WO2025096221A1 - Devices and methods for internal imaging - Google Patents

Abstract

The invention relates to devices and methods for visualizing and/or interacting with internal body tissues. More particularly, the present invention relates to endoscopic methods and devices for visualizing and/or interacting with the gastrointestinal and/or pancreaticobiliary systems. Further, the present invention relates to one use or disposable devices for visualizing and/or interacting with the gastrointestinal and/or pancreaticobiliary systems, such as with duodenoscopes. In general, a device for visualizing and/or interacting with internal body tissues may generally include a handpiece, a distal assembly, and/or a connecting conduit. A plurality of conduits and/or channels may span through the connecting conduit from the handpiece to the distal assembly, and may, for example, carry fluid/gas connections, electrical/sensor connections, such as for a camera, mechanical connections and/or carry medical devices through a working channel. The device may utilize or be utilized with a machine learning system for training and modeling, and giving guidance to a user.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a Patent Cooperation Treaty International Application and claims the benefit and priority of U.S. provisional patent applications Ser. No. 63/595,150, filed November 1, 2023, entitled “DEVICES AND METHODS FOR INTERNAL IMAGING”, the contents of which is hereby incorporated by reference in its entirety.

FIELD OF THE INVENTION

[0002] The invention relates to devices and methods for visualizing and/or interacting with internal body tissues. More particularly, the present invention relates to endoscopic methods and devices for visualizing and/or interacting with the gastrointestinal and/or pancreaticobiliary systems. Further, the present invention relates to one use or at least partially disposable devices for visualizing and/or interacting with the gastrointestinal and/or pancreaticobiliary systems, such as with duodenoscopes. The present invention also relates to systems and methods for training and implementing usage of machine learning and/or artificial intelligence augmented or guided usage of endoscopic methods and devices for visualizing and/or interacting with the gastrointestinal and/or pancreaticobiliary systems.

BACKGROUND OF THE INVENTION

[0003] Endoscopes for medical use have been adopted for various diagnostic and medical treatment procedures. Endoscopes have been used for the diagnosis and treatment of a wide range of diseases and disorders that often require a physician to access the tortuous and relatively small cross-sectional areas of a patient's internal anatomical body lumens. A patient's pancreaticobiliary system (including the anatomical regions of the gall bladder, pancreas, and the biliary tree), for example, is accessed for diagnosis, and/or treatment of disorders of certain portions of the digestive system.

[0004] During treatment of the digestive system, endoscopes are often used to access and visualize a patient's pancreaticobiliary system. Once the endoscope is positioned in the desired body portion, a treatment instrument can be advanced through the working channel of the endoscope to the desired body portion. The endoscope and treatment instrument may then be manipulated as desired for visualization and treatment respectively.

[0005] Endoscopic retrograde cholangiopancreatography (ERCP) is one example of a medical procedure that uses an endoscope. ERCP enables the physician to diagnose problems in the liver, gallbladder, bile ducts, and pancreas. The liver is a large organ that, among other things, makes a liquid called bile that helps with digestion. The gallbladder is a small, pear- shaped organ that stores bile until it is needed for digestion. The bile ducts are tubes that carry bile from the liver to the gallbladder and small intestine. These ducts are sometimes called the biliary tree. The pancreas is a large gland that produces chemicals that help with digestion and hormones such as insulin.

[0006] The biliary system delivers bile produced by the liver to the duodenum where the bile assists other gastric fluids in digesting food. The biliary system includes the liver, as well as a plurality of bodily channels and organs that are disposed between the liver and the duodenum. Within the liver lobules, there are many fine “bile canals” that receive secretions from the hepatic cells. The canals of neighboring lobules unite to form larger ducts, and these converge to become the “hepatic ducts.” They merge, in turn, to form the “common hepatic duct.” The “common bile duct” is formed by the union of the common hepatic and the cystic ducts. It leads to the duodenum, where its exit is guarded by a sphincter muscle. This sphincter normally remains contracted until the bile is needed, so that bile collects in the common bile duct and backs up to the cystic duct. When this happens, the bile flows into the gallbladder and is stored there.

[0007] ERCP is used primarily to diagnose and treat conditions of the bile ducts, including gallstones, inflammatory strictures, leaks (from trauma and surgery), and cancer. ERCP combines the use of x-rays and an endoscope. Through the endoscope, the physician can see the inside of the stomach and duodenum, and inject dyes into the ducts in the biliary tree and pancreas so they can be seen on x-rays.

[0008] An ERCP is performed primarily to identify and/or correct a problem in the bile ducts or pancreas. For example, if a gallstone is found during the exam, it can often be removed by means of a treatment instrument, eliminating the need for major surgery. If a blockage in the bile duct causes yellow jaundice or pain, it can be relieved through the use of a treatment instrument inserted through the endoscope.

[0009] Recent attention has been directed to cases of patient illness due to contamination and improper sterilization of reusable endoscopes such as duodenoscopes. High infection rates secondary to current reusable duodenoscopes have sparked significant problems for patients, hospitals, and doctors. Various methods of reprocessing and additional steps within the reprocessing have been implemented. Currently this is a major problem in medicine related to infections and deaths that should be avoidable.

SUMMARY OF THE INVENTION [0010] The invention relates to devices and methods for visualizing and/or interacting with internal body tissues. More particularly, the present invention relates to endoscopic methods and devices for visualizing and/or interacting with the gastrointestinal and/or pancreaticobiliary systems. Further, the present invention relates to one use or disposable devices for visualizing and/or interacting with the gastrointestinal and/or pancreaticobiliary systems, such as with duodenoscopes. The present invention also relates to systems and methods for training and implementing usage of machine learning and/or artificial intelligence augmented or guided usage of endoscopic methods and devices for visualizing and/or interacting with the gastrointestinal and/or pancreaticobiliary systems.

[0011] In general, a device for visualizing and/or interacting with internal body tissues may generally include a handpiece, a distal assembly, and/or a connecting conduit. The device may further generally be used to introduce the distal assembly to a location in proximity to an internal body tissue of interest, such as, for example, portions of the gastrointestinal and/or pancreaticobiliary systems, further for example the tubular body structures of those systems. In some exemplary embodiments, a plurality of conduits and/or channels may span through the connecting conduit from the handpiece to the distal assembly, and may, for example, carry fluid/gas connections, electrical/sensor connections, mechanical connections and/or carry medical devices through a working channel. The connecting conduit may generally be flexible and/or deformable and interact with the actions of the pull wires to direct the distal end of the connecting conduit in a desired direction. The device may also be, in general, disposable and/or single use. Disposable or single use devices may be desirable, for example, to aid in reducing the incidence of infection or contamination from improper handling or sterilizing of reusable devices, reducing the need for maintenance, allowing for selection of different materials that do not necessarily require durability against repeated use/sterilization and allowing for lower cost materials. Devices may also utilize modular designs which may include independently replaceable portions, such as disposable portions and reusable portions. Portions may also be designed to be hot-swappable, such as to accommodate replacement of portions, such as due to malfunction or the like, during use.

