Robot-assisted navigation and control for airway management procedures, assemblies, and systems

Abstract

It provides robot-assisted navigation for airway management procedures, assemblies, and systems. [Solution] The airway management method, device, assembly, and system may include robotic motion and robotic control of an intubation tube introducer or guide, and may include a step of utilizing image data from one or more image sensors. The method, device, assembly, and system may optionally be used for endotracheal intubation procedures.

Description

Related Applications

[0001]

[0001] (Incorporation by Reference) This application claims priority to the following U.S. provisional patent applications: U.S. Provisional Patent Application No. 63 / 026,963, filed May 19, 2020; U.S. Provisional Patent Application No. 63 / 150,558, filed February 17, 2021; and U.S. Provisional Patent Application No. 63 / 159,348, filed March 10, 2021, and each of these provisional applications is hereby incorporated by reference in its entirety for all purposes.

[0002]

[0002] All publications and patent applications mentioned in this specification are hereby incorporated by reference as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

Technical Field

[0003] The present disclosure relates to robotic-assisted navigation and control for airway management procedures, assemblies, and systems.

Background Art

[0004]

[0003] Airway management encompasses a variety of procedures aimed at handling, supervising, caring for, applying, manipulating, controlling, establishing, and securing a patient's upper and / or lower airways, which may occur in a variety of medical environments and locations and in different patient populations. Airway management procedures may include navigating medical devices within a patient and, optionally, visualizing the navigation. Some airway management procedures may include establishing an artificial airway within a patient's body. For example, endotracheal intubation ("TI") is an airway management procedure that involves placing an intubation tube (in this embodiment, an endotracheal tube "ETT") into a patient's trachea to ventilate the patient's lungs, ensure adequate oxygenation and gas exchange, and help protect the patient's airway from aspiration of substances such as gastric contents, blood, secretions, and / or surgical debris. TI may be performed, for example, in the operating room (OR) when a patient is under anesthesia for elective or emergency surgery, or in broader emergency and / or critical airway situations outside the OR, such as in the intensive care unit (ICU), in the emergency department, in out-of-OR procedures and code situations, and in out-of-hospital settings (e.g., by paramedics, EMS (emergency medical services), and other forms of patient transport). TI is the most critical technique for managing high-risk or difficult cases and is a common life-saving technique when other forms of airway management have failed. If TI is unsuccessful or completely unsuccessful on the first attempt, it may typically result in serious harm to the patient, such as hypoxia-related adverse events or complications (e.g., cardiac arrest, brain injury, death) or airway trauma, or may require more invasive treatment such as surgical airway management (eFONA: emergency front of neck access) to establish the airway. In addition, it may be used in non-emergency or non-critical situations. Even with standard airway management procedures, if the airway cannot be established, secured, or controlled, or if the desired airway location cannot be safely navigated during the initial TI attempt, the procedure can become complicated and potentially harm the patient.

[0005]

[0004] TI difficulty or failure usually arises from the operator experiencing difficulties associated with visualizing the anatomical structure of the patient's airway, difficulties associated with navigating the ETT to the larynx (e.g., the glottal opening and vocal cords), and difficulties associated with manually placing the ETT past the vocal cords into the patient's trachea. Each of these critical TI steps (visualization, navigation, and placement) can result in TI difficulty / failure, either individually or in combination.

[0006]

[0005] The most commonly used conventional techniques for TI include direct laryngoscopy, video laryngoscopy, and the use of flexible intubators, but their performance is not optimal. For example, direct laryngoscopy involves the use of a metal plate to retract the patient's tongue in order to directly visualize the patient's airway and to manually navigate the ETT into the patient's trachea. Direct laryngoscopy is limited by drawbacks such as the need to align the airway axis to better visualize the patient's larynx and vocal cords, a narrow field of view that is easily obscured by blood and secretions, and challenges in controlling the patient's tongue, making it difficult to visualize, navigate, and pass the ETT both to and through the vocal cords. Direct laryngoscopy also does not allow for visual confirmation of whether the ETT is properly positioned in the trachea, so ETT misplacement (e.g., esophageal intubation) may go unnoticed, potentially leading to life-threatening hypoxia.

[0007]

[0006] Video laryngoscopy provides magnified visualization of anatomical structures using a fixed video camera placed inside the patient's upper airway (above the vocal cords). However, difficulties in ETT navigation and placement remain, and it does not address all the challenges in successfully performing TI. Navigation of the ETT to and through the glottal opening is impaired due to the indirect visualization of the patient's upper airway anatomy on the video monitor and the sharp angle of ETT manipulation relative to the vocal cords. It is often necessary to place a metal stylet inside the ETT to facilitate ETT navigation and placement, and stylet-induced airway trauma occurs in at least 1.1% of cases. While visualization of the ETT passing through the vocal cords is greatly enhanced by video laryngoscopy, ETT misplacement (e.g., esophageal intubation) and the resulting life-threatening hypoxia can still occur. Furthermore, video laryngoscopy does not address troubleshooting of ETT navigation and placement in the lower airway (below the vocal cords) where ETT advancement can occur blindly. Additionally, video laryngoscopy does not allow for immediate confirmation of ETT placement within the trachea. Moreover, video laryngoscopy still does not enable users to properly position the ETT within the patient's trachea, avoiding both overly deep and overly high placement.

[0008]

[0007] Flexible intubation scopes (FIS) that utilize a steerable video endoscope camera may be useful for patients with severely impaired airways, but they remain disadvantageous due to their narrow field of view and the complex maneuvers required, which demand advanced training and expertise. Visualization of airway anatomical structures is greatly reduced, only close-up views are provided, and directional landmarks are lost. Furthermore, such visualizations can easily be obscured or lost due to the presence of even small amounts of blood and / or secretions. When using an FIS, the operator must be extremely skilled at maneuvering the device around the soft airway tissue obstruction, especially when TI must be performed rapidly in unconscious patients. Another significant limitation of FIS is that the advancement of the ETT into the patient's trachea cannot be observed or troubleshooted from above the vocal cords.

[0009]

[0008] Airway management medical procedures (e.g., TI) using existing techniques and devices result in suboptimal success rates and outcomes, such as first-pass success rates. For example, the first-pass TI failure rate in difficult airway situations can range from 8% to 54% with conventional techniques, depending on the device used, the location of the TI, the patient population, and the provider's expertise. In addition, significantly higher first-pass TI failure rates have been observed in pediatric patients with difficult airways and in other patient classifications, such as obese patients, patients with head and neck cancer, and patients with cervical spine (C-spine) problems. Failure to achieve TI on the first attempt leads to an increased incidence of major complications such as major airway trauma, airway swelling, oxygen deficiency (hypoxia), cardiac arrest, and brain injury. [Prior art documents] [Patent Documents]

[0010] [Patent Document 1] U.S. Provisional Patent Application No. 63 / 026,963 [Patent Document 2] U.S. Provisional Patent Application No. 63 / 150,558 [Patent Document 3] U.S. Provisional Patent Application No. 63 / 159,348 [Overview of the project] [Problems that the invention aims to solve]

[0011]

[0009] There is a need for airway management methods, systems, and devices that can provide better outcomes more reliably and consistently, such as being able to provide a higher first-pass success rate and / or to navigate medical devices more reliably. For example, there is a need for new and improved devices and methods to assist intubation and improve TI success rates.

[0012]

[0010] In addition, it would be beneficial to provide a multifunctional airway management platform that can be used in various airway management procedures, clinical situations, locations and environments, and various patient populations. [Means for solving the problem]

[0013]

[0011] The disclosure herein relates to methods, devices, and systems for airway management. While tracheal intubation is provided herein as an example of airway management, the disclosure is not limited in this way, and the concepts herein may or may be applicable to other airway management procedures and settings. For example, the concepts herein may be used in bronchoscopy procedures or in otolaryngological procedures such as endoscopic procedures (e.g., flexible nasolaryngoscopy, esophagoscopy, etc.) and endoscopic-assisted surgical airway procedures (e.g., vocal cord injection, laryngoscopy, etc.).

[0014]

[0012] One aspect of the disclosure herein relates to systems, devices, and methods for robotically assisting in the intubation of a patient. In some cases, the robotic assistance includes one or more of the automatic and / or manual robotic control and / or robotic motion of an introducer, which may include a visualization guide. The device may include an integrated handheld assembly adapted and / or configured to enable robotic control (motion) of an introducer, such as a visualization guide. The introducer may further serve as a visualization delivery guide for an intubation tube, such as an ETT. In some embodiments, the introducer may include or may be an endoscope.

[0015]

[0013] In some variations, an integrated device for robotically assisting patient intubation may include: a handheld housing (which may include, for example, a display or other monitor screen); a laryngoscope connected to the housing and including a first image sensor; a movable actuator within the housing; an endoscope extending from the actuator, the endoscope member including a second image sensor and configured to be detachably connected to an intubation tube; and at least one actuator within the housing configured to automatically guide the endoscope via the actuator based at least partially on one or more images from at least one of the first image sensor and / or the second image sensor.

[0016]

[0014] In some variations, a method for performing robot-assisted intubation on a patient includes the step of acquiring one or more images using at least one of a laryngoscope connected to a handheld housing and an endoscope connected to a handheld housing. The endoscope may extend from a movable actuation member within the handheld housing, and the endoscope may be detachably connected to an intubation tube. The method acquires one or more images. The method may further include the step of automatically guiding the endoscope and intubation tube via a working member based on the image (e.g., advancing, retracting, and / or rotating). In some variations, the method may further include the step of detaching the intubation tube from the endoscope (e.g., manually or automatically detaching and advancing the intubation tube from the endoscope).

[0017]

[0015] In some variations, the integrated robotic device may include: a handheld housing (which may include, for example, a display or other monitor screen); a laryngoscope connected to the housing and including a first image sensor; a working member that is movable within the housing and connectable to an endoscope including a second image sensor; and at least one actuator. The actuator (one or more) may be configured to automatically move the working member based at least partially on one or more images from at least one of the first and second image sensors. The endoscope may be configured to be detachably connected to, for example, an intubation tube.

[0018]

[0016] In some variations, the integrated robotic device may include: a handheld housing (which may include, for example, a display or other monitor screen); a movable actuation member within the housing that can be coupled to an endoscope equipped with an image sensor; and at least one actuator within the housing configured to automatically move the actuation member based at least partially on one or more images from the image sensor.

[0019]

[0017] One of the advantages of some of the devices described herein is that they are configured to be operated by a single user, are handheld, and are portable.

[0020] One aspect of the disclosure is a method for performing a robotic-assisted airway management procedure (e.g., an intubation procedure) on a patient, the method comprising: obtaining one or more images using at least one of a first imaging member coupled to a handheld housing and an introducer (e.g., a flexible or rigid endoscope) coupled to the handheld housing, the introducer extending from an actuating member that is movable within the handheld housing and the introducer being removably coupled to an insertion tube; and automatically guiding the introducer via the actuating member based on the one or more acquired images.

[0021] One aspect of the disclosure is a robotic-assisted handheld airway management device, the device comprising: a handheld housing sized and configured to be held by one hand of a user; a first imaging member coupler (e.g., including a laryngoscope coupler); and a second imaging member coupler having at least one surface sized and configured to be releasably fixed to a second imaging member, the second imaging member coupler enabling one-handed movement of the first and second imaging members using one hand of an operator when the second imaging member coupler is releasably fixed to the second imaging member.

[0022] One aspect of the disclosure is a robotic-assisted handheld airway management device (e.g., an intubation device), the device comprising: a handheld housing sized and configured to be held by one hand of a user; a first imaging member or a first imaging member coupler; and an introducer coupler having at least one surface configured to be indirectly or directly releasably fixed to an introducer (e.g., a flexible endoscope), coupling the introducer to the introducer coupler smoothing a controlled robotic-assisted movement of the introducer relative to the handheld housing.

[0023] One aspect of the disclosure is a handheld airway management (e.g., intubation) device capable of providing one or more images and adapted for robotic-assisted control of an introducer during an airway management (e.g., intubation) procedure A method of assembling an intubation system, the method comprising providing a handheld housing configured to be held by a user's one hand, the housing including a direct or indirect introducer coupler and either a first imaging member or a first imaging member coupler; connecting a blade to the handheld housing such that the first imaging member is disposed in a blade channel lumen; releasably securing a tracheal tube to a tracheal tube coupler of the blade; positioning an introducer within the tracheal tube; and creating an operative communication between the introducer and the housing.

[0024]

[0022] One aspect of the disclosure is a blade sized and configured to be releasably secured to a handheld airway management (e.g., intubation) housing, the blade having a first channel lumen having a curved configuration and a tracheal tube channel, the tracheal tube channel being disposed on a side surface of the blade such that at least a portion of the tracheal tube lumen substantially follows the curved configuration of the first channel lumen when the tracheal tube is releasably coupled to the tracheal tube channel.

[0025]

[0023] One aspect of the disclosure is a handheld robot-assisted handheld airway management (e.g., intubation) assembly, the assembly comprising a handheld housing including an introducer coupler; a laryngoscope or a laryngoscope coupler; a blade; and a tracheal tube, wherein an introducer (e.g., a flexible endoscope) is releasably secured directly or indirectly to the handheld housing, and when disposed within the tracheal tube, the first optical sensor on the laryngoscope and the second optical sensor on the distal end of the introducer are dimensioned and configured to interact integrally such that they are maintained within 2 cm of each other axially, optionally aligned distally, or optionally substantially aligned distally.

[0026]

[0024] One aspect of the disclosure is an integrated handheld device for robot-assisted airway management (e.g., intubation) of a patient, comprising: a handheld housing sized and configured to be held by the user's hand; a first image sensor; and an actuation member (optionally comprising a motor), wherein the housing has a coupler configured to connect an introducer to the housing in a detachable manner, either directly or indirectly.

[0027]

[0025] One aspect of the disclosure is a handheld robot-assisted handheld airway management assembly. The assembly is configured such that, when the imaging member (e.g., a second imaging member) is releasably fixed to the housing, the assembly can move the introducer of the imaging member distally by at least 10 cm, and optionally 10 cm to 60 cm.

[0028]

[0026] Any of the second imaging members of the specification optionally does not include an image sensor. One aspect of the disclosure is any of the second imaging members of this specification without an image sensor, wherein the second imaging member may include a flexible introducer. The second imaging member without an image sensor may be configured to be connected to any of the housings of this specification to create an operable communication between the housing and the introducer.

[0029]

[0027] One aspect of the disclosure is a method for facilitating patient airway management (e.g., intubation), the method comprising: receiving input about patient conditions relating to one or more of the following: intubation procedures, patient conditions relating to the nasal cavity, and / or patient conditions relating to the oral cavity, and / or conditions relating to the upper airway structure and / or lower airway structure; accessing historical image data relating to one or more of the following: intubation procedures, patient conditions relating to the nasal cavity, or patient conditions relating to the oral cavity, and / or conditions relating to the upper airway structure and / or lower airway structure; and using the accessed historical image data to determine at least a portion of the patient's anatomical structure The process includes the step of recognizing, or controlling the delivery of an imaging device through the patient's nasal cavity or oral cavity and / or upper and / or lower airway structures.

[0030]

[0028] One aspect of this disclosure is a one-piece handheld assembly. The assembly includes a detachable inleter assembly and a housing, the inleter assembly including the inleter housing. One end of the inleter is fixed to one region of the inleter housing, and one region of the inleter may be movable through and relative to the inleter housing (for example, one embodiment of which is shown in Figure 19F).

[0031]

[0029] One aspect of the disclosure is a handheld airway management (e.g., intubation) system comprising a handheld housing (e.g., 1410, 1710) and an induction unit assembly (e.g., 1499, 1740), wherein the handheld housing and the induction unit assembly are sized and configured such that the induction unit assembly is removably fixed to the handheld housing, thereby creating an operational communication between the handheld housing and the induction unit assembly.

[0032]

[0030] A device, system, assembly, or handheld or introducer according to this specification, wherein the introducer includes a working channel which may optionally extend to the distal end of the introducer.

[0033]

[0031] A device, system, assembly, or method of the Spec Specified wherein an image processor is located in an external device (e.g., an external computer with a graphics processing unit, a smartphone, etc.) that communicates (wired or wirelessly) with any of the housings of the Spec Specified, and optionally, information relating to acquired image data is communicated from the housing to the external device for processing.

[0034]

[0032] One aspect of the present disclosure is an intubation system comprising a one-piece handheld dual-video endotracheal intubation assembly ("Assembly") sized and configured to be held in one hand of a user, the Assembly comprising: an elongated housing (e.g., 1710) having an elongated endotracheal tube channel (1713); a first elongated imaging member (e.g., 1730) including a first image sensor; and a flexible elongated endotracheal tube introducer ("Introducer"), which is sized to be positioned within an endotracheal tube and to allow the endotracheal tube to move axially over the elongated endotracheal tube introducer, and the remote The present invention relates to a second elongated imaging member (e.g., 1740) including a second image sensor positioned in a region; and a cover sized and configured to be releasably connected to a housing, the cover including an elongated channel defining an elongated lumen and sized and dimensioned such that at least a portion of the first imaging member is positioned within the elongated lumen, and an endotracheal tube channel, wherein when the cover is releasably connected to the housing, the endotracheal tube channel of the housing (e.g., 1713) and the endotracheal tube channel of the cover are positioned and configured to form a continuous elongated endotracheal tube channel.

[0035]

[0033] One aspect of the disclosure is a disposable cartridge for use with a robot-controlled medical system. The cartridge may include a flexible, elongated introducer (e.g., 1770); a cartridge housing (e.g., 1744), the first end of the introducer being fixed to the cartridge housing, and the cartridge housing includes, namely, a plurality of introducer deflection actuators (e.g., 1741, 1743); and a plurality of pull wires, at least one of which is fixed to each of the plurality of introducer deflection actuators. The apparatus comprises a set of pull wires and a set of injector axial motion actuators, wherein the injector extends between a first injector axial motion actuator and a second injector axial motion actuator and is axially movable relative to the set of injector axial motion actuators in response to the motion of the set of injector axial motion actuators.

[0036]

[0034] One aspect of the disclosure relates to a system adapted to display a first image and a second image on a display accessible to the operator, the first image and the second image may be acquired using either the first image sensor and the second image sensor of this specification. Either of the displays of this specification may be part of any of the assemblies of this specification, or they may be components of a separate entity that is not considered part of an assembled assembly but is still accessible to the operator during the procedure.

[0037]

[0035] One aspect of the disclosure is a dual-video integrated intubation assembly comprising a housing and a second imaging member sized and configured to be releasably fixed to the housing, wherein the housing and the second imaging member have a flat or substantially flat surface or portion, and the flat or substantially flat surface or portion is fitted with one or more communicating elements fitted to communicate with each other when they are interfaced (for example, an embodiment thereof is shown as illustrative in Figures 14A, 14B, and 17A-19K, and the flat or substantially flat interface surface or portion is easily seen in the side views of Figures 17A, 17F, 18A, 19C-19E, 19J, and 19K). The communicating elements of two surfaces or portions may be located within or on the surface or portion so as to communicate with the corresponding communicating elements of the other surface or portion when the surfaces or portions are interfaced with each other.

[0038]

[0036] One aspect of the disclosure is a computer-executable method adapted to receive an input indicating image data from at least one of a first image sensor or a second image sensor, and in response to start or cause a robotic control movement of an introducer, thereby moving the introducer to or toward at least one identified, or voluntarily automatically identified, anatomical landmark. [Brief explanation of the drawing]

[0039] [Figure 1] This diagram shows a schematic representation of a modified example of a device for assisting patient navigation and / or intubation. [Figure 2A] This depicts a modified example of a device for assisting patient navigation and / or intubation. [Figure 2B] Figure 2A shows a modified front view of the device, including the cover, as an example. [Figure 2C] Figure 2 shows a rear view of a modified version of the device as an example. [Figure 3A] This diagram shows a modified cross-sectional view of an example of a manual actuation system for guiding the actuation members of a device used to assist in patient navigation and / or intubation. [Figure 3B] A modified perspective view is shown as an example of an automated actuation system for guiding the actuarial components in a device for assisting patient navigation and / or intubation. [Figure 3C] This depicts a variation of an actuation unit for guiding actuation members in a device that assists patient navigation and / or intubation. [Figure 3D] This depicts a variation of an actuation unit for guiding actuation members in a device that assists patient navigation and / or intubation. [Figure 4A]This depicts a variation of a cover for a device used to assist with patient navigation and / or intubation. [Figure 4B] This depicts a variation of a cover for a device used to assist with patient navigation and / or intubation. [Figure 5] This shows a variation of an automated actuation system for articulating the distal end of a scope component in a device for assisting patient navigation and / or intubation. [Figure 6] This shows a variation of an automated actuation system for articulating the distal end of a scope component in a device for assisting patient navigation and / or intubation. [Figure 7] This is a modified flowchart illustrating one example of a method for tracheal intubation in a patient. [Figure 8A] This sequence is shown as an example illustrating automated image / landmark recognition. [Figure 8B] This sequence is shown as an example of manual image / landmark recognition. [Figure 9A] This shows a sequence illustrating image recognition and subsequent automated robot control of the introduced device. [Figure 9B] This shows a sequence illustrating image recognition and subsequent manual robotic control of the introduced device. [Figure 10] The following are illustrative examples of processes that include manual robot control at a certain point following automatic robot control. [Figure 11] This shows a part of an integrated, handheld tube insertion assembly as an example. [Figure 12] This shows a part of an integrated, handheld tube insertion assembly as an example. [Figure 13] This shows a part of an integrated, handheld tube insertion assembly as an example. [Figure 14A] An example of an integrated, handheld dual-video endotracheal intubation assembly is shown. [Figure 14B]A housing and a first imaging member are shown as examples. [Figure 14C] A second imaging member is shown as an example. [Figure 14D] This shows a portion of a second imaging member as an example. [Figure 15] This image shows an example of an integrated, handheld, dual-video endotracheal intubation assembly positioned in the upper airway. [Figure 16A] This shows an illustrative view on a display of image data from a first image sensor while it is maintained in the upper airway. [Figure 16B] This shows an exemplary view of image data from a first image sensor and a second image sensor, displayed on an exemplary display. [Figure 16C] This shows an exemplary view of image data from the first and second image sensors, displayed on an exemplary display, with the first image sensor maintained in the upper airway. [Figure 16D] This shows an exemplary view of image data from the first and second image sensors, displayed on an exemplary display, with the first image sensor maintained in the upper airway. [Figure 17A] This shows a side view of an integrated, handheld dual-video endotracheal intubation assembly (the first imaging member is not shown) before assembly, as an example. [Figure 17B] This image shows a top view of an integrated, handheld dual-video endotracheal intubation assembly (the first imaging member is not shown) before assembly, as an example. [Figure 17C] This shows a bottom view of an assembled, integrated, handheld dual-video endotracheal intubation assembly as an example. [Figure 17D] This shows a side view of an assembled, integrated, handheld dual-video endotracheal intubation system as an example. [Figure 17E]This image shows a top view of an assembled, integrated, handheld dual-video endotracheal intubation system as an example. [Figure 17F] This image shows a side view of an integrated, handheld, dual-video endotracheal intubation assembly before assembly, as an example. [Figure 17G] This image shows a top view of an integrated, handheld, dual-video endotracheal intubation assembly before assembly, as an example. [Figure 18A] A side view of a housing is shown as an example. [Figure 18B] Figure 18A shows an exemplary side cross-sectional view of the housing. [Figure 18C] Figure 18A shows an example of a top view of the housing. [Figure 18D] Figure 18 shows an example of a front view of the housing. [Figure 18E] Figure 18 shows an example of a perspective top view of the housing. [Figure 18F] Figure 18 shows an example of a perspective top view of the housing. [Figure 18G] This shows an example of a housing and optional internal components. [Figure 18H] This shows an example of a housing and optional internal components. [Figure 18I] This shows an example of a housing and optional internal components. [Figure 18J] This shows an example of a housing and optional internal components. [Figure 19A] The image shows a bottom view of a second imaging member, as an example, which includes an optional image sensor in its distal end region. [Figure 19B] A top view of a second imaging member is shown as an example. [Figure 19C] A side view of a second imaging member is shown as an example. [Figure 19D] This shows a rear view of the second imaging member connected to the intubation tube. [Figure 19E] This shows a front view of the second imaging member connected to the intubation tube. [Figure 19F] A top view of a second imaging member is shown as an example, with the top surface removed to reveal the internal components. [Figure 19G] A lower perspective view of the housing is shown as an example of a second imaging member. [Figure 19H] A bottom view of the housing is shown as an example of a second imaging member. [Figure 19I] A top perspective view of the housing, which serves as an example of a second imaging member, is shown. [Figure 19J] The image shows a front view of the housing as an example of a second imaging member. [Figure 19K] The rear end view of the housing is shown as an example of a second imaging member. [Figure 20] A schematic diagram of an integrated, handheld dual video assembly is shown as an example. [Figure 21] This specification illustrates an exemplary method using one of the integrated handheld assemblies described herein. [Modes for carrying out the invention]

[0040]

[0089] Various embodiments and variations of the invention are described herein and illustrated in the accompanying drawings. The following description is not intended to limit the invention to these embodiments, but rather to enable those skilled in the art to create and use these embodiments.

