback into the interface device, etc.- 51 -SG Docket No.: 13668-740.600

[0240] Any appropriate tool may be adapted to include one or more connectors at the distal end of the tool configured to engage with a driver (an endoscope tool driver). Any number of connectors may be used, including 1, 2, 3, 4, 5, etc. The connectors may be arranged in series at the proximal end region of the tool’s elongate body for attachment to a plurality of different endoscope tool drivers, s shown above. In some cases the connectors may include one or more radial projections that may engage with the tool receiver on the endoscope tool driver seating region. For example, the connector(s) may have a flared shape.

[0241] The tools described herein may be configured to be stored and / or dispensed so as to minimize storage space and packaging. FIG. 44 shows an example of a packaging 4441 for a plurality of tools 4401 within a prism container (e.g., a tube, such as a cylinder) that may be configured so that individual tools may be withdrawn from the container and coupled to the robotic system, as shown, by coupling the connectors 4421 to the tool driver 4490 after inserting the tool into the inner (e.g., endoscope) nested member 4471 of the robotic system, which may be already coupled to the endoscope driver 4491.

[0242] In general, the tools described herein have a robotic interface so they may not need to interface with an operator’s hands, which enables them to be smaller in scale. This may enable tools which are packed more to a given shipping box, which may reduce packaging cost, shipping cost, landfill, and storage space. For example the o.d. of the tool may include one or more robot engagement features that are only nominally bigger than the device shaft (for example, 10% more, 50% more, 2x more, 3x more, 4x, 5x). In some cases the profile of the tool at the proximal end region may be only modestly different than the main shaft diameter , which is one benefit of the linearly arranged actuator s / controls at the proximal end region of the tools.Tool Shields

[0243] Also described herein are shields that may prevent or reduce contamination of the apparatuses described herein. Any of these shields may be configured as sleeves (and may be referred to as sleeves). In general, these shields may be applied over an endoscope tool to protect it from contamination during use. These shields may be adapted for use with any of the tools and robotic apparatuses described herein, although they may be used with any appropriate endoscope tool.

[0244] FIGS. 45A-45C illustrate an example of a tool shield applied over an elongate tool having a pair of jaws as the end effector. The shields described herein may be configured for use with any appropriate tool, including tools that may be used with any of the apparatuses described herein, including the nested, rigidizing robotic apparatuses.- 52 -SG Docket No.: 13668-740.600

[0245] A shield for a tool may be formed of a material, such as polymeric material, that is configured to extend over the tool 4540 including elongate tool shaft 4542 and distal end effector 4545. The shield may extend over the entire length of the tool, to the proximal end tool. Thus, in some examples the shield 4550 may extend to proximal end of the tool or beyond. In some case the proximal end of the shield 4558 may be configured to couple to the proximal end of the tool. In some cases the shield may be configured to seal over the tool so that pressure, e.g., positive and / or negative pressure, may be applied. In some cases pressure may be applied to test the patency of the shield, e.g., to ensure that it has not tom or been breached, which may indicate exposure of the tool to the contaminating external environment (e.g., within a body lumen). Alternatively or additionally, pressure may be used when inserting the tool into the shield, in order to assist in inserting the tool into the shield. For example, the shield may be inflated before and / or during insertion of the tool. The tool shield may be placed on a surface and at least partially inflated. In some cases positive pressure may be applied (e.g., by pumping air into the shield or entraining air into the shield). The proximal end of the shield may include a gasket or seal (e.g. O-ring, etc.) that may be configured to receive the distal end of the tool so that the tool may be slid over the shield to insert it. The pressure port may be distal to the gasket / seal. In some cases the pressure and / or air flow within the shield may be monitored, e.g., though the pressure port, which may be connected to an external sensor (pressure sensor, flow sensor, etc.). In some examples, once the tool has been inserted into the shield, the pressure may be reversed, so that the shield may be drawn down onto tool, which may assist in minimizing the profile of the tool with the shield over it; this may make it easier to insert / withdraw the tool within a working channel and / or operate the tool (including the end effector). As mentioned, the pressure (positive or negative) may be monitored to detect leaking, which may indicate that the tool has been exposed to the external environment.

[0246] The tool shield may therefore include one or more pressure connectors or ports 1467 (e.g., see FIGS. 45A-45B). A pressure connector may be located at the proximal end region of the shield.

[0247] In general the shield material may be a biocompatible material that may form a thin barrier that is flexible, such as polymeric materials (e.g., polyvinyl alcohol (PVA), polyethylene oxide (PEO), polyurethane (PU), poly vinyl pyrrolidone (PVP), polyglycolic acid (PGA), PTFE, tec.), and natural and synthetic rubbers (e.g., latex). The shield may be formed of multiple materials. In some cases the shield may be formed of different materials at the proximal and / or distal end regions. In some cases the regions of the shield configured to extend over the distal end effector (e.g., jaws, electrode(s), etc.) may be formed of a different - 53 -SG Docket No.: 13668-740.600material than the portion of the shield extending along the elongate body portion of the tool. For example, the elongate body portion of the shield may be formed of a relatively thin and flexible material having a thickness that is less than a thickness of the portion at the distal end region covering the end effector.

[0248] In FIG. 45A the distal end region of the tool shield is configured for use with a tool having a pair of jaws 4545. In general, the distal end region of the tool shield may be adapted or configured for use with a variety of different end effectors. FIG. 45 A shows the elongate tool with the jaws each covered by a bifurcating distal end region. The jaws 4545 in FIG. 45 A are shown closed, while the jaws 4545’ in FIG. 45B are shown open. In this example the distal end region of the shield 4554 is divided into two jaw covers that are shown in greater detail in FIG. 45C. As shown in FIG. 45C the portion of the shield over the jaws may be configured to enhance gripping 4556. For example, the material forming this gripping region may be configured to have a higher coefficient of friction (e.g., may be tacky and / or less smooth). In some cases this region may be coated with an agent to increase friction between the outer surface of the portion of the shield over the jaws and the tissue (or may be uncoated compared with other regions that may have, e.g., a hydrophobic coating). The portion of the shield over the end effector may be reinforced. In some cases this region may be thicker than other regions of the shield (e.g., more proximal regions 4550). Shields for use with other end effectors, e.g. end effectors for applying or receiving electrical energy (e.g., sensing and / or electroendoscope tools) may include conductive regions. Shields for use with optical tools (e.g., tools including cameras, laser / led sources) may include one or more optically transparent regions at the distal end region configured to mate with and cover the end effector. Shields for use with thermal tools (e.g., tools configure to sense temperature and / or apply heat / cold) may include thermally conductive region(s) at the distal end region.

[0249] In FIGS. 45A-45C the shield is shown ‘loose’ on the tool, but it some variations the shield may be applied more closely to the outer surface of the tool. For example, the shield may be configured to be held tightly against the tool. In some cases the shield material may be elastomeric and may be stretched over the tube and / or may collapse down on to the tool. In some cases the shield material may be drawn down onto the tool by applying a negative pressure, as described above.

[0250] In some cases regions of the shield may be configured to secure more tightly or more loosely to the tool, as illustrated in FIGS. 46A-46B. The tool 4640 in this example is similar to the tool shown in FIGS. 45A-45C and includes a distal end effector having a pair of jaw 4645. The shield 4650 may include regions that are configured to be more loosely held around region of the tool. In some cases, the shield may be more tightly held to the tool. For - 54 -SG Docket No.: 13668-740.600example, in FIG. 46A the shield may include a constricting region 4662, e.g., a band or a ring (e.g., elastic / elastomeric region). In some cases it may be desirable to include a ‘bunched up’ region, particularly around articulating regions of the tool (e.g. joints) which may be helpful if the shield material is less elastomeric. Constrictive regions may be positioned on either sides of such regions.

[0251] In some cases the shield may include a constrictive region before the distal end region configured to cover the distal end effector, which may help maintain the distal end region of the shield over the distal end effector. For example, FIG. 46B shows the distal end region 4654 of a shield 4660 including a constrictive region 4662 and a pair of gripping regions 4656 configured to fit over the jaws of a tool.

[0252] Any of the disposable tools described herein may be configured to include a disposable end effector coupled to the shield, so that the end effector does not need to include a shield cover. The shield portion (sleeve, cover, etc.) that may be fluid-impermeable, may extend proximally from the disposable / single use end effector. The single-use end effector may engage with a reusable / multi-use tools shaft so that the end effector actuator (e.g., tendon, power line, sensing line, etc.) extending through the tool shaft from the proximal control region (or in some cases, handle region) to the distal end may engage with the disposable tool in a secure contact that may be releasably locked in place. The engagement portion may be within the shielded lumen of the shield and may allow actuation of the end effector by the proximal end of the tool shaft (handle, control, etc.).

[0253] For example, FIG. 47A shows a shield portion 4790 including a shield portion 4791 that is sealed to a disposable end effector 4792 (shown in this example as a forceps 4792, 4792’, though any end effector may be used, including loop / lasso, cutter, scissor, electrosurgical cutter, suture passer, etc.). The shield portion may include a proximal sealing region 4765 with a pressure port 4767 as described above. A reusable tool body 4740 may be included and may have an elongate body with a proximal handle or control(s) / connectors similar to those described above. In some cases the body (e.g., distal end region) may be steerable in one or more axis and / or may include tandem steerable regions. In FIG. 47A the tool body includes a tendon within the tool body for actuating the distal end effector once the disposable distal end effector is engaged with the shield, as shown in FIG. 47B. Once engaged, the reusable portion of the tool body is protected by the shied. The end effector may be actuated, as shown in FIG. 47C as described above, e.g., by actuating the control / connector 4750 at the proximal end of the tool. Once used, the distal end effector may be disengaged (e.g., unlocked) from the tool body and the shield portion removed so that- 55 -SG Docket No.: 13668-740.600another shield portion (with the same or a different type of end effector) may be coupled for use.

