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

Abstract

Airway management methods, devices, assemblies, and systems. The methods, devices, assemblies, and systems include robotic movement and control of an intubation tube introducer or guide and may include utilizing image data from one or more image sensors. The methods, devices, assemblies, and systems may optionally be used in endotracheal intubation procedures.

Description

Related Applications

[0001]

[0001] (Incorporated 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, which provisional applications are incorporated herein by reference in their entirety for all purposes.

[0002]

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent 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 technology]

[0004] Airway management includes a variety of procedures aimed at handling, supervising, caring for, administering treatment to, manipulating, controlling, establishing, and securing a patient's upper and / or lower airway, which may occur in a variety of healthcare settings and locations and with different patient populations. Airway management procedures may involve navigating a medical device within a patient, and optionally visualizing the navigation. Some airway management procedures may involve establishing an artificial airway within the patient's body. For example, tracheal intubation ("TI") is an airway management procedure that involves placing an intubation tube (in this example, 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 material such as gastric contents, blood, secretions, and / or surgical debris. TI may be performed, for example, in the operating room (OR) while the patient is anesthetized for elective or emergency surgery, or in a wide variety of emergency and / or critical airway situations outside the OR, such as in the intensive care unit (ICU), emergency department, out-of-OR procedures and code events, and in out-of-hospital settings (e.g., paramedics, EMS (emergency medical services), and other forms of patient transport). TI is a critical technique for the management of high-risk or difficult cases and is a common lifesaving technique when other forms of airway management have failed. Unsuccessful or complete failure of TI on the first attempt typically results in significant 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 procedures, such as surgical airway management (eFONA) to establish an airway. Additionally, even in non-emergency or non-urgent airway management procedures, failure to establish, secure, or control the airway or to safely navigate to the desired airway location on the first TI attempt can complicate the procedure and potentially harm the patient.

[0005]

[0004] TI difficulties or failures typically arise when the surgeon experiences difficulty visualizing the anatomy of the patient's airway, difficulty navigating the ETT to the larynx (e.g., glottic opening and vocal cords), and difficulty manually placing the ETT past the vocal cords and into the patient's trachea. Each of these critical TI steps (visualization, navigation, placement) can individually or in combination lead to TI difficulties / failures.

[0006]

[0005] The most commonly used conventional techniques for TI include direct laryngoscopy, video laryngoscopy, and the use of flexible intubation scopes, but their performance is suboptimal. 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 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 with the patient's tongue control, making visualization, navigation, and passage of the ETT both to and through the vocal cords difficult. Direct laryngoscopy also does not provide visual confirmation of proper ETT placement in the trachea, meaning that ETT misplacement (e.g., esophageal intubation) may go unrecognized and potentially result in life-threatening hypoxia.

[0007]

[0006] Videolaryngoscopy utilizes a fixed video camera placed inside the patient's upper airway (above the vocal cords) to provide magnified visualization of the anatomy. However, it does not address all of the challenges to successfully performing TI, as ETT navigation and placement remain difficult. Navigation of the ETT to and through the glottic opening is impaired by indirect visualization of the patient's upper airway anatomy on the video monitor and maneuvering the ETT at an acute angle relative to the vocal cords. Placing a metal stylet inside the ETT to facilitate ETT navigation and placement is often necessary, resulting in stylet-induced airway trauma in at least 1.1% of cases. Although visualization of the ETT passing the vocal cords is greatly enhanced with videolaryngoscopy, ETT misplacement (e.g., esophageal intubation) and resulting life-threatening hypoxia can still occur. Additionally, video laryngoscopy does not address ETT navigation and placement troubleshooting below the vocal cords (lower airway), where ETT advancement occurs blindly. Also, video laryngoscopy does not provide immediate confirmation of ETT placement within the trachea. Additionally, video laryngoscopy still does not enable the user to properly position the ETT within the patient's trachea, avoiding both too deep and too high ETT placement.

[0008]

[0007] Flexible intubation scopes (FISs), which utilize a steerable video endoscopic camera, may be useful in patients with severely compromised airways, but remain disadvantaged by a limited field of view and the need for complex maneuvers that require advanced training and expertise. Visualization of airway anatomy is greatly diminished, providing only a close-up view and losing orientation landmarks. Furthermore, such visualization is easily obscured or lost due to the presence of even small amounts of blood and / or secretions. When using FISs, the surgeon must be highly adept at maneuvering the device around soft airway tissue obstructions, especially when TI must be performed rapidly in unconscious patients. Another significant limitation of FISs includes the inability to observe and troubleshoot the advancement of the ETT into the patient's trachea from above the vocal cords.

[0009]

[0008] Airway management medical procedures (e.g., TI) utilizing existing techniques and devices result in suboptimal success rates and outcomes, including first-pass success rates. For example, first-pass TI failure rates in difficult airway situations can range between 8% and 54% with conventional techniques, depending on the device used, the location of 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 categories, 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 increased incidence of major complications, including major airway trauma, airway swelling, oxygen deprivation (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 Summary of the Invention [Problem to be solved by the invention]

[0011] There is a need for airway management methods, systems, and devices that can more reliably and consistently provide better outcomes, such as providing higher first-pass success rates and / or more reliably navigating medical devices. For example, there is a need for new and improved devices and methods for assisting intubation and improving TI success rates.

[0012] Additionally, it would be beneficial to provide a multi-functional airway management platform that can be used in a variety of airway management procedures, clinical situations, locations and environments, and with a variety of 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, it is understood that the disclosure is not so limited, and the concepts herein may be applied or may be applicable to other airway management procedures and settings. For example, the concepts herein may be used in bronchoscopy procedures or in otolaryngology procedures such as endoscopy (e.g., flexible nasal laryngoscopy, esophagoscopy, etc.) and endoscopy-assisted surgical airway procedures (e.g., vocal cord injection, laryngeal surgery, etc.).

[0014] One aspect of the disclosure herein relates to systems, devices, and methods for robotically assisting tracheal intubation of a patient. In some cases, the robotic assistance includes one or more of automatic and / or manual robotic control(s) and / or robotic movement(s) 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 (movement) of the introducer, such as a visualization guide. The introducer may also serve as a visualization delivery guide for an intubation tube, such as an ETT. In some embodiments, the introducer includes or may be an endoscope.

[0015]

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

[0016] In some variations, a method for performing a robotic-assisted intubation procedure on a patient includes acquiring one or more images using at least one of a laryngoscope coupled to a handheld housing and an endoscope coupled to the handheld housing. The endoscope may extend from an actuation member movable within the handheld housing, and the endoscope may be removably coupled to an intubation tube. The method may further include automatically guiding (e.g., advancing, retracting, and / or rotating) the endoscope and intubation tube via the actuation member based on the one or more acquired images. In some variations, the method may further include decoupling the intubation tube from the endoscope (e.g., manually or automatically advancing the intubation tube away from the endoscope).

[0017] In some variations, an integrated robotic device may include a handheld housing (which may include, for example, a display or other monitor screen); a laryngoscope coupled to the housing and including a first image sensor; an actuation member movable within the housing and connectable to an endoscope including a second image sensor; and at least one actuator. The actuator(s) may be configured to automatically move the actuation member based at least in part on one or more images from at least one of the first image sensor and the second image sensor. The endoscope may be configured, for example, to removably connect to 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); an actuating member movable within the housing and connectable to an endoscope equipped with an image sensor; and at least one actuator within the housing configured to automatically move the actuating member based at least in part on one or more images from the image sensor.

[0019]

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

[0020]

[0018] 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 the steps of acquiring 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 movable within the handheld housing, the introducer being removably coupled to an intubation tube; and automatically guiding the introducer via the actuating member based on the one or more acquired images.

[0021]

[0019] One aspect of the disclosure is a robotically 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 secured to a second imaging member, the second imaging member coupler enabling one-handed movement of the first and second imaging members using one of the surgeon's hands when the second imaging member coupler is releasably secured to the second imaging member.

[0022]

[0020] One aspect of the disclosure is a robotically assisted handheld airway management device (e.g., an intubation 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 releasably secured indirectly or directly to an introducer (e.g., a flexible endoscope), wherein coupling the introducer to the introducer coupler facilitates controlled robotically assisted movement of the introducer relative to the handheld housing.

[0023]

[0021] One aspect of the disclosure is a method for assembling a handheld airway management (e.g., for intubation) system capable of providing one or more images and adapted for robotically assisted control of an introducer during an airway management (e.g., intubation) procedure, the method comprising the steps of: providing a handheld housing configured to be held by one hand of a user, the housing including a direct or indirect introducer coupler and either a first imaging member or a first imaging member coupler; coupling a blade to the handheld housing so that the first imaging member is positioned in a channel lumen of the blade; releasably securing an endotracheal tube to the endotracheal tube coupler of the blade; positioning an introducer within the tracheal tube; and creating an operable 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 arranged on a side 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 connected to the tracheal tube channel.

[0025]

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

[0026]

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

[0027] One aspect of the disclosure is a handheld robotic-assisted handheld airway management assembly configured such that when an imaging member (e.g., a second imaging member) is releasably secured to the housing, the assembly is adapted to enable distal movement of an imaging member introducer at least 10 cm, and optionally between 10 cm and 60 cm.

[0028] Any of the second imaging members herein optionally does not include an image sensor. One aspect of the disclosure is any of the second imaging members herein 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 couple to any of the housings herein to create 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 including the steps of receiving input regarding a patient condition related to one or more of the intubation procedure, a patient condition related to the nasal cavity, and / or a patient condition related to the oral cavity, and / or a condition related to upper and / or lower airway structures; accessing historical image data related to one or more of the intubation procedure, a patient condition related to the nasal cavity, or a patient condition related to the oral cavity, and / or a condition related to upper and / or lower airway structures; and using the accessed historical image data to perform one or more of the following: recognizing at least a portion of the patient's anatomical structure or controlling delivery of an imaging device through the patient's nasal cavity or oral cavity and / or upper and / or lower airway structures.

[0030] One aspect of this disclosure is an integrated handheld assembly. The assembly includes a separable introducer assembly and a housing, where the introducer assembly includes an introducer housing. One end of the introducer may be fixed to a region of the introducer housing, and the region of the introducer may be movable through and relative to the introducer housing (e.g., one embodiment of which is shown in FIG. 19F).

[0031]

[0029] One aspect of the disclosure is a handheld airway management (e.g., intubation) system, the system comprising: a handheld housing (e.g., 1410, 1710); and an introducer assembly (e.g., 1499, 1740), the handheld housing and the introducer assembly each sized and configured so that the introducer assembly can be releasably secured to the handheld housing, thereby creating operable communication between the handheld housing and the introducer assembly.

[0032]

[0030] Any of the devices, systems, assemblies, or handheld or introducers herein, wherein the introducer includes a working channel, which may optionally extend to the distal end of the introducer.

[0033]

[0031] In any of the devices, systems, assemblies, or methods herein, the image processor is located in an external device (e.g., an external computer with a graphics processing unit, a smartphone, etc.) that is in communication (wired or wireless) with any of the housings herein, and optionally, information related to the acquired image data is communicated from the housing to the external device for processing.

[0034] One aspect of the present disclosure is an intubation system comprising an integrated handheld dual video tracheal intubation assembly ("assembly") sized and configured to be held in one hand of a user, the assembly including: an elongated housing (e.g., 1710) with an elongated endotracheal tube channel (1713); a first elongated imaging member (e.g., 1730) including a first image sensor; a flexible elongated endotracheal tube introducer ("introducer") sized to be positioned within the endotracheal tube and to allow the endotracheal tube to be moved axially over the elongated endotracheal tube introducer; and a distal end of the introducer. a second elongate imaging member (e.g., 1740) including a second image sensor disposed in the distal region; and a cover sized and configured to be releasably coupled to the housing, the cover including an elongate channel defining an elongate lumen, the elongate channel sized and dimensioned for at least a portion of the first imaging member to be disposed within the elongate lumen, and an endotracheal tube channel, wherein the endotracheal tube channel (e.g., 1713) of the housing and the endotracheal tube channel of the cover are positioned and configured to form a continuous elongate endotracheal tube channel when the cover is releasably coupled to the housing.

[0035] One aspect of the disclosure is a disposable cartridge for use with a robotically controlled medical system. The cartridge may include a flexible, elongate introducer (e.g., 1770); a cartridge housing (e.g., 1744), a first end of the introducer secured to the cartridge housing, the cartridge housing including: a plurality of introducer deflection actuators (e.g., 1741, 1743); a plurality of pull wires, at least one pull wire secured to each one of the plurality of introducer deflection actuators; and a plurality of introducer axial motion actuators, the introducer extending between a first introducer axial motion actuator and a second introducer axial motion actuator and axially movable relative to the plurality of introducer axial motion actuators in response to movement of the plurality of introducer axial motion actuators.

[0036] One aspect of the disclosure relates to a system adapted to display a first image and a second image on a display viewable by a surgeon, the first image and the second image being acquired using any of the first and second image sensors herein. Any of the displays herein may be part of any of the assemblies herein, or they may be separate components that are not considered part of the assembled assembly but are still viewable by the surgeon during the procedure.

[0037] One aspect of the disclosure is a dual-video integrated intubation assembly including a housing and a second imaging member sized and configured to be releasably secured to the housing, the housing and the second imaging member having flat or substantially flat surfaces or portions adapted with a communication element or communication elements adapted to communicate with each other when they are interfaced (e.g., examples of which are shown in illustrative FIGS. 14A, 14B, and 17A-19K, where the flat or substantially flat interfacing surfaces or portions are readily visible in the side views of FIGS. 17A, 17F, 18A, 19C-19E, 19J, and 19K). The communication elements of the two surfaces or portions may be positioned within or on the surfaces or portions such that they communicate with corresponding communication 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 input indicative of image data from at least one of a first image sensor or a second image sensor, and in response initiate or cause robotically controlled movement of an introducer, thereby moving the introducer toward or towards at least one identified anatomical landmark, optionally automatically identified by the computer-executable method. [Brief explanation of the drawings]

[0039] [Figure 1] 1 illustrates a schematic diagram of certain example variations of a device for assisting in navigation and / or intubation in a patient. [Figure 2A] 1 depicts certain example variations of devices for assisting in navigation and / or intubation in a patient. [Figure 2B] 2B depicts a front view of an example variation of the device shown in FIG. 2A, including the cover. [Figure 2C]3 illustrates a rear view of an example variation of the device shown in FIG. 2. [Figure 3A] 1 illustrates a cross-sectional view of one example variation of a manual actuation system for guiding an actuation member in a device for assisting in navigation and / or intubation in a patient. [Figure 3B] 1 illustrates a perspective view of an example variation of an automated actuation system for guiding an actuation member in a device for assisting in navigation and / or intubation in a patient. [Figure 3C] 10 illustrates certain example variations of an actuation unit for guiding an actuation member in a device for assisting navigation and / or intubation in a patient. [Figure 3D] 10 illustrates certain example variations of an actuation unit for guiding an actuation member in a device for assisting navigation and / or intubation in a patient. [Figure 4A] 10 depicts certain example variations of a cover on a device for assisting in navigation and / or intubation in a patient. [Figure 4B] 10 depicts certain example variations of a cover on a device for assisting in navigation and / or intubation in a patient. [Figure 5] 10 illustrates certain example variations of an automated actuation system for articulating the distal end of a scope member in a device for assisting in navigation and / or intubation in a patient. [Figure 6] 10 illustrates certain example variations of an automated actuation system for articulating the distal end of a scope member in a device for assisting in navigation and / or intubation in a patient. [Figure 7] 1 is a flowchart of one example variation of a method for tracheal intubation of a patient. [Figure 8A] 1 shows an example sequence illustrating automatic image / landmark recognition. [Figure 8B] 1 shows an example sequence illustrating manual image / landmark recognition. [Figure 9A]1 illustrates an exemplary sequence of image recognition and subsequent automated robotic control of an introducer. [Figure 9B] 1 illustrates an exemplary sequence of image recognition and subsequent manual robotic control of an introducer. [Figure 10] Illustrative steps are shown that include automatic robotic control followed at some point by manual robotic control. [Figure 11] 1 illustrates a portion of an exemplary integrated handheld intubation assembly. [Figure 12] 1 illustrates a portion of an exemplary integrated handheld intubation assembly. [Figure 13] 1 illustrates a portion of an exemplary integrated handheld intubation assembly. [Figure 14A] 1 illustrates an exemplary integrated handheld dual video tracheal intubation assembly. [Figure 14B] 1 illustrates an exemplary housing and first imaging member. [Figure 14C] 1 illustrates an exemplary second imaging member. [Figure 14D] 1 illustrates a portion of an exemplary second imaging member. [Figure 15] 1 illustrates an exemplary integrated handheld dual video tracheal intubation assembly positioned in the upper airway. [Figure 16A] 1 shows an example view of image data from a first image sensor when maintained in the upper airway on an example display. [Figure 16B] 1 illustrates an example view of image data from a first image sensor and a second image sensor displayed on an example display. [Figure 16C] 1 illustrates an example view of image data from a first image sensor and a second image sensor displayed on an example display with the first image sensor maintained in the upper airway. [Figure 16D]1 illustrates an example view of image data from a first image sensor and a second image sensor displayed on an example display with the first image sensor maintained in the upper airway. [Figure 17A] 1 illustrates an unassembled side view of an exemplary integrated handheld dual video tracheal intubation assembly (first imaging member not shown). FIG. [Figure 17B] 1 illustrates a top view of an exemplary integrated handheld dual video tracheal intubation assembly (first imaging member not shown) prior to assembly. [Figure 17C] FIG. 1 illustrates an assembled bottom view of an exemplary integrated handheld dual video tracheal intubation assembly. [Figure 17D] FIG. 1 illustrates an assembled side view of an exemplary integrated handheld dual video tracheal intubation assembly. [Figure 17E] FIG. 1 illustrates a top view of an assembled example integrated handheld dual video tracheal intubation assembly. [Figure 17F] FIG. 1 illustrates a side view of an exemplary integrated handheld dual video tracheal intubation assembly before assembly. [Figure 17G] FIG. 1 illustrates a top view of an exemplary integrated handheld dual video tracheal intubation assembly prior to assembly. [Figure 18A] 1 illustrates a side view of an example housing. [Figure 18B] 18B shows an exemplary cross-sectional side view of the housing from FIG. 18A. [Figure 18C] 18B shows a top view of the example housing from FIG. 18A. [Figure 18D] 19 illustrates a front end view of the example housing from FIG. 18. [Figure 18E] 19 illustrates a perspective top view of the example housing from FIG. 18. [Figure 18F] 19 illustrates a perspective top view of the example housing from FIG. 18. [Figure 18G]1 shows an exemplary housing and optional internal components. [Figure 18H] 1 shows an exemplary housing and optional internal components. [Figure 18I] 1 shows an exemplary housing and optional internal components. [Figure 18J] 1 shows an exemplary housing and optional internal components. [Figure 19A] 10 illustrates a bottom view of an exemplary second imaging member including an optional image sensor in a distal end region. [Figure 19B] 1 illustrates a top view of an exemplary second imaging member. [Figure 19C] 1 illustrates a side view of an exemplary second imaging member. [Figure 19D] FIG. 10 shows a rear end view of a second imaging member coupled to an intubation tube. [Figure 19E] FIG. 10 shows a front end view of a second imaging member coupled to an intubation tube. [Figure 19F] 1 illustrates a top view of an example second imaging member with the top surface removed to reveal the internal components. [Figure 19G] 10 illustrates a bottom perspective view of an exemplary housing of a second imaging member. [Figure 19H] 10 illustrates a bottom view of an exemplary housing of a second imaging member. [Figure 19I] 1 illustrates a top perspective view of an exemplary housing of a second imaging member. [Figure 19J] 10 illustrates a front end view of an exemplary housing of a second imaging member. [Figure 19K] 10 illustrates a rear end view of an exemplary housing of a second imaging member. [Figure 20] 1 illustrates a schematic diagram of an exemplary integrated handheld dual video assembly. [Figure 21]10 illustrates one exemplary method of using any of the integrated handheld assemblies herein. DETAILED DESCRIPTION OF THE INVENTION

[0040]

[0089] Examples of various aspects 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 one of ordinary skill in the art to make and use the invention.

[0041]

[0090] The disclosure herein relates to methods, devices, and systems for airway management. While tracheal intubation is provided herein as an example of airway management, it is understood that the disclosure is not so limited, and the concepts herein may be applied or applicable to other airway management procedures, locations, and settings. For example, the concepts herein may be used in bronchoscopy procedures or endoscopic otolaryngology procedures, such as flexible nasal laryngoscopy, esophagoscopy, vocal cord injection, certain laryngeal surgical procedures, and other endoscopic procedures involving the upper gastrointestinal (GI) tract (e.g., gastroscopy, esophagoscopy).

[0042]

[0091] Airway management procedures herein may include any of the following exemplary, non-limiting procedures in both adult and pediatric patients: 1) endoscopic evaluation of the airway to determine or establish the following in a patient: (a) the presentation of and the relationships between different portions of the upper airway anatomy; (b) the size and location of the lesion(s) and / or lesion site(s) and the extent of the pathological process(es); (c) the feasibility of placement of a supraglottic airway device (SGA, e.g., laryngeal mask airway) and the likelihood of successful SGA ventilation; (d) whether awake intubation and / or TI is feasible; and (e) optimal TI to the larynx. 1) endoscopic evaluation of the airway to determine or establish a navigation pathway, (f) optimal TI device use and optimal TI strategy; 2) facilitating ETT exchange; 3) assessing ETT positioning and / or patency and / or confirming correct placement of the ETT within the trachea; 4) facilitating placement of a double lumen tube and confirming proper positioning; 5) facilitating extubation attempts; 6) performing bronchoscopy; 7) performing nasal and / or oral TI; 8) performing ENT procedures such as endoscopy, esophagoscopy, biopsy, injection, and certain laryngeal surgical procedures; and 9) performing other therapeutic, interventional, and / or diagnostic procedures related to the airway.