[0041]

[0090] The disclosures herein relate to methods, devices, and systems for airway management. While tracheal intubation is provided herein as an example of airway management, the disclosures are not limited thereto, and the concepts herein may or may be applicable to other airway management procedures, locations, and environments. For example, the concepts herein may be used in bronchoscopic procedures or endoscopic otolaryngological procedures, such as flexible nasolaryngoscopy, esophagoscopy, vocal cord inflation, and certain laryngological surgical procedures, as well as other endoscopic procedures involving the upper gastrointestinal (GI) tract (e.g., gastroscopy, esophagoscopy).

[0042]

[0091] The airway management procedures described herein may include any of the following exemplary and non-limiting procedures in both adult and pediatric patients: 1) Endoscopic evaluation of the airway in a patient to determine or establish: (a) the presentation of different parts of the upper airway anatomical structure and the relationships between those parts; (b) the size and location of (one or more) lesions and / or lesion sites, and the extent of (one or more) pathological processes; (c) the feasibility of placement of a supraglottic airway device (SGA, e.g., laryngeal mask) and the likelihood of successful SGA ventilation; (d) whether awake intubation and / or TI is feasible; and (e) the optimal TI to the larynx. This may include any of the following: (f) Endoscopic evaluation of the airway to determine or establish the navigation route, the use of the optimal TI device and the optimal TI strategy; (g) Facilitating the exchange of the ETT; (h) Evaluating the positioning and / or patency of the ETT and / or confirming the correct placement of the ETT inside the trachea; (g) Facilitating the placement and confirming the proper positioning of the double-lumen tube; (h) Facilitating the extubation attempt; (g) Performing bronchoscopy; (i) Performing transnasal and / or transoral TI; (h) Performing otolaryngological procedures such as endoscopic examinations, esophagoscopy, biopsies, infusions, and certain laryngological procedures; and (g) Performing any other therapeutic, interventional, and / or diagnostic procedures relating to the airway.

[0043]

[0092] For use in this specification, airway management procedures may be used in any of the following non-limiting locations and environments, namely, in an OR, ICU, ED, or outside of an OR (e.g., endoscopy rooms, imaging scanners, various outpatient and hospital environments, treatment rooms, etc.), and in airway management in the field (e.g., EMS) or on the battlefield, and may be used both in the field and during patient transport.

[0044]

[0093] In use herein, airway management includes, or may be used in, visualization procedures, diagnostic procedures, interventional procedures, surgical procedures, and / or therapeutic diagnostic procedures.

[0045]

[0094] The airway management concepts described herein may find practical applications in non-medical uses.

[0046] Devices and systems adapted to assist navigation and / or intubation.

[0096] Some non-limiting aspects of the disclosure herein are directed toward a portable, handheld, integrated dual-video enhanced visualization and navigation system adapted for guiding an ETT into a patient's trachea during a TI procedure. Such a system is adapted and configured to provide and improve all three critical steps necessary for a successful TI: visualization, navigation / movement, and placement. An integrated dual-video system configured, adapted, and sized to be held in the user's hand provides the benefit of allowing the user to hold and voluntarily control the dual-video integrated enhanced visualization and navigation system with one hand, enabling a single operator to reliably and smoothly navigate and move the ETT guide into the patient's trachea. The integrated dual video system described herein provides enhanced visualization of the patient's airway anatomical structure, which facilitates enhanced navigation of the ETT within and around the patient's anatomical structure, and facilitates improved ETT placement (insertion) whether passing through the glottal opening or entering the patient's trachea during TI procedures, all of which help reduce TI trauma and increase the likelihood of first-pass TI success (TI success on the first TI attempt).

[0047]

[0097] The disclosures herein may refer to navigation when describing the movement of an induction device. Where appropriate, navigation may also refer to the automated determination of how or where the induction device will be moved robotically. In embodiments in which the operator determines how or where the induction device will be moved, navigation may be performed manually, for example, based on viewing images on a display.

[0048]

[0098] This specification describes various variations of devices, systems, and methods for robotically assisting the navigation and movement of an introducer in the airway or other passage in a patient, for example, during intubation procedures (e.g., oral endotracheal intubation, nasotracheal intubation, etc.). In some embodiments of this specification, the robotically assisted movement described herein may also include the use of artificial intelligence (AI) to enable robotically assisted navigation. As shown in the schematic diagram of Figure 1, in some variations, an integrated robotic device or system 100 may include a housing 110, a laryngoscope or baton 120 (e.g., a video laryngoscope) connected to the housing and containing a first image sensor, and an actuator 140 at least partially located within the housing. The housing 110 may be, for example, a handheld device integrated to be portable and / or may be configured to be easily operated by a single person. The actuator is movable within the housing, and an introducer such as an endoscope 150 (e.g., a video endoscope) may extend from the actuator 140. The introducer may include a second image sensor and be configured to slide into an endotracheal tube such as an ETT, the connection of which may include sliding the ETT around the introducer. Once the introducer is robotically moved into the patient's passage (e.g., the trachea), it can function as a steering guide for advancing the endotracheal tube during the intubation procedure. Advancing the endotracheal tube may be performed, for example, by passing the endotracheal tube over the introducer, either manually or automatically. Once the endotracheal tube placement (e.g., in the trachea) is confirmed via real-time images from one or more image sensors (e.g., an introducer image sensor when the introducer is in the trachea), the endotracheal tube is detached from the introducer (this may include sliding the introducer proximal to the ETT), and the introducer and the remainder of the device 100 may be withdrawn from the patient's anatomical structure, leaving the endotracheal tube (e.g., ETT) in place.

[0049]

[0099] In any of the examples and embodiments described herein, robot-assisted navigation / movement may include robot-assisted navigation of the introducer, among which the endoscope (sometimes referred to herein as a scope) described herein is an example. In this specification, the introducer is generally described as including one or more image sensors, but in alternative systems, the introducer may not include an image sensor, or an image sensor may not be used continuously. In embodiments in which the introducer does not include an image sensor (or an image sensor is not used continuously), the introducer may be robotically navigated using AI assistance with images obtained from an integrated image sensor, such as an image sensor associated with a first imaging member, such as a video laryngoscope, which is described in detail as an example herein. When using a non-optical introducer, the placement of the intubation tube below the vocal cords (lower airway) is not visualized by the non-optical introducer, and therefore, the placement of the intubation tube below the vocal cords cannot be instantly confirmed. However, depending on the application and clinical situation, non-optical induction devices may offer advantages in terms of simplicity and cost compared to optical induction devices, such as those described herein, which include one or more image sensors.

[0050]

[0100] While the devices, systems, assemblies, and methods described herein primarily relate to intubation procedures, it should be understood that they may also be used to assist other medical airway management procedures involving navigation through one or more passages, such as endoscopic procedures (e.g., bronchoscopy). For example, the navigation of an introducer may be robotically assisted using devices and methods as described herein, but the introducer would be automatically guided using AI / automation technology without being connected to an intubation tube. For example, a device can robotically assist the navigation of an introducer during any appropriate medical endoscopic procedure to provide a faster and / or less traumatic endoscopic procedure compared to conventional manual techniques. As an embodiment for illustrative purposes, the devices, systems, assemblies, and methods described herein, instead of automatically guiding the intubation tube, guide an introducer (e.g., endoscope 150) to the introducer or a third The system may be automatically guided based on one or more images obtained using an imaging device (e.g., a laryngoscope). In some variations, the introduction device (e.g., endoscope 150) may include one or more channels for, for example, irrigation, drug delivery, tissue biopsy, and / or deployment of surgical instruments.

[0051]

[0101] Furthermore, in some variations, the devices, systems, assemblies, and methods described herein may be used in other applications where automated navigation / movement may be useful, such as navigation in passages that are otherwise difficult to access (e.g., non-medical applications).

[0052]

[0102] System 100 as an example in Figure 1 may optionally include at least one display 118 configured to display one or more images from a first image sensor in a first imaging member (e.g., a laryngoscope) and / or a second image sensor in a second imaging member (which may include an introducer), and / or the display 118 may be configured to display images from both the first and second image sensors simultaneously, such as in a split screen or picture-in-picture. The images may be displayed continuously, substantially continuously, or sequentially during the procedure. System 100 may further include at least one actuator 116 in the housing configured to automatically guide / move the introducer (e.g., an endoscope) via an actuator 140, at least partially based on one or more images from the first and / or second image sensors. In some variations, the system further includes a cover or blade connected to the housing, the cover may include a first channel sized and configured to receive a first elongated imaging member (e.g., a video baton), and a second channel configured to stably receive at least a portion of an intubation tube (in which an induction device may be placed). The cover may further include a tongue retraction member (e.g., an angled or curved member) configured to retract the patient's tongue during the intubation procedure, several embodiments of which are shown in the figures herein.

[0053]

[0103] In some variations, one or more actuators may be under the operational control of one or more processors 112 configured to analyze images or image data from one or both of the first and second image sensors in the system using appropriate AI (e.g., machine learning methods). Various electronic devices 114 (e.g., one or more power sources, electronic communication lines, etc.) within the system or housing 110 and / or display 118 may power one or more processors, image sensors, light guides, etc. in the system. Real-time or near-real-time AI-based image recognition of the patient's upper airway anatomical structures (above the vocal cords) and / or lower airway anatomical structures (below the vocal cords) may trigger, for example, robot-assisted tracheal intubation using the system. As will be described in more detail later, visualization and navigation / movement to or toward the vocal cords may be based on identifying one or more important anatomical recognition points provided by the image sensors (one or more) of the first and / or second imaging members. The system can perform robot-assisted navigation that is automatically activated in response to recognition of airway anatomical structures and / or activated in response to manual activation (e.g., through user interaction of user interface elements). For example, in the fully automated mode of the exemplary device or assembly 100, the actuators may be configured to automatically maneuver the endoscope using AI and / or other robot-assisted navigation and electromechanical control of the working members.

[0054]

[0104] Additionally or alternatively, the device or system may operate in an automated mode with manual assistance, as exemplifies. In such an automated-manual-assisted mode... For example, the actuator and / or introducer can be manually controlled by using a user interface device (e.g., a joystick) or through the device display 118. When the device is in automated-manual-assisted mode, joint movement of the distal end of the introducer may occur automatically, for example, under the automated robotic control of one or more actuators in the system.

[0055]

[0105] When used for intratubation (TI), the system herein can be a user-friendly, portable, handheld, video-triggered, AI-enabled robot-assisted automated intubation system with enhanced functionality that improves all three critical steps necessary for successful TI: visualization, navigation, and placement, thereby increasing the first-pass intubation success rate, reducing overall intubation time, reducing intubation-related airway trauma, and / or improving patient safety. For example, the system herein may combine multiple imaging (e.g., video) modules, enabling the device to perform intubation using AI or robot-assisted guide navigation, within an ergonomic package operable by a single user. The robot-assisted intubation interface can, for example, maneuver at least a guide guide into the patient's trachea through the glottis, with the guide guide serving as a guide for the advancement and placement of the ETT. The ETT may, for example, be pre-loaded on the guide and advanced on the guide after the guide has been advanced into the trachea and proper placement within the trachea has been confirmed.

[0056]

[0106] Among other advantages described herein, the system herein is configured to provide continuous visual feedback and voluntary closed-loop robotic assistance for real-time troubleshooting and / or intelligent intervention from both above and below the vocal cords during tracheal intubation, thereby improving TI success rates, increasing intubation speed, and reducing TI trauma. In addition, the combined use of the first and second imaging members enables more reliable and rapid triggering of the AI ​​and associated robotic interface, at least in part, thanks to the magnified and clear view of upper airway anatomical landmarks provided by the first imaging member (e.g., laryngoscope 120). Another advantage of obtaining initial imaging through the first imaging member is that the visualization of the patient's anatomical structure is far less affected by blood and secretions compared to images provided by the second imaging member (e.g., an imaging sensor in the distal region of the inducer). Furthermore, the combined use of the first and second imaging members, the angular orientation of their individual video cameras, and the close axial proximity and maintenance of these video cameras relative to each other and to the glottal opening provide the shortest and fastest navigation path to the vocal cords and trachea for the inducer and ETT. In addition, the operation of the inducer within the patient's airway is greatly facilitated by the creation of a larger pharyngeal space for the operation and manipulation of the inducer by a device cover or blade configured to perform tongue retraction. One of the optional significant benefits of some of the systems described herein is that the system can be configured to allow the user to observe the intubation procedure holistically from both above (upper airway) and below (lower airway) the vocal cords, to enable immediate visual confirmation of the placement of the intubation tube inside the trachea during intubation using the inducer imaging sensor, and to ensure that the intubation tube is optimally positioned inside the patient's airway, and several exemplary embodiments thereof are described below.

[0057]

[0107] Furthermore, the integrated dual-video capability of the system herein can significantly reduce intubation-related airway trauma and soft tissue injury often associated with conventional devices, even in situations where visualization of upper airway anatomical landmarks is limited (e.g., when complete glottal exposure is not available). The system automatically guides the intubator through the glottal opening into the patient's trachea after identifying anatomical structures (e.g., epiglottis, arytenoid cartilage, etc.) reliably associated with the glottal opening during initial video image capture using, for example, a first image sensor, even when the glottal opening cannot be visualized. It can be precisely controlled. The device may also reduce the risks of esophageal intubation and / or complications during intubation, such as when a tumor or other space-occupying lesion is present inside the patient's airway, defragmentation, bleeding, and / or airway contamination.

[0058]

[0108] In some variations, the system would be useful in situations where increasing the distance from the patient's airway is desirable to reduce the likelihood of airborne and / or contact transmission of infection from the patient to the operator of the device. For example, due to the nature of requiring minimal airway manipulation and the automated intubation performed, the operator of an integrated system can hold the system from an appropriate distance (e.g., arm length), avoiding the risk of directly viewing the inside of the patient's airway to reduce the likelihood of infection transmission (e.g., from a patient with a contagious bacterial and / or viral disease such as COVID-19).

[0059]

[0109] The system described herein may be used for routine elective tracheal intubation and / or for anticipated and / or unexpected difficult tracheal intubation in any appropriate setting, such as OR, ICU, emergency department, locations outside of OR (e.g., clinics, code situations, etc.), pre-hospital care conditions (e.g., field and battlefield airway management), and / or other elective and / or emergency and / or emergency situations. In addition, the system may be used for TI across a wide range of patients and various diagnostic and / or therapeutic procedures, for example, when airway support and / or airway protection and / or lung hygiene are desired or applicable, such as when a patient is undergoing an interventional endoscopic procedure (e.g., bronchoscopy, GI endoscopy), transesophageal echocardiography, CT, and MRI imaging procedures, or a medical procedure that may require sedation and / or airway support and / or airway protection. The system would be useful for intra-arterial respiration (TI) in specific patient populations where TI is expected to be more challenging, such as obese individuals, those with obstructive sleep apnea, those with head and neck cancer and other lesions, elderly patients, patients at high risk of dental damage, patients for whom neck movement is undesirable, trauma patients, patients for whom minimizing poor cardiovascular responses to intubation (e.g., hypertension, tachycardia, arrhythmias, etc.) is important, and critically ill patients. In some variants, the device would be useful for TI in both adult and pediatric patients.

[0060]

[0110] Figures 2A–2C are schematic diagrams of a portable, handheld, integrated dual video robot assembly or system 200, which may be adapted for visualization, navigation, and placement during intubation procedures, and are merely illustrative. As shown in Figure 2A, the system 200 may include a handheld housing 210, an electronics system 214 (including, for example, one or more processors, one or more power sources, etc., the embodiments thereof which are described herein), and one or more actuators 216. The device may further include a first imaging member (or other imaging member), such as a laryngoscope having a baton 220 equipped with at least one image sensor 222 positioned in its distal region as shown, and an actuation member 240 that is movable within the housing 210. In addition, the system 200 may include an introducer, such as an endoscope 250 equipped with an image sensor 252 positioned in the distal region of the introducer as shown. The introducer 250 may be configured to connect to an intubation tube (e.g., an ETT for use during TI procedures). In this context, “connected” includes the ETT being axially movable around or on the introducer. As shown in Figures 2B, 4A, and 4B, the system 200 may further include a cover 260, which includes a channel sized and configured to receive a first imaging member (e.g., a laryngoscope baton 220) and at least a portion of the ETT and introducer (e.g., an endoscope 250) therein. As shown in Figures 4A and 4B, the cover 260 may further include a distal region which includes a member 268 configured to manipulate tissue (e.g., a patient's tongue) during an intubation procedure. Any of the covers herein may include a member similar to the member 268 configured to manipulate tissue (e.g., a patient's tongue) during an intubation procedure. Enhanced visualization and navigation during intubation Further examples of the System 200 will be described in more detail later with reference to Figures 2A-2C, 3A-3D, 4A-4B, 5, and 6, but it should be understood that the described embodiments may be applicable to other modified systems and devices having different sizes, shapes, etc.

[0061] Handheld housing

[0112] The example housing 210 can be sized and configured to enclose various software and hardware components for performing robot-assisted TI, such as electronic components (e.g., one or more processors, memory, one or more power sources, one or more motors, etc.) and / or actuators (one or more) for guiding the introducer during intubation procedures, etc. The housings of this specification can further be sized and configured to integrate a first imaging member (e.g., a video laryngoscope) and a second imaging member (e.g., an endoscope) into a single user-friendly, portable handheld system that can be operated and controlled by one hand or by a single user. Both the handheld housings of this specification (e.g., housing 210) and the integrated dual-video assemblies of this specification (which may include handheld housings) are conveniently sized and configured to be held in the hand of a single operator, thereby providing the benefits described herein.

[0062]

[0113] The housings of this specification (e.g., housing 210) may be configured as handheld housings that can be ergonomically held in the user's hand. The handheld housings may be contoured (e.g., with finger grips) or otherwise configured for a particular hand (e.g., left hand, right hand), or may be designed to fit either hand. For example, as shown in the front view depicted in Figure 2A, the handheld housings may be configured for left-handed use. In some variations, the housings may include one or more other ergonomic features, such as cushioning (e.g., foam or rubber pads, silicone gel, etc.) or friction features (e.g., rubberized grips, ribbed or other textured features, etc.) to improve user comfort.

[0063]

[0114] In some embodiments, the handheld housing may be between approximately 10 cm and 75 cm in length, for example between approximately 15 cm and 45 cm, but can be any appropriate size that is ergonomically suited to a device that can be held in one hand by the operator. In some embodiments, the housing is between 2 cm and 15 cm in width, for example between 4 cm and 10 cm. In some embodiments, the housing is between 5 cm and 20 cm measured from top to bottom, for example between 5 cm and 15 cm.

[0064]

[0115] The housings described herein (e.g., housing 210) may be made of any suitable rigid or semi-rigid material. For example, the housing may include a plastic formed by a suitable injection molding process. In some variations, the housing may include one or more separate components (e.g., shells) that are integrally connected via one or more suitable fasteners (e.g., epoxy or other adhesives, mechanical fasteners) and / or fitting features (e.g., threaded or snap-fit ​​or complementary features on different housing components). The housing may enclose various electronic devices, (one or more) actuators, and / or other embodiments of devices within its internal volume, such embodiments are described herein.

[0065] Electronic Systems

[0117] The systems or assemblies described herein may include at least one processor and / or at least one memory device, which may be electronic equipment systems (e.g., electronic equipment system 2 14) may include. At least a portion of the electronic system 214 may be located, for example, within a housing and / or within a display connected to the housing as described in more detail later. The memory device may store instructions (e.g., in the form of software, a computer-executable method) for one or more processors to analyze images from a first imaging sensor and / or a second imaging sensor and / or to perform AI-based analysis (using smart image recognition technology and / or machine learning) of such images in order to automatically navigate the inducer into the trachea during intubation. One or more processors may also be configured to perform automated control of actuators within the device to guide the working members and / or at least a portion of the inducer as intubation assistance. Automated navigation allows intubation to be performed in a user-friendly manner with little to no user training or experience required to enable successful intubation. Further details of such AI or machine learning algorithms are described in more detail later.

[0066]

[0118] Conceptually, the electronic equipment system designated as electronic equipment system 214 as an example may further include other components to support the device, such as at least one power supply. In some variations, the power supply may include at least one battery as a self-contained power supply (for example, to help facilitate the portability of the device). Additionally or alternatively, the housing and / or display may include a power supply connector or port 211 that can enable a wired power connection to an external AC or DC power supply, etc. Additionally or alternatively, the housing may include a wired connection (e.g., a cable) and / or a wireless communication module for communicating with a standalone video monitor. Furthermore, in some variations, the housing may include emergency stop control (e.g., a button) to interrupt the automated robotic assistance of the device by the operator's intent (e.g., suddenly cutting off current to (one or more) actuators). In some variations, the housing may further include a power button to control the power supply of the system on and off, and / or one or more ports for downloading images and updating one or more software programs.

[0067] (One or more) operating units, actuators, or operating members

[0120] The housings of this specification (e.g., housing 210) may include one or more actuators 216 configured to automatically guide the movement of an actuator 240 for AI or robot-assisted intubation while the introducer is connected to the intubation tube (e.g., releasably connected). In the embodiment of Figure 2A, the forward movement of the actuator 240 further extends the effective operating length or working length of the endoscope 250. As will be described in more detail later, one or more actuators 216 are integrated within the housing and can act on the actuator 240 through a connected interface, so that the resulting movement is transmitted along the longitudinal axis of the actuator and along the longitudinal axis of the endoscope 250 extending from the actuator. One or more actuators 216 may be additionally included to actuate and / or articulate the distal end of the endoscope 250, as will be described later.

[0068]

[0121] The device may include any suitable actuator and mechanical or electromechanical assemblies for controlling the actuator 240 and / or the introducer. For example, an (one or more) exemplary actuator 216 and associated (one or more) controllers may include suitable drive electronics, one or more electric motors, a hydraulic system and / or a pneumatic system, and suitable mechanical assemblies, connections, joints and / or controllers. For example, control assemblies, connections and joints for controlling the actuator and / or endoscope may include longitudinal elements, bidirectional push-pull cables, wire pulley assemblies, chain drives, hinges, slide crank mechanisms, piezoelectric elements, pneumatic elements and assemblies, magnetic The actuator assembly 216 may include elements, adjustable couplings, sleeves, belts, gears, pushers, plungers, movable racks, compression springs, translational-to-linear and / or linear-to-rotation motion modules, gear drives, or other suitable motors and / or couplings. Other suitable fasteners and bearing surfaces may further be included in the (one or more) actuator assemblies 216.

[0069]

[0122] The (one or more) exemplary actuators 216 may be activated automatically and / or manually. For example, in some embodiments, the (one or more) actuators 216 may be activated through the execution of image recognition software instructions by one or more processors, in response to the processors recognizing one or more anatomical landmarks through such image recognition techniques. This automatic activation may, for example, be part of a fully automated mode of the device. Additionally or alternatively, the (one or more) actuators 216 may be selectively engaged and / or disengaged in response to user selection of one or more user interface elements. For example, the (one or more) actuators 216 may be activated by selection such as the AI ​​action button 280 as shown in Figure 2C, or deactivated by selection such as the STOP button 284 as shown in Figure 2C. The system may, additionally or alternatively, include other user interface elements for activating / deactivating the device's fully automated mode, such as toggle switches, touch-sensitive pads, touchscreens, or user interface icons on a display screen. In some variants, manual operation of the actuator 240 (e.g., using a joystick or other user interface element, as described below) may immediately override the fully automated mode. In these variants, the fully automated mode is then permitted to be resumed after the user presses, for example, the AI ​​operation button 280. Additionally or alternatively, the fully automated mode may be resumed after a predetermined period of time (e.g., a period of inactivity or non-movement of the actuator 240, a predetermined duration, etc.) while in manual assist mode. In yet another variant, manual assist mode selection may override the fully automated mode as long as a clutch (e.g., a button, switch, joystick, or other suitable selectable mechanism) is engaged, while releasing the clutch button may resume the fully automated mode.

[0070] display

[0124] As illustrated in Figures 2A–2C, any system or assembly of this specification (e.g., system 200) may optionally further include a display, such as display 218, e.g., a monitor screen, a touch screen, etc. The display may be configured to display image data and / or a user interface. For example, the display may be configured to display a single-channel image from only a first image sensor (e.g., laryngoscope image sensor 222) or only a second image sensor (e.g., introducer image sensor 252). In another embodiment, the display of this specification may be configured to display a multi-channel image from both the first and second image sensors (e.g., 222 and 252), and may display images from the laryngoscope image sensor and / or endoscopic image sensor in a split-screen and / or picture-in-picture arrangement, just as an example. In some variations, the display may consist of a default or pre-programmed display sequence. As one embodiment of the default display sequence, the display initially shows a video feed or signal from a video laryngoscope to provide visual feedback of the initial entry into the patient's airway (e.g., upper airway) and / or identified (one or more) anatomical structures, and then, as soon as the AI-based operation is activated (either automatically or via manual activation as described above), and / or the device and / Alternatively, the system may be configured to automatically transition to displaying a multi-channel set of images (e.g., split screen, picture-in-picture) from an endoscopic image sensor (e.g., 252) and / or a laryngoscope image sensor (e.g., 222) as soon as a selectable user interface element on the display is pressed. In some variations, other toggling of video feeds from various image sensors may be achieved through specific pre-programmed actions of the user interface element (e.g., pressing a picture-in-picture button or icon two or more times in succession to obtain a full image of the patient's trachea and intubation tube placement (or other anatomical structures) provided by the endoscopic image sensor 252).