[0254] Any of the tools described herein may be configured for torque, e.g., for rotation of the tool. For example, described herein are torsion-based apparatuses (e.g., tools) to rotationally drive the tool. In some cases the tool may include a suture passer that may rotationally drive a needle for passing a suture through the tissue. FIGS. 48A-48B illustrate an example of such an endoscope tool. In FIG. 48 A and 48B, a nested dual rigi dizing flexible endoscope system 4805 may be used with a tool 4807 having a long length that can navigate significant tortuosity, while still achieving high torsional strength and stiffness from a stable and concentric base. This enables the placement and driving of suture though organ walls. Different organs have different thicknesses and different requisite forces to fully drive a suture through the tissue. While the colon wall can be very thin (and therefore with a low requisite needle driving force), the stomach can be demonstrably thicker. For example, a typical colon wall may have a thickness is about 2.5 to 3 mm. A typical stomach wall thickness may be about 5 to 12 mm. It would therefore be very valuable to have a system that was highly flexible to reach distal regions of anatomy, including the GI tract, but also exhibiting high stiffness and strength to drive suture though a thicker and tough organ wall. This could enable, for example, gastroplasty. It could enable driving suture to close defects or to close regions that had malignant disease removed.

[0255] In the example shown in FIGS. 48A-48B, the apparatus may include a torsionally stiff endoscope, overtube and an endoscope torquing system driving rotation of a tool, such as a tool including a needle 4817 as an end effector on the tool 4807, as shown. The needle 4815 may pass a suture 4816 through a tissue wall 4815. Thus, described herein are flexible nested rigidizing systems / apparatus in which at least one of the nested elements exhibits high torsion stiffness, and may be torqued relative the other nested element to drive a needle and suture through tissue.

[0256] In general, the tool drivers, e.g., endoscope tool drivers, described herein may be integrated with the telescoping link assembly of the robotic driver, instead of, or in addition to, being part of the mount to which the inner member (e.g., endoscope, rigidizing shield, etc.) are mounted. Also described herein are tools that are adapted for use with these tool drivers. For example, FIG. 59A schematically illustrate a first example of an apparatus for dispensing and / or controlling a nested pair of flexible tubular members, including in particular rigidizing nested flexible members. These apparatuses may be adapted specifically to control the operation of one or more tools. In FIG. 59A the apparatus 300 is shown to be configured for use with a nested endoscope that includes both an outer “overtube” an inner - 56 -SG Docket No.: 13668-740.600endoscope that may be moved proximally / distally relative to each other and may each be rigidized to guide and / or steer the device through the patient’s body. However, it should be understood that these apparatuses may be used with any flexible tubular member, including those that are not nested and that do not rigidize (e.g., single-body endoscopes).

[0257] In FIG. 59A the system 300 shown includes a base 341 that my support the weight of the rest of the system, including a flexible tubular member attached to the telescoping links 305, 307, 309. The base 341 may be weighted so as to allow the telescoping link assembly and any attached flexible tubular members to cantilever distally or proximally away from the base, while remaining stable. The base may house one or more additional components, including power source, power conditioners, motors, pressure source / pressure supplies / pressure regulators, controllers, control circuitry, etc. The base 341 may include wheels 351 to allow the apparatus to be moved and positioned relative to a patient’s bed. In some examples the base 341 may include an anchoring region 353 that may be lowered and / or raised to allow or prevent movement. The wheels may be locking or lockable.

[0258] FIG. 59A includes a link assembly 301 configured as a vertically arranged links: a first link 305 (e.g., outer link), a second link 307 (e.g., an intermediate link) and a third link 309 (e.g., inner link). The first link is coupled to a yaw adjust arm 337 that is also configured as (or may be coupled to) a vertical lift arm 335 connecting the link assembly 301 to the base 341. The system 300 shown in FIG. 59A also includes a mount assembly comprising a three mounts, e.g., mounting plates or mount regions 323, 333, 390 that are coupled to the third link. The third mount region is configured as the endoscope tool driver in the example.

[0259] In FIG. 59A, the first mount region 323 is configured as an overtube mount for coupling with an overtube of an endoscope. The overtube mount is located at or near the distal end region of the third link 309 and includes an overtube drive assembly (e.g., driver) 321 that may interface with the overtube of the endoscope. In some examples, the overtube drive assembly may include drive components for controlling roll, for steering (optionally, in examples in which the overtube may be steered at the distal end), and / or pressure inputs / outputs for rigidizing / de-rigidizing. The overtube mount 323 may be configured to secure to the overtube portion separately from the inner endoscope. In some examples the overtube mount 323 may secure by including a securing mechanism such as a clamp, clasp, latch, lock, etc.

[0260] The second mount region 333 is configured as an inner endoscope mount and may also include an inner endoscope drive assembly 331, as shown. The inner endoscope drive assembly (driver) may interface with the inner endoscope member and may include the drive components described above in reference to FIG. 2, including steering components (e.g., for - 57 -SG Docket No.: 13668-740.600steering the distal end / tip region), roll control, pressure input / output (e.g., for rigidizing / de- rigidizing, etc.). The inner endoscope mount 331 may be configured to secure to the inner endoscope separately from the overtube, e.g., by including a securing mechanism such as a clamp, clasp, latch, lock, etc.

[0261] The third mount assembly 390 is configured as an endoscope tool driver (also referred to herein as a working channel driver), and is shown in greater detail in FIG. 59B, below. The third mount assembly 390 may be movable 5961 along the length of the third link 309, and may therefore move relative to the third link 309 in a proximal -and-distal axis, independently of the first 323 and second 333 mounts. As described above, at least the second mount 333 may be moveable 5960 relative to the third link 309 also in the proximal- to-distal direction. In other examples the endoscope tool driver is coupled to the second mount 333. In any of these examples the endoscope tool driver, or a portion of the endoscope tool driver, may separately move in the proximal -to-distal direction. In FIGS. 59A-59B, the distal portion of the endoscope tool driver (formed by the third mount 390) moves in the proximal-to-distal direction 5962 relative to the proximal portion. Thus, the endoscope tool driver may include two portions, a proximal portion and a distal portion, one of which may move in the proximal-to-distal direction 5962 relative to the other.

[0262] Two examples of endoscope tool drivers are shown in FIGS. 60A-60C and 61A- 61C, each illustrating how the tools described herein may be engaged to the tool driver (endoscope tool driver). In both cases the endoscope tool driver is formed as a third mount platform 390 that is movably coupled to the third line 309. In both cases the endoscope tool driver is configured as an approximately C-shaped proximal grip hold an end of the tool shaft, which may have a non-circular cross-section, to allow the endoscope tool driver to deliver a roll motion without slipping. The grip may roll to create the end-effector roll motion. The grip can be back-drivable to easily adjust its pose for tool engagement.

[0263] For example in FIG. 60A, the endoscope tool driver is configured as a mount 390 having a base 6007 (tool mount base) with a proximal tool handle attachment 6005 and tool end-effector articulating member 6009. The tool end-effector articulating member 6009 includes a rotatable tool shaft grip 6015 that is configured to engage with the proximal end 6013 of the tool and may rotate relative to the tool handle 6011 to rotate the end effector. The proximal end of the tool 6013 may be configured as a tool actuator for actuating the tool. As mentioned, the tool (the proximal end of the tool handle) and the rotatable tool shaft grip 6015 may be keyed to prevent slipping as the rotatable tool shaft grip 6015 is driven to rotate the proximal end of the tool and therefore the end effector. In the example shown in FIGS. 60A-60C the tool handle attachment region 6005 at the proximal end of the mount includes a - 58 -SG Docket No.: 13668-740.600tool handle receiver 6026, which may be configured as a dock, seat or grip for securing the tool handle 6011 to the endoscope tool driver 390. In some cases the tool handle receiver6025 includes a securement such as a removable lock, latch, coupler, etc. to secure the tool in or to the tool handle receiver 6025. In FIGS. 60A-60C the tool handle receiver 6026 is a dock that receives a projection (e.g., tool handle projection 6025) extending from the handle, which may be referred to as a tool engagement projection 6025. This tool engagement projection may also be keyed with the tool handle receiver 6026. The tool handle receiver6026 also includes a securement (not visible) that releasably locks into the tool engagement projection until released. The lock may be a slider, a deflectable latch, a biased (e.g., spring- biased) latch, etc., and may prevent the handle from inadvertently disengaging from the tool handle attachment. In some cases the connection between the tool handle and the mount (e.g., the tool handle attachment 6005 and the tool handle 6011 (e.g., a tool engagement region 6025) may be mechanical. In some case the connection may be magnetic or both magnetic and mechanical.

[0264] In the example shown in FIGS. 60A-60C the tool handle engagement projection 6025 plugs into the tool handle attachment (dock 6026), as shown in FIG. 60B. In some cases the tool engagement projection may make an electrical connection when engaging with the attachment. This electrical connection may power and / or drive the actuator at the distal end of the tool. Alternatively or additionally, a described below in FIGS. 63A-63B, 64B, 64D and 64F, the handle 6011 and / or proximal end 6013 of the tool may include a separate electrical connector. In any of these examples the system may be configured to detect that a tool is attached. The endoscope tool driver may include a reader detect and / or identify the tool. The reader may be an RFID reader, and optical reader, etc. The tool may include a chip or marking indicating the type or otherwise identifying the tool to the system. In some cases the system may identify the type of tool and may adjust the endoscope tool driver to accommodate the tool (e.g., tool size, shape, electrical connectors, etc.). In some cases the system may adjust movement(s) of the endoscope tool driver to minimizing hysteresis depending on the type of tool being engaged.