[0043]

[0092] As used herein, airway management procedures may be used in the following non-limiting locations and environments: OR, ICU, ED, or any of the locations outside the OR (e.g., endoscopy labs, imaging scanners, various outpatient and hospital settings, procedure rooms, etc.), and in field (e.g., EMS) and battlefield airway management, both in the field and during patient transport.

[0044]

[0093] As used herein, airway management can include or be used for visualization procedures, diagnostic procedures, interventional procedures, surgical procedures, and / or therapeutic-diagnostic procedures.

[0045]

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

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

[0096] Some non-limiting aspects of the present disclosure are directed to 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 successful TI: visualization, navigation / movement, and placement. An integrated, dual-video system configured, adapted, and sized to be held in one of a user's hands provides the user with the benefit of being able to hold and optionally control the dual-video, integrated, enhanced visualization and navigation system in one hand, allowing a single operator to reliably facilitate navigation and movement of an ETT introducer guide into a patient's trachea. The integrated dual video system herein provides enhanced visualization of the patient's airway anatomy, which facilitates enhanced navigation of the ETT within and around the patient's anatomy, as well as improved ETT placement (insertion) both through the glottic opening and into the patient's trachea during the TI procedure, all of which help reduce TI trauma and increase the likelihood of first-pass TI success.

[0047]

[0097] The disclosure herein may refer to navigation when describing the movement of an introducer. It is understood that in some cases navigation may also refer to the automated determination of how or where the introducer will be robotically moved. In embodiments where the surgeon determines how or where to move the introducer, navigation may also be accomplished manually, for example, based on viewing an image on a display.

[0048]

[0098] Described herein are variations of devices, systems, and methods for robotically assisting the navigation and movement of an introducer within an airway or other passageway in a patient, for example, during an intubation procedure (e.g., orotracheal intubation, nasotracheal intubation, etc.). In some embodiments herein, the robotically assisted movement herein may include using artificial intelligence (AI) to enable robotically assisted navigation. As shown in the schematic diagram of FIG. 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) coupled to the housing and including a first image sensor, and an actuation member 140 at least partially disposed within the housing. The housing 110 may be, for example, an integrated handheld device for portability and / or configured to be easily operated by a single person. The actuation member is movable within the housing, and an introducer, such as an endoscope 150 (e.g., a video endoscope), may extend from the actuation member 140. The introducer may include a second image sensor and be configured to slidably couple to an intubation tube, such as an ETT, where the coupling may comprise slidingly disposing the ETT around the introducer. Once the introducer is robotically moved into the patient's passageway (e.g., trachea), the introducer can serve as a steering guide for intubation tube advancement during the intubation procedure. Intubation tube advancement may be accomplished, for example, by threading the intubation tube over the introducer, either manually or automatically. Once intubation tube placement (e.g., endotracheal) is confirmed via real-time images from one or more image sensors (e.g., introducer image sensors when the introducer is in the trachea), the intubation tube may be disconnected from the introducer (which may include sliding the introducer proximally away from the ETT) and the introducer and remainder of device 100 may be withdrawn from the patient's anatomy, leaving the intubation tube (e.g., ETT) in place.

[0049]

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

[0050]

[0100] While the devices, systems, assemblies, and methods are described herein primarily with respect to intubation procedures, it should be understood that the devices and methods can also be used to assist other medical airway management procedures involving navigation through one or more passageways, such as endoscopy procedures (e.g., bronchoscopy, etc.). For example, introducer navigation may be robotically assisted using devices and methods such as those described herein, except that the introducer is not coupled to an intubation tube but is automatically guided using AI / automation techniques. For example, the devices can robotically assist introducer navigation during any suitable medical endoscopic procedure to provide a faster and / or less traumatic endoscopic procedure compared to traditional manual techniques. As an illustrative example, the devices, systems, assemblies, and methods described herein may automatically guide an introducer (e.g., endoscope 150) based on one or more images obtained using the introducer or a first imaging member (e.g., a laryngoscope) instead of automatically guiding an intubation tube. In some variations, the introducer (eg, 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 herein may be used in other applications (e.g., non-medical applications) where automated navigation / motion may be useful, such as, for example, navigating through passageways that are otherwise difficult to access.

[0052]

[0102] The example system 100 of FIG. 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 comprise 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 format. Images may be displayed continuously, substantially continuously, or sequentially during a procedure. The system 100 may further include at least one actuator 116 within the housing configured to automatically guide / move an introducer (e.g., an endoscope) via an actuation member 140 based at least in part on one or more images from the first image sensor and / or the second image sensor. In some variations, the system further includes a cover or blade coupled to the housing, the cover including a first channel sized and configured to receive a first elongated imaging member (e.g., a video baton, etc.) and a second channel configured to securely receive at least a portion of an intubation tube (in which the introducer may be disposed). The cover may further include a tongue retraction member (e.g., an angled or curved member, etc.) configured to retract the patient's tongue during the intubation procedure, examples of which are shown in the figures herein.

[0053]

[0103] In some variations, the one or more actuators may be under operational control of one or more processors 112 configured to analyze image 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 electronics 114 (e.g., power source(s), 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 anatomy (above the vocal cords) and / or lower airway anatomy (below the vocal cords) may trigger, for example, robotic-assisted tracheal intubation using the system. As described in more detail below, visualization and navigation / movement to or toward the vocal cords may be based, for example, on identifying one or more key anatomical recognition points provided by the image sensor(s) of the first and / or second imaging members. The system may perform robotic-assisted navigation that is activated automatically in response to recognition of the airway anatomy and / or in response to manual activation (e.g., through user manipulation of user interface elements). For example, in a fully automated mode of the exemplary device or assembly 100, the actuators may be adapted to automatically steer the endoscope using AI and / or other robotic-assisted navigation and electromechanical control of the actuation members.

[0054]

[0104] Additionally or alternatively, the device or system can operate in an automated mode, illustratively with manual assistance. In such an automated-manually assisted mode, for example, the actuation member and / or introducer can be manually controlled through the use of a user interface device (e.g., a joystick) or through the device display 118. Articulation of the distal tip of the introducer when the device is in the automated-manually assisted mode can occur automatically, for example, under automated robotic control of one or more actuators in the system.

[0055]

[0105] When used for 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; improves first-pass intubation success rates; shortens overall intubation time; reduces intubation-related airway trauma; and / or improves patient safety. For example, the system herein may combine multiple imaging (e.g., video) modules into an ergonomic package operable by a single user, enabling the device to perform intubation using AI or robot-assisted introducer navigation. The robot-assisted intubation interface, for example, can maneuver at least a guide introducer through the glottis into the patient's trachea, which will serve as a guide for advancement and placement of the ETT. The ETT may, for example, be pre-loaded onto the introducer and advanced over the introducer after the introducer has been advanced into the trachea and proper placement within the trachea has been confirmed.

[0056]

[0106] Among other advantages as described herein, the systems herein are configured to provide continuous visual feedback and optional 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. Additionally, the combined use of a first and second imaging member can enable reliable and faster triggering of AI and associated robotic interfaces, due at least in part to the magnified, 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 due to the fact that visualization of the patient's anatomy is much less affected by blood and secretions compared to images provided by a second imaging member (e.g., an image sensor in the distal region of the introducer). Furthermore, the combined use of the first and second imaging members, the angular orientation of their respective video cameras, and the close axial proximity and maintenance of the video cameras relative to each other and to the glottic opening provide the shortest, fastest navigation path for the introducer and ETT to the vocal cords and trachea. Maneuvering of the introducer within the patient's airway is also significantly facilitated by the device cover or blade configured to effect tongue retraction, which creates a larger pharyngeal space for maneuvering and steering the introducer. One optional and significant benefit of some of the systems herein is that the system can be configured to allow the user to view the entire intubation procedure from both above the vocal cords (upper airway) and below the vocal cords (lower airway), to enable immediate visual confirmation of intubation tube placement within the trachea during intubation using an introducer imaging sensor, and to ensure optimal positioning of the intubation tube within the patient's airway, exemplary embodiments of which are described below.

[0057]

[0107] Furthermore, the integrated dual-video capabilities of the systems herein may significantly reduce intubation-related airway trauma and soft tissue damage often associated with conventional devices, even in situations where visualization of upper airway anatomical landmarks is limited (e.g., in the absence of complete glottic exposure). The system can automatically steer an introducer through the glottic opening and into the patient's trachea, even when the glottic opening cannot be visualized, for example, after identifying anatomical structures reliably associated with the glottic opening (e.g., the epiglottis, arytenoid cartilages, etc.) during initial video image capture using the first image sensor. The device may also reduce the risk of esophageal intubation and / or the risk of obstruction, defragmentation, bleeding, and / or airway contamination during intubation, such as when a tumor or other space-occupying lesion is present within the patient's airway.

[0058]

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

[0059]

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

[0060]

[0110] 2A-2C are schematic diagrams of an exemplary portable, handheld, integrated, dual-video robot assembly or system 200 that may be adapted for visualization, navigation, and placement during an intubation procedure. As shown in FIG. 2A, system 200 may include a handheld housing 210, an electronics system 214 (e.g., including one or more processors, one or more power sources, etc., embodiments of 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 with at least one image sensor 222 disposed at its distal region, as shown, and an actuation member 240 movable within housing 210. In addition, system 200 may include an introducer, such as an endoscope 250, with an image sensor 252 disposed at a distal region of the introducer, as shown. The introducer 250 may be configured to couple to an intubation tube (e.g., an ETT for use during a TI procedure). In this context, "coupled" includes that the ETT is axially movable around or over the introducer. As shown in FIGS. 2B, 4A, and 4B, the system 200 may further include a cover 260 including a channel sized and configured to receive therein a first imaging member (e.g., a laryngoscope baton 220) and at least a portion of the ETT and introducer (e.g., endoscope 250). As shown in FIGS. 4A and 4B, the cover 260 may further include a distal region including 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. Additional exemplary aspects of the system 200 for enhanced visualization and navigation during intubation are described in further detail below with reference to Figures 2A-2C, 3A-3D, 4A-4B, 5, and 6, although it should be understood that the described aspects may be applied to other variations of systems and devices having other sizes, shapes, etc.

[0061] Handheld Housing

[0112] The exemplary 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., processor(s), memory, power source(s), motor(s), etc.) and / or actuator(s) for guiding an introducer, such as during an intubation procedure. The housings herein 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 with one hand or by a single user. Both the handheld housings herein (e.g., housing 210) and the integrated dual-video assemblies herein (which may include handheld housings) can advantageously be sized and configured to be held by one hand of a single operator and provide the benefits described herein.

[0062]

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

[0063]

[0114] In some embodiments, the handheld housing may be between about 10 cm and 75 cm in length, such as between about 15 cm and about 45 cm in length, but may be any suitable size that allows the device to be held in one hand of a surgeon and is ergonomically compatible. In some embodiments, the housing is between 2 cm and 15 cm in width, such as between 4 cm and 10 cm in width. In some embodiments, the housing is between 5 cm and 20 cm in width, such as between 5 cm and 15 cm, measured from top to bottom.

[0064]

[0115] Housings herein (e.g., housing 210) may be made of any suitable rigid or semi-rigid material. For example, the housing may include plastic formed via a suitable injection molding process. In some variations, the housing may include one or more separate components (e.g., shells) coupled together via one or more suitable fasteners (e.g., epoxy or other adhesive, mechanical fasteners) and / or mating features (e.g., threads or snap fits or complementary features on different housing components). The housing may enclose within its interior volume various electronics, actuator(s), and / or other aspects of the device, examples of which are described herein.

[0065] Electronic Equipment Systems

[0117] The systems or assemblies herein may include an electronics system (e.g., electronics system 214), which may include at least one processor and / or at least one memory device. At least a portion of electronics system 214 may be located, for example, within the housing and / or within a display coupled to the housing, as described in more detail below. The memory device may store instructions (e.g., in the form of software, computer-executable methods) for one or more processors to analyze images from the first imaging sensor and / or the second imaging sensor and / or perform AI-based analysis (using smart image recognition techniques and / or machine learning) of such images to automatically navigate the introducer into the trachea during intubation. The processor(s) may also be configured to perform automated control of actuators within the device to guide the actuation member and / or at least a portion of the introducer as an intubation aid. Automated navigation can perform intubation in a user-friendly manner, requiring little user training or experience to enable successful intubation. Additional details of such AI or machine learning algorithms are described further below.

[0066]

[0118] The electronics system, conceptually designated as exemplary electronics system 214, 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 (e.g., to help facilitate device portability). Additionally or alternatively, the housing and / or display may include a power supply connector or port 211 that may allow for a wired power connection, such as to an external AC or DC power supply. Additionally or alternatively, the housing may include a wired connection (e.g., cable) and / or a wireless communication module for communicating with a freestanding video monitor. Furthermore, in some variations, the housing may include an emergency stop control (e.g., button) for interrupting the automated robotic assistance of the device upon operator intent (e.g., by suddenly cutting off current to the actuator(s)). In some variations, the housing may further include a power button to control powering the system on and off, and / or a port(s) for downloading images and updating software program(s).

[0067] Actuating unit(s), actuator, actuating member

[0120] The housing herein (e.g., housing 210) may include one or more actuators 216 configured to automatically guide the movement of actuation member 240 for AI or robotic-assisted intubation while the introducer is coupled (e.g., releasably coupled) to an intubation tube. In the embodiment of FIG. 2A , advancement of actuation member 240 further extends the effective operating length or working length of endoscope 250. As described in more detail below, actuator(s) 216 may be integrated within the housing and apply their actuation to actuation member 240 through a coupled interface, with the resulting motion being transmitted along the longitudinal axis of the actuation member and along the longitudinal axis of endoscope 250 extending from the actuation member. One or more actuators 216 may additionally be included to operate and / or articulate the distal end of endoscope 250, as described further below.

[0068]

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

[0069]

[0122] The example actuator(s) 216 may be activated automatically and / or manually. For example, in some embodiments, the actuator(s) 216 may be activated through one or more processors executing image recognition software instructions, such as in response to the processor recognizing one or more anatomical landmarks through such image recognition techniques. This automatic activation may be part of a fully automated mode of the device, for example. Additionally or alternatively, the actuator(s) 216 may be selectively engaged and / or disengaged in response to user selection of one or more user interface elements. For example, the actuator(s) 216 may be activated by selection of an AI action button 280, as shown in FIG. 2C, or deactivated by selection of a STOP button 284, as shown in FIG. 2C. It should be understood that the system may additionally or alternatively include other user interface elements for activating / deactivating the device's fully automated mode, such as a toggle switch, a touch-sensitive pad, a touch screen, a user interface icon on a display screen, etc. In some variations, manual actuation of the actuation member 240 (e.g., using a joystick or other user interface element, as described below) may immediately override the fully automated mode. In these variations, the fully automated mode would then be allowed to resume after the user presses, for example, the AI ​​action button 280. Additionally or alternatively, the fully automated mode may resume after a predetermined period of time while in the manual assist mode (e.g., a period of inactivity or non-movement of the actuation member 240, a predetermined duration, etc.). In yet other variations, 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 release of the clutch button resumes the fully automated mode.

[0070] display

[0124] As shown in exemplary FIGS. 2A-2C , any of the systems or assemblies herein (e.g., system 200) may optionally further include a display, such as display 218, e.g., a monitor screen, a touch screen, or the like. The display may be configured to display image data and / or a user interface. For example, the display may be configured to display single-channel images from only the first image sensor (e.g., laryngoscope image sensor 222) or only the second image sensor (e.g., introducer image sensor 252). As another example, a display herein may be configured to display multi-channel images from both the first and second image sensors (e.g., 222 and 252), and may display images from the laryngoscope image sensor and / or the endoscope image sensor in a split-screen and / or picture-in-picture arrangement, by way of example only. In some variations, the display may be configured with a default or preprogrammed display sequence. As one example of a default display sequence, the display may be configured to initially display a video feed or signal from the video laryngoscope to provide visual feedback of initial entry into the patient's airway (e.g., upper airway) and / or identified anatomical structure(s), and then automatically transition to display a multi-channel set (e.g., split screen, picture-in-picture) of images from the endoscopic image sensor (e.g., 252) and / or laryngoscope image sensor (e.g., 222) upon activation of AI-based operation (either automatically as described above or via manual activation) and / or upon pressing of a selectable user interface element on the device and / or display. In some variations, other toggling of the video feeds from the various image sensors may be achieved through specific pre-programmed operation of user interface elements (e.g., pressing a picture-in-picture button or icon two or more times in succession to obtain a complete image of the patient's trachea and intubation tube placement (or other anatomical structure) as provided by the endoscopic image sensor 252).

[0071]

[0125] In some embodiments, a display herein may be coupled to housing 210 or other housing herein (e.g., on a proximal portion of the housing). The display may include any suitable display element (e.g., an LCD). In some variations, the display may be coupled to the housing via a rotating or pivoting coupling, such that the display can swivel about a longitudinal axis and / or tilt about a vertical and / or horizontal axis, making it viewable from multiple angles. Alternatively, the systems herein may include a multi-sided (e.g., dual-sided) display that allows displayed content to be simultaneously viewable from multiple angles. In any of the embodiments herein, a display coupled to a handheld housing may be portable, such as about 8 cm to 15 cm in height and about 10 cm to 18 cm in width, although the display may be any suitable size and / or shape.

[0072]

[0126] Additionally or alternatively, any of the systems herein may include and be communicatively coupled to a remote display that is not part of the integrated assembly. 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. As another example, 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, WiFi, etc.).

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

[0128] Any of the integrated dual-video systems or assemblies 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) disposed in a distal region of the elongated body. Any of the first imaging members herein may also be referred to as a first elongated imaging member, implying that they generally have an elongated configuration. For example, as shown in illustrative FIGS. 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 housing 210, as shown. Baton 220 may include high-resolution image sensor(s) (e.g., video camera) located in the distal region to provide video images, one or more light guides to provide illumination to the image sensor's field of view, and electronic signal wires to transmit video data or images for processing and / or display on display 218 (or other suitable display). Image sensor(s) 222 may be located at the distal end of the elongate member and may be adapted to provide a relatively wide angle of view to provide enhanced visualization of the patient's anatomy in both the axial and horizontal planes during the intubation procedure. The relatively wide angle of view and angular position (relative to the second image sensor) of the first imaging sensor can aid in reliably visualizing and identifying critical anatomical landmarks within the upper airway, thereby enhancing navigation as the introducer is moved distally relative to the first image sensor. As described in more detail below, the combined use of the first and second imaging members, the optional wide angle of view, and the placement and maintenance of the first and second imaging member cameras in close axial proximity to each other and to the glottic opening provide the shortest and fastest navigation path for the introducer and ETT to the vocal cords and trachea. In some non-limiting, merely optional, embodiments, the first imaging sensor(s) of the first imaging member may have a wider angle of view than the second imaging sensor of the introducer.The first imaging member can then provide a larger, clearer image of the patient's anatomy compared to conventional devices, facilitating faster and more reliable AI image recognition and / or initiation of robotic-assisted control and movement of the introducer using the system. Any of the image sensor(s) herein may optionally include a charge-coupled device (CCD), a CMOS sensor, and / or other suitable sensor(s) 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 angle of view, while the first image sensor can still provide visualization of a larger area of ​​the anatomy compared to the second image sensor, for example, by maintaining the first image sensor proximal or rearward of the second image sensor as the introducer is advanced distally toward the glottic opening. Additionally, in some embodiments, although the first video camera has a narrower angle of view than the second video camera, the first image sensor can still provide visualization of a larger area of ​​the anatomy compared to the second image sensor, for example, by maintaining the first image sensor proximal or behind the second image sensor as the introducer is advanced distally toward the glottic opening. Exemplary methods of use, including utilizing first and second simultaneously provided video signals from the first and second video cameras, are included in more detail below.

[0074]

[0129] In any of the systems herein, the first imaging member includes a laryngoscope, which may include a baton or other elongated member between about 10 cm and about 15 cm in length, but may be any size suitable for adult and / or pediatric patient populations. As described below, the systems herein may optionally include a universal handheld housing adapted for interchangeable use with different sized first imaging members for different patient populations (e.g., adults and children) to provide greater functionality. As shown in exemplary FIG. 2A , the exemplary laryngoscope baton 220 may generally taper in diameter as it extends away from the housing 210 and / or may be gently curved or flared to accommodate the imaging components and / or provide better angulation during an intubation procedure. However, the first imaging member 220 may have any appropriate shape and size for use with a patient's anatomy. In some embodiments, the first imaging member 220 (which may include, for example, a laryngoscope baton) may be flexible and may have a curved configuration at rest, or in some embodiments, it may have a straight or substantially straight configuration adapted to bend within the cover. The first imaging member 220 may be detachably or releasably coupled to the housing 210, or may be integrally or permanently coupled to the housing 210 (e.g., intended for reuse). For example, the first imaging member 220 may be kept sterile between uses by use of a disposable cover 260 (as described further below), or may be sterilized between uses using an appropriate disinfectant, etc. Alternatively, in some variations, the first imaging member 220 may be modular or detachable from the housing 210 (e.g., via a snap-fit ​​connection, etc.) and disposable, and / or may be swapped and replaced with a different first imaging member 220 for different uses of the system 200. For example, the first imaging member 220 may be swapped and replaced with a different first imaging member 220 to avoid the need to sterilize the baton after each use.As another example, first imaging member 220 may be removed separately after each use to facilitate sterilization. As another example, different first imaging members 220 may have different lengths, diameters, and / or shapes for different types of patients (e.g., adult patients, pediatric patients), such that first imaging member 220 can be replaced with a different first imaging member 220 of a different desired size depending on the patient and / or situation. Also, as described in more detail below, a cover (such as, for example, cover 260) may be appropriately sized for the dimensions of first imaging member 220 (e.g., having a channel defining a lumen of an appropriate diameter and / or length).

[0075] Actuating member and introducer (e.g., endoscope)

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

[0076]

[0132] Generally, the combination of the actuating member 240 and the endoscope 250 or other introducer may include a flexible insertion tube (or a rigid video stylet, etc.) for engaging an intubation tube, at least one image sensor 252 disposed at the distal end of the introducer 250, and an articulating distal tip of the introducer 250, which may be controllable by one or more tensioning elements, such as one or more pull wires secured to the distal region of the introducer, or other suitable control mechanism(s).