[0071]

[0125] In some embodiments, the display herein may be coupled to the housing 210 or other housing herein (e.g., on the proximal portion of the housing). The display may include any suitable display element (e.g., LCD). In some variations, the display may be coupled to the housing via a rotary or pivotal coupling, so that the display can swivel around a longitudinal axis and / or tilt around a vertical axis and / or a lateral axis, making it viewable from multiple angles. Alternatively, the system herein may include a multi-sided (e.g., double-sided) display that allows the displayed content to be viewed simultaneously from multiple angles. In any embodiment herein, the display coupled to a handheld housing may be portable in size, such as approximately 8 cm to 15 cm in height and approximately 10 cm to 18 cm in width, but the display may be any suitable size and / or shape.

[0072]

[0126] Additionally or alternatively, any of the systems herein may include a remote display that is not part of the integrated assembly and may be communicatively connected to the remote display. For example, any of the systems herein may include one or more ports in any of the housings herein for wired communication to a display device. In another embodiment, the system may include a wireless communication module and antenna for communicating content for display to another screen (e.g., via a cellular mobile network, Wi-Fi, etc.).

[0073] First (elongated) imaging member (e.g., laryngoscope)

[0128] Any integrated dual video system or assembly described herein may include a first imaging member (e.g., a video laryngoscope) which may include an elongated flexible body and a first image sensor (e.g., a video camera) positioned in the distal region of the elongated body. Any of the first imaging members described herein may also be referred to as the first elongated imaging member, implying that they generally have an elongated configuration. For example, as shown in illustrative Figures 2A–2C, system 200 may include a first imaging member (e.g., a video laryngoscope). The first imaging member may include a baton 220 (or other elongated member) extending distally from the housing 210, as shown. The baton 220 may include (one or more) high-resolution image sensors (e.g., video cameras) for providing video images located in the distal region, one or more light guides for providing illumination to the field of view of the image sensors, and electronic signal wires for transmitting video data or images for processing and / or display on the display 218 (or other suitable display). The (one or more) image sensors 222 may be located at the distal end of an elongated member and may be adapted to provide a relatively wide field of view to provide magnified, clear visualization of the patient's anatomical structures in both axial and horizontal planes during intubation. The relatively wide field of view and angular position (relative to the second image sensor) of the first imaging sensor can help to reliably visualize and identify key anatomical landmarks within the upper airway, thus enhancing navigation as the introducer is moved distally to the first image sensor. As will be described in more detail later, the combination of the first and second imaging members may be used. The use of a flexible wide field of view, and the close axial proximity and maintenance of the cameras of the first imaging member and the second imaging member relative to each other and to the glottal opening, provide the shortest and fastest navigation path to the vocal cords and trachea for the introducer and ETT. In some, but not limited to, simply optional embodiments, the (one or more) first image sensors of the first imaging member may have a wider field of view than the second image sensors of the introducer. In such cases, the first imaging member can provide a more magnified and sharper image of the patient's anatomical structure compared to conventional devices, facilitating faster and more reliable AI image recognition and / or robot-assisted control and movement initiation of the introducer using the system. Any (one or more) image sensors herein may optionally include a charge-coupled device (CCD), a CMOS sensor, and / or other suitable (one or more) sensors, and may be combined with any suitable optical element such as an objective lens. In some embodiments, the video camera of the first imaging member and the video camera of the second imaging member have the same field of view, while the first image sensor is kept proximal or posterior to the second image sensor, for example, when the introducer is advanced distally toward the glottal opening, thereby allowing the first image sensor to still provide visualization of a wider anatomical area compared to the second image sensor. Furthermore, in some embodiments, the first video camera has a narrower field of view than the second video camera, but the first image sensor is kept proximal or posterior to the second image sensor, for example, when the introducer is advanced distally toward the glottal opening, thereby allowing the first image sensor to still provide visualization of a wider anatomical area compared to the second image sensor. Exemplary uses, including the process of utilizing the first and second simultaneously provided video signals from the first and second video cameras, are described in more detail below.

[0074]

[0129] In any of the systems described herein, the first imaging member includes a laryngoscope, which may include a baton or other elongated member between approximately 10 cm and 15 cm in length, but may be of any size suitable for adult and / or pediatric patient populations. As will be described later, the systems described herein may optionally include a universal handheld housing adapted to be interchangeable with different sizes of first imaging members for different patient populations (e.g., adults and children) to provide greater functionality. As shown in illustrative Figure 2A, the illustrative laryngoscope baton 220 may generally taper in diameter as it extends away from the housing 210, and / or be gently curved or flared to adapt to imaging components and / or to provide better angle during intubation procedures. Nevertheless, the first imaging member 220 may have any suitable shape and size for use with the patient's anatomical structure. In some embodiments, the first imaging member (e.g., which may include a laryngoscope baton) may be flexible and have a reclined configuration, and in some embodiments, it may have a linear or substantially linear configuration adapted to bend within the cover. The first imaging member 220 may be removably or detachably connected to the housing 210, or it may be integrally or permanently connected to the housing 210 (e.g., intended for reuse). For example, the first imaging member 220 may be kept sterile by the use of a disposable cover 260 after each use (as further described later), or it may be sterilized with an appropriate disinfectant after each use. Alternatively, in some variations, the first imaging member 220 may be modular or detachable from the housing 210 (e.g., by a snap-fit ​​connection), and may be disposable, and / or may be replaced and swapped with different first imaging members 220 for different uses of the system 200. For example, the first imaging member 220 may be replaced with a different first imaging member 220 to avoid the need to sterilize the baton after each use.In another embodiment, the first imaging member 220 may be removed separately to facilitate sterilization after each use. In yet another embodiment, different first imaging members 220 may be of different lengths, diameters, and / or for different types of patients (e.g., adult patients, pediatric patients). The cover may have a shape, so that the first imaging member 220 can be replaced with different first imaging members 220 of different desired sizes depending on the patient and / or situation. Furthermore, as will be described in more detail later, the cover (e.g., cover 260) may be appropriately sized for the dimensions of the first imaging member 220 (e.g., having a channel defining a lumen of appropriate diameter and / or length).

[0075] Actuating components and introducing devices (e.g., endoscopes)

[0131] In some embodiments, the integrated assembly or system may optionally include one or more actuators and introducers. For example, in the illustrative Figures 2A–2C, the device 200 may include an actuator 240 and an introducer (e.g., an endoscope 250) extending from the actuator 240. In this non-limiting embodiment, the actuator 240 and the endoscope 250 may be joined or connected end to end, for example, to form a flexible member.

[0076]

[0132] In general, the combination of the operating member 240 with the endoscope 250 or other introduction device may include a flexible insertion tube (or rigid video stylet, etc.) for engaging with the intubation tube, at least one image sensor 252 located at the distal end of the introduction device 250, and an articulated distal tip of the introduction device 250 which may be controllable by one or more tensile elements such as one or more pull wires or other suitable (one or more) control mechanisms fixed to the distal region of the introduction device.

[0077]

[0133] For example, the introducer (e.g., introducer 250) may include at its distal end (one or more) high-resolution image sensor or video chip camera modules, such as those shown in illustrative Figure 2A, including (e.g.) one or more CCD or CMOS image sensors, objective lenses, and / or other suitable optical configurations. In one exemplary embodiment, the image sensor may be, for example, between about 2 mm and about 4 mm in size and provide a wide field of view (e.g., at least 90 degrees, at least 180 degrees, at least 270 degrees, or 360 degrees). One or more light guides (e.g., carrying LEDs or other illumination) may pass through the working member and the shaft of the introducer to provide illumination during airway management procedures. Signal wires along the shaft of the introducer may carry images or image data from the image sensor to an image processor which may be optionally located in the housing and / or display or in an external device. The distal end of the introducer 250 may also include an angle-forming pull wire or tension cable or (one or more) It may also include a flexible joint movement structure (e.g., having an articulated segment) that can be controlled by other suitable mechanisms. Such a bending angle forming wire may, for example, control the up-and-down and left-and-right steering movements of the articulated tip of the introducer 250.

[0078]

[0134] At least the proximal end of the voluntary actuator 240 may be connected to and / or located within the housing 210 and controlled by one or more actuators. The actuator 240 can be advanced longitudinally (e.g., at least partially outside the housing 210), retracted proximal along the longitudinal axis, and / or rotated by one or more actuators 216, thereby controlling the forward, retraction, and / or rotation of the introducer 250. In some variations, the actuator 240 may extend the working length of the introducer 250, so that the forward movement of the actuator 240 can position the distal end of the introducer 250 distally, further than the introducer 250 could do on its own. Furthermore, the actuator 240 may be retractable inside the housing 210, for example, by using a selectable button 290 as shown in Figure 2C.

[0079]

[0135] In some variations, the operating member 240 and the introducer 250 are, for example, permanently installed. It may be connected to the body. In other words, the actuator 240 and the introducer may optionally be structurally and functionally integrated. Thus, in some variations, the entire flexible member, including both the actuator 240 and the introducer 250, may remain connected to the housing 210, and the entire flexible member (and possibly the entire device 200) may be completely sterilized after each use. In other variations, the actuator 240 may be detachable from the housing 210, so that the actuator 240 and the introducer 250 can be sterilized separately from the housing 210. For example, the actuator 240 may be detachably connected to the housing 210 by connector fittings, fasteners, mechanical interlocking (e.g., threaded parts, interference fittings), nesting, or by any suitable method. In some variations, a disposable protective sheath or other cover may be removable and installed over at least the introducer 250, thereby eliminating the need to completely sterilize the actuator, introducer, and / or the entire device after each use. In other variations, the actuator 240 may be integrated into a single module that is removable (e.g., by snap-fit, "plug-and-play" connection, etc.) to the housing 210 and the actuator control unit 216, along with a connection to the user interface device 270 (e.g., including a guide 217 and / or a control member 274 such as a joystick, as shown in Figures 2C and 3). In yet another variation, the actuator control unit may be included in whole or in part in such a module. Such an integrated module, having either a permanent or detachable connection to the introducer 250, can be easily removed from the housing 210 and replaced with a new instance of a similar module, and / or replaced with a new, different module containing a different actuator 240, for example, having a different outer diameter, length, etc. This further allows the housing to function as a universal handheld unit adapted for use with induction devices of different sizes, potentially enabling a single handheld housing to be used to treat different patient populations (e.g., adults and children).

[0080]

[0136] Alternatively, in some variations, any of the actuators and any of the introducers (e.g., endoscopes) described herein may be detachable from each other. The actuators and introducers may be connected integrally by connector fittings, fasteners, electromechanical mating (e.g., threaded parts, interference fittings), bands, nests, or in any suitable manner. Once connected, the actuators and introducers function as a continuous single unit. For example, the introducer 250 may be detachably attached to the actuator 240 or housing 210 so that the introducer 250 can be disposable. In this embodiment, the introducer 250 does not need to be sterilized as it may be optionally discarded after use.

[0081]

[0137] The external surfaces of the actuator and introducer may optionally be covered with a coating (e.g., a polymer material) that provides a smooth, non-traumatic, biocompatible, and watertight surface. In some embodiments, the actuator and / or introducer may have an outer diameter between about 2.5 mm and about 7.0 mm. The proximal portion of the actuator (e.g., between about 0.5 cm and about 6.0 cm in length) or even the entire length of the actuator may, in some modifications, have a larger outer diameter as needed to accommodate various connections to (one or more) actuators within the housing and / or user interface device (as further described below). The combined total length of the actuator and introducer may, for example, be between about 30 cm and about 70 cm. In some modifications, the actuator may be between about 10 cm and about 40 cm in length, and the introducer may be between about 20 cm and about 30 cm in length. However, the diameter and length of the actuator and / or introducer may be varied to suit different applications (e.g., adult patients versus pediatric patients). For example, a variant of a device suitable for assisting nasotracheal intubation may include a longer induction device, such as one between approximately 20 cm and 60 cm, which would result in an overall combined length between the actuator and the induction device being between approximately 30 cm and 100 cm. This may contribute to the above. Other exemplary structural embodiments of the operating members and introducers will be described in more detail later.

[0082] Actuating member

[0139] Any integrated system or assembly described herein may optionally include one or more actuators, and the following disclosures may apply to any actuator described herein. At least the proximal end of an exemplary actuator 240 may be located within the housing 210 and / or display 218. The actuator 240 may be driven in multiple degrees of freedom to produce corresponding movements of the introducer (e.g., endoscope 250). For example, the actuator 240 may be actuated via electromechanical coupling in a linear forward (forward and backward along the longitudinal axis) and axial rotation (rotation around the longitudinal axis). Other actsuated in or near the actuator, such as via the guidewire described above, may cause the distal end of the introducer to additionally articulate vertically and / or horizontally.

[0083]

[0140] The actuator 240 and the introducer may be configured collectively such that the actuation and motion in the actuator 240 can result in the transmission of all desired degrees of freedom to the introducer. The device may include, as described above, any suitable (one or more) actuators 216 and associated control systems for driving the actuator 240, and may appropriately include, for example, drive electronics, one or more electric motors, hydraulic systems, pneumatic systems, and / or various mechanical components (assemblies, connectors, joints, controllers, etc.). The control unit assemblies, connections, and joints may be configured so that the desired actuated mechanical motion is smoothly and accurately transmitted along the actuator of the introducer to the distal articulated tip of the introducer.

[0084]

[0141] As illustrated in Figure 2A, in some variations, the actuator 240 may move along a designated path within the housing 210. For example, as shown in Figure 2C, the actuator 240 may be positioned along a guide 217 within (or on the surface of) the housing 210. The guide 217 may include, for example, a guide channel (e.g., at least about 0.5 cm to about 1.0 cm wider than the actuator 240), or any suitable rail, track, or other guide structure. In other words, in the fully automated mode of the device, the actuator 240 will move within the guide channel when driven by one or more of the actuators 216 described above. Although the guide 217 is shown as curved in Figure 2C, it should be understood that in other variations, the guide 217 may be straight or in another suitable shape that fits within the housing 210.

[0085]

[0142] Figures 3B–3D illustrate various exemplary variations of actuators configured to move the actuator of this specification along a guide. Figure 3B is a schematic diagram of an axial actuator 216a configured to move the actuator 240 axially or longitudinally (e.g., forward and / or backward), thereby moving the introducer axially in a similar manner. For example, as shown in Figure 3C, the axial actuator 216a may include one or more matching pairs of opposing drive wheels that engage with the actuator 240 via grooves, friction elements, and / or the like. The drive wheels (wheels A and B) of each matching pair of drive wheels are located on opposite sides of the actuator 240 or introducer, and their synchronous rotation in opposite directions may push the actuator 240 of the introducer forward and backward in the axial or longitudinal direction, for example, along the guide 217. Other suitable mechanisms, such as one or more of a slider-crank system, belt or pulley system, plunger actuator, or corkscrew mechanism, may additionally or alternatively provide axial movement of the actuator 240. Furthermore, one or more actuator connections to a rotary actuator 216r may also be connected to the actuator 240, as shown in Figures 3B and 3D. The rotary actuator 216r is described later with respect to Figure 3B. It may also include one or more pull wires or other tension element attachments connected to the actuator 240, configured to control lateral or left-right motion, similar to the above. However, any other suitable mechanism, such as rollers, may be used to automatically operate the rotational motion of the actuator 240 and, consequently, the guide introducer.

[0086]

[0143] Additionally or alternatively, the actuarial member 240 may move within the guide 217 when it is manually driven via a user interface device 270, a touch screen, voice commands, etc., such as when the actuarial member 240 is in manual assist mode. For example, as shown in Figure 3A, the user interface device 270 (including, for example, a control member 274 such as a joystick) may be connected to the actuarial member 240. The user interface device 270 may be engaged within a control member guide 272 which may generally follow the trajectory of the guide 217 for the actuarial member 240 or be parallel to the trajectory, as shown in Figures 2C and 3A. The user interface device 270 including a control member 274 such as a joystick may be connected to the actuarial member 240 via control wires 276 attached (for example, by fasteners, welding, or any other suitable method) to connection points 278 and 279, as shown in Figure 3A. For example, the upper connection 278 between the control member 274 and the actuator 240 can control manual forward movement (F) when the user manually operates the control member 274 forward and backward within the guide 272 (e.g., pushing and / or pulling). In another embodiment, the lateral connection 279 between the control member 274 and the actuator 240 can control lateral or left-right movement (L) and (R) when the user manually operates the control member 274 within the guide 272. Thus, the user interface device 270 can enable a manual assist mode (e.g., enabling manual forward movement and / or manual rotation of the actuator 240 and thus the guide (e.g., endoscope 250), while the distal articulated tip of the endoscope remains in automated operation). These connections 278 and 279 remain inactive in fully automated mode.In some variations, the manual assist mode is confirmed using a user interface element 282 (e.g., a button) shown in Figure 2C, and when the user interface element 282 is selected, the device may enter a mode in which automated movement is limited to joint movement of the distal tip of the endoscopic device (e.g., endoscope 250), while linear and / or rotational endoscopic movement is manually controlled as described above (e.g., using the user interface device 270). The user interface element 282 helps, for example, the operator to activate the manual assist mode as desired.

[0087]

[0144] In some variations, any of the actuators described herein may be self-deploying. For example, as shown in Figure 2A, the actuator 240' may include a self-deploying structure, such as including an interlocking ring and / or helical element that transitions from a compressed state to an unfolded state. As described above, the actuator 240' may be oriented along the guide 217' and actuated using (one or more) actuators 216', and / or manually actuated using an appropriate user interface device. Although the actuator 240' is shown compressed within a linear guide channel in Figure 2A, it should be understood that other shapes of guide channels may also be implemented.

[0088]

[0145] Furthermore, at least a portion of one or more of the actuating members, actuators, user interface devices, and / or guides may be located within a module (e.g., a display 218) connected to the housing 210. For example, in some variations, as shown in Figure 2A, the proximal end of the actuating member 240'' may terminate within the display, and one or more actuators 216'', similar to those described above, may automatically move the actuating member (axially and / or rotationally) within the guide 217'' located within the display, causing the tip of the endoscope to articulate. Additionally or alternatively, in some variations, the proximal end of the actuating member 240 may terminate within the display A user interface device similar to that described above may be used to manually move the actuator 240'' within a guide (axially and / or rotationally) within a display, terminating within a display or module. Additionally or alternatively, in some variations, the proximal end of the actuator 240'' may terminate within a display, and the actuator may self-deploy in a similar manner to the actuator 240' as described above. For example, the actuator 240'' having its proximal portion within a display may be linear or axially aligned with the endoscope 250, and the self-deployment of the actuator 240'' may result in an easy extension of the endoscope's working length.

[0089] Introducing device (e.g., flexible or rigid endoscope)

[0147] Any of the dual-video integrated systems or assemblies described herein may include an introducer sized for use in guiding the delivery of an intubation tube, such as an ETT, into the trachea. The ETT will be advanced over any of the introducers described herein. Any endoscope described or illustrated herein may be considered merely an embodiment of an ETT introducer. It should be understood that any description of any endoscope or scope herein is essentially a description of a more general introducer as the term is used herein. In some embodiments described herein, the introducer 250 is an endoscope and therefore may be detachably connected (e.g., engaged telescopically) to an intubation tube for intubation procedures. The endoscope 250 may be configured to enter and navigate into the patient's airway and act as an introducer for ETT advancement during intubation procedures. As described above, the introducer may have multiple degrees of freedom, including longitudinal forward and backward movement, axial left and right rotation, and articulated vertical and left and right movements of its distal end, which are controlled by driving an actuating member. For example, as shown in Figure 5, the device 600 including the distal end of the introducer 250 may include one or more sets of antagonist cables 62 and 63 extending from the navigation wheel 61 toward the distal end region 250d of the introducer 250. Each set of antagonist cables may correspond, for example, to a degree of freedom for the articulated tip of the introducer 250.

[0090]

[0148] As illustrated in Figure 6, for example, the device 650 may include at least a first set 64a of antagonistic cables operated by a navigation wheel 61a to control left-right joint movement, a second set 64b of antagonistic cables operated by a navigation wheel 61b to control up-down joint movement, and / or a third set 64c of antagonistic cables operated by a navigation wheel 61c to provide tension on the working member 240. Alternatively, the device for articulated scope tip movement may include only one or two of these sets (e.g., only the set 64b of antagonistic cables operated by the navigation wheel 61b to control up-down joint movement). The cables may be connected to the working part 240 via, for example, mechanical fasteners, welds, etc. The navigation wheels 61a-61c may include wheels, sprockets, rotary knobs, and / or similar components. In some variations, the length of the distal tip curvature section may be between approximately 4 cm and 5 cm, and the joint movement (steering) of the tip curvature section may be between approximately 120 degrees and 180 degrees in all directions (up and down, left and right). Furthermore, the axial rotation of the introduction device may be between approximately 90 degrees and 180 degrees in both the left and right directions.

[0091]

[0149] In some variations, the introducer (e.g., endoscope) includes a flexible member having optical, electrical, and mechanical functionality, including light transmission, video capture, mechanical operation, and distal end joint movement, as described above. Alternatively, in some variations, the introducer may include a video stylet. The stylet may have the same optical, electrical, and mechanical functionality as, for example, the flexible scope member, but may be more rigid due to the material and / or structure (e.g., a more rigid structure including metal). Therefore, at least a portion of the stylet may be malleable. For example, in some applications where greater torsional rigidity is desirable to allow for better transmission of linear and rotational motion between the working member and the induction device, easier maneuverability around the patient's airway (e.g., obstructive glottic lesions), smoother advancement during insertion and navigation in the patient's anatomical structures, and easier advancement of the intubation tube, it may be useful to use a rigid video stylet instead of a flexible member.

[0092]

[0150] As described herein, the endoscopes herein are embodiments of more generalized introducers for intubation tubes, which may or may not include an image sensor (e.g., an endoscope). In such a case, any description herein of a device or system including an endoscope or scope is understood to include an introducer which may or may not include an image sensor.

[0093] Transition area

[0152] Any integrated assembly or system described herein may optionally include a transition region or transition segment between the actuator and the introducer. The transition region may have intermediate bending stiffness and / or other gradual changes in structural properties to help ensure a smooth and uninterrupted transmission of action from the actuator to the introducer. In some variations, the transition region may additionally or alternatively include a series of gradually increasing flexibility segments and / or coil springs to transition from a more bending stiffer actuator to a more flexible introducer.

[0094]

[0153] Alternatively and / or additionally, in variants where the actuator and inducer are detachably connected, a relatively flexurally rigid transition region (e.g., between approximately 1 and 2.5 times the outer diameter of the actuator and / or inducer) may be useful between the actuator and inducer to restore the continuity of electromechanical and / or other functions. The transition region may include a connection that provides the same structural and task-oriented functionality (including uninterrupted light transmission, video capture / analysis, and mechanical operation, etc.) as described elsewhere for variants where the actuator and inducer are integrally connected. Optical / electrical functionality can be maintained between the actuator and the endoscope using one or more suitable mating connectors (e.g., connectors associated with their respective PCB wiring). Distal tip control may also be maintained by mechanical solutions such as coaxial cable connectors, push-button latches, pin and socket devices, wire lugs, plates, pins, screws, and articulated joints.

[0095] Other structural features

[0155] Any integrated system or assembly described herein may include one or more structural features adapted to help prevent buckling and / or loop formation during forward and / or rotational advancement and / or rotational movement along its linear axis, thereby improving smooth motion transmission from the actuator to the introducer. In some variations, the bending stiffness and torqueability of the shaft may be increased by incorporating a flat helical interlocking metal strip (e.g., a strip under an outer polymer cover) with a gear gap in between to maintain flexibility. These helical strips may be covered with thin strands of stainless steel wire or other suitable material, woven into a tubular mesh, and covered with an extruded polymer layer to create a smooth outer surface. Several exemplary solutions for improving forward ("extrusion") and rotational ("torquability") are described in further detail below.

[0096]

[0156] For example, the actuator and / or introducer may be guided through a rather continuous physical guide, such as a guide channel (similar to an overtube environment). This guide channel restrains and controls the actuator and / or introducer. The internal components also help to keep the combined length taut, thereby reducing kinking and other problems. For example, as described above, the working member 240 may be constrained to a guide 217 in the housing 210 and / or display 218, and the endoscope 250 may be housed in the intubation tube, with the intubation tube itself providing a rigid guide channel for the endoscope 250. In addition, as will be described later, the endoscope 250 may be constrained to an intubation tube channel 266 in the cover 260. Furthermore, as will be described in more detail later, the overtube environment can provide an active channel that allows for easy manipulation of the intubation tube (e.g., manual manipulation) while maintaining automated robot-assisted guidance of the endoscope.

[0097]

[0157] Furthermore, the surrounding intubation tube and / or cover helps to restrain the induction device in a generally aligned, linear path with the patient's airway during intubation, further reducing buckling and / or loop formation within the operating member and / or induction device.

[0098]

[0158] Other structural features may help reduce friction. To provide reduced friction during operation of the working member, for example, guides for the working member (such as guide 217), the working member itself, and / or the inlet itself may be lubricated (e.g., with a commercially available lubricant that has a long-lasting effect) and / or have outer surfaces made of low-friction material.