[0265] As described above, in some cases the proximal end of the tool 6013 may be configured as a tool actuator for actuating the tool. For example, the proximal end of the tool may be pulled / push in / out to actuate bending of the tool tip region and / or to actuate opening / closing of the jaws. For example, a pull / push wire (e.g., tendon, cable, etc.) may be connected to the proximal end region 6013 and may be used to drive bending. The proximal end of the tool 6013 may be rotated relative to the tool handle 6011 to rotate the end effector of the tool. For example, a torque transmitter (e.g., laser cut tube, braid, etc.) may extend - 59 -SG Docket No.: 13668-740.600from the proximal end of the tool 6013 to the tool and may rotate relative to an outer surface of the length of the tool 6012.

[0266] FIG. 60C illustrates various degrees of freedom / axis of movement that may be actuated by the endoscope tool driver shown in FIGS. 60A-60C, including rotation 6025 of the proximal end region 6013 of the tool handle relative to the tool handle 6011, linear (proximal / distal) movement 6027 of the proximal end region 6013 of the tool handle relative to the tool handle 6011, and linear (proximal / distal) 6021 movement of the entire stage forming the endoscope tool driver to move the entire tool in / out relative to the rest of the system. The insertion / retraction of the tool may be generated by moving the entire mount 690 relative to the link 609 and / or moving the nested overtube and endoscope relative to the tool. The mount forming the endoscope tool driver shown in this example may be relatively easy to engage and disengage from the robotic system. The end-effector articulator portion may be easily engaged / disengaged with the proximal end of the tool handle and may both roll and / or move linearly. Thus the end-effector articulator portion may be on a track, which may include linear bearings, for moving relative to the tool handle attachment region.

[0267] As shown in FIGS. 60A-60B, in operation a tool handle may be coupled to the tool handle receiver 6026, e.g., by inserting a projection 6025 on the tool handle, or otherwise seating the tool handle, and coupling the tool proximal end 6013 to the stool shaft grip 6015. One or more securements (e.g., latches) may hold the tool handle and / or proximal end in place. Note that in FIGS. 60A-60C (as well as FIGS. 61 A-61C, 62A-62B, 63A-63B and 64A- 64F) only a proximal region of the tool shaft 6012 is shown, including an outer cover. The tool shaft may extend distally to a tool end effector such as any of those described above (e.g., loop / lasso, cutter, scissor, electrosurgical cutter, suture passer, etc.).

[0268] FIGS. 61A-61C illustrate another example of an endoscope tool driver (tool driver 390) similar to that shown in FIGS. 60A-60C. In this example, the tool may be coupled to the tool handle attachment 6115, which may include a tool handle receiver 6126 as discussed above. In FIGS. 61A-61C the tool end-effector articulator 6109 may be different from the tool end-effector articulator 6009 shown in FIGS. 60A-60C as it may generate the rotation of the proximal end of the tool 6013 (to actuate the end effector of the tool) using a driving friction wheel 6141 and optionally one or more (e.g., two) idlers 6143, 6143’. The tool endeffector articulator 6109 may move in the proximal / distal direction relative to the tool handle attachment 6105. The tool end-effector articulator 6109 may extend from a tool mount base 6107 or it may couple directly to the link. As described in reference to FIGS. 60A-60C, the tool end effector actuator 6109 may be coupled to a linear drive to drive movement of the tool end effector actuator proximally / distally under control of the system to actuate the tool end - 60 -SG Docket No.: 13668-740.600effector (e.g., in some cases for bending, for opening / closing jaws, expanding / contracting a loop / lasso, etc.).

[0269] FIGS. 61 A-61B illustrate coupling of the tool handle to the mount 390 forming the endoscope tool driver. The tool may be inserted / retracted by moving the entire tool driver, as described for FIGS. 60A-60C. The tool end-effector may be actuated, e.g., to open / close or roll, by driving the friction wheel to rotate the tool actuator 6013 on the tool.

[0270] In any of the endoscope tool drivers described herein the endoscope tool driver may be configured to minimize concave areas to allow easy cleaning of the tool driver.

[0271] FIG. 61C illustrates the various degrees of freedom / axis of movement that may be actuated by the endoscope tool driver shown in FIGS. 61 A-61C, including rotation 6125 of the proximal end region 6013 of the tool handle relative to the tool handle 6011, linear (proximal / distal) movement 6127 of the proximal end region 6013 of the tool handle relative to the tool handle 6011, and linear (proximal / distal) 6121 movement of the entire stage forming the endoscope tool driver to move the entire tool in / out relative to the rest of the system. The insertion / retraction of the tool may be generated by moving the entire mount 690 relative to the link and / or moving the nested overtube and endoscope relative to the tool.

[0272] The apparatus shown in FIGS. 61 A-61C may therefore include a tool handle receiver 6026 extending from the base 6107. The tool handle receiver 6126 includes a receiving surface that is configured to engage with a tool handle of a tool. In FIGS.61 A-61C the tool handle receiver 6026 is configured as a dock (the inner surface of which forms the receiving surface. In some examples the receiving surface is a seat, which may conform to the handle, as described above. The endoscope tool driver apparatus shown in FIGS. 16A- 61C also includes a tool end effector actuator 6009 extending from the base. This end effector actuator is configured to engage a proximal end of the tool and to rotate the proximal end of the tool. The end effector actuator may include a rotary drive within the tool end effector actuator to drive rotation of the tool shaft grip 6015 that is part of the tool end effector actuator and connects to the proximal end of the tool.

[0273] Any of the endoscope tool driver apparatuses described herein may include a linear drive that may be coupled to the tool end effector actuator and is configured to move the tool end effector actuator proximally and distally relative to the tool handle receiver. In some cases the linear drive may be contained within the baes 6007. The linear drive may include one or more gears, a rack / pinion, belts, etc.

[0274] The handle portions of the tools described herein may be adapted for use with the endoscope tool drivers described herein. For example, FIGS. 62A-62B illustrate examples of proximal handles for a variety of different tools (e.g., tools having different end effector- 61 -SG Docket No.: 13668-740.600types). In FIG. 62A the tool includes a tool handle 6211 and a proximal end configured as a tool actuator 6213. The proximal tool actuator 6211 is configured to be rotated as described above. In this example the proximal end also includes an electrical connector 6218 for coupling to an energy source, which may be used to apply energy or acuate some end effectors (e.g., ablation tools, powered tools, etc.). The electrical connector may be at least partially recessed into the proximal end. As in any of the example tools illustrated, the elongate length 6012 of the tool may include a tool jacket 6152 over one or more end effector articulating cables, tubes, tendons, etc. 6151. The tool jacket may not rotate as the proximal end (and therefore the end effector) is rotated. FIG. 62B illustrates an example of the degrees of freedom (movement) of the tool handle shown. In FIG. 62B the proximal end region 6213 may rotate 6227 to rotate (or otherwise actuate) the end effector and / or may be pushed / pulled 6225 relative to the handle 6211 to actuate an end effector. The entire handle may be moved linearly in the insertion / withdrawal (e.g., proximal / distal) axis 6223.

[0275] FIGS. 63A-63B illustrate an alternative example of a tool handle configuration that may be used. The tool handle 6011 may include a tool engagement projection 6025 as described above in reference to FIGS. 60A-60C and 61 A-61C. This tool engagement projection may be referred to as a tool mounting unit. As mentioned, this tool mounting unit 6025 may be configured to easily engage / dis-engage from the endoscope tool driver (and therefore the robotic drive). In some cases the tool may include an identifier, such as an RFID identifier, or other detectable marker that may be read by the system. In this example the tool handle also includes an energy device connector (e.g., electrical connector 6018) on the handle 6011. The energy device connector 6018 may be compatible with any energy source (e.g., including a pulse generator for delivery RF or other energy modality), and may include a socket region (shown in FIG. 63 A-63B as a cylindrical chamber) for coupling with a connector / cable. In this example, the electrical connector is configured so that the electrical connection may be made from the side of the tool handle, as shown, but continuous electrical connection may be maintained even as the end effector is rotated (e.g., by rotating the proximal end 6013). As is shown in FIG. 63B, the electrical connector 6018 makes contact, e.g., via a brush or sliding contact 6020.

[0276] The tool handle shown in FIGS. 63A-63B also includes a proximal tool actuator 6013 at the proximal end that may be rotated and / or moved proximally / distally relative to the more distal region of the handle 6011 to actuate and / or rotate the end effector of the tool. This end effector articulating unit 6013 may be relatively easy to engage / di sengage from the endoscope tool driver, as described above.- 62 -SG Docket No.: 13668-740.600

[0277] Any of the tools described herein may include an outer jacket 6152 over the length of the elongate body 6012 of the tool. The outer surface of the tool elongate length may be flexible but may have sufficient column strength to avoid collapse under compression and may be formed and / or coated with a lubricious material, such as a hydrophilic coating. In some cases the jacket is formed of an insulative (e.g., electrically insulating) material.