[0012] In one aspect, a device for visualizing and/or interacting with internal body tissues may generally utilize a plurality of mechanical directors for guiding the trajectory of the distal assembly when being inserted and/or navigated through body tubes and/or cavities. In some exemplary embodiments, the mechanical directors may generally include a plurality of pull wires which may pull and/or push on the distal assembly while contained within the connection conduit for altering and/or articulating the directi on/trajectory of the distal assembly. A further mechanical director may also be used, for example, to control an elevator and/or other feature for manipulating a medical device at the distal assembly. Mechanical directors may be controlled by manual mechanisms or powered mechanisms, such as motors. Either analog interfaces, digital interfaces or a combination thereof between controls and the mechanical directors may be utilized. With digital interfaces, a variety of different controllers may be utilized, such as controls on the handpiece, wireless controls (e.g. control from a mobile device, tablet, remote control, computer or wireless controller), wired controllers, and/or any other appropriate controller.

[0013] In another aspect, the device may generally include a camera in the distal assembly for visualizing body tissues. In some exemplary embodiments, the camera may be side viewing relative to the axis of the insertion of the device. Further, the camera may generally be connected through the connecting conduit and/or handpiece for real time viewing and/or on demand visual capture during a procedure. The camera and/or processing system for the camera may also include, for example, dynamic and/or directional brightness control, such as with a light sensor, panoramic image capture/image stitching, image stabilization and/or other features. The distal assembly may also include a light source(s), such as for aiding in illuminating an area for the camera and/or other sensor.

[0014] In an exemplary embodiment, a device for imaging a body cavity comprises a handpiece, a connecting conduit extending from said handpiece from a proximal end, a distal assembly connected to a distal end of said connecting conduit, a plurality of controls coupled to said handpiece connected to said distal assembly through a plurality of pull wires extending from mechanical actuators in said handpiece through said connecting conduit to said distal assembly, said plurality of pull wires being adapted to alter the trajectory of said distal assembly, a working channel having an entry point on said handpiece and extending through said connecting conduit to an aperture on said distal assembly, and at least one sensor disposed on said distal assembly in communication with a sensor port on said handpiece.

[0015] In an exemplary embodiment, a device for imaging a body cavity comprises a handpiece, a connecting conduit extending from said handpiece from a proximal end, a distal assembly connected to a distal end of said connecting conduit, a plurality of controls digitally coupled to powered actuators in said handpiece connected to said distal assembly through a plurality of pull wires extending from said handpiece through said connecting conduit to said distal assembly, said plurality of pull wires being adapted to alter the trajectory of said distal assembly, a working channel having an entry point on said handpiece and extending through said connecting conduit to an aperture on said distal assembly, and at least one sensor disposed on said distal assembly in communication with a sensor port on said handpiece. Digitally coupled controls to the powered actuators may be desirable, for example, to reduce or eliminate the need for particular physical arrangement of components to maintain connections between the controls and the powered actuators, and may thus also enable more ideal, comfortable and/or ergonomic placement of the controls for a user. Digitally coupling controls may also enable, for example, flexibility in functionality, such as by allowing customization and/or alteration of which control couples to what function, the degree of responsiveness, enabling small control movements or inputs to generate more diverse responses, and/or any other appropriate form of customization or alteration of function. Digitally coupled controls to the powered actuators may also be desirable such that the inputs of the user to the controls may be recorded for record keeping, analysis, and/or utilization in computer-aided operations, such as discussed below.

[0016] In a further aspect, a device for imaging a body cavity may be utilized to train a machine learning (ML) system which may be utilized to advise or suggest to a user of the device, such as by identifying potential abnormal tissue or features, detecting device problems/issues, providing location/path guidance or control assistance, and/or any other appropriate advice or suggestion to the user. In general, the ML system may be trained by utilizing the device, or through computerized modeling therewith, in a plurality of usage scenarios and with sufficient sampling instances to enable analysis and/or trend development to inform the ML system training. Training the ML system may generally include using the device in various scenarios and/or settings while recording the various user inputs, parameters and data gathered by the device (together the “training collection”). The training collection information compiled over multiple uses/users may then be reviewed, analyzed and/or annotated, such as by an expert, engineers, other users, etc., to train the ML system to recognize particular situations for use of the device and/or recognize particular features of the tissue being examined by the device. In general, the greater amount of reviewed, analyzed and/or annotated training collection data used to train the ML system, the higher the likelihood that the ML system will be able to find trends and/or profiles to enable it to recognize situations with the same or similar user inputs, parameters and/or gathered data (e.g. tissue features) in order to provide advice, suggestion or guidance to a user when encountering such situations. Situations may include, for example, recognizing particular pathing for giving guidance to the user to reach or enter a desired anatomical feature, recognizing normal or abnormal tissue or features, recognizing situations where the device is encountering a problem or issue that may be resolved through the advice or suggestion, and/or any other appropriate user guidance. The trained or partially trained ML system may then be integrated into or otherwise coupled with the device such that it may begin to provide possible recognition of encountered features or situations during use and advice, suggestion and/or other appropriate user guidance. This trained or partially trained ML system may further be augmented by further use, such as with multiple further users, to gain additional data for the training collection to be reviewed, analyzed and/or annotated, as above, to improve the abilities of the ML system by generating a further trained ML system. In this non-naive state, the user of the ML system coupled device may annotate or otherwise provide feedback as to the quality, correctness or other assessment of the recognition abilities, advice, suggestion and/or other appropriate user guidance provided by the ML system during use, which may be utilized for additional training and refinement as part of the training collection data. In this manner, the ML system may be continuously, periodically or selectively updated, improved, augmented or otherwise supplemented with additional training through continued use after initial implementation.

[0017] The present invention together with the above and other advantages may best be understood from the following detailed description of the embodiments of the invention and as illustrated in the drawings. The following description, while indicating various embodiments of the invention and numerous specific details thereof, is given by way of illustration and not of limitation. Many substitutions, modifications, additions or rearrangements may be made within the scope of the invention, and the invention includes all such substitutions, modifications, additions or rearrangements.

BRIEF DESCRIPTION OF THE FIGURES

[0018] The drawings accompanying and forming part of this specification are included to depict certain aspects of the invention. A clearer impression of the invention, and of the components and operation of systems provided with the invention, will become more readily apparent by referring to the exemplary, and therefore non-limiting, embodiments illustrated in the drawings, wherein identical reference numerals designate the same components. Note that the features illustrated in the drawings are not necessarily drawn to scale.

[0019] FIGs. 1 and la illustrate the external features of a device for visualizing and/or interacting with internal body tissues in some exemplary embodiments of the present invention; [0020] FIGs. lb and 2 illustrate embodiments of the internal conduits and mechanical mechanisms of the device of FIG. 1;

[0021] FIGs. 1c and Id illustrate alternative external features of a device of FIG. 1;

[0022] FIGs. 2a and 2b illustrate flexion of a connecting conduit from pushing/pulling pull wires;

[0023] FIG. 2c illustrates pinning of a support structure to provide resistance to compression and a return action;

[0024] FIGs. 3 and 3a illustrates an embodiment of a distal assembly of the device of FIGs. 1, 1c and Id;

[0025] FIG. 3b illustrates an embodiment of an elevator mechanism;

[0026] FIGs. 4 and 4a illustrate an example of a support structure for a connecting conduit including interconnecting segments;

[0027] FIGs. 5 and 5a illustrate an example of a support structure for a connecting conduit including a unitary flexible structure;

[0028] FIGs. 6, 6a, 6b and 6c illustrate an example of powered actuators and reels for the device of FIGs. 1, 1c or Id;

[0029] FIGs. 7, 7a, 9, 9a and 9b illustrate embodiments of a device for visualizing and/or interacting with internal body tissues in some exemplary embodiments of the present invention that utilize powered actuators, digitally coupled controls and streamlined component placement and mechanical linkages;

[0030] FIGs. 7b, 7c, 7d and 9a illustrate embodiments of a working channel access port(s); and

[0031] FIGs. 8, 8a, 8b, 8c and 8d illustrate embodiments of an elevator mechanism controller.