[0099]

[0159] Additionally or alternatively, the actuator may have increased shaft bending stiffness to help prevent buckling and loop formation during linear advancement and rotation within the curved trajectory of the guide. For example, the actuator 240 may have higher bending stiffness than the introducer 250, which is more flexible and pliable to facilitate operation. In some variations, the shaft bending stiffness along the length of the combined actuator 240 and introducer 250 may be varied by changing the outer layer material composition of the actuator and / or introducer 250. For example, the outer base layer may contain a polymer having two types of resins, and the polymer may be extruded over a wire mesh to form the outer structure. The bending stiffness can be varied by changing the composition of the combined resins, and the resulting polymer layer may further provide a non-traumatic, biocompatible, and watertight surface. The shaft bending stiffness may additionally or alternatively be varied using adjustable shaft stiffening coil wires or other suitable mechanical elements. In some variations, the shaft bending stiffness is additionally or alternatively increased by the actuarial member 240, and at least a portion of the actuarial member 240 may have a larger outer diameter. For example, the proximal end of the actuarial member 240 may have a flared diameter, which is advantageous as it further allows for an increased operating surface with (one or more) actuators 216.

[0100] cover

[0161] Any system or assembly of this specification may further include a cover (e.g., cover 260) adapted to enable and provide an integrated dual imaging-enhanced visualization and navigation system adapted to be held and controlled by one hand of a single operator. The cover of this specification is configured to be advanced over the patient's tongue both above the patient's epiglottis (e.g., in or near the vallecula epiglottis) and below the patient's epiglottis, providing a multi-purpose mounting of the cover. Additionally or alternatively, the cover may be configured to preferentially mount either above or below the epiglottis. In some variations, such as those shown in Figures 4A and 4B, the cover 260 (or any other cover, such as those shown in Figures 17A–17G) may further include a displacement member 268 configured to facilitate retraction of the patient's tongue, thereby improving pharyngeal space and improving scope movement within the airway. The displacement member may be, for example, angled, straight, curved, or otherwise shaped to be installed inside the patient's mouth in a non-traumatic manner. In one example of a modified form, the displacement member may have a width of approximately 3 cm to 4 cm (for example, (This is for adult patients; a smaller size would be more appropriate for pediatric patients.)

[0101]

[0162] As shown in Figure 4A, the cover may comprise two sections including a first channel (e.g., 264) and a second channel (e.g., 266). The first channel includes a lumen sized and configured to receive a first imaging member (e.g., a laryngoscope baton) therein, and the second channel may be sized and configured to releasably secure an intubation tube (e.g., an ETT) thereto and to restrict the movement of the tracheal tube relative to the cover in at least one direction. The channels may optionally be fitted to snugly accommodate the receiving first imaging member and tracheal tube. The first channel 264 may be adapted to be releasably connected to the housing 210, such as by snapping into place at a connector 262, thereby being removablely attached to the housing 210. In some variations, the first channel may be between 15 cm and 20 cm in length and angled forward between approximately 4 cm and 6 cm from the tip in a manner and direction that attempts to maximize the view of the patient's upper airway anatomical structure (above the vocal cords) and different parts of the glottal structure for enhanced visualization and movement of the induction device. However, these dimensions may differ in covers adapted for use in pediatric patients.

[0102]

[0163] The second channel 266 is adapted to be releasably secured to an endotracheal tube (e.g., ETT), and the endotracheal tube may be positioned around the introducer (e.g., pre-loaded ETT). The endotracheal tube channel may function to provide a mechanism for ensuring the positioning of the endotracheal tube in close proximity to the displacement member 268. The endotracheal tube channel 266 may optionally be configured to be connected to the housing 210 at a connector 263 (e.g., snap-on). The endotracheal tube channel may further include one or more latches, clips, or other fasteners 267 to help hold the endotracheal tube within the endotracheal tube channel. In one example variation, the endotracheal tube channel may be about 15 cm to 30 cm in length for adult patients and about half this length for pediatric patients. Endotracheal tubes of various sizes (e.g., diameters) can be accommodated within the endotracheal tube channel 266. Furthermore, the second channel (intubation tube channel) does not need to define an internal lumen, and may rather be partially open on its sides (e.g., having a longitudinal slot) to allow removal of the intubation tube from the cover when intubation is complete. For example, the second channel may have a semicircular cross-sectional configuration or a cross-sectional configuration in which a groove or recess is formed and sized and configured to be releasably fixed to the ETT (see also 1713 in Figure 17A).

[0103]

[0164] As shown in Figure 4B, in some embodiments, the intubation tube channel 266 and the first imaging member channel 264 may optionally be detachable from each other along a detachable joining region 269 having one or more connectors, punch holes, etc. This may be useful, for example, as one option to allow the laryngoscope to provide a backup intubation option using only effective video laryngoscopy in the event that AI navigation fails or malfunctions. For example, if the intubation tube channel 266 is detached and removed along the joining region 269, the first imaging member and the remainder of the cover 260 can be used in a conventional manual video laryngoscopy intubation method, and the intubation tube will be operated by the operator outside the cover 260 (it should be understood that detaching the intubation tube channel 266 is not necessary for all patients if a pre-loaded intubation tube can be pushed into the patient's trachea through the intubation tube channel 266 of the cover 260). In another backup intubation option, the intubation tube channel 266 of the cover may be used for a combined video laryngoscopy-flexible endoscopy technique in which one operator performs video laryngoscopy and a second operator manually performs flexible video endoscopy-assisted intubation. In yet another variation of the backup intubation technique, the detachable introducer 250 (or any other introducer described herein) may be used manually as an intubation tube introducer to facilitate the placement of the intubation tube into the trachea.

[0104]

[0165] At the distal end of the cover 260, the two channels 264 and 266 may terminate adjacent to each other and substantially axially aligned, such that the image sensor of the first imaging member and the image sensor of the intubator are in very close proximity to each other. In this configuration, the distal end of the intubation tube (optionally coaxially surrounding the intubator 250) can be better localized to the field of view, thereby improving the ability to position the intubator 250 and the intubation tube. In addition, the dual-channel configuration allows for the shortest distance robotically controlled movement of the intubator to the glottis and into the trachea (compared to other access methods in which the intubator is advanced separately over a longer total distance), thereby resulting in faster and more successful intubation on the first attempt. A dual-channel cover or blade can result in the first imaging member and the intubator exhibiting or having similar curvature along the length of the cover, which is illustrated overall, for example, in Figures 17C and 17D.

[0105] The integrated dual image sensor systems and assemblies described herein are generally adapted such that the first and second image sensors are positioned or maintained at an initial distance from each other when the introducer or second imaging member (optionally its housing) is releasably connected to the housing, the initial distance optionally provides the image sensors with a predictable starting position relative to each other, although this initial distance is not necessarily required. For use herein, positioned or maintained at an initial distance from each refers to any reference frame, which may include any distance between them in space. For example, the image sensors may be maintained at a certain distance from each other in the horizontal and axial directions. In some embodiments, the sensors may be aligned within a single reference frame, but still be maintained at a certain distance from each other with respect to different reference points or reference axes. For example, in some exemplary embodiments, the first and second image sensors may be aligned substantially axially (proximal-distal) and spaced some distance apart from each other in the lateral or horizontal directions. In these embodiments, the sensors are assumed to be positioned and maintained at an initial distance from each other, even though they are axially aligned. In some exemplary embodiments, the two image sensors may be substantially axially aligned with each other initially, even if there is some minimal axial offset when assembled. The image sensors may be very close to each other, and in some embodiments, the two image sensors may be maintained relative to each other such that the axial distance between the two sensors does not exceed 3 cm when the second imaging member (including the introducer) is releasably connected to the housing. The actual distance between sensors may differ from the axial distance between them (if there is an axial distance) due to the natural horizontal lateral offset of the two sensors when assembled together. When integrated into an assembly, the integrated system with the two image sensors positioned or maintained at an initial distance from each other such that the axial distance does not exceed 3 cm can be held in one hand by the operator.In some embodiments, the second image sensor may initially be located within the proximal region of the ETT, or it may be located within the second imaging member housing but not yet advanced into the ETT. In these embodiments, however, the assembly is still considered to be adapted to position the first video camera at an initial distance from the second video camera before the actuator is activated.

[0106]

[0166] In some embodiments, when the sensors are assembled into an assembly, the two image sensors are maintained at a certain distance from each other, and at some point during use, the sensors may become axially aligned with each other while the two sensors are positioned in the upper airway. This can occur if, after assembly, the second image sensor is initially at some maintained initial distance proximal to the first image sensor, and the second image sensor is at the same distance as the first image sensor. The first image sensor is moved a certain distance distally until it is aligned axially. In this embodiment, the two sensors may only be aligned axially for a moment if, for example, the second image sensor continues to move distally.

[0107] An exemplary method for providing enhanced visualization and navigation of endotracheal tube introduction devices in airway management procedures (and optionally during intubation).

[0168] The disclosures herein include embodiments relating to enhanced visualization, navigation, and placement methods for intubation tube introduction devices. Figure 7 shows, as a flowchart, a method for positioning an ETT in the trachea during an intubation procedure, purely as an example. As illustrated in Figure 7, a method 700 for assisting the performance of a robot-assisted intubation procedure may include the steps of: acquiring one or more images using a first imaging member (e.g., a laryngoscope) or a second imaging member (e.g., an endoscope) relating to an integrated handheld system or assembly; initializing the automatic guidance of a guide device (e.g., an endoscope) using an actuator 720; automatically guiding the guide device (e.g., an endoscope) via the actuator based on one or more images 730; advancing the intubation tube from above the guide device (e.g., an endoscope) 732; visually confirming the placement of the intubation tube using a guide device image sensor or the like 740; uncoupling the guide device and the intubation tube 750; and withdrawing the handheld system or assembly (including the guide device and the first imaging member portion) from the patient's mouth 760. In some variations, the method 700 may be performed in conjunction with one or more variations of the devices described herein.

[0108]

[0169] Step 710, which involves acquiring one or more images, may include acquiring one or more images using one or more image sensors within an integrated system or assembly, such as image sensors relating to a laryngoscope (e.g., a video laryngoscope) and / or endoscope, which are part of an integrated system or assembly. The images may be manually translated, and then the automated guidance of the endoscopic device may be initiated, for example, by user selection of an automated mode (e.g., by activating an "AI" button such as button 280 shown in Figure 2C), or by selection of an automated-manual-assisted mode as described herein. Additionally or alternatively, the images may be translated by one or more processors that apply one or more appropriate computer vision and / or machine learning algorithms to one or more images to identify appropriate anatomical targets and automatically initiate the activated guidance of the endoscope. In some variations, the automatic guidance initialization (720) of the guide device (e.g., endoscope) is based on one or more images acquired from a laryngoscope; in some variations, such initialization is based on one or more images acquired from both a laryngoscope and a guide device; and in some embodiments, such initialization may be based on one or more images acquired from the guide device alone.

[0109]

[0170] As illustrated in Figure 7, the method may include a step (730) of automatically guiding an introducer (e.g., an endoscope) via an actuator in a handheld housing based on one or more images from a laryngoscope and / or endoscope. The step of guiding the introducer may include, for example, a step of automatically guiding the introducer longitudinally forward and backward and / or axially left and right rotations via an actuator. Furthermore, the step of guiding the introducer may include a step of articulating the distal end of the introducer in at least one of several degrees of freedom, including vertical and left and right joint movements. In some variations, the introducer may be automatically guided using a robotic system utilizing appropriate AI image processing techniques, and additionally or alternatively, the introducer may be manually robotically guided using an appropriate user interface device (e.g., a joystick) (e.g., an automated-manual-assisted mode), in which case an actuator located in the handle can robotically control the movement of the introducer in response to manual interaction by the operator with the system.

[0110]

[0171] Various AI or machine learning methods may be employed to automatically guide the intubation device. For example, an appropriate image recognition or processing algorithm may be configured to identify anatomical landmarks in images from a device such as those described herein. The AI-assisted intubation targeting of the vocal cords may utilize dedicated targeting software that analyzes multiple image streams, marks and displays targets (e.g., target crosses), analyzes expected intubation tube navigation trajectories, identifies distinct features of visible tracheal openings between the vocal cords, and / or displays this information on a display screen in real time.

[0111]

[0172] Different targeting methods are described in the literature. One or more modules performing specific functions, including but not limited to real-time computerized image processing, recognition, and mapping, visual guidance, guidance information, and interfacing with robot intubation interfaces, can be used to achieve fully automated robot intubation or automated-manual-assisted robot intubation. Methods and devices such as those described herein may utilize dedicated logic circuit configurations such as FPGAs (Field-Programmable Gate Arrays) and / or ASICs (Application-Specific Integrated Circuits) and / or other applications.

[0112]

[0173] One or more diverse computer vision and machine learning algorithms may be used in this invention, including SLAM (Simultaneous Localization and Mapping), techniques inspired by spatial transformer modules (STMs), deep neural network (DNN) and convolutional neural network (CNN) training, and others.

[0113]

[0174] Method 700, if performed during an intubation procedure, may further include the step (732) of advancing an intubation tube connected to (or positioned around) an induction device (e.g., an endoscope). The intubation tube may be engaged with the induction device in a telescopic manner (e.g., surrounding the induction device). While the induction device is guided manually or automatically, the intubation tube may be advanced over the induction device toward the target position. In some variations, the intubation tube may be advanced manually. In some variations, the intubation tube may be advanced automatically using one or more suitable operating systems such as those described herein. Furthermore, in some variations, the intubation tube may be advanced manually for a certain portion of its advancement and automatically for the other portion of its advancement (e.g., as desired by the user).

[0114]

[0175] Furthermore, in some variations, the method may include a step of manually advancing the endotracheal tube while maintaining the automated guidance of the induction device. For example, the user may hold the integrated system with one hand and manually manipulate the endotracheal tube from above the induction device with the other hand toward a location in a target image, such as an image from an induction device image sensor placed in the trachea (e.g., pushing the endotracheal tube forward on the induction device and / or rotating the endotracheal tube (and / or the induction device together as a unit)). Thus, in some variations, manual advancement of the endotracheal tube can help, for example, shorten the distance the endotracheal tube travels toward the target position and further improve the speed of intubation.

[0115]

[0176] Throughout the intubation procedure, as the intubator and intubation tube are advanced automatically and / or manually to the target position, images from the first imaging member and / or the second imaging member can be optionally displayed to the user in real time or near real time for a certain epoch or period of time. Images such as those from the intubator image sensor while inside the trachea are used to instantly confirm proper intubation tube placement, optionally the optimal positioning of the intubation tube (740), and / or the intubation tube It may be used to enable immediate identification of misplacement of the tube and / or to enable the user to troubleshoot the intubation procedure from both above and below the vocal cords, including issues related to the advancement of the intubation tube, which will prompt appropriate (one or more) interventions. For example, the first imaging sensor may be spaced proximal to the introducer imaging sensor to provide a view and identification of a wider anatomical area, such a view may provide an additional view of the tracheal tube movement and provide more information about placement than if the introducer imaging sensor were used alone. Once it is visually confirmed that the intubation tube is properly placed in the trachea, i.e., generally confirmed using an introducer imaging sensor also placed in the trachea and below the vocal cords, the introducer is then automatically and / or manually removed from the intubation tube via robotic action (750), and the introducer is withdrawn, leaving the intubation tube in place (760).

[0116] Examples

[0177] Non-limiting methods for performing the TI using an integrated dual video system or assembly as described herein are described below, but are merely illustrative. Not all steps need to be performed, and the order may be modified as appropriate.

[0117]

[0178] (1) A disposable dual-channel cover (e.g., 260) is connected to a handheld housing (e.g., housing 210), and a laryngoscope baton (e.g., 220) is placed inside the laryngoscope channel of the cover. The system is powered on. (2) A disposable introducer (e.g., endoscope) is connected directly or indirectly to the handheld housing, for example to the system's operating components. Once the introducer is connected to the handheld housing and, for example to the operating components, the device automatically checks for full functionality. (3) The introducer is optionally lubricated and placed inside the selected ETT. The ETT is placed inside the intubation tube channel of the cover (it does not need to be the internal lumen). (4) The user performs a manual video laryngoscopy using the video laryngoscope (the display screen is in the default single-picture mode and shows the laryngoscope image feed) and identifies (one or more) anatomical structures on the system's display. The image recognition and / or AI interface is activated, initiating automated robotic operation of the actuator and inducer through the actuator interface. The movement of the actuator is fully transmitted to the inducer. (Operation can also be manually activated by selecting the AI ​​operation mode button on the device housing or by using the automated-manual assist mode). (5) Once activated, a split or picture-in-picture video screen function is displayed, allowing the user to observe the entire TI voluntarily, continuously and in real time. This display mode can be activated automatically or manually. (6) In fully automated mode, the device automatically maneuvers the inducer into the patient's trachea using AI or robot-assisted navigation, including steering forward and backward movements, axial rotation, and / or end-joint movements. In some embodiments, this is performed using video data from the first image sensor alone, and in some embodiments, this can be performed using video data from the first and second image sensors. For example, the initial movement of the inducer may be automatically based primarily or solely on video data from the first imaging sensor (which may be a video laryngoscope image sensor).(7) In automated-manual-assisted mode and manual-assisted mode, manual operation of the device using, for example, a user interface device, immediately overrides the fully automated mode. In manual mode, the forward and backward movement and / or axial rotation of the working members can be controlled manually, and the joint movement of the distal end of the endoscope may be automated. The fully automated mode can be restarted, for example, after the user presses the AI ​​operation mode button. In automated-manual-assisted mode, the operator manually activates the control of the automated actuators in the system. (8) When the anatomical structure of the airway is recognized during navigation of the transporter, a visual indicator is displayed. A cater (e.g., a square or a circle) may be voluntarily made to appear around the airway displayed on the screen. The guide joint movement should be such that the tip moves in the direction of the geometric center point of the detected glottal opening and passing through the vocal cords. (9) The operation of the guide around the anatomical structure during the TI sequence can be continuously visualized by the user, for example, via a video laryngoscopy image feed or signal displayed on the display. Visually presenting video data from a first image sensor with a wider field of view (e.g., a video laryngoscopy image sensor) on the display allows the operator / user to better troubleshoot navigation and enable manual intervention or assistance if necessary. For example, while viewing the video signal from the first image sensor, the user can use a single handle to move the entire integrated system as a unit and provide slight adjustments in the positioning of the integrated system. (10) The guide will be automatically navigated around the patient's anatomical structure and advanced into the patient's trachea through the tracheal opening. (11) The ETT can be manually (or automatically) advanced distally into the patient's trachea away from the introducer, and image data from the introducer image source can be used to visually confirm proper ETT placement. ETT advancement can be continuously observed on the display screen from both above the vocal cords (first image sensor data) and below the vocal cords (send image sensor) to visually confirm tracheal ETT placement. In addition, visual confirmation of tracheal ETT placement can be observed more closely by obtaining an overall view of the anatomical structure of the patient's trachea, or by voluntarily pressing the picture-in-picture button on the display screen twice (voluntarily achieved using other mechanisms such as remote control, audio commands, or touch screen / display). In addition, the ETT can be optimally positioned (not too deep or too high) in the trachea above the tracheal carina. (12) The ETT can be released from the intubation tube channel 266 of the cover. The system is removed from the patient's mouth, leaving the ETT in place in the trachea.(13) Once the cuff of the ETT is inflated, manual or mechanical ventilation through the ETT can be initiated using a ventilation bag or an automated ventilation device. ETT tracheal placement may optionally be further confirmed by any appropriate means (e.g., breath sounds, EtCO2). (14) One of the advantages of the integrated dual video system herein is that if AI / robot-assisted TI fails for any reason, the operator has a backup option to complete TI using the system as a video laryngoscope alone, for example, using various conventional TI options as described above. (15) In embodiments in which the actuator and guide are separable, if a problem occurs while advancing the ETT through the vocal cords (e.g., the ETT repeatedly "gets stuck" in the glottal structure), the guide can be detached from the actuator and used as a handheld guide (endoscope) to further facilitate the orientation of the ETT through the glottal opening.

[0118]

[0179] Figure 15 shows an overall view of an integrated dual-video handheld intubation assembly (including any of those described herein) after it has been positioned in the patient's upper airway.

[0119]

[0180] Figures 16A–16D show images, merely illustrative, that are captured and / or displayed on a display during any of the described intubation procedures, which may include steps using either of the handheld systems or assemblies specified herein. The subsequent disclosure describes Figures 16A–16D in the context of the illustrative benefits of the systems specified herein adapted to display video data or video images displayed on a display during an intubation system, and image data from a first and a second image sensor. Figure 16A shows a view provided by a first image source positioned in the distal region of a first imaging member, such as a video camera. The epiglottis and larynx are marked in Figure 16A, which may optionally be a panoramic view, as shown. As can be seen, it is difficult or impossible to see the vocal cords in this image. Any of the methods specified optionally includes the steps of receiving data as input showing the anatomical view shown in Figure 16A and generating an output that initiates the automated robotic control movement of the introducer. The process may include the steps of causing the system to move. In alternative embodiments (described in the context of modes as examples herein), the system does not need to automatically control the motion; rather, the user may manually generate the robotic motion of the introducer through an operable communication between the disposable introducer and the housing.

[0120]

[0181] Figure 16B shows image (e.g., video) data from the first image sensor on the left and image data from the second image sensor on the right. The image data from the first image sensor on the left provides a visualization of the introducer as it appears after it has been moved distally relative to its initial position (at which point the second image sensor (e.g., video camera) is initially maintained at a certain distance from the first image sensor (e.g., video camera)) and the first image source. As can be seen, as the introducer is moved distally (and optionally further rotated and / or deflected), the second image sensor at the distal end of the introducer is also advanced distally relative to the first image sensor. As illustrated, the image data captured by the first image sensor provides a view of the introducer as it is moved robotically (automatically and / or manually), and further provides a view of a wider anatomical area than the view provided by the introducer image sensor. If the second image data is compromised (for example, due to blood or secretions near the second image sensor), the image from the first image sensor can conveniently help determine the location of the inducer and further facilitate the continued movement (automatic or manual robotic movement) of the inducer. Figure 16B shows the inducer after being robotically moved to some extent below the epiglottis toward the glottal opening, as illustrated.

[0121]

[0182] Figure 16C shows image data from the first and second image sensors after the inducer has been advanced through the glottal opening, with the second image sensor providing a visualization of the trachea as shown in the right-hand view of Figure 16C. The first image sensor (image data on the left side of the figure) continues to show the properly positioned inducer, which is another benefit of the integrated nature of the dual-video intubation assembly described herein.

[0122]

[0183] Figure 16D shows image data from the same two image sources as before, and as shown, it shows the endotracheal tube after it has been advanced along the induction device toward the glottal opening and entered the trachea through the glottal opening. The window or opening shown in the upper left part of the right image of Figure 16D is a standard lateral opening (called Murphy's eye) in the ETT. The nearly straight line extending from the top right corner is the radiopaque line of the ETT, indicating the location of the main distal opening of the ETT.

[0123]

[0184] Some of the disclosures described above describe identifying or recognizing anatomical landmarks or locations in images to help guide the induction device toward the vocal cords and through the vocal cords into the trachea. For example, landmarks include, but are not limited to, the epiglottis, vocal cords, arytenoid cartilage, piriform sinus, tongue, the geometric center point of the glottal opening, the tracheal wall (tracheal ring), and areas of the image that are darker than adjacent areas. In some of the methods and devices described herein, the step of identifying or recognizing anatomical landmarks or locations (which may generally be referred to herein as image recognition) may be performed or achieved automatically. For example, but is not limited to, as described above, image or landmark recognition may be performed using AI or image recognition software configured and adapted to automatically recognize specific landmarks based on one or more images or image data received during use of the system. Figure 8A shows an illustrative sequence illustrating automated image / landmark recognition, which can then facilitate robotic control and navigation of an introducer (e.g., a flexible and / or rigid endoscope), further details of which are described herein. In some methods and devices herein, the step of identifying or recognizing anatomical landmarks may be performed or achieved manually by a medical professional or other (one or more) operators. For example, A physician may provide input (e.g., touch, voice, etc.) to the system to identify or recognize one or more aspects of an image displayed on the screen or display. For example, a physician may touch the location of a recognized vocal cord in the displayed image or the location where the operator wants to move the guide device on a touch screen. Figure 8B shows an illustrative sequence demonstrating manual image / landmark recognition, which can then facilitate robotic control and navigation of the endoscope, with further details described herein. The aspects of Figure 8A and Figure 8B may be combined. For example, but not limited to, automatic recognition may be performed (e.g., as part of a device mode), and manual confirmation of the automatically recognized aspects of the image (e.g., touching a confirmation icon on the display) may be required before endoscopic navigation begins.

[0124]

[0185] Any system of this specification may include one or more processors that store therein an executable method (e.g., software, firmware, (one or more) algorithms) adapted to receive commands or inputs directly or indirectly based on user interaction with a display (optionally touch and / or voice interaction and / or haptic feedback) while the display is presenting at least one image (still image or video). The (one or more) executable method may facilitate robotic control of the introducer motion via the actuarial member and / or other member operably communicating with the first imaging member or introducer within the housing.

[0125]

[0186] Some of the disclosures described above describe robotic control of the movement of an introducer into the trachea via the vocal cords. For example, some disclosures herein relate to the automated robotic control of an introducer. Figure 9A shows an illustrative sequence of image recognition (e.g., one of those shown in Figures 8A and 8B) followed by automated control of an introducer into the trachea (or other lumen depending on the medical procedure). For example, following one or more image recognition and / or processing steps, automated movement of the introducer may occur using any of the actuators and / or working members herein. In some cases, the movement of the introducer may be controlled at least partially manually, such as by the user moving an actuator (not limited to) such as a joystick, wheel, slider, or other similar actuator (which may be operably communicated with an internal housing actuator) to control one or more types of movement of the introducer. Additional details of types of voluntary movement control (e.g., distal-proximal direction, rotation, and / or distal tip deflection) are described elsewhere herein. The robot control processes shown as examples in Figures 9A and 9B may be combined with image processing and / or image recognition as shown in Figures 8A and / or 8B.