[0278] FIGS. 64A-64F illustrate examples of different proximal handles that may be used and may include the features described. FIG. 64A is an example of a proximal handle for a snare or net device. In FIG. 64A a tool handle 6011 also includes a proximal tool actuator 6013 that may rotate and may move in / out relative to the handle to expand / retract the snare / loop. The tool handle also includes a tool engagement projection 6025. FIG. 64B illustrates an example of a tool handle for a “hot” snare that includes an electrical connector 6018 for applying electrical energy to the snare. The tool may otherwise be similar or identical to that shown in FIG. 64A.

[0279] FIG. 64C shows an example of a handle for a hemostatic clip tool. This example has a shorter handle 6011 length that may provide a smaller stroke and allow a higher pull force. The proximal tool actuator 6013 may rotate and may move in / out relative to the handle to actuate the clip. FIG. 64D shows an example of a coagulation grasper tool that also has a relatively short stoke, as well as an energy connector 6018. FIG. 64E shows an example of a handle for a biopsy forceps having a relatively short stroke due to the short tool handle 6011 length. FIG. 64F shows an example of a handle for an injection knife tool. In this example, the tool is also configured to apply fluid via a fluid connector (port 6415) that extends from the tool handle 6011. The tool handle also includes an electrical connector 6018 similar to that shown in FIG. 63B. This handle is configured to have a relatively short stroke based on the relatively short length of the handle region 6011.

[0280] Also described herein are endoscope tool drivers that are configured to couple to the robotic endoscope apparatus, without needing to be permanently affixed to it. Any of the endoscope tool drivers described herein may be configured to operate in this manner. For example, FIGS. 65A-65B illustrate an endoscope tool driver 6500 that is coupled to an elongate body of a tool 6501. The endoscope tool driver is configured to enable robotic control over the insertion and retraction of an otherwise manually operated endoscope tools. Any of these endoscope tool drivers may be referred to as an adapter that allows a manual endoscope tool to be securely coupled (e.g., clamped) to the endoscope tool driver and may drive advancement / withdrawal of the tool and to interface with a robotic endoscope apparatus (through the robotic tool driver), for precise linear motion control. Thus, as shown in FIGS. 65A-65B the endoscope tool driver may be attached to the endoscope driver 6503 of the- 63 -SG Docket No.: 13668-740.600robotic endoscope apparatus. Once mounted, the robotic system can advance or retract the tool without requiring manual manipulation, streamlining workflow and improving procedural consistency. The endoscope tool driver (e.g., adapter) in this example may be compatible with a mount of the robotic tool driver may mate with a mating feature on the robotic endoscope apparatus (e.g., on the endoscope driver). When not mounted to the robotic endoscope apparatus the endoscope tool driver may act as a handle of a standard simple endoscope tool. This may ensures seamless integration and interchangeability between manual and robotic tool systems. In the example shown in FIG. 65 A the endoscope tool driver 6500 includes a female portion of a coupler 6520 that engages with a projection configured as a male portion on the endoscope driver 6503. In contrast in FIG. 65B the endoscope tool driver includes a projecting portion (male portion 6521) that engages with a complementary receiving (female) portion 6525. In the example shown in FIG. 65B the projecting connection region (male portion 6521) include a wireless communication circuit, e.g., RFID, or may include other means of tool identification.

[0281] To support automated system recognition, any of these endoscope tool drivers may include a tool identification feature such as an RFID chip or QR code. This identifier may allow the robotic endoscope apparatus to detect that a manual tool is in use and adjust its control parameters accordingly, enhancing safety and efficiency. The endoscope tool driver may be manufactured as either a reusable or disposable component. Reusable versions can be sterilized between procedures, while disposable versions offer convenience and reduce the risk of cross-contamination.

[0282] The endoscope tool driver (e.g., adapter) may securely hold the manual endoscope tool securely in place without the need for moving parts within the endoscope tool driver itself. This may reduce mechanical complexity and enhance reliability. In some examples, the insertion and retraction movements of the tool may be driven entirely by the endoscope tool driver mechanism, eliminating the need for manual adjustments and allowing for precise, motor-controlled operation.

[0283] FIGS. 66 and 67 illustrate alternative examples of various securement for an endoscope tool driver that may be used to secure a portion (e.g., distal end region) of the endoscope tool within a seating region of an endoscope tool driver similar to those discussed above (e.g., in FIGS. 40D-40E). In FIG. 66, the endoscope tool driver 6600 includes a hingetype clamp (securement) that may be used as part of the endoscope tool driver (e.g., tool adapter). The hinge-type clamp may be configured to securely hold a region of an endoscopic tool in place during robotic or assisted procedures. In FIG. 66 the clamp may operate similarly to the endoscope tool drivers described above, including a lid having a hinged- 64 -SG Docket No.: 13668-740.600mechanism to open and close around the tool shaft. This design may allow for quick and reliable engagement, ensuring that the tool remains firmly positioned during use. The securement (e.g., clamp) may incorporate magnets and / or mechanical latches, which may lock or help lock the endoscope tool in place once the endoscope tool driver is clamped, preventing unintended movement or dislodgement during operation. This secure hold may be especially helpful in dynamic environments where precision and consistency are critical, as during a medical procedure. In addition to mechanical retention features, the clamp may include components made from elastic or compliant materials. These materials serve two important functions: first, they help prevent damage to the tool by cushioning it during clamping; second, they allow the clamp to accommodate tools of varying diameters. This flexibility ensures a snug fit across a range of tool sizes, making the adapter versatile and compatible with different instruments.

[0284] The endoscope tool driver 6700 shown in FIG. 67 includes a collet-type securement (e.g., clamp). This collet-type clamp may be a precision-engineered mechanism designed to securely hold a manual tool 6501 within a robotic or assisted tool adapter. This endoscope tool driver may utilizes a threaded cap 6781 with a through-hole, allowing the elongate body of the tool to pass through while being firmly gripped by the collet. As the cap is tightened, it compresses the collet around the tool shaft, creating a secure and stable hold.

[0285] The clamp body in this example may include an integrated collet structure that may be segmented and tapered to allow uniform radial compression when the cap is engaged. This configuration may ensure that the tool is held firmly in place without slipping, even during dynamic movements or high-torque operations. The collet mechanism is particularly well-suited for tools having cylindrical bodies. To accommodate tools having bodies of varying diameters, the clamp allows for adjustable tightening torque. This flexibility ensures that a wide range of tool sizes can be securely mounted without damaging delicate components. The ability to fine-tune the clamping force also helps maintain tool integrity and prevents deformation or wear during repeated use. In some examples, the collet-type endoscope tool driver may also incorporate a tool identification feature, such as an RFID chip embedded within the clamp or tool interface. This chip enables automatic recognition by the robotic system, allowing it to adjust control parameters and confirm compatibility. As with any of these endoscope tool driver, including such identification features may enhance workflow efficiency and reduce the risk of human error during setup.

[0286] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by- 65 -SG Docket No.: 13668-740.600reference. Furthermore, it should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein and may be used to achieve the benefits described herein.

[0287] Any of the methods (including user interfaces) described herein may be implemented as software, hardware or firmware, and may be described as a non-transitory computer-readable storage medium storing a set of instructions capable of being executed by a processor (e.g., computer, tablet, smartphone, etc.), that when executed by the processor causes the processor to control perform any of the steps, including but not limited to: displaying, communicating with the user, analyzing, modifying parameters (including timing, frequency, intensity, etc.), determining, alerting, or the like. For example, any of the methods described herein may be performed, at least in part, by an apparatus including one or more processors having a memory storing a non-transitory computer-readable storage medium storing a set of instructions for the processes(s) of the method.

[0288] While various embodiments have been described and / or illustrated herein in the context of fully functional computing systems, one or more of these example embodiments may be distributed as a program product in a variety of forms, regardless of the particular type of computer-readable media used to actually carry out the distribution. The embodiments disclosed herein may also be implemented using software modules that perform certain tasks. These software modules may include script, batch, or other executable files that may be stored on a computer-readable storage medium or in a computing system. In some embodiments, these software modules may configure a computing system to perform one or more of the example embodiments disclosed herein.

[0289] As described herein, the computing devices and systems described and / or illustrated herein broadly represent any type or form of computing device or system capable of executing computer-readable instructions, such as those contained within the modules described herein. In their most basic configuration, these computing device(s) may each comprise at least one memory device and at least one physical processor.

[0290] The term “memory” or “memory device,” as used herein, generally represents any type or form of volatile or non-volatile storage device or medium capable of storing data and / or computer-readable instructions. In one example, a memory device may store, load, and / or maintain one or more of the modules described herein. Examples of memory devices comprise, without limitation, Random Access Memory (RAM), Read Only Memory (ROM), flash memory, Hard Disk Drives (HDDs), Solid-State Drives (SSDs), optical disk drives,- 66 -SG Docket No.: 13668-740.600caches, variations or combinations of one or more of the same, or any other suitable storage memory.

[0291] In addition, the term “processor” or “physical processor,” as used herein, generally refers to any type or form of hardware-implemented processing unit capable of interpreting and / or executing computer-readable instructions. In one example, a physical processor may access and / or modify one or more modules stored in the above-described memory device. Examples of physical processors comprise, without limitation, microprocessors, microcontrollers, Central Processing Units (CPUs), Field-Programmable Gate Arrays (FPGAs) that implement softcore processors, Application-Specific Integrated Circuits (ASICs), portions of one or more of the same, variations or combinations of one or more of the same, or any other suitable physical processor.

[0292] Although illustrated as separate elements, the method steps described and / or illustrated herein may represent portions of a single application. In addition, in some embodiments one or more of these steps may represent or correspond to one or more software applications or programs that, when executed by a computing device, may cause the computing device to perform one or more tasks, such as the method step.