DETAILED DESCRIPTION OF THE INVENTION

[0032] The detailed description set forth below is intended as a description of the presently exemplified methods, devices and systems provided in accordance with aspects of the present invention, and is not intended to represent the only forms in which the present invention may be practiced or utilized. It is to be understood, however, that the same or equivalent functions and components may be accomplished by different embodiments that are also intended to be encompassed within the spirit and scope of the invention. [0033] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which this invention belongs. Although any methods, devices and systems similar or equivalent to those described herein can be used in the practice or testing of the invention, the exemplified methods, devices and systems are now described.

[0034] The invention relates to devices and methods for visualizing and/or interacting with internal body tissues. More particularly, the present invention relates to endoscopic methods and devices for visualizing and/or interacting with the gastrointestinal and/or pancreaticobiliary systems. Further, the present invention relates to one use or at least partially disposable devices for visualizing and/or interacting with the gastrointestinal and/or pancreaticobiliary systems, such as with duodenoscopes.

[0035] In general, a device for visualizing and/or interacting with internal body tissues may generally include a handpiece, a distal assembly, and/or a connecting conduit. The device may further generally be used to introduce the distal assembly to a location in proximity to an internal body tissue of interest, such as, for example, portions of the gastrointestinal and/or pancreaticobiliary systems, further for example the tubular body structures of those systems. In some exemplary embodiments, a plurality of conduits and/or channels may span through the connecting conduit from the handpiece to the distal assembly, and may, for example, carry fluid/gas connections, electrical/sensor connections, mechanical connections and/or carry medical devices through a working channel or multiple working channels. Sensing devices, such as cameras, pH sensors, pressure sensors, oxygen sensors, temperature sensors, position/orientation sensors, accelerometers, chemical composition sensors, tissue or fluid analysis sensors, imaging sensors and/or any other appropriate sensing devices may be utilized in the distal assembly to collect data from the body structure being examined and/or about the state of the distal assembly in the body. Transmission of information from sensors in the working channel may, for example, be accomplished through a wired connection carried through the working channel to an external device, such as a signal processor, computer or mobile device, or also through wireless transmission, such as via proprietary signal transmission or standard connectivity, such as WiFi, Ant+ or Bluetooth.

[0036] The device may also be, in general, disposable and/or single use. Disposable or single use devices may be desirable, for example, to aid in reducing the incidence of infection or contamination from improper handling or sterilizing of reusable devices, reducing the need for maintenance, allowing for selection of different materials that do not necessarily require durability against repeated use/sterilization and allowing for lower cost materials. With disposable and/or single use devices, the materials and components may be selected for lower cost and/or without requiring higher durability/longevity, such as may be necessary for repeated sterilization and/or other cleaning procedures with multi-use devices.

[0037] FIGs. 1 and la illustrate the exterior of an example of a device 100 for visualizing and/or interacting with internal body tissues with a handpiece body 100a, a plurality of mechanical controls 101, 102, 103, 104, fluid/gas controls 105, 106, a working channel port 107, a connecting conduit 110, a distal assembly 120, a power/water connector 111, air connection 109, and vacuum connection 108.

[0038] FIGs. 7, 7b, 7c, 7d, 9a and 9b illustrate the exterior of examples of a device 400 for visualizing and/or interacting with internal body tissues with a handpiece body 420 with a housing 421 substantially enclosing or mounting other components or features, such as, for example, a plurality of digital, electric and/or electronic controls via a joystick control 424, fluid/gas controls 424c (e.g. a single dual throw button 424c may be utilized to actuate water, air and/or a combination thereof (e.g. by utilizing a double throw or similar button, where a certain amount of depression actuates one control, e.g. air, and further depression actuates another control, e.g. for water), suction control 424d, image capture, light and/or sensor controls 424a, 424b, elevator control 424e, a working channel port 422, a connecting conduit aperture 426 to connect to connecting conduit 110, a distal assembly 120, a power/water connector, air connection, data and/or electronic connections and vacuum connection via control connector 428. Control connector 428 and connecting conduit aperture 426 may further include flexible and/or deforming portions, such as for easing handling and/or positioning, as illustrated with flexible portions 428a, 426a. The housing 421 may further be shaped or have features for ease, ergonomics and/or control of handling or use, such as shaping for contouring to a user’s hand, gripping features, such as the gripping surface features 421a, and/or any other appropriate shaping or features. In general, the housing 421 may be shaped in as a rod or cylinder-like enclosure, such as with a long axis, for example, running approximately from the connecting conduit aperture 426 to the end of the handpiece 420 with the controls 424, etc., as illustrated in FIGs. 7, 7b and 9a.

[0039] In some embodiments, the working channel port 422 may include features for aiding in positioning or orienting an inserted medical device, such as for convenience, routing or space concerns during a procedure. For example, the working channel port 422 may include a pivoting section 422d which may enable the working channel port 422 to switch between sides of the handpiece 420, such as with a right orientation port 422a illustrated in FIG. 7c, or a left orientation port 422b illustrated in FIG. 7d. The working channel port 422 may also, for example, include multiple entry ports 422a, 422b connected to a Y-connector 422c, such as illustrated in FIGs. 7b and 9a. The working channel port 422 may also include a cover or cap for closing, such as when not in use, as illustrated with cap 422e in FIG. 7.

[0040] In one aspect, a device for visualizing and/or interacting with internal body tissues may generally utilize a plurality of mechanical directors for guiding the trajectory of the distal assembly when being inserted and/or navigated through body tubes and/or cavities. In some exemplary embodiments, the mechanical directors may generally include a plurality of pull wires which may pull and/or push on the distal assembly while contained within the connection conduit for altering and/or articulating the direction/trajectory of the distal assembly, as illustrated in FIGs. lb, 2, 7a and 9. Pull wires may be made from any appropriate material, such as metal and metal alloys, carbon fibers, fiber glass, polymer strands, natural fibers and/or any other appropriate material or combination thereof. In some embodiments, control wheels or other actuator controls, such as control wheels 102, 103 as illustrated, may generally articulate pull wires to direct right, left, up and down orienting of the distal assembly, with control wheel 102 directing right and left and control wheel 103 directing up and down, as illustrated. A locking mechanism may also be included to lock the mechanicals in place, as illustrated with locking switch 101. In some embodiments, the locking mechanicals may not be employed, such as where the pull wires remain in a position without locking, as illustrated with the handpiece body 100a in FIGs. 1c and Id. The control wheels 102, 103 may be mechanically coupled to the actuators or they may be digitally coupled. In digital coupled embodiments, the motion or responsiveness of the control wheels 102, 103 may be adjustable and/or tuned to provide more natural or predictable control for a user. Further, digital controls may be adapted to provide more constant or smooth operation by automatically varying control signals to the actuators, such as due to variability in the mechanical portions of the device 100. With digital interfaces, a variety of different controllers may be utilized, such as controls on the handpiece, wireless controls (e.g. control from a mobile device, tablet, remote control, computer or wireless controller), wired controllers, and/or any other appropriate controller.