[0126]

[0187] The methods, devices, and / or systems described herein do not necessarily include automated image processing and / or recognition. Alternatively, the methods, devices, and systems described herein may be adapted and configured for modes that do not involve the use of automated image processing and / or recognition, or may be used in a manner that does not involve the use of automated image processing and / or recognition. In either case, these may generally be referred to herein as manual modes. Figure 8B includes illustrative steps that may be included in manual modes (it is clear that the overall introducer navigation process may include other steps such as any of the steps described herein). The introducer control shown in Figure 9A and / or Figure 9B (or elsewhere described herein) may also be included in manual modes. In some cases, manual modes may be initiated in response to user actions or trigger events, such as pressing a button to initiate manual modes or touching a touch screen to identify a portion of an image. In some cases, any of the devices described herein may be in manual mode by default, or may not be adapted for AI or other automated image processing and / or recognition.

[0127]

[0188] As described herein, the methods, systems, and devices herein may use or include automated modes (however, they may also have other modes or may be used in other ways). Automated modes may include automated image processing or recognition (as shown in Figure 8A) and automated robot scope control and / or navigation (as shown in Figure 9A), which may be performed optionally in a continuous closed-loop manner. In some cases, devices and methods operate in automated modes in response to user selection or initiation of an automated mode, such as by pressing an AI button on the handheld (e.g., Figure 2C) (as merely an example). In some cases, automated modes may be the default and function in automated modes without requiring user initiation. In some cases, automated modes may be initiated or occur after any number of already occurring modes or processes, for example, after a manual control mode (e.g., Figure 9B) that the user wishes to interrupt and return to automated mode. Any of the devices, systems, and methods herein may use or have a mode in which the automated mode continues as long as a medical professional continues to operate an actuator, such as a button or switch on the handheld device. In these modes, the system may be adapted so that the automated scope control and / or navigation stops when the user stops operating the actuator (e.g., when the button or switch is released). As just one example, any of the "AI" buttons on the handheld device may function as an actuator of the type that stops the automated mode once released (e.g., a dead man's switch). This mode may be used in conjunction with any other mode or method herein.

[0128]

[0189] Any of the devices and systems described herein may be adapted to allow a user to override or stop automated scope control / navigation by interacting with a handheld unit (including any associated display). Figure 10 (similar to Figure 9B) shows an example of a process that includes manual robotic control at a point following automated robotic control (which may, of course, include other processes). As just one example, the operator can use a handheld housing actuator (e.g., a joystick, wheel, slider, etc.) to override the automated navigation (optionally, to immediately stop or pause the automated mode). User control may provide one or more of forward / backward (distal-proximal) and rotation. Some systems may be adapted so that the automated mode is reactivated after user interaction with the handheld unit (e.g., pressing an "AI" button). For example, in Figure 10, after manual control, the method returns to automated control, allowing the operator or device to move back or forward in the loop as desired.

[0129]

[0190] Any of the systems, devices, and methods described herein may be adapted to allow the operator to point to a navigation path (or a location along a path) on a display, for example, by touching a specific location on an image presented on the display, or by using a voice command adapted for the system to receive, process, and initiate an event. The system may then be adapted to automatically navigate to or toward that location. This is similar to Figure 9A, in which landmark recognition comprises the step of pointing to a location or an intermediate path location (which is not necessarily a specific anatomical landmark).

[0130]

[0191] As shown in Figure 9A, any of the devices and systems of this specification may be adapted to automatically control introducer navigation (e.g., having a mode adapted to provide this functionality). In automated image processing and / or recognition, the system may be adapted to receive image data and determine a path for the introducer (e.g., scope). In manual image recognition, the system processes manual identification and scope It may be adapted to determine the route for the tube. The onboard AI then communicates commands to facilitate the control of the onboard actuators, thereby facilitating smart, non-traumatic, AI-enabled robot-assisted navigation of the scope into the patient's airway. The sequence may be repeated in a closed-loop manner. As shown above, once the scope is positioned inside the patient's trachea, the operator can manually advance the tracheal tube from above the scope, using the scope as a non-traumatic intubation guide, similar to a guidewire in other medical procedures. The advancement of the tracheal tube can be continuously visualized by the operator on a display screen (e.g., handheld or fixed monitor) showing a single image (switchable between two or more at will) or at least two images simultaneously, optionally from both above and below the vocal cords.

[0131]

[0192] Where the term laryngoscope is used herein, it refers to a traditional laryngoscope, but is understood to also refer to any type of device adapted to provide the operator with at least video images, preferably (but not required) panoramic video. Generally, these are referred to herein as the first imaging member (or first elongated imaging member). The first imaging member may be manufactured and packaged coupled to a handheld housing, or the first imaging member may be detachably coupled to the housing by the operator or assistant immediately before the procedure. The laryngoscopes herein are generally referred to as a video guide ("VG"), a voluntary panoramic video guide ("PVG"), or the first imaging member, and may include an image sensor at its distal end (e.g., a video camera), and optical and electrical wiring and communication functionality. The first imaging member may be functionally similar to the video baton of an existing video laryngoscope and may include any of its features or functionality.

[0132]

[0193] Furthermore, any of the video monitors (e.g., displays) herein may be integrated into any of the handheld housings herein, or they may be separate, freestanding video monitors (including being part of a detachable component that can be removably attached to the handheld portion). As shown herein, any of the video monitors may further include a touchscreen adapted to respond to taps, swipes, and any other type of manual command. Any of the video monitors herein may be adapted to respond to voice input (e.g., voice commands) or haptic commands. The terms display, screen, and monitor may be used interchangeably herein.

[0133]

[0194] In any of the systems described herein, the introducer may be an endoscope (rigid and / or flexible), and is sometimes referred to herein simply as a scope. The term is not understood to necessarily limit functionality. In some cases, the introducer may be adapted to be robotically controlled (automatic and / or manual) and may include a flexible (at least partially voluntary) elongated tubular member or shaft and one or more of the following: a voluntary distal camera, electrical wiring, voluntary (one or more) optical transmission elements, or one or more elongated elements (e.g., pull wires) used to articulate the distal end. As shown herein, the introducer may be adapted to be voluntarily fixed via a coupler so as to be releasably fixed to any housing (indirectly or directly), and the coupling creates a movable robotic communication between the introducer and the handheld housing to facilitate robotic control of the introducer, which is described in more detail elsewhere herein.

[0134]

[0195] Any of the covers (sometimes referred to herein as blades) herein may include a first elongated channel adapted therein to receive a first imaging member, and the cover may also include a tracheal tube, in at least one direction relative to the cover The cover may be adapted to be releasably secured to the tracheal tube to restrict its movement. The cover may include a separate tracheal tube lumen, or the cover may consist of a tracheal tube stabilizer, e.g., one or more clips or partial channels, to which the tracheal tube is releasably secured. The cover is generally configured such that the position of the tracheal tube relative to the first imaging member channel and lumen is maintained when the tracheal tube is initially releasably secured to the cover, and further details thereof are shown above.

[0135]

[1096] As shown herein, the housing may be packaged with an introducer (e.g., an endoscope) or other elongated tracheal tube guiding device that is pre-attached to or coupled to the housing. In alternative embodiments, the introducer is not fixedly coupled to and packaged with the housing, but is removably fixed or coupled to the housing by the operator or assistant prior to the medical procedure. In either scenario, the introducer is operably communicating with the housing to facilitate robotic control of the introducer and, optionally, to transmit optical data from the introducer to the housing to be displayed on a display as shown herein. The introducer may optionally be removably fixed to a coupler on the housing, and the coupler may be any suitable one or more components (including separate components such as an adapter that connects to both the handheld and the introducer) that are sized and configured to interact with or interface with the guiding introducer and be removably fixed to the introducer. In this context, "releasably fixed" means that the introducer can be fixed to the housing so that the introducer and housing are not easily separated during normal use of the device during intubation, and may include the operation of an additional locking mechanism to lock the introducer to the handheld housing. For example, the locking mechanism may include an additional step or movement of the introducer to lock the introducer in place against the handheld housing. Figure 2A shows one embodiment of an introducer 250 releasably fixed to a coupler of the housing, which may be thought to include the end of an actuator 240. In the embodiment of Figure 2A, the actuator 240 (and other similar internal movable actuators) may be thought to be a robotic extension of the introducer after the introducer is releasably fixed to the coupler of the housing. That is, the actuator and the introducer can move together and can be thought to be part of the same movable unit, and data can be communicated from the introducer to the housing. Figure 2C shows an additional embodiment of a housing including an internal movable robotic extension or actuator.

[0136]

[0197] As shown in the embodiment of Figure 2C, the internal movable robot extension or actuation member is positioned or arranged, at least partially, along and / or within the guide 217 within the housing. As described above, the guide is sized and shaped to allow the actuation member to move relative to the guide and to guide the movement of the actuation member within the housing.

[0137]

[0198] Figure 11 shows an additional embodiment of a robotic handheld device or assembly adapted to facilitate the delivery of an endotracheal tube (or other devices to different lumens depending on the procedure) into the trachea. Any other features that can be appropriately incorporated into or modify the embodiment of Figure 11 may be included, even if not explicitly mentioned herein. The device or assembly 1100 includes, among other components, a handheld housing 1110, a cover or blade 1160 connected thereto, and a display 1118. In this embodiment, the handheld housing 1110 includes a universal docking station 1130 that may be located within the housing. The introducer delivered into the patient's trachea (or other lumen) will need to be within anatomical and / or application-specific outer diameter limits. For example, in the case of a pediatric patient, the scope will need to be smaller than that used for an adult patient. There will be a need for this. Depending on the use of the devices herein, it may be desirable that multiple introducers, whether flexible or rigid, can be removably fixed to a common (e.g., universal) handheld housing, and these scopes may have different outer diameters ("OD") and different sizes and / or possibly different relative locations of optical transmission lines within the introducer. One consideration is to ensure that the introducer, regardless of its OD and size, can be removably fixed to the handheld housing and will be in operational communication with the housing (e.g., robotically movable and optionally facilitating the transmission of optical (e.g., image) data). Therefore, it is beneficial for the handheld device to include a universal docking station or other universal coupler (e.g., station 1130 in Figure 11) adapted to allow various flexible and rigid introducers with different ODs and different sizes to be removably fixed to the handheld housing and to ensure operational communication with the housing. A universal docking station or universal coupler may be adapted to accommodate introducers of different sizes (e.g., different circular outer cross-sectional dimensions, different introducer lengths, different locations of optional optical transmission elements, etc.). In some embodiments, a universal docking station may include a plurality of adapters, each sized and configured to properly interface with flexible / rigid introducers regardless of their OD and size.

[0138]

[0199] In the embodiment shown in Figure 11, the robotically controllable introducer 1150 is located in the housing. It is shown as being pre-coupled to the docking station 1130 located within the housing. Once coupled, the introducer 1150 can be moved using actuators within the housing in any of the manner described herein (e.g., distal-proximal direction, rotation, tip deflection in at least four different directions).

[0139]

[0200] Figure 11 further shows an example of a scope or introducer guide 1117 associated with (and possibly extending from the outer housing surface) an outer or near-outer region of the housing, compared, for example, with the internal guide 217 in Figure 2C. Figure 11 shows that in this embodiment, the introducer 1150 is stably received within a guide 1117 located in the upper region of the housing. This location allows the introducer to be fixed and movable relative to the upper part of the housing, and allows the central introducer region to extend through the tracheal tube ETT. The guide 1117 may have a tubular configuration through which the introducer passes before being connected to the coupler and universal docking station 11130. Alternative guide configurations may also be used. For example, the guide 1117 may not form a full lumen, as long as the introducer is movable relative to the guide and the guide prevents the introducer from separating from the guide, such as when the guide 1117 has a substantially "C" cross-sectional shape.

[0140]

[0201] As shown above, in some embodiments, when the induction device is directly or indirectly releasably connected to a handheld housing (e.g., during intubation), the induction device can be moved robotically, including distal advancement toward the trachea. In some embodiments, the assembly may be adapted to allow the induction device to be voluntarily advanced robotically (using either automatic or manual robotic navigation) beyond at least 10-12 cm beyond the tip of the ETT, so that the induction device can be advanced sufficiently deep into the patient's trachea to a secure position within the trachea.

[0141]

[0202] In some embodiments, the handheld assembly is configured to allow the introducer to be robotically moved 5cm to 40cm or 5cm to 60cm distally once the introducer is operably connected to the housing (directly or indirectly). As just one example, the handheld housing can move the robotic extension (and thus the introducer) 5cm to 40cm, or optionally The assembly may be adapted to move distally only up to 40 cm. Alternatively, referring to Figure 11, the assembly may be configured to allow the introducer to move distally from 5 cm to 40 cm, or (for example, if the assembly does not include an actuator or robot extension) from 5 cm to 60 cm. In this disclosure, the terms actuator, robot extension, and introducer (or endoscope) extension may be used interchangeably.

[0142]

[0203] The total length of the introduction device may depend on the procedure. For example, in a bronchoscopy procedure, the introduction device may optionally have a length of 50 cm to 60 cm. In addition, not all procedures utilizing the handheld systems and assemblies specified herein require the use of a cover and / or a first imaging member (e.g., bronchoscopy). When used in these procedures, the first imaging member and cover can optionally be removed / detached from the handheld unit to eliminate unnecessary components and simplify the procedure.

[0143]

[0204] Any of the devices described herein may include an introducer distal motion limiter adapted to prevent the introducer (or robot extension) from moving distally beyond a certain distance relative to the starting axial position. This may be due to the structure of the assembly or a specific feedback mechanism from AI and software to the handheld, and essentially the distal motion limiter may appear when the introducer is simply unable to move distally any further due to actuators to the handheld housing or assembly and / or the structure of the robot extension. This limiter may therefore be considered a passive motion limiter or an active motion limiter.

[0144]

[0205] In some robotic handheld devices and assemblies described herein, at least part of the robotic functionality of the device may be incorporated into components that are removable from the handheld housing but can be removably fixed to the housing prior to the procedure. This allows some components to be more easily reused, while others can be discarded, for example, after the procedure. This may further allow some of the removable components to be used with, for example, various handheld devices. This may help and / or facilitate the manufacture of specific components. Figures 12 and 13 show an exemplary assembly having removable components that include at least some robotic control functionality. Figure 12 shows a handheld housing 1200 and a removable robotic block 1270 (sometimes referred to herein as a removable introducer controller) shown as being removably fixed to the handheld housing 1200. In this context, the term "block" is not limited to any particular structure or function, but generally refers to the removable functionality of a component. In this embodiment, the removable block 1270 includes an introducer coupler 1222, a robot extension or actuator 1240 at least partially located within the housing of block 1270, and a guide 1217 within block 1270 which may include any feature of any of the guides specified herein, enabling the movement of the robot extension 1240 but maintaining the extension 1240 within the guide or maintaining it in association with the guide 1217. An actuator 1216 is also shown which may include any functionality or feature of any of the actuators specified herein (e.g., motor control to move the extension 1240 and thereby move the introducer 1250).

[0145]

[0206] In this embodiment, the handheld housing 1210 may include a block coupler 1272 (sometimes referred to herein as an introducer controller coupler) sized and configured to be releasably fixed to a removable block. The block 1270 may similarly include any type of suitable corresponding fitting structure sized and configured to interface releasably but permanently with the block coupler 1272 on the housing 1210 side. The block coupler 1272 is a block The block may include a wide variety of coupling features (e.g., press-fit, male / female parts, etc.) that allow the block to be removably secured to the housing 1210. Once the block 1270 is secured to the housing 1210 and the introducer 1250 is removably secured to the introducer coupler 1222, the device may be used in any other way described herein (e.g., image processing / recognition, scope motion, optical transmission, video capture, mechanical action, distal end joint motion, etc.). Any of the removable “blocks” described herein may also be referred to herein as introducer controller, introducer controller, or second imaging member including introducer.

[0146]

[0207] Figure 12 further shows a removable cover 1260 having a first channel and a second channel, which are releasably fixed to the housing 1210 (which may include any cover or blade features or functions described herein).

[0147]

[0208] The handheld housing 1210 in this embodiment may include an integrated or built-in display (e.g., a touchscreen) 1218, which may include any feature or functionality of any of the displays described herein and may be used in accordance with any of the methods or processes described herein (e.g., manual anatomical landmark recognition). Alternatively, the system may have a display (integrated or removable) located on the side of the housing 1210 rather than on the top surface of the housing 1210, as shown in Figure 12.

[0148]

[0209] Certain aspects of the disclosure herein optionally include steps during intubation that utilize preoperative information about the patient, such as preoperative images (e.g., CT, X-ray, MRI, PET scans, and / or 3D reconstructed images of the airway) or videos that may be useful or assist in navigation during intubation. For example, it may be beneficial to utilize preoperative endoscopic video examinations for improved or enhanced navigation. Optionally, patient characteristics or conditions can be incorporated into the navigation procedure. For example, if the patient's disease and / or characteristics and / or pathology (all of which may generally be referred to herein as “conditions”) can be outlined, the operator may be able to select, prior to the procedure, the applicable conditions (e.g., from a software image library) that match the patient’s (one or more) conditions from a set of selectable conditions, so that the device can take such conditions into account during intubation (e.g., via AI and / or related trained machine learning algorithms) to further improve visualization, navigation, and ETT placement, thereby further improving the speed, success rate, accuracy, and safety of intubation. For example, such an interface may include a pull-down application menu (or a voice command to free the user from using their hands) presented on either a mobile phone or a computer display or screen as described herein, which allows the selection of conditions personalized for the medical care of this particular patient. For example, conditions or information about a procedure may include "laryngeal cancer," "tongue base tumor," or "nasal intubation," or "airway exchange via intubation LMA." Combinations of procedures and conditions may further be presented as "nasal intubation for a patient with a tongue base tumor" or otherwise selectable. An image library may be retrieved from the cloud or built-in device software for any of these conditions and / or procedures, optionally stored in the handheld unit, and used as part of navigation.

[0149]

[0210] In some embodiments, existing patient images may be delivered and stored on a handheld device (e.g., wirelessly) and used during navigation (e.g., by AI). As an example, these images may include one or more of the following: preoperative videos, photographs of the patient's anatomical structures, or reconstructed images / videos from CT / X-ray / MRI / PET scans and / or other imaging tests.

[0150]

[0211] Any handheld device or assembly described herein may further include a video recording button (or other type of actuator) on the device to enable recording of video from either or both of the VG or the scope.

[0151]

[0212] Any information from any of the procedures (e.g., video and / or image data) may be transmitted automatically or manually to a central location (e.g., the cloud). The data may be used to train AI to enhance the navigation capabilities of the system and other systems.

[0152]

[0213] Any information from any part of the procedure (e.g., video and / or image data) may be transmitted automatically (e.g., wirelessly) or manually to the patient's electronic medical record (EMR) to document the intubation procedure for enhanced record-keeping, billing purposes, and / or teaching purposes.

[0153]

[0214] In any of the embodiments herein, the endotracheal tube (e.g., ETT) may also be used as an additional maneuvering tool for the flexible induction device. Moving the endotracheal tube would be beneficial in assisting in navigating the scope and / or orienting the scope connected to the ETT. Rotating and / or moving the endotracheal tube forward (distally) when the induction device is automatically robotically navigated (e.g., Figure 9A) or manually robotically navigated (e.g., Figure 9B) may help enhance proper induction device alignment, operation, and advancement. For example, moving the endotracheal tube in the anterior-posterior (distal-proximal) direction and / or rotating it axially can optimize the visualization and / or navigation / movement of the induction device toward the target, improving the speed of intubation and the success rate of the first pass. Depending on the use, the endotracheal tube may be moved (e.g., advanced distally and / or rotated axially) before the start of the automated induction device navigation sequence. Depending on the application, the tracheal tube may be moved during the automated scope navigation sequence (e.g., advanced distally and / or rotated axially). In some embodiments, the assembly is adapted so that if the tracheal tube is manipulated during the automated navigation sequence (e.g., Figure 9A), the tracheal tube manipulation will automatically stop the robot interface.

[0154]

[0215] One aspect of the disclosure herein relates to an integrated dual video system including an introducer guide or (one or more) guide features. As shown herein, the device (in either a handheld portion or a detachable block portion) may include an introducer guide which allows motion of the introducer (or robot extension) relative to the guide but still restricts the motion to a specific or known path (e.g., restricting it within the guide and preventing it from detaching from the guide). As partially described above, any of the guides herein may include guide rails for the proximal portion of the introducer (or robot introducer extension) inside or outside the device housing. In addition, the guide may be sized and configured to prevent buckling of the proximal portion of the introducer (including the robot extension). In addition, the proximal region of the introducer or robot extension may have a bending stiffness adapted to prevent buckling of the scope, and the bending stiffness may be greater than the bending stiffness of the scope shaft located outside the housing. In addition, one of the guides may be configured to orient the introductor to a preferred angle and / or preferred trajectory and / or path inside or outside the device housing. Furthermore, as described above, the guidance of the introductor can be enhanced by positioning the distal region of the introductor inside the tracheal tube so as to keep the scope taut due to frictional engagement between the introductor and the tracheal tube.

[0155]

[0216] One aspect of the disclosure is that once connected to a handheld housing (connected to the handheld part or The introducer, once connected via a removable block, is robotically movable distally and optionally by at least a certain distance. In some purely illustrative uses, the total introducer length (with or without the robot extension) may be approximately 25 cm to 70 cm. In some illustrative uses, the device is configured to allow at least 5 cm of robot distal introducer advancement, optionally allowing 10 cm to 40 cm, for example, 10 cm to 25 cm. This is facilitated by the allowable movement within the handheld by the robot extension, if the system includes one.

[0156]

[0217] In any embodiment of this specification, any of the introducer guides in the handheld housing may include a coating or other lubricating material (e.g., silicone) that helps to facilitate the scope movement relative to the guide and prevent buckling or binding.

[0157]

[0218] In any embodiment of this specification, the introducer may include one or more sensors at the distal tip to avoid excessive operating force during navigation (e.g., during tip deflection).

[0158]

[0219] In any embodiment of this specification, deflection or steering of the distal scope tip may be facilitated without the use of pull wires or other elongated tensioning structures, such as piezoelectrics, alloys (bimetallic, nitinol).

[0159]

[0220] In any embodiment of this specification, the introducer may have a bending stiffness that varies along its length. For example, but not limited to, the introducer of this specification may comprise one or more polymer materials (e.g., PEBAX) that have a bending stiffness (e.g., different durometers) that varies along its length and optionally provide a distal tip that is more flexible or deflection-prone than the proximal region of the scope. The concept of varying polymer slender shaft bending stiffness is generally known, and any concept relating thereto may be incorporated into embodiments of this specification. For example, the robot extension may include a polymer material having a higher durometer than the introducer material at the distal end of the introducer. As before, merely as an example, the proximal region of the introducer (such as the region of the introducer that interfaces with the guide outside the handgrip, as shown in Figure 11) may have a higher durometer than the distal region of the introducer to help prevent buckling during distal motion.

[0160]

[0221] One aspect of the disclosure herein is that the described devices and systems may be adapted and configured to be a highly useful, handheld, portable, multifunctional dual-video airway management platform that can be optionally and conveniently operated by a single user with one hand. As merely one example, the handheld housing described herein may be adapted for use in a variety of different airway management procedures and / or for use with a variety of different introducers and / or different first imaging components (e.g., video laryngoscopes). In these embodiments, the handheld housing can be considered a universal or common handheld housing that allows for the interchangeable connection and use of a variety of different introducers and / or first imaging components. For example, it would be desirable to have a universal platform that can be connected to introducers sized for pediatric patients and also to introducers sized for adult patients. Additionally or alternatively, it would be desirable to have a universal platform (e.g., the handheld housing specified herein) that can be used with introducers of different lengths, such as introducers that are relatively long and can be used in bronchoscopy and other airway management procedures described herein, or introducers that are relatively short and can be used in intubation or intubation-related airway management procedures. The platform technology is further adapted to allow robotic control of different introducers that can be connected to the platform, regardless of whether they are for airway management procedures, medical, diagnostic, or surgical purposes. The handheld housings described herein may be adapted such that one or more of the introducer, cover or blade, or first imaging member (e.g., video laryngoscope) can be removably connected to the handheld housing (directly or indirectly) to provide multifunctionality. Thus, this disclosure includes devices and systems that can be adapted to provide multifunctionality and versatility not yet observed or provided in existing medical airway management techniques.

[0161]

[0222] In addition, the devices and systems of this specification may be adapted so that the introducer can be temporarily or permanently removed (or simply not connected to the housing) if it is not required for a particular airway management procedure or part of a procedure. For example, if the introducer is not required for a procedure or part of a procedure, the introducer may not be used, and may be optionally temporarily or permanently disconnected from the housing if it was previously connected to the housing. In addition, if the first imaging member is not required for a procedure or part of a procedure, the first imaging member may not be used, and may be optionally temporarily or permanently disconnected from the housing if it was previously connected to the housing. In addition, if the blade is not required for a particular procedure or part of a procedure (e.g., bronchoscopy), the blade may be temporarily or permanently removed or not used.