[0293] In addition, one or more of the devices described herein may transform data, physical devices, and / or representations of physical devices from one form to another. Additionally or alternatively, one or more of the modules recited herein may transform a processor, volatile memory, non-volatile memory, and / or any other portion of a physical computing device from one form of computing device to another form of computing device by executing on the computing device, storing data on the computing device, and / or otherwise interacting with the computing device.

[0294] The term “computer-readable medium,” as used herein, generally refers to any form of device, carrier, or medium capable of storing or carrying computer-readable instructions. Examples of computer-readable media comprise, without limitation, transmission-type media, such as carrier waves, and non-transitory-type media, such as magnetic-storage media (e.g., hard disk drives, tape drives, and floppy disks), optical-storage media (e.g., Compact Disks (CDs), Digital Video Disks (DVDs), and BLU-RAY disks), electronic-storage media (e.g., solid-state drives and flash media), and other distribution systems.

[0295] A person of ordinary skill in the art will recognize that any process or method disclosed herein can be modified in many ways. The process parameters and sequence of the steps described and / or illustrated herein are given by way of example only and can be varied as desired. For example, while the steps illustrated and / or described herein may be shown or- 67 -SG Docket No.: 13668-740.600discussed in a particular order, these steps do not necessarily need to be performed in the order illustrated or discussed.

[0296] The various exemplary methods described and / or illustrated herein may also omit one or more of the steps described or illustrated herein or comprise additional steps in addition to those disclosed. Further, a step of any method as disclosed herein can be combined with any one or more steps of any other method as disclosed herein.

[0297] The processor as described herein can be configured to perform one or more steps of any method disclosed herein. Alternatively or in combination, the processor can be configured to combine one or more steps of one or more methods as disclosed herein.

[0298] When a feature or element is herein referred to as being "on" another feature or element, it can be directly on the other feature or element or intervening features and / or elements may also be present. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being "connected", "attached" or "coupled" to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being "directly connected", "directly attached" or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature.

[0299] Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and / or "comprising," when used in this specification, specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ".

[0300] Spatially relative terms, such as "under", "below", "lower", "over", "upper" and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of- 68 -SG Docket No.: 13668-740.600the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as "under”, or "beneath" other elements or features would then be oriented "over" the other elements or features. Thus, the exemplary term "under" can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms "upwardly", "downwardly", "vertical", "horizontal" and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.

[0301] Although the terms “first” and “second” may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another feature / element. Thus, a first feature / element discussed below could be termed a second feature / element, and similarly, a second feature / element discussed below could be termed a first feature / element without departing from the teachings of the present invention.

[0302] In general, any of the apparatuses and methods described herein should be understood to be inclusive, but all or a sub-set of the components and / or steps may alternatively be exclusive and may be expressed as “consisting of’ or alternatively “consisting essentially of’ the various components, steps, sub-components or sub-steps.

[0303] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word "about" or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and / or position to indicate that the value and / or position described is within a reasonable expected range of values and / or positions. For example, a numeric value may have a value that is + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value " 10" is disclosed, then "about 10" is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that "less than or equal to" the value, "greater than or equal to the value" and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value "X" is disclosed the "less than or equal to X" as well as "greater than or equal to X" (e.g., where X is a numerical value) is also- 69 -SG Docket No.: 13668-740.600disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0304] Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.

[0305] The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.

[0306] The present disclosure contains the following clauses:

[0307] Clause 1. A robotic endoscope apparatus, the apparatus comprising: an endoscope driver comprising a robotic assembly configured to engage an endoscope assembly, and to move an endoscope of the endoscope assembly; an endoscope tool driver coupled to the endoscope driver, wherein the endoscope tool driver is configured to secure to a proximal end region of an endoscope tool and to advance or withdraw the endoscope tool relative to a working channel of the endoscope; one or more control inputs; and a controller receiving input from the one or more control inputs and configured to control operation of the robotic - 70 -SG Docket No.: 13668-740.600assembly to drive insertion, withdrawal and steering of the endoscope and to control advancing and / or withdrawal of the endoscope tool.

[0308] Clause 2. The apparatus of clause 1, wherein the endoscope tool driver is configured to roll a distal end effector of the endoscope tool.

[0309] Clause 3. The apparatus of any of clauses 1-2, wherein the endoscope tool driver is configured to actuate a distal end effector of the endoscope tool.

[0310] Clause 4. The apparatus of any of clauses 1-3, wherein the endoscope tool driver comprises a base and a seating region movably coupled to the base, wherein the seating region is configured to secure a proximal end region of the endoscope tool.

[0311] Clause 5. The apparatus of clause 4, wherein the endoscope tool driver comprises a securement configured to secure over the seating region and to secure the proximal end region within the seating region.

[0312] Clause 6. The apparatus of clause 4, wherein the endoscope tool driver comprises a drive coupled to the seating region and configured to drive the seating region in a liner path to insert and retract the endoscope tool.

[0313] Clause 7. The apparatus of clause 6, wherein the drive is configured as a linear drive.

[0314] Clause 8. The apparatus of clause 6, wherein the drive is configured as a rotary drive.

[0315] Clause 9. The apparatus of any of clauses 1-8, wherein the robotic assembly comprises one or more links and an endoscope mount configured to engage the endoscope assembly.

[0316] Clause 10. The apparatus of any of clauses 1-9, wherein the endoscope driver is configured to drive a nested endoscope assembly comprising an endoscope and an overtube.

[0317] Clause 11. The apparatus of any of clauses 1-10, wherein the robotic assembly comprises an arm assembly comprising two or more pivotally joined links.

[0318] Clause 12. The apparatus of any of clauses 1-11, wherein the robotic assembly comprises a telescoping robotic assembly comprising two or more telescoping links.

[0319] Clause 13. The apparatus of any of clauses 1-12, wherein the endoscope driver is configured to engage a rigidizing endoscope and / or rigidizing overtube.

[0320] Clause 14. The apparatus of any of clauses 1-13, wherein the one or more control inputs comprises a first input control configured to receive user inputs to advance or retract the endoscope tool coupled to the endoscope tool driver and a second input control configured to receive user inputs to move the endoscope.- 71 -SG Docket No.: 13668-740.600

[0321] Clause 15. A robotic endoscope apparatus, the apparatus comprising: an endoscope driver comprising a robotic assembly comprising one or more links and an endoscope mount configured to engage an endoscope assembly comprising an elongate flexible endoscope having one or more working channels, and to move the elongate flexible endoscope of the endoscope assembly; an endoscope tool driver coupled to the endoscope driver, wherein the endoscope tool driver is configured to secure to a proximal end region of an endoscope tool and to advance or withdraw the endoscope tool relative to a working channel of the elongate flexible endoscope; one or more control inputs; and a controller receiving input from the one or more control inputs and configured to control operation of the robotic assembly to drive insertion, withdrawal and steering of the elongate flexible endoscope and to control advancing and / or withdrawal of the endoscope tool.

[0322] Clause 16. An endoscope tool driver device, the device comprising: a base; a seating region movably coupled to the base, the seating region configured to seat a proximal end region of an elongate flexile endoscope tool, wherein the seat is configured to frictionally engage with the proximal end region; an endoscope tool driver securement configured to secure over the seating region and to secure the proximal end region within the seating region; and a drive coupled to the seating region and configured to drive the seating region in a liner path to insert and retract the flexible elongate tool.

[0323] Clause 17. The device of clause 16, wherein the seating region comprises an elastomeric material configured to conform to the proximal end region.

[0324] Clause 18. The device of any of clauses 16-17, further comprising a sensor configured to detect that a proximal end region is seated in the seating region.

[0325] Clause 19. The device of any of clauses 16-18, further comprising a choke configured to hold the position of the seating region relative to the base when the choke is engaged.

[0326] Clause 20. The device of any of clauses 16-19, wherein the base is configured to mount to a robotic driver.

[0327] Clause 21. The device of any of clauses 16-20, wherein the endoscope tool driver securement comprises a lid.

[0328] Clause 22. The device of any of clauses 16-21, further comprising a lock configured to releasably lock the endoscope tool driver securement in position over the seating region.

[0329] Clause 23. The device of clause 22, wherein the lock comprises a magnetic lock.- 72 -SG Docket No.: 13668-740.600

[0330] Clause 24. A method of controlling operation of a flexible endoscope tool, the method comprising: inserting the flexible endoscope tool through a working channel; securing a proximal end region of the flexible endoscope tool into a seating region of an endoscope tool driver so that the proximal end region is frictionally secured to the endoscope tool driver; and activating a driver in the endoscope tool driver to advance and / or retract the seating region relative to a base of the seating region to advance and / or retract the flexible endoscope tool based on input from a user control input.

[0331] Clause 25. The method of clause 24, further comprising engaging a choke to hold the position of the seating region relative to the base when the driver is not activated.

[0332] Clause 26. The method of any of clauses 24-25, wherein inserting the flexible endoscope tool through the working channel comprises inserting the flexible endoscope tool through an external working channel.

[0333] Clause 27. The method of any of clauses 24-26, wherein inserting the flexible endoscope tool through the working channel comprises inserting the flexible endoscope tool through an internal working channel of the endoscope.

[0334] Clause 28. The method of any of clauses 24-27, wherein securing the proximal end region of the flexible endoscope tool into the seating region comprises engaging a securement over the seating region.

[0335] Clause 29. The method of clause 28, further comprising locking the securement to secure the proximal end region of the flexible endoscope tool into the seating region.