[0077]

[0133] For example, an introducer (e.g., introducer 250) may include high-resolution image sensor(s) or video chip camera module(s) at its distal end, such as illustrated in exemplary FIG. 2A , including CCD or CMOS image sensor(s), objective lenses, and / or other suitable optical configurations. In certain exemplary embodiments, the image sensor may be, for example, between about 2 mm and about 4 mm in size and provide a wide angle 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 actuation member and introducer shaft to provide illumination during the airway management procedure. Signal wires along the introducer shaft may carry image or image data from the image sensor to an image processor, which may optionally be located within the housing and / or display or in an external device. The distal end of introducer 250 may also include a flexible articulating structure (e.g., having articulating segments) that may be controlled by an angulation pullwire or tension cable or other suitable mechanism(s). Such angulation wires may, for example, control the up / down and left / right steering motion of the articulating tip of introducer 250.

[0078]

[0134] At least the proximal end of optional actuation member 240 may be coupled to and / or located within housing 210 and controlled by one or more actuators. Actuation member 240 may be advanced longitudinally (e.g., at least partially out of housing 210), retracted proximally along a longitudinal axis, and / or rotated by one or more actuators 216, thereby controlling the advancement, retraction, and / or rotation of introducer 250. In some variations, actuation member 240 may extend the working length of introducer 250, such that advancement of actuation member 240 may enable the distal end of introducer 250 to be distally positioned farther than introducer 250 could do alone. Additionally, actuation member 240 may be retractable within housing 210, such as by using a selector button 290 as shown in FIG. 2C .

[0079]

[0135] In some variations, the actuating member 240 and the introducer 250 may be connected together, for example, permanently. In other words, the actuating member 240 and the introducer may optionally be structurally and functionally integrated. Thus, in some variations, the entire flexible member, including both the actuating member 240 and the introducer 250, may remain connected to the housing 210, such that the entire flexible member (and possibly the entire device 200) is fully sterilized between uses. In other variations, the actuating member 240 may be separable from the housing 210, such that the actuating member 240 and the introducer 250 can be sterilized separately from the housing 210. For example, the actuating member 240 may be releasably connected to the housing 210 by a connector fitting, a fastener, a mechanical interfit (e.g., threads, an interference fitting), a telescoping, or in any other suitable manner. In some variations, a disposable protective sheath or other cover may be removably placed over at least the introducer 250, thereby eliminating the need to thoroughly sterilize the actuation member, introducer, and / or the entire device after each use. In other variations, the actuation member 240, along with connections to a user interface device 270 (e.g., including a guide 217 and / or a joystick-like control member 274, as shown in FIGS. 2C and 3), may be integrated into a single module that removably attaches (e.g., snap-fit, “plug-and-play” connection, etc.) to the housing 210 and to the actuation control 216. In another variation, the actuation control may also be included, in whole or in part, in such a module. Such an integrated module, having either a permanent or severable 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 a new, different module including a different actuation member 240, e.g., having a different outer diameter, length, etc.This may further allow the housing to function as a universal handheld adapted for use with introducers of different sizes, allowing a single handheld housing to be used to treat different patient populations (e.g., adults and children).

[0080]

[0136] Alternatively, in some variations, any actuation member and any introducer (e.g., endoscope) herein may be detachable from one another. The actuation member and introducer may be coupled together by a connector fitting, fastener, electromechanical interfit (e.g., threads, interference fitting), band, telescoping, or any other suitable manner. Once coupled, the actuation member and introducer function as a continuous, single member. For example, introducer 250 may be removably attached from actuation member 240 or housing 210, allowing introducer 250 to be disposable. In this embodiment, introducer 250 does not need to be sterilized, as it may optionally be discarded after use.

[0081]

[0137] The exterior surfaces of the actuation member and introducer may optionally be coated with a coating (e.g., a polymeric material) that provides a smooth, atraumatic, biocompatible, and watertight surface. In some embodiments, the actuation member and / or introducer may include an outer diameter between about 2.5 mm and about 7.0 mm. The proximal portion of the actuation member (e.g., between about 0.5 cm and about 6.0 cm in length) or even the entire length of the actuation member may, in some variations, have a larger outer diameter as needed to accommodate various connections to actuator(s) within the housing and / or user interface device (discussed further below). The total combined length of the actuation member and introducer may be, for example, between about 30 cm and about 70 cm. In some variations, the actuation member 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 actuation member and / or introducer may be varied to accommodate different applications (e.g., adult vs. pediatric patients). For example, variations of the device that may be suitable for assisting nasotracheal intubation may include a longer introducer, e.g., between about 20 cm and about 60 cm, which may contribute to an overall combined length between the actuation member and the introducer of between about 30 cm and about 100 cm. Other exemplary structural aspects of the actuation member and introducer are described in further detail below.

[0082] Actuating member

[0139] Any of the integrated systems or assemblies herein may optionally include one or more actuation members, and the following disclosure may apply to any actuation member herein. At least the proximal end of the exemplary actuation member 240 may be located within the housing 210 and / or display 218. The actuation member 240 may be driven in multiple degrees of freedom to effect corresponding movement of the introducer (e.g., endoscope 250). For example, the actuation member 240 may be actuated in a linear (advance-retract along the longitudinal axis) and axial (rotation about the longitudinal axis) manner via an electromechanical linkage. Other actuations at or near the actuation member, such as via the guidewire described above, may additionally articulate the distal end of the introducer in an up-down and / or left-right tip motion manner.

[0083]

[0140] The actuation member 240 and introducer may be collectively configured such that actuation and movement at the actuation member 240 can result in transmission of all desired degrees of freedom to the introducer. The device may include any suitable actuator(s) 216 and associated control system for driving the actuation member 240, similar to those described above, including, for example, drive electronics, one or more electric motors, hydraulic systems, pneumatic systems, and / or various mechanical components (e.g., assemblies, connectors, couplings, controllers, etc.), as appropriate. The control assemblies, connections, and couplings may be configured such that the desired actuated mechanical movement is smoothly and precisely transmitted along the introducer actuation member to the distal articulating tip of the introducer.

[0084]

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

[0085]

[0142] 3B-3D illustrate exemplary variations of actuators configured to move the actuating member herein along the guide. FIG. 3B is a schematic diagram of an axial actuator 216a configured to move the actuating member 240 axially or longitudinally (e.g., forward and / or backward), thereby moving the introducer axially in a similar manner. For example, as shown in FIG. 3C, the axial actuator 216a may include one or more aligned pairs of opposed drive wheels that engage the actuating member 240 via grooves, friction elements, and / or the like. The drive wheels (wheel A and wheel B) of each aligned pair of drive wheels may be located on opposite sides of the actuating member 240 or introducer, such that their coordinated rotation in opposite directions urges the introducer actuating member 240 axially or longitudinally forward and backward, for example, along the guide 217. Other suitable mechanisms, such as one or more of a slider-crank system, a belt or pulley system, a plunger actuator, a corkscrew mechanism, or the like, may additionally or alternatively provide axial actuation of actuation member 240. Further, as shown in FIGS. 3B and 3D , one or more actuator connections to rotary actuator 216r may also be coupled to actuation member 240. Rotary actuator 216r may include one or more pull wires or other tensioning element attachments coupled to actuation member 240 configured to control lateral or side-to-side movement, similar to that described below with respect to FIG. 3B . However, any other suitable mechanism, such as rollers, may be used to automatically actuate the rotational movement of actuation member 240 and, therefore, the guiding introducer.

[0086]

[0143] Additionally or alternatively, actuation member 240 may be adapted to travel within guide 217 when actuation member 240 is manually driven, such as via a user interface device 270, touch screen, voice command, etc., in a manual assist mode. For example, as shown in FIG. 3A , a user interface device 270 (including, e.g., a joystick-like control member 274) may be coupled to actuation member 240. User interface device 270 may be engaged within control member guide 272, which may generally follow or be parallel to the trajectory of guide 217 for actuation member 240, as shown in FIGS. 2C and 3A . User interface device 270, including joystick-like control member 274, may be coupled to actuation member 240 via control wire 276 attached (e.g., by fastener, welding, or any other suitable manner) to connection points 278 and 279, as shown in FIG. 3A . For example, top connection 278 between control member 274 and actuation member 240 can control manual forward motion (F) when a user manually manipulates (e.g., pushes and / or pulls) control member 274 forward and backward within guide 272. As another example, side connection 279 between control member 274 and actuation member 240 can control lateral or left-right motion (L) and (R) when a user manually manipulates control member 274 within guide 272. Thus, user interface device 270 may enable a manually assisted mode (e.g., enabling manual advancement and / or rotation of actuation member 240 and thus introducer (e.g., endoscope 250), while the distal articulating tip of the endoscope remains automated). These connections 278 and 279 remain inactive in a fully automated mode.2C (e.g., a button), whereby selection of user interface element 282 causes the device to enter a mode in which automated motion is limited to articulation of the distal tip of the introducer (e.g., endoscope 250), while linear and / or rotational endoscopic motion is manually controlled (e.g., with user interface device 270) as described above. User interface element 282 may, for example, assist the surgeon in activating the manual assist mode as desired.

[0087]

[0144] In some variations, any of the actuation members herein may be self-expanding. For example, as shown in FIG. 2A , actuation member 240′ may include a self-expanding structure, such as including interlocking rings and / or helical elements that transition from a compressed state to a deployed state. As described above, actuation member 240′ may be directed along guide 217′ and actuated using actuator(s) 216′ and / or manually actuated using an appropriate user interface device. While actuation member 240′ is shown in FIG. 2A as being compressed within a linear guide channel, it should be understood that other shapes of guide channel may be possible.

[0088]

[0145] Additionally, at least a portion of one or more of any actuation member, any actuator, user interface device, and / or guide may be within a module (e.g., display 218) coupled to housing 210. For example, as shown in FIG. 2A , in some variations, the proximal end of actuation member 240″ may terminate within the display, and one or more actuators 216″ similar to those described above may automatically move (axially and / or rotationally) the actuation member within guides 217″ within the display to articulate the tip of the endoscope, as described above. Additionally or alternatively, in some variations, the proximal end of actuation member 240″ may terminate within a display or module, and a user interface device similar to those described above may be used to manually move actuation member 240″ (axially and / or rotationally) within guides within the display. Additionally or alternatively, in some variations, the proximal end of actuation member 240″ may terminate within the display, and the actuation member may self-deploy in a manner similar to actuation member 240′, as described above. For example, the actuating member 240'' having a proximal portion within the display may be straight or axially aligned with the endoscope 250 so that self-deployment of the actuating member 240'' provides for easy extension of the endoscope working length.

[0089] An introducer (e.g., a flexible or rigid endoscope)

[0147] Any of the dual-video integrated systems or assemblies 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 may be advanced over any of the introducers herein. Any endoscope described or illustrated herein may be considered merely an example of an ETT introducer. It is understood that any reference to an endoscope or scope herein, as those terms are used herein, may be considered to essentially describe a more general introducer. In some embodiments herein, the introducer 250 is an endoscope, and thus the endoscope 250 may be adapted to be removably coupled (e.g., telescopically engaged) to an intubation tube for an intubation procedure. The endoscope 250 may be configured to enter and navigate within a patient's airway and serve as an introducer for the advancement of the ETT during an intubation procedure. As mentioned above, the introducer may have multiple degrees of freedom, including longitudinal forward and backward movement controlled by driving an actuation member, axial left and right rotation, and up and down and left and right articulating movement of its distal end. For example, as shown in FIG. 5, a device 600 including the distal end of introducer 250 may include one or more sets of antagonism cables 62 and 63 extending from navigation wheel 61 toward distal end region 250d of introducer 250. Each set of antagonism cables may correspond to a degree of freedom for the articulating tip of introducer 250, for example.

[0090]

[0148] As shown in illustrative FIG. 6 , for example, device 650 may include at least a first set 64a of antagonistic cables operated by navigation wheel 61a to control left-right articulation, a second set 64b of antagonistic cables operated by navigation wheel 61b to control up-down articulation, and / or a third set 64c of antagonistic cables operated by navigation wheel 61c to provide tension in actuation member 240. A device for articulating scope tip movement may alternatively include only one or two of these sets (e.g., only set 64b of antagonistic cables operated by navigation wheel 61b to control up-down articulation). The cables may be coupled to actuation member 240 via, for example, mechanical fasteners, welding, etc. Navigation wheels 61a-61c may include wheels, sprockets, rotation knobs, and / or the like. In some variations, the length of the distal tip bending section may be between about 4 cm and 5 cm, the articulation (steering) of the tip bending section may be between about 120 degrees and 180 degrees in all directions (up and down, left and right), and the axial rotation of the introducer may be between about 90 degrees and about 180 degrees in both 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 actuation, and distal tip articulation, 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, similar to, for example, a flexible scope member, but may be more rigid due to its material and / or construction (e.g., a more rigid construction including metal). In some variations, at least a portion of the stylet may be malleable. For example, using a rigid video stylet instead of a flexible member may be useful in some applications where greater torsional stiffness is desirable to allow for better transmission of linear and rotational motion between the actuation member and the introducer, easier maneuverability around the patient's airway (e.g., obstructive glottic lesions), smoother advancement during insertion and navigation through the patient's anatomy, and easier advancement of the intubation tube.

[0092]

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

[0093] Transition Area

[0152] Any of the integrated assemblies or systems herein may optionally include a transition region or segment between the actuation member and the introducer. The transition region may have an intermediate bending stiffness and / or other gradual change in structural properties to help ensure smooth and uninterrupted transfer of actuation from the actuation member to the introducer. In some variations, the transition region may additionally or alternatively include a series of incrementally flexible segments and / or coil springs to transition from a stiffer bending actuation member to a more flexible introducer.

[0094]

[0153] Alternatively and / or additionally, in variations in which the actuation member and introducer are removably coupled, a relatively stiff transition region (e.g., a length between approximately 1 and 2.5 times the outer diameter of the actuation member and / or introducer) between the actuation member and introducer may be useful to restore continuity of electromechanical and / or other functionality. The transition region may include connections that provide the same structural and task functionality (including uninterrupted light transmission, video capture / analysis, and mechanical actuation) as described elsewhere for variations in which the actuation member and introducer are integrally coupled. Optical / electrical functionality can be maintained between the actuation member and endoscope using one or more appropriate mating connectors (e.g., connectors associated with respective PCB traces). 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 articulating joints.

[0095] Other structural features

[0155] Any of the integrated systems or assemblies herein may include one or more structural features adapted to help prevent buckling and / or looping during forward and backward advancement and / or rotation along its linear axis, which helps improve smooth motion transfer from the actuation member to the introducer. In some variations, the bending stiffness and torqueability of the shaft may be increased by incorporating flat, helical, interlocking metal bands (e.g., bands under an outer polymer covering) with gaps between them to maintain flexibility. These helical bands may be covered with thin strands of stainless steel wire or other suitable material, braided into a tubular mesh, and covered with an extruded polymer layer to create a smooth outer surface. Some exemplary solutions for improving advancement ("pushability") and rotation ("torqueability") are described in more detail below.

[0096]

[0156] For example, the actuation member and / or introducer may be guided through a more or less continuous physical guide, such as a guide channel (e.g., similar to an overtube environment). This guide channel helps constrain the actuation member and / or introducer, keeping their combined length taut during manipulation, thereby reducing kinking and other problems. For example, as described above, actuation member 240 may be constrained in guides 217 within housing 210 and / or display 218, and endoscope 250 may be housed within an intubation tube, which itself provides a rigid guide channel for endoscope 250. Additionally, as described below, endoscope 250 may be constrained in intubation tube channel 266 in cover 260. Also, as described in more detail below, an overtube environment can provide an active channel through which manipulation (e.g., manual manipulation) of the intubation tube may be easily accomplished while maintaining automated, robotically assisted guidance of the endoscope.

[0097]

[0157] Additionally, the enclosed intubation tube and / or cover may help constrain the introducer into a straight path generally aligned with the patient's airway during intubation, further reducing buckling and / or loop formation within the actuation member and / or introducer.

[0098]

[0158] Other structural features may help reduce friction. For example, guides for the actuation members (such as guide 217), the actuation members themselves, and / or the introducer itself may be lubricated (e.g., with a long-lasting commercially available lubricant) and / or have outer surfaces of low-friction material to provide reduced friction during actuation of the actuation members.

[0099]

[0159] Additionally or alternatively, the actuation member may have an 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 actuation member 240 may have a higher bending stiffness than the softer, more flexible introducer 250 to facilitate easier manipulation. In some variations, the shaft bending stiffness along the length of the combined actuation member 240 and introducer 250 may be varied by changing the outer layer material composition of the actuation member and / or introducer 250. For example, the outer base layer may include a polymer with two resins, which are extruded over a wire mesh to form the outer structure. Bending stiffness can be varied by changing the composition of the combined resins, and the resulting polymer layer may further provide an atraumatic, biocompatible, and watertight surface. Shaft bending stiffness may also be varied using an adjustable shaft stiffening coil wire or other suitable mechanical element. In some variations, shaft bending stiffness may additionally or alternatively be increased in actuation member 240, with at least a portion of actuation member 240 having a larger outer diameter. For example, the proximal end of actuation member 240 may have a flared diameter, which may further advantageously allow for an increased working surface with actuator(s) 216.

[0100] cover

[0161] Any of the systems and assemblies herein may further include a cover (e.g., cover 260) adapted to enable and provide an integrated dual-image enhanced visualization and navigation system adapted to be held and controlled by one hand of a single operator. The covers herein may be configured to be advanced over a patient's tongue both above the patient's epiglottis (e.g., in or near the vallecula) and below the patient's epiglottis, providing versatile placement of the cover. Additionally or alternatively, the cover may be configured to preferentially place the cover either above the epiglottis or below the epiglottis. In some variations, such as those shown in FIGS. 4A and 4B, cover 260 (or any other cover, such as those shown in FIGS. 17A-17G) may further include a displacement member 268 configured to facilitate retraction of the patient's tongue, thereby improving pharyngeal clearance and scope movement within the airway. The displacement member may be, for example, angled, straight, curved, or otherwise shaped to be placed atraumatically inside the patient's mouth. In one example variation, the displacement member may be between about 3 cm and about 4 cm wide (e.g., for an adult patient, with smaller widths appropriate for pediatric patients).

[0101]

[0162] As shown in FIG. 4A , the cover may have 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 limit movement of the tracheal tube relative to the cover in at least one direction. The channels may optionally be configured to fit over the received first imaging member and tracheal tube. First channel 264 may be adapted to be releasably coupled, such as by snapping, to housing 210 at connection 262, thereby removably attaching to housing 210. In some variations, the first channel may be between 15 cm and 20 cm in length and angled forward between about 4 cm and about 6 cm from the tip in a manner and direction that seeks to maximize views of different portions of the patient's upper airway anatomy (above the vocal cords) and glottal structures for enhanced visualization and movement of the introducer, although these dimensions will be different for covers adapted for use in pediatric patients.

[0102]

[0163] Second channel 266 is adapted to be releasably secured to an intubation tube (e.g., an ETT), which may be disposed about the introducer (e.g., a pre-loaded ETT). The intubation tube channel may function to provide a mechanism for securing the positioning of the intubation tube adjacent displacement member 268. Intubation tube channel 266 may optionally be configured to couple (e.g., snap) to housing 210 at connection 263. The intubation tube channel may further include one or more latches, clips, or other fasteners 267 to help retain the intubation tube within the intubation tube channel. In one exemplary variation, the intubation tube channel may be about 15 cm to about 30 cm in length for an adult patient, and about half this length for a pediatric patient. Intubation tubes of various sizes (e.g., diameters) may be accommodated within intubation tube channel 266. Furthermore, the second channel (intubation tube channel) need not define an internal lumen, but rather may be partially open-sided (e.g., have a longitudinal slot) to allow removal of the intubation section from the cover once intubation is complete. For example, the second channel may have a semicircular cross-sectional configuration or a grooved or recessed cross-sectional configuration sized and configured for releasable securing to the ETT (see also 1713 in FIG. 17A).

[0103]

[0164] As shown in FIG. 4B , in some embodiments, intubation tube channel 266 and first imaging member channel 264 may be detachable from one another, optionally along a detachable junction region 269 having one or more connectors, perforations, or the like. This may be useful, for example, as an option to allow the laryngoscope to provide a backup intubation option using only effective video laryngoscopy, should AI navigation fail or become problematic. For example, intubation tube channel 266 may be detached and removed along junction region 269, allowing the first imaging member and the remainder of cover 260 to be used in a conventional manual video laryngoscope intubation method, with the intubation tube being manipulated by the surgeon outside cover 260. (It should be understood that detaching intubation tube channel 266 may not be necessary for all patients, as a pre-loaded intubation tube can be pushed through intubation tube channel 266 of cover 260 and into the patient's trachea.) In another backup intubation option, the cover's intubation tube channel 266 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 endoscope-assisted intubation. In yet another variation of the backup intubation technique, the detachable introducer 250 (or any other introducer herein) may be manually used as an intubation tube introducer to facilitate placement of an 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 one another and in substantial axial alignment, such that the image sensor of the first imaging member and the image sensor of the introducer are in close proximity to one another. In this manner, the location of the distal end of the intubation tube (optionally coaxially surrounding the introducer 250) can be better oriented relative to the field of view, thereby improving the ability to place the introducer 250 and the intubation tube. Additionally, the dual-channel arrangement can enable robotically controlled movement of the introducer over the shortest distance into the glottis and into the trachea (compared to other approaches in which the introducer is separately advanced over a longer total distance), 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 introducer exhibiting or having similar curvatures along the length of the cover, as generally shown, for example, in FIGS. 17C and 17D.