[0162]

[0223] Therefore, the devices, assemblies, systems, and methods of this specification can be adapted and configured to be a multifunctional, universal, and highly useful handheld portable platform adapted for single-user operation, capable of treating various patient populations in various clinical environments and locations, and usable for various airway management procedures, offering a great deal of functionality not observed or available in existing methods, including at will, and while the movement of the introducer is robotically controlled (e.g., using AI, smart navigation, etc.). In addition, the devices of this specification can be rapidly modified as needed based on the needs of the procedure (e.g., by temporarily or permanently removing and / or reattaching the introducer or the first imaging member).

[0163]

[0224] The disclosure herein describes several systems and devices that can be used to generate and view two images (either simultaneously on the same screen or by switching views), but the disclosure herein also includes the use of handheld assemblies when only one image source is used. As merely an example, the methods and devices herein may be used without an introducer (e.g., a scope) and with only the first imaging member. This may occur, for example, in situations where the introducer module is malfunctioning or ineffective, such as when blood and secretions are obstructing the airway. The assemblies may be adapted so that the operator can use the device as a normal video laryngoscope (or VG) without disconnecting or at least using an introducer. The assemblies may have a separate mode that includes only the use of video from the first imaging member (VG).

[0164]

[0225] Another typical scenario in which only one video or imaging device may be used includes using only the introducer video, with the first imaging member disconnected or at least not in use. In some cases where the first imaging member is removed from the housing, this may include disconnecting the first imaging member from the housing or at least deactivating the first imaging member. One example scenario of airway management in which the introducer may be used without the first imaging member is transnasal flexible endoscopic intubation, which includes the option of connecting the first imaging member at a later time to facilitate endoscopic manipulation as the endoscope passes through the nose to the oral cavity. Another example scenario of airway management in which the scope may be used without the first imaging member is O is the case of the use of an endoscope to facilitate intubation via a supraglottic airway device ("SGA"), which is a small mask positioned inside the patient's mouth to provide lung ventilation / oxygenation (when connected to a ventilator). SGAs (e.g., laryngeal arma squareway, LMA, etc.) are often used to temporarily address difficult airway situations when intubation is suspected or difficult. Another example scenario of airway management in which an induction device may be used without a first imaging component is in the case of a diagnostic upper airway endoscopy or bronchoscopy, where the procedure may or may not be performed through an indwelling endotracheal tube. Another example scenario of airway management in which an induction device may be used without a first imaging component is when confirming the proper positioning of an indwelling ETT inside the patient's trachea and / or optimizing the positioning of an ETT inside the patient's trachea. Another example scenario of airway management in which the induction device may be used without the first imaging component is to facilitate the placement and positioning of a double-lumen endotracheal tube—for example, a special type of ETT used for thoracic surgery, which is often difficult to place. Another example scenario of airway management in which the induction device may be used without the first imaging component is to facilitate the endoscopically assisted replacement of a patient's existing (indwelling) ETT, optionally in the operating room, ICU, emergency department, or other location. Another example scenario of airway management in which the induction device may be used without the first imaging component is to facilitate an extubation attempt. In any of these exemplary airway management procedures in which the induction device may be used without the first imaging component, the cover may be detached from the handheld housing (if the blade is actually pre-connected to the handheld housing).

[0165]

[0226] In some alternative uses, the devices or assemblies described herein may be used in one or more otolaryngological airway management procedures such as biopsies or injections (e.g., vocal cord injections). In some alternative uses, the devices described herein may be used in one or more other medical and / or surgical endoscopic procedures.

[0166]

[0227] In addition, although the applications described herein relate to medical procedures, the devices and methods described herein may also be used for non-medical procedures. For example, the devices described herein may be used for industrial applications where, for instance, an introducer needs to "twist and turn" into an orifice to evaluate hard-to-reach machinery.

[0167]

[0228] Any of the systems described herein may optionally be adapted for use in a manner in which a first imaging component, such as a video laryngoscope (sometimes referred to herein as VL or VG), is used, in which case the system does not need to be connected to an introducer, or the introducer does not need to be used as part of the procedure.

[0168]

[0229] Any of the systems described herein may be used in a manner in which the introducer is used without using a first imaging member (e.g., a video laryngoscope), or the first imaging member may be removed from the handheld housing and not used in the procedure, or the first imaging member may be reattached to the handheld housing at a later time during the procedure.

[0169]

[0230] Any of the systems described herein may be adapted to connect to multiple covers, each of which has at least one dimension different from the dimensions of at least one of the other covers, which may allow for different sized covers, for example, for children and adults.

[0170]

[0231] Any of the systems described herein may be adapted to be connected to multiple introducers of different sizes and / or lengths, and the handheld portion described herein may be made available for use with, for example, adults and children.

[0171]

[0232] Any of the systems described herein is adapted to be connected to a plurality of deflectable injectors, which may be flexible or rigid, or partially flexible and partially rigid, and may have different lengths and diameters.

[0172]

[0233] Some illustrative systems or assemblies herein include an introducer (e.g., a mechanical guide, a flexible endoscope, a rigid endoscope, etc.) that can be removably fixed to a handheld housing, thereby enabling the handheld housing to operably communicate with the introducer when the introducer is fixed to the housing, so that the handheld housing is adapted to provide controlled movement of the introducer, and the introducer is adapted to receive and respond to such control. One aspect of the disclosure herein relates to an introducer that is optionally disposable or single-use, sized and configured to be removably fixed to a handheld housing. After being removably fixed to the handheld housing (directly or indirectly), the movement of the introducer can be controlled using the handheld housing. After the procedure is completed, or at a time determined by the operator, the introducer may be released from the handheld housing and optionally discarded. The handheld housing may be reused on the same patient or reused after cleaning and / or sterilization.

[0173]

[0234] After exposure to a patient, the intubation system must generally be cleaned and sterilized before being reused on a different patient. In some systems of this specification, it may be difficult to clean and / or sterilize one or more components that facilitate the axial movement of the introducer. Therefore, depending on the use, it may be desirable to have a disposable or single-use introducer that can be removed after use, so that the handheld housing can be cleaned and sterilized and used with a new introducer in subsequent uses. Hence, it would be desirable to use a disposable and affordable introducer. Any of the introducers of this specification (e.g., flexible or rigid endoscopes) may be disposable and / or incorporated into a disposable introducer housing assembly, any of which may be sized and configured to be removably fixed to a handheld housing. The introducer housing assembly of this specification is generally sometimes referred to as the second imaging member.

[0174]

[0235] Figures 14A–14D illustrate an embodiment of an intubation system including an exemplary handheld housing and an exemplary induction device housing assembly (also called a second imaging member), the handheld housing and the induction device housing assembly being sized and configured so that the induction device housing assembly can be removably fixed to the handheld housing to create an operational communication between the handheld housing and the induction device housing assembly. In this context, the induction device housing assembly may also be simply referred to as the induction device assembly or the second imaging member. The induction device housing assembly described herein may be disposable and can be easily detached from the handheld housing at the operator's request after the procedure or in the event of a malfunction of the induction device assembly. When the induction device housing assembly is removably fixed to the handheld housing, the two components as a whole may be referred to as the handheld device device or assembly.

[0175]

[0236] In this embodiment, the intubation system or assembly 1400 includes a handheld housing 1410, which may include any other suitable features described herein with respect to any other handheld housing, such as a display (screen), one or more internal actuators (e.g., one or more motors), electronic equipment, one or more computer-executable methods, firmware, a microprocessor, a blade coupler, a laryngoscope or laryngoscope coupler, etc. In some embodiments, the housing 1400 includes an integrated first imaging member (e.g., a laryngoscope). In some embodiments, the housing 1400 also includes a laryngoscope coupler adapted to be releasably fixed to a laryngoscope. In some embodiments, the housing 1400 is coupled to or comprises a video device which is not necessarily considered a laryngoscope but is adapted to provide video images. In some embodiments, the handheld housings herein do not include a laryngoscope and are not adapted to be coupled to a laryngoscope.

[0176]

[0237] In this embodiment, the system 1400 optionally includes a detachable cover 1460, which in this embodiment includes a first imaging member channel 1462 defining a lumen and a tracheal tube channel 1461. Any other suitable cover features or descriptions herein (including those of any claim) may be incorporated into the assembly 1400 shown in Figures 14A–14D.

[0177]

[0238] The assembly 1400 includes an introducer assembly 1499 (sometimes referred to herein as a second imaging member), the introducer assembly 1499 includes an introducer housing 1490 fixed to a movable introducer 1450, the introducer housing 1490 is sized and configured to be releasably fixed to a handheld housing 1410, and the introducer assembly 1499 may be disposable.

[0178]

[0239] In this embodiment, the handheld housing 1410 includes a plurality of electrical connections (Figure 14B) adapted to be in electrical communication with the corresponding electrical connections 1495 (Figures 14C and 14D) of the introducer housing, which facilitates the implementation of at least one type of controlled motion of the introducer as described later. The electrical connections of the handheld housing 1410 communicate with an onboard handheld housing controller which can be adapted to generate motion of the introducer by facilitating the transmission of electrical signals to the electrical connections. For example, as described elsewhere in this specification, the onboard controller may include one or more processors and / or computer-executable methods for facilitating automated motion of the introducer based on an automatic or manual image recognition method (e.g., via AI). Any suitable feature of any other housing described herein for facilitating controlled motion of the introducer may be incorporated into the handheld housing 1410.

[0179]

[0240] In this embodiment, the handheld housing 1410 contains one or more motors, which are in rotational communication with or considered part of the motor coupling 1413, which may have a motor shaft that is rotated when the motor is rotating. In this embodiment, the motors are adapted to produce axial motion of the introducer, which will be described later, when operated.

[0180]

[0241] Figures 14C and 14D illustrate the features of an introducer housing 1490 and an introducer 1450 as examples. In this embodiment, the introducer housing 1490 includes an electrical coupling 1495 having a plurality of illustrated electrical connections adapted and positioned to create electrical communication with the electrical connections of the handheld housing (Figure 14B) when the introducer assembly 1499 is removably fixed to the handheld housing 1410. The electrical coupling between the handheld housing and the introducer housing can provide one or more types of controlled motion of the introducer. Note that the electrical coupling is optional, and in alternative designs, the electrical coupling may be replaced with one or more motors in the handheld housing. The electrical coupling 1495 may also include a connection for communicating image data from the introducer to the handheld housing.

[0181]

[0242] The introducer housing 1490 is adapted to be removably connected to a handheld housing, and the connection is made to one or more controllers within the handheld housing and introducer. This creates an operable communication between the devices. In this embodiment, the connection creates both electrical and mechanical communication, but in other embodiments, it may be mechanical only or electrical only. In this embodiment, the mechanical connection is adapted to control the axial movement of the introducer, and the electrical connection is adapted to produce deflection of one or more types of joint movement segments of the introducer shown in Figure 14C, which can smooth 360-degree deflection.

[0182]

[0243] In this embodiment, the motor coupling section includes a motor rotatably coupled to a shaft within the handle, as shown in Figure 14B. The motor shaft is sized and configured to be positioned within the motor coupling section 1496, which is the inlet housing shown in Figure 14C. The motor shaft may also be sized and configured to interface with one of the inner surfaces of rollers 1494a or 1494b, as shown in Figure 14D. Thus, motor activation is adapted to drive the rotation of one of rollers 1494a or 1494B, and both rollers rotate around an axis in this embodiment. One end region of the inlet 1450 (optionally one end of the flexible inlet shaft) is fixed to the housing 1490 at position 1491, while the inlet and housing are further adapted to allow the inlet to move axially relative to the housing 1490 in regions distal to position 1491. It is shown that the introducer 1450 is positioned through the opening 1493 of the housing body 1492 and through the opening 1497 of the housing body 1492.

[0183]

[0244] The handheld housing may be designed to be used with introducers of different sizes. The motor shaft may be a common or universal drive element sized and configured to fit into rollers of various sizes, for example, depending on the dimensions of the rollers and / or introducers. This is an example of how a universal handheld part may be releasably fixed to different introducers having at least one difference in size / dimension (e.g., diameter). This allows the handheld housing to be used by children as well as adults.

[0184]

[0245] For the purposes of this specification, the inlet housing may or may not completely enclose or enclose the inlet. For example, an inlet housing may have one side open to the surrounding environment, yet it may still be considered an inlet housing for the purposes of this specification.

[0185]

[0246] The introducer 1450 is positioned between rollers or wheels 1494a and 1494b as shown, and as a result, the rotation of the rollers toward the introducer in opposite directions produces axial motion of the introducer as indicated by the arrows in Figure 14D. In the first configuration, the rotation of the rollers may produce distal motion, and the rotation in the opposite configuration may produce proximal motion. Any other disclosures herein relating to controlled axial motion (e.g., axial distance, for example 10 cm to 40 cm) may be incorporated into the disclosures of Figures 14A-14D. One or both rollers may have grooves or other friction interfaces similar to those shown in the upper right of Figure 14D, or alternatively, one or more rollers may have modest teeth or grooves. In alternative configurations, one or more of the one or more rollers may be made of polymer, plastic to reduce or avoid the possibility of damage to the introducer shaft. The roller may have a smooth interface surface or a non-smooth interface surface.

[0186]

[0247] The introducer housing described herein includes a main body (e.g., housing body 1492), the housing body being fixed together with one or more components, optionally, to define the housing body at least partially (e.g., by adhesive, welding, etc.). It may comprise two or more components.

[0187]

[0248] The introducer housing assemblies described herein include a plurality of electrical connections 1495 (e.g., comprising pins and / or vias), each connected to a wire (three wires as an example shown in Figure 14D), each of which may extend through the introducer shaft or be in electrical communication with a wire extending through the introducer shaft. For example, any of the wires (e.g., 4 to 9) may communicate video signals from a camera in the distal end region of the introducer (e.g., Figure 14C), or the wires may be configured to facilitate deflection control of the introducer's joint movement segments, for example, by using shape memory material (e.g., nitinol) or bimetallic wires (e.g., 5 to 8 wires). The general concept of communicating electrical signals through wires made of shape memory material to deflect the shaft has been described, and the basic concept may be used to incorporate one or more such wires to produce the deflection of the introducer's joint movement segments as described herein. For example, electrical signals may be communicated to one or more introducer wires to transition the distal section of the introducer between multiple shape-memory states, thereby controlling the deflection of the introducer in one or more directions. Any of the wires in this specification may also include a bimetallic wire, which can also be used to produce deflection of the introducer by communicating signals to and through one or more wires. Additional electrical signals may be communicated to the wires to change the shape of the distal region of the wire and return it to its original, undefended, or linear shape. Electrical signals may be communicated to any combination of wires to produce or generate a desired deflection or configuration of a joint movement section, which may be automatically controlled, for example, by AI. For example, deflection may be produced by changing the shape of any combination of wires within the introducer, thereby creating various shapes and configurations of the deflectable section of the introducer.

[0188]

[0249] Figures 14A–14D show an embodiment of a system that uses mechanical couplings to control the axial movement of the introducer, and electrical couplings to cause distal end region deflection of the joint movement segments of the introducer, an example of which is shown in Figure 14C.

[0189]

[0250] Any of the disclosures herein relating to automatic and / or manual introducer control may be incorporated into System 1400. For example, deflection of the distal region of the introducer using one or more shape memory materials (e.g., nitinol) or bimetals may be used to control the deflection of the introducer in one or more of the automatic and / or manual modes herein, including partially automatic and partially manual modes.

[0190]

[0251] As can be seen in Figure 14D, the axial movement of the injector is controlled (e.g., by applying a force) at a location distal to the proximal end of the injector shaft (which in this embodiment is connected to the injector housing at location 1491). The force applied to the shaft that causes the axial movement is applied where the injector shaft interfaces with the rotary roller. Although not shown in Figure 14A, the injector 1450 is generally adapted to guide the advancement of the tracheal tube, and any relevant disclosure herein may be incorporated into this embodiment. By controlling the axial movement of the injector closer to the tracheal tube (e.g., by applying a force), as in this embodiment, the axial movement of the injector is less likely to cause buckling of the injector. Applying a force to the injector further away from the tracheal tube may increase the likelihood of buckling, for example, of the injector shaft. An additional example of the advantage of controlling axial induction device movement at one or more specific locations relatively close to the tracheal tube is that, if desired or required, better force feedback may be provided.

[0191]

[0252] Any of the handheld housings described herein (e.g., 1410) may be equipped with an encoder on the motor to control the axial distance over which the introducer is moved. Additionally or alternatively, any of the introducers described herein may include a plurality of visual markings (e.g., axially spaced lines) on the introducer used to control the amount of axial movement of the introducer. Additionally or alternatively, any of the blades described herein may include an RFID tag (or EEPROM) which may be used to control the initial advancement of the introducer and / or to communicate the blade type to the system, since the blade type may also affect the first visual field.

[0192]

[0253] Any component that may include an introducer housing (e.g., 1490) that can be removably fixed to a handheld housing may include an RFID tag (or EEPROM) adapted to inform the system or control unit of what type of introducer is being used and / or whether it is adapted to enable and disable certain features such as the introducer diameter, the introducer length, and video resolution.

[0193]

[0254] In any of the embodiments described herein, the inlet housing (e.g., 1490) may be adapted to be removably fixed to the rear or side of a handheld housing (e.g., 1410).

[0194]

[0255] In the embodiment of Figure 14C, the section of the introducer referred to in the figure as the auxiliary loop is shown not enclosed by the housing (until a portion of the introducer is fed through the housing 1490). In an alternative design, this region of the introducer may be at least partially housed or positioned within a housing that provides protection to the introducer and, in some cases, reduces the possibility of objects getting caught or obstructed in the loop region of the introducer. Such a housing may be fixed to the housing 1490 or may be part of the housing 1490, allowing the introducer to move relative to an additional loop housing. For example, this loop region of the introducer may be located within a cylindrical housing that is fixed to the housing 1490. Alternatively, the loop region of the introducer may be located within a helical housing or containment fixed to the housing 1490, and the introducer may be movable relative to the helical housing to facilitate axial movement.

[0195]

[0256] In the embodiments shown in Figures 14A–14D, deflection is generated by wires within the introducer adapted to change shape in response to a communicated signal. In alternative configurations, the introducer's deflection may instead be driven by an additional motor coupling between the handheld housing and the introducer housing. In these alternative configurations, the system may include mechanical couplings for the axial motion of the introducer as well as for the introducer's deflection. In these alternative configurations, the wires within the introducer may communicate with one or more motors, which are used to tension the wires to produce deflection of the steerable section of the introducer. For example, the system may include two or four additional motors to smooth the deflection of the deflectable section. For example, the system may include four motors to tension a pull wire (or other elongated tension element) to produce deflection and / or transition it back to a linear configuration. Including four additional motors helps maintain tension on the pull wires when pull wires are tensioned at different circumferential locations to deflect the housing, which can reduce abrupt recoil by reducing slack in other wires not tensioned for the deflection. For example, having four motors can help maintain tension on all pull wires not tensioned for the deflection at that particular location. Alternatively, the system may include two additional motors, which are adapted to deflect the deflectable sections of the introducer.

[0196]

[0257] Any of the inlet housings specified herein may be further adapted as working lumens. The housing may include or house a lumen within it. The housing may include one or more ports communicating with one or more lumens to enable the delivery of one or more substances and / or devices into the working lumen. A schematic diagram of ports and lumens is shown in Figure 14D. For example, housing 1490 may be adapted to connect to and accept a syringe to facilitate the delivery of one or more substances, such as one or more therapeutic drugs. It would be beneficial to have drug delivery ports and lumens within a disposable housing that does not require cleaning. In addition, ports and lumens may enable the delivery of one or more other devices, such as one or more diagnostic (e.g., ultrasound imaging) devices and / or therapeutic devices or other medical tools. One or more delivery ports may be located on sides or areas of the housing other than those shown in Figure 14D, for example, penetrating the bottom or top surface. In addition, the common location 1491 (other fixing locations 1491 may be used) where the introducer is fixed may include a port through which a substance or device can be delivered. The fixing location may offer more functionality and options because the introducer does not move relative to the housing at that location. In addition, any of the introducers specified herein may also include a working channel or working lumen through which any device and / or substance can be delivered.

[0197]

[0258] As discussed above, an exemplary benefit of some embodiments of this specification is that the distal end of the introducer and the distal end of the first imaging member can be initially positioned within the patient as a unit (e.g., both connected to a handheld housing). This initial positioning of the introducer can enable the system to immediately advance the introducer sufficiently distally within the patient's airway, and moreover, to advance in a manner that requires substantially the shortest distance for the introducer to navigate to the desired location (e.g., the laryngeal entrance). This would be the opposite of the standard situation in which the introducer is not connected to a handheld unit and must be advanced distally from a starting point located far from the desired location. For example, depending on the use, the introducer may be only about 2 cm to 7 cm from the desired location when it is inserted into its initial position, connected to the first imaging member and the assembly as a whole. Subsequently, optionally, even in difficult airway conditions, the first imaging member can provide reliable and stable anatomical landmarks by viewing a wide anatomical area, so the guide can be guided to the desired location using imaging from the first imaging member alone and the resulting robotic control. One illustrative benefit of these embodiments is that the guide and the first imaging member can be connected to a common assembly in such a way that the field of view of the guide and the field of view of the first imaging member overlap at least partially.

[0198]

[0259] Some of the benefits of certain embodiments of this specification that incorporate a common handheld housing connecting the introducer and the first imaging member are that the overall footprint or envelope occupied by the structural device when placed in the patient can be smaller or at least more reliably controlled, which in the case of tracheal intubation can further improve the first-pass success rate, shorten intubation time, and reduce the risk of injury to the patient.

[0199]

[0260] Any of the image processing described herein may be performed within or outside the handheld housing. For example, image processing may be performed at least partially within a device outside the handheld housing, such as a computer with a graphics processing unit or a smartphone. The handheld unit may communicate (wired or wirelessly) with the external device, and it is optional that information related to the acquired optical information is communicated from the handheld unit to the external device for processing. The external device may also be adapted to communicate information to the handheld housing to facilitate control of the introducer, which is described in detail herein.

[0200]

[0261] Figures 17A–17G show at least a portion of an illustrative intubation system 1700, and Figures 17A and 17B show an illustrative integrated handheld dual-video endotracheal intubation assembly 1702 before assembly, which, and other integrated assemblies, may be abbreviated as assemblies in this specification. Any individual component of any of the assemblies described herein may be assembled together prior to the procedure to create the assembly. Figures 17C–17E show the assembled assembly 1702. The assembly 1702 includes a housing 1710, which includes a first imaging member coupler 1712, a second imaging member coupler 1714, and a cover coupler 1716. The housing 1702 is configured to be releasably connected to a cover 1780, a first elongated imaging member 1730 (one embodiment of which is shown in Figures 17F and 17G), and optionally a disposable second elongated imaging member 1740. As shown in Figures 17F and 17G, assembly 1702' (which may include any suitable features of assembly 1702, and vice versa) includes a first elongated imaging member 1730 having a first connecting region sized and configured to be releasably connected to a first imaging member coupler 1712. The first elongated imaging member 1730 includes an elongated flexible body 1732 and a first image sensor 1734 (e.g., a video camera) located in the distal region 1736 of the elongated body 1732.

[0201]

[0262] The assembly 1702 further includes a second elongated imaging member 1740, the second imaging member 1740 including a second connecting region 1742 sized and configured to be releasably connected to a second imaging member coupler 1714 of the housing 1710. The second elongated imaging member 1740 includes a flexible, navigable elongated endotracheal tube introduction device 1770 ("introducer"), at least a portion of which is deflectable. The introducer 1770 is sized to be positioned within an endotracheal tube 1790 and to allow the endotracheal tube 1790 to move axially over the introducer 1770. The second imaging member 1740 includes a second image sensor 1773 (e.g., a video camera) located in the distal region 1772 of the introducer 1770. As will be described in more detail later, the introducer includes a first end or first end region fixed to the housing of the second imaging member, and a movable portion that is movable relative to the housing of the second imaging member.

[0202]

[0263] Assembly 1702 also includes a cover 1780 having a cover connection area 1782 sized and configured to be releasably connected to a cover coupler 1716 of the housing 1710. The cover includes an elongated channel defining an elongated lumen, which is sized and dimensional such that at least a portion of the elongated body 1732 of the first imaging member 1730 is positioned within the elongated lumen when a first connection area of ​​the first imaging member 1730 is releasably connected to the first imaging member coupler 1712 and the cover connection area 1782 is releasably connected to the cover coupler 1716.

[0203]

[0264] The cover 1780 further includes an endotracheal tube channel 1784 positioned on the side of the cover 1780 as shown in the figure, the endotracheal tube channel 1784 interfaces with an endotracheal tube 1790 and is sized and dimensioned to restrict the movement of the endotracheal tube 1784 relative to the cover 1780 in at least one direction. The endotracheal tube channel 1784 is further configured to allow the endotracheal tube 1790 to move laterally relative to the endotracheal tube channel 1784. In this embodiment, the channel 1784 includes a recess or trough formed on the side of the cover 1780 and is sized and configured to interface with a portion of the outer wall of the endotracheal tube 1790, and in some embodiments, the channel 1784 is the trachea The cross-sectional configuration may include a surface that forms a partial circle interfacing with the circular outer surface of the inner tube 1790.

[0204]

[0265] The endotracheal tube 1790 includes a lumen sized to movably receive the inlet 1770, as shown in Figure 17C.