[0336] Clause 30. The method of clause 28, wherein locking comprise magnetically locking.

[0337] Clause 31. An endoscope tool driver device, the device comprising: a base; a tool handle receiver extending from the base and having a receiving surface configured to engage with a tool handle of a tool; a tool end effector actuator extending from the base and configured to engage a proximal end of the tool and to rotate the proximal end of the tool; and a drive coupled to the tool end effector actuator and configured to move the tool end effector actuator proximally and distally relative to the tool handle receiver; wherein the base is configured to be mounted to a link of a robotic driver to insert and retract the flexible elongate tool.

[0338] Clause 32. The device of clause 31, wherein the tool handle receiver comprises a dock configured to receive a projection extending from the tool handle.

[0339] Clause 33. The device of any of clauses 31-32, wherein the tool handle receiver comprises a seating region.- 73 -SG Docket No.: 13668-740.600

[0340] Clause 34. The device of clause 33, wherein the seating region comprises an elastomeric material configured to conform to the tool handle.

[0341] Clause 35. The device of any of clauses 31-34, further comprising a sensor configured to detect that a tool handle is engaged with the tool handle receiver.

[0342] Clause 36. The device of any of clauses 31-35, further comprising a lock configured to lock a tool handle to the tool handle receiver.

[0343] Clause 37. The device of any of clauses 31-36, further comprising a rotatable tool shaft grip rotatably coupled to the tool end effector actuator configured to engage the proximal end of the tool and to rotate the proximal end of the tool handle.

[0344] Clause 38. The device of any of clauses 31-37, wherein the tool end effector actuator is configured to rotate the proximal end of the tool handle relative to the tool handle.

[0345] Clause 39. The device of any of clauses 31-38, wherein the tool end effector actuator comprises a friction wheel configured to drive rotation of the proximal end of the tool.

[0346] Clause 40. The device of any of clauses 31-39, wherein the drive is embedded within the base.

[0347] Clause 41. An endoscope tool driver device, the device comprising: a base; a tool handle receiver comprising a dock having a receiving surface configured to engage with a projection from a tool handle of a tool; a rotatable tool shaft grip rotatably coupled to a tool end effector actuator configured to engage a proximal end of the tool and to rotate the proximal end of the tool handle relative to the tool handle; and a drive coupled to the tool end effector actuator and configured to move the tool end effector actuator proximally and distally relative to the tool handle receiver; wherein the base is configured to be mounted to a link of a robotic driver to insert and retract the flexible elongate tool.

[0348] Clause 42. A method of controlling operation of a flexible tool for use with an endoscope, the method comprising: inserting the flexible tool through a working channel of the endoscope; securing a handle region of the flexible tool in a tool handle receiver of an endoscope tool driver and a proximal end of the flexible tool in a tool end effector actuator; and activating a driver of the endoscope tool driver to advance and / or retract the proximal end of the flexible tool relative to the handle region to steer and / or actuate a distal end effector of the tool.

[0349] Clause 43. The method of clause 42, further comprising activating a rotary driver of the endoscope tool driver to rotate the proximal end of the flexible tool relative to the handle region steer and / or actuate the distal end effector of the tool.- 74 -SG Docket No.: 13668-740.600

[0350] Clause 44. The method of any of clauses 42-43, wherein inserting the flexible endoscope tool through the working channel comprises inserting the flexible endoscope tool through an external working channel.

[0351] Clause 45. The method of any of clauses 42-44, wherein inserting the flexible endoscope tool through the working channel comprises inserting the flexible endoscope tool through an internal working channel of the endoscope.

[0352] Clause 46. The method of any of clauses 42-45, wherein securing the handle region of the flexible tool in the tool handle receiver comprises inserting a tool engagement projection on the tool handle into a tool handle dock.

[0353] Clause 47. The method of any of clauses 42-46, further comprising locking the handle region of the flexible tool in the tool handle receiver.

[0354] Clause 48. A method of controlling operation of a flexible tool for use with an endoscope, the method comprising: inserting the flexible tool through a working channel of the endoscope; securing a handle region of the flexible tool in a tool handle receiver of an endoscope tool driver and a proximal end of the flexible tool in a tool end effector actuator; and activating a driver of the endoscope tool driver to advance and / or retract the proximal end of the flexible tool relative to the handle region to steer and / or actuate a distal end effector of the tool; and activating a rotary driver of the endoscope tool driver to rotate the proximal end of the flexible tool relative to the handle region steer and / or actuate the distal end effector of the tool.

[0355] Clause 49. A endoscope tool for a nested rigidizing apparatus, the tool comprising: an elongate body having a first distal region configured to bend in a single plane and a second distal region proximal to the first distal region configured to bend in two or more planes; a distal end effector extending distally from the fist distal end region comprising a pair of graspers; wherein the distal end effector is configured to be moved to apply 0.2 N or force or greater to lift a tissue when extended from a distal end of a working channel of the nested rigidizing apparatus.

[0356] Clause 50. The tool of clause 49, wherein the first distal region is configured to be articulated by a first pair of cables.

[0357] Clause 51. The tool of any of clauses 49-50, wherein the second distal region is configured to be articulated by two or more pairs of cables.

[0358] Clause 52. The tool of any of clauses 49-51, wherein the first distal region comprises a hypotube cut into an interlocking pivot flex section oriented to pivot in one direction.- 75 -SG Docket No.: 13668-740.600

[0359] Clause 53. The tool of any of clauses 49-52, wherein the elongate body is covered by an angulation mesh configured to provide a low-friction exterior.

[0360] Clause 54. The tool of any of clauses 49-53, wherein the grasper comprises a rattooth grasper.

[0361] Clause 55. The tool of any of clauses 49-54, wherein the first distal region is separated from the second distal region by a first flex interface region including a cable termination region the first pair of cables.

[0362] Clause 56. The tool of any of clauses 49-55, wherein the second distal region comprises a hypotube cut into an interlocking pivot flex section oriented to pivot in two or more directions.

[0363] Clause 57. The tool of any of clauses 49-56, wherein the elongate body comprises a plurality of eyelets within the elongate body for stabilizing the first pair of cables and the second two or more pairs of cables.

[0364] Clause 58. The tool of any of clauses 49-57, wherein the first distal region is between about 1 cm and 10 cm, and the second distal region is between about 1 cm and about 10 cm.

[0365] Clause 59. A method of operating a tool for a nested rigidizing apparatus, the method comprising: inserting the tool through a working channel of a nested rigidizing apparatus, wherein the working channel is external to the outer rigidizing member of the nested rigidizing apparatus; extending the distal end region of the endoscope tool distally from the working channel; navigating the endoscope tool to a tissue region by: advancing and / or retracting the endoscope tool longitudinally; bending a first distal end region of the endoscope tool in a first plane; bending a second distal end region of the endoscope tool, proximal to the first distal end region, in two or more planes; and rotating the endoscope tool relative to the working channel; grasping a tissue of the tissue region with a distal grasper.

[0366] Clause 60. The method of clause 59, wherein inserting comprises inserting the endoscope tool through a tool liner within the working channel.

[0367] Clause 61. The method of clause 60, wherein the liner comprises a spiral-cut hypotube.

[0368] Clause 62. The method of clause 60, wherein applying 0.2 N of force comprises applying the force against the overtube.

[0369] Clause 63. The method of clause 59, wherein applying 0.2 N of force comprises moving the distal grasper at least 1 cm of travel relative to the tissue region.- 76 -SG Docket No.: 13668-740.600

[0370] Clause 64. The method of clause 59, wherein navigating the endoscope tool comprises moving the distal grasper within the field of view of an imaging sub-assembly of the nested rigidizing apparatus.

[0371] Clause 65. The method of clause 59, wherein grasping the tissue comprises grasping a polyp.

[0372] Clause 66. The method of clause 59, wherein each of the steps of bending the first distal end region, bending the second distal end region, rotating the endoscope tool and grasping the tissue are separately controlled, wherein each of the steps of bending the first distal end region, bending the second distal end region, rotating the endoscope tool and grasping the tissue are controlled by a tool driver coupled to the endoscope tool.

[0373] Clause 67. The method of clause 59, wherein navigating the endoscope tool to the tissue region comprises navigating the endoscope tool when the outer rigidizing member is in a rigid configuration.

[0374] Clause 68. The method of clause 59, further comprising removing the endoscope tool from the working channel.

[0375] Clause 69. A shield for an endoscopy tool, the shield comprising: a proximal region elongate shield body covering the tool shaft, comprising a flexible layer of fluid- impermeable material; a distal region comprising a flexible and fluid-impermeable glove configured to fit over jaws of the tool.

[0376] Clause 70. The shield of clause 69, wherein the distal glove region comprises a first jaw covering and a second jaw covering; and wherein there is a first textured region on the first jaw covering and a second textured region on the second jaw covering, wherein the first and second textured regions are configured to extend over a tissue contacting surface of the clamping actuator when the shield is worn over the tool.

[0377] Clause 71. The shield of clause 69, wherein the distal glove region is formed of the same material as the elongate shield body.

[0378] Clause 72. The shield of any of clauses 69-71, further comprising a securement at a distal end region of the shield, proximal to the distal glove region, that is configured to secure the shield to an outer surface of the tool.

[0379] Clause 73. The shield of clause 72, wherein the securement comprises an elastic securement.

[0380] Clause 74. The shield of any of clauses 69-73, further wherein the distal glove region is reinforced relative to the elongate shield body.