[0105] The integrated dual image sensor systems and assemblies herein are generally adapted to position or maintain the first and second image sensors at an initial distance relative to each other when the introducer or second imaging member (and optionally its housing) is releasably coupled to the housing, which initial distance optionally, but not necessarily, provides a predictable starting location for the image sensors relative to each other. As used herein, positioned or maintained at an initial distance from each other refers to any frame of reference and can include any spacing between them in space. For example, the image sensors may be maintained at a horizontal and axial distance from each other. In some examples, the sensors may be aligned within one frame of reference but still be maintained at a distance from each other relative to different reference points or axes. For example, in some exemplary embodiments, the first and second image sensors may be substantially axially aligned (proximal-distal) with each other and spaced some distance from each other laterally or horizontally. In these examples, the sensors are considered to be positioned and maintained at an initial distance from each other despite being axially aligned. In some exemplary embodiments, two image sensors may initially be substantially axially aligned with each other, even if there is some minimal axial offset when assembled. The image sensors may be in close proximity 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 coupled to the housing. The actual inter-sensor distance may differ from the axial spacing between the two sensors (if any) due to a natural horizontal lateral offset of the two sensors when assembled together. When integrated into an assembly, the integrated system can be held in one hand by the surgeon with the two image sensors positioned or maintained at an initial distance of not more than 3 cm axially from each other.In some embodiments, the second image sensor may be initially located within a proximal region of the ETT, or may be located within the second imaging member housing but not yet advanced into the ETT. In these embodiments, the assembly is still considered to be adapted to position the first video camera at an initial distance from the second video camera prior to actuation of the actuator.

[0106]

[0166] In some embodiments, the two image sensors may be maintained at a distance from one another when the sensors are assembled into an assembly, and at some point during use, the two sensors may become axially aligned while the two sensors are positioned in the upper airway. This may 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 moved distally some distance relative to the first image sensor until it is axially aligned with the first image sensor. The two sensors in this embodiment may only become axially aligned momentarily if the second image sensor continues to move, for example, distally.

[0107] Exemplary method for providing enhanced visualization and navigation of an intubation tube introducer in an airway management procedure, optionally during an intubation procedure

[0168] The disclosure herein includes aspects related to methods for enhanced visualization, navigation, and placement of an intubation tube introducer. Figure 7 illustrates, as a flow chart, a merely exemplary method for positioning an ETT in the trachea during an intubation procedure. 7 , a method 700 for assisting in the performance of a robotic-assisted intubation procedure may include step 710 of acquiring one or more images using a first imaging member (e.g., a laryngoscope) or a second imaging member (e.g., an endoscope) associated with an integrated handheld system or assembly, step 720 of initializing automatic guidance of an introducer (e.g., an endoscope) using an actuation member, step 730 of automatically guiding the introducer (e.g., an endoscope) via the actuation member based on the one or more images, step 732 of advancing an intubation tube over the introducer (e.g., an endoscope), step 740 of visually confirming intubation tube placement, such as using an introducer image sensor, step 750 of decoupling the introducer and intubation tube, and step 760 of withdrawing the handheld system or assembly (including the introducer and first imaging member portion) from the patient's mouth. In some variations, method 700 may be performed in conjunction with one or more variations of the devices described herein.

[0108]

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

[0109]

[0170] As shown in exemplary FIG. 7 , the method may include automatically guiding (730) an introducer (e.g., an endoscope) via an actuation member within a handheld housing based on one or more images from a laryngoscope and / or an endoscope. Guiding the introducer may include, for example, automatically guiding the introducer in a longitudinal forward and backward motion and / or an axial left-right rotation via the actuation member. Further, guiding the introducer may include articulating the distal end of the introducer in at least one of several degrees of freedom, including up-down and left-right articulation. In some variations, the introducer may be automatically guided using a robotic system utilizing appropriate AI image processing techniques. Additionally or alternatively, the introducer may be manually robotically guided (e.g., automated-manual-assisted mode) using an appropriate user interface device (e.g., a joystick), in which case an actuation mechanism located within the handle can robotically control the movement of the introducer in response to the surgeon's manual interaction with the system.

[0110]

[0171] Various AI or machine learning methods may be implemented to automatically guide the introducer. For example, suitable image recognition or processing algorithms may identify anatomical landmarks in images from devices such as those described herein. AI-assisted intubation targeting of the vocal cords may utilize specialized targeting software that analyzes multiple image streams, marks and displays targets (e.g., target crosses), analyzes the expected intubation tube navigation trajectory, identifies the defining features of the tracheal opening visible between the vocal cords, and / or displays this information in real time on a display screen.

[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 a robotic intubation interface, can be used to achieve fully automated robotic intubation or automated-manually assisted robotic intubation. Methods and devices such as those described herein can use dedicated logic circuitry such as FPGAs (field programmable gate arrays) and / or ASICs (application-specific integrated circuits) and / or other applications.

[0112]

[0173] One or more of a variety of computer vision and machine learning algorithms may be used in the present invention, including SLAM (Simultaneous Localization and Mapping), Spatial Transformer Module (STM) inspired techniques, Deep Neural Network (DNN) and Convolutional Neural Network (CNN) learning, and others.

[0113]

[0174] Method 700, when performed during an intubation procedure, may further include the step (732) of advancing an intubation tube coupled to (disposed around) an introducer (e.g., an endoscope). The intubation tube may, for example, be telescopically engaged with (e.g., surrounding) the introducer. The intubation tube may be advanced over the introducer toward the target location while the introducer is manually or automatically guided. 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 actuation systems, such as those described herein. Furthermore, in some variations, the intubation tube may be advanced manually during certain portions of its travel and automatically during other portions of its travel (e.g., as desired by the user).

[0114]

[0175] Additionally, in some variations, the method may include manually advancing the intubation tube while maintaining automated guidance of the introducer. For example, a user may hold the integrated system with one hand and manually manipulate the intubation tube over the introducer with the other hand (e.g., by pushing the intubation tube forward on the introducer and / or rotating the intubation tube (and / or introducer together as a unit)) toward a location in a target image, such as an image from an introducer image sensor positioned in the trachea. Thus, in some variations, manual advancement of the intubation tube can help, for example, to shorten the travel distance of the intubation tube toward the target location, further improving the speed of intubation.

[0115]

[0176] Throughout the intubation procedure, images from the first and / or second imaging members can optionally be displayed to the user continuously over a number of epochs or time periods in real time or near real time as the introducer and intubation tube are automatically and / or manually advanced to the target location. Images, such as images from the introducer image sensor while in the trachea, can be used to instantly confirm proper intubation tube placement, optionally optimal intubation tube positioning (740), and / or to enable immediate identification of intubation tube misplacement and / or to allow the user to troubleshoot the intubation procedure from both above and below the vocal cords, including problems with intubation tube advancement that may prompt appropriate intervention(s). For example, the first imaging sensor may be spaced proximally from the introducer image sensor to provide a view and identification of a wider anatomical region; such views can provide additional views of tracheal tube movement and provide more information about placement than would be possible using the introducer image sensor alone. Once proper placement of the intubation tube within the trachea has been visually confirmed, typically using an introducer imaging sensor also positioned within the trachea and below the vocal cords, the introducer is then automatically and / or manually removed from within the intubation tube via robotic actuation (750), and the introducer is withdrawn (760), leaving the intubation tube in place.

[0116] Example

[0177] A merely exemplary, non-limiting method of performing TI using an integrated dual video system or assembly as described herein is set forth below, it being understood that not all steps need be performed and the order may be modified where appropriate.

[0117]

[0178] (1) A disposable dual channel cover (e.g., 260) is coupled to a handheld housing (e.g., housing 210), and a laryngoscopy baton (e.g., 220) is placed within the cover's laryngoscopy channel. The system is powered on. (2) A disposable introducer (e.g., endoscope) is coupled, directly or indirectly, to the handheld housing, e.g., to an actuating member of the system. The introducer is automatically checked by the device for full functionality upon connection with the handheld housing and, e.g., to an actuating member. (3) The introducer is optionally lubricated and placed within the selected ETT. The ETT is placed within the cover's intubation tube channel (not necessarily the inner lumen). (4) The user performs manual video laryngoscopy using the video laryngoscope (the display screen is in the default single-picture mode showing the laryngoscope image feed) and identifies anatomical structure(s) on the system's display. The image recognition and / or AI interface is activated, initiating automated robotic actuation of the actuation member and introducer through the actuation interface. The actuation member movement is fully transmitted to the introducer. (Actuation can also be manually activated by selecting an AI operation mode button on the device housing or by using the automated-manual assist mode.) (5) Upon actuation, a split or picture-in-picture video screen function is displayed, allowing the user to observe the entire TI, optionally continuously and in real time. This display mode can be activated automatically or manually. (6) In fully automated mode, the device automatically navigates the introducer into the patient's trachea using AI or robot-assisted navigation, including steering forward and backward motion, pivoting, and / or tip articulation. In some embodiments, this is accomplished using video data from the first image sensor alone, and in some embodiments, this can be accomplished using video data from the first and second image sensors. For example, the initial movement of the introducer can be automatically based primarily or solely on video data from the first imaging sensor (which may be a video laryngoscope image sensor).(7) In the automated-manual-assist and manual-assist modes, manual movement of the device, e.g., using a user interface device, instantly overrides the fully automated mode. In the manual mode, the advancement / retraction and / or axial rotation of the actuation members can be manually controlled, and articulation of the distal tip of the endoscope may be automated. The fully automated mode can be resumed, e.g., after the user presses the AI ​​operation mode button. In the automated-manual-assist mode, the surgeon manually controls the automated actuators within the system. (8) During introducer navigation, if the airway anatomy is recognized, a visual indicator (e.g., a square or circle) may optionally appear around the displayed airway on the screen. Introducer articulation simply involves moving the tip toward the geometric center point of the detected glottic opening and passing through the vocal cords. (9) The movement of the introducer around the anatomy during the TI sequence can be continuously visualized by the user, e.g., via a video laryngoscopy image feed or signal displayed on the display. Visually presenting video data from a first image sensor (e.g., a video laryngoscope image sensor) with a wider field of view on the display allows the surgeon / 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 minor adjustments in the positioning of the integrated system. (10) The introducer is automatically navigated around the patient's anatomy and advanced through the tracheal opening into the patient's trachea. (11) The ETT can be manually advanced (or automatically advanced) distally away from the introducer and into the patient's trachea, allowing visual confirmation of proper ETT placement using image data from the introducer image source. 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), visually confirming tracheal ETT placement.Additionally, visual confirmation of tracheal ETT placement can be more closely observed by obtaining a full view of the patient's tracheal anatomy, optionally by pressing the picture-in-picture button twice on the display screen (optionally achieved using other mechanisms such as a remote control, audio command, or the use of a touch screen / display). Additionally, the ETT can be optimally positioned (not too deep, not too high) within the trachea above the tracheal carina. (12) The ETT can be released from the intubation tube channel 266 in the cover. The system is removed from the patient's mouth, leaving the ETT in place within the trachea. (13) The ETT cuff is inflated, and manual or mechanical ventilation through the ETT can then be initiated using a ventilation bag or an automated ventilator. ETT tracheal placement may optionally be further confirmed by any appropriate means (e.g., breath sounds, EtCO2). (14) One advantage of the integrated dual video system herein is that if the AI / robotic-assisted TI fails for any reason, the surgeon has a backup option to use the system as a video laryngoscope alone to complete the TI using various conventional TI options, for example, as described above. (15) In embodiments where the actuating member and introducer are separable, if a problem occurs while advancing the ETT through the vocal cords (e.g., the ETT repeatedly "gets stuck" on the glottic structures), the introducer can be disconnected from the actuating member and used as a handheld introducer (endoscope) to further facilitate directing the ETT through the glottic opening.

[0118]

[0179] FIG. 15 generally illustrates an integrated dual video handheld intubation assembly (including any described herein) after it has been positioned into a patient's upper airway.

[0119]

[0180] 16A-16D show merely exemplary images captured and / or projected on a display during any of the described intubation procedures, which may include using any of the handheld systems or assemblies described herein. The following disclosure describes FIGS. 16A-16D in the context of exemplary benefits of the systems herein adapted to display video data or images on a display during an intubation system and image data from a first image sensor and a second image sensor. FIG. 16A shows a view provided by a first image source disposed at a distal region of a first imaging member, such as a video camera. The epiglottis and larynx are labeled in FIG. 16A, which may optionally, but not necessarily, be a panoramic view as shown. As can be seen, it is difficult or impossible to visualize the vocal cords in this image. Any of the methods herein may optionally include receiving as input data representing the anatomical view shown in FIG. 16A and generating an output that initiates automated, robotically controlled movement of an introducer. In an alternative embodiment (described in the context of the exemplary mode herein), the system need not automatically control the movement; rather, the user may manually effect robotic movement of the introducer via operable communication between the disposable introducer and the housing.

[0120]

[0181] 16B shows image (e.g., video) data from a first image sensor on the left and image data from a second image sensor on the right. The image data from the first image sensor on the left provides a visualization of the introducer after it is moved distally relative to its initial position (in which the second image sensor (e.g., video camera) is initially maintained at a distance from the first image sensor (e.g., video camera)) and relative to the first image source. As can be seen, as the introducer is moved distally (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 shown, the image data captured by the first image sensor provides a view of the introducer as it is robotically (automatically and / or manually) advanced and also provides a view of a wider anatomical region than the view provided by the introducer image sensor. If the second image data becomes compromised (e.g., due to blood or secretions near the second image sensor), the image from the first image sensor will advantageously help determine where the introducer is and further facilitate continued movement (automated or manual robotic) of the introducer. Figure 16B shows the introducer after it has been robotically moved somewhat under the epiglottis toward the glottic opening, as shown.

[0121]

[0182] Figure 16C shows image data from the first and second image sensors after the introducer has been advanced through the glottic opening, with the second image sensor providing visualization of the trachea as seen in the view on the right of Figure 16C. The first image sensor (image data on the left of the figure) continues to image the properly positioned introducer, again benefiting from the integrated nature of the dual video intubation assembly herein.

[0122]

[0183] Figure 16D again shows image data from two image sources, showing the endotracheal tube after it has been advanced over the introducer toward the glottic opening and through it into the trachea as shown. The window or opening visible in the upper left portion of the right image in Figure 16D is the standard lateral opening in the ETT (called a Murphy eye). The roughly linear feature extending from the top right corner is the radiopaque line on the ETT, indicating where the main distal opening of the ETT is located.

[0123]

[0184] Some of the disclosures set forth above describe identifying or recognizing anatomical landmarks or locations in an image to aid in guiding an introducer 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 cartilages, pyriform sinuses, tongue, the geometric center of the glottic opening, tracheal walls (tracheal rings), areas of the image that are darker than adjacent areas, etc. In some methods and devices herein, the step of identifying or recognizing anatomical landmarks or locations (sometimes generally referred to herein as image recognition) may be performed or accomplished automatically. For example, but not limited to, as set forth 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 image or image data received during use of the system. FIG. 8A shows an example sequence illustrating automatic image / landmark recognition, which can then facilitate robotic control and navigation of an introducer (e.g., a flexible and / or rigid endoscope), as described in additional detail herein. In some methods and devices herein, identifying or recognizing anatomical landmarks may be performed or accomplished manually by a medical professional or other operator(s). 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 a screen or display. For example, a physician may touch a touch screen at the location of the recognized vocal cords in the displayed image or at a location where the operator wants to move the introducer. FIG. 8B shows an example sequence illustrating manual image / landmark recognition, which can then facilitate robotic control and navigation of an endoscope, as described in additional detail herein. It is understood that the aspects of FIG. 8A and FIG. 8B may be combined. For example, but not by way of limitation, 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., by manually touching a confirmation icon on the display) may be required before endoscopic navigation begins.

[0124]

[0185] Any of the systems herein may include one or more processors having executable method(s) stored therein (e.g., software, firmware, algorithm(s), etc.) adapted to receive instructions or input based directly or indirectly on user interaction with the display (optionally touch and / or voice interaction and / or haptic feedback) while the display presents at least one image (still or video). The executable method(s) may facilitate robotic control of introducer movement via an actuation member within the housing and / or first imaging member or other member in operative communication with the introducer.

[0125]

[0186] Some of the disclosures set forth above describe robotic control of the movement of an introducer through the vocal cords and into the trachea. For example, several disclosures herein relate to automated robotic control of introducers. FIG. 9A illustrates one exemplary sequence of image recognition (such as any of those shown in FIGS. 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 actuation members described herein. In some cases, introducer movement may be at least partially controlled manually, such as by a user moving an actuator, such as, but not limited to, a joystick, wheel, slider, or other similar actuator (which may be in operative communication with an internal housing actuator), to control one or more types of introducer movement. Additional details of optional types of movement control (e.g., distal-proximal direction, rotation, and / or distal tip deflection) are described elsewhere herein. It will be appreciated that the exemplary robot control processes of Figures 9A and 9B may be combined with image processing and / or image recognition according to Figures 8A and / or 8B.

[0126]

[0187] The methods, devices, and / or systems herein may not include automated image processing and / or recognition. Alternatively, the methods, devices, and systems herein may be adapted and configured for a mode that does not include the use of automated image processing and / or recognition, or may be used in a manner that does not include the use of automated image processing and / or recognition. Either case may generally be referred to herein as a manual mode. FIG. 8B includes example steps that may be included in a manual mode (it should be apparent that the overall introducer navigation process may include other steps, such as any of the steps described herein). The introducer controls of FIG. 9A and / or FIG. 9B (or described elsewhere herein) may also be included in a manual mode. In some cases, the manual mode may be initiated in response to a user action or trigger event, such as by pressing a button that initiates manual mode or by touching a touchscreen to identify a portion of an image. In some cases, any of the devices herein may default to manual mode or may not be compatible with AI or other automated image processing and / or recognition.

[0127]

[0188] As described herein, the methods, systems, and devices herein may use or include an automated mode (although it is understood that they may have other modes or be used in other ways). The automated mode may include automated image processing or recognition (as shown in FIG. 8A ) and automated robotic scope control and / or navigation (as shown in FIG. 9A ), which may optionally be performed in a continuous, closed-loop manner. In some cases, the devices and methods operate in the automated mode in response to a user selecting or initiating the automated mode, such as by (by way of example only) pressing an AI button on the handheld (e.g., FIG. 2C ). In some cases, the automated mode may be the default and function in the automated mode without the need for user initiation. In some cases, the automated mode may be initiated or occur after any number of previously occurring modes or steps, such as after a manual control mode (e.g., FIG. 9B ) that the user wishes to interrupt and return to the automated mode. Any of the devices, systems, and methods herein may use or have a mode in which the automated mode continues while and for as long as a medical professional continues to activate an actuator, such as a button or switch, on the handheld. In these modes, the system may be adapted so that automated scope control and / or navigation ceases when the user stops activating the actuator (e.g., when the button or switch is released). By way of example only, any of the "AI" buttons on the handheld may act as a type of actuator (e.g., a deadman's switch) that, once released, terminates the automated mode. This mode may be used in conjunction with any other mode or method herein.

[0128]

[0189] Any of the devices and systems herein may be adapted to allow a user to override or stop automated scope control / navigation by interacting with the handheld (including any display associated therewith). FIG. 10 (similar to FIG. 9B) illustrates exemplary steps involving manual robotic control at a point following automated robotic control (which may, of course, include other steps). By way of example only, the surgeon may use a handheld housing actuator (e.g., a joystick, wheel, slider, etc.) to override automated navigation (optionally 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 to reactivate the automated mode after user interaction with the handheld (e.g., pressing an "AI" button). For example, in FIG. 10, after manual control, the method again reverts to automated control, and can loop back and forth as desired by the surgeon or device.

[0129]

[0190] Any of the systems, devices, and methods herein may be adapted to allow the surgeon to indicate a navigation path (or a location along the path) on the display, such as by touching a specific location on an image presented on the display, or even by using a voice command that the system is adapted 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 FIG. 9A, where landmark recognition in this example comprises indicating a location or intermediate path location (and not necessarily a specific anatomical landmark).

[0130]

[0191] As shown in FIG. 9A , any of the devices and systems herein may be adapted to automatically control introducer navigation (e.g., have a mode adapted to provide this functionality). In automatic image processing and / or recognition, the system may be adapted to receive image data and determine a path for the introducer (e.g., a scope). In manual image recognition, the system may be adapted to process manual identification and determine a path for the scope. An on-board AI can then communicate instructions to facilitate control of on-board actuators, thereby facilitating smart, atraumatic, 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 placed inside the patient's trachea, the surgeon can manually advance a tracheal tube over the scope, using the scope as an atraumatic intubation guide, similar to a guidewire in other medical procedures. The advancement of the tracheal tube can be continuously visualized by the surgeon on a display screen (e.g., a handheld or fixed monitor) by displaying either a single image (optionally switchable between two or more) or at least two images simultaneously, optionally from both above and below the vocal cords.

[0131]

[0192] As used herein, the term laryngoscope refers to a traditional laryngoscope, but it is understood that the term can also refer to any type of device adapted to provide at least video imaging, preferably (but not necessarily) panoramic video, to a surgeon. Generally, these are referred to herein as first imaging members (or first elongated imaging members). The first imaging members may be manufactured and packaged coupled to a handheld housing, or the first imaging members may be releasably coupled to the housing by a surgeon or assistant immediately prior to a procedure. Laryngoscopes herein are generally referred to as either a video guide ("VG"), an optional panoramic video guide ("PVG"), or a first imaging member, and may include an image sensor (e.g., a video camera) at its distal end, as well as optical and electrical wiring and communication functionality. The first imaging member may be functionally similar to the video baton of existing video laryngoscopes and include any of their features or functionality.

[0132]

[0193] It is further understood that any of the video monitors (e.g., displays) herein may be integrated into any of the handheld housings herein, or they may be separate, free-standing video monitors (including being part of a detachable component that can be releasably secured to the handheld). As shown herein, any of the video monitors may also include a touch screen adapted to respond to taps, swipes, and any other type of manual command. Any of the video monitors herein may also be adapted to respond to audio input (e.g., voice commands) or tactile commands. The terms display, screen, and monitor may be used interchangeably herein.