[0041] In general, as illustrated in FIGs. 2a and 2b, pulling/pushing of a corresponding pair of pull wires, such as direction A/C for pull wires 102c, 102d and/or direction B/D for pull wires 103 c, 103 d may cause flexion of at least a portion of the connecting conduit 110 as shown in FIG. 2b. [0042] A further mechanical director may also be used, for example, to control an elevator and/or other feature for manipulating a medical device at the distal assembly, as illustrated with elevator actuator 104 or 424e controlling elevator 122 in FIGs. 3, 3a. The elevator 122 may generally, for example, push on the medical device exiting the working channel aperture 121 to elevate and/or articulate the medical device to a desired location, such as to collect samples and/or place the medical device in proximity with the tissue wall. The elevator may include a partial channel, cutout or other feature for aiding in holding a medical device, as illustrated with indentation 122a in FIG. 3b. The actuation of the elevator 122 may generally be mechanically controlled. For example, the elevator 122 may be coupled to a pull wire, such as illustrated with pull wire 462 connected to elevator actuator 424e, which may cause the elevator 122 to raise and lower by pulling/pushing E/F along path G/H by pivoting on axel 122b.

[0043] In some exemplary embodiments, such as illustrated in FIGs. 8, 8a and 8b, an elevator actuator 424e may employ a mechanical mechanism 460 with an eccentric cam, such as cam 463, which may interact with a pin such that rotation of the cam (such as rotation of cam 463 in connection with rotation of elevator actuator 424e) may cause the pin to slide into a different position to pull or push the pull wire, as illustrated with pin 464 connected to pull wire 462 moving in response to pin portion 464a traveling in the track 461 between cam 463 and the body of the elevator actuator 424e, such as to a retracted position (pull of pull wire 462) illustrated in FIG. 8a and an extended position (push of pull wire 462) in FIG. 8b. In some embodiments, the rotation of the elevator actuator 424e in either direction may be utilized to effect the actuation of the elevator 122, such as, for example, to enable easier use for a user by enabling either direction of rotation or to allow for the preferences for right vs left handed users.

[0044] In some exemplary embodiments, such as illustrated in FIGs. 8c, 8d and 9a, an elevator actuator 424e’ may employ a mechanical mechanism where the actuator 424e’ sliding in the directions J, as shown in FIG. 8c, may move a pull wire 462, as shown in FIG. 8d. In general, the movement of actuator 424e’ may, for example, cause a corresponding directional movement (e.g. by pulling or pushing) pull wire 462. The actuator 424e’ may be directly coupled to the pull wire 462 or it may employ a mechanism, such as mechanical coupling 465, to couple and affect the pull wire 462. For example, as illustrated in FIG. 8d, a rack and pinion coupling may be utilized, such as with rack 466 coupled to the actuator 424e’ through mechanical coupling 465 such that it moves linearly in the directions J with the actuator 424e’ . The rack 466 may then act on an elevator pull wire rack 486, which may be attached to the pull wire 462, through a pinion gear 467. This arrangement or similar may be desirable as the gearing of the racks and pinions may be tailored or adapted to provide an amount of pull/push on the pull wire 462 at a set ratio to the amount of linear travel in direction J of the actuator 424e’. For example, the gearing may be selected such that the travel of the actuator 424e’ corresponds to a longer amount of travel of the pull wire 462, or vice versa. This may be desirable to providing the user differing degrees of response from the linear motion on the actuator 424e’, such as to, for example, enable the user to use less hand motion to achieve a greater degree of elevator action (e.g. when the actuator 424e’ motion translates to more pull wire 462 motion), or to give finer control over the degree of elevator action (e.g. when the actuator 424e’ motion translates to less pull wire 462 motion).

[0045] In general, any appropriate mechanical actuators may be utilized to control pull wires for altering the directi on/trajectory of the distal assembly and/or controlling the elevator. FIGs. lb and 2 illustrate the use of rack and pinion-like mechanisms for controlling the motion of pull wires, as shown with pinions 102-2 (connected to the control wheels and/or actuators) acting on racks 102-1 coupled to pull wire rods 102a, 103a, 102b, 103b, 104a connected to pull wires 102c, 103c, 102d, 103d, 104b, respectively, which may generally be housed within sheaths 113a, 113b, 113c, 113d, 113e, respectively, for conveyance in the connecting conduit 110. A sheath/conduit guide 112 may also be utilized to arrange the various sheaths and conduits leading into the connecting conduit 110. The connecting conduit 110 may be, in general, flexible and/or compressible/stretchable such that it may deform in response to the pulling/pushing forces of the pull wires to effect the alteration in trajectory/orientation of the distal assembly 120. Elastomeric or otherwise flexible materials may be utilized, or for example, woven materials that may accommodate flexing and compression.

[0046] In some embodiments, motorized or powered mechanical actuators may be utilized to control pull wires. FIGs. 6 and 6a illustrate the use of powered actuators, as shown with example motors 130, 140. In some embodiments, the motors 130, 140 may be utilized to wind and dewind pull wires 102c, 102d, 103c, 103d onto and off reels 132, 142 to direct right, left, up and down orienting of the distal assembly by flexion of at least a portion of the connecting conduit 110. The pull wires 102c, 102d, 103c, 103d may further pass into the connecting conduit 110 through a wire guide 150 with entries 151, 152. This may be desirable to aid in guiding the pull wires 102c, 102d, 103 c, 103d with the change of direction from the winding/ dewinding from the reels 132, 142 to the linear direction along the connecting conduit 110. The reels 132, 142 may also be positioned in other orientations where the directional change is not present. In general, the pull wires 102c, 102d, 103c, 103d may attach to the reels 132, 142, such as at attachment points 131/141, 133/143 as illustrated in FIGs. 6a, 6b and 6c. It may be desirable to position the attachment points 131/141, 133/143 close in an arc, such as less than 90 degrees apart or more particularly less or equal to 45 degrees apart on the arc of the reels 132, 142, such that during rotation of the reels 132, 142, tension is better maintained with less slack in the pull wires 102c, 102d, 103c, 103d, as shown between the rotation in FIGs. 6a and 6b. In some embodiments, the reels 132, 142 may include features for preventing overturning in either or both directions of rotation, such as to prevent damage or overflexion of the connecting conduit 110 during use. In some embodiments, the reels 132, 142 may feature mechanical stops to prevent overturning. In other embodiments, the reels 132, 142 may feature position sensing such that the motors 130, 140 are stopped to prevent overturning. FIG. 6a illustrates an example of position sensing with limit sensors 137/147 and 138/148 detecting the alignment of fiducials 136/146 and 135/145 during the rotation of the reels 132, 142. The position sensing may employ any appropriate sensing or switching technology, such as, for example, magnetic Hall Effect sensors, electric contact switches, optical sensors/switches, tension sensors on the pull wires, physical switches and/or other appropriate position or limit sensors. For example, the fiducials 136/146 and 135/145 may include magnets such that when aligned with the limit sensors 137/147 and 138/148, the magnetic field may trigger a Hall effect sensor in the limit sensors to stop the motors. This may be particularly desirable in digital control systems where there is no direct mechanical coupling between the controls and the motors/reels. Position sensing may also be employed to modulate the speed of the motors in portions of the rotation of the reels 132, 142. For example, due to the shape and reeling/unreeling of the pull wires, there may be certain portions of the rotations where there is additional slack or lack of tension in the pull wires that may generate a “dead zone” or an observable slowing down in the response if the motors remained at a constant speed. The position sensing may be utilized to detect these dead zones to speed up the motors to provide a more constant response during use.