[0381] Clause 75. The shield of any of clauses 69-74, wherein the elongate shield body comprises a polymeric material.- 77 -SG Docket No.: 13668-740.600

[0382] Clause 76. The shield of any of clauses 69-75, further comprising a proximal seal configured to seal the proximal end of the shield over the tool.

[0383] Clause 77. The shield of any of clauses 69-76, further comprising an inflation port configured to apply pressure between the shield and the tool to detect leaks within the shield.

[0384] Clause 78. The shield of any of clauses 69-77, wherein the first and second textured region comprise a gripping surface.

[0385] Clause 79. A method of operating a tool shield, the method comprising: loading the elongate shield over a length of an endoscopy tool; inserting a clamping actuator of the tool into a distal glove region of the shield; and inserting the tool covered by the shield though a working channel.

[0386] Clause 80. The method of clause 79, wherein inserting the clamping actuator of the tool into the distal glove region of the shield comprises inserting the clamping actuator so that a first jaw of the clamping actuator is within a first jaw covering and a second jaw of the clamping actuator is within a second jaw covering.

[0387] Clause 81. The method of clause 80, further comprising extending an elongate shield body of the shield over a length of the tool from the clamping actuator to a proximal region of the tool.

[0388] Clause 82. The method of clause 79, further comprising gasping tissue between the first and second jaws so that the tissue contacts a gripping surface of the first jaw covering and a gripping surface of the second jaw covering.

[0389] Clause 83. The method of clause 79, wherein extending the elongate shield body of the shield over the length of the tool comprises securing the elongate shield body to an outer surface of the tool at one or more discrete regions.

[0390] Clause 84. The method of clause 83, wherein securing the elongate shield body comprises securing the elongate shield body so that a region of material forming the elongate shield comprises an excess of length of the elongate shield body to prevent binding of the tool by the shield body when bending the tool.

[0391] Clause 85. The method of clause 79, further comprising sealing a proximal end of the shield over the tool.

[0392] Clause 86. The method of clause 85, further comprising testing the shield for leaks.

[0393] Clause 87. The method of clause 86, wherein testing the shield for leaks comprises applying positive or negative pressure between the shield and the tool.

[0394] Clause 88. A shield for an endoscopy tool, the shield comprising: an elongate body forming a lumen configured to receive the tool therein; a proximal seal configured to- 78 -SG Docket No.: 13668-740.600seal the elongate body over or against the tool so that a distal portion of the endoscopy tool is sealed within the lumen; a proximal port on the elongate body configured to couple to a pressure source, wherein the proximal port is in fluid communication with the lumen so that pressure may be applied between the elongate body and the endoscopy tool to identify a leak through the elongate body before and / or after a procedure.

[0395] Clause 89. The shield of clause 88, wherein a distal end region of the elongate body comprises a glove region comprises a first jaw covering and a second jaw covering; and wherein there is a first textured region on the first jaw covering and a second textured region on the second jaw covering, wherein the first and second textured regions are configured to extend over a tissue contacting surface of a clamping actuator of the tool when the shield is worn over the tool.

[0396] Clause 90. The shield of clause 89, wherein the distal glove region is formed of the same material as the elongate body.

[0397] Clause 91. The shield of any of clauses 88-90, further comprising a securement at a distal end region of the shield configured to secure the shield to an outer surface of the tool.

[0398] Clause 92. The shield of clause 91, wherein the securement comprises an elastic securement.

[0399] Clause 93. The shield of clause 89, further wherein the distal glove region is reinforced relative to the elongate shield body.

[0400] Clause 94. The shield of any of clauses 88-93, wherein the elongate shield body comprises a polymeric material.

[0401] Clause 95. An endoscope tool device, the device comprising: a flexible elongate body; a distal end effector; a proximal control region comprising one or more actuators arranged in series, wherein each of the one or more actuator is configured to be independently actuated relative to a region of the flexible elongate body that is distal to the proximal control region, and is configured to actuate a distal end region of the flexible elongate body and / or the distal end effector, further wherein each of the one or more actuators has an outer diameter that is less than five times an outer diameter of the flexile elongate body.

[0402] Clause 96. The device of clause 95, wherein the proximal control region is configured to dock into a seating region of an endoscope tool driver.

[0403] Clause 97. The device of clause 95, wherein each of the one or more actuators is coupled to a pull and / or push tendon extending within the flexible elongate body.

[0404] Clause 98. The device of clause 95, wherein at least one of the one or more actuators is coupled to the distal end effector.- 79 -SG Docket No.: 13668-740.600

[0405] Clause 99. The device of clause 95, further comprising an end effector actuator within the proximal control region configured to actuate the distal end effector.

[0406] Clause 100. The device of clause 95, wherein the each of the one or more actuators has an outer diameter that is less than two times an outer diameter of the flexile elongate body.

[0407] Clause 101. The device of clause 95, wherein the distal end effector comprises a pair of jaws.

[0408] Clause 102. The device of clause 95, wherein the distal end effector comprises a lasso.

[0409] Clause 103. The device of clause 95, wherein the distal end effector comprises a net.

[0410] Clause 104. The device of clause 95, wherein the distal end effector comprises an energy applicator.

[0411] Clause 105. The device of clause 95, wherein the one or more actuators is configured to actuate the distal end region of the flexible elongate body and / or the distal end effector to deflect in one or more planes and / or to roll and / or to apply energy.

[0412] Clause 106. The device of clause 95, wherein the flexible elongate body is configured to be inserted through an internal working channel of an endoscope.

[0413] Clause 107. The device of clause 95, wherein the flexible elongate body is configured to be inserted through an external working channel.

[0414] Clause 108. A multi-axis endoscope tool driver device, the device comprising: a base comprising a track; a plurality of seating regions each movably coupled to the base in series, wherein each seating region is configured to seat a corresponding actuator of a proximal end region of an elongate flexile endoscope tool, wherein each seating region is further configured to frictionally engage with the corresponding actuator of a proximal end region; a plurality of endoscope tool driver securements, wherein each endoscope tool driver securement of the plurality of endoscope tool driver securement is configured to secure over one of the seating regions of the plurality of seating regions and to secure the corresponding actuator of the proximal end region thereto; and a plurality of linear drives, wherein each linear driver of the plurality of linear drives is coupled to a corresponding seating region of the plurality of seating regions and is configured to drive the corresponding seating region along the track in a liner path to actuate the corresponding actuator; wherein one of the seating region of the plurality of seating regions is configured to insert and retract the elongate flexile endoscope tool.- 80 -SG Docket No.: 13668-740.600

[0415] Clause 109. The device of clause 108, wherein the one of the seating region configured to insert and retract the elongate flexible endoscope tool is a proximal-most seating region of the plurality of seating regions.

[0416] Clause 110. The device of clause 108, wherein each seating region of the plurality of seating regions comprises an elastomeric material configured to conform to the proximal end region.

[0417] Clause 111. The device of clause 108, further comprising a sensor configured to detect that the proximal end region of an elongate flexile endoscope tool is seated in the plurality of seating regions.

[0418] Clause 112. The device of clause 108, further comprising a plurality of chokes, wherein each choke is associated with a linear drive and is configured to hold the position of a corresponding seating region relative to the base when the choke is engaged.

[0419] Clause 113. The device of clause 108, wherein the base is configured to mount to a robotic driver.

[0420] Clause 114. A shield for an endoscopy tool, the shield comprising: a proximal region elongate shield body covering the tool shaft, comprising a flexible layer of fluid- impermeable material; a distal region comprising a disposable distal end effector extending distally from the shield region; and an engagement region within the shield body in mechanical communication with the disposable end effector that is configured to releasably engage with a distal end of a tool body.

[0421] Clause 115. The shield of clause 114, further comprising a securement at a distal end region of the shield, proximal to the distal glove region, that is configured to secure the shield to an outer surface of the tool.

[0422] Clause 116. The shield of clause 115, wherein the securement comprises an elastic securement.

[0423] Clause 117. The shield of any of clauses 114-116, wherein the elongate shield body comprises a polymeric material.

[0424] Clause 118. The shield of any of clauses 114-117, further comprising a proximal seal configured to seal the proximal end of the shield over the tool.

[0425] Clause 119. The shield of any of clauses 114-118, further comprising an inflation port configured to apply pressure between the shield and the tool to detect leaks within the shield.- 81 -SG Docket No.: 13668-740.600

Claims

CLAIMSWhat is claimed is:

1. A robotic endoscope apparatus, the apparatus comprising: an endoscope driver comprising a robotic assembly configured to engage an endoscope assembly, and to move an endoscope of the endoscope assembly; an endoscope tool driver coupled to the endoscope driver, wherein the endoscope tool driver is configured to secure to a proximal end region of an endoscope tool and to advance or withdraw the endoscope tool relative to a working channel of the endoscope; one or more control inputs; and a controller receiving input from the one or more control inputs and configured to control operation of the robotic assembly to drive insertion, withdrawal and steering of the endoscope and to control advancing and / or withdrawal of the endoscope tool.

2. The apparatus of claim 1, wherein the endoscope tool driver is configured to roll a distal end effector of the endoscope tool.

3. The apparatus of any of claims 1-2, wherein the endoscope tool driver is configured to actuate a distal end effector of the endoscope tool.

4. The apparatus of any of claims 1-3, wherein the endoscope tool driver comprises a base and a seating region movably coupled to the base, wherein the seating region is configured to secure a proximal end region of the endoscope tool.

5. The apparatus of claim 4, wherein the endoscope tool driver comprises a securement configured to secure over the seating region and to secure the proximal end region within the seating region.

6. The apparatus of claim 4, wherein the endoscope tool driver comprises a drive coupled to the seating region and configured to drive the seating region in a liner path to insert and retract the endoscope tool.

7. The apparatus of claim 6, wherein the drive is configured as a linear drive.

8. The apparatus of claim 6, wherein the drive is configured as a rotary drive.- 82 -SG Docket No.: 13668-740.6009. The apparatus of any of claims 1-8, wherein the robotic assembly comprises one or more links and an endoscope mount configured to engage the endoscope assembly.

10. The apparatus of any of claims 1-9, wherein the endoscope driver is configured to drive a nested endoscope assembly comprising an endoscope and an overtube.

11. The apparatus of any of claims 1-10, wherein the robotic assembly comprises an arm assembly comprising two or more pivotally joined links.

12. The apparatus of any of claims 1-11, wherein the robotic assembly comprises a telescoping robotic assembly comprising two or more telescoping links.

13. The apparatus of any of claims 1-12, wherein the endoscope driver is configured to engage a rigidizing endoscope and / or rigidizing overtube.

14. The apparatus of any of claims 1-13, wherein the one or more control inputs comprises a first input control configured to receive user inputs to advance or retract the endoscope tool coupled to the endoscope tool driver and a second input control configured to receive user inputs to move the endoscope.

15. A robotic endoscope apparatus, the apparatus comprising: an endoscope driver comprising a robotic assembly comprising one or more links and an endoscope mount configured to engage an endoscope assembly comprising an elongate flexible endoscope having one or more working channels, and to move the elongate flexible endoscope of the endoscope assembly; an endoscope tool driver coupled to the endoscope driver, wherein the endoscope tool driver is configured to secure to a proximal end region of an endoscope tool and to advance or withdraw the endoscope tool relative to a working channel of the elongate flexible endoscope; one or more control inputs; and a controller receiving input from the one or more control inputs and configured to control operation of the robotic assembly to drive insertion, withdrawal and steering of the elongate flexible endoscope and to control advancing and / or withdrawal of the endoscope tool.

16. An endoscope tool driver device, the device comprising: a base;- 83 -SG Docket No.: 13668-740.600a seating region movably coupled to the base, the seating region configured to seat a proximal end region of an elongate flexile endoscope tool, wherein the seat is configured to frictionally engage with the proximal end region; an endoscope tool driver securement configured to secure over the seating region and to secure the proximal end region within the seating region; and a drive coupled to the seating region and configured to drive the seating region in a liner path to insert and retract the flexible elongate tool.

17. The device of claim 16, wherein the seating region comprises an elastomeric material configured to conform to the proximal end region.

18. The device of any of claims 16-17, further comprising a sensor configured to detect that a proximal end region is seated in the seating region.

19. The device of any of claims 16-18, further comprising a choke configured to hold the position of the seating region relative to the base when the choke is engaged.

20. The device of any of claims 16-19, wherein the base is configured to mount to a robotic driver.

21. The device of any of claims 16-20, wherein the endoscope tool driver securement comprises a lid.

22. The device of any of claims 16-21, further comprising a lock configured to releasably lock the endoscope tool driver securement in position over the seating region.

23. The device of claim 22, wherein the lock comprises a magnetic lock.

24. A method of controlling operation of a flexible endoscope tool, the method comprising: inserting the flexible endoscope tool through a working channel; securing a proximal end region of the flexible endoscope tool into a seating region of an endoscope tool driver so that the proximal end region is frictionally secured to the endoscope tool driver; and activating a driver in the endoscope tool driver to advance and / or retract the seating region relative to a base of the seating region to advance and / or retract the flexible endoscope tool based on input from a user control input.- 84 -SG Docket No.: 13668-740.60025. An endoscope tool driver device, the device comprising: a base; a tool handle receiver extending from the base and having a receiving surface configured to engage with a tool handle of a tool; a tool end effector actuator extending from the base and configured to engage a proximal end of the tool and to rotate the proximal end of the tool; and a drive coupled to the tool end effector actuator and configured to move the tool end effector actuator proximally and distally relative to the tool handle receiver; wherein the base is configured to be mounted to a link of a robotic driver to insert and retract the flexible elongate tool.

26. An endoscope tool driver device, the device comprising: a base; a tool handle receiver comprising a dock having a receiving surface configured to engage with a projection from a tool handle of a tool; a rotatable tool shaft grip rotatably coupled to a tool end effector actuator configured to engage a proximal end of the tool and to rotate the proximal end of the tool handle relative to the tool handle; and a drive coupled to the tool end effector actuator and configured to move the tool end effector actuator proximally and distally relative to the tool handle receiver; wherein the base is configured to be mounted to a link of a robotic driver to insert and retract the flexible elongate tool.

27. A method of controlling operation of a flexible tool for use with an endoscope, the method comprising: inserting the flexible tool through a working channel of the endoscope; securing a handle region of the flexible tool in a tool handle receiver of an endoscope tool driver and a proximal end of the flexible tool in a tool end effector actuator; and activating a driver of the endoscope tool driver to advance and / or retract the proximal end of the flexible tool relative to the handle region to steer and / or actuate a distal end effector of the tool.- 85 -SG Docket No.: 13668-740.60028. A method of controlling operation of a flexible tool for use with an endoscope, the method comprising: inserting the flexible tool through a working channel of the endoscope; securing a handle region of the flexible tool in a tool handle receiver of an endoscope tool driver and a proximal end of the flexible tool in a tool end effector actuator; and activating a driver of the endoscope tool driver to advance and / or retract the proximal end of the flexible tool relative to the handle region to steer and / or actuate a distal end effector of the tool; and activating a rotary driver of the endoscope tool driver to rotate the proximal end of the flexible tool relative to the handle region steer and / or actuate the distal end effector of the tool.

29. An endoscope tool for a nested rigidizing apparatus, the tool comprising: an elongate body having a first distal region configured to bend in a single plane and a second distal region proximal to the first distal region configured to bend in two or more planes; a distal end effector extending distally from the fist distal end region comprising a pair of graspers; wherein the distal end effector is configured to be moved to apply 0.2 N or force or greater to lift a tissue when extended from a distal end of a working channel of the nested rigidizing apparatus.

30. A method of operating a tool for a nested rigidizing apparatus, the method comprising: inserting the tool through a working channel of a nested rigidizing apparatus, wherein the working channel is external to the outer rigidizing member of the nested rigidizing apparatus; extending the distal end region of the endoscope tool distally from the working channel; navigating the endoscope tool to a tissue region by: advancing and / or retracting the endoscope tool longitudinally; bending a first distal end region of the endoscope tool in a first plane; bending a second distal end region of the endoscope tool, proximal to the first distal end region, in two or more planes; and rotating the endoscope tool relative to the working channel;- 86 -SG Docket No.: 13668-740.600grasping a tissue of the tissue region with a distal grasper.

31. A shield for an endoscopy tool, the shield comprising: a proximal region elongate shield body covering the tool shaft, comprising a flexible layer of fluid-impermeable material; a distal region comprising a flexible and fluid-impermeable glove configured to fit over jaws of the tool.

32. A method of operating a tool shield, the method comprising: loading the elongate shield over a length of an endoscopy tool; inserting a clamping actuator of the tool into a distal glove region of the shield; and inserting the tool covered by the shield though a working channel.

33. A shield for an endoscopy tool, the shield comprising: an elongate body forming a lumen configured to receive the tool therein; a proximal seal configured to seal the elongate body over or against the tool so that a distal portion of the endoscopy tool is sealed within the lumen; a proximal port on the elongate body configured to couple to a pressure source, wherein the proximal port is in fluid communication with the lumen so that pressure may be applied between the elongate body and the endoscopy tool to identify a leak through the elongate body before and / or after a procedure.

34. An endoscope tool device, the device comprising: a flexible elongate body; a distal end effector; a proximal control region comprising one or more actuators arranged in series, wherein each of the one or more actuator is configured to be independently actuated relative to a region of the flexible elongate body that is distal to the proximal control region, and is configured to actuate a distal end region of the flexible elongate body and / or the distal end effector, further wherein each of the one or more actuators has an outer diameter that is less than five times an outer diameter of the flexile elongate body.

35. A multi-axis endoscope tool driver device, the device comprising: a base comprising a track; a plurality of seating regions each movably coupled to the base in series,- 87 -SG Docket No.: 13668-740.600wherein each seating region is configured to seat a corresponding actuator of a proximal end region of an elongate flexile endoscope tool, wherein each seating region is further configured to frictionally engage with the corresponding actuator of a proximal end region; a plurality of endoscope tool driver securements, wherein each endoscope tool driver securement of the plurality of endoscope tool driver securement is configured to secure over one of the seating regions of the plurality of seating regions and to secure the corresponding actuator of the proximal end region thereto; and a plurality of linear drives, wherein each linear driver of the plurality of linear drives is coupled to a corresponding seating region of the plurality of seating regions and is configured to drive the corresponding seating region along the track in a liner path to actuate the corresponding actuator; wherein one of the seating region of the plurality of seating regions is configured to insert and retract the elongate flexile endoscope tool.

36. A shield for an endoscopy tool, the shield comprising: a proximal region elongate shield body covering the tool shaft, comprising a flexible layer of fluid-impermeable material; a distal region comprising a disposable distal end effector extending distally from the shield region; and an engagement region within the shield body in mechanical communication with the disposable end effector that is configured to releasably engage with a distal end of a tool body.- 88 -SG Docket No.: 13668-740.600

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