[0133]

[0194] In any of the systems herein, the introducer may be an endoscope (rigid and / or flexible), sometimes simply referred to herein as a scope. It is understood that the term does not necessarily limit functionality. In some cases, the introducer is adapted to be robotically controlled (automatically and / or manually) and may include a flexible (optionally at least partially flexible) elongate tubular member or shaft and one or more of an optional distal camera, electrical wiring, optional optical transmission element(s), or one or more elongate elements (e.g., pull wires) used in articulating the distal tip. As shown herein, the introducer may be adapted to be releasably secured (indirectly or directly) to any of the housings, optionally secured via a coupler, the coupling creating an operable robotic communication between the introducer and the handheld housing to facilitate robotic control of the introducer, as described in more detail elsewhere herein.

[0134]

[0195] Any of the covers (sometimes referred to herein as blades) herein may include a first elongate channel adapted to receive a first imaging member therein, and the cover may also be adapted to be releasably secured to the tracheal tube to limit movement of the tracheal tube in at least one direction relative to the cover. The cover may include a separate tracheal tube lumen, or the cover may be configured with a tracheal tube stabilizer, such as one or more clips or partial channels, to which the tracheal tube may be releasably secured. The cover is generally configured, additional details of which are provided above, to maintain the position of the tracheal tube relative to the first imaging member channel and lumen when the tracheal tube is initially releasably secured to the cover.

[0135]

[1096] As shown herein, the housing may be packaged with an introducer (e.g., an endoscope) or other elongate tracheal tube guiding device pre-attached or coupled to the housing. In alternative embodiments, the introducer is not packaged and fixedly coupled to the housing, but is releasably secured or coupled to the housing by the surgeon or assistant prior to the medical procedure. In either scenario, the introducer is in operative communication with the housing to facilitate robotic control of the introducer and, optionally, to transmit optical data from the introducer to the housing for display on a display, as shown herein. The introducer is optionally releasably secured to a coupler on the housing, which may be any suitable component or components sized and configured to interact with or interface with the guiding introducer and become releasably secured to the introducer (including separate components such as adapters that connect to both the handpiece and the introducer). Releasably secured in this context refers to the ability to secure the introducer to the housing so that the introducer and housing are not easily separated during normal use of the device during an intubation procedure, and may include the actuation 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 relative to the handheld housing. FIG. 2A shows an embodiment of an introducer 250 releasably secured to a housing coupler, which may be considered to include the end of the actuation member 240. In the embodiment of FIG. 2A, the actuation member 240 (and other similar internally movable actuation members) may be considered to be a robotic extension of the introducer after the introducer is releasably secured to the housing coupler. That is, the actuation member and introducer can be moved together and considered to be part of the same movable unit, and data can be communicated from the introducer to the housing. FIG. 2C shows an additional embodiment of a housing containing an internally movable robotic extension or actuation member.

[0136]

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

[0137]

[0198] FIG. 11 illustrates an additional embodiment of a robotic handheld device or assembly adapted to facilitate delivery of a tracheal tube (or other device into a different lumen depending on the procedure) to the trachea. Any other features that may be suitably incorporated into or modified by the embodiment of FIG. 11 may be included, even if not mentioned herein. The device or assembly 1100 includes, among other components, a handheld housing 1110, a cover or blade 1160 coupled thereto, and a display 1118. In this embodiment, the handheld housing 1110 includes a universal docking station 1130 that may be disposed within the housing. An introducer delivered into a patient's trachea (or other lumen) may need to be within the outer diameter limits of the anatomy and / or application. For example, for a pediatric patient, a scope may need to be smaller than an introducer that can be used with an adult patient. Depending on the use of the devices herein, it may be desirable to be able to releasably secure multiple introducers, whether flexible or rigid, to a common (e.g., universal) handheld housing, where the scopes may have different outer diameters (“OD”) and different sizes and / or possibly different relative locations of optical transmission lines within the introducers. One consideration is ensuring that introducers, regardless of their OD and size, can be releasably secured to the handheld housing and placed in operative communication with the housing (e.g., robotically movable, optionally facilitating 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 FIG. 11 ) adapted to enable a variety of flexible and rigid introducers of different ODs and sizes to be releasably secured to the handheld housing and placed in operative communication with the housing.A universal docking station or universal coupler may be adapted to accept 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, the universal docking station may include multiple adapters, each sized and configured to properly interface with a flexible / rigid introducer regardless of its OD and size.

[0138]

[0199] 11, a robotically controllable introducer 1150 is shown pre-coupled to a housing 1110 and a docking station 1130 located within the housing. Once coupled, the introducer 1150 can be moved in any of the manners described herein (e.g., distal-proximal, rotational, tip deflection in at least four different directions) using actuators within the housing.

[0139]

[0200] FIG. 11 further illustrates an exemplary scope or introducer guide 1117 associated with an outer or near-outer region of the housing (and which may extend from an outer housing surface), as compared to, for example, the inner guide 217 of FIG. 2C. FIG. 11 shows that the introducer 1150 is securely received within the guide 1117, which in this embodiment is located in the upper region of the housing. This location allows the introducer to be fixed and movable relative to the upper portion of the housing, yet allows the central introducer region to extend through the tracheal tube ETT. The guide 1117 may have a tubular configuration through which the introducer is threaded before coupling to the coupler and universal docking station 11130. Alternative guide configurations may also be used. For example, the guide 1117 need not form a complete lumen, such as if it has a generally "C" cross-sectional shape, so long as the introducer is movable relative to the guide and prevents the introducer from becoming separated from the guide.

[0140]

[0201] As indicated above, in some embodiments, when the introducer is releasably coupled directly or indirectly to the handheld housing (e.g., for an intubation procedure), the introducer can be robotically moved, including distal advancement toward the trachea. In some embodiments, the assembly may optionally be adapted to robotically advance (using either automated and / or manual robotic navigation) the introducer at least 10-12 cm beyond the tip of the ETT so that the introducer 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 robotically move the introducer distally between 5 cm and 40 cm or between 5 cm and 60 cm once the introducer is operably coupled (directly or indirectly) to the housing. By way of example only, the handheld housing may be adapted to move the robotic extension (and thus the introducer) distally between 5 cm and 40 cm, optionally by 40 cm or less. Alternatively, with reference to FIG. 11 , the assembly may optionally be adapted to move the introducer distally between 5 cm and 40 cm, or (e.g., if the assembly does not include an actuation member or robotic extension) between 5 cm and 60 cm. In this disclosure, the terms actuation member, robotic extension, and introducer (or endoscopic) extension may be used interchangeably.

[0142]

[0203] The total length of the introducer can depend on the procedure. For example, for a bronchoscopy procedure, the introducer may optionally have a length of 50 cm to 60 cm. Additionally, not all procedures utilizing the handheld systems and assemblies herein require the use of a cover and / or first imaging member (e.g., bronchoscopy), and when used for these procedures, the first imaging member and cover can optionally be detached / separated from the handheld portion to remove unnecessary components and simplify the procedure.

[0143]

[0204] Any of the devices herein may include an introducer distal motion limiter adapted to prevent the introducer (or robotic extension) from being moved distally beyond a certain distance relative to a starting axial position. This may occur due to the structure of the assembly, a specific feedback mechanism from the AI ​​and software to the handheld, or the distal motion limiter may essentially manifest itself when the introducer simply cannot be moved distally any further due to actuators on the handheld housing or assembly and / or the structure of the robotic extension. This limiter may therefore be considered a passive or active motion limiter.

[0144]

[0205] In some robotic handheld devices and assemblies herein, at least a portion of the device's robotic functionality may be incorporated into components that are removable from the handheld housing but can be releasably secured to the housing prior to a procedure. This allows some components to be more easily reused, while other components can be discarded, for example, after a procedure. This may also allow some removable components to be used with a variety of handheld devices, for example. This may aid in and / or facilitate the manufacture of certain components. FIGS. 12 and 13 illustrate example assemblies with removable components that contain at least some robotic control functionality. FIG. 12 illustrates a handheld housing 1200 and a removable robot block 1270 (sometimes referred to herein as a removable introducer controller) that is shown removably secured to the handheld housing 1200. Block, as used in this context, is not limited to any particular structure or function, but generally refers to the removable functionality of a component. In this example, removable block 1270 includes introducer coupler 1222, robotic extension or actuation member 1240 at least partially within the housing of block 1270, and guide 1217 within block 1270, which may include any feature of any of the guides herein that allows movement of robotic extension 1240 but maintains extension 1240 within or associated with guide 1217. Actuator 1216 is also shown, which may include any of the functionality or features of any of the actuators herein (e.g., motor control to move extension 1240 and thereby move 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 releasably secure to the removable block. The block 1270 may, in turn, include any type of suitable corresponding mating structure sized and configured to releasably but fixedly interface with the block coupler 1272 on the housing 1210. The block coupler 1272 may include a variety of interlocking features (e.g., press fit, male / female portions, etc.) that allow the block to be releasably secured to the housing 1210. Once the block 1270 is secured to the housing 1210 and the introducer 1250 is releasably secured to the introducer coupler 1222, the device may be used in any other manner described herein (e.g., image processing / recognition, scope movement, optical transmission, video capture, mechanical actuation, distal tip articulation, etc.). Any of the removable "blocks" herein may also be referred to herein as an introducer controller, an introducer controller, or a second imaging member including an introducer.

[0146]

[0207] FIG. 12 further shows a removable cover 1260 (which may include any cover or blade feature or functionality described herein) having a first channel and a second channel releasably secured to the housing 1210.

[0147]

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

[0148]

[0209] Certain aspects of the present disclosure optionally include utilizing preoperative information about the patient during the intubation procedure, such as preoperative images (e.g., CT, X-ray, MRI, PET scan, and / or 3D reconstruction of the airway) or video that can be useful or assistive in navigating during the intubation procedure. For example, it may be beneficial to utilize a preoperative endoscopic video examination to improve or enhance navigation. Optionally, patient characteristics or conditions can be incorporated into the navigation procedure. For example, if the patient's diseases and / or characteristics and / or pathologies (all of which may be generally referred to herein as "conditions") can be outlined, the surgeon may be able to select (e.g., from a software image library) from multiple selectable conditions prior to the procedure that match the patient's condition(s). The device can then take such conditions into account during the intubation procedure (e.g., via AI and / or associated trained machine learning algorithms) to further improve visualization, navigation, and ETT placement, further increasing the speed, success rate, accuracy, and safety of intubation. For example, such an interface may include a pull-down application menu (or voice command to free up hands) presented on any display or screen herein, including a cell phone or computer, that can allow selection of a condition personalized to this particular patient's medical care. For example, the condition or information about a procedure may include "laryngeal cancer," "base of tongue tumor," or "nasotracheal intubation," or "airway exchange via intubating LMA." Procedure and condition combinations may also be presented or otherwise selectable, such as "nasotracheal intubation for patient with base of tongue tumor." An image library may be retrieved for any of these conditions and / or procedures from the cloud or on-device software, optionally stored in the handheld, and used as part of the navigation.

[0149]

[0210] In some embodiments, existing patient images may be delivered (e.g., wirelessly) and stored on the handheld device and utilized (e.g., by AI) during navigation. By way of example, these images may include one or more of pre-operative videos, photographs of the patient's anatomy, or reconstructed images / videos from CT / X-ray / MRI / PET scans and / or other imaging studies.

[0150]

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

[0151]

[0212] Any information (e.g., video and / or image data) from any of the procedures may be automatically or manually transmitted to a central location (e.g., to the cloud), and 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 of the procedures (e.g., video and / or image data) may be automatically (e.g., wirelessly) or manually transmitted to the patient's electronic medical record (EMR) to document the intubation procedure for enhanced record-keeping, billing, and / or teaching purposes.

[0153]

[0214] In any of the embodiments herein, the tracheal tube (e.g., ETT) may also be utilized as an additional manipulation tool for the flexible introducer. Moving the tracheal tube may be beneficial to aid in navigating the scope and / or orienting a scope coupled to the ETT. Whether the introducer is automatically robotically navigated (e.g., FIG. 9A ) or manually robotically navigated (e.g., FIG. 9B ), rotating and / or moving the tracheal tube forward (distally) may help enhance proper introducer alignment, actuation, and advancement. For example, moving the tracheal tube anterior-posterior (distal-proximal) and / or rotating axially can optimize visualization and / or navigation / movement of the introducer toward the target, improving speed of intubation and first-pass success. Depending on the application, the tracheal tube may be moved (e.g., advanced distally and / or rotated axially) prior to initiating the automatic introducer navigation sequence. In some uses, the tracheal tube may be moved (e.g., advanced distally and / or rotated axially) during the automated scope navigation sequence. In some embodiments, the assembly is adapted such that if the tracheal tube is manipulated during the automated navigation sequence (e.g., FIG. 9A ), manipulation of the tracheal tube automatically stops the robotic interface.

[0154]

[0215] One aspect of the disclosure herein relates to an integrated dual-video system that includes an introducer guide or guide feature(s). As shown herein, the device (in either the hand-held portion or the removable block portion) may include an introducer guide that allows movement of the introducer (or robotic extension) relative to the guide but still restricts movement to a specific or known path (e.g., restricts movement within the guide and prevents disengagement from the guide). As partially described above, any of the guides herein may include guide rails for the proximal portion of the introducer (or robotic introducer extension) inside or outside the device housing. Additionally, the guide may be sized and configured to prevent buckling of the proximal portion of the introducer (including the robotic extension). Additionally, the proximal region of the introducer or robotic extension may have a bending stiffness adapted to prevent buckling of the scope, which may be greater than the bending stiffness of the scope shaft disposed outside the housing. Additionally, any of the guides may be adapted to direct the introducer at a preferred angle and / or a preferred trajectory and / or path within or outside the device housing. Additionally, as discussed above, guiding the introducer may be enhanced by positioning the distal region of the introducer inside the tracheal tube to keep the scope taut due to frictional engagement between the introducer and the tracheal tube.

[0155]

[0216] One aspect of the disclosure relates to an introducer that, once coupled to a handheld housing (either to the handheld or via a removable block), is robotically movable distally, optionally at least a certain distance. In some merely exemplary uses, the total introducer length (with or without the robotic extension) may be approximately 25 cm to 70 cm. In some exemplary uses, the device is configured to allow at least 5 cm of robotic distal introducer advancement, optionally 10 cm to 40 cm, e.g., 10 cm to 25 cm. This will be facilitated by the amount of movement allowed within the handheld by the robotic extension, if the system includes one.

[0156]

[0217] In any of the embodiments herein, any of the introducer guides within the handheld housing may include a coating or other lubricious material (e.g., silicone) that facilitates scope movement relative to the guide and helps prevent buckling or binding.

[0157]

[0218] In any of the embodiments herein, the introducer may include one or more sensors at the distal tip to avoid excessive manipulation forces during navigation (eg, during tip deflection).

[0158]

[0219] In any of the embodiments herein, deflection or steering of the distal scope tip may be facilitated without the use of pull wires or other elongated tensile structures, e.g., piezo, alloys (bimetal, nitinol).

[0159]

[0220] In any of the embodiments herein, the introducer may have a varying bending stiffness along its length. For example, without limitation, the introducers herein may comprise one or more polymeric materials (e.g., PEBAX) that have varying bending stiffness (e.g., different durometers) along their length and optionally provide a more flexible or deflectable distal tip than the proximal region of the scope. The concept of varying polymeric elongate shaft bending stiffness is generally known, and any related concepts may be incorporated into the embodiments herein. For example, the robotic extension may include a polymeric material having a higher durometer than the introducer material at the distal end of the introducer. Again, by way of example only, the proximal region of the introducer (such as the region of the introducer that interfaces with the guide outside the hand-handle, as shown in FIG. 11 ) may have a higher durometer than the distal region of the introducer to help prevent buckling during distal movement.

[0160]

[0221] One aspect of the disclosure herein is that the described devices and systems can be adapted and configured to be highly useful, handheld, portable, multi-function, dual-video airway management platforms that can, optionally and advantageously, be operated with one hand by a single user. By way of example only, the handheld housing herein can be adapted for use with a variety of different airway management procedures and / or with a variety of different introducers and / or a variety of different first imaging elements (e.g., video laryngoscopes). In these embodiments, the handheld housing can be considered a universal or common handheld housing that allows a variety of different introducers and / or first imaging elements to be interchangeably coupled and utilized. For example, it would be desirable to have a universal platform that can couple to an introducer sized for pediatric patients and also couple to an introducer sized for adult patients. Additionally or alternatively, it would be desirable to have a universal platform (e.g., the handheld housing herein) that can be used with introducers of different lengths, such as relatively long introducers that can be used for bronchoscopy and other airway management procedures described herein, and relatively short introducers that can be used in intubation or intubation-related airway management procedures. Platform technology can also be adapted to allow robotic control of different introducers, whether airway management procedural, medical, diagnostic, or surgical, that can be coupled to the platform. The handheld housing herein can be adapted so that one or more of the introducer, cover or blade, or first imaging member (e.g., a video laryngoscope) can be releasably coupled (directly or indirectly) to the handheld housing to provide multifunctionality. Thus, the present disclosure includes devices and systems that can be adapted to provide multifunctionality and versatility not yet observed or provided in existing medical airway management procedures.

[0161]

[0222] Additionally, the devices and systems herein may be adapted so that an introducer may be temporarily or permanently removed (or simply not coupled to the housing) if it is not needed for a particular airway management procedure or portion of a procedure. For example, if an introducer is not needed for a procedure or portion of a procedure, it may not be used and, optionally, may be temporarily or permanently decoupled from the housing if previously coupled to the housing. Additionally, if a first imaging member is not needed for a procedure or portion of a procedure, it may not be used and, optionally, may be temporarily or permanently decoupled from the housing if previously coupled to the housing. Additionally, if a blade is not needed for a particular procedure or portion of a procedure (e.g., bronchoscopy), it may be temporarily or permanently removed or not used.

[0162]

[0223] Thus, the devices, assemblies, systems, and methods herein can be adapted and configured to be multifunctional, universal, and highly useful handheld portable platforms adapted to be operated by a single user, capable of treating a variety of patient populations in a variety of clinical environments and locations, and for a variety of airway management procedures, optionally while controlling introducer movement robotically (e.g., using AI, smart navigation, etc.), providing significant functionality not observed or available in existing approaches. Additionally, the devices herein can be rapidly modified as needed (e.g., by temporarily or permanently removing and / or reattaching the introducer or first imaging member) based on the needs of the procedure.

[0163]

[0224] While 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), the disclosure herein also includes the use of a handheld assembly when only one image source is used. By way of example only, the methods and devices herein may be used without an introducer (e.g., a scope) and with only the first imaging element. For example, this may occur in situations where the introducer module is malfunctioning or ineffective, such as when blood and secretions obstruct the airway. The assembly may be adapted to allow the operator to disconnect, or at least not use, the introducer and use the device as a regular video laryngoscope (or VG). The assembly may have a separate mode that only involves the use of video from the first imaging element (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 left unused. 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 exemplary airway management scenario in which an introducer may be used without a first imaging member is for nasal flexible endoscopic intubation, with the option of later connecting a first imaging member to facilitate endoscopic manipulation as the endoscope passes through the nose and reaches the oral cavity. Another exemplary airway management scenario in which a scope may be used without a first imaging member is the use of an endoscope to facilitate intubation through a supraglottic airway device (“SGA”), a small mask positioned inside a patient's mouth to provide ventilation / oxygenation of the lungs (when connected to a ventilator). SGAs (e.g., laryngeal mask airways, LMAs, etc.) are often used to temporize difficult airway situations when difficult intubation is suspected or encountered. Another exemplary airway management scenario in which an introducer may be used without a first imaging element is during diagnostic upper airway endoscopy or bronchoscopy, where the procedure may be performed with or without an indwelling tracheal tube. Another exemplary airway management scenario in which an introducer may be used without a first imaging element is to confirm proper positioning of an indwelling ETT within a patient's trachea and / or to optimize ETT positioning within a patient's trachea. Another exemplary airway management scenario in which an introducer may be used without a first imaging element is to facilitate placement and positioning of a double-lumen tracheal tube, e.g., a special type of ETT used for thoracic surgery, which is often difficult to place.Another exemplary airway management scenario in which an introducer may be used without a first imaging member is to facilitate endoscope-assisted exchange of a patient's existing (indwelling) ETT, optionally in an operating room, ICU, emergency department, or other location. Another exemplary airway management scenario in which an introducer may be used without a first imaging member is to facilitate an extubation attempt. In either of these exemplary airway management procedures in which an introducer may be used without a first imaging member, the cover may be detached from the handheld housing (if the blade has actually been previously coupled to the handheld housing).

[0165]

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

[0166]

[0227] Additionally, although the applications herein relate to medical procedures, the devices and methods herein can also be used for non-medical procedures. For example, the devices herein may be used for industrial applications where an introducer needs to "sniff" into an orifice, for example, to evaluate hard-to-access machinery.

[0167]

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

[0168]

[0229] Any of the systems herein may be used in a manner in which an introducer is used without the use of a first imaging member (e.g., a video laryngoscope), or the first imaging member may be detached 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 herein may be adapted to be coupled to multiple covers, each of which may have at least one dimension that differs from the dimension of at least one other cover, allowing for different sizing of covers for children and adults, for example.

[0170]

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

[0171]

[0232] Any of the systems herein are adapted to be coupled to multiple deflectable introducers, which may be flexible or rigid, or partially flexible and partially rigid, and may have different lengths and diameters.

[0172]

[0233] Some example systems or assemblies herein include an introducer (e.g., a mechanical guide, a flexible endoscope, a rigid endoscope, etc.) that can be releasably secured to a handheld housing, whereby, when the introducer is secured to the housing, the handheld housing is in operative communication with the introducer, 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 optionally disposable or single-use introducer sized and configured to be releasably secured to a handheld housing. After being releasably secured (directly or indirectly) to the handheld housing, the movement of the introducer can be controlled using the handheld housing. After the procedure is completed, or at a time determined by the surgeon, 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, an intubation system typically must be cleaned and sterilized before reuse with a different patient. In some systems herein, cleaning and / or sterilizing one or more components that facilitate axial movement of the introducer may be difficult. Therefore, in some applications, it may be desirable to have a disposable or single-use introducer that can be removed after use, allowing the handheld housing to be cleaned and sterilized and used with a new introducer for subsequent use. Therefore, it would be desirable to utilize an introducer that is disposable and yet affordable. Any of the introducers herein (e.g., flexible or rigid endoscopes, etc.) may be disposable and / or incorporated into a disposable introducer housing assembly, any of which may be sized and configured to be releasably secured to the handheld housing. The introducer housing assembly herein may generally be referred to as a second imaging member.

[0174]

[0235] 14A-14D illustrate an embodiment of an intubation system including an exemplary handheld housing and an exemplary introducer housing assembly (also referred to as a second imaging member) sized and configured to allow the introducer housing assembly to be releasably secured to the handheld housing to create operable communication between the two. The introducer housing assembly in this context may also be referred to simply as an introducer assembly or a second imaging member. The introducer housing assembly herein may be disposable, allowing it to be easily released from the handheld housing as desired by the operator, such as after a procedure or in the event of introducer assembly failure. When the introducer housing assembly is releasably secured to the handheld housing, the two components as a whole may also be referred to as a handheld device or assembly.

[0175]

[0236] In this embodiment, 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), electronics, one or more computer-executable methods, firmware, a microprocessor, a blade coupler, a laryngoscope, or a laryngoscope coupler. In some embodiments, housing 1400 may include an integral first imaging member (e.g., a laryngoscope), and in some embodiments, housing 1400 includes a laryngoscope coupler adapted to be releasably secured to a laryngoscope. In some embodiments, housing 1400 is coupled to or includes a video device adapted to provide video images, although not necessarily considered a laryngoscope. In some embodiments, the handheld housings herein do not include or are not adapted to be coupled to a laryngoscope.

[0176]

[0237] In this embodiment, 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 assembly 1400 of Figures 14A-14D.

[0177]

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

[0178]

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

[0179]

[0240] In this embodiment, the handheld housing 1410 contains one or more motors therein that are in rotational communication with or considered part of the motor linkage 1413, which may include a motor shaft that is rotated when the motor rotates. In this embodiment, the motor is adapted, when actuated, to cause axial movement of the introducer, as described below.

[0180]

[0241] 14C and 14D show exemplary features of the introducer housing 1490 and the introducer 1450. In this embodiment, the introducer housing 1490 includes an electrical coupling 1495 with the illustrated plurality of electrical connections adapted and positioned to establish electrical communication with the hand-held housing's electrical connections (FIG. 14B) when the introducer assembly 1499 is releasably secured to the hand-held housing 1410. The electrical coupling between the hand-held housing and the introducer housing can provide one or more types of controlled movement of the introducer. Note that the electrical coupling is optional, and in alternative designs, the electrical coupling may be replaced by one or more motors in the hand-held housing. The electrical coupling 1495 may also include a connection for communicating image data from the introducer to the hand-held housing.

[0181]

[0242] The introducer housing 1490 is adapted to releasably couple to the handheld housing, the coupling creating operative communication between the introducer and one or more controllers in the handheld housing. In this embodiment, the coupling creates both electrical and mechanical communication, but in other embodiments, the coupling may be solely mechanical or solely electrical. In this embodiment, the mechanical coupling is adapted to control the axial movement of the introducer, and the electrical coupling is adapted to effect one or more types of deflection of the introducer's articulating section shown in FIG. 14C to facilitate 360-degree deflection.

[0182]

[0243] In this embodiment, the motor coupling includes a motor within the handpiece that is rotationally coupled to a shaft, as shown in FIG. 14B. The motor shaft is sized and configured to be disposed within motor coupling 1496, which is the introducer housing shown in FIG. 14C. The motor shaft may be sized and configured to interface with the inner surface of one of rollers 1494a or 1494b, as shown in FIG. 14D. Thus, motor activation drives the rotation of one of rollers 1494a or 1494b, with both rollers adapted to rotate about an axis in this embodiment. One end region of introducer 1450 (optionally one end of a flexible introducer shaft) is fixed relative to housing 1490 at location 1491, while the introducer and housing are further adapted to allow the introducer to move axially relative to housing 1490 in a region distal to location 1491. Introducer 1450 is shown positioned through opening 1493 in housing body 1492 and through opening 1497 in housing body 1492 .

[0183]

[0244] The hand-held housing may be adapted for use with introducers of different sizes. The motor shaft may be a common or universal drive element sized and configured to fit within rollers of various sizes, depending, for example, on the size of the roller and / or introducer. This is one example of how a universal hand-held portion may be releasably securable to different introducers having at least one difference in size / dimension (e.g., diameter). This allows the hand-held housing to be used by children as well as adults.

[0184]

[0245] As used herein, an introducer housing may or may not completely surround or enclose the introducer. For example, an introducer housing may have one side open to the surrounding environment and still be considered an introducer housing herein.

[0185]

[0246] The introducer 1450 is positioned between rollers or wheels 1494a and 1494b as shown, such that counter-rotation of the rollers toward the introducer causes axial movement of the introducer, as indicated by the arrows in FIG. 14D. Rotation of the rollers in one direction may cause distal movement, while rotation in the opposite direction may cause proximal movement. Any other disclosures herein relating to controlled axial movement (e.g., axial distances, e.g., 10 cm to 40 cm, for example) may be incorporated into the disclosures of FIGS. 14A-14D. One or both rollers may have grooves or other friction interfaces similar to those shown in the upper right corner of FIG. 14D, while in an alternative version, one or more rollers may have modest teeth or grooves. In an alternative version, one or more of the one or more rollers may be made from a polymer, plastic, to reduce the likelihood of or avoid damage to the introducer shaft. The rollers may have a smooth interfacing surface or a non-smooth interfacing surface.

[0186]

[0247] The introducer housing of this specification includes a body (e.g., housing body 1492, etc.), which may comprise one or more components, optionally two or more components secured together (e.g., with an adhesive, welding, etc.) to at least partially define the housing body.

[0187]

[0248] The introducer housing assembly herein includes a plurality of electrical connections 1495 (e.g., comprising pins and / or vias) each coupled to a wire (three exemplary wires shown in FIG. 14D ), each of which may extend through the introducer shaft or may be in electrical communication with a wire extending through the introducer shaft. For example, any of the wires (e.g., four to nine) may communicate a video signal from a camera (e.g., FIG. 14C ) at the distal end region of the introducer, or the wires may facilitate deflection control of the introducer's articulating section, such as by using shape memory material (e.g., nitinol) or bimetallic wires (e.g., five to eight wires). The general concept of communicating electrical signals through wires with shape memory material to deflect a shaft has been described, and the basic concept may be used to incorporate one or more of such wires to cause deflection of the introducer's articulating section herein. For example, electrical signals can be communicated to one or more introducer wires to transition the distal section of the introducer between multiple shape memory states and be used to control deflection of the introducer in one or more directions. Any of the wires herein may also comprise bimetallic wires, which can also be used to cause deflection of the introducer by communicating signals to and through one or more wires. Additional electrical signals can be communicated to the wires to cause the distal regions of the wires to change shape and return to their original, undeflected, or straight shape. Electrical signals can be communicated to any combination of wires to create or cause a desired deflection or configuration of the articulating section, which can be automatically controlled, for example, by AI. For example, deflection can be caused by changing the shape of any combination of wires within the introducer, which can be used to create various shapes and configurations of the deflectable section of the introducer.

[0188]

[0249] Figures 14A-14D show one embodiment of a system that uses a mechanical linkage to control the axial movement of the introducer and an electrical linkage to cause deflection of the distal end region of the articulating section 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 of a shape memory material (e.g., nitinol) or a bimetal may be used to control deflection of the introducer in any one or more of the automatic and / or manual modes herein, including partially automatic and partially manual.

[0190]

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

[0191]

[0252] Any of the handheld housings herein (e.g., 1410) may include an encoder on the motor to control the axial distance the introducer is moved. Additionally or alternatively, any of the introducers herein may include multiple visual markings (e.g., axially spaced lines) thereon that are used to control the amount of axial movement of the introducer. Additionally or alternatively, any of the blades herein may include an RFID tag (or EEPROM) that can be used to control initial introducer advancement and / or to communicate the blade type to the system, as the blade type may also affect the first visual.

[0192]

[0253] Any of the components, including the introducer housing (e.g., 1490), which may be releasably secured to the handheld housing, may include an RFID tag (or EEPROM) adapted to inform the system or control unit what type of introducer is being used, such as information related to introducer diameter, introducer length, video resolution, and / or whether it is adapted to enable and disable certain features, such as reuse.

[0193]

[0254] In any of the embodiments herein, the introducer housing (eg, 1490) may be adapted to be releasably secured to the rear or side of the handheld housing (eg, 1410).

[0194]

[0255] In the embodiment of FIG. 14C , a section of the introducer, referred to in the figure as the pre-loop, is shown not enclosed in the housing (until a portion of the introducer has been fed through the housing 1490). In an alternative design, this region of the introducer may be at least partially contained or disposed within a housing that provides protection to the introducer and potentially reduces the likelihood of objects getting caught or obstructed in the loop region of the introducer. Such a housing may be fixed relative to the housing 1490, or may be part of the housing 1490 that allows the introducer to move relative to an additional loop housing. For example, this loop region of the introducer may be disposed within a cylindrical housing in fixed relation to the housing 1490. Alternatively, the loop region of the introducer may be disposed within a helical housing or container that is fixed to the housing 1490, with the introducer movable relative to the helical housing to facilitate axial movement.

[0195]

[0256] In the embodiment of FIGS. 14A-14D, deflection is caused by wires within the introducer adapted to change shape in response to a communicated signal. In alternative versions, deflection of the introducer may instead be driven by an additional motor connection between the handheld housing and the introducer housing. In these alternative versions, the system may include a mechanical connection for axial movement of the introducer as well as deflection of the introducer. In these alternative versions, the wires within the introducer may be in communication with one or more motors, which are used to tension the wires and cause deflection of the steerable section of the introducer. For example, the system may include two or four additional motors to facilitate deflection of the deflectable section. For example, the system may include four motors to tension pull wires (or other elongated tension elements) to cause deflection and / or transition back to a straight configuration. The inclusion of four additional motors can help maintain tension on the pull wires at different circumferential locations as they are tensioned to deflect the housing, which can reduce sudden recoil by reducing slack in other wires that are not tensioned for deflection. For example, having four motors can help maintain tension on all pull wires that are not tensioned for deflection at that particular location. Alternatively, the system can include two additional motors, the additional motors adapted to deflect the deflectable section of the introducer.

[0196]

[0257] Any of the introducer housings herein may further include or house a lumen adapted as a working lumen. The housing may include one or more ports in communication with one or more lumens, for example, to allow delivery of one or more substances and / or devices into the working lumen. A schematic representation of the ports and lumens is shown in FIG. 14D. For example, housing 1490 may be adapted to connect to and receive a syringe to facilitate delivery of one or more substances, such as one or more therapeutic agents. It would be beneficial to have a drug delivery port and lumen within a housing that is disposable and does not need to be cleaned. Additionally, the ports and lumens may allow delivery of one or more other devices, such as one or more diagnostic (e.g., ultrasound imaging) and / or therapeutic devices or other medical tools. The one or more delivery ports may be on sides or regions of the housing other than those shown in FIG. 14D, for example, through the bottom or top surface. Additionally, the general location 1491 where the introducer is anchored (although other anchoring locations 1491 may be used) may include a port through which a substance or device can be delivered. An anchoring location may provide more functionality and options at that location because the introducer does not move relative to the housing. Additionally, any of the introducers herein may also include a working channel or working lumen thus allowing any device and / or substance to be delivered.

[0197]

[0258] As discussed above, one exemplary benefit of some embodiments herein is that the distal end of the introducer and the distal end of the first imaging member may be initially positioned within the patient as a coupled unit (e.g., both coupled to a handheld housing). This initial positioning of the introducer may allow the system to immediately advance the introducer distally sufficiently within the patient's airway, and may allow the introducer to be advanced in a manner that requires a substantially minimal distance to navigate to the desired location (e.g., the laryngeal inlet). This would be in contrast to the typical situation where the introducer is not coupled to a handheld and must be advanced distally from a starting point located far from the desired location. For example, in some uses, the introducer may be only about 2 cm to 7 cm from the desired location when coupled to the first imaging member and the assembly as a whole and inserted into its initial position. Optionally, the introducer can then be guided to the desired location using imaging from the first imaging member alone and the resulting robotic control, since the first imaging member can view a wide anatomical region and provide reliable and stable anatomical landmarks even in difficult airway situations. One illustrative benefit of these embodiments is that the introducer and first imaging member can be coupled to a common assembly in a manner such that the field of view of the introducer and the field of view of the first imaging member at least partially overlap.

[0198]

[0259] One exemplary benefit of some of the embodiments herein that incorporate a common handheld housing to which the introducer and first imaging member are connected is that the overall footprint or envelope occupied by the structural device when placed within a patient can be smaller or at least more reliably controlled, which in the case of tracheal intubation can further improve first-pass success rates, reduce intubation times, and reduce the risk of injury to the patient.

[0199]

[0260] Any of the image processing herein may occur within the handheld housing or may occur externally to the handheld housing. For example, image processing may occur at least partially within a device external to the handheld housing, such as a computer with a graphics processing unit, a smartphone, etc. The handheld may be in communication (wired or wireless) with an external device, and information related to the acquired optical information may optionally be communicated from the handheld 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, as described in more detail herein.

[0200]

[0261] 17A-17G illustrate at least a portion of an exemplary intubation system 1700, with FIGS. 17A and 17B illustrating an unassembled view of an exemplary integrated handheld dual video tracheal intubation assembly 1702; this and other integrated assemblies may be referred to herein simply as assemblies. Any of the individual components of any of the assemblies herein may be assembled together prior to a procedure, thereby assembling and creating an assembly. FIGS. 17C-17E illustrate 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. Housing 1702 is configured to be releasably coupled to cover 1780, first elongate imaging member 1730 (one embodiment of which is shown in FIGS. 17F and 17G), and optionally, disposable second elongate imaging member 1740. As shown in FIGS. 17F and 17G, assembly 1702′ (which may include any suitable features of assembly 1702, and vice versa) includes first elongate imaging member 1730 having a first coupling region sized and configured to be releasably coupled to first imaging member coupler 1712. First elongate imaging member 1730 includes an elongate, flexible body 1732 and a first image sensor 1734 (e.g., a video camera) disposed at a distal region 1736 of elongate body 1732.

[0201]

[0262] Assembly 1702 further includes a second elongate imaging member 1740 including a second coupling region 1742 sized and configured to be releasably coupled to second imaging member coupler 1714 of housing 1710. Second elongate imaging member 1740 includes a flexible, navigable, elongate endotracheal tube introducer 1770 (“introducer”), at least a portion of which is deflectable. Introducer 1770 is sized to be disposed within endotracheal tube 1790 and to allow endotracheal tube 1790 to be moved axially over introducer 1770. Second imaging member 1740 includes a second image sensor 1773 (e.g., a video camera) disposed at a distal region 1772 of introducer 1770. As described in more detail below, 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 coupling region 1782 sized and configured to be releasably coupled to cover coupler 1716 of housing 1710. The cover includes an elongate channel defining an elongate lumen, the elongate channel sized and dimensioned such that at least a portion of elongate body 1732 of first imaging member 1730 is disposed within the elongate lumen when first coupling region of first imaging member 1730 is releasably coupled to first imaging member coupler 1712 and cover coupling region 1782 is releasably coupled to cover coupler 1716.

[0203]

[0264] The cover 1780 further includes an endotracheal tube channel 1784 located on a side of the cover 1780 as shown, the endotracheal tube channel 1784 being sized and dimensioned to interface with an endotracheal tube 1790 and limit movement of the endotracheal tube 1784 in at least one direction relative to the cover 1780. The endotracheal tube channel 1784 is further configured to allow the endotracheal tube 1790 to be moved laterally relative to the endotracheal tube channel 1784. In this example, the channel 1784 includes a recess or trough formed in the side of the cover 1780 that 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 may have a cross-sectional configuration that includes a surface that forms a partial circle that interfaces with the circular outer surface of the endotracheal tube 1790.

[0204]

[0265] Endotracheal tube 1790 includes a lumen sized to movably receive introducer 1770 therein, as shown in Figure 17C.

[0205]

[0266] The assembly 1720 further includes one or more actuators disposed within the housing 1710, the actuators being configured and arranged to facilitate controlled robotic movement 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 connection region 1742 of the disposable second elongate 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 may be configured to receive as input information indicative of a signal received from a first image sensor (e.g., a video camera) when the first image sensor is positioned in the patient's upper airway and cause communication to actuators in the housing (e.g., housing 1710) to control robotic movement of the introducer and second image sensor (e.g., a video camera) relative to the first image sensor and toward one or more upper airway anatomical landmarks. Details of exemplary methods of use are described in more detail elsewhere herein.

[0207]

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

[0208]

[0269] Figure 17C shows an assembled view of assembly 1702 with reference to a bottom view showing the first and second image sensors. The horizontal distance between the image sensors is measured in the "H" direction as labeled in Figure 17C.

[0209]

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

[0210]

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

[0211]

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

[0212]

[0273] 17F and 17G illustrate an assembly 1702′ that may include any of the disclosures from assembly 1702. FIGS. 17F and 17G illustrate a first imaging member 1730 that includes an elongated flexible body 1732 and a first image sensor (e.g., a video camera) disposed in a distal region 1736 of flexible body 1732. In some embodiments, first imaging member 1730 is considered to be integrated into or part of the cover, with the first imaging member and cover being releasably coupled to housing 1710 as a subassembly. In some examples, first imaging member 1730 may be releasably coupled to the housing separately from the cover prior to use. In some examples, the housing (e.g., housing 1710) and first imaging member (e.g., imaging member 1730) are an integral unit and do not need to be coupled by the surgeon prior to a medical procedure. It may be advantageous to be able to detach the first imaging member from the housing and reuse the housing, such as when a different sized first imaging member is needed for a subsequent procedure (e.g., between different patients or pediatric patients versus adult patients), the advantages of which are described elsewhere herein. Thus, it is understood that any of the assemblies herein may include an integrated housing and first imaging member, a cover and first imaging member that are integrated and coupled to the housing as a unit, or a cover and first imaging member that are separately releasably coupled to the housing. Components in system 1702′ that are not labeled or described are understood to be the same as the corresponding components or subassemblies in assembly 1702.

[0213]

[0274] 18A-18J illustrate an example housing 1710. It is understood that 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 labeling for housing 1710 from FIGS. 17A-17G may be included in FIGS. 18A-18J even if not labeled in those figures.

[0214]

[0275] The housing 1710 includes a communication region 1720 adapted to communicate with an optionally disposable second imaging member 1740. The communication region 1720 can be configured to be placed in one or more of electrical, mechanical, optical, and / or video communication with the second imaging member 1740 when the second imaging member 1740 is releasably coupled to the housing 1710 (see FIGS. 17C-17E ). In this embodiment, the communication region 1720 includes a mechanical interface 1721 and a mechanical interface 1722 adapted to mechanically interface with the second imaging member 1740, as described in more detail below. In this embodiment, the mechanical interfaces 1721 and 1722 are positioned and configured to mechanically interface with corresponding features on the second imaging member 1740 to effect deflection of the introducer via one or more pull wires or other tensioning elements, as described below. Mechanical interfaces 1721 and 1722 may be actuated by a motor or motors, or may be actuated by a motor located, for example, within housing 1710. A motor in this context may be considered part of a robotic control mechanism adapted to robotically control the movement of the introducer, optionally in response to image processing as described elsewhere herein. Motors of this type of design may be considered actuators, or one or more motors may be considered to be part of an actuator, a term that is used exclusively herein, where actuator may refer, for example, to one or more separate components operating together as a mechanical and / or electrical system (e.g., a motor and drive shaft, etc.).

[0215]

[0276] The assembly herein includes one or more actuators 1761 (see FIG. 20) that facilitate (directly or indirectly) robotically controlled movement of the introducer. The motor within housing 1710 described in this example is one example of an actuator 1761 within the assembly. The pull wires included in this example embodiment are also considered actuators, and in this example they are located within the example second imaging member 1740.

[0216]

[0277] The communication region 1720 may also include a mechanical interface 1723 arranged to mechanically interface with a second imaging member and cause or facilitate axial movement of the introducer, as will be described in further detail below. One or more motors within the housing may cause the mechanical movement of the mechanical interface.

[0217]

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

[0218]

[0279] Communication region 1720 also optionally includes a plurality of electrical connectors 1725 (e.g., a plurality of electrical connections) that can be adapted to interface with a plurality of corresponding connectors on second imaging member 1740 to receive data (e.g., video camera signals) communicated from the second image sensor to the housing, where the signals can be processed or communicated to an external device for processing and / or a display on the device. Exemplary image processing and robotic control (automated and / or manual robotic control) utilizing second image sensor data are described elsewhere herein.

[0219]

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

[0220]

[0281] FIG. 18G also illustrates an exemplary axial drive motor 1804 (sometimes referred to herein as an axial actuation mechanism), which may include an axial drive servo and may be adapted to facilitate axial movement of the introducer herein, as described in more detail elsewhere herein. For example, the axial drive motor 1804 may be adapted to cause rotation of the mechanical interface 1723, as described in more detail herein and shown in FIG. 18J. The axial drive motor 1804 is one example of an actuator, as that term is used herein only (and in this example, is an example of an actuator disposed within a housing). FIG. 18H illustrates merely exemplary first and second deflection (or articulation) drive motors 1805 (sometimes referred to herein as an actuation mechanism), which may include a deflection servo and may be adapted to facilitate deflection of the introducer (e.g., tension a pull wire), as described in more detail elsewhere herein. For example, first and second deflection drive motors 1805 may be adapted to cause rotation of mechanical interfaces 1721 and 1722, respectively, as described in more detail herein and shown in FIGURE 18J. First and second deflection (or articulation) drive motors 1805 are an example of an actuator, as that term is used herein (and in this example, an example of an actuator located within a housing). FIGURE 18I shows an example location for a microcontroller.

[0221]

[0282] 19A-19K illustrate an exemplary second elongate imaging member and exemplary features thereof. While FIGS. 19A-19K are shown and described in the context of second imaging member 1740, any suitable aspect of the second imaging member in FIGS. 19A-19K may be incorporated with respect to any other second elongate imaging member herein, and vice versa. For example, FIG. 14A herein illustrates an exemplary system 1400, which may also be considered an integrated assembly, as that term is used herein. The system 1400 (or assembly 1400) of FIG. 14A includes an introducer assembly 1499 (which may be considered to be any of the second imaging members herein), which includes an introducer housing 1490 (which may be considered to be any of the second imaging member housings herein) secured to a movable introducer 1450, which is sized and configured to be releasably secured to a handheld housing 1410 (which may be considered to be any of the housings herein), and which may be disposable.

[0222]

[0283] 19A is a view of the underside of a second imaging member 1740 including a housing 1744 and an introducer 1770. In this embodiment, the introducer 1770 is secured to the housing 1744 at an end (or end region) of the introducer 1770 and is movable relative to the housing 1744 along a section of the introducer 1770 distal to where the introducer 1770 is secured to the housing 1744. This is similar to the introducer 1450 shown in FIGS. 14A-14D herein. The housing 1744 includes a communication region 1746 that includes one or more communication elements adapted to communicate with the handle when the second imaging member is releasably coupled to the housing. The communication elements may optionally be positioned and configured to communicate mechanically, electrically, video, and / or optically with the handle. The communication element may be configured to communicate information (e.g., image data) and / or to be in operable communication with the handle to cause movement of the introducer in one or more directions, as described in more detail herein.

[0223]

[0284] In this exemplary embodiment, communication region 1746 of second imaging member 1740 includes mechanical interfaces 1741 and 1743 that are positioned relative to housing 1744 and configured to mechanically interface with mechanical interfaces 1721 and 1722 in communication region 1720 (see FIG. 18C ) of housing 1710. The mechanical interfaces may include, by way of example only, toothed, geared interaction such that rotation of mechanical interfaces 1721 and 1722 of housing 1710 (e.g., in response to activation of a housing motor) causes rotation of mechanical interfaces 1741 and 1743, respectively. As described in more detail below, one or more tensioning elements (e.g., one or more pull wires) may be operably coupled to mechanical interfaces 1741 and 1743 such that rotation of interfaces 1741 and 1743 causes tension in the one or more pull wires, which in turn causes deflection of the introducer.

[0224]

[0285] In this embodiment, communication region 1746 of second imaging member 1740 further includes mechanical interface 1747 disposed relative to housing 1744 and configured to mechanically interface with mechanical interface 1723 in communication region 1720 of housing 1710 (see FIG. 18C ). The mechanical interface may include, by way of example only, a geared interaction using teeth such that rotation of mechanical interface 1723 of housing 1710 (e.g., in response to activation of a housing motor) causes rotation of mechanical interface 1747. In this embodiment, interface 1745 is configured to have a geared interaction with interface 1747 such that rotation of interface 1747 causes rotation of 1745 as well (see FIG. 19F ). The introducer passes through housing 1744 and is disposed between rotary mechanical interfaces 1747 and 1745 such that rotation thereof causes axial translation (distal or proximal) of introducer 1770, and Figure 19A shows an axial direction "A" representing axial movement of introducer 1770 relative to housing 1744. Additional details of communication region 1746 are provided below.

[0225]

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

[0226]

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

[0227]

[0288] FIG. 19F shows a top view of the second imaging member 1740 with a top surface layer of the housing removed to illustrate example internal components within the communication region 1746 of the housing 1744. The view in FIG. 19F is the same view as FIG. 19B, but with a portion of the housing removed to reveal the internal components of the housing 1744. FIG. 19A shows a bottom view of the second imaging member 1740. FIG. 19F shows an example geared interface between the rotatable interfaces 1745 and 1747 described above. The mechanical interface 1747 may interface with the rotatable interface 1723 in the handle, such that rotation of the rotatable interface 1723 (e.g., driven by a motor) causes rotation of the mechanical interface 1747. The geared interface between interfaces 1745 and 1747 causes interface 1745 to rotate in a direction opposite to the rotation of interface 1747, causing axial movement of introducer 1770, which is disposed between interfaces 1745 and 1747. The geared relationship between interfaces 1745 and 1747 can amplify the force on the introducer and help prevent slippage during axial movement of the introducer.

[0228]

[0289] FIG. 19F also shows a plurality of electrical connectors 1749 positioned and configured within the housing to interface with electrical connectors 1725 in the handle and to communicate image data from an image sensor at the distal end of the introducer to the housing 1710 as described in more detail herein.

[0229]

[0290] 19F also shows a window or opening 1748 aligned with and adjacent to a section of the introducer 1770, as shown. The window 1748 is positioned to align with a housing sensor 1724 (e.g., an optical sensor) within the housing so that the sensor can track the movement or position of the introducer as it moves in the axial direction "A." The introducer may have one or more markers on its exterior surface to facilitate position tracking or sensing by the housing sensor 1724. The housing sensor 1724 may be adapted to communicate sensed information to a processor (directly or indirectly) 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 housing 1710. In this example, mechanical interfaces 1741 and 1743 rotate in response to rotation of mechanical interfaces 1721 and 1722 within housing 1710, which rotation, in this example, is used to cause deflection of the distal region or tip of the introducer in multiple directions (e.g., one or more of up, down, left, right, or combinations thereof). Figure 19F shows just one example of using first and second motors within housing 1710 to cause rotation of interfaces 1741 and 1743, respectively. In this embodiment, interfaces 1741 and 1743 are coupled to first and second pull wires, respectively, such that when rotated in a first direction, one pull wire is tensioned, causing deflection of the introducer distal tip, and when rotated in the opposite direction, the second pull wire is tensioned, causing deflection in a different direction (e.g., 180 degrees from the first direction). In some embodiments, rotation of interface 1741 can cause deflection of the introducer in a first plane (each direction 180 degrees from the other, e.g., left and right), and rotation of interface 1743 can cause deflection of the introducer in a second plane transverse to the first plane (each direction 180 degrees from the other, e.g., up and down). Both interfaces 1741 and 1743 can be separately controlled, such as with different motors within their housings, in response to robotic control of introducer movement (either automatic or manual robotic control).

[0231]

[0292] 19F embodiment, pull wires (e.g., first and second pull wires 1757 are shown for clarity and illustrative purposes) can be connected to interfaces 1741 and 1743 at locations 1754 and 1753, respectively, using any of a variety of fixation techniques or mechanisms. The pull wires extend from interfaces 1741 and 1743 through pull wire channels generally labeled 1752 and then into introducer 1770. The pull wires extend through the introducer and are fixed to the distal region of the introducer to cause deflection of the distal tip of the introducer using existing pull wire routing techniques and methods.

[0232]

[0293] In some alternative versions, the housing motor may be in operative communication with only one pull wire. For example, in a variation of that shown in FIG. 19F, the housing 1710 may contain four motors therein, each tensioning a respective pull wire.

[0233]

[0294] 19G-19K illustrate exemplary second imaging member housings, and it is understood that any second imaging member housing herein may include any of the exemplary features of exemplary housing 1744 shown in FIGS. 19G-19K, and vice versa. FIG. 19G is a perspective view of the underside of housing 1744. FIG. 19H is a bottom view of housing 1744. FIG. 19I is a perspective view of housing 1744. FIG. 19J is a front end view of housing 1744, showing first and second windows 1755 and 1756 through which introducer 1770 extends. FIG. 19K illustrates a rear end view of housing 1744, including endotracheal tube coupler 1750. As shown herein, an end region of a first end of introducer 1770 may be secured within housing 1710, and in FIG. 19F, a first end of introducer 1770 is secured to element 1751 within housing 1751. From element 1751, introducer 1770 extends out of the housing through housing opening or window 1756 (see FIG. 19J). Introducer 1770 then forms a loop configuration as shown (e.g., FIGS. 17B, 17C, 17E, 17G, 19A, 19B, 19E) and then returns into the housing through housing opening or window 1755 (see FIG. 19J). The introducer then extends through optional endotracheal coupler 1750 of housing 1744, as seen in FIG. 19F.

[0234]

[0295] As shown, housing 1744 has a generally rectangular configuration (and in this embodiment, a generally square configuration) with both a width and a height that are greater than a thickness measured vertically. The corresponding mating area of ​​housing 1710 has a similar rectangular configuration, as shown in the unassembled view of FIG. 17B.

[0235]

[0296] The second imaging member 1740 includes an endotracheal tube coupler 1750, which in this embodiment has 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 that is dimensioned and sized to interface with the endotracheal tube coupler 1750 on the housing 1744 of the second imaging member 1740. The endotracheal tube 1790 also has a lumen sized to receive an introducer therein when the coupler region 1791 is interfaced with the endotracheal tube coupler 1750 on the housing 1744, as shown in Figure 17C.

[0236]

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

[0237]

[0298] A housing (e.g., housing 1710) or integrated handheld assembly herein may include one or more image processors, although 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, for example, a USB interface.

[0238]

[0299] Any of the assemblies may further include one or more microcontrollers, optionally located within a housing (e.g., housing 1710). Any of the assemblies may further include one or more motor interfaces (e.g., part of the robotic control of introducer movement), optionally located within a housing (e.g., housing 1710). Any of the assemblies herein may further include an electronics control board, optionally providing power to one or more motors, optionally located within a housing, during robotic movement of the introducer.

[0239]

[0300] As shown in FIG. 17D (in combination with FIG. 17C), the first and second image sensors (e.g., both video cameras) are maintained at an axial distance relative to one another when the assembly is assembled. In FIG. 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 one another axially and may optionally be axially aligned. The image sensors are also at a horizontal distance "H" (see FIG. 17C) of 2 cm or less from the other sensor. When assembled, the first and second image sensors are thus maintained at a relatively close distance (both axially and horizontally) from one another, the benefits of which are described herein. Assembly 1702 is thus one embodiment of an integrated handheld dual video tracheal intubation assembly configured such that when a first imaging member is coupled to the housing, a second imaging member is coupled to the housing, a cover is releasably coupled to the housing, and an endotracheal tube is releasably coupled to the assembly, the assembly maintains a first image sensor at a distance from a second image sensor prior to actuation of the actuator, an embodiment of which is shown in Figures 17C and 17D. In this embodiment, the lengths and configurations of the endotracheal tube, introducer, cover, flexible body 1732 of first imaging member 1730, and body 1711 of housing 1710, all (collectively and individually) enable and encourage the first and second image sensors to be positioned at a maintained distance from each other and contribute to the overall small profile and footprint of the assembly, allowing the assembly to be held and moved with one hand of the surgeon.

[0240]

[0301] Assembly 1702 is one example 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. In use, the introducer generally needs to be able to robotically move axially approximately 3 cm to 5 cm to move to or toward the glottic opening. The assembly is also adapted to allow the introducer to be moved axially through the glottic opening and within the trachea. Thus, the assembly herein, when used for tracheal intubation, can robotically effect at least 3 cm of axial movement of the introducer and second image sensor relative to the first image sensor, which is maintained in the upper airway.

[0241]

[0302] Assemblies herein may include a distal motion limiter configured to limit distal motion of the introducer relative to an initial position and relative to the first image sensor. For example, assembly 1720 includes a distal motion limiter configured to limit distal motion of introducer 1770 relative to an initial position (e.g., as shown in FIGS. 17C and 17D ) and relative to the first image sensor of first imaging member 1730. In this embodiment, as shown in FIG. 19F , the first end of the introducer is fixed to housing 1744, but the introducer is allowed to be moved axially robotically using an axial motion mechanism (e.g., including mechanical interfaces 1745 and 1747) within housing 1744. By fixing the first end of introducer 1770, in this embodiment there is a limit to how far introducer 1770 can be advanced distally. The length of the introducer outside the housing 1744 between openings 1755 and 1756 in 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 introducer 1770 outside the housing 1744 between openings 1755 and 1756 is very short, the distal motion limiter will significantly impede distal advancement of the introducer relative to the housing 1744.

[0242]

[0303] FIG. 20 schematically illustrates one exemplary integrated handheld dual video assembly 2002 that may incorporate any and all aspects of assembly 1702 and assembly 1702′. Assembly 2002 includes housing 2010, which may incorporate any and all aspects of any of the housings herein (e.g., housing 1710). Assembly 2002 includes cover 2080, which may incorporate any and all aspects of any of the covers herein (e.g., cover 1780). Assembly 2002 optionally includes disposable second imaging member 2040, which may incorporate any and all aspects of any of the second imaging members herein (e.g., second imaging member 1740). Assembly 2002 includes endotracheal tube 2090, which may incorporate any and all aspects 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 aspects of any one of the actuators (e.g., one or more actuators 1761) herein (the actuators can be within housing 2010 and / or within second imaging member 2040, for example). Any of the assemblies (e.g., 1702, 1702') herein can be generalized as shown in the schematic diagram of FIG.

[0243]

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

[0244]

[0305] FIG. 21 illustrates an exemplary method of using any of the assemblies herein. In the illustrated method, an assembled assembly (e.g., assembly 1702) is positioned in a patient's upper airway at step 2110 (e.g., as shown in FIG. 15 ). The method may include having a system processor receive a signal indicative of image data from a first image sensor (e.g., a video camera) of the assembly at step 2120. The method may include processing the signal indicative of the data from the first image sensor at step 2130. The method may include initiating automated or manual robotically controlled movement of an introducer of the assembly away from the assembly's first image source and toward at least one upper airway anatomical landmark while maintaining the first image sensor at the upper airway at step 2140. The method may further include, at step 2150, moving the introducer within the endotracheal tube and advancing it past the glottic opening and into the trachea while at least a portion of the cover of the assembly and the first image sensor remain 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 FIG.

[0245]

[0306] Any of the second elongate imaging members (eg, 1740) may also be referred to herein as a cartridge, as the cartridge may be releasably secured to a housing (eg, housing 1710).

[0246]

[0307] In some variations of the embodiments herein, the system is adapted to allow a remote operator to remotely control the robotic movement of the introducer herein. For example, a first operator may be present with the patient and place the assembly, for example, in the patient's upper airway. The first operator activates operation of the first and / or second image sensors. Image data may be communicated (e.g., wirelessly) to a remote location where a second operator may remotely control the introducer (e.g., using a workstation). The second operator may have a display that displays video data from the first and / or second image sensors. Aside from the fact that the first operator would be directly handling the assembly in these examples, this type of remote control arrangement may provide advantages of the integrated dual-video intubation assembly herein.

[0247]

[0308] Any of the processors herein may have stored thereon a number of computer-executable methods (e.g., software, algorithms) that may be adapted, alone or in combination, to receive one or more inputs that may be indicative of image or video data from one or more image sensors herein, and to determine or contribute to determining a path for the introducer in a number of directions, including causing motion of the introducer such that the introducer is moved to or toward one or more anatomical landmarks. This type of determination or planning is sometimes referred to herein as navigating or part of the navigation process.

[0248]

[0309] It is understood that any feature, component, or method step 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 foregoing description, for purposes of explanation, used specific nomenclature to provide a thorough understanding of the inventions herein. However, it will be apparent to one skilled in the art that specific details may not be required to practice one or more of the inventions herein. Accordingly, the foregoing descriptions of specific embodiments of the inventions herein are presented for purposes of illustration and description.

[0250]

[0311] Although not specifically indicated, one or more techniques or methods described in this disclosure may optionally be implemented, at least in part, in hardware, software, firmware, or any combination thereof. For example, various aspects of the techniques or components may be implemented 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., alone or in any suitable combination. The term "processor" or "processing circuitry" generally refers to any of the above circuitry, whether alone or in combination with other circuitry, or may refer to any other equivalent circuitry. Such hardware, software, or firmware may be implemented within the same device or in separate devices to support the various operations and functions described in this disclosure. Additionally, any of the described units, modules, or components may be implemented together as discrete but interoperable logic devices, or separately. The depiction of different features as modules or units is intended to highlight different functional aspects and does not necessarily imply that such modules or units must be implemented by separate hardware or software components. Rather, the functionality associated with one or more modules or units may be performed by separate hardware or software components or may be integrated within common or separate hardware or software components. When implemented in software, the functionality attributed to the systems, devices, and techniques described in this disclosure may optionally be embodied as instructions on a computer-readable medium, such as, for example, random access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), electrically erasable programmable ROM (EEPROM), flash memory, etc.The instructions (eg, 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 example is an integrated device for robotically assisting in airway management (e.g., intubation) of a patient, the device comprising: a handheld housing; a laryngoscope coupled to the housing and having a first image sensor; an actuation member movable within the housing; an endoscope extending from the actuation member, the endoscope having a second image sensor and configured for removably coupling to an intubation tube; and at least one actuator within the housing configured to automatically guide the endoscope through the actuation member based at least in part on one or more images from at least one of the first image sensor and the second image sensor.

[0252]

[0314] In this embodiment, the device may further include a cover coupled to the housing, the cover including 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 include a first portion including the first channel and a second portion including the second channel, the first portion and the second portion being removably coupled. The cover may include a displacement member configured to retract the patient's tongue during an intubation procedure. The displacement member may be angled or curved. The cover may be configured to be advanced over the patient's tongue into or near the patient's vallecula or below the patient's epiglottis. The distal ends of the first channel and the second channel may be adjacent and substantially parallel. The cover may be removably coupled to the 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 about 40 degrees and about 180 degrees in both the axial and horizontal planes. The viewing angle may be between about 40 degrees and about 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 the first image sensor, the second image sensor, or both, and may be configured to display the images from the first image sensor and the second image sensor in a split screen or picture-in-picture arrangement.

[0255]

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

[0256]

[0318] In this embodiment, the actuation 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 coupled to the housing. At least a portion of the guide may be curved. The guide may be straight. The at least one actuator may be configured to automatically guide the actuation member within the guide. The actuation member may be manually movable within the guide. This embodiment may further include a user input device aligned with the guide and coupled to the actuation member to enable manual control of movement of the actuation member within the guide. The actuation member is longitudinally translatable within the guide, thereby longitudinally advancing and retracting the endoscope. The at least one actuator is configured to automatically articulate the distal end of the endoscope. The 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 the first image sensor or the second image sensor. The at least one processor may be configured to process the one or more images by identifying at least one recognizable anatomical feature. The at least one processor may be configured to identify the at least one anatomical feature by applying a trained machine learning algorithm to the one or more images. The at least one processor may be configured to control at least one actuator to automatically guide the endoscope toward the at least one anatomical feature. The at least one processor may be configured to initiate control of the at least one actuator based on one or more images from the laryngoscope. The at least one processor may be configured to automatically guide the endoscope toward the at least one anatomical feature based on one or more images from the laryngoscope, one or more images from the endoscope, or both. The at least one processor may be configured to initiate control of the at least one actuator based on one or more images from the endoscope.

[0258]

[0320] In this embodiment, the endoscope may be removably coupled to the actuation member.

[0259]

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

[0260]

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

[0261]

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

[0262]

[0324] In this embodiment, the endoscope comprises a flexible member, although the endoscope may also comprise a rigid stylet having a deflectable distal end.

[0263]

[0325] In this embodiment, the device is operable by a single user.

[0264]

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

[0265]

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

[0266]

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

[0267]

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

[0268]

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

[0269]

[0331] In this example, the device may be configured to assist in orotracheal intubation, or the device may be configured to assist in nasotracheal intubation.