[0047] In some embodiments, motorized or powered mechanical actuators may be utilized to control pull wires via linear actuators. FIGs. 7, 7a, 9, 9a and 9b illustrate the use of powered actuators, as shown with example motors 430, 440. In some embodiments, the motors 430, 440 may be utilized to actuate linear actuators, as illustrated with linear actuator pairs 403, 405 and 404, 406, which in turn control pull wires 403a, 405a and 404a, 406a, respectively, to direct right, left, up and down orienting of the distal assembly by flexion of at least a portion of the connecting conduit 110. The pull wires 403a, 405a and 404a, 406a may further pass into the connecting conduit 110, such as through a wire guides 403b, 405b and 404b, 406b. The linear actuators may, for example, take the form of rack and pinion mechanisms, similar to those illustrated in FIGs. lb and 2, as shown in FIGs. 7a, 9 with pinions 438, 448 acting on racks (linear actuators 403, 405 and 404, 406, respectively). The pinions 438, 448 may be rotated by motors 430, 440, respectively, such as through driving gears 433, 443 (e.g. worm gears) driving pinion gears 436, 446 which are connected to pinions 438, 448 via axles 434, 444. The use of rack and pinion actuators may be desirable as the housing 421 may be utilized to aid in limiting the motion of the rack and pinion actuators, such as by providing physical obstruction, which may be desirable to aid in preventing overflexion. Rack and pinion actuators may also be desirable as their gearing and physical connections are relatively rigid and may be provide a more discrete and/or metered response, which may also aid in being recorded or detected, such as for use in tracking or analysis. For example, the rack and pinion actuators may include fiducials, position sensors and/or other features that may be used to indicate their physical relative position, which may be correlated to their effect on the distal assembly 120. [0048] In some embodiments, some components may be arranged in the device to optimize use of space and/or provide for use of preferable components within the form factor of the device. FIGs. 7a and 9 illustrate an embodiment of an arrangement of components within the handpiece 420 of device 400 in FIGs. 7 and 9a/9b, where multiple components are substantially aligned along the linear long axis of the handpiece 420 running from the connecting conduit aperture 426 to the controls (e.g. 424, 424a, 424b, 424c, 424d, 424e). In this arrangement, such as with the longer linear axis of the motors 430, 440 are oriented parallel to the linear actuators 403, 404, 405, 406 and their directions of travel, which may, as illustrated, be substantially parallel to the long axis of the handpiece 420 (e.g. the axis formed approximately from the space may be conserved within the housing 421 and/or a smaller housing or housing without extensions or protrusions to accommodate positioning of components may be utilized, such as to aid in maintaining ergonomics. The arrangement may also be desirable as in a housing 421 which is longer than it is across, longer and more powerful motors 430, 440 may be utilized in the space without compromising the ergonomic shape of the handpiece 420 as opposed to motors mounted in the perpendicular orientation. Use of digital or electric/electronic controls for the motors 430, 440, such as illustrated with joystick control 424, may be desirable for this configuration as the controls need not be positioned or mechanically connected to the motors 430, 440 in a physically constrained manner, which may thus free positioning of components for other considerations.

[0049] In some exemplary embodiments, some components of the device may be contained and/or arranged in a modular or compartmentalized manner, such that, for example, the components may be removed and/or replaced as a unit, and/or be adapted to operate without the entire device being assembled and/or present. This may be desirable to group connected or related components together, such as for ease of maintenance, repair, replacement, etc. In some embodiments, a grouping of the mechanical actuation components, such as motors and their associated gearing mechanisms and linear actuators may be grouped together in a modular unit. FIG. 9 illustrates an arrangement of components of the device 400 within a handpiece 420, with the several components forming a modular assembly 500 which may be placed, removed and/or replaced in the handpiece 420 as a whole. The modular assembly 500 may, for example, include a component retainer 502 which may enclose, connect and/or contain components, such as illustrated in FIG. 9 holding motors 430, 440, linear actuators 403, 404, 405, 406, and/or other components (e.g. pinions, axles, gearing mechanisms, controllers/PCBs, etc.) which may generally be desirable to be associated in a modular unit. The modular assembly 500 may include other components or features, such as, for example, an integral wire guide 504 for managing the pull wires 403a, 405a and 404a, 406a. The use of a component retainer 502 may also, for example, be useful to retain the associated components while the housing of the handpiece 420 is opened to observe the components during operation, such as for maintenance or troubleshooting purposes.

[0050] Motors such as gear motors may be utilized to provide the powered rotation of the reels 132, 142. In general, gear motors with high gearing ratios may be utilized such that the high gearing ratio may act as a form of rotation lock when the motor is not on, as this may remove the need for a separate locking mechanism to prevent further rotation or backrotation of the reels 132, 142 when the motors are off. For example, -500: 1 or higher gear ratio motors may be utilized to generate the locking effect.

[0051] In some embodiments, the connecting conduit 110 or portions thereof may be constructed from any appropriate material, such as, for example, medical grade plastic tubing, such as polycarbonate (PC), polyurethane, polyethylene (PE), polypropylene (PP), polylactic acid (PLA), silicone, nylon, polyvinylchloride (PVC), polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), acrylonitrile butadiene styrene (ABS), poly ether sulphone (PES), polyetheretherketone (PEEK), fluorinated ethylene propylene (FEP), other biocompatible polymers, or any combination thereof.

[0052] In some exemplary embodiments, the connecting conduit 110 may include a flexible or deformable support structure, such as within an outer sheathing or being integral to a sheathing. The support structure may interact generally with the pull wires to direct the distal assembly 120 of the connecting conduit 110 in a desired direction or orientation, in addition to, for example, providing increased rigidity or resistance to pinching/crushing for a sheathing. In general, the pull wires may be carried in the connecting conduit 110, such as, for example, within a working channel or close to the center of the connecting conduit 110 such that when the pull wires are pulled to cause curvature of the connecting conduit 110 or portion thereof, less slack is generated in the corresponding pull wires due to the curvature and shortening of portions of the connecting conduit 110 during flexing.

[0053] In some embodiments, a plurality of interconnecting segments may be utilized that connect and articulate relative to each other. FIG. 4 illustrates an example of interconnecting segments 202 forming a support structure 200 for connecting conduit 110 with a channel 201 along its length for carrying conduits or connections within, as discussed below. As illustrated, the interconnecting segments 202 may be substantially identical and in the form of a ring 202a and may link to each other via rivets 203 extending from rivet extensions 203a that rest in and freely rotate in node rings 204 extending from node extensions 204a. Further, the connections between successive interconnecting segments 202 may be offset, such as, for example, at 90 degrees as illustrated, such that two adjacent interconnecting segments 202 may pivot in one axis, and the successive pair may pivot in a different axis, such as with vertical pivot A and horizontal pivot B such that the support structure 200 may be steered in two dimensions by pulling and/or pushing an appropriate pull wire(s), which may rest in wire carriers 205 and attach or be anchored at a distal end plate, as shown with anchoring points 206 at end piece 207 of the distal portion of support structure 200 in FIG. 4b. Other variations, such as offsets of different angles and the addition or subtraction of pairs of pull wires may also be utilized. Further examples of interconnecting segments are disclosed in U.S. Patent Publication US20090209819, which is hereby incorporated by reference in its entirety.

