Disposable control, reusable device and using method thereof

Abstract

The invention discloses a disposable control, a reusable device and a using method thereof. The disposable control and the reusable device are adapted to operably communicate during a program or process, and thereafter the disposable control may be discarded, while the reusable device may be reused during a subsequent program or process.

Description

Incorporated by Reference

[0001] This application claims priority to U.S. Provisional Application No. 63 / 329,449 filed on April 10, 2022 and U.S. Provisional Application No. 63 / 352,774 filed on June 16, 2022, the entire disclosures of which are incorporated herein by reference in their entirety for all purposes.

[0002] The following references are fully incorporated herein by reference in their entirety for all purposes: PCT Publication No. WO2021 / 236677, published on November 25, 2021; U.S. Patent No. 11147634, issued on October 19, 2021; and PCT Application No. PCT / US2023 / 062952, filed on February 21, 2023.

[0003] 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. background

[0004] Various medical devices include controllable parts during the procedure. For example, but not limited to, any of the following may include one or more controllable components: colonoscopes, bronchoscopes, esophagoscopes, articulating laparoscopes, other endoscopes, articulated surgical tools, feeding tube systems, articulated catheters, laparoscopic devices, bone surgical devices, any handheld controllable devices or other devices that can be used in the procedure using the aforementioned devices. The device or system may generally include one or more operator controls or parts (e.g., buttons, joysticks, sliders, etc.) that are suitable for being actuated by the operator to control a part of the device. Once contaminated during the procedure, the controls must be sterilized before the device can be used again. For handheld devices, controls are generally integrated into the parts of the device that are difficult to sterilize or expensive to sterilize. It is necessary to allow the medical device to be accurately controlled to achieve its intended purpose. Devices and systems, while allowing one or more of its components (e.g., expensive components and / or integrated controls) to be reused in subsequent procedures without the need for re-sterilization. Other applications outside the medical device industry may also exist, such as in industrial applications. Overview of the Disclosure

[0005] The present disclosure relates to disposable controls and methods of use. The disposable controls may have applications in the field of medical devices and may have applications in other fields such as industrial applications. The phrases disposable controls and disposable controllers may be used interchangeably herein.

[0006] Disposable controls or controllers are generally adapted to be placed in operable communication with a reusable device. The disposable controls are adapted to be controlled by an operator to control one or more components of the reusable device. Once the procedure or process is completed, the disposable controls can be separated from the reusable device and discarded. The reusable device can be reused for subsequent procedures or processes, and in the field of medical devices, the reusable device does not need to be sterilized before reuse.

[0007] Merely exemplary implementations of the disposable controls and reusable devices herein are in the field of medical devices, and even more exemplary are for airway management, examples of which are described throughout this disclosure.

[0008] One aspect of the present disclosure is a disposable controller for a controllable medical system. The controller optionally includes a body or housing including at least one control member adapted to be actuated (optionally manually actuated) by a user. The body optionally also includes a cavity located therein.

[0009] In this aspect, the disposable controller optionally has an articulatable tool at its distal end, such as, but not limited to, a grasper, scissors, energy delivery device, or the like.

[0010] In this aspect, the disposable controller is optionally adapted to couple and decouple with a reusable electronics kit, an example of which is shown in Fig.33 Shown in.

[0011] This aspect may include any appropriately combinable features from any other aspect, embodiment or example herein (including the drawings and claims).

[0012] One aspect of the present disclosure is a reusable device. The reusable device may optionally include at least one control member interface element adapted and positioned to be in operative communication with at least one control member of a disposable controller and responsive to actuation of the at least one control member when the reusable and disposable controllers are placed in operative communication.

[0013] This aspect may include any appropriately combinable features from any other aspect, embodiment or example herein (including the drawings and claims).

[0014] One aspect of the present disclosure is a controllable medical system. The system may optionally include a disposable controller and a robotically controllable medical device ("medical device").

[0015] In this aspect, the disposable controller optionally includes a body including at least one control member adapted to be actuated (optionally manually actuated) by a user. The body also optionally includes a cavity.

[0016] In this aspect, at least a portion of the robotically controllable medical device is sized and configured to be disposed within the cavity of the disposable controller.

[0017] In this aspect, the medical device optionally includes at least one control member interface element adapted and positioned to be placed in operative communication with at least one control member of the disposable controller (optionally within the cavity) and optionally responsive to actuation of the at least one control member when at least a portion of the medical device is disposed within the cavity.

[0018] In this aspect, the medical device optionally includes a controllable member, at least a portion of which is movable in at least one direction during a procedure or process (eg, a controllable or articulatable shaft, tool, etc.).

[0019] In this aspect, the reusable medical device optionally includes at least one controllable member actuator (e.g., a motor) that is operably connected to at least one control member interface element and to the controllable member to cause controlled robotic movement of the controllable member in response to user actuation of the at least one control member.

[0020] In this aspect, the controllable member optionally comprises an endoscope.

[0021] In this aspect, the controllable member optionally comprises a controllable catheter.

[0022] In this aspect, the controllable member optionally comprises a surgical tool.

[0023] In this aspect, the controllable member optionally comprises an endotracheal tube introducer, such as any of the ETT introducers described herein.

[0024] This aspect may include any appropriately combinable features from any other aspect, embodiment or example herein (including the drawings and claims).

[0025] One aspect of the present disclosure is a method of performing a medical procedure on a subject using a disposable controller.

[0026] In this aspect, the method may include positioning at least a portion of the reusable device into a cavity of a disposable controller, whereby the positioning step positions a control member of the disposable controller proximate a control member interface element of the reusable device such that the control member interface element is responsive to user actuation (e.g., manual actuation) of the control member, wherein the reusable medical device further includes a controllable member interface element and at least one controllable member actuator, the at least one controllable member actuator being operably connected to the at least one control member interface element and to the controllable member.

[0027] In this aspect, the method may further include manually moving the control member to cause controlled robotic movement of the controllable member in at least one direction of movement.

[0028] In this aspect, the method may include removing the reusable set from the disposable controller such that a control member interface element of the reusable set is no longer responsive to user actuation of a control member of the disposable controller.

[0029] This aspect may include any appropriately combinable features from any other aspect, embodiment or example herein (including the drawings and claims).

[0030] One aspect of the present disclosure is a disposable controller for an intubation procedure. In this aspect, the disposable controller may include a distal blade region that is sized and configured to be positioned in the oral cavity. In this aspect, the disposable controller may include an extension that extends from the distal region and is optionally integral with the distal region, and the extension is configured and sized to be handheld. The extension may include a disposable controller device for actuation by a user to communicate with a reusable device (e.g., a joystick, a magnet, a button, etc.).

[0031] This aspect may include any appropriately combinable features from any other aspect, embodiment or example herein (including the drawings and claims).

[0032] One aspect of the present disclosure is a reusable introducer assembly suitable for an intubation procedure. In this aspect, at least a portion of the assembly can be sized and configured to be disposed in a cavity of a disposable controller. In this aspect, the assembly can optionally include a response control device for responding to actuation of at least one control member of the disposable controller, optionally when at least a portion of the assembly is disposed in the cavity of the disposable controller.

[0033] In this aspect, the assembly may also include at least one guide actuator, which is operably connected to at least one response control device, for causing the guide to respond in response to user actuation of at least one control member and is operably connected to the guide to cause controlled robotic movement of at least one degree of freedom of movement of the guide.

[0034] This aspect may include any appropriately combinable features from any other aspect, embodiment or example herein (including the drawings and claims).

[0035] One aspect of the present disclosure is a cannula system.

[0036] In this aspect, the system can include a disposable blade including a distal region sized and configured to be positioned in the oral cavity and an extension extending from the distal region and sized and configured to be hand-held. The extension can include at least one control member or control device adapted to be actuated (e.g., manually) by an operator. The extension can optionally include a cavity.

[0037] In this aspect, the system may include a reusable introducer assembly ("assembly"), at least a portion of which is optionally sized and configured to be disposed in a cavity of a disposable blade. The assembly may optionally include at least one control member interface element adapted to be disposed in the cavity, positioned to be operably connected to at least one control member and responsive to manual actuation of at least one control member when at least a portion of the assembly is disposed in the cavity. The assembly may optionally include an ETT introducer ("introducer"). The assembly may optionally include at least one introducer actuator operably connected to at least one control member interface element and operably connected to the introducer to cause controlled robotic movement of the introducer in at least one direction of motion in response to user actuation of at least one control member.

[0038] In this aspect, at least one control member interface element may be adapted and positioned to sense one or more of motion, proximity, position, velocity, acceleration, or current.

[0039] In this aspect, at least one control member may include a magnet and at least one control member interface element may include a Hall sensor.

[0040] In this aspect, at least one control member may include a joystick and at least one control member interface element may include one or more metallic contact surfaces.

[0041] In this aspect, the at least one control member and the at least one control member interface element are optionally in at least one of electrical, magnetic, mechanical or optical operable communication.

[0042] In this aspect, at least one control member may comprise a flexible material.

[0043] In this aspect, the extension may comprise a rigid material.

[0044] In this aspect, at least one control member may comprise a rigid moveable material.

[0045] In this aspect, the at least one control member may include one or more pogo pins.

[0046] In this aspect, the assembly may include a housing comprising at least one control member interface element and at least one guide actuator, and wherein the guide is optionally adapted to be releasably coupled to the housing to facilitate operable communication between at least one guide actuator and the guide when the guide is releasably coupled to the housing.

[0047] In this aspect, the disposable blade may include an endotracheal tube side channel, examples of which are shown and described herein.

[0048] In this aspect, at least one introducer actuator may include a motor.

[0049] This aspect may include any appropriately combinable features from any other aspect, embodiment or example herein (including the drawings and claims).

[0050] One aspect of the present disclosure is a cannula system. The system may include a disposable controller configured and dimensioned to be handheld, wherein the disposable controller includes at least one control member adapted to be actuated (eg, manually) by an operator. The disposable controller may optionally further include a cavity.

[0051] In this aspect, the system includes a reusable housing, at least a portion of which is optionally sized and configured to be disposed in an optional cavity of a disposable controller. The reusable housing may include at least one control member interface element, which is optionally adapted to be disposed in the cavity, positioned to be operably connected to at least one control member, and optionally responsive to manual actuation of at least one control member when at least a portion of the assembly is disposed in the cavity. The reusable housing may also include at least one endotracheal tube introducer actuator, which is operably connected to at least one control member interface element and adapted to be operably connected to an endotracheal tube introducer, to cause the introducer to perform controlled robotic motion in at least one direction of motion in response to user actuation of at least one control member.

[0052] This aspect may include any appropriately combinable features from any other aspect, embodiment or example herein (including the drawings and claims).

[0053] One aspect of the present disclosure relates to packaging a disposable controller and a reusable device, wherein the disposable controller and the reusable device can be packaged together or separately, and if packaged together, they can be packaged in operable communication or inoperable communication. In this aspect, a plurality of disposable controllers (e.g., any of the disposable blades with controllers herein) can be packaged together, with or without a reusable device, wherein the plurality of disposable controllers are suitable for use with the reusable device during a procedure or process.

[0054] One aspect disclosed herein is simply a reusable device, and does not necessarily require a disposable controller. For example, the reusable device can be packaged separately and can be adapted for use with a variety of disposable controllers. This aspect can include any appropriately combinable features from any other aspect, embodiment, or example (including drawings and claims) herein.

[0055] One aspect of the present disclosure is a disposable handheld cannula controller including a distal blade region sized and configured to be positioned in an oral cavity, an extension extending from the distal blade region, the extension configured and sized to be handheld.