[0270]

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

[0271]

[0333] A third additional embodiment is an integrated robotic device adapted for airway management, the device comprising: a handheld housing; an actuation member movable within the housing and connectable to an introducer having an image sensor; and at least one actuator within the housing configured to automatically move the actuation member based at least in part on one or more images from the image sensor. [Aspect 1] 1. An intubation system, comprising: an integrated handheld dual video tracheal intubation assembly ("assembly") sized and configured to be held by one hand of a user, said assembly comprising: Housing and; a first elongate imaging member including an elongate body and a first video camera disposed at a distal region of the elongate body; a disposable second elongated imaging member sized and configured to be releasably coupled to the housing to create operable communication therebetween, the disposable second elongated imaging member including a flexible elongated endotracheal tube introducer ("introducer") sized to be positioned within the endotracheal tube and to allow the endotracheal tube to be moved axially thereover, and a second video camera disposed at a distal region of the introducer; A cover sized and configured to be releasably coupled to said housing, said cover including: an elongated channel defining an elongated lumen, the elongated channel being sized and dimensioned such that at least a portion of the elongated body of the first imaging member is disposed within the elongated lumen; and a cover including an endotracheal tube channel sized and dimensioned to releasably secure the endotracheal tube, the endotracheal tube including a lumen sized to receive the introducer therein, to the endotracheal tube channel and to limit movement of the endotracheal tube relative to the cover relative to the endotracheal tube channel in at least one direction; an actuator disposed within the housing and configured to be in operative communication with the introducer when the disposable second elongate imaging member is releasably coupled to the housing, such that the actuator is configured to be activated to facilitate the controlled movement of the introducer and the second video camera relative to the first video camera; the assembly is configured such that when the endotracheal tube is interfaced with the endotracheal tube channel and the disposable second elongate imaging member is releasably coupled to the housing, the assembly positions the first video camera at an initial distance from the second video camera prior to actuation of the actuator. [Aspect 2] 2. The system of claim 1, the system further comprising a processor configured to receive as input one or more of information indicative of a signal of one or more upper airway anatomical landmarks from the first video camera or information indicative of a signal 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 robotic movement of the introducer and the second video camera relative to the first video camera. Aspect 3 In the system of aspect 1, The system includes a first video camera having a first angle of view and a second video camera having a second angle of view, the first angle of view being greater than the second angle of view, and the first video camera provides visualization of a wider area of ​​the patient's upper airway anatomy as compared to the second video camera when the introducer and the second video camera are moved relative to the first video camera. Aspect 4 In the system of aspect 1, The system is further configured such that, when the endotracheal tube is releasably coupled to the endotracheal tube channel and the disposable second elongate imaging member is releasably coupled to the housing and extends through the endotracheal tube lumen, the first video camera is maintained at an initial axial distance of no more than 3 cm relative to the second video camera prior to actuation of the actuator. Aspect 5 In the system of aspect 1, The assembly is sized and configured so that when the second imaging member is coupled to the housing, the cover is releasably coupled to the housing, and the endotracheal tube is releasably coupled to the endotracheal tube channel, the assembly including the first video camera and the second video camera can be moved as an integrated unit with the user's one hand. Aspect 6 In the system of aspect 1, The system, wherein the actuator is configured to facilitate one or more of the controlled axial navigation or the controlled deflection of the introducer and the second video camera relative to the first video camera. Aspect 7 In the system of aspect 1, The system includes: a first imaging member having a length; a first video camera having an angle of view; and the endotracheal tube channel of the cover having a configuration adapted to visualize the axial control movement of the introducer relative to the first video camera when a portion of the introducer is moved within the endotracheal tube lumen. Aspect 8 In the system of aspect 1, The system wherein the first video camera is maintained in substantial axial alignment with the second video camera prior to actuation of the actuator. Aspect 9 In the system of aspect 1, 2. The system of claim 1, wherein the first video camera is maintained in axial alignment with the second video camera prior to actuation of the actuator. Aspect 10 In the system of aspect 1, The system wherein prior to actuation of the actuator, the second video camera is maintained at an initial axial distance of no more than 3 cm from the first video camera. Aspect 11 In the system of aspect 10, The system wherein prior to actuation of the actuator, the second video camera is maintained at a horizontal distance of no more than 4 cm from the first video camera. Aspect 12 In the system of aspect 1, The system, wherein the actuator is configured to facilitate controlled distal movement of the introducer of at least 2 cm relative to an initial position of the introducer. Aspect 13 In the system of aspect 1, The system, wherein the assembly further comprises a distal movement limiter configured to limit distal movement of the introducer relative to the initial position and relative to the first video camera. Aspect 14 In the system of aspect 13, The system, wherein 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. Aspect 15 In the system of aspect 13, The system, wherein the assembly is configured to prevent the introducer from being moved distally more than 40 cm from the initial position. Aspect 16 In the system of aspect 13, The system, wherein the assembly is configured to prevent the introducer from being moved distally more than 30 cm from the initial position. Aspect 17 In the system of aspect 1, The system, wherein the actuator is configured to facilitate controlled distal movement of the introducer of at least 5 cm relative to an initial position of the introducer. Aspect 18 In the system of aspect 1, The system, wherein the disposable second elongated imaging member comprises a disposable housing, the proximal end of the introducer is disposed within and fixed to the disposable housing, and a section of the introducer distal to the proximal end is movable relative to the disposable housing. Aspect 19 In the system of embodiment 18, The disposable housing has a window through which the introducer extends outside the disposable housing. Aspect 20 2. The system of claim 1, The system further comprises a manually activated controller for facilitating manual robotic movement of the introducer relative to the first video camera. Aspect 21 In the system of embodiment 20, The system is further adapted to allow 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. Aspect 22 In the system of aspect 1, The system is further adapted to allow manual robotic control of the introducer when the introducer is positioned within the upper airway and the first video camera is positioned within the upper airway. Aspect 23 In the system of aspect 1, The system wherein the disposable second elongate imaging member comprises one or more introducer deflection actuators. Aspect 24 24. The system of claim 23, A system wherein the one or more introducer deflection actuators are adapted to rotate. Aspect 25 24. The system of claim 23, further comprising: The system further comprises a plurality of pull wires extending through the introducer that, when tensioned, cause deflection of the introducer, at least one pull wire secured to each of the one or more introducer deflection actuators such that movement of the deflection actuator tensions the at least one pull wire secured thereto. Aspect 26 26. The system of claim 25, The system, wherein the disposable second elongate imaging member further comprises a plurality of introducer axial motion actuators. Aspect 27 27. The system of claim 26, The introducer extends between a first introducer axial movement actuator and a second introducer axial movement actuator, such that movement of the first introducer axial movement actuator and the second introducer axial movement actuator causes axial movement of the introducer. Aspect 28 28. The system of claim 27, A system wherein a section of the introducer is outside the disposable housing proximal to the first and second introducer axial motion actuators. Aspect 29 24. The system of claim 23, The system wherein each of the one or more introducer deflection actuators is in operative communication with a rotary actuator disposed within the housing. Aspect 30 30. The system of claim 29, The rotary actuator is in operative communication with a motor disposed within the housing. Aspect 31 In the system of aspect 1, The system wherein the disposable second elongate imaging member comprises a plurality of introducer axial motion actuators. Aspect 32 32. The system of claim 31, The system wherein the plurality of introducer axial motion actuators have geared interfaces. Aspect 33 32. The system of claim 31, The system wherein the introducer extends between a first introducer axial movement actuator and a second introducer axial movement actuator. Aspect 34 In the system of aspect 1, The system, wherein the disposable second elongated imaging member has an opening facing the housing when coupled to the housing, and the housing has a sensor positioned to sense axial movement of the introducer through the opening facing the housing. Aspect 35 1. A method of intubating a patient, the method comprising: Positioning an integrated handheld dual video tracheal intubation assembly ("assembly") within a patient's upper airway, the assembly being sized and configured to be held by one hand of a user, said assembly comprising: Housing and; a first elongated imaging member extending from the housing, the first elongated imaging member including an elongated body and a first video camera disposed at a distal region of the elongated body; a disposable second elongated imaging member releasably coupled to the housing to create operable communication therebetween, the disposable second elongated imaging member including a flexible elongated endotracheal tube introducer ("introducer") sized to be positioned within the endotracheal tube and to allow the endotracheal tube to be moved axially thereover, and a second video camera positioned at a distal region of the introducer; a cover releasably connected to said housing, said cover including: an elongated channel defining an elongated lumen, the elongated channel being sized and dimensioned such that at least a portion of the elongated body of the first imaging member is disposed within the elongated lumen; and a cover including an endotracheal tube channel sized and dimensioned to interface with the endotracheal tube including a lumen sized to receive the introducer therein and to limit movement of the endotracheal tube relative to the cover relative to the endotracheal tube channel in at least one direction; an actuator disposed within the housing and configured to facilitate the robotically controlled movement of the introducer and the second video camera relative to the elongate body and the first video camera; causing said movement of said introducer through the larynx and into the trachea while maintaining said first video camera within said upper airway; displaying a video signal indicative of one or more upper airway landmarks from the first video camera while the first video camera is maintained within the upper airway; displaying a video signal from the second video camera while the introducer and the second video camera are in the trachea; advancing the endotracheal tube over the introducer, through the larynx, and into the trachea while the video signal from the first video camera in the upper airway is displayed and a video signal from a second video camera is displayed; the first video signal providing a view of an exterior surface of the endotracheal tube as the endotracheal tube is advanced toward the larynx; advancing the endotracheal tube, the second video signal providing a view of the endotracheal tube within the trachea as it is advanced over the introducer; confirming placement of the endotracheal tube in the trachea using the second video signal while the first video camera is maintained in the upper airway; and removing the system from the patient while leaving the endotracheal tube in the trachea. Aspect 36 36. A method according to embodiment 35, comprising: The method further comprising the step of causing the processor to receive the first video signal while the first video camera is maintained within the upper airway above the vocal cords. Aspect 37 37. The method of claim 36, wherein causing the movement of the introducer through the larynx and into the trachea while maintaining the first video camera in the upper airway comprises causing the robotically controlled movement of the introducer through the larynx and into the trachea automatically. Aspect 38 37. The method of claim 36, wherein causing the movement of the introducer through the larynx and into the trachea while maintaining the first video camera in the upper airway comprises causing the robotically controlled movement of the introducer through the larynx and into the trachea manually. Aspect 39 37. A method according to embodiment 36, comprising: The method further comprising the step of causing the processor to receive the second video signal when the introducer is positioned within the trachea. Aspect 40 36. A method according to embodiment 35, comprising: The method further comprises the steps of distally moving the introducer to a position within the trachea and providing visualization of the tracheal carina. Aspect 41 36. The method of 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 and movement of an endotracheal tube toward and through the larynx. Aspect 42 1. An intubation system, comprising: an integrated handheld dual video tracheal intubation assembly ("assembly") sized and configured to be held by one hand of a user, said assembly comprising: Housing and; a first elongate imaging member including an elongate body and a first video camera disposed at a distal region of the elongate body; a disposable second elongated imaging member sized and configured to be releasably coupled to the housing to create operable communication therebetween, the disposable second elongated imaging member including a flexible elongated endotracheal tube introducer ("introducer") sized to be positioned within the endotracheal tube and to allow the endotracheal tube to be moved axially thereover, and a second video camera disposed at a distal region of the introducer; A cover sized and configured to be releasably coupled to said housing, said cover including: an elongated channel defining an elongated lumen, the elongated channel being sized and dimensioned such that at least a portion of the elongated body of the first imaging member is disposed within the elongated lumen; and a cover including an endotracheal tube channel sized and dimensioned to releasably secure the endotracheal tube, the endotracheal tube including a lumen sized to receive the introducer therein, to the endotracheal tube channel and to limit movement of the endotracheal tube relative to the cover relative to the endotracheal tube channel in at least one direction; an actuator disposed within the housing and configured to be in operative communication with the introducer when the disposable second elongate imaging member is releasably coupled to the housing, such that the actuator is configured to be activated to facilitate the controlled movement of the introducer and the second video camera relative to the first video camera; the elongated channel of the cover and the endotracheal tube channel are positioned and arranged such that when the cover is connected to the housing and the endotracheal tube is secured to the endotracheal tube channel, the second video camera can be positioned axially within 3 cm of the first video camera. Aspect 43 43. The system of claim 42, The elongated channel of the cover and the endotracheal tube channel are positioned and arranged such that when the second video camera is positioned within 3 cm of the first video camera in an axial direction, the second video camera is not further positioned more than 4 cm horizontally from the first video camera. Aspect 44 44. The system of claim 43, The elongated channel of the cover and the endotracheal tube channel are positioned and arranged such that when the second video camera is positioned within 3 cm of the first video camera in an axial direction, the second video camera is not further positioned more than 3 cm horizontally from the first video camera. [Explanation of symbols]

[0272] 61a, 61b, 61c Navigation Wheel 62, 63 Antagonistic Cable 64a, 64b, 64c Antagonistic Cable Set 100 Integrated robotic device or system 110 Housing 112 processors 114 Electronic equipment 116 Actuator 118 Display 120 Laryngoscope 140 Actuating member 150 Endoscope 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'' actuator 216a Axial Actuator 216r Rotary Actuator 217, 217', 217'' Guide 218 Display 220 Baton 222 Image Sensor 240, 240', 240'' operating member 250 Endoscope 250d distal end region 252 Image Sensor 260 Cover 262, 263 Connection 264 first channel, first imaging member channel 266 Second channel, intubation tube channel 267 Fasteners 268 Displacement member 269 ​​Separable joint area 270 User Interface Devices 272 Control member guide 274 Control Members 276 Control Wire 278 Upper Connection 279 Side Connection 280 AI operation button 282 User Interface Elements 284 STOP button 290 Selective Button 600 Devices for joint movement 650 Devices for joint movement 1100 Device or assembly 1110 Handheld Housing 1117 Introducer Guide 1118 Display 1130 Universal Docking Station 1150 Introducer 1160 Cover or blade 1200 Handheld Housing 1210 Housing 1216 Actuator 1217 Introducer Coupler 1218 Display 1222 Introducer Coupler 1240 Robot extensions or actuating members 1250 Introducer 1260 Removable Cover 1270 Robot Block 1272 Block Coupler 1400 Intubation system or assembly 1410 Handheld Housing 1413 Motor connection part 1450 Introducer 1460 Cover 1461 Tracheal Tube Channel 1462 first imaging member channel 1490 Introducer Housing 1491 Fixing location of introducer to housing 1492 Housing body 1493 Aperture 1494a, 1494b Rollers or wheels 1495 Electrical connection of introducer housing, electrical coupling 1496 Motor connection part 1497 Aperture 1499 Introducer assembly 1700 Intubation System 1702, 1702' assembly 1710 Housing 1711 Housing body 1712 first imaging member coupler 1713 Housing Channel 1714 Second imaging member coupler 1716 Cover coupler 1720 Communication area 1721, 1722, 1723 Mechanical Interface 1724 Optical Sensor 1725 Electrical Connector 1730 first elongated imaging member 1732 Elongated flexible body 1734 First Image Sensor 1736 a distal region of the elongated body 1732 1740 second elongated imaging member 1741 Mechanical Interface 1742 Second Connected Region 1743 Mechanical Interface 1744 Housing 1745 Mechanical Interface 1746 second imaging member communication region 1747 Mechanical Interface 1748 Windows or openings 1749 Electrical Connector 1750 Endotracheal Tube Coupler 1751 Elements in Housing 1752 Pull Wire Channel 1753, 1754 Pull wire connection location 1755, 1756 windows 1757 First and second pull wires 1770 Endotracheal Tube Introducer 1772 Distal region of introducer 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 1803 Example location for USB hub 1804 Axial drive motor 1805 First and second deflection (or articulation) drive motors 2002 Integrated Handheld Dual Video Assembly 2010 Housing 2040 Second imaging member 2061 Actuator 2080 Cover 2090 Endotracheal tube ETT endotracheal tube A axis direction H horizontal direction L is the axial location of the first and second image sensors F Manual forward movement L leftward movement R Rightward movement

Claims

1. 1. An intubation system, comprising: an integrated handheld dual video tracheal intubation assembly ("assembly") sized and configured to be held by one hand of a user, said assembly comprising: Housing and; a first elongate imaging member including an elongate body and a first video camera disposed at a distal region of the elongate body; a disposable second elongated imaging member sized and configured to be releasably coupled to the housing to create operable communication therebetween, the disposable second elongated imaging member including a flexible elongated endotracheal tube introducer ("introducer") sized to be positioned within the endotracheal tube and to allow the endotracheal tube to be moved axially thereover, and a second video camera disposed at a distal region of the introducer; A cover sized and configured to be releasably coupled to said housing, said cover including: an elongate channel defining an elongate lumen, the elongate channel being sized and dimensioned such that at least a portion of the elongate body of the first elongate imaging member is disposed within the elongate lumen; and a cover including an endotracheal tube channel sized and dimensioned to releasably secure the endotracheal tube, the endotracheal tube including a lumen sized to receive the introducer therein, to the endotracheal tube channel and to limit movement of the endotracheal tube relative to the cover relative to the endotracheal tube channel in at least one direction; an actuator disposed within the housing and configured to be in operative communication with the introducer when the disposable second elongate imaging member is releasably coupled to the housing, such that the actuator is configured to be activated to facilitate the controlled movement of the introducer and the second video camera relative to the first video camera; the assembly is configured such that when the endotracheal tube is interfaced with the endotracheal tube channel and the disposable second elongate imaging member is releasably coupled to the housing, the assembly positions the first video camera at an initial distance from the second video camera prior to actuation of the actuator.

2. 10. The system of claim 1, The system further comprises a processor configured to receive as input one or more of information indicative of signals of one or more upper airway anatomical landmarks from the first video camera or information indicative of 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 robotic movement of the introducer and the second video camera relative to the first video camera.

3. 3. The system of claim 2, The system includes a first video camera having a first angle of view and a second video camera having a second angle of view, the first angle of view being greater than the second angle of view, and the first video camera provides visualization of a wider area of ​​the patient's upper airway anatomy as compared to the second video camera when the introducer and the second video camera are moved relative to the first video camera.

4. 10. The system of claim 1, The system is further configured such that, when the endotracheal tube is releasably coupled to the endotracheal tube channel and the disposable second elongate imaging member is releasably coupled to the housing and extends through the lumen of the endotracheal tube, the first video camera is maintained at an initial axial distance of no more than 3 cm relative to the second video camera prior to actuation of the actuator.

5. 10. The system of claim 1, the assembly is sized and configured so that when the disposable second elongated imaging member is coupled to the housing, the cover is releasably coupled to the housing, and the endotracheal tube is releasably coupled to the endotracheal tube channel, the assembly including the first video camera and the second video camera can be moved as an integrated unit with the user's one hand.

6. 10. The system of claim 1, The system, wherein the actuator is configured to facilitate one or more of controlled axial navigation or controlled deflection of the introducer and the second video camera relative to the first video camera.

7. 10. The system of claim 1, The system includes: a first elongated imaging member having a length; a first video camera having an angle of view; and an endotracheal tube channel of the cover configured such that the first video camera is adapted to visualize the controlled axial movement of the introducer relative to the first video camera when a portion of the introducer is moved within the lumen of the endotracheal tube.

8. 10. The system of claim 1, The system wherein the first video camera is maintained in substantial axial alignment with the second video camera prior to actuation of the actuator.

9. 10. The system of claim 1, The system of claim 1 , wherein the first video camera is maintained in axial alignment with the second video camera prior to actuation of the actuator.

10. 10. The system of claim 1, The system wherein prior to actuation of the actuator, the second video camera is maintained at an initial axial distance of no more than 3 cm from the first video camera.

11. 11. The system of claim 10, The system wherein prior to actuation of the actuator, the second video camera is maintained at a horizontal distance of no more than 4 cm from the first video camera.

12. 10. The system of claim 1, The system, wherein the actuator is configured to facilitate controlled distal movement of the introducer of at least 2 cm relative to an initial position of the introducer.

13. 10. The system of claim 1, The system, wherein the assembly further comprises a distal movement limiter configured to limit distal movement of the introducer relative to an initial position of the introducer and relative to the first video camera.

14. 14. The system of claim 13, The system, wherein the distal movement 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. 14. The system of claim 13, The system, wherein the assembly is configured to prevent the introducer from being moved distally more than 40 cm from the initial position of the introducer.

16. 14. The system of claim 13, The system, wherein the assembly is configured to prevent the introducer from being moved distally more than 30 cm from the initial position of the introducer.

17. 10. The system of claim 1, The system, wherein the actuator is configured to facilitate controlled distal movement of the introducer of at least 5 cm relative to an initial position of the introducer.

18. 10. The system of claim 1, The system, wherein the disposable second elongated imaging member comprises a disposable housing, the proximal end of the introducer is disposed within and fixed to the disposable housing, and a section of the introducer distal to the proximal end is movable relative to the disposable housing.

19. 20. The system of claim 18, The disposable housing has a window through which the introducer extends outside the disposable housing.

20. 3. The system of claim 2, The system further comprises a manually activated controller for facilitating manual robotic movement of the introducer relative to the first video camera.

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

22. 3. The system of claim 2, The system is further adapted to allow manual robotic control of the introducer when the introducer is positioned within the upper airway of the patient and the first video camera is positioned within the upper airway.

23. 10. The system of claim 1, The system wherein the disposable second elongate imaging member comprises one or more introducer deflection actuators.

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

25. 24. The system of claim 23, The system further comprises a plurality of pull wires extending through the introducer that, when tensioned, cause deflection of the introducer, at least one pull wire secured to each of the one or more introducer deflection actuators such that movement of the introducer deflection actuator tensions the at least one pull wire secured thereto.

26. 26. The system of claim 25, The system, wherein the disposable second elongate imaging member further comprises a plurality of introducer axial motion actuators.

27. 27. The system of claim 26, The introducer extends between a first introducer axial movement actuator and a second introducer axial movement actuator, such that movement of the first introducer axial movement actuator and the second introducer axial movement actuator causes axial movement of the introducer.

28. 28. The system of claim 27, A system wherein a section of the introducer is outside the disposable housing proximal to the first and second introducer axial motion actuators.

29. 24. The system of claim 23, The system wherein each of the one or more introducer deflection actuators is in operative communication with a rotary actuator disposed within the housing.

30. 30. The system of claim 29, The rotary actuator is in operative communication with a motor disposed within the housing.

31. 10. The system of claim 1, The system wherein the disposable second elongate imaging member comprises a plurality of introducer axial motion actuators.

32. 32. The system of claim 31, The system wherein the plurality of introducer axial motion actuators have geared interfaces.

33. 32. The system of claim 31, The introducer extends between a first introducer axial movement actuator and a second introducer axial movement actuator.

34. 10. The system of claim 1, The system, wherein the disposable second elongated imaging member has an opening facing the housing when coupled to the housing, and the housing has a sensor positioned to sense axial movement of the introducer through the opening facing the housing.

35. 1. An intubation system, comprising: an integrated handheld dual video tracheal intubation assembly ("assembly") sized and configured to be held by one hand of a user, said assembly comprising: Housing and; a first elongate imaging member including an elongate body and a first video camera disposed at a distal region of the elongate body; a disposable second elongated imaging member sized and configured to be releasably coupled to the housing to create operable communication therebetween, the disposable second elongated imaging member including a flexible elongated endotracheal tube introducer ("introducer") sized to be positioned within the endotracheal tube and to allow the endotracheal tube to be moved axially thereover, and a second video camera disposed at a distal region of the introducer; A cover sized and configured to be releasably coupled to said housing, said cover including: an elongate channel defining an elongate lumen, the elongate channel being sized and dimensioned such that at least a portion of the elongate body of the first elongate imaging member is disposed within the elongate lumen; and a cover including an endotracheal tube channel sized and dimensioned to releasably secure the endotracheal tube, the endotracheal tube including a lumen sized to receive the introducer therein, to the endotracheal tube channel and to limit movement of the endotracheal tube relative to the cover relative to the endotracheal tube channel in at least one direction; an actuator disposed within the housing and configured to be in operative communication with the introducer when the disposable second elongate imaging member is releasably coupled to the housing, such that the actuator is configured to be activated to facilitate the controlled movement of the introducer and the second video camera relative to the first video camera; the elongated channel of the cover and the endotracheal tube channel are positioned and arranged such that when the cover is connected to the housing and the endotracheal tube is secured to the endotracheal tube channel, the second video camera can be positioned axially within 3 cm of the first video camera.

36. 36. The system of claim 35, The elongated channel of the cover and the endotracheal tube channel are positioned and arranged such that when the second video camera is positioned within 3 cm of the first video camera in an axial direction, the second video camera is not further positioned more than 4 cm horizontally from the first video camera.

37. 37. The system of claim 36, The elongated channel of the cover and the endotracheal tube channel are positioned and arranged such that when the second video camera is positioned within 3 cm of the first video camera in an axial direction, the second video camera is not further positioned more than 3 cm horizontally from the first video camera.

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