WO2025199090A1

WO2025199090A1 - Airway management devices, systems and methods of use and assembly

Info

Publication number: WO2025199090A1
Application number: PCT/US2025/020354
Authority: WO
Inventors: Vladimir Nekhendzy; Dimitri Sokolov
Original assignee: Spiro Robotics Inc
Current assignee: Spiro Robotics Inc
Priority date: 2024-03-18
Filing date: 2025-03-18
Publication date: 2025-09-25
Anticipated expiration: 2026-09-18

Abstract

Handheld robotic systems that include a robotically controllable elongate introducer, a handheld portion, an optional elongate external introducer, and an endotracheal tube ("ETT"). Methods of providing airway access that include robotically controlling an ETT introducer to facilitate ETT placement. Detachable clips for releasably attaching to a laryngoscope to create a removable ETT channel.

Description

AIRWAY MANAGEMENT DEVICES, SYSTEMS AND METHODS OF USE AND

ASSEMBLY

INCORPORATION BY REFERENCE

[0001] This application claims priority to U.S. Prov. App. No. 63/566,837, filed March 18, 2024, the entire disclosure of which is incorporated by reference herein in its entirety.

[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.

[0003] The following references are incorporated by reference herein in their entireties for any and all purposes: WO2021/236677, W02023/060241, and WO/2023/164434A2.

BACKGROUND

[0004] Improved and/or differentiated airway access and/or management (e.g., for intubation) devices, systems, and methods of use and assembly are needed.

SUMMARY OF THE DISCLOSURE

[0005] The disclosure herein relates to airway access and/or management methods, devices and systems. While tracheal intubation is provided as an example of airway access/management herein, it is understood that the disclosure is not so limited, and that the concepts herein may be applied or applicable to other airway management procedures and settings. For example, concepts herein may be used in bronchoscopy procedures or in ENT procedures such as endoscopies (e.g. flexible nasolaryngoscopy, esophagoscopy, etc.), and endoscopy-assisted surgical airway procedures (e.g. vocal cord injections, laryngologic surgery, etc.).

[0006] The disclosure herein is related to universal handheld robotic systems and optional methods of use with direct laryngoscopes or video laryngoscopes (e.g., Glidescope® video laryngoscope, C-MAC system video laryngoscope, McGrath™ video laryngoscope, etc.). Direct laryngoscopes (“DL”) and video laryngoscopes (“VL”) described herein may be referred to generally as laryngoscopes.

[0007] Aspects of this disclosure include a multi-purpose robotic system including a controllable elongate device (examples of which include the introducers herein) and one or more actuators adapted to robotically control movement of the controllable elongate device in one or more of x (+x, -x), y (+y, -y), or z (forward/distal, backward/proximal (axial)) directions. The endotracheal tube (“ETT”) introducers 1770 in the WO2021/236677 (‘677) publication (for example) may be or have any features of any of the elongate devices herein (see FIGS. 17A-19K in the WO2021/236677 publication, for example). The universal handheld robotic systems herein generally refer to systems and devices that optionally may be used with a blade (coupled to the blade (directly or indirectly), or completely uncoupled from the blade) and that are adapted for manual and/or automatic robotic movement of an elongate device (optionally an endotracheal tube introducer). The robotic systems herein may be re-usable in that they may be used for multiple procedures and with different types of VL and DL devices.

[0008] An exemplary and optional aspect of the disclosure is related to assemblies that include a blade that is coupled (directly or indirectly) to a robotically controlled endotracheal tube introducer, where the introducer is adapted to facilitate introduction of an endotracheal tube over the introducer and into a trachea. The blade is optionally part of a traditional “VL” (or having other vision capabilities), but it may be part of a “DL” without a camera. Dual-camera assemblies, examples of which are described in WO2021/236677 and which are fully incorporated by reference herein, can provide advantages over single camera systems. Some assemblies herein can provide one or more of the same advantages, such as having first and second cameras aligned or substantially aligned during at least a portion of the procedure, which is described in more detail in WO2021/236677. Even if a blade herein is not part of a VL, however (e.g., no “first” camera), the robotically controlled ETT introducers herein can provide visualization (e.g., via its own camera at a distal end thereof).

[0009] One or more aspects of the “robotic block” concept from WO2021/236677 (e.g., FIGS. 12 and 13) may be incorporated into one or more examples herein. For example, universal robotic systems herein may be releasable coupled to VL or DL in a manner similar to how robotic blocks from WO2021/236677 are releasable coupled to a first camera device (e.g., VL).

[0010] An exemplary and optional aspect of the disclosure is related to assemblies that include a blade that is not coupled at all (i.e., uncoupled) to a robotically controlled endotracheal tube introducer, where the introducer is adapted to facilitate introduction of an endotracheal tube over the introducer and into a trachea. In this aspect, a universal handheld robotic system can be used with a VL or DL without being coupled to the VL or DL at all (two freestanding devices/sy stems), but optionally if used with a VL can be used under guidance from the video from a VL. In this aspect, however, while the robotic system can be used uncoupled from a VL or DL, other features herein may be implemented such that the robotic system can optionally be coupled to the VL or DL (e.g., one or more side channels, retaining elements, hooks, etc.).

[0011] One aspect of this disclosure is related to a robotic system, optionally handheld.

[0012] In this aspect, the system optionally includes a robotically controlled elongate inner introducer with a camera at a distal end thereof.

[0013] In this aspect, the system optionally includes a handheld portion. The optional handheld portion optionally includes at least one actuator in operable communication with the introducer to facilitate the robotic control of the inner introducer in at least one direction, and optionally a user interface element in operable communication with the at least one actuator, the user interface element adapted to respond to user interaction therewith to cause activation of the at least one actuator.

[0014] In this aspect, the system optionally includes an elongate external introducer having a lumen (channel) therein, the lumen sized to accommodate the inner introducer therethrough. The optional external introducer may comprise a rigid section, or a malleable section whose shape is changeable upon the external application of force and maintained when the force is no longer applied (e.g., bent).

[0015] In this aspect, the system optionally includes an endotracheal tube (“ETT”) that is sized and configured to receive the external introducer therethrough.

[0016] In this aspect, optionally when the inner introducer is positioned in the external introducer and the external introducer is positioned within the ETT, the inner introducer and the ETT assume the shape of the rigid or malleable section of the external introducer. [0017] One aspect of the disclosure is a detachable clip for a laryngoscope to create a removable ETT channel.

[0018] In this aspect, the clip optionally includes first, second and third side portions that define an inner channel with a side opening, the second portion extending between the first and third portions, and the side opening extending between the first and third portions, the side opening sized to allow an endotracheal tube to the positioned through the side opening and be partially surrounded by the clip and the laryngoscope, wherein the clip is configured to be releasably attached to a curved portion of a laryngoscope such that when coupled to the curved portion, the clip and at least one surface of the laryngoscope create a channel for the ETT (and optionally for an introducer with the ETT).

BRIEF DESCRIPTION OF THE FIGURES

[0019] FIGS. 1A, IB, 1C and ID illustrate an exemplary robotically controlled introducer and endotracheal tube. [0020] FIGS. 2A, 2B, 2C, 2D and 2E illustrate an exemplary existing system including a blade and stylet.

[0021] FIGS. 3A, 3B, 3C, 3D, 3E and 3F illustrate an exemplary handheld robotic system with exemplary inner and external introducers.

[0022] FIGS. 4A, 4B, 4C and 4D illustrate an exemplary existing VL.

[0023] FIGS. 5A, 5B, 5C, 5D, 5E, 5F, 5G, 5H, 51, 5J, 5K, and 5L illustrate an existing securing member or clip configured to be releasable attached to a blade to create an ETT channel.

[0024] FIGS. 6A, 6B, 6C, 6D, 6E, 6F, 6G, 6H, 61, 6J, 6K, and 6L illustrate an existing securing member or clip configured to be releasable attached to a blade to create an ETT channel.

[0025] FIG. 7 illustrates an exemplary handheld robotic system that includes inner and external introducers for placing an ETT.

DETAILED DESCRIPTION

[0026] As set forth above, an aspect of this disclosure is related to robotic systems and is related to the disclosure in WO2021/236677. WO2021/236677 includes exemplary assemblies with robotically controlled ETT introducers (e.g., in FIGS. 17A-21), and the robotic systems herein can include one or more components of the assemblies in WO2021/236677. For example, the universal, handheld robotic systems herein (also referred to herein as universal robotic systems or simply robotic systems) can include any of the electronic and/or actuators in WO2021/236677 to robotically control movement of the introducer in one or more of x (+x, -x), y (+y, -y), and z (forward/distal, backward/proximal (axial)) directions. For example, the ETT introducers 1770 in the ‘677 publication may be or have any features of any of the introducers herein (see FIGS. 17A-19K in the ‘677 publication, for example). Additionally for example, any of the electronics and/or actuators described in WO2021/236677 (for example only: pull-wires, gears, motor(s), processors, power sources, memory, software, hardware) may also be included in any of the universal robotic systems herein to facilitate robotic control of the introducers herein.

[0027] FIGS. 1 A and 1C (side-view) illustrate a merely exemplary universal robotic system 1740 including robotically controllable introducer 1770, and a body or housing 1744 that is adapted and configured to robotically control movement of the introducer in any of the directions herein (x, y and/or z). Body or housing 1744 may comprise a plurality of bodies or housing coupled together and does not necessarily require any particular implementation other than to be configured and arranged to robotically control movement of introducer 1770. [0028] FIGS. IB and ID illustrate an exemplary ETT 1745 with optional coupler 1746 at its proximal end (as shown), the coupler 1746 sized and configured to facilitate coupling to optional coupler 1750 of the robotic system (shown in FIGS. 1A and 1C), which may be part of, or integral with, body 1744. Coupler 1750 may have an annular configuration with a channel therein sized and configured to receive therein and interface with an annular configuration of coupler 1746 of the ETT. WO2021/236677 describes exemplary ETT coupling features that may be implemented into any of the robotic systems herein. The ETT is sized and configured to be positioned over controllable introducer 1770 and can be coupled to robotic system ETT coupler 1750.

[0029] Body or housing 1744, which may also be referred to herein as a “box,” may include any of the electronics and/or actuators (and any other component) configured and arranged to robotically control movement of introducer 1770.

[0030] Additionally, the body or housing can include one or more controls 1747 (shown in FIG. 1C), such as buttons, a joystick, or any other desired user control that is adapted to respond to user interaction therewith, examples of which are described in WO2021/236677. User controls may be adapted and configured to facilitate manual robotic control of the introducer or may be used to initiate automatic robotic control (or a combination thereof). [0031] Any of the introducers herein (e.g. introducer 1770) may be adapted to be uncoupled and removed from the body or box 1744. For example, the introducer can be removed, and the body 1744 can be reused with a new or different introducer. Different types of introducers may optionally be used with a single body 1744, such as introducers of different sizes (e.g., lengths) and/or introducers used for different types of medical procedures.

[0032] It is understood that universal robotic system 1740 is exemplary, and other universal robotic systems may have different arrangements. For example, robotic handheld system 1740 includes a looped region of the introducer that is disposed outside of body 1744, as shown, which is described in more detail in WO2021/236677, while in other arrangements, for example, a looped region of the introducer may be disposed within body 1744.

[0033] Examples below provide exemplary implementations of assemblies and methods that incorporate any of the universal handheld robotic systems herein with a blade, wherein the blade may be part of a VL or a DL. It is understood that the Examples herein may include features or concepts that can be incorporated into any other example (and optionally are incorporated into any other example by reference) unless specifically indicated to the contrary.

[0034] Example 1 [0035] FIGS. 2A, 2B, 2C, 2D and 2E illustrate an exemplary prior art system (the disclosure of which is part of Example 1 described in detail below) and assembly including a “Bullard” scope with blade (the top component in FIG. 2A), including a blade tip, fiberoptic channel and LED, as shown and labeled directly in the figures. The back of the blade 1749 includes grooves 1748 on either side, as shown in FIG. 2C. FIG. 2A also illustrates a second component of the system, which includes an attachment arm as labeled (configured to attach to the Bullard blade), and a hollow metal tube (or stylet) longer than the attachment arm, which is shaped to resemble the shape of a groove on the back of the blade, and which allows an ETT to be positioned over the metal tube so that the ETT can be positioned adjacent the groove when the attachment arm is attached to the attachment arm coupler (see FIGS. 2A, 2D and 2E). The blade is relatively very thin, with an elongate structure running along the curved blade, which carries the fiberoptic channel and LED, as shown.

[0036] FIG. 2D illustrates a back perspective view of the system when the attachment arm is attached to the Bullard scope with blade (ETT not shown to illustrate the components more clearly), with the components labeled, including the hollow metal tube (stylet) following or resembling the curved shape of the right backside groove 1748 of the blade, as shown in FIGS. 2D and 2E. FIG. 2E illustrates a “bottom” view showing the metal tubular structure following the right back groove 1748 of the blade.

[0037] FIGS. 3 A, 3B, 3C, 3D, 3E and 3F are representative of the system 1800 of Example 1 herein. System 1800 which includes a laryngoscope with a video baton and a single channel disposable VL blade that may mimic the profile of the reusable Bullard scope blade shown. System 1800 includes a disposable attachment to the VL that comprises an attachment arm 1803 and a hollow external introducer 1805 (a merely exemplary disposable attachment is shown in FIGS. 3A-3F). System 1800 includes a handheld robotic system that includes a box or body and a robotically controllable introducer, wherein any of the robotically controllable introducers herein may be referred to herein as an internal introducer. The robotically controllable inner introducer and the external introducer are each sized and configured so that the inner introducer can be placed through the hollow external introducer. The external introducers herein are optionally any of the tubular structures herein that include at least a section that is rigid and or malleable, such as any of the stylets shown or described herein.

[0038] The system 1800 of Example 1 is considered to also include a representative handheld robotic system 1801, which includes a robotically controlled inner introducer, and which can be used with the normal geometry unchanneled VL blades (e.g. Macintosh or Miller type) or hyperangulated unchanneled VL blades (e.g. Glidescope, D-blade, etc.), and optionally with DL blades that do not contain any channels/cameras. [0039] Once the systems herein are assembled such that the inner introducer is within the external introducer and the ETT is placed over the external introducer, the hollow external introducers herein (optionally rigid, or malleable) provide structural support for the inner introducer and the ETT, a channel for the inner introducer that is within the external introducer, and placement and direction for the inner introducer and ETT. The external introducers can thus provide structural support (for the ETT and inner introducer) and positioning benefits without requiring a blade side channel. It also allows the operator to effectively deliver the introducer-ETT assembly in close proximity to the glottic opening under indirect (VL) or direct (DL) vision, thus greatly simplifying the navigation of the introducer and ETT delivery through the vocal cords and into the trachea, making tracheal intubation easy and more successful on the first attempt, with reduced complications.

[0040] The system in FIGS. 3A-3F provides the optional benefit that a VL (if the system includes a VL) and inner introducer cameras can be positioned at the same or substantially the same level when the system is coupled together without requiring a blade side channel (WO2021/236677 describes example with a side ETT channel for structural support and positioning). For example, by positioning the introducer camera at the same level as the VL camera, the VL camera can reliably visualize the introducer, and the introducer does not need to travel a significant distance (distally) to enter the glottic opening and the vocal cords.

[0041] While robotic system 1801 is FIG. 3 A is merely representative, any of the robotics systems herein may be robotic system 1801 is system 1800. For example, robotic system 1740 includes robotically controlled introducer 1770 that may be the inner introducer that is placed within the external introducer. It is thus understood that FIG. 3 A represents any robotic system herein advanced through a metal stylet (or other tubular structure) to facilitate ETT placement. Inner introducer tip 1802 is thus representative of a distal tip of any of the robotically controlled ETT introducers herein.

[0042] The disposable attachment (which may include an attachment arm and hollow external introducer) may be sized and configured to be coupled and used with any video laryngoscope (e.g., Storz, Verathon, etc.) blade and/or handle. As such, the assemblies herein that include a VL provide for video laryngoscopy-assisted tracheal intubation with the robotically controlled introducer systems herein.

[0043] In alternatives, and as described below, the system assembly (and more particularly the disposable attachment) may not include an external hollow introducer, with the introducer within the ETT, and maintained by the side of the VL. In these alternatives, the ETT can be secured to the side of existing blades (or a specialized two channel blade; described below) so that the introducer/ETT configuration follows the undersurface profile of the blade to facilitate dual video (VL and introducer) input of the anatomical structures and intubation procedure.

[0044] FIG. 3 A is a representative example of a system herein assembled but that can be modified such that any of the robotic systems herein can be positioned within the elongate external tubular structure, wherein the tubular structure is optionally a malleable tubular structure (e.g., metal, polymeric material), but which may comprise other non-malleable structures and/or materials, such as non-malleable polymeric materials.

[0045] FIG. 3B is a representative example of system 1800 coupled together, illustrating an exemplary ETT positioned over the elongate tubular external introducer 1805, with a merely representative inner introducer of robotic handheld system extending through the external tubular structure 1805 and extending distally therefrom to inner introducer tip 1802. System 1800 includes attachment arm 1803 that is coupled to the bladed part of the system, wherein the blade includes a blade tip 1804.

[0046] FIGS. 3C and 3D show the representative system coupled with the ETT (with external introducer 1805) follows the blade curvature, as shown. A representative distal end or tip 1802 of any of the inner introducers herein is shown extending from a distal end of the external introducer (which may be malleable). FIG. 3D is back or rear view of FIG. 3C. FIGS. 3E (back view) and 3F (side view) are additional representative views of a coupled or integrated system 1800 showing a distal tip 1802 of an inner introducer extending from the distal end of the external introducer 1805, as shown. An ETT is also shown (transparent material, with inflatable cuff).

[0047] In this example, the attachment arm 1803 of the disposable attachment may be modified in any manner (e.g., size, configuration, number of parts), and may be any other coupling member or mechanism to couple any of the handheld robotic systems herein to any type of DL, VL, or other bladed visualization device. Additionally, in this example, the hollow tubular external introducer (e.g., stylet) is part of the disposable attachment, and may be modified in any manner (including length or other dimension), and which may be referred to herein as an “external” introducer in scenarios in which an inner introducer is positioned therein.

[0048] The examples in FIGS. 3A-3F illustrate a merely exemplary bladed component that includes a blade 1804, which can be modified in any of the assemblies herein to include a video baton and a single channel disposable VL blade that mimics, even in part the profile of the Bullard scope blade as shown. [0049] The examples in FIGS. 3A-3F illustrate an exemplary disposable attachment that comprises an attachment arm 1803 and a hollow tubular element (external introducer 1805), which may be incorporated into any of the systems herein.

[0050] The examples in FIGS. 3A-3F also illustrate representative exemplary reusable robotic systems 1801 (the introducer part of the system may, however, be disposable) that can be positioned within a hollow external introducer 1805.

[0051] As described herein, any of the systems (optionally part of a disposable attachment) herein may include an external introducer, which is optionally malleable so that it can be customized to optimally fit the patient’s anatomy to minimize intubation trauma and improve first pass success rate, as opposed to current video stylets that have very limited, if any, malleability and have to be maneuvered around the airway with certain force in order to get aligned with the glottic opening and get pushed through the vocal cords. One intent of some of the robotic systems herein (universal systems) is not to do an intubation by pushing the external introducer tip through the cords, but to optimally deliver a flexible introducer (and attached ETT) to the glottic opening in order to facilitate introducer-assisted intubation with or without concomitant VL (DL) input (although it may be desirable in certain clinal scenarios to engage the tip of the an external introducer through the cords first before deploying the internal introducer robotically). In this example, the hollow elongate member (external introducer) does not include any electronics or light delivery systems, but it may conceivably be modified to include electronics or optical components.

[0052] Any of the robotic systems herein may include a cable connecting the robotic system to an optional split monitor screen used by, for example, Verathon, Storz, etc., to display video feed in real time. Any of the robotic systems herein may also include an integrated monitor on the handheld, or optionally an external monitor. Any of the robotic systems herein may include a power cord, and optionally a power source only for a short period of time. [0053] As set forth herein, the robotic systems herein that include robotically controlled introducers and ETTs may interface with the profile of a regular VL blade (or DL blade). In some examples, the introducer and ETT can be positioned at the level of the VL camera window, similar to the positioning of the introducer and ETT inside an optional 2-channel blade (e.g., as described in WO2021/236677), to optimize both camera orientations, video inputs of the critical anatomic structures, and FIS navigation towards the glottis. If desired, the introducer-assembly therefore can tightly follow the curvature of the manufacturer's VL blade and not hang out loosely, as this will direct the introducer with ETT down and away from the larynx. Examples 2, 3 and 4 below are examples of system assemblies that are adapted to maintain the introducer/ETT in a desired position and/or orientation relative to a VL camera.

[0054] Example 2

[0055] In this example, the blade of any existing VL herein is replaced with a custom two- channel blade that is adapted to accommodate the existing VL baton used as well as an introducer (any of the inner introducers or introducers herein) with a preloaded ETT. Any custom blade may be created and used to satisfy the manufacturers' specification. The two channel blades will also interface with the ETT (with introducer therein), as described herein and in WO2021/236677.

[0056] Example 3

[0057] Example 3 provides an exemplary system to position an ETT and robotic system along existing VL blades, and terminating it next to a VL camera. FIGS. 4A, 4B, 4C and 4D provide different views of an exemplary existing VL, including a transparent blade 1901, video baton 1902, and handle 1903, all as shown. The VL display is shown in FIGS. 5J-5L. [0058] FIGS. 5A, 5B, 5C, 5D, 5E, 5F, 5G, 5H, 51, 5J, 5K, and 5L illustrate an exemplary retaining element or clip 1904 (or securing element) that is sized and configured to be releasably coupled to an existing VL blade 1901, and its size and configuration can be customized to the particular VL blade configuration, and that when coupled, creates a bottom opening for an ETT. Clip 1904 may be releasably coupled to the blade 1901 using a wide variety of mechanical mechanisms, such as being snapped onto the blade. In this example, the retaining element has a portion that extends downward (towards the bottom) on the right side of the blade (as shown), with an opening 1911 or exposed region below the blade (as shown). In this example, the retaining element 1904 also extends about a left side of the blade, as shown. In this example, the overhang on the right side (as shown) creates a partial channel 1912 (not fully enclosed) and provides stability to the ETT/introducer in a plurality of directions, and positions the introducer camera at the level of the VL camera. The exemplary ETT is shown within channel 1912, after being passed through opening 1911, in the different views of FIGS. 5G-5L. The size and configuration of the retaining element can be adjusted based on the VL manufacturer’s needs. The components may not be labeled in every figure. [0059] This Example 3 is an example of a clip 1904 for a laryngoscope to create a removable ETT (and optionally also in introducer) channel. Clip 1904 includes first side portion 1908, second side portion 1909, and third side portion 1910 that at least partially define inner channel 1912, with an opening or open side 1911. Second portion 1909 extends between the first and third portions 1908 and 1910, respectively, and the open side 1911 extends between edges of first portion 1908 and third portion 1910, the opening or open side 1911 sized to allow an ETT to be positioned through the opening. Clip 1904 is an example of a clip configured to be releasably attached to a curved portion of a laryngoscope such that when coupled to the curved portion, inner surfaces of clip 1904 and at least one surface of the laryngoscope, as shown, create a channel for the ETT, and optionally an introducer within the ETT.

[0060] Example 4

[0061] Example 4 provides an exemplary device(s) and arrangement to position an ETT and robotic system along existing VL blades, and terminating it next to a VL camera. FIGS. 6A- 6F illustrate an exemplary retaining element or clip 1965 (securing element) that is sized and configured to be releasably coupled to an existing VL blade, and its size and configuration can be customized to the particular VL blade configuration, and that when coupled, creates a side or lateral opening for an ETT (similar to the bottom opening in Example 3). The clip 1965 may be releasably coupled to the blade using a wide variety of mechanical mechanisms, such as being snapped onto the blade. In this example, the retaining element has a portion that extends under the blade (as shown), with an opening 1966 or exposed region on the lateral right side (as shown). In this example, the retaining element also extends about left and top sides of the blade, as shown. In this example, the support from below and above (as shown) creates a partial channel 1967 (not fully enclosed) and prevents motion of the ETT/introducer in a plurality of directions, and positions the introducer camera at the level of the VL camera. The exemplary ETT is shown in the different views of FIGS. 6G-6L. The size and configuration of the retaining element can be adjusted based on the VL manufacturer’s needs. The components may not be labeled in every figure. This example, once releasably attached to the blade, creates a general structure that is similar to the two-channel blades described in WO2021/236677, which are accessible on the right side.

[0062] In these examples or with any other assembly herein, one or more adjustable disposable retaining clip(s) may be incorporated to help stabilize the ETT. A retaining clip may include two sections (e.g., rings) that are configured to snap around the top and lower part of the blade (VL blade or DL blade). Any of these disposable retaining rings can be made adjustable to accommodate different ETT sizes.

[0063] Additionally, any of the assemblies herein may include a blade that includes a hook near a distal end, such as the blade hook 2906 shown in W02023/060241. Any hook can optionally engage inside the Murphy eye to help maintain the ETT along the blade profile, and will extend somewhat up along the blade for stability. The operator can disengage the ETT from the hook before advancing it over the introducer into the trachea. [0064] Example 5 [0065] While exemplary system assemblies herein may include a robotic system that is physically coupled (directly or indirectly) to one or more of a handle or blade of a laryngoscope (a blade may be part of a VL or DL), Example 5 includes robotic handheld systems that dot not have to be coupled to a laryngoscope. In this example, the components are considered to be uncoupled, or not attached to one another. A blade, however, and optionally a VL, may still be used in combination with the robotic handheld system. This example is related to the disclosure from FIGS. 3A-3F herein, which is fully incorporated into this example by reference. In this example, the robotic system is not coupled to the VL (or DL). Example 5 is described at least partially in reference to FIG. 7. In FIG. 7, the system 1980 includes a robotically controllable inner introducer 1981, which may be any of the introducers herein (including those incorporated by reference). System 1980 also includes a hollow external introducer 1987 though which inner introducer 1981 extends, and wherein external introducer 1987 is optionally metal or polymeric and optionally malleable (described in more detail herein). System 1980 also includes an ETT 1984, which is sized and configured to be positioned over external introducer 1987 (with inner introducer within external introducer 1987). Additionally, as shown, a proximal end of external introducer 1987 and a proximal end of ETT 1984 are sized and configured to be coupled to the robotic body or housing (e.g. body or housing 1744 herein).

[0066] In this Example 5, an inner introducer 1981 may be considered to be surrounded by first and second sheath-like structures, in this case an external introducer 1987 and an ETT 1984. The connections between proximal ends of both the ETT and external introducer and the housing are shown generally as connections 1983. A distal end of inner introducer 1981 is generally shown as distal end 1985, which may be extending distally beyond the distal end of the external introducer 1987 at least when in initially ready for use. A general distal end 1986 of external introducer is also shown. User interfaces 1982 that are adapted to robotically control movement of inner introducer 1981 are generally referred to and not shown can be considered to be on the opposite side of the image shown in FIG. 7.

[0067] This Example 5 may be referred to as robotically controlled, video-assisted tracheal intubation. The robotic handheld system shown in FIG. 7 can be used with any laryngoscope, such as a VL that uses a regular, disposable or reusable normal geometry or hyperangulated VL blade (DL may be used, but two cameras may be preferred). In this example, the hollow external introducer 1987 (optionally malleable (metal)) is able to accommodate therein the inner introducer 1981 of the robotic introducer system (reusable or disposable). ETT 1984 is mounted over external introducer 1987. System 1980 may optionally include a power cord coupled to the body or housing (it may also operate on batteries for a short period of time). The inner introducer 1981 may be configured to be removably attached to the handheld robotic box (disposable). System 1980 may include an integrated video monitor coupled to the body or housing to view introducer video data captured via a camera at a distal end of inner introducer 1981. The system may optionally include functionality to connect a cable for visualizing the inner introducer video feed on an outside, external video monitor.

[0068] In an exemplary use of the system of Example 5, a VL may be used by an operator’s first hand, while the robotic system 1980 is held by the second hand. In this example, with the robotic box and inner introducer completely disengaged from the VL, the robotic system 1980 can also be used with any 2-channel blade, without the need for external hollow introducer 1987. As such, external hollow introducer 1987 is optional in this example. Introducer 1981 may simply be placed within the ETT. In this example, there isn’t necessarily a need to position a VL camera and introducer 1981 cameras at the same level. If malleable, external introducer 1987 shall be anatomically shaped to begin with, but can be adapted further to the patient’s anatomy. The malleability of existing video stylets is very limited due to internal electronics, for example. In use, the anatomically shaped external introducer 1987 can be advanced under VL vision close to the glottis, followed by introducer navigation to and through the vocal cords.

[0069] In this example, the robotic handheld system 1980 can conceivably be any robotically operated introducer system. The robotic system may also optionally be used as a stand-alone device or with any VL system with reusable, disposable blades, regular or 2-channel blades, and even with DL, although a concomitant use of VL may be strongly preferred.

[0070] Example 5 may be used in conjunction with any of the disclosure from Examples 2, 3 and/or 4 herein.

[0071] Example 6

[0072] Example 6 includes assemblies in which the robotic system is sized configured and arranged to be attachable and detachable from a VL. In this Example, the VL and the robotic system can each be specifically designed to be attachable and detachable from each other, and a variety of coupling mechanisms may be employed. In one merely exemplary implementation, a removable or detachable portion of a VL handle body that is free of internal functionality parts (but which forms part of the ergonomic outer surface of the VL body) may be removed from the VL handle body, and the robotic system can be couped to the VL (after the removable portion is removed). By coupling the robotic system to the VL, the ergonomic outer profile of the assembly is regained due to the shape of the remaining VL handle body and the now-coupled robotic system body (similar to joining puzzle pieces). In this example, the coupling can automatically align the cameras, described in more detail herein. Additionally or alternatively, the robotic system originally integrated into the VL handle can be detached from the VL and used separately as a standalone device or used with video assistance of the VL but not coupled to it.

Claims

CLAIMS What is claimed is:

1. A handheld robotic system, comprising: a robotically controlled elongate inner introducer with a camera at a distal end thereof; a handheld portion that includes, at least one actuator in operable communication with the introducer to facilitate the robotic control of the inner introducer in at least one direction, and a user interface element in operable communication with the at least one actuator, the user interface element adapted to respond to user interaction therewith to cause activation of the at least one actuator, an elongate external introducer having a lumen therein, the lumen sized to accommodate the inner introducer therethrough, wherein the external introducer comprises a rigid section, or a malleable section whose shape is changeable upon the external application of force and maintained when the force is no longer applied; and an endotracheal tube (“ETT”) that is sized and configured to receive the external introducer therethrough, and wherein, when the inner introducer is positioned in the external introducer and the external introducer is positioned within the ETT, the inner introducer and the ETT assume the shape of the rigid or malleable section of the external introducer.

2. The system of claim 1, further comprising, a blade with a curved surface, the blade sized and configured to be disposed within an oral cavity of a subject, wherein the external introducer has a rigid section with the same curvature as the blade curved surface or has a malleable section that can be shaped to have the same curvature of the curved surface of the blade.

3. The system of claim 2, wherein the blade is coupled to an integrated video camera.

4. The system of claim 2, wherein the blade is not coupled to an integrated video camera.

5. The system of claim 1, further comprising an attachment member that is sized, configured and adapted to couple, directly or indirectly, the external introducer with a blade.

6. The system of claim 5, wherein the attachment member is integrated with the external introducer.

7. The system of claim 6, wherein the attachment member includes a section that extends away from the shape of the external introducer to facilitate coupling with the blade.

8. The system of claim 5, wherein, when the external introducer is coupled to the blade with the attachment member and when the inner introducer is positioned in the external introducer, the camera at the distal end of the inner introducer is maintained at an initial position relative to a distal end of the blade.

9. The system of claim 1, wherein the handheld portion comprises an ETT coupler sized and configured to releasable couple a proximal end of the ETT, and wherein the handheld portion further comprises an external introducer coupler sized and configured to releasable couple a proximal end of the external introducer.

10. The system of claim 1, wherein the inner introducer and the external introducer have lengths such that the distal end of the inner introducer extends distally beyond a distal end of the external introducer when the inner introducer is fully inserted into and through the external introducer.

11. The system of claim 1, wherein the robotic system includes a port adapted to couple to a cable to connect to a display to display video information.

12. The system of claim 1, wherein the robotic system includes a display coupled to or part of the handheld portion.

13. The system of claim 1, wherein the external introducer comprises at least one of a metal or polymeric material.

14. The system of claim 1, wherein the external introducer is a hollow structure and excluding electronics or optical components.

15. A robotic system that includes a robotically controlled introducer, comprising: a robotically controlled elongate inner introducer with a camera at a distal end thereof; a handheld portion that includes, at least one actuator in operable communication with the introducer to facilitate the robotic control of the introducer in at least one direction, and a user interface element in operable communication with the at least one actuator, the user interface element adapted to respond to user interaction therewith to cause activation of the at least one actuator, an external introducer having a lumen therein, the lumen sized to accommodate the inner introducer therethrough, wherein the external introducer has a rigid section, or a malleable section whose shape is changeable upon the external application of force and maintained when the force is no longer applied; and an endotracheal tube (“ETT”) that is sized and configured to receive the external introducer therethrough, and wherein, when the inner introducer is positioned in the external introducer and the external introducer is positioned within the ETT, the inner introducer and the ETT assume the shape of the rigid or malleable section of the external introducer, and wherein the handheld portion comprises an ETT coupler sized and configured to releasable couple a proximal end of the ETT, and wherein the handheld portion comprises an external introducer coupler sized and configured to releasable couple a proximal end of the external introducer.

16. The system of claim 15, wherein the inner introducer is adapted to be removed from the handheld portion.

17. An airway management method of use of the system of claim 15, comprising: positioning a distal end of the inner introducer in an oral cavity.

18. The method of claim 17, further comprising positioning a laryngoscope into the oral cavity, wherein the laryngoscope is uncoupled from the robotic system.

19. A detachable clip for a laryngoscope to create a removable ETT channel, comprising: a clip comprising first, second and third side portions that define an inner channel with an opening, the second portion extending between the first and third portions, and the opening extending between the first and third portions, the opening sized to allow an endotracheal tube to the positioned through the opening and be partially surrounded by the clip and the laryngoscope, the clip configured to be releasably attached to a curved portion of a laryngoscope such that when coupled to the curved portion, the clip and at least one surface of the laryngoscope create a channel for the ETT.

20. The detachable clip of claim 19, wherein the clip is configured such that when coupled to the laryngoscope, the open side is positioned on a lateral side of the laryngoscope.

21. The detachable clip of claim 19, wherein the clip is configured such that when coupled to the laryngoscope, the open side is positioned on a bottom side of the laryngoscope.

22. The detachable clip of claim 19, wherein the clip has a length that is less than a length of the curved portion of the blade.

23. The detachable clip of claim 19, wherein the clip comprises a body with a general “U” or “C” shape in cross section along at least a portion of its length.

24. A method of attaching a clip to a curved potion of a laryngoscope blade to create a channel for an endotracheal tube, comprising: attaching a clip to a curved portion of a laryngoscope blade to create an opening and channel for an ETT, the opening sized to allow the ETT to be positioned through the opening and into the channel defined by an inner surface of the clip and the laryngoscope.

25. The method of claim 24, wherein the opening is a lateral side opening for the ETT.

26. The method of claim 24, wherein the opening is a bottom opening for the ETT.