[0054] In other exemplary embodiments, the connecting conduit 110 may include a unitary flexible or deformable support structure which may interact with the pull wires to direct the distal assembly 120 of the connecting conduit 110 in a desired direction or orientation. FIGs. 5 and 5a illustrate an example of a unitary support structure 300 featuring a channel 301 with a series of offset ring-shaped sections with a first set 302 and a second set 303 offset at 90 degrees from first set 302. The first set 302 may generally connect to second set 303 with pairs of flexing bridges 304a, 304b, each pair of which may generally allow for flexion in at least one direction. The first set 302 and second set 303 may further include scalloped or other cutouts, such as scalloped cutouts 302a, 303a, which may generally form gaps in the structure and conform to each other when the unitary support structure 300 is flexed. Further, the connections at the bridges 304a, 304b between successive sets 302, 303, such as, for example, at 90 degrees as illustrated, may allow a pivot in one axis, and the successive sets may pivot in a different axis, such as with vertical pivot A and horizontal pivot B such that the support structure 300 may be steered in two dimensions by pulling and/or pushing an appropriate pull wire(s), which may rest in wire carriers 305 and attach or be anchored at a distal end plate, as shown with anchoring points 306 at end piece 307 of the distal portion of support structure 300 in FIG. 5a. Other variations, such as offsets of different angles and the addition or subtraction of pairs of pull wires may also be utilized.

[0055] The support structures, such as support structures 200, 300, may be made from any suitable material, such as polymers, metals, composites, and/or any other appropriate material or combinations thereof. For the unitary support structure 300 and similar embodiments, the material chosen may generally be flexible and durable against repeated flexions without failure. Suitable polymers may include, but are not limited to, polyethylene; polypropylene; polybutylene; polystyrene; polyester; polytetrafluoroethylene (PTFE); acrylic polymers; polyvinylchloride; Acetal polymers such as polyoxymethylene or Delrin (available from DuPont Company); natural or synthetic rubber; polyamide, or other high temperature polymers such as polyetherimide like ULTEM®, a polymeric alloy such as Xenoy® resin, which is a composite of polycarbonate and polybutyleneterephthalate, Lexan® plastic, which is a copolymer of polycarbonate and isophthalate terephthalate resorcinol resin (all available from GE Plastics); liquid crystal polymers, such as an aromatic polyester or an aromatic polyester amide containing, as a constituent, at least one compound selected from the group consisting of an aromatic hydroxycarboxylic acid (such as hydroxybenzoate (rigid monomer), hydroxynaphthoate (flexible monomer), an aromatic hydroxyamine and an aromatic diamine, (exemplified in U.S. Patent Nos. 6,242,063, 6,274,242, 6,643,552 and 6,797,198, the contents of which are incorporated herein by reference), polyesterimide anhydrides with terminal anhydride group or lateral anhydrides (exemplified in U.S. Patent No. 6,730,377, the content of which is incorporated herein by reference) or combinations thereof. Some of these materials are recyclable or may be made to be recyclable. Compostable or biodegradable materials may also be used and may include any biodegradable or biocompostable polyesters such as a polylactic acid resin (comprising L-lactic acid and D-lactic acid) and polyglycolic acid (PGA), polyhydroxy valerate/hydroxybutyrate resin (PHBV) (copolymer of 3 -hydroxy butyric acid and 3 -hydroxy pentanoic acid (3 -hydroxy valeric acid) and polyhydroxyalkanoate (PHA) copolymers, and polyester/urethane resin. Some non-compostable or non-biodegradable materials may also be made compostable or biodegradable by the addition of certain additives, for example, any oxo-biodegradable additive such as D2W™ supplied by (Symphony Environmental, Borehamwood, United Kingdom) and TDPA® manufactured by EPI Environmental Products Inc. Vancouver, British Columbia, Canada.

[0056] In addition, any polymeric composite such as engineering prepregs or composites, which are polymers filled with pigments, carbon particles, silica, glass fibers, or mixtures thereof may also be used. For example, a blend of polycarbonate and ABS (Acrylonitrile Butadiene Styrene) may be used for the housing. For further example, carbon- fiber and/or glass-fiber reinforced plastic may also be used.

[0057] Useful metals or metallic materials may include metal and metal alloys such as aluminum, steel, stainless steel, nickel titanium alloys, shape memory alloys and so on.

[0058] In some embodiments, the support structures 200, 300 may be supplemented to aid in preventing unwanted compression or to provide a return force, such as with a return spring. For example, when the support structures 200, 300 are bent or deformed during use, the supplementation may be utilized to return the support structures 200, 300 to their original states. For example, a conduit tube may be provided, such as a working channel, which may provide additional rigidity and/or act as a return spring. The conduit tube may be, for example, pinned or otherwise attached to the ends of the support structures 200, 300, as illustrated in FIG. 2c with pins 114, 115 pinning ends of the support structure 200/300 to a semi-rigid conduit tube 110b within the connecting conduit 110.

[0059] In some embodiments, the support structure 200 or 300 may be integral to the connecting conduit 110, such as by forming the support structure 200 or 300 by modification of the connecting conduit material or a portion thereof, such as by cutting or otherwise removing portions of the material to form the support structure 200 or 300. The connecting conduit 110 may further include an outer sheath to cover the modified portions.

[0060] In some exemplary embodiments, connections may be utilized to provide fluid/gas/vacuum supplies for fluid communication to the distal assembly, as illustrated in FIGs. 1, la, lb. In general, for insertion and/or guiding the device 100 into a body cavity, such as a body tube, for example, the intestines and/or connecting structures, fluid, gas and or vacuum may be useful to aid in lubricating, opening and/or otherwise manipulating the body cavity for ease of access and/or directing of the device 100. The use of fluid, gas and/or vacuum may also be useful, for example, to aid in cleaning or unobstructing a sensor, such as a camera, of the device 100. As illustrated, fluid/gas/vacuum may be controlled with control valve 105, which may actuate valves for vacuum lines 108a, 108b, and control valve 106, which may actuate valves for water line I l la, air line 109a for feeding into fluid line 109b. The fluid/gas/vacuum may further be connected to act on the working channel aperture 121 of the distal assembly 120 to affect the body cavity.

[0061] The distal assembly 120 may also be adapted to ease access into the body, such as with rounded and/or contoured tip 124, as illustrated in FIG. 3. In general, the distal assembly 120 may also feature rounded and/or non-sharp features for minimizing and/or preventing damage to body tissues during use.

[0062] In another aspect, the device may generally include a camera in the distal assembly for visualizing body tissues. In some exemplary embodiments, the camera may be side viewing relative to the axis of the insertion of the device. FIGs. 3 and 3a illustrate the distal assembly 120 or 120’ of the device 100 with a side viewing camera 123, working channel aperture 121, elevator 122. FIG. 3a further illustrates accessory features, such as, for example, a light source 125 for aiding in illuminating an area for viewing or other sensing, such as by the camera 123.

[0063] Further, the camera may generally be connected through the connecting conduit and/or handpiece for real time viewing and/or on demand visual capture during a procedure. The camera and/or processing system for the camera may also include, for example, dynamic and/or directional brightness control, such as with a light sensor, panoramic image capture/image stitching, image stabilization and/or other features.