[0056] In this aspect, the extension portion may comprise at least one user control member or control adapted to be actuated (optionally manually) by a user.

[0057] In this aspect, the extension may include a lumen, optionally an elongated lumen, such as those shown and described herein.

[0058] In this aspect, at least one control member can be offset 180 degrees from the distal end of the distal blade region, as shown in the representative figures herein.

[0059] This aspect may include any appropriately combinable features from any other aspect, embodiment or example herein (including the drawings and claims). BRIEF DESCRIPTION OF THE DRAWINGS

[0060] Figure 1 Schematic diagrams of exemplary variations of devices for assisting with navigation and / or cannulation within a patient are depicted.

[0061] Figure 2A Exemplary variations of devices for assisting with navigation and / or cannulation within a patient are depicted.

[0062] Figure 2B Depicts the covering Figure 2A 0026] Figure 2 is a front view of an exemplary variation of the device shown in FIG.

[0063] Figure 2C Depicted in Figure 2B Rear view of an exemplary variation of the device shown in .

[0064] Figure 3A Depicted are cross-sectional views of exemplary variations of manual actuation systems for guiding an actuation member in a device for assisting with navigation and / or cannulation within a patient.

[0065] Figure 3B Depicted are perspective views of exemplary variations of automated actuation systems for guiding an actuation member in a device for assisting with navigation and / or cannulation within a patient.

[0066] Figure 3C and Figure 3D Exemplary variations of an actuation unit for guiding an actuation member in a device for assisting navigation and / or cannulation in a patient are depicted.

[0067] Figure 4A and Figure 4B Depicted are exemplary variations of coverings for use in devices for assisting with navigation and / or cannulation within a patient.

[0068] Figure 5 and Figure 6 Illustrated are exemplary variations of automated actuation systems for articulating a distal end of a mirror member in a device for assisting navigation and / or cannulation within a patient.

[0069] Figure 7 is a flow chart of an exemplary variation of a method for intubating a patient.

[0070] Fig. 8A An exemplary sequence illustrating automatic image / landmark recognition is illustrated.

[0071] Figure 8B An exemplary sequence illustrating manual image / landmark recognition is illustrated.

[0072] Fig. 9A An exemplary sequence of image recognition and subsequent automatic robotic control of an introducer is illustrated.

[0073] Fig. 9B An exemplary sequence of image recognition and subsequent manual robotic control of an introducer is illustrated.

[0074] Fig.10 Exemplary steps are illustrated including manual robotic control at a time subsequent to automatic robotic control.

[0075] Fig.11 A portion of an exemplary integrated and handheld cannula assembly is illustrated.

[0076] Fig.12 A portion of an exemplary integrated and handheld cannula assembly is illustrated.

[0077] Fig.13 A portion of an exemplary integrated and handheld cannula assembly is illustrated.

[0078] Fig.14A An exemplary integrated and handheld dual video endotracheal tube assembly is illustrated.

[0079] Fig. 14B An exemplary housing and first imaging member are illustrated.

[0080] Fig. 14C An exemplary second imaging member is illustrated.

[0081] Fig.14D A portion of an exemplary second imaging member is illustrated.

[0082] Fig.15 An exemplary integrated and handheld dual video endotracheal tube assembly positioned in the upper airway is illustrated.

[0083] Fig.16A An exemplary view of image data from a first image sensor on an exemplary display while the first image sensor is retained in the upper airway is illustrated.

[0084] Fig. 16B An exemplary view of image data from a first image sensor and a second image sensor displayed on an exemplary display is illustrated.

[0085] Fig. 16C Illustrated are exemplary views of image data from a first image sensor and a second image sensor displayed on an exemplary display while the first image sensor is retained in the upper airway.

[0086] Fig.16D Illustrated are exemplary views of image data from a first image sensor and a second image sensor displayed on an exemplary display while the first image sensor is retained in the upper airway.

[0087] Fig.17A and Fig. 17B Illustrated are side and top views, respectively, of an exemplary integrated and handheld dual video endotracheal tube assembly (first imaging member not shown) shown in an unassembled condition.

[0088] Fig. 17C A bottom view of an exemplary integrated and handheld dual video endotracheal tube assembly is illustrated, shown in an assembled condition.

[0089] Fig.17D A side view of an exemplary integrated and handheld dual video endotracheal tube assembly shown in an assembled condition is illustrated.

[0090] Fig.17E A top view of an exemplary integrated and handheld dual video endotracheal tube assembly shown in an assembled condition is illustrated.

[0091] Fig.17F A side view of an exemplary integrated and handheld dual video endotracheal tube assembly shown in an unassembled condition is illustrated.

[0092] Figure 17G A top view of an exemplary integrated and handheld dual video endotracheal tube assembly shown in an unassembled condition is illustrated.

[0093] Fig.18A A side view of an exemplary housing is shown.

[0094] Fig.18B Shown from Fig.18A A side view of an exemplary cross-sectional view of a housing.

[0095] Fig. 18C Shown from Fig.18A A top view of an exemplary housing.

[0096] Fig.18D Shown from Fig.18A A front end view of an exemplary housing.

[0097] Fig.18E and Fig.18F Shown from Fig.18A A perspective top view of an exemplary housing.

[0098] Figure 18G , Fig.18H , Fig.18I and Fig.18J An exemplary housing and optional internal components are illustrated.

[0099] Fig.19A A bottom view of an exemplary second imaging member including an optional image sensor at a distal region is illustrated.

[0100] Fig.19B A top view of an exemplary second imaging member is illustrated.

[0101] Fig.19C A side view of an exemplary second imaging member is shown.

[0102] Fig.19D A rear end view of a second imaging member coupled to an intubation catheter is illustrated.

[0103] Fig.19E A front end view of a second imaging member coupled to an intubation catheter is illustrated.

[0104] Fig.19F A top view of an exemplary second imaging member is illustrated with the top surface removed to show the internal components.

[0105] Figure 19G A bottom perspective view of an exemplary housing for a second imaging member is shown.

[0106] Fig.19H A bottom view of an exemplary housing for a second imaging member is shown.

[0107] Fig.19I A top perspective view of an exemplary housing for a second imaging member is shown.

[0108] Fig.19J A front end view of an exemplary housing of a second imaging member is shown.

[0109] Figure 19K A rear end view of an exemplary housing of a second imaging member is shown.

[0110] Fig. 20 An exemplary integrated and handheld dual video assembly is schematically shown.

[0111] Fig.21 Exemplary methods of using any of the integrated handheld assemblies described herein are illustrated.

[0112] Fig. 22A "resposable" embodiment is shown, meaning that it can be sterilized and reused in limited quantities.

[0113] Fig.23 An embodiment of an exemplary disposable controller (in this example a disposable blade) is shown including an extension that includes a control member such as a magnet.

[0114] Fig.24 An embodiment of a disposable blade is shown that includes an extension that includes a control member that includes a joystick.

[0115] Fig.25 An exemplary reusable housing (optionally part of an introducer assembly) is shown.

[0116] Fig.26 Shown in Fig.25 The reusable introducer assembly housing Fig.24 The blades are also shown coupled to Fig.25 An exemplary introducer housing of a reusable housing in FIG. 1 (introducer not shown for clarity).

[0117] Fig. 27 , Fig.28 and Fig.29 Details of an exemplary Hall sensor magnet interface are shown.

[0118] Fig.30 , Fig.31 and Fig.32 Details of an exemplary joystick are shown, which may be part of a disposable blade or other disposable controller.

[0119] Fig.33 An exemplary medical system is shown that includes a reusable portion and a disposable portion, the disposable portion including one or more control components.

[0120] Fig.34 is a block diagram of an exemplary data processing system. Detailed Description

[0121] 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 is intended to enable those skilled in the art to make and use these inventions.

[0122] The present disclosure relates to a device including a disposable control (not intended to be reused in a subsequent procedure) and a reusable portion. The disposable control and the reusable portion are generally adapted so that the disposable control can be actuated (e.g., hand-held) by an operator to control one or more parts of the reusable portion. During a procedure or process, the reusable portion remains sterile and does not require sterilization for reuse, while the disposable control can be separated from the reusable device and discarded after the procedure or process. A new disposable control can be used with the reusable portion in a subsequent procedure or process.

[0123] Some of the exemplary devices herein that incorporate the disposable controls herein are related to airway management, but these are merely exemplary devices and uses, and it should be understood that the disposable controls and controllers herein have broader applicability with other medical devices and in other fields such as industrial applications. Although endotracheal intubation is provided herein as an example of airway management, the concepts herein may be applied or adapted to other airway management procedures, locations, and scenarios. For example, the concepts herein may be used in bronchoscopic procedures or endoscopic ENT procedures, such as flexible nasopharyngeal laryngoscopy, esophagoscopy, vocal cord injections, certain laryngeal surgical procedures, and other endoscopic procedures involving the upper gastrointestinal (GI) tract (e.g., gastroscopy, esophagoscopy), etc.

[0124] Airway management procedures herein may include any of the following exemplary and non-limiting procedures in adult and pediatric patients: 1) endoscopic assessment of the patient's airway to determine or establish: (a) the presentation of and relationship between the various components of the upper airway anatomy, (b) the size and location of lesions and / or the location and extent of pathologic processes, (c) the feasibility of supraglottic airway device (SGA, e.g., laryngeal mask airway, etc.) placement and the likelihood of successful SGA ventilation, (d) whether awake and / or TI is feasible, (e) optimal TI navigation pathway to the larynx, (f) optimal TI device use and optimal TI strategy; 2) facilitate exchange of an ETT; 3) assess positioning and / or patency of the ETT and / or confirm proper placement of the ETT within the trachea; 4) facilitate placement and confirm proper positioning of a double-lumen tube; 5) facilitate extubation trials; 6) perform bronchoscopy; 7) perform nasal and / or oral TI; 8) perform ENT procedures such as endoscopy, esophagoscopy, biopsy, injections, certain laryngeal surgical procedures; and 9) perform other airway therapeutic, interventional, and / or diagnostic procedures.

[0125] As used herein, airway management procedures may be used in any of these non-limiting locations and settings: OR, ICU, ED, locations outside the OR (e.g., endoscopy suit, imaging scanner, various outpatient and hospital settings, operating rooms, etc.), as well as field (e.g., EMS) and battlefield airway management, both in situ and during patient transport.

[0126] As used herein, airway management may include or be used in visualization procedures, diagnostic procedures, interventional procedures, surgical procedures, and / or therapeutic and diagnostic procedures.

[0127] The airway management concepts described herein may be useful in non-medical applications.

[0128] The devices and systems are suitable for assisting with navigation and / or intubation.

[0129] Some non-limiting aspects of the disclosure of this article relate to a portable, handheld and integrated dual-video enhanced visualization and navigation system, which is suitable for guiding an ETT into a patient's trachea during a TI procedure. Such a system is suitable and configured to provide and improve all 3 key steps required for a successful TI: visualization, navigation / movement and placement. An integrated dual-video system configured, suitable for and sized to be held in one hand by a user provides the benefits of a dual-video integrated and enhanced visualization and navigation system that a user can hold and optionally control 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 of this article provides enhanced visualization of the patient's airway anatomy, which facilitates enhanced navigation of the ETT in and around the patient's anatomy and improved ETT placement (insertion) through the glottic opening and into the patient's trachea during a TI procedure, all of which help reduce TI trauma and increase the likelihood of TI first-pass success (TI success on the first TI attempt).