[0205]

[0266] The assembly 1720 further includes one or more actuators located within the housing 1710, the actuators being configured and positioned to facilitate controlled robotic motion of the introducer 1770 and the second image sensor 1772 (e.g., a video camera) relative to the first image sensor 1734 (e.g., a video camera) when the second connecting region 1742 of a disposable second elongated imaging member 1740 is releasably connected to the second imaging member coupler 1714 of the housing 1710.

[0206]

[0267] System 1700 may also include one or more processors, which may or may not be part of the assembly. The one or more processors receive, as input, information indicative of signals received from a first image sensor (e.g., a video camera) when the first image sensor is disposed in a patient's upper airway, and cause communication to an actuator within a housing (e.g., housing 1710) to control robotic movement of an introducer and a second image sensor (e.g., a video camera) toward the first image sensor and one or more upper airway anatomical landmarks. Details regarding exemplary methods of use are described in more detail elsewhere in this specification.

[0207]

[0268] As described elsewhere in this specification, an exemplary advantage of the assembly of this specification is that, once assembled, it is sized and configured to be held and moved by one hand of an operator as an assembly. Assembly 1702 is an example of an assembly that is sized and configured such that when a first coupling region of a first imaging member 1730 is releasably coupled to a first imaging member coupler 1712, a second coupling region 1742 is coupled to a second imaging member coupler 1714, a cover coupling region 1782 is releasably coupled to a cover coupler 1716, and an endotracheal tube 1790 is releasably coupled to an endotracheal tube channel 1784, the assembly including the first and second image sensors can be moved using one hand of an operator as an integrated unit.

[0208]

[0269] FIG. 17C shows a view of the assembled assembly 1702 with reference to a bottom view in which the first and second image sensors are visible. The horizontal distance between the image sensors is measured in the "H" direction as indicated in FIG. 17C.

[0209]

[0270] Figure 17D shows a rear side view of the assembly 1702. As described herein, the relative axial distance between the image sensors when the assembly is assembled is measured in the axial direction "A" as shown in Figure 17D. The axial direction "A" is understood to depend on the orientation of the assembled assembly. For example, if the assembly of Figure 17D is rotated 90 degrees counterclockwise, the axial direction "A" will also be rotated 90 degrees.

[0210]

[0271] As shown herein, an advantage of some exemplary assemblies herein is that they are sized and configured to be held and moved by one hand of an operator. When assembled, the relative connection between the housing, the cover, the first elongated imaging member, and the endotracheal tube maintains the first image sensor at a distance from the second image sensor prior to activation of the actuator, and embodiments thereof are shown in FIGS. 17C - 17E. Depending on the use, when the assembly is assembled, the first image sensor and the second image sensor may preferably be axially aligned or as close as possible to an axially aligned state. In some cases, the image sensors are axially aligned. In some cases, they are substantially axially aligned. In some cases, when the assembly is assembled, the first image sensor and the second image sensor are maintained within 3 cm of each other in the axial direction "A". In any case, the horizontal distance H between the first image sensor and the second image sensor can be 2 cm or less when the assembly is assembled. Maintaining the proximity of the image sensors when assembled helps to reduce the overall profile or footprint of the assembly and will help to make it easier and safer for a single operator to hold the dual video intubation assembly in one hand.

[0211]

[0272] Figure 17E shows a top view of the assembled assembly 1702 with the second imaging member 1740 connected to the housing 1710 as shown. The first image sensor and the second image sensor face downward, or face into the depth of the paper in this top view.

[0212]

[0273] Figures 17F and 17G show an assembly 1702' which may include any of the disclosures from assembly 1702. Figures 17F and 17G show a first imaging member 1730 which includes an elongated flexible body 1732 and a first image sensor (e.g., a video camera) positioned in the distal region 1736 of the flexible body 1732. In some embodiments, the first imaging member 1730 is integrated with or considered part of a cover, and the first imaging member and cover are releasably connected to the housing 1710 as a subassembly. In some embodiments, the first imaging member 1730 may be releasably connected to the housing separately from the cover before use. In some embodiments, the housing (e.g., housing 1710) and the first imaging member (e.g., imaging member 1730) are a single unit and do not need to be connected by the operator prior to medical procedures. It may be advantageous to be able to remove the first imaging member from the housing and reuse the housing, for example, when different sized first imaging members are needed for subsequent procedures (e.g., between different patients or between pediatric and adult patients), the advantages of which are described elsewhere in this specification. Therefore, any assembly described herein may include an integrated housing and the first imaging member, or a cover and the first imaging member integrated and connected to the housing as a unit, or a cover and the first imaging member separately and releasably connected to the housing. Any unmarked or undescribed component in system 1702' is understood to be the same as the corresponding component or subassembly in assembly 1702.

[0213]

[0274] Figures 18A–18J show an illustrative housing 1710. Any of the housing features described with respect to housing 1710 may be incorporated into any of the housings herein that are part of any of the assemblies herein. Any of the markings on housing 1710 from Figures 17A–17G may be included in Figures 18A–18J, even if they are not marked in those figures.

[0214]

[0275] The housing 1710 includes a communication region 1720 adapted to communicate with a second imaging member 1740, which is optionally disposable. The communication region 1720 can be configured to be in one or more communication with the second imaging member 1740, such as electrical communication, mechanical communication, optical communication, and / or video communication, when the second imaging member 1740 is removably connected to the housing 1710 (see Figures 17C-17E). In this embodiment, the communication region 1720 includes mechanical interfaces 1721 and 1722 adapted to mechanically interface with the second imaging member 1740, which will be described in more detail later. In this embodiment, mechanical interfaces 1721 and 1722 mechanically interface with corresponding features on the second imaging member 1740 side. The motors are toughened and arranged and configured to cause deflection of the introducer via one or more pull wires or other tensioning elements, as described below. The mechanical interfaces 1721 and 1722 may be actuated by one or more motors, or by motors located, for example, within the housing 1710. In this context, the motors can be considered as part of a robotic control mechanism adapted to robotically control the motion of the introducer, and optionally to control in response to image processing as described elsewhere in this specification. The motors of this type of design may be considered as actuators, a term used herein, or one or more motors may be considered as part of an actuator, where actuator may also refer to, for example, one or more separate components acting together as a mechanical and / or electrical system (e.g., a motor and a drive shaft).

[0215]

[0276] The assemblies of this specification include one or more actuators 1761 (see Figure 20) that (directly or indirectly) facilitate the robotic control motion of the introducer. The motor in the housing 1710 described in this embodiment is one embodiment of the actuator 1761 in the assembly. The pull wires included in this exemplary embodiment are also considered actuators, and in this embodiment they are located in an exemplary second imaging member 1740.

[0216]

[0277] The communication region 1720 may further include a mechanical interface 1723 that mechanically interfaces with the second imaging member and is arranged to generate or facilitate axial motion of the introducer, which will be described in more detail later. One or more motors within the housing may generate the mechanical motion of the mechanical interface.

[0217]

[0278] The communication region 1720 of the housing optionally includes an optical sensor 1724, which is optionally adapted to optically track the axial motion and / or axial position of the introducer as the introducer is moved axially relative to the optical sensor, as described in more detail elsewhere in this specification. Other sensors may be used to track the axial motion and / or position of the introducer.

[0218]

[0279] The communication region 1720 also optionally includes a plurality of electrical connectors 1725 (e.g., a plurality of electrical connections) which can be adapted to interface with a plurality of corresponding connectors on the second imaging member 1740 side to receive data (e.g., video camera signals) communicated from the second image sensor to the housing, and the signals may be processed in the housing or communicated to an external device and / or the device's display for processing. Image processing and robot control (automatic and / or manual robot control) as examples of utilizing the second image sensor data are described elsewhere in this specification.

[0219]

[0280] Figures 18G–18J show the housing 1710 with at least one housing body component (e.g., half of the shell) removed to illustrate an example of an internal housing component that may be arranged in any of the housings herein. Figure 18G is a side view of the housing 1710. Figure 18H is a bottom perspective view of the housing 1710. Figure 18I is a bottom view of the housing 1710. Figure 18J is a top perspective view of the housing 1710. In this embodiment, the housing includes a camera control unit 1801, which may be a camera control unit for any of the first image sensors herein and may be adapted to translate a raw camera signal from the first image sensor into, for example, a USB. The housing 1710 further includes a second camera control unit 1802, which is the first camera control unit. This may be a camera control unit for any of the second image sensors described herein, and may be adapted to translate the raw camera signal from the second image sensor into, for example, a USB. Location 1803 provides an exemplary location for an exemplary USB hub.

[0220]

[0281] Figure 18G also shows an illustrative axial drive motor 1804 (sometimes referred to herein as an axial actuation mechanism), which may include an axial drive servo and be adapted to smooth the axial motion of the introducer as described in more detail elsewhere herein. For example, the axial drive motor 1804 may be configured to cause rotation of the mechanical interface 1723, which is described in more detail herein and shown in Figure 18J. The axial drive motor 1804 is an embodiment of an actuator, a term used herein (and in this embodiment, an embodiment of an actuator located within a housing). Figure 18H shows first and second deflection (or articulation) drive motors 1805 (sometimes referred to herein as actuation mechanisms) simply as illustrative examples, which may include a deflection servo and be adapted to smooth the deflection of the introducer as described in more detail elsewhere herein (for example, it may be configured to tension a pull wire). For example, the first and second deflection drive motors 1805 may be configured to cause rotation of the mechanical interfaces 1721 and 1722, respectively, as described in detail herein and shown in Figure 18J. The first and second deflection (or articulation) drive motors 1805 are embodiments of actuators, a term used herein only (and in this embodiment, embodiments of actuators located within a housing). Figure 18I shows an example location for a microcontroller.

[0221]

[0282] Figures 19A–19K illustrate a second elongated imaging member and its exemplary features. Although Figures 19A–19K are shown and described in the context of the second imaging member 1740, any suitable embodiment of the second imaging member in Figures 19A–19K may be incorporated with respect to any other second elongated imaging member herein, and vice versa. For example, Figure 14A herein illustrates a system 1400, which can also be considered an integral assembly, a term used herein. The system 1400 (or assembly 1400) in Figure 14A includes an introducer assembly 1499 (which may be considered one of the second imaging members specified herein), the introducer assembly 1499 includes an introducer housing 1490 (which may be considered one of the second imaging member housings specified herein) fixed to a movable introducer 1450, the introducer housing 1490 is sized and configured to be releasably fixed to a handheld housing 1410 (which may be considered one of the housings specified herein), and the introducer assembly 1499 may be disposable.

[0222]

[0283] Figure 19A is a view of the bottom of the second imaging member 1740, which includes the housing 1744 and the introducer 1770. In this embodiment, the introducer 1770 is fixed at one end (or end region) to the housing 1744 and is movable relative to the housing 1744 along a portion of the introducer 1770 distal to where it is fixed to the housing 1744. This is similar to the introducer 1450 shown in Figures 14A–14D of this specification. The housing 1744 includes a communication region 1746 which includes one or more communication elements adapted to communicate with a handle when the second imaging member is releasably connected to the housing. The communication elements may optionally be arranged and configured to communicate with the handle mechanically, electrically, videomatically, and / or optically. The communication elements communicate information (e.g., image data) and / or cause movement of the introducer in one or more directions, as described in detail herein. It may be configured to communicate with the handle in an operable manner.

[0223]

[0284] In this exemplary embodiment, the communication region 1746 of the second imaging member 1740 includes mechanical interfaces 1741 and 1743, which are positioned relative to the housing 1744 and configured to mechanically interface with mechanical interfaces 1721 and 1722 in the communication region 1720 of the housing 1710 (see Figure 18C). The mechanical interfaces may, for example, include gear-type interactions using teeth, such that rotation of mechanical interfaces 1721 and 1722 of the housing 1710 (e.g., in response to activation of a housing motor) causes rotation of mechanical interfaces 1741 and 1743, respectively. As will be described in more detail later, one or more tension elements (e.g., one or more pull wires) may be operably connected to the mechanical interfaces 1741 and 1743, such that rotation of interfaces 1741 and 1743 causes tension in one or more pull wires, which causes deflection of the introducer.

[0224]

[0285] In this embodiment, the communication region 1746 of the second imaging member 1740 further includes a mechanical interface 1747 positioned relative to the housing 1744 and configured to mechanically interface with a mechanical interface 1723 in the communication region 1720 of the housing 1710 (see Figure 18C). The mechanical interface may include, as merely one example, a gear-type interaction using teeth, such that the rotation of the mechanical interface 1723 of the housing 1710 (e.g., in response to the activation of a housing motor) causes the rotation of the mechanical interface 1747. In this embodiment, interface 1745 is configured to have a gear-type interaction with interface 1747 such that the rotation of interface 1747 similarly causes the rotation of 1745 (see Figure 19F). The introducer passes through housing 1744 and is positioned between rotary mechanical interfaces 1747 and 1745, the rotation of which causes axial translation (distal or proximal) of introducer 1770, and Figure 19A shows axial direction "A" representing the axial motion of introducer 1770 relative to housing 1744. Further details of the communication region 1746 will be described later.

[0225]

[0286] Figure 19B shows a top view of the second imaging member 1740, which includes an endotracheal tube coupler 1750. Figure 19C shows a side view of the second imaging member 1740. Figure 19C shows an inlet having a curved configuration. When one or more system or assembly components are described herein as having length, length generally refers to the length along the component (e.g., from a first end or first location of the component to a second end or second location). For example, the inlet in Figure 19C may have a length extending between a first end fixed to the housing 1742 and the most distal end of the inlet, and the length of the inlet would in this embodiment be measured along the length of the inlet itself from the first fixed end to the second end, even if there is one or more curved regions.

[0226]

[0287] Figures 19D and 19E show end views of the second imaging member 1740.

[0227]

[0288] Figure 19F shows a top view of the second imaging member 1740 with the upper surface layer of the housing removed to illustrate an example of internal components within the communication region 1746 of the housing 1744. The figure in Figure 19F is the same as Figure 19B, but a portion of the housing has been removed to show the internal components of the housing 1744. Figure 19A shows a bottom view of the second imaging member 1740. Figure 19F shows an example of a geared interface between the rotary interfaces 1745 and 1747 described above. The mechanical interface 1747 interfaces with the rotary interface 1723 in the handle, and the rotation of the rotary interface 1723 (e.g., by a motor) The drive may cause the mechanical interface 1747 to rotate. A geared interface between interfaces 1745 and 1747 rotates interface 1745 in the opposite direction to the rotation of interface 1747, moving the introducer 1770, which is located between interfaces 1745 and 1747, in the axial direction. The geared relationship between interfaces 1745 and 1747 can help amplify the force on the introducer and prevent slippage during the axial motion of the introducer.

[0228]

[0289] Figure 19F also shows a number of electrical connectors 1749, which are located and configured within the housing to interface with electrical connectors 1725 in the handle, and can communicate image data from the distal end image sensor of the introducer to the housing 1710, as described in more detail herein.

[0229]

[0290] FIG. 19F also shows a window or opening 1748 that is aligned and adjacent to a section of the introducer 1770, as illustrated. Window 1748 is arranged to align with a housing sensor so that the movement or position of the introducer as it moves in the axial direction "A" can be tracked by a sensor 1724 (e.g., an optical sensor) within the housing. The introducer may have one or more markers on its outer surface to facilitate position tracking or sensing by the housing sensor 1724. The housing sensor 1724 may be adapted to communicate (directly or indirectly) the sensed information to a processor to track the axial movement and / or position of the introducer.

[0230]

[0291] Figure 19F also shows mechanical interfaces 1741 and 1743 positioned and configured to interact with mechanical interfaces 1721 and 1722 within the housing 1710. In this embodiment, mechanical interfaces 1741 and 1743 rotate in response to the rotation of mechanical interfaces 1721 and 1722 within the housing 1710, and this rotation is used in this embodiment to cause deflection of the distal region or distal tip of the introducer in one or more directions (e.g., up, down, left, right, or any combination thereof). Figure 19F shows just one embodiment in which the rotation of interfaces 1741 and 1743 is caused by using first and second motors within the housing 1710, respectively. In this embodiment, interfaces 1741 and 1743 are connected to first and second pull wires, respectively, so that when they are rotated in the first direction, one pull wire is taut, causing deflection of the distal tip of the introducer, and when they are rotated in the opposite direction, the second pull wire is taut, causing deflection in a different direction (for example, 180 degrees to the first direction). In one embodiment, rotation of interface 1741 can cause deflection of the introducer in a first plane (each direction being 180 degrees to the other, e.g., left and right), and rotation of interface 1743 can cause deflection of the introducer in a second plane traversing the first plane (each direction being 180 degrees to the other, e.g., up and down). Interfaces 1741 and 1743 may both be controlled separately, for example, by using different motors within the housing, in response to robotic control of the introducer motion (either automatic or manual robotic control).

[0231]

[0292] In the embodiment shown in Figure 19F, pull wires (for example, first and second pull wires 1757 are shown for illustrative and explanatory purposes) can be connected to interfaces 1741 and 1743 at locations 1754 and 1753, respectively, using any of various fixing techniques or mechanisms. The pull wires extend from interfaces 1741 and 1743 through a pull wire channel collectively labeled 1752, and then into the introducer 1770. The pull wires extend through the introducer using existing pull wire wiring techniques and methods to cause deflection of the distal tip of the introducer. It is fixed to the distal region of the induction device.

[0232]

[0293] In one of the alternative configurations, the housing motor may be operationally connected to only one pull wire. For example, in a variation of the configuration shown in Figure 19F, the housing 1710 may contain four motors, each of which tensions its own pull wire.

[0233]

[0294] Figures 19G–19K show an exemplary second imaging member housing, and any second imaging member housing described herein may include any of the exemplary features of the exemplary housing 1744 shown in Figures 19G–19K, and vice versa. Figure 19G is a bottom perspective view of the housing 1744. Figure 19H is a bottom view of the housing 1744. Figure 19I is a top perspective view of the housing 1744. Figure 19J is a front end view of the housing 1744, showing first and second windows 1755 and 1756 through which the inlet 1770 extends. Figure 19K shows a rear end view of the housing 1744 including the endotracheal tube coupler 1750. As described herein, the end region of the first end of the inlet may be fixed within the housing 1710, and in Figure 19F, the first end of the inlet 1770 is fixed to an element 1751 within the housing 1751. From element 1751, the inlet 1770 extends out of the housing through the housing opening or window 1756 (see Figure 19J). The inlet 1770 then forms a loop configuration as shown (e.g., Figures 17B, 17C, 17E, 17G, 19A, 19B, 19E), and then returns into the housing through the housing opening or window 1755 (see Figure 19J). The inlet then extends through the optional endotracheal coupler 1750 of the housing 1744, as seen in Figure 19F.

[0234]

[0295] As illustrated, the housing 1744 in this embodiment has a substantially rectangular configuration (and in this embodiment, a substantially square configuration), with both its width and height being greater than its thickness measured in the vertical direction. The corresponding fitting area of ​​the housing 1710 has a similar rectangular configuration, as shown in the pre-assembly diagram of Figure 17B.

[0235]

[0296] The second imaging member 1740 includes an endotracheal tube coupler 1750 having a circular cross-section and a cylindrical configuration. As shown in Figure 17A, the endotracheal tube has a first end with an illustrated coupler region 1791, which is dimensioned and sized to interface with the endotracheal tube coupler 1750 on the housing 1744 side of the second imaging member 1740. The endotracheal tube 1790 also has a lumen sized to receive an introducer when the coupler region 1791 interfaces with the endotracheal tube coupler 1750 on the housing 1744, as shown in Figure 17C.

[0236]

[0297] As shown in Figure 17A, the body 1711 of the housing 1710 further includes a lateral endotracheal tube channel 1713, which is positioned and configured such that when the cover 1780 is releasably fixed to the housing 1710, the channel 1713 of the housing 1710 and the channel 1784 in the cover form a continuous channel for the endotracheal tube as shown in Figure 17D. In this context, the term continuous includes any minimum axial gap (e.g., 0.01 cm to 2 cm) between the two channels, to the extent that the endotracheal tube 1790 can interface with the housing channel 1713 and the cover channel 1784 when the cover 1780 is connected to the housing 1710. Both channels 1713 and 1784 are open on one side to allow the endotracheal tube to be removed from the channel by detaching it from the channel laterally or horizontally.

[0237]

[0298] The housings (e.g., housing 1710) or integrated handheld assemblies of this specification may include one or more image processors, however, in some embodiments, data may be communicated to components not integrated into the assembly where image processing occurs, such as an external computer and / or system display. Any type of connection may be used for data transfer, such as a USB interface.

[0238]

[0299] Any of the assemblies further includes one or more microcontrollers, which may optionally be located within a housing (e.g., housing 1710). Any of the assemblies further includes one or more motor interfaces (e.g., as part of the robotic control of the introducer motion), which may optionally be located within a housing (e.g., housing 1710). Any of the assemblies herein further includes an electronic control board, which may provide power to one or more motors optionally located within a housing during the robotic motion of the introducer.

[0239]

[0300] As shown in Figure 17D (in combination with Figure 17C), the first and second image sensors (e.g., both video cameras) are maintained at a certain axial distance from each other when the assembly is assembled. In Figure 17D, the axial locations of the first and second image sensors are labeled L, and in this embodiment, the image sensors are within 3 cm of each other axially and may optionally be aligned axially. The image sensors are further at a horizontal distance "H" of 2 cm or less from the other sensor (see Figure 17C). When assembled, the first and second image sensors are therefore maintained at relatively close distances from each other (both axial and horizontal), the advantages of which are described herein. Assembly 1702, thus, is an embodiment of an integrated, handheld, dual-video endotracheal intubation assembly, configured such that when the first imaging member is connected to the housing, the second imaging member is connected to the housing, the cover is releasably connected to the housing, and the endotracheal tube is releasably connected to the assembly, the assembly maintains the first image sensor at a certain distance from the second image sensor prior to the operation of the actuator, an embodiment of which is shown in Figures 17C and 17D. In this embodiment, the length and configuration of the endotracheal tube, the inlet, the cover, the flexible body 1732 of the first imaging member 1730, and the body 1711 of the housing 1710, all (overall and individually), enable and direct the first and second image sensors to be placed at a maintenance distance from each other, and contribute to an overall small profile and footprint of the assembly, enabling the assembly to be held and moved with one hand by the operator.

[0240]

[0301] Assembly 1702 is an embodiment of an assembly that can be used for tracheal intubation. One advantage is that the first and second image sensors are maintained at a relatively close axial distance (e.g., 3 cm or less, and optionally axially aligned) when the assembly is assembled. When in use, the introducer generally needs to be able to move robotically axially about 3 cm to 5 cm to or toward the glottal opening. The assembly is also adapted to allow the introducer to move axially through the trachea via the glottal opening. Thus, when used for tracheal intubation, the assembly of this specification can robotically generate at least 3 cm of axial movement of the introducer and the second image sensor relative to the first image sensor maintained in the upper airway.

[0241]

[0302] The assemblies of this specification may include a distal motion limiter configured to restrict the distal motion of the introducer relative to its initial position and relative to the first image sensor. For example, assembly 1720 includes a distal motion limiter configured to restrict the distal motion of the introducer 1770 relative to its initial position (as shown, for example, in Figures 17C and 17D) and the distal motion of the first imaging member 1730 relative to the first image sensor. This embodiment As shown in Figure 19F, although the first end of the introducer is fixed to the housing 1744, the introducer is permitted to be moved axially robotically using an axial motion mechanism inside the housing 1744 (including, for example, mechanical interfaces 1745 and 1747). Fixing the first end of the introducer 1770 limits how far the introducer 1770 can be advanced distally in this embodiment. The length of the introducer outside the housing 1744 between the openings 1755 and 1756 of the housing 1744 can also affect how far the introducer can be advanced distally, and is therefore considered to be part of or affecting the distal motion limiter. For example, if the length of the introducer 1770 outside the housing 1744 between the openings 1755 and 1756 is very short, the distal motion limiter should significantly hinder the distal advance of the introducer relative to the housing 1744.

[0242]

[0303] Figure 20 schematically shows an integrated handheld dual video assembly 2002 as an example that can incorporate any and all forms of assembly 1702 and assembly 1702'. Assembly 2002 includes a housing 2010 that can incorporate any and all forms of any of the housings herein (e.g., housing 1710). Assembly 2002 includes a cover 2080 that can incorporate any and all forms of any of the covers herein (e.g., cover 1780). Assembly 2002 optionally includes a disposable second imaging member 2040 that can incorporate any and all forms of any of the second imaging members herein (e.g., second imaging member 1740). Assembly 2002 includes an endotracheal tube 2090 that can incorporate any and all forms of any of the ETTs herein (e.g., endotracheal tube 1790). Assembly 2002 includes one or more actuators 2061 that can incorporate any and all embodiments of any one of the actuators of this specification (e.g., one or more actuators 1761) (the actuators may be located, for example, within the housing 2010 and / or within the second imaging member 2040). Any of the assemblies of this specification (e.g., 1702, 1702') can be generalized as shown in the schematic diagram of Figure 20.

[0243]

[0304] Any description relating to assembly 1702, including any features or methods of use, may be integrated with assembly 1702', and vice versa.

[0244]

[0305] Figure 21 shows an exemplary method using any of the assemblies of this specification. In the illustrated method, the assembled assembly (e.g., assembly 1702) is positioned in the patient's upper airway (e.g., as shown in Figure 15) in step 2110. The method may include, in step 2120, causing the system's processor to receive a signal indicating image data from the assembly's first image sensor (e.g., a video camera). The method may include, in step 2130, processing the signal indicating data from the first image sensor. The method may include, in step 2140, while maintaining the first image sensor in the upper airway, initiating an automated or manually robotically controlled movement of the assembly's introducer toward at least one upper airway anatomical landmark away from the assembly's first image source in response to the processing step. The method may further include, in step 2150, moving the introducer within the endotracheal tube, passing through the glottal opening and advancing into the trachea, while keeping at least a portion of the assembly cover and the first image sensor in the upper airway and while the first image sensor receives video data from the first image sensor during the automated movement of the introducer. Any additional method steps may be incorporated into the exemplary method shown in Figure 21.

[0245]

[0306] One of the second elongated imaging members (e.g., 1740) may also be referred to herein as a cartridge, and the cartridge is housed in a housing (e.g., housing 1710). It is called that because it can be fixed in a way that allows it to be released.

[0246]

[0307] In some variations of the embodiments described herein, the system is adapted to allow a remote operator to remotely control the robotic motion of the introducer described herein. For example, assuming a first operator is with the patient, the assembly is placed, for example, in the patient's upper airway. The first operator activates the operation of the first and / or second image sensors. Image data is transmitted to a remote location (e.g., wirelessly), where a second operator can remotely control the introducer (e.g., using a workstation). The second operator only needs to have a display that shows the video data from the first and / or second image sensors. Apart from the fact that the first operator will be directly handling the assembly in these embodiments, this type of remote control arrangement can provide the advantages of the integrated dual video intubation assembly described herein.

[0247]

[0308] Any of the processors herein may store on the processor a number of computer-executable methods (e.g., software, algorithms) that can be adapted individually or in combination to determine or contribute to determining several directions for the inducer, including receiving one or more inputs that may represent image or video data from one or more image sensors herein, and causing motion of the inducer such that the inducer is moved to or toward one or more anatomical landmarks. This type of determination or planning may be referred to herein as navigating or part of a navigation process.

[0248]

[0309] Any feature, component, or method described herein in one embodiment may be incorporated into any other suitable embodiment herein, unless the description suggests otherwise. For example, any feature or method of use in any embodiment or aspect herein may be included with or incorporated into any other suitable embodiment or aspect herein.

[0249]

[0310] The above description, intended for explanatory purposes, uses specific nomenclature to provide a complete understanding of the inventions herein. However, it will be apparent to those skilled in the art that specific details may not be necessary to practice one or more of the inventions herein. Accordingly, the above description of specific embodiments of the inventions herein is presented for illustrative and explanatory purposes only.

[0250]

[0311] Even if not specifically indicated, one or more techniques or methods described in this disclosure may, at their discretion, be implemented, at least in part, in hardware, software, firmware, or any combination thereof. For example, various aspects of a technique or component may be implemented, alone or in any appropriate combination, within one or more processors, including one or more microprocessors, digital signal processors (DSPs), application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), programmable logic circuits, etc. The terms “processor” or “processing circuit configuration” may generally refer to any of the above circuit configurations, whether alone or in combination with other circuit configurations, or to any other equivalent circuit configuration. Such hardware, software, or firmware may be implemented in the same device or in separate devices to support the various operations and functions described in this disclosure. In addition, any of the units, modules, or components described may be implemented together as discrete but interoperable logic devices, or separately. The description of different features as a module or unit is intended to highlight different functional aspects, and such modules or units do not necessarily have to be realized by separate hardware or software components. This does not imply that the functionality associated with one or more modules or units may be performed by separate hardware or software components, or they may be integrated within a common or separate hardware or software component. When implemented in software, the functionality belonging to the systems, devices, and techniques described in this disclosure may optionally be embodied as instructions on a computer-readable medium, such as random access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), electrically erasable programmable ROM (EEPROM), or flash memory. Instructions (e.g., methods) may be executed by a processor to support one or more aspects of the functionality described in this disclosure.

[0251] Additional examples

[0313] A first additional embodiment is an integrated device for robotically assisting patient airway management (e.g., intubation), comprising: a handheld housing; a laryngoscope connected to the housing and equipped with a first image sensor; a movable actuation member within the housing; an endoscope extending from the actuation member, equipped with a second image sensor and configured to be detachably connected to an intubation tube; and at least one actuator within the housing configured to automatically guide the endoscope via the actuation member based at least partially on one or more images from at least one of the first and second image sensors.

[0252]

[0314] In this embodiment, the device may further comprise a cover connected to a housing, the cover comprising a first channel configured to receive a laryngoscope and a second channel configured to receive at least a portion of an endoscope. The cover may comprise a first portion having the first channel and a second portion having the second channel, the first and second portions being detachably connected. The cover may comprise a displacement member configured to retract the patient's tongue during intubation. The displacement member may be angled or curved. The cover may be configured to advance over the patient's tongue into or near the patient's vallecula epiglottis, or below the patient's epiglottis. The distal ends of the first channel and the distal ends of the second channel may be adjacent and substantially parallel. The cover may be detachably connected to a housing.

[0253]

[0315] In this embodiment, at least one of the first image sensor and the second image sensor may provide a viewing angle of at least 40 degrees in both the axial and horizontal planes. The viewing angle may be between approximately 40 degrees and approximately 180 degrees in both the axial and horizontal planes. The viewing angle may be between approximately 40 degrees and approximately 360 degrees in both the axial and horizontal planes.

[0254]

[0316] This embodiment may further include a video monitor configured to display at least one image from a first image sensor, a second image sensor, or both. The video monitor may be configured to display the images from the first and second image sensors in a split-screen or picture-in-picture arrangement.

[0255]

[0317] In this embodiment, the actuating member may be axially extendable. The actuating member may comprise one or more interlocking rings or one or more helical elements.

[0256]

[0318] In this embodiment, the actuarial member may be movable within the guide. At least a portion of the guide may be within the housing. At least a portion of the guide may be within a video monitor connected to the housing. At least a portion of the guide may be curved. The guide may be straight. At least one actuator is located within the guide. The moving member may be configured to automatically guide the guide. The operating member may be manually moved within the guide. This embodiment may further include a user input device aligned with the guide and connected to the operating member to enable manual control of the movement of the operating member within the guide. The operating member is capable of longitudinal translation within the guide, thereby allowing the endoscope to move forward and backward in the longitudinal direction. At least one actuator is configured to automatically articulate the distal end of the endoscope. At least one actuator may be configured to articulate the distal end of the endoscope in a first plane.

[0257]

[0319] This embodiment may further include at least one processor configured to process images acquired by at least one of a first image sensor or a second image sensor. The at least one processor may be configured to process one or more images by identifying at least one recognizable anatomical feature. The at least one processor may be configured to identify at least one anatomical feature by applying a trained machine learning algorithm to one or more images. The at least one processor may be configured to control at least one actuator to automatically guide the endoscope toward at least one anatomical feature. The at least one processor may be configured to initiate control of at least one actuator based on one or more images from a laryngoscope. The at least one processor may be configured to automatically guide the endoscope toward at least one anatomical feature based on one or more images from a laryngoscope, one or more images from an endoscope, or both. The at least one processor may be configured to initiate control of at least one actuator based on one or more images from an endoscope.

[0258]

[0320] In this embodiment, the endoscope may be detachably connected to the operating member.

[0259]

[0321] In this embodiment, the operating member may be reusable, and the endoscope may be disposable.

[0260]

[0322] In this embodiment, the endoscope may be integrally formed with the operating member.

[0261]

[0323] In this embodiment, the distal end of the operating member may be aligned axially with the proximal end of the endoscope.

[0262]

[0324] In this embodiment, the endoscope is equipped with a flexible member, but the endoscope may also be equipped with a rigid stylet having a deflectable distal end.

[0263]

[0325] In this embodiment, the device can be operated by a single user.

[0264]

[0326] In this embodiment, the operating member may be between approximately 10 cm and approximately 40 cm in length.

[0265]

[0327] In this embodiment, the endoscope may be between approximately 20 cm and 30 cm in length.

[0266]

[0328] In this embodiment, the endoscope may be between approximately 20 cm and 60 cm in length.

[0267]

[0329] In this embodiment, the device may be configured for use with adult patients or pediatric patients.

[0268]

[0330] In this embodiment, the intubation tube may be an endotracheal tube.

[0269]

[0331] In this embodiment, the device may be configured to assist oral endotracheal intubation, or the device may be configured to assist nasotracheal intubation.

[0270]

[0332] A second additional embodiment is an integrated robotic device adapted for airway management, comprising: a handheld housing; a laryngoscope connected to the housing and equipped with a first image sensor; an actuator that is movable within the housing and connectable to an introducer equipped with a second image sensor; and at least one actuator within the housing configured to automatically move the actuator based at least partially on one or more images from at least one of the first and second image sensors.

[0271]

[0333] A third additional embodiment is an integrated robotic device adapted for airway management, comprising: a handheld housing; a working member that is movable within the housing and connectable to an introducer equipped with an image sensor; and at least one actuator within the housing configured to automatically move the working member based at least partially on one or more images from the image sensor. [Explanation of Symbols]

[0272] 61a, 61b, 61c Navigation Wheel 62, 63 Antagonistic Cables Set of 64a, 64b, and 64c antagonistic cables 100 Integrated robotic devices or systems 110 Housing 112 processors 114 Electronic equipment 116 Actuators 118 displays 120 Laryngoscope 140 Operating member 150 Endoscopes 200 Portable Handheld Integrated Dual Video Robot Assembly or System 210 Handheld Housing 211 Power supply connector or port 214 Electronic Equipment Systems 216, 216', 216'' actuators 216a Axial actuator 216r Rotary Actuator 217, 217', 217'' Guide 218 displays 220 Baton 222 Image Sensor 240, 240', 240'' Actuator 250 Endoscopes 250d distal end region 252 Image Sensors 260 Cover 262, 263 Connection section 264 First channel, first imaging member channel 266 Second channel, intubation tube channel 267 Fasteners 268 Displacement member 269 ​​Detachable bonding area 270 User Interface Devices 272 Control Component Guide 274 Control Member 276 Control wires 278 Upper connection part 279 Side connection section 280 AI Action Buttons 282 User Interface Elements 284 STOP button 290 Selectable Buttons 600 Devices for joint movement 650 Devices for joint movement 1100 Device or assembly 1110 Handheld Housing 1117 Installation Guide 1118 Display 1130 Universal Docking Station 1150 Introducer 1160 Cover or blade 1200 Handheld Housing 1210 Housing 1216 Actuator 1217 Introducer coupler 1218 displays 1222 Introducer coupler 1240 Robot extension or operating member 1250 Introducer 1260 Removable cover 1270 Robot Blocks 1272 Block Coupler 1400 Intubation system or assembly 1410 Handheld Housing 1413 Motor connection section 1450 Introducer 1460 cover 1461 Tracheal tube channel 1462 First imaging member channel 1490 Introducer Housing 1491 Fixing location of the introducing device to the housing 1492 Housing body 1493 Aperture 1494a, 1494b Rollers or wheels 1495 Electrical connection part, electrical coupling part of the introduction unit housing 1496 Motor connection section 1497 Aperture 1499 Introducer assembly 1700 Intubation System 1702, 1702' assembly 1710 Housing 1711 Housing body 1712 First imaging component coupler 1713 Housing Channel 1714 Second imaging component coupler 1716 Cover coupler 1720 Communication area 1721, 1722, 1723 Mechanical Interface 1724 Optical Sensor 1725 Electrical Connector 1730 First elongated imaging member 1732 Long and slender flexible body 1734 First image sensor 1736 The distal region of the elongated main body 1732 1740 Second elongated imaging member 1741 Mechanical Interface 1742 Second connecting area 1743 Mechanical Interface 1744 Housing 1745 Mechanical Interface 1746 Communication area of ​​the second imaging member 1747 Mechanical Interface 1748 Window or opening 1749 Electrical Connector 1750 Endotracheal tube coupler 1751 Elements within housing 1752 Pull Wire Channel 1753, 1754 Pull wire connection locations 1755, 1756 windows 1757 First and second pull wires 1770 Endotracheal tube insertion device 1772 Distal region of the introduction device 1773 Second image sensor 1780 cover 1782 Cover connection area 1784 Endotracheal tube channel, cover channel 1790 Endotracheal tube 1791 Coupler Area 1801 Camera Control Unit 1802 Second camera control unit Location as an example for 1803 USB hubs 1804 Axial drive motor 1805 First and second deflection (or joint movement) drive motors 2002 Integrated Handheld Dual Video Assembly 2010 Housing 2040 Second imaging member 2061 Actuator 2080 Cover 2090 Endotracheal tube Endotracheal tube (ETT) A-axis H horizontal direction L Axial location of the first and second image sensors F Manual forward movement L leftward movement R Rightward movement

Claims

1. An intubation system, wherein the intubation system is The system comprises a one-piece, handheld dual-video endotracheal intubation assembly ("Assembly") sized and configured to be held in one hand by the user, the Assembly comprising: Housing and; A first elongated imaging member comprising an elongated body and a first video camera positioned in the distal region of the elongated body; A disposable second elongated imaging member comprising: a flexible elongated endotracheal tube introducer ("introducer"), sized and configured to be releasably connected to the housing to create an operational communication with the housing, the introducer being positioned within an endotracheal tube and sized to allow the endotracheal tube to move axially over it; and a second video camera positioned in the distal region of the introducer; A cover sized and configured to be releasably connected to the housing, the cover comprising the following: An elongated channel defining an elongated lumen, wherein the elongated channel is sized and dimensionally set such that at least a portion of the elongated body of the first imaging member is positioned within the elongated lumen, and An endotracheal tube channel comprising a cover including an endotracheal tube channel, which includes an endotracheal tube having a lumen sized to receive the inlet therein, and which is releasably fixed to the endotracheal tube channel and is sized and dimensioned to restrict the movement of the endotracheal tube in at least one direction relative to the cover with respect to the endotracheal tube channel; The system comprises an actuator disposed within the housing and configured to communicate operably with the introducer when the disposable second elongated imaging member is releasably connected to the housing, the actuator being activated to facilitate the control movement of the introducer and the second video camera relative to the first video camera, The assembly is configured to position the first video camera at an initial distance from the second video camera prior to the operation of the actuator, when the endotracheal tube is interfaced with the endotracheal tube channel and the disposable second elongated imaging member is releasably connected to the housing.

2. The system according to claim 1, A system further comprising a processor configured to receive as input information indicating one or more signals of upper airway anatomical landmarks from the first video camera or information indicating signals from the second video camera when the cover is at least partially positioned within the patient's upper airway, and to cause communication to the actuator to control the robotic movement of the introducer and the second video camera relative to the first video camera.

3. In the system described in claim 1, A system in which the first video camera has a first field of view, the second video camera has a second field of view, the first field of view is larger than the second field of view, and the first video camera provides visualization of a wider area of ​​the patient's upper airway anatomical structure when the introducer and the second video camera are moved relative to the first video camera, compared to the second video camera.

4. In the system described in claim 1, The system further comprises the endotracheal tube being releasably connected to the endotracheal tube channel, and the disposable second elongated imaging member being releasably connected to the housing, wherein the first video camera is maintained at an initial axial distance not exceeding 3 cm from the second video camera when extended through the endotracheal tube lumen, prior to the operation of the actuator.

5. In the system described in claim 1, The assembly is a system in which, when the second imaging member is connected to the housing, the cover is releasably connected to the housing, and the endotracheal tube is releasably connected to the endotracheal tube channel, the assembly, including the first video camera and the second video camera, is sized and configured to be moved by the user with one hand as a single unit.

6. In the system described in claim 1, A system in which the actuator is configured to facilitate the controlled axial navigation or controlled deflection of the introducer and the second video camera relative to the first video camera, or one or more of the latter.

7. In the system described in claim 1, A system wherein the first imaging member has length, the first video camera has field of view, and the endotracheal tube channel of the cover is configured such that the first video camera is adapted to visualize the axial control motion of the introducer relative to the first video camera when a portion of the introducer is moved within the endotracheal tube lumen.

8. In the system described in claim 1, Prior to the operation of the actuator, the first video camera is maintained in a state substantially aligned axially with the second video camera, in a system.

9. In the system described in claim 1, Prior to the operation of the actuator, the first video camera is maintained in an axially aligned state with the second video camera, according to claim 1.

10. In the system described in claim 1, Prior to the operation of the actuator, the second video camera is maintained at an initial axial distance not exceeding 3 cm from the first video camera, in a system.

11. In the system according to claim 10, Prior to the operation of the actuator, the second video camera is maintained at a horizontal distance not exceeding 4 cm from the first video camera, in a system.

12. In the system described in claim 1, The actuator is configured to facilitate the controlled distal movement of the introducer by at least 2 cm relative to the introducer's initial position.

13. In the system described in claim 1, The assembly further comprises a distal motion limiter configured to restrict the distal motion of the introducer relative to the initial position and the first video camera, wherein the assembly is a system.

14. In the system described in claim 13, The distal motion limiter is configured to prevent the introducer from contacting the tracheal carina when the first video camera is maintained within the patient's upper airway.

15. In the system described in claim 13, The assembly is configured to prevent the introducer from being moved distally beyond 40 cm from its initial position.

16. In the system described in claim 13, The assembly is configured to prevent the introducer from being moved distally beyond 30 cm from its initial position.

17. In the system described in claim 1, The actuator is configured to facilitate the controlled distal movement of the introducer by at least 5 cm relative to the introducer's initial position.

18. In the system described in claim 1, The system comprises a disposable second elongated imaging member, a disposable housing, the proximal end of the introducer positioned within the disposable housing and fixed to the disposable housing, and a distal section of the introducer relative to the disposable housing.

19. In the system according to claim 18, The system wherein the disposable housing has a window through which the inlet passes and extends to the outside of the disposable housing.

20. The system according to claim 1, The system further comprises a controller which is manually activated to facilitate the manual robotic movement of the introducing device relative to the first video camera.

21. In the system described in claim 20, The system is further adapted to enable manual robotic control of the introducer when the second video camera is positioned in the lower airway and the first video camera is positioned in the upper airway.

22. In the system described in claim 1, The system is further adapted to enable manual robotic control of the introducer when the introducer is positioned in the upper airway and the first video camera is positioned in the upper airway.

23. In the system described in claim 1, The system comprises a disposable second elongated imaging member equipped with one or more introducer deflection actuators.

24. In the system described in claim 23, The system wherein one or more of the aforementioned introducer deflection actuators are adapted to rotate.

25. The system according to claim 23, A system further comprising a plurality of pull wires extending through the introducer and causing deflection of the introducer when tensioned, wherein at least one pull wire is fixed to each of the one or more introducer deflection actuators, and the motion of the deflection actuators tensions the at least one pull wire fixed thereto.

26. In the system described in claim 25, The system further comprises a plurality of actuators for axial motion of the introducer, wherein the disposable second elongated imaging member is further equipped with a plurality of introducer axial motion actuators.

27. In the system described in claim 26, The system wherein the introducer extends between a first introducer axial motion actuator and a second introducer axial motion actuator, and the motion of the first introducer axial motion actuator and the second introducer axial motion actuator causes axial motion of the introducer.

28. In the system described in claim 27, A system in which one section of the introducer is located proximal to the first and second introducer axial motion actuators and outside the disposable housing.

29. In the system described in claim 23, A system in which each of the one or more introducer deflection actuators is operably connected to a rotary actuator located within the housing.

30. In the system described in claim 29, The rotary actuator is in operable communication with a motor located within the housing, in a system.

31. In the system described in claim 1, The system comprises a disposable second elongated imaging member equipped with a plurality of actuators for motion in the introduction axial direction.

32. In the system described in claim 31, The system comprises multiple actuators with axial motion, each having a gear-type interface.

33. In the system described in claim 31, The system comprises an introducer extending between a first introducer axial motion actuator and a second introducer axial motion actuator.

34. In the system described in claim 1, The system comprises a disposable second elongated imaging member having an opening that faces the housing when connected to the housing, and the housing having a sensor positioned to sense the axial movement of the introducer through the opening facing the housing.

35. A method of intubating a patient, wherein the method is A step of positioning a one-piece, handheld, dual-video endotracheal intubation assembly ("Assembly"), which is sized and configured to be held by one hand of a user, within the upper airway of a patient, wherein the Assembly comprises the following: Housing and; A first elongated imaging member extending from the housing, comprising an elongated body and a first video camera positioned in the distal region of the elongated body; A disposable second elongated imaging member comprising: a flexible elongated endotracheal tube introduction device ("introducer"), which is releasably connected to the housing to create an operational communication with the housing and is sized to be positioned within an endotracheal tube and to allow the endotracheal tube to move axially over it; and a second video camera positioned in the distal region of the introduction device; A cover removably connected to the housing, the cover comprising the following, namely, An elongated channel defining an elongated lumen, wherein the elongated channel is sized and dimensionally set such that at least a portion of the elongated body of the first imaging member is positioned within the elongated lumen, and An endotracheal tube channel interface with the endotracheal tube, which includes a lumen sized to receive the inlet therein, and a cover including an endotracheal tube channel that is sized and dimensioned to restrict the movement of the endotracheal tube in at least one direction relative to the cover with respect to the endotracheal tube channel; A step of positioning an assembly within a patient's upper airway, the assembly comprising an actuator located within the housing and configured to facilitate the robotic control movement of the introducer and the second video camera relative to the elongated body and the first video camera; The process of maintaining the first video camera within the upper airway while generating the motion of the introduction device through the larynx into the trachea; The steps include: displaying a video signal from the first video camera indicating one or more upper airway markers while the first video camera is maintained within the upper airway; The steps include: displaying the video signal from the second video camera while the introduction device and the second video camera are inside the trachea; The process involves advancing the endotracheal tube from above the introduction device through the larynx into the trachea while the video signal from the first video camera in the upper airway is displayed and the video signal from the second video camera is displayed, The first video signal provides a view of the outer surface of the endotracheal tube as the endotracheal tube is advanced toward the larynx. The second video signal provides a view of the endotracheal tube as it is advanced from above the introducer within the trachea, comprising the step of advancing the endotracheal tube; The steps include: confirming the placement of the endotracheal tube in the trachea using the second video signal while the first video camera is maintained in the upper airway; A method comprising the step of removing the system from the patient while leaving the endotracheal tube in the trachea.

36. The method according to claim 35, A method further comprising the step of causing the processor to receive a first video signal when the first video camera is maintained above the vocal cords in the upper airway.

37. In the method according to claim 36, A method comprising the step of generating the movement of the introducer through the larynx into the trachea while maintaining the first video camera within the upper airway, the step of generating the automatic robot-controlled movement of the introducer through the larynx into the trachea.

38. In the method according to claim 36, A method comprising the step of generating the movement of the introducer through the larynx into the trachea while maintaining the first video camera within the upper airway, the step of generating the manually controlled robotic movement of the introducer through the larynx into the trachea.

39. The method according to claim 36, A method further comprising the step of causing the processor to receive the second video signal when the introducer is placed in the trachea.

40. The method according to claim 35, A method further comprising the steps of moving the introduction device distally to a position within the trachea, and providing visualization of the tracheal carina.

41. In the method according to claim 35, The integrated system is capable of continuously receiving the first video signal to facilitate visualization of the automated movement of the introducer toward and through the larynx, as well as the movement of the endotracheal tube toward and through the larynx.

42. An intubation system, wherein the intubation system is The system comprises a one-piece, handheld dual-video endotracheal intubation assembly ("Assembly") sized and configured to be held in one hand by the user, the Assembly comprising: Housing and; A first elongated imaging member comprising an elongated body and a first video camera positioned in the distal region of the elongated body; A disposable second elongated imaging member comprising: a flexible elongated endotracheal tube introducer ("introducer"), sized and configured to be releasably connected to the housing to create an operational communication with the housing, the introducer being positioned within an endotracheal tube and sized to allow the endotracheal tube to move axially over it; and a second video camera positioned in the distal region of the introducer; A cover sized and configured to be releasably connected to the housing, the cover comprising the following: An elongated channel defining an elongated lumen, wherein the elongated channel is sized and dimensionally set such that at least a portion of the elongated body of the first imaging member is positioned within the elongated lumen, and An endotracheal tube channel comprising a cover including an endotracheal tube channel, which includes an endotracheal tube having a lumen sized to receive the inlet therein, and which is releasably fixed to the endotracheal tube channel and is sized and dimensioned to restrict the movement of the endotracheal tube in at least one direction relative to the cover with respect to the endotracheal tube channel; The system comprises an actuator disposed within the housing and configured to communicate operably with the introducer when the disposable second elongated imaging member is releasably connected to the housing, the actuator being activated to facilitate the control movement of the introducer and the second video camera relative to the first video camera, The system is such that the elongated channel of the cover and the endotracheal tube channel are arranged and positioned so that the second video camera can be positioned within 3 cm axially from the first video camera when the cover is connected to the housing and the endotracheal tube is fixed to the endotracheal tube channel.

43. In the system according to claim 42, The system is such that the elongated channel of the cover and the endotracheal tube channel are positioned and arranged so that when the second video camera is within 3 cm in the axial direction of the first video camera, the second video camera is no more than 4 cm further away from the first video camera in the horizontal direction.

44. In the system described in claim 43, The system is such that the elongated channel of the cover and the endotracheal tube channel are positioned and arranged so that when the second video camera is within 3 cm of the axial position of the first video camera, the second video camera is no more than 3 cm further away from the first video camera in the horizontal direction.

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