[0064] Devices may also utilize modular designs which may include independently replaceable portions, such as disposable portions and reusable portions. Portions may also be designed to be hot-swappable, such as to accommodate replacement of portions, such as due to malfunction or the like, during use. For example, portions of the device 100 may be separable from each other to enable swapping of components and/or disposal of certain portions. In some embodiments, the handpiece 100a, connecting conduit 110, the distal assembly 120, and/or the controls 101, 102, 103, 104 may be separate pieces which may be replaced independently. [0065] In exemplary embodiments, digitally coupled controls to the powered actuators may be desirable, for example, to reduce or eliminate the need for particular physical arrangement of components to maintain connections between the controls and the powered actuators, and may thus also enable more ideal, comfortable and/or ergonomic placement of the controls for a user. Digitally coupling controls may also enable, for example, flexibility in functionality, such as by allowing customization and/or alteration of which control couples to what function, the degree of responsiveness, enabling small control movements or inputs to generate more diverse responses, and/or any other appropriate form of customization or alteration of function. Digitally coupled controls to the powered actuators may also be desirable such that the inputs of the user to the controls may be recorded for record keeping, analysis, and/or utilization in computer-aided operations, such as discussed below.

[0066] In a further aspect, a device for imaging a body cavity may be utilized to train a machine learning (ML) system which may be utilized to advise or suggest to a user of the device, such as by identifying potential abnormal tissue or features, detecting device problems/issues, providing location/path guidance or control assistance, and/or any other appropriate advice or suggestion to the user. In general, the ML system may be trained by utilizing the device, or through computerized modeling therewith, in a plurality of usage scenarios and with sufficient sampling instances to enable analysis and/or trend development to inform the ML system training. Training the ML system may generally include using the device in various scenarios and/or settings while recording the various user inputs, parameters and data gathered by the device (together the “training collection”). In some embodiments, the device, such as the device 100, may provide features or otherwise be adapted to provide information to be utilized in the training collection.

[0067] In some examples, digital, electric and/or electronic controls may be utilized on the device that may have features or be adapted to enable collecting and/or recording of user inputs, such as user navigation input to controls of the motors 130, 140 or 430, 440, such as through controls 102, 103, 424, as illustrated in FIGs. 1, la, 1c, Id, 7, 9a and 9b. In addition to such inputs and/or in correlation with such inputs, the device may also have features or be adapted to enable collecting and/or recording the state of the device in response to user input, such as, for example, the location or orientation of at least a portion of the device (e.g. the distal assembly 120). This may be desirable to record and/or correlate the effect or impact of the user input to the actual physical state of the portion of the device it is meant to affect, such as to, for example, aid the ML system in modeling the resistance of the device and/or the physical environment to the user input, as different users, iterations or variations of the device, and/or physical environments may respond or give input differently. This may employ, for example, location, position and/or orientation sensors of the device, external monitoring (e.g. with scanning or navigation equipment) and/or annotation by a user or observer.

[0068] In some examples, the device may further collect, record and/or correlate other data, inputs or parameters from use, such as use of the elevator control (e.g. elevator actuator 104 or 424e/424e’ controlling elevator 122 in FIGs. 3, 3a), the use of fluid/air/suction, image or video capture data or parameters (e.g. from camera 123 and/or usage of a light source, e.g. light source 125), the number, duration, amount of force, etc. of the user input, and/or any other appropriate data, inputs or parameters.

[0069] In usage of the device, it may generally include or be connected to a computing device such as a PC workstation, a laptop, a tablet, or some other general computing device that may connect to a larger network such as the internet or a private network, such as to a cloud service. At least one service device may be connected either via a wired data transmission technology such as for example USB or FireWire (e.g. through a physical connection, such as the control connector 428 in FIG. 7) or via a wireless data transmission technology such as Bluetooth. The system may further include a base station for interfacing with the device and the service device. The service device may generally include at least one program logic module running with a processing unit to receive and analyze the data from the usage of the device, such as for training the ML system (which may reside on such service device) and/or for processing input from the device and providing output to the device (e.g. giving suggestions, guidance or advisory to the user during usage).

[0070] The training collection information compiled over multiple uses/users may then be reviewed, analyzed and/or annotated, such as by an expert, engineers, other users, etc., to train the ML system to recognize particular situations for use of the device and/or recognize particular features of the tissue being examined by the device. The training collection may also be analyzed in a manner that compares use between different classes of users, such as novice or beginner users and expert or experienced users, which may be desirable in training the ML system to provide better guidance for particular user classes.

[0071] In general, the greater amount of reviewed, analyzed and/or annotated training collection data used to train the ML system, the higher the likelihood that the ML system will be able to find trends and/or profiles to enable it to recognize situations with the same or similar user inputs, parameters and/or gathered data (e.g. tissue features) in order to provide advice, suggestion or guidance to a user when encountering such situations. Situations may include, for example, recognizing particular pathing for giving guidance to the user to reach or enter a desired anatomical feature (e.g. by showing location/position/orientation information), recognizing normal or abnormal tissue or features (e.g. by giving notifications/alerts/overlaid display/etc.), recognizing situations where the device is encountering a problem or issue that may be resolved through the advice or suggestion or automatic action (e.g. usage of fluid/air/suction such as for clearing an obstruction or cleaning a dirty or occluded sensor/light source, etc.), and/or any other appropriate user guidance. The trained or partially trained ML system may then be integrated into or otherwise coupled with the device such that it may begin to provide possible recognition of encountered features or situations during use and advice, suggestion and/or other appropriate user guidance. This trained or partially trained ML system may further be augmented by further use, such as with multiple further users, to gain additional data for the training collection to be reviewed, analyzed and/or annotated, as above, to improve the abilities of the ML system by generating a further trained ML system. In this non-naive state, the user of the ML system coupled device may annotate or otherwise provide feedback as to the quality, correctness or other assessment of the recognition abilities, advice, suggestion and/or other appropriate user guidance provided by the ML system during use, which may be utilized for additional training and refinement as part of the training collection data. In this manner, the ML system may be continuously, periodically or selectively updated, improved, augmented or otherwise supplemented with additional training through continued use after initial implementation.

[0072] In some embodiments, the device data and/or annotations may be stored using a distributed computing environment, such as a cloud. Storage on, for example, a cloud may allow multiple annotations to be collected simultaneously and decrease the time for accumulating an expert annotation dataset in order to improve prediction and/or guidance accuracy. In some embodiments, device data and/or annotations may be collected on multiple instances of the system and consolidated onto one or more of those instances. In some embodiments, the device data and/or annotations entries may be encrypted.

[0073] Machine learning techniques used by the ML system may include regression (e.g., logistic, linear), clustering (e.g., k-means), neural networks (e.g., deep learning), classifiers (e.g., support vector machine, decision tree, random forest), deep learning, etc.

[0074] Although the invention has been described with respect to specific embodiments thereof, these embodiments are merely illustrative, and not restrictive of the invention. The description herein of illustrated embodiments of the invention, including the description in the Abstract and Summary, is not intended to be exhaustive or to limit the invention to the precise forms disclosed herein (and in particular, the inclusion of any particular embodiment, feature or function within the Abstract or Summary is not intended to limit the scope of the invention to such embodiment, feature or function). Rather, the description is intended to describe illustrative embodiments, features and functions in order to provide a person of ordinary skill in the art context to understand the invention without limiting the invention to any particularly described embodiment, feature or function, including any such embodiment feature or function described in the Abstract or Summary. While specific embodiments of, and examples for, the invention are described herein for illustrative purposes only, various equivalent modifications are possible within the spirit and scope of the invention, as those skilled in the relevant art will recognize and appreciate. As indicated, these modifications may be made to the invention in light of the foregoing description of illustrated embodiments of the invention and are to be included within the spirit and scope of the invention. Thus, while the invention has been described herein with reference to particular embodiments thereof, a latitude of modification, various changes and substitutions are intended in the foregoing disclosures, and it will be appreciated that in some instances some features of embodiments of the invention will be employed without a corresponding use of other features without departing from the scope and spirit of the invention as set forth. Therefore, many modifications may be made to adapt a particular situation or material to the essential scope and spirit of the invention.

[0075] Reference throughout this specification to "one embodiment", "an embodiment", or "a specific embodiment" or similar terminology means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment and may not necessarily be present in all embodiments. Thus, respective appearances of the phrases "in one embodiment", "in an embodiment", or "in a specific embodiment" or similar terminology in various places throughout this specification are not necessarily referring to the same embodiment. Furthermore, the particular features, structures, or characteristics of any particular embodiment may be combined in any suitable manner with one or more other embodiments. It is to be understood that other variations and modifications of the embodiments described and illustrated herein are possible in light of the teachings herein and are to be considered as part of the spirit and scope of the invention.

[0076] In the description herein, numerous specific details are provided, such as examples of components and/or methods, to provide a thorough understanding of embodiments of the invention. One skilled in the relevant art will recognize, however, that an embodiment may be able to be practiced without one or more of the specific details, or with other apparatus, systems, assemblies, methods, components, materials, parts, and/or the like. In other instances, well-known structures, components, systems, materials, or operations are not specifically shown or described in detail to avoid obscuring aspects of embodiments of the invention. While the invention may be illustrated by using a particular embodiment, this is not and does not limit the invention to any particular embodiment and a person of ordinary skill in the art will recognize that additional embodiments are readily understandable and are a part of this invention.

[0077] As used herein, the terms “comprises,” “comprising,” "includes," "including," "has," "having," or any other variation thereof, are intended to cover a non-exclusive inclusion. For example, a process, product, article, or apparatus that comprises a list of elements is not necessarily limited only those elements but may include other elements not expressly listed or inherent to such process, process, article, or apparatus.

[0078] Furthermore, the term "or" as used herein is generally intended to mean "and/or" unless otherwise indicated. For example, a condition A or B is satisfied by any one of the following: A is true (or present) and B is false (or not present), A is false (or not present) and B is true (or present), and both A and B are true (or present). As used herein, including the claims that follow, a term preceded by "a" or "an" (and "the" when antecedent basis is "a" or "an") includes both singular and plural of such term, unless clearly indicated within the claim otherwise (i.e., that the reference "a" or "an" clearly indicates only the singular or only the plural). Also, as used in the description herein, the meaning of "in" includes "in" and "on" unless the context clearly dictates otherwise.

Claims

1. A device for imaging a body cavity comprising: a handpiece having a long axis; a connecting conduit extending from said handpiece from a proximal end substantially along said long axis; a distal assembly connected to a distal end of said connecting conduit; a plurality of controls digitally coupled to powered actuators in said handpiece connected to said distal assembly through a plurality of pull wires extending from said handpiece through said connecting conduit to said distal assembly, said plurality of pull wires being adapted to alter the trajectory of said distal assembly; a working channel having an entry point on said handpiece and extending through said connecting conduit to an aperture on said distal assembly; and at least one sensor disposed on said distal assembly in communication with a sensor port on said handpiece.

2. The device of claim 1, wherein said mechanical actuators comprise rack and pinion actuators to impart linear motion onto said plurality of pull wires.

3. The device of claim 2, wherein said powered actuators comprise motors coupled to rack and pinion actuators to impart linear motion onto said plurality of pull wires, said motors having rotational axes.

4. The device of claim 3, wherein said rack actuators and said rotational axes of said motors are oriented in said handpiece substantially parallel to said long axis of said handpiece.

5. The device of claim 3, wherein said mechanical actuators and said powered actuators are connected in a motor assembly unit.

6. The device of claim 1, further comprising a plurality of fluid connections on said handpiece for supplying fluid, gas and/or vacuum to said aperture.

7. The device of claim 1, wherein at least one of said handpiece, connecting conduit, distal assembly, motor assembly unit and plurality of controls are modular sections which are removable and swappable.

8. The device of claim 1, wherein said at least one sensor is selected from the group consisting of a camera, digital camera, pH sensor, oxygen sensor, pressure sensor, accelerometer, position sensor, orientation sensor, temperature sensor, fluid or tissue analysis sensor, chemical composition sensor, imaging sensor and light sensor.

9. The device of claim 1, wherein said working channel is adapted to receive a medical device and convey it to said aperture.

10. The device of claim 1, further comprising an elevator and elevator actuator adapted to push on a medical device proximal to said aperture.

11. The device of claim 1, further comprising at least one additional working channel.

12. The device of claim 1, wherein said plurality of pull wires comprise at least a first set for altering the trajectory of said distal assembly up and down and a second set for altering the trajectory of said distal assembly left and right.

13. The device of claim 1, wherein said plurality of pull wires are constructed from a material selected from the group consisting of metal and metal alloys, carbon fibers, fiber glass, polymer strands, and natural fibers.

14. The device of claim 1, wherein said plurality of controls comprise a joystick.

15. The device of claim 1, wherein said connecting conduit comprises a flexible section proximal to said distal assembly.

16. The device of claim 3, wherein said rack and pinion actuators are driven by said motors by worm gears coupled on said rotational axes to said motors.

17. A method for generating a learning model, the method comprising: acquiring user inputs, usage parameters, procedure data and manipulation information regarding a manipulation of a user from a device for imaging a body cavity in each stage of operation in a procedure from multiple users in different procedures to generate a dataset (the “Acquiring Step”); annotating said dataset with identified issues of concern and resolutions to generate an annotated dataset (the “Annotating Step”); and generating a machine learning model trained on said annotated dataset so as to enable said machine learning model to receive inputs from said device and output suggestions or guidance based on detected issues of concern which are the same or similar to said identified issues of concern from said annotated dataset (the “Generating Step”).

18. The method of claim 17, wherein aid device for imaging a body cavity comprises: a handpiece having a long axis; a connecting conduit extending from said handpiece from a proximal end substantially along said long axis; a distal assembly connected to a distal end of said connecting conduit; a plurality of controls digitally coupled to powered actuators in said handpiece connected to said distal assembly through a plurality of pull wires extending from said handpiece through said connecting conduit to said distal assembly, said plurality of pull wires being adapted to alter the trajectory of said distal assembly; a working channel having an entry point on said handpiece and extending through said connecting conduit to an aperture on said distal assembly; and at least one sensor disposed on said distal assembly in communication with a sensor port on said handpiece; wherein said plurality of controls, powered actuators and at least one sensor together comprise input sources which are electronically coupled to a data receiver which is adapted to receive or record usage or activity information from said input sources for said Acquiring Step.