[0130] When describing the movement of the guide, the disclosure herein may refer to navigation. It should be understood that in some cases, navigation may also refer to automatically determining how or where the guide will be moved robotically (e.g., using image recognition). In embodiments where an operator determines how or where to move the guide, such as based on viewing an image on a display, navigation may be performed manually.

[0131] Described herein are variations of devices, systems, and methods for robotically assisted navigation and movement of an introducer within a patient's airway or other pathway, such as during an intubation procedure (e.g., orotracheal intubation, nasotracheal intubation, etc.). In some examples herein, the robotically assisted movement herein may include the use of artificial intelligence (AI) to enable robotically assisted navigation. Figure 1 As shown in the schematic diagram of , 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 in the housing. For example, the housing 110 may be an integrated handheld device so as to be portable and / or configured to be easily operated by a single person. The actuation member may be 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 may be configured to be slidably coupled to an intubation catheter such as an ETT, wherein the coupling may include slidably disposing the ETT around the introducer. During the intubation procedure, the introducer may be used as a steering guide for intubation catheter advancement when the introducer is robotically moved to a patient's passage (e.g., trachea). Intubation catheter advancement may be performed manually or automatically, for example, by passing the intubation catheter over the introducer. Once intubation catheter placement (e.g., in the trachea) is confirmed via real-time images from one or more image sensors (e.g., an introducer image sensor when the introducer is in the trachea), the intubation catheter can be disconnected from the introducer (which can include sliding the introducer proximally from and relative to the ETT) and the introducer and the remainder of the device 100 can be withdrawn from the patient's anatomy, leaving the intubation catheter (e.g., ETT) in place.

[0132] In any of the examples and embodiments herein, the robot-assisted navigation / movement may include the robot-assisted navigation of the introducer, wherein the endoscope described herein (which may be referred to herein as a mirror) is an example. The introducer herein is generally described as including one or more image sensors, but in an alternative system, the introducer herein may not include an image sensor, or the image sensor may not be used continuously. In an example where the introducer does not include an image sensor (or the image sensor is not used continuously), the introducer may be navigated robotically with the assistance of AI using an image obtained from an integrated image sensor, such as an image sensor associated with a first imaging member, such as a video laryngoscope, and exemplary details thereof are described herein. When a non-optical introducer is used, the placement of the intubation catheter below the vocal cords (lower airway) is not visible with a non-optical introducer, and therefore the placement of the intubation catheter below the vocal cords cannot be immediately confirmed. However, depending on the application and clinical situation, a non-optical introducer may provide simplicity and cost advantages compared to an optical introducer (such as an optical introducer including one or more image sensors described herein).

[0133] Although the apparatus, system, assembly, and method are described herein primarily with reference to intubation procedures, it should be understood that the apparatus and method can be used to assist other medical airway management procedures involving navigation through one or more pathways, such as endoscopic procedures (e.g., bronchoscopy, etc.). For example, in addition to the fact that the introducer can be automatically guided using AI / automation techniques without being connected to an intubation catheter, the navigation of the introducer can be robotically assisted using apparatus and methods such as those described herein. For example, the apparatus can robotically assist the navigation of the introducer during any suitable medical endoscopic procedure to provide a faster and / or less traumatic endoscopic procedure compared to conventional manual techniques. As an illustrative example, the apparatus, system, assembly, and method described herein can automatically guide the introducer (e.g., endoscope 150) based on one or more images obtained with the introducer and / or a first imaging member (e.g., laryngoscope), rather than automatically guiding the intubation catheter. In some variations, the introducer (e.g., endoscope 150) can include, for example, one or more channels for flushing, drug delivery, tissue biopsy, and / or deployment of surgical instruments.

[0134] Even further, in some variations, the devices, systems, assemblies, and methods herein may be used in other applications (eg, non-medical applications) where automated navigation / movement may be helpful, such as navigating within otherwise difficult to access pathways.

[0135] Figure 1The exemplary system 100 in can optionally include at least one display 118, which is configured to display one or more images from a first image sensor in a first imaging member (e.g., a laryngoscope) and / or from a second image sensor in a second imaging member (which may include an introducer), and can be configured to display the images from the first image sensor and the second image sensor simultaneously (e.g., split-screen or picture-in-picture). During the procedure, the images can be displayed continuously or substantially continuously or sequentially. The system 100 can also include at least one actuator 116 located in the housing, which is configured to automatically guide / move the 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 may further include a cover or blade coupled to the housing, wherein the cover may include a first channel sized and configured to receive a first elongated imaging member (e.g., a video wand) and a second channel configured to stably receive at least a portion of an intubation catheter (the introducer may be disposed in the intubation catheter). The cover may also include a tongue retraction member (such as an angled or curved member) configured to retract the patient's tongue during an intubation procedure, examples of which are shown in the figures herein.

[0136] In some variations, one or more actuators may be under the operational control of one or more processors 112 configured to analyze images or image data from one or both of the first image sensor and the second image sensor in the system using suitable AI (e.g., machine learning methods). Various electronic devices 114 (e.g., power supplies, electronic communication lines, etc.) and / or displays 118 in the system or housing 110 may power one or more processors, image sensors, light guides, etc. in the system. For example, 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 be used to trigger robot-assisted endotracheal intubation with the system. For example, as described in further detail below, visualization and navigation / movement to or toward the vocal cords may be based on identifying one or more key anatomical identification points provided by the image sensors of the first imaging member and / or the second imaging member. The system may perform robot-assisted navigation that is automatically activated in response to identifying airway anatomy and / or activated in response to manual activation (e.g., by user operation of a user interface element). For example, in a fully automated mode of the exemplary device or assembly 100, the actuator may automatically steer the endoscope using AI and / or other robotically assisted navigation and electromechanical control of the actuation members.

[0137] Additionally or alternatively, the device or system can operate in an automatic mode with exemplary manual assistance. In such an automatic-manual assistance mode, for example, the actuating member and / or the introducer can be manually controlled, such as using a user interface device (e.g., a joystick) or manually controlled through the device display 118. When the device is in the automatic-manual assistance mode, articulation of the distal end of the introducer can occur automatically, for example, under automatic robotic control of one or more actuators in the system.

[0138] When used for TI, the system of the present invention can be a user-friendly, portable, handheld, video-triggered, and AI-enabled robotic-assisted automatic intubation system with enhanced functionality that improves all three key steps required for successful TI: visualization, navigation, and placement, and increases the success rate of first-pass intubation, reduces total intubation time, reduces airway trauma associated with intubation, and / or improves patient safety. For example, in an ergonomic kit that can be operated by a single user, the system of the present invention can combine multiple imaging (e.g., video) modules that allow the device to perform intubation using AI or robot-assisted guide navigation. For example, a robot-assisted intubation interface can at least manipulate the guide guide through the glottis and into the patient's trachea, where the robot-assisted intubation interface can be used as a guide for ETT advancement and placement. For example, the ETT can be pre-loaded on the introducer, and after the introducer is advanced into the trachea and after confirming the correct placement in the trachea, the ETT is advanced on the introducer.

[0139] In addition to the advantages such as described herein, the system of the present invention can be configured to provide continuous visual feedback and optional closed-loop robotic assistance from above and below the vocal cords during tracheal intubation for real-time troubleshooting and / or intelligent intervention, thereby improving TI success rates, increasing intubation speed, and reducing TI trauma. In addition, the combined use of the first imaging member and the second imaging member can allow reliable and faster triggering of the AI ​​and the associated robotic interface, which is at least in part due to the enlarged and clear view of the upper airway anatomical landmarks provided by the first imaging member (such as the laryngoscope 120). Another advantage of obtaining the initial imaging through the first imaging member refers to the fact that the visualization of the patient's anatomical structure is much less affected by blood and secretions than the image provided by the second imaging member (e.g., an image sensor located at the distal region of the introducer). In addition, the combined use of the first imaging member and the second imaging member, the angular orientation of the cameras of the first imaging member and the second imaging member, and the placement and maintenance of the cameras of the first imaging member and the second imaging member in close proximity to each other and in close proximity to the glottic opening in the axial direction provide the introducer and ETT with the shortest and fastest navigation path to the vocal cords and trachea. Additionally, actuation of the introducer within the patient's airway is greatly facilitated by the device cover or blades, which are configured to perform tongue retraction, thereby creating a greater pharyngeal space for introducer actuation and manipulation. One of the optional significant benefits of some of the systems herein is that the system can be configured to allow the user to observe the entire intubation procedure from above the vocal cords (upper airway) and below the vocal cords (lower airway) to allow immediate visual confirmation of placement of the intubation catheter within the trachea using an introducer imaging sensor during intubation and to ensure that the intubation catheter is optimally positioned within the patient's airway, an exemplary embodiment of which is described below.

[0140] In addition, the optional integrated dual video capability of some exemplary systems herein can significantly reduce intubation-related airway trauma and soft tissue damage typically associated with conventional devices, even in situations where visualization of upper airway anatomical landmarks is limited (e.g., where the glottis is not fully exposed). For example, during initial video image capture with a first image sensor, after reliably identifying anatomical structures associated with the glottic opening (e.g., epiglottis, arytenoid cartilages, etc.), the system can automatically steer an introducer through the glottic opening into the patient's trachea even when the glottic opening cannot be visualized. The device can also reduce the risk of interference, debris, bleeding, and / or airway contamination during esophageal intubation and / or during intubation (such as when a tumor or other space-occupying lesion is present in the patient's airway).

[0141] In some variations, the system may be used in situations where it is desirable to increase the distance from the patient's airway to reduce the likelihood of airborne and / or contact transmission of infection to the device operator from the patient. For example, due to the minimal airway manipulation required and the automated nature of the intubation performed, an operator of the integrated system is able to hold the system from a suitable distance (e.g., arm's length) and avoid the risk of directly viewing the interior of the patient's airway to reduce the likelihood of infection transmission (e.g., from a patient suffering from an infectious bacterial and / or viral disease such as COVID-19, etc.).

[0142] The system herein can be used, for example, for routine selective and / or expected and / or unexpected difficult endotracheal intubation in any suitable setting, such as an OR, ICU, emergency department, out-of-OR location (e.g., clinic, emergency call situation, etc.), pre-hospital state (e.g., field and battlefield airway management), and / or other selective and / or emergency and / or critical situations. In addition, the system can be used for TI for a variety of patients and across a variety of diagnostic and / or therapeutic procedures, such as in situations where airway support and / or protection and / or lung hygiene of the patient's airway is desired or indicated, such as when the patient is undergoing an interventional endoscopic procedure (bronchoscopy, GI endoscopy, etc.), transesophageal echocardiogram, CT and MRI imaging procedures, any medical procedure that may require sedation and / or airway support and / or airway protection, etc. The system may be used for TI in specific patient populations where increased difficulty with TI may be expected, such as those who are obese, patients with obstructive sleep apnea, patients with head and neck cancer and other diseases, elderly patients, patients at high risk for dental injuries, patients who do not want neck movement, trauma patients, patients for whom minimizing adverse cardiovascular responses to intubation (e.g., hypertension, tachycardia, arrhythmias, etc.) is important, critically ill patients, etc. In certain variations, the device may be used for TI in both adult and pediatric patients.

[0143] FIG. 2A to FIG. 2Cis a schematic diagram of a merely exemplary portable, handheld integrated dual video robotic assembly or system 200 that may be suitable for visualization, navigation, and placement during an intubation procedure. Figure 2A As shown, the system 200 may include a handheld housing 210, an electronic system 214 (e.g., including one or more processors, one or more power supplies, etc., examples of which are described herein), and one or more actuators 216. The device may also include a first elongated imaging member, such as a laryngoscope (or other imaging member) having a wand 220, wherein at least one image sensor 222 is disposed at a distal region of the first imaging member, as shown, and the device may also include an actuation member 240 movable within the housing 210. In addition, the system 200 may include an introducer, such as an endoscope 250, wherein the image sensor 252 is disposed at a distal region of the introducer, as shown. The introducer 250 may be configured to be coupled to an intubation catheter (e.g., an ETT for use during a TI procedure). In this case, "coupled to" includes that the ETT is movable axially about or on the introducer. As shown in FIG. Figure 2B , Figure 4A and Figure 4B As shown, the system 200 may also include a cover 260 including a channel sized and configured to receive a first imaging member (e.g., laryngoscope wand 220) and at least a portion of an ETT and an introducer (e.g., endoscope 250) therein. Figure 4A and Figure 4B As shown, the cover 260 may also 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 member 268 configured to manipulate tissue (e.g., a patient's tongue) during an intubation procedure. Although reference is made below to FIG. 2A to FIG. 2C , FIG. 3A to FIG. 3D , FIG. 4A to FIG. 4B , Figure 5 and Figure 6 Additional exemplary aspects of the system 200 for enhanced visualization and navigation during intubation are described in further detail, but it should be understood that the described aspects may be applied to other variations of systems and devices having other sizes, shapes, and the like.

[0144] Handheld housing The exemplary housing 210 can be sized and configured to enclose various software and hardware components (such as electronic components (e.g., processors, memory, power supplies, motors, etc.)) for performing robotic-assisted TI and / or actuators for guiding an introducer, such as during an intubation procedure. The housings herein can also 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 and handheld system that can be operated and controlled by a single hand or a single user. Both the handheld housings herein (e.g., housing 210) and the integrated dual video assemblies herein (which can include a handheld housing) can advantageously be sized and configured to be held by a single hand of a single operator, thereby providing the benefits described herein.

[0145] The housings herein (e.g., housing 210) can be configured as handheld housings that can be ergonomically held in a user's hand. The handheld housings can be contoured (e.g., with finger grips, etc.) or otherwise configured for a particular hand (e.g., left hand, right hand), or can be adapted for either hand. For example, Figure 2A As shown in the front view depicted in , the handheld housing can be configured for use with the left hand. In some variations, the housing can include one or more other ergonomic features, such as cushioning (e.g., foam or rubber padding, silicone gel, etc.) to improve user comfort, friction features (e.g., rubber grips, texture features (such as ribbing), etc.).

[0146] In some examples, the length of the handheld housing can be between about 10 cm and 75 cm, such as between about 15 cm and about 45 cm, but the handheld housing can be any suitable size that is ergonomically compatible with a device that can be held in one hand of an operator. In some embodiments, the housing is 2 cm to 15 cm wide, such as 4 cm to 10 cm wide. In some embodiments, the housing measures 5 cm to 20 cm from top to bottom, such as 5 cm to 15 cm.

[0147] The housing (e.g., housing 210) herein can be made of any suitable rigid or semi-rigid material. For example, the housing can include plastic formed by a suitable injection molding process. In some variations, the housing can include one or more separate components (e.g., a housing) that are coupled together by one or more suitable fasteners (e.g., epoxy or other adhesive, mechanical fasteners) and / or mating features (e.g., threaded features or snap-fit ​​features or complementary features on different housing components). The housing can enclose various electronic components, actuators, and / or other aspects of the device in an internal volume, examples of which are described herein.

[0148] Electronic Systems The system or component herein may include an electronic system (e.g., electronic system 214), which may include at least one processor and / or at least one memory device. At least a portion of the electronic system 214 may be, for example, arranged in a housing and / or a display, which is coupled to the housing, as will be described in further detail below. The memory device may store instructions for one or more processors (e.g., in the form of software, a computer executable method) to analyze images from a first imaging sensor and / or a second imaging sensor, and / or perform AI-based analysis (using intelligent image recognition technology and / or machine learning) on ​​these images to automatically navigate the introducer into the trachea during intubation. The processor may also be configured to perform automatic control of an actuator in the device for guiding at least a portion of the actuating member and / or the introducer for intubation assistance. Automatic navigation may perform intubation procedures in a user-friendly manner, with little need for user training or experience to successfully intubate. Additional details of such AI or machine learning algorithms are further described below.

[0149] The electronic system (conceptually designated as exemplary electronic system 214) may further include other components for supporting the device, such as at least one power source. In some variations, the power source may include at least one battery as an independent power source (e.g., to help promote the portability of the device). Additionally or alternatively, the housing and / or the display may include a power connector or port 211 that may enable a wired power connection, such as connection to an external AC or DC power source. Additionally or alternatively, the housing may include a wired connection (e.g., a cable) and / or a wireless communication module for communicating with a stand-alone video monitor. In addition, in some variations, the housing may include an emergency stop control (e.g., a button) that terminates the automatic robotic assistance of the device, such as via the operator's intention (e.g., suddenly stopping the current of the actuator, etc.). In some variations, the housing may also include a power button for controlling the power on and off of the system and / or a port for downloading images and updating software programs.

[0150] Actuating unit, actuator, actuating member The housing (eg, housing 210) herein may include one or more actuators 216 configured to automatically direct movement of actuation member 240 when the introducer is coupled (eg, releasably coupled) to an intubation catheter for AI or robotic-assisted intubation. Figure 2AIn the example of , advancement of the actuation member 240 can also extend the effective operating length or working length of the endoscope 250. As described in further detail below, the actuator 216 can be integrated into the housing, and actuation of the actuator 216 is applied to the actuation member 240 through a coupled interface so that the resulting movement is transmitted along the longitudinal axis of the actuation member and along the longitudinal axis of the endoscope 250 extending from the actuation member. One or more actuators 216 can be additionally included to operate the distal end of the endoscope 250 and / or articulate the distal end of the endoscope 250, as described further below.

[0151] The device may include any suitable actuator and mechanical or electromechanical components for controlling the actuating member 240 and / or the guide. For example, the exemplary actuator 216 and the associated controller may include suitable drive electronics, one or more electric motors, hydraulic devices and / or pneumatic devices, and suitable mechanical components, connectors, joints and / or controllers. For example, the control components, connectors and joints for controlling the actuating member and / or the endoscope may include longitudinal elements with bidirectional push-pull cables, wire pulley assemblies, chain transmissions, hinges, slider-crank mechanisms, piezoelectric elements, pneumatic elements and assemblies, magnetic elements, adjustable couplings, sleeves, belts, gears, pushers, plungers, movable racks, compression springs, translational rotation to linear and / or linear to rotational motion modules, gear transmissions or other suitable motors and / or joints, etc. Other suitable fasteners and bearing surfaces may also be included in the actuator assembly 216.

[0152] The exemplary actuator 216 can be automatically and / or manually activated. For example, in some examples, the actuator 216 can be activated by one or more processors executing image recognition software instructions in response to the processor recognizing one or more anatomical landmarks through such image recognition technology. For example, this automatic activation can be part of a fully automatic mode of the device. Additionally or alternatively, the actuator 216 can be selectively engaged and / or disengaged in response to a user selecting one or more user interface elements. For example, the actuator 216 can be activated by selecting an AI operation button 280 or the like (e.g., Figure 2C ) to activate the actuator 216 and by selecting the stop button 284 or the like (as shown) Figure 2C) to deactivate the actuator 216. It should be understood that the system may additionally or alternatively include other user interface elements for activating / deactivating the fully automatic mode of the device, 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 actuating member 240 (e.g., as described below, with a joystick or other user interface element) can immediately override the fully automatic mode. In these variations, for example, after the user presses the AI ​​operation button 280, the fully automatic mode can then be allowed to be restored. Additionally or alternatively, when in the manual assist mode, the fully automatic mode can be restored after a predetermined period of time (e.g., a period of time when the actuating member 240 is inactive or not moving, a predetermined duration, etc.). In still other variations, as long as the clutch (e.g., a button, switch, joystick or other suitable selectable mechanism) is engaged, the selected manual assist mode can override the fully automatic mode, and the release of the clutch button can allow the fully automatic mode to be restored.

[0153] monitor As an example FIG. 2A to FIG. 2CAs shown, any system or component herein (e.g., system 200) may optionally further include a display, such as display 218, such as a monitor screen, a touch screen, or a similar display. The display may be configured to display image data and / or a user interface. For example, the display may be configured to display only a single-channel image from a first image sensor (e.g., a laryngoscope image sensor 222) or only a second image sensor (e.g., an introducer image sensor 252). As another example, the display herein may be configured to display multi-channel images from both the first image sensor and the second image sensor (e.g., 222 and 252), such as in a split-screen and / or picture-in-picture arrangement of images from, for example, only a laryngoscope image sensor and / or an endoscope image sensor. In some variations, the display may be configured with a default or preprogrammed display sequence. As an example of a default display sequence, the display may be configured to initially display a video feed or video signal from a video laryngoscope to provide visual feedback of initial entry into a patient's airway (e.g., upper airway) and / or visual feedback of identified anatomical structures, and then automatically transition to displaying a multi-channel image set (e.g., split screen, picture-in-picture) from an endoscopic image sensor (e.g., 252) and / or a laryngoscope image sensor (e.g., 222) upon activation of an AI-based actuation (automatically or by manual activation as described above) and / or upon pressing of an optional user interface element on the device and / or display. In some variations, additional switching of video feeds from various image sensors may be accomplished by certain preprogrammed operations of the user interface elements (e.g., pressing a picture-in-picture button or icon two or more times in succession may produce a complete image of the patient's trachea and intubation tube placement (or other anatomical structures) provided by the endoscopic image sensor 252).

[0154] In some examples, the display of this article can be connected to the housing 210 or other housings of this article (for example, on the proximal part of the housing). The display can include any suitable display element (for example, LCD). In some variations, the display can be connected to the housing via a rotatable or pivoting connector so that the display can be rotated around the longitudinal axis and / or tilted around the vertical axis and / or the lateral axis, and can be viewed from multiple angles. Alternatively, the system of this article can include a multi-faceted (for example, double-sided) display to allow the displayed content to be viewed simultaneously from multiple angles. In any embodiment of this article, the display connected to the handheld housing can be portable in size, such as between about 8cm and 15cm in height and between about 10cm and about 18cm in width, but the display can be of any suitable size and / or shape.

[0155] Additionally or alternatively, any system herein may include a remote display and be communicatively coupled to the remote display, which is not part of the integrated assembly. For example, a system herein may include one or more ports in any housing herein for wired communication with a display device. As another example, a system may include a wireless communication module and antenna to transmit content for display to other screens (e.g., via a cellular mobile network, Wi-Fi, etc.).

[0156] First (elongated) imaging member (eg, laryngoscope) Any integrated dual video system or assembly herein may include a first imaging member (e.g., a video laryngoscope) that may include an elongated flexible body and a first image sensor (e.g., a camera) disposed at a distal region of the elongated body. Any first imaging member herein may also be referred to as a first elongated imaging member, which generally indicates that it has an elongated configuration. For example, as shown in the exemplary FIG. 2A to FIG. 2CAs shown, the system 200 may include a first imaging member (e.g., a video laryngoscope). As shown, the first imaging member may include a rod 220 (or other elongated member) extending distally from the housing 210. The rod 220 may include a high-resolution image sensor (e.g., a camera) located at a distal region for providing a video image, one or more light guides for providing illumination to the image sensor field of view, and electronic signal lines for transmitting video data or images for processing and / or display on a display 218 (or other suitable display). The image sensor 222 may be located at the distal end of the elongated member and may be adapted to provide a relatively wide viewing angle during an intubation procedure for magnifying and clearly visualizing the patient's anatomical structures in both the axial plane and the horizontal plane. The relatively wide viewing angle and angular position (relative to the second image sensor) of the first imaging sensor may help to reliably visualize and discern key anatomical landmarks in the upper airway, thereby enhancing the navigation of the introducer as the introducer moves distally relative to the first image sensor. The combined use of the first imaging member and the second imaging member, the optional large viewing angle of the cameras of the first imaging member and the second imaging member, and the placement and maintenance of the cameras of the first imaging member and the second imaging member in close axial proximity to each other and in close proximity to the glottic opening provide the shortest and fastest navigation path to the vocal cords and trachea for the introducer and ETT, as described in more detail below. In some examples that are merely optional but not limiting, the first image sensor of the first imaging member may have a wider viewing angle than the second image sensor of the introducer. Therefore, compared with conventional devices, the first imaging member can provide an enlarged and clearer image of the patient's anatomical structure, which can facilitate faster and more reliable AI image recognition and / or use of the system to initiate robotic-assisted control and movement of the introducer. Any image sensor herein may optionally include a charge-coupled device (CCD), a CMOS sensor, and / or other suitable sensors, and may be combined with any suitable optical element (such as an objective lens, etc.). In some embodiments, the first camera and the second camera of the first imaging member and the second imaging member can have the same viewing angle, while the first image sensor can still provide visualization of a larger anatomical area relative to the second image sensor by remaining proximal or rearward of the second image sensor (e.g., when the introducer is advanced distally toward the glottic opening). In some embodiments, the first camera can have a smaller viewing angle than the second camera, but the first image sensor can still provide visualization of a larger anatomical area relative to the second image sensor by remaining proximal or rearward of the second image sensor (e.g., when the introducer is advanced distally toward the glottic opening). Exemplary methods of use including utilizing the simultaneously presented first and second video signals from the first camera and the second camera are included in more detail below.

[0157] In any of the systems herein, the first imaging member may include a laryngoscope, which may include a rod or other elongated member having a length between about 10 cm and about 15 cm, but may be of any size suitable for adult and / or pediatric patient populations. As described below, the systems herein may optionally include a universal handheld housing adapted to be interchangeable with first imaging members of different sizes for different patient populations (e.g., adults and children), which provides greater functionality to the universal handheld housing. As exemplified Figure 2A As shown, the diameter of the exemplary laryngoscope rod 220 may generally taper as the exemplary laryngoscope rod 220 extends away from the housing 210, and / or the exemplary laryngoscope rod 220 may be slightly bent or flared to accommodate the imaging component, and / or the exemplary laryngoscope rod 220 provides better angling during the intubation procedure, etc. However, the first imaging member 220 may have any suitable shape and size for the patient's anatomy. In some examples, the first imaging member (e.g., which may include a laryngoscope rod) may be flexible and may have a static curved configuration, and in some examples, the first imaging member may have a straight or substantially straight configuration adapted to bend within the cover. The first imaging member 220 may be removably or releasably coupled to the housing 210, or integrally or permanently coupled to the housing 210 (e.g., intended for repeated use). For example, the first imaging member 220 may be kept sterile between each use by using a disposable cover 260 (as further described below), or may be sterilized with a suitable disinfectant between each use, etc. Alternatively, in some variations, the first imaging member 220 may be modular or removable from the housing 210 (e.g., snap-fit ​​connection, etc.), and the first imaging member 220 may be disposable and / or swapped out and replaced with a different first imaging member 220 between different uses of the system 200. For example, the first imaging member 220 may be swapped out and replaced with a different first imaging member 220 to avoid the need to sterilize the wand between each use. As another example, the first imaging member 220 may be removed to facilitate separate sterilization between each use. 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 the first imaging member 220 may be replaced with different first imaging members 220 of different desired sizes depending on the patient and / or condition. In addition, as described in further detail below, a cover (such as the cover 260) may be appropriately sized for the size of the first imaging member 220 (e.g., having a channel defining a cavity with a suitable diameter and / or length).

[0158] Actuating member and introducer (eg, endoscope) In some examples, the integrated assembly or system may optionally include one or more actuation members and an introducer. Figure 2A-2C In the embodiment of the present invention, the device 200 may include an actuation member 240 and an introducer (eg, endoscope 250) extending from the actuation member 240. In this non-limiting example, the actuation member 240 and the endoscope 250 may be coupled or connectable together, for example, end-to-end, to form a flexible member.

[0159] Typically, the combination of the actuating member 240 and the endoscope 250 or other guide may include a flexible insertion catheter (or a rigid video probe or the like) engaged with an intubation catheter, at least one image sensor 252 disposed at the distal end of the guide 250, and an articulatable distal tip of the guide 250, the articulatable distal tip of the guide 250 being controllable by one or more tensioning elements (such as one or more pull wires secured to the distal region of the guide) or other suitable control mechanism.

[0160] For example, an introducer (e.g., introducer 250) may include a high-resolution image sensor or video chip camera module at its distal end, such as the exemplary Figure 2A As shown, such as CCD or CMOS image sensor, objective lens and / or other suitable optical configuration. In an exemplary embodiment, the size of the image sensor can be, for example, between about 2 mm and about 4 mm, and the image sensor provides a wide viewing angle (e.g., at least 90 degrees, at least 180 degrees, at least 270 degrees or 360 degrees, etc.). One or more light guides (e.g., carrying LEDs or other lighting) can pass through the actuating member and the axis of the guide to provide lighting during the airway management procedure. The signal line along the axis of the guide can convey the image or image data from the image sensor to the image processor, which can be optionally arranged in the housing and / or the display, or can be arranged in an external device. In addition, the distal end of the guide 250 can include a bendable articulated structure (e.g., with a connected segment), which can be controlled by an angled pull line or tension cable or other suitable mechanism. For example, such an angled line can control the upward-downward and right-left steering movement of the articulated end of the guide 250.

[0161] At least the proximal end of the optional actuation member 240 can be coupled to the housing 210 and / or located within the housing 210 and controlled by one or more actuators. The actuation member 240 can be advanced longitudinally (e.g., at least partially pushed out of the housing 210) and retracted proximally and rearwardly along the longitudinal axis by one or more actuators 216 and / or rotated by one or more actuators 216, and thereby control the advancement, retraction and / or rotation of the introducer 250. In some variations, the actuation member 240 can extend the working length of the introducer 250 because the advancement of the actuation member 240 can cause the distal end of the introducer 250 to be located more distally than when the introducer 250 alone is able to do so. In addition, the actuation member 240 can be retracted within the housing 210, such as, for example, using a Figure 2C The selectable button 290 is shown retracted within the housing 210 .

[0162] In some variations, the actuating member 240 and the guide 250 can be integrally connected, such as connected in a permanent manner. In other words, the actuating member 240 and the guide can be optionally integrated in structure and function. Therefore, in some variations, the entire flexible member including both the actuating member 240 and the guide 250 can remain connected to the housing 210, and the entire flexible member (and possibly the entire device 200) can be completely sterilized between each use. In other variations, the actuating member 240 can be detachable from the housing 210 so that the actuating member 240 and the guide 250 can be sterilized separately from the housing 210. For example, the actuating member 240 can be releasably connected to the housing 210 by connector fittings, fasteners, mechanical mutual cooperation (e.g., threads, interference fit), nesting or in any suitable manner. In some variations, a disposable protective sleeve or other covering may be removably placed over at least the introducer 250, which may eliminate the need to fully sterilize the actuation member, the introducer, and / or the entire device between each use. In other variations, the actuation member 240 and its interaction with the user interface device 270 (e.g., including the guide 217 and / or the control member 274, such as a joystick, such as Figure 2C3 ) can be integrated into a single module that is removably attached to the housing 210 and the actuation control 216 (e.g., a snap fit, a "plug-and-play" connection, etc.). In another variation, the actuation control may also be included in whole or in part in such a module. Such an integrated module with a permanent or removable 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 exchanged for a new and different module containing a different actuation member 240, e.g., having a different outer diameter, length, etc. This can further allow the housing to be used as a universal handheld housing suitable for use with introducers of different sizes, which can allow a single handheld housing to be used to treat different patient populations (e.g., adults and children).

[0163] Alternatively, in some variations, any actuating member and any guide (e.g., endoscope) herein can be detachable from each other. The actuating member and guide can be coupled together by connector fittings, fasteners, electromechanical interfits (e.g., threads, interference fits), bands, nesting, or in any suitable manner. Once coupled, the actuating member and guide can be used as a continuous single member. For example, the guide 250 can be removably attached from the actuating member 240 or the housing 210 so that the guide 250 can be disposable. In this example, the guide 250 does not need to be sterilized because it can be optionally discarded after use.

[0164] The outer surface of the actuating member and the guide may optionally be covered with a coating (e.g., a polymer material) that provides a smooth surface that is non-traumatic, biocompatible, and waterproof. In some embodiments, the actuating member and / or the guide may include an outer diameter between about 2.5 mm and about 7.0 mm. In some variations, the proximal portion of the actuating member (e.g., between about 0.5 cm and about 6.0 cm) or even the entire length of the actuating member may have a larger outer diameter as required to accommodate various connections (as further described below) with the actuator and / or user interface device in the housing. The total combined length of the actuating member and the guide may, for example, be between about 30 cm and about 70 cm. In some variations, the length of the actuating member may be between about 10 cm and about 40 cm, and the length of the guide may be between about 20 cm and about 30 cm. However, the diameter and length of the actuating member and / or the guide may vary for different applications (e.g., adult patients and pediatric patients, etc.). For example, variations of the device that may be adapted to assist nasotracheal intubation may include a longer introducer, such as between about 20 cm and about 60 cm, which may contribute to a total combined length between the actuating member and the introducer of between about 30 cm and about 100 cm long. Other exemplary structural aspects of the actuating member and the introducer will be described in further detail below.

[0165] Actuating member Any integrated system or assembly herein may optionally include one or more actuating members, and the following disclosure may apply to any actuating member herein. At least the proximal end of an exemplary actuating member 240 may be located in the housing 210 and / or the display 218. The actuating member 240 may be driven in multiple degrees of freedom to cause corresponding movement of an introducer (e.g., an endoscope 250). For example, the actuating member 240 may be actuated via an electromechanical coupling in a linearly propulsive (forward-backward along the longitudinal axis) and axially rotating (rotating around the longitudinal axis). Other actuations at or near the actuating member 240 (e.g., via the guide wire described above) may cause the distal end of the introducer to additionally articulate with an upward-downward and / or rightward-leftward distal end movement.

[0166] In summary, the actuation member 240 and the guide can be configured so that actuation and movement at the actuation member 240 can result in all desired degrees of freedom being transmitted to the guide. Similar to the above, any suitable actuator 216 and accompanying control system for driving the actuation member 240 can be included in the device, such as drive electronics, one or more electric motors, hydraulic devices, pneumatic devices and / or various mechanical parts (assemblies, connectors, joints, controllers, etc.), as long as appropriate. The control assembly, connectors and joints can be configured to smoothly and accurately transmit the desired actuation mechanical motion to the guide and the distal articulated end of the guide along the actuation member.

[0167] As an example Figure 2A As shown, in some variations, the actuation member 240 can travel along a specified path within the housing 210. For example, Figure 2C As shown, the actuating member 240 can be arranged along the guide 217 in the housing 210 (or arranged on the surface of the housing 210). For example, the guide 217 can include a guide channel (e.g., at least about 0.5 cm to about 1.0 cm wider than the actuating member 240) or any suitable guide rail, track or other guide structure. In other words, when the actuating member 240 is driven by the one or more actuators 216 described above in the fully automatic mode of the device, the actuating member 240 can travel within the guide channel. Although the guide 217 is Figure 2C 210 , but it will be appreciated that in other variations the guide 217 may be straight or other suitable shapes adapted within the housing 210 .

[0168] FIG. 3B to FIG. 3D Exemplary variations of actuators configured to move the actuation member herein along a guide are illustrated. Figure 3B2 is a schematic diagram of an axial actuator 216a that is configured to move the actuation member 240 in an axial or longitudinal direction (eg, advance and / or retract) to similarly move the introducer axially. Figure 3C As shown, the axial actuator 216a may include one or more matched pairs of opposing drive wheels that engage the actuating member 240 via grooves, friction elements, and / or the like. The drive wheels in each matched pair of drive wheels (wheel A and wheel B) may be located on opposite sides of the actuating member 240 or the guide, such that synchronous rotation of the drive wheels in opposite directions pushes the actuating member 240 of the guide forward and backward in an axial or longitudinal direction, such as pushing the actuating member 240 of the guide along the guide 217. Other suitable mechanisms (such as one or more of a crank slider system, a belt or pulley system, a plunger actuator, a corkscrew mechanism, etc.) may additionally or alternatively provide axial actuation of the actuating member 240. In addition, as Figure 3B and Figure 3D As shown, one or more actuator connectors connected to the rotary actuator 216r can also be coupled to the actuation member 240. The rotary actuator 216r may include one or more pull wires or other tension element attachments that are coupled to the actuation member 240 and configured to control movement from side to side or left and right, similar to the following description of the actuation member 240. Figure 3B However, any other suitable mechanism, such as rollers or the like, may be used to automatically actuate the rotational movement of the actuation member 240 and thus the guiding of the introducer.

[0169] Additionally or alternatively, the actuation member 240 may travel within the guide 217 when the actuation member 240 is manually driven, for example, in a manual assist mode, such as via the user interface device 270, a touch screen, a voice command, etc. Figure 3A As shown, a user interface device 270 (eg, including a control member 274 such as a joystick) can be coupled to the actuation member 240. The user interface device 270 can be engaged within a control member guide 272, such as Figure 2C and Figure 3A As shown, the control member guide 272 can generally follow or be parallel to the trajectory of the guide 217 of the actuation member 240. The user interface device 270 (including the control member 274, such as a joystick) can be connected to the actuation member 240 via a control line 276 attached at connection points 278 and 279 (e.g., with fasteners, welding, or in any other suitable manner), such as Figure 3AAs shown. For example, when the user manually manipulates the control member 274 forward and backward within the guide 272 (e.g., pushes and / or pulls), the top connector 278 between the control member 274 and the actuation member 240 can control manual forward movement (F). As another example, when the user manually manipulates the control member 274 within the guide 272 (e.g., pushes from side to side), the side connectors 279 between the control member 274 and the actuation member 240 can control movement from side to side or to the left (L) and to the right (R). Thus, the user interface device 270 can allow a manual assisted mode (e.g., manual advancement and / or rotation of the actuation member 240 and therefore the guide (e.g., endoscope 250), but automatic actuation of the distal articulated movable end of the endoscope). These connectors 278 and 279 can remain inactive in the fully automatic mode. In some variations, the manual assisted mode can be used Figure 2C 270), whereby selection of user interface element 282 may cause the device to enter a mode in which automatic movement is limited to articulation of the distal tip of the introducer (e.g., endoscope 250), while linear and / or rotational endoscope movement is manually controlled as described above (e.g., using user interface device 270). For example, user interface element 282 may assist the operator in activating a manual assist mode if such a mode is desired.

[0170] In some variations, any actuation member herein may be self-expanding. Figure 2A As shown, the actuation member 240' may include a self-expanding structure, such as including interlocking rings and / or spiral elements that transition from a compressed state to an extended state. Similar to the above, the actuation member 240' can be directed along the guide 217' and actuated by the actuator 216' and / or manually actuated using a suitable user interface device. Although the actuation member 240' is Figure 2A Shown as being compressed within a straight guide channel, but it will be appreciated that other shapes of guide channels are possible.

[0171] In addition, at least a portion of one or more of any actuation member, any actuator, user interface device, and / or guide may be in a module (e.g., display 218) coupled to housing 210. For example, Figure 2AAs shown, in some variations, the proximal end of the actuation member 240" may terminate in a display, wherein one or more actuators 216" similar to the actuators described above may automatically move the actuation member (axially and / or rotationally) within a guide 217" in the display and articulate the distal end of the endoscope, as described above. Additionally or alternatively, in some variations, the proximal end of the actuation member 240 may terminate in a display or module, wherein a user interface device similar to that described above may be used to manually move the actuation member 240" within a guide in the display (axially and / or rotationally). Furthermore, additionally or alternatively, in some variations, the proximal end of the actuation member 240" may terminate in a display, wherein the actuation member may self-expand in a manner similar to the actuation member 240' described above. For example, the actuation member 240" having the proximal portion in the display may be straight and axially aligned with the endoscope 250, such that self-expansion of the actuation member 240" results in easier extension of the working length of the endoscope.

[0172] An introducer (eg, flexible or rigid endoscope) Any dual video integrated system or assembly herein may include an introducer that is sized so that it can be used, for example, to guide the delivery of an intubation catheter (such as an ETT) into the trachea. The ETT can be advanced on any introducer herein. Any endoscope described or shown herein can be considered to be merely an example of an ETT introducer. It should be understood that the description of any endoscope or scope herein can be considered to be essentially a description of a more general introducer, as the term is used herein. In the examples herein, the introducer 250 can be an endoscope so that the endoscope 250 can be removably coupled (e.g., telescopically engaged) to an intubation catheter for use in an intubation procedure. The endoscope 250 can be configured to enter and navigate within the patient's airway and to serve as an introducer for ETT advancement during an intubation procedure. As described above, the introducer can have multiple degrees of freedom controlled by driving an actuating member, including longitudinal forward-backward movement, axial right-left rotation, and upward-downward and right-left articulated motion at the distal end of the introducer. For example, as Figure 5 As shown, the arrangement 600 including the distal end of the guide 250 may include one or more sets of antagonistic cables 62 and 63 extending from the navigation wheel 61 toward the distal end region 250d of the guide 250. For example, each set of antagonistic cables may correspond to a degree of freedom of the articulated end of the guide 250.

[0173] As an example Figure 6As shown, for example, arrangement 650 may include at least a first set of antagonistic cables 64a operated by navigation wheel 61a to control right-left articulation, a second set of antagonistic cables 64b operated by navigation wheel 61b to control up-down articulation, and / or a third set of antagonistic cables 64c operated by navigation wheel 61c to provide tensioning of actuation member 240. The arrangement for articulating the mirror tip may alternatively include only one or two of these sets (e.g., only one set of antagonistic cables 64b operated by navigation wheel 61b to control up-down articulation). For example, the cables may be coupled to actuation portion 240 via 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 can be between about 4-5 cm, and the articulation (steering) of the tip at the bending section can be between about 120 and 180 degrees in all directions (up-down, right-left). In addition, the axial rotation of the introducer can be between about 90 and about 180 degrees in both the right and left directions.

[0174] In some variations, the guide (e.g., endoscope) includes a flexible member having optical, electrical, and mechanical functions as described above (including transmission of light, video capture, mechanical actuation, and distal end articulation). Alternatively, in some variations, the guide may include a video probe. For example, the probe may have the same optical, electrical, and mechanical functions as a flexible mirror member, but the probe may be more rigid due to material and / or structure (e.g., a more rigid structure including metal). In some variations, at least a portion of the probe may be extensible. Using a rigid video probe instead of a flexible member may be useful, for example, in some applications, where greater torsional stiffness is desired to allow better transmission of linear and rotational motion between the actuating member and the guide, easier manipulation around the patient's airway (e.g., obstructive glottic lesions), smoother advancement during insertion into and navigation in the patient's anatomical structure, and easier advancement of the intubation catheter.

[0175] As explained herein, an endoscope herein is an example of a more generalized introducer for an intubation catheter, and an introducer (e.g., an endoscope) may or may not include an image sensor. Therefore, any description herein of a device or system including an endoscope or a scope should be understood to include an introducer, which may optionally not include an imaging sensor.

[0176] Transition Zone Any integrated assembly or system herein may optionally be included in a transition region or transition segment between the actuating member and the introducer. The transition region may have an intermediate stiffness and / or other gradual changes in structural characteristics to help ensure a smooth and uninterrupted transmission of the actuation from the actuating member to the introducer. In some modifications, the transition region may additionally or alternatively include a series of continuously increasing flexible segments and / or coil springs to transition from a more rigid actuating member to a more flexible introducer.

[0177] Alternatively and / or additionally, in variations such as the actuating member and the guide being detachably connected, a relatively rigid transition region (e.g., between about 1-2.5 times the length of the outer diameter of the actuating member and / or the guide) can help to restore continuity of electromechanical and / or other functions between the actuating member and the guide. The transition region can include a connector that provides the same structure and mission functions (including uninterrupted transmission of light, video capture / analysis, and mechanical actuation, etc.) as described elsewhere for variations in which the actuating member and the guide are integrally connected. The optical / electrical functions between the actuating member and the endoscope can be maintained with one or more suitable mating connectors (e.g., connectors associated with corresponding wiring PCBs), etc. The control of the distal end can also be maintained by mechanical solutions (e.g., coaxial cable connectors, button latches, pin and socket arrangements, wire lugs, plates, pins, screws, articulated joints, etc.).

[0178] Other structural features Any integrated system or assembly herein may include one or more structural features that are suitable for helping to prevent buckling and / or looping during forward-backward propulsion and / or rotation of the integrated system or assembly along a linear axis, which helps to improve the smooth transmission of motion from the actuating member to the introducer. In some variations, shaft stiffness and torsibility can be increased by including flat spiral interlocking metal bands having gaps therebetween (e.g., bands under an outer polymer covering) to maintain flexibility. These spiral bands can be covered with fine strands of stainless steel wire or other suitable material, which are braided into a tubular mesh and covered with an extruded polymer layer to produce a smooth outer surface. Some exemplary solutions for improving propulsion ("pushability") and rotation ("torsionability") will be described in further detail below.

[0179] For example, the actuating member and / or the guide can be guided through a somewhat continuous physical guide, such as a guide channel (e.g., similar to an overtube environment). The guide channel can help constrain the actuating member and / or the guide during manipulation and keep the combined length taut, thereby reducing kinking and other problems. For example, as described above, the actuating member 240 can be constrained in a guide 217 in the housing 210 and / or the display 218, and the endoscope 250 can be retained in the intubation catheter, which itself provides a rigid guide channel for the endoscope 250. In addition, as described below, the endoscope 250 can be constrained in the intubation catheter channel 266 in the cover 260. In addition, as described in further detail below, the overtube environment can provide a working channel, wherein manipulation of the intubation catheter (e.g., manual manipulation) can be easily performed, even while maintaining automatic, robot-assisted guidance of the endoscope.

[0180] Additionally, the surrounding intubation catheter and / or covering may help constrain the introducer into a straight path substantially aligned with the patient's airway during intubation, which further reduces buckling and / or looping within the actuation member and / or introducer.

[0181] Other structural features may help reduce friction. For example, a guide for the actuation member (such as guide 217), the actuation member itself, and / or the guide itself may be lubricated (e.g., with a durable commercial lubricant) and / or have an outer surface of a low friction material to provide reduced friction during actuation of the actuation member.

[0182] Additionally or alternatively, the actuating member may have an increased shaft stiffness, which can help prevent buckling and looping during linear advancement and rotation of the actuating member within the curved trajectory of the guide. For example, the actuating member 240 may be more rigid than the guide 250, which may be softer and more flexible to better facilitate manipulation. In some variations, the shaft stiffness along the length of the combined actuating member 240 and the guide 250 may be changed by changing the outer layer material composition of the actuating member and / or the guide 250. For example, the outer base layer may include a polymer having two types of resins, and the polymer may be extruded onto a metal mesh to form an outer structure. The stiffness may be changed by changing the composition of the combined resin, and the resulting polymer layer may further provide a non-damaging, biocompatible and waterproof surface. The shaft stiffness may be changed additionally or alternatively with an adjustable shaft stiffening coil wire or other suitable mechanical element. In some variations, shaft stiffness may additionally or alternatively be increased at actuation member 240 by providing at least a portion of actuation member 240 with a larger outer diameter. For example, the proximal end of actuation member 240 may have a flared diameter, which may also advantageously allow an increased operative surface for use of actuator 216.

[0183] Covering Any of the systems and components herein may also include a covering (e.g., covering 260) that allows and is adapted to provide an integrated dual imaging enhanced visualization and navigation system that is adapted to be held and controlled by a single hand of a single operator. The covering herein may be configured to be advanced on the patient's tongue above the patient's epiglottis (e.g., in or near the valleculae) and below the patient's epiglottis, thereby providing a versatile placement of the covering. Additionally or alternatively, the covering may preferably be configured to be placed above or below the epiglottis. In some variations, such as Figure 4A and Figure 4B In the variation shown in FIG. , the cover 260 (or any other cover, such as Figure 17A-17G The cover shown in FIG. 20 may also include a displacement member 268 configured to facilitate retraction of the patient's tongue, thereby improving the pharyngeal space to improve movement of the scope within the airway. The displacement member may be, for example, angled, linear, curved, or otherwise shaped so as to be placed within the patient's oral cavity in an atraumatic manner. In an exemplary variation, the width of the displacement member may be between about 3 cm and about 4 cm (e.g., for adult patients, and appropriately smaller for pediatric patients).

[0184] like Figure 4AAs shown, the cover may include two sections, including a first channel (e.g., 264) and a second channel (e.g., 266). The first channel may include a cavity that is sized and configured to receive a first imaging member (e.g., a laryngoscope stick) therein, and the second channel may be sized and configured to releasably secure an intubation tube (e.g., an ETT) thereto and limit the movement of the endotracheal tube relative to the cover in at least one direction. The channel may optionally be formfit to the received first imaging member and endotracheal tube. The first channel 264 may be adapted to be releasably coupled to the housing 210 at the connection 262, such as snapping onto the housing 210, so as to be removably attached to the housing 210. In some variations, the length of the first channel may be between 15 cm and 20 cm, and the first channel may be angled forward between about 4 cm and about 6 cm from the tip in a manner and direction that maximizes the view of different portions of the patient's upper airway anatomy (above the vocal cords) and the glottic structure to enhance visualization and movement of the introducer. However, for a covering adapted for use with a pediatric patient, these dimensions may differ.

[0185] The second channel 266 is adapted to be releasably fixed to an intubation catheter (e.g., ETT), which can be arranged around an introducer (e.g., a preloaded ETT). The intubation catheter channel can be used to provide a mechanism for firmly positioning the intubation catheter close to the displacement member 268. The intubation catheter channel 266 can optionally be configured to be coupled to (e.g., snapped to) the housing 210 at the connection 263. The intubation catheter channel can also include one or more latches, clips or other fasteners 267 to help keep the intubation catheter in the intubation catheter channel. In an exemplary variation, for adult patients, the length of the intubation catheter channel can be between about 15 cm and about 30 cm, and for pediatric patients, the length of the intubation catheter channel can be about half of the length. Intubation catheters of various sizes (e.g., diameters) can be accommodated in the intubation catheter channel 266. In addition, the second channel (intubation catheter channel) does not need to define an internal cavity, but can be partially open on one side thereof (e.g., with a longitudinal groove) to allow the intubation to be removed from the cover when the intubation is completed. For example, the second channel may include a semicircular cross-sectional configuration, or may have a groove or depression formed therein (see also Fig.17A 1713), the groove or recess is sized and configured to be releasably secured to the ETT.

[0186] In some examples, such as Figure 4BAs shown, the intubation catheter channel 266 and the first imaging member channel 264 can be optionally detachable from each other, such as along a detachable connection area 269 having one or more connectors, perforations, etc. This is useful, for example, as one of the options for enabling the laryngoscope to provide effective video laryngoscopy in the event of AI navigation failure or problems (only as a backup intubation option). For example, the intubation catheter channel 266 can be detached and removed along the connection area 269, which allows the first imaging member and the remaining portion of the cover 260 to be used in a conventional manual video laryngoscope intubation manner, where the intubation catheter is manipulated by the operator outside the cover 260 (it should be understood that if a pre-loaded intubation catheter can be pushed into the patient's trachea through the intubation catheter channel 266 of the cover 260, it may not be necessary to remove the intubation catheter channel 266 for all patients). In another alternate intubation option, the intubation catheter channel 266 of the cover can be used for a combined video laryngoscopy-flexible endoscope 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 alternate intubation technique, the detachable introducer 250 (or any other introducer herein) can be manually used as an intubation catheter introducer to facilitate placement of the intubation catheter into the trachea.

[0187] At the distal end of the cover 260, the two channels 264 and 266 can terminate adjacent to each other 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 each other. In this manner, the position of the distal end of the intubation catheter (optionally coaxial with and surrounding the introducer 250) can be better positioned into the field of view, thereby improving the ability to place the introducer 250 and the intubation catheter. In addition, the dual channel arrangement can allow the introducer to be robotically controlled to move to the glottis and into the trachea a minimum distance (compared to other methods where the introducer is advanced alone a longer total distance), thereby resulting in faster and more successful intubation on the first attempt. The dual channel cover or blade can cause the first imaging member and the introducer to present or have similar curvatures along the length of the cover, which can be useful in, for example, Fig. 17C and Fig.17D Roughly shown in the figure.

[0188] The integrated dual image sensor systems and assemblies herein are generally adapted so that when the introducer or the second imaging member (optionally, its housing) is releasably coupled to the housing, the first image sensor and the second image sensor are set or maintained at an initial distance relative to each other, which can optionally but not necessarily provide the image sensors with a predictable starting position relative to each other. As used herein, being set or maintained at an initial distance from each other can refer to any reference system and can include any spacing between them in space. For example, the image sensors can maintain horizontal and axial distances relative to each other. In some examples, the sensors can be aligned in one reference system, but still maintain a distance from each other through different reference points or reference axes. For example, in some exemplary embodiments, the first image sensor and the second image sensor can be substantially axially aligned with each other (in the proximal-distal direction) and spaced apart from each other laterally or horizontally. In these examples, although the sensors are axially aligned, the sensors are considered to be set and maintained at an initial distance from each other. In some exemplary embodiments, even if there is some minimal axial offset, the two image sensors can be initially substantially axially aligned with each other when assembled. The image sensors can be very close to each other, and in some embodiments, the two image sensors can be held relative to each other so that when the second imaging member (which includes the introducer) is releasably coupled to the housing, the axial distance between the two sensors is no greater than 3 cm. Due to the natural horizontal lateral offset of the two sensors when assembled together, the actual distance between the sensors can be different from the axial spacing between the sensors (if any axial spacing exists). When integrated into the assembly, the operator's single hand can hold the integrated system with the two image sensors set or maintained at an initial distance relative to each other, such as an axial distance of no more than 3 cm. In some examples, the second image sensor can initially be set in the proximal region of the ETT, or even set within the second imaging member housing, and has not yet been advanced into the ETT. In these examples, the assembly is still considered suitable so that before the actuator is actuated, the assembly causes the first camera to be set at an initial distance from the second camera.

[0189] In some examples, when the sensors are assembled into an assembly, the two image sensors can be maintained at a certain distance relative to each other, and at some time during use, when the two sensors are positioned in the upper airway, the sensors can become axially aligned. This may occur if, after assembly, the second image sensor is initially proximate to the first image sensor at a certain maintained initial distance, and wherein the second image sensor is moved distally a certain distance relative to the first image sensor until it is axially aligned with the first image sensor. For example, if the second image sensor continues to move distally, the two sensors in this example may be axially aligned for only a moment.

[0190] For providing an enhanced intubation catheter introducer during an airway management procedure (optionally during an intubation procedure) Exemplary Methods of Visualization and Navigation The disclosure herein includes aspects related to methods for enhanced visualization, navigation, and placement of intubation catheter introducers. Figure 7 A merely exemplary method of positioning an ETT in the trachea during an intubation procedure is illustrated in a flow chart. Figure 7 As shown, a method 700 for assisting in performing a robotic-assisted intubation procedure may include acquiring one or more images 710 using a first imaging member (e.g., laryngoscope) or a second imaging member (e.g., endoscope) of an integrated handheld system or assembly; initiating automatic guidance of an introducer (e.g., endoscope) using an actuation member 720; automatically guiding the introducer (e.g., endoscope) via the actuation member based on the one or more images 730; advancing an intubation catheter over the introducer (e.g., endoscope) 732; visually confirming intubation catheter placement 740 (e.g., using an introducer image sensor); separating the introducer and the intubation catheter 750; and withdrawing the handheld system or assembly (including the introducer 760 and a portion of the first imaging member 710) from the patient's oral cavity. In some variations, the method 700 may be performed using one or more variations of the devices described herein.

[0191] The step 710 of acquiring one or more images may include one or more images acquired using one or more image sensors in the integrated system or assembly, such as one or more images acquired using a laryngoscope (e.g., a video laryngoscope) and / or an endoscope as part of the integrated system or assembly. The images may be interpreted manually and may subsequently be automatically retrieved by, for example, the user selecting an automatic mode (e.g., activating an "AI" button, such as Figure 2C 280 shown in the figure) or by selecting the automatic-manual assisted mode described herein to initiate automatic guidance of the guide. 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 actuation guidance of the endoscope. In some variations, initialization (720) of automatic guidance of the guide (e.g., endoscope) may be based on one or more images acquired from a laryngoscope, while in some variations such initialization may be based on one or more images acquired from both the laryngoscope and the guide, and in some examples such initialization may be based on one or more images acquired only from the guide.

[0192] As an example Figure 7As shown, the method may include automatically guiding an introducer (e.g., an endoscope) (730) via an actuation member in 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 axial left-right rotation via the actuation member. In addition, 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. Although in some variations, a robotic system utilizing suitable AI image processing techniques may be used to automatically guide the introducer, additionally or alternatively, the introducer may be manually guided robotically using a suitable user interface device (e.g., a joystick) (e.g., an automatic-manual assisted mode), wherein an actuation mechanism disposed in the handle may robotically control movement of the introducer in response to an operator's manual interaction with the system (e.g., a joystick).

[0193] Various AI or machine learning methods can be implemented to automatically guide the introducer. For example, suitable image recognition or processing algorithms can identify anatomical landmarks in images from devices such as those described herein. AI-assisted intubation targeting of the vocal cords can utilize specialized targeting software that analyzes multiple image streams, marks and displays targets (e.g., target crosshairs), analyzes the expected intubation catheter navigation trajectory, identifies the distinct features of the tracheal opening visible between the vocal cords, and / or displays this information in real time on a display screen.

[0194] Different aiming methods have been described in the literature. One or more modules that perform specific functions (including but not limited to real-time computerized image processing, recognition and mapping, visual guidance, guidance information, and engagement with the robotic intubation interface) can be used to achieve fully automatic or automatic-manual assisted robotic intubation. Special logic circuits such as FPGAs (field programmable gate arrays) and / or ASICs (application-specific integrated circuits) and / or other applications can be used in methods and devices such as those described herein.

[0195] One or more different 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, etc.

[0196] If performed during an intubation procedure, method 700 may further include advancing an intubation catheter (732) coupled to an introducer (e.g., an endoscope) (disposed around the introducer). The intubation catheter may, for example, be telescopically engaged with the introducer (e.g., surrounding the introducer). The intubation catheter may be advanced over the introducer toward a target location as the introducer is manually or automatically guided. In some variations, the intubation catheter may be manually advanced. In some variations, the intubation catheter may be automatically advanced using a more suitable actuation system (such as those described herein). Additionally, in some variations, the intubation catheter may be manually advanced during certain portions of its travel and automatically advanced during other portions of its travel (e.g., as desired by the user).

[0197] In addition, in some variations, the method can include manually advancing the intubation catheter while maintaining automatic guidance of the introducer. For example, the user can hold the integrated system with one hand and manually manipulate the intubation catheter on the introducer with the other hand (e.g., push the intubation catheter forward on the introducer and / or rotate the intubation catheter (and / or as a unit with the introducer) toward a position in a target image (such as an image from an introducer image sensor disposed in the trachea)). Thus, in some variations, manual advancement of the intubation catheter can, for example, help reduce the distance that the intubation catheter travels toward the target location and further increase the speed of intubation.

[0198] Throughout the intubation procedure, images from the first imaging member and / or the second imaging member can be displayed to the user in real time or near real time, optionally continuously for some period or time period, as the introducer and intubation catheter are automatically and / or manually advanced to the target location. These images (such as images from the introducer image sensor when the introducer image sensor is in the trachea) can be used to immediately confirm correct intubation catheter placement (740), optionally optimal intubation catheter positioning and / or allow immediate identification of intubation catheter misplacement, and / or allow the user to troubleshoot the intubation procedure from above and below the vocal cords, including problems with intubation catheter advancement, which may indicate the need for appropriate intervention. For example, the first imaging sensor is separated from the introducer image sensor proximally and can provide views and identification of a larger anatomical area, which can provide additional views of tracheal tube movement that provide more information about placement than using only the introducer image sensor alone. Once visual confirmation of proper placement of the intubation catheter in the trachea is achieved (this is typically confirmed using an introducer imaging sensor also placed within the trachea and beneath the vocal cords), the introducer can be automatically removed from the intubation catheter by robotic actuation and / or manually (750), and the introducer can be withdrawn while leaving the intubation catheter in place (760).

[0199] Example. The following describes a merely exemplary, non-limiting method of performing TI using an integrated dual video system or assembly such as described herein. It should be understood that not all steps need to be performed and the order may be modified if appropriate.

[0200] 1. A disposable dual channel cover (e.g., 260) is coupled to a handheld housing (e.g., housing 210) and a laryngoscope wand (e.g., 220) is placed within the laryngoscope channel of the cover. The system is powered on. 2. A disposable introducer (e.g., endoscope) is coupled directly or indirectly to the handheld housing, such as to an actuation member of the system. Full functionality of the introducer is automatically checked by the device when connected to the handheld housing, such as to the actuation member. 3. The introducer is optionally lubricated and placed within a selected ETT. The ETT is placed within the intubation catheter channel (the intubation catheter channel is not necessarily an internal lumen) of the cover. 4. The user performs manual video laryngoscopy using the video laryngoscope (the display is in the default single-view mode showing the laryngoscope image feed) and identifies the anatomical structure on the display of the system. The image recognition and / or AI interface is activated and automated robotic actuation of the actuation member and the introducer is initiated through the actuation interface. The motion of the actuation member is fully transmitted to the introducer. (Actuation may also be manually activated by selecting an AI operating mode button on the housing of the device or by using an automatic-manual assisted mode). 5. Upon actuation, a split or picture-in-picture video screen feature is displayed, allowing the user to fully, optionally continuously, and in real time view the TI. This display mode may be activated automatically or manually. 6. In fully automatic mode, the device automatically maneuvers the introducer into the patient's trachea using AI or robotic assisted navigation, including forward-backward movement, axial rotation, and / or steering distal articulation. In some examples, this is performed using video data from the first image sensor only, and in some examples, this may be performed using video data from the first image sensor and the second image sensor. For example, initial movement of the introducer may be automatically based primarily on video data from the first imaging sensor (which may be a video laryngoscope image sensor) or based solely on video data from the first imaging sensor (which may be a video laryngoscope image sensor). 7. In both the automatic-manual assisted mode and the manual assisted mode, for example, manual operation of the device with a user interface device may immediately override the fully automatic mode. In manual mode, the forward-backward and / or axial rotation of the actuating member can be manually controlled, and the articulation of the distal end of the endoscope can be automated. For example, after the user presses the AI ​​operating mode button, the fully automatic mode can be restored. In the automatic-manual assisted mode, the operator manually exerts control over the automatic actuators in the system. 8. During navigation of the introducer, once the airway anatomy is identified, a visual indicator (e.g., a square or circle) can optionally appear on the screen around the displayed airway. The introducer articulation can move the tip in the direction of the detected geometric center point of the glottic opening and move the tip through the vocal cords.9. During the TI sequence, introducer actuation around the anatomy can be continuously visualized by the user via, for example, a video laryngoscope image feed or signal displayed on a display. Visually presenting video data from a first image sensor (e.g., a video laryngoscope image sensor) at a larger viewing angle on the display provides the operator / user with better navigation troubleshooting and enables manual intervention or assistance if needed. For example, while viewing the video signal from the first image sensor, the user can move the entire integrated system as a unit with a single handle, which can provide slight adjustments in positioning of the integrated system. 10. The introducer can be automatically navigated around the patient's anatomy, through the tracheal opening, and advanced into the patient's trachea. 11. The ETT can be manually advanced (or automatically advanced) distally away from the introducer into the patient's trachea, allowing for visual confirmation of proper placement of the ETT using image data from the introducer image source. ETT advancement can be continuously viewed on the display screen from above the vocal cords (first image sensor data) and below the vocal cords (transmitting image sensor), and tracheal ETT placement can be visually confirmed. In addition, by optionally pressing the picture-in-picture button twice on the display screen (optionally accomplished using other mechanisms such as using a remote control, audio command, or touch screen / display), a closer visual confirmation of tracheal ETT placement can be obtained by obtaining a complete picture of the patient's tracheal anatomy. In addition, the ETT can be optimally positioned in the trachea above the tracheal carina (not too deep, not too high). 12. The ETT can be released from the intubation tube channel 266 of the cover. The system is removed from the patient's mouth while leaving the ETT in place in the trachea. 13. The cuff of the ETT can be inflated and manual or mechanical ventilation through the ETT is initiated using a ventilation bag or automatic ventilator. ETT tracheal placement can optionally be further confirmed by any suitable means (e.g., breath sounds, EtCO2). 14. One of the advantages of the integrated dual video system herein is that if the AI / robotic-assisted TI fails for any reason, the operator has a backup option to complete the TI using the system as a video laryngoscope only, for example, as described above, using various conventional TI options. 15. In embodiments where the actuation member and introducer are detachable, if problems arise in advancing the ETT through the vocal cords (e.g., the ETT repeatedly "gets caught" on the glottic structures), the introducer can be disconnected from the actuation member and used as a handheld introducer (endoscope) to further facilitate guiding the ETT through the glottic opening.

[0201] Fig.15 An integrated dual video handheld intubation assembly (including any intubation assembly described herein) is generally illustrated after being positioned in the upper airway of a patient.

[0202] Figures 16A-16DOnly exemplary images that may be captured and / or displayed on a display during any of the described intubation procedures are illustrated, which may include the use of any of the handheld systems or components herein. The following disclosure describes video data or video images displayed on a display during an intubation system in the context of Figures 16A-16D , and exemplary benefits of a system adapted for displaying image data from a first image sensor and a second image sensor herein. Fig.16A The view provided by a first image source disposed at a distal region of a first imaging member, such as a camera, is illustrated. Fig.16A is marked in Fig.16A It may optionally but not necessarily be a panoramic image, as indicated. It can be seen that it is difficult or even impossible to see the vocal cords in this image. Any method herein may optionally include receiving an indication Fig.16A The system may be configured to provide input data of the anatomical view shown in the embodiment of the present invention and cause output of automatic robotically controlled movement of the introducer to be initiated. In an alternative embodiment (described in the context of the exemplary mode of this article), the system does not require automatic control of movement, but the user may manually cause robotic movement of the introducer via operable communication between the disposable introducer and the housing.

[0203] Fig. 16B The left side of shows image (eg, video) data from a first image sensor, Fig. 16B The right side of the diagram illustrates image data from a second image sensor. As shown, the image data from the first image sensor on the left provides visualization of the introducer after the introducer has been moved distally relative to its initial position (in which the second image sensor (e.g., camera) is initially held at a distance from the first image sensor (e.g., camera)) and relative to the first image source. It can be seen that as the introducer moves distally (optionally also rotates and / or deflects), 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 advanced (automatically and / or manually), and also provides a view of a larger anatomical area than the view provided by the introducer image sensor. In the event that the second image data is impaired (e.g., due to blood or secretions near the second image sensor), the image from the first image sensor can advantageously help determine where the introducer is, and can also help further facilitate continued movement of the introducer (automatically or manually robotically). Fig. 16B The illustration shows the introducer after it has been robotically moved to a certain extent toward the glottic opening and beneath the epiglottis, as shown.

[0204] Fig. 16C1 illustrates image data from a first image sensor and a second image sensor after an introducer has been advanced through the glottic opening, wherein the second image sensor provides visualization of the trachea, such as Fig. 16C The first image sensor (image data on the left side of the figure) continues to show the correctly positioned introducer, which is also a benefit of the integrated nature of the dual video cannula assembly herein.

[0205] Fig.16D Image data from two image sources is again shown, and shows the endotracheal tube after it has been advanced over the introducer toward the glottic opening, through the glottic opening, and into the trachea, as shown. Fig.16D The window or opening shown in the upper left portion of the right image is the standard side opening in an ETT (called the eye of Murphy). The generally linear feature extending from the upper right corner is the radiopaque portion of the ETT, illustrating the location of the primary distal opening of the ETT.

[0206] Some of the disclosures set forth above describe identifying or recognizing anatomical landmarks or locations in an image to help guide an introducer toward the vocal cords, through the vocal cords, and into the trachea. For example, landmarks include, but are not limited to, the epiglottis, vocal cords, arytenoid cartilages, pyriform sinuses, tongue, the geometric center point of the glottal opening, tracheal walls (tracheal rings), image areas that are darker than adjacent areas, and the like. In some methods and devices herein, identifying or recognizing anatomical landmarks or locations (which may be generally described herein as image recognition) may be performed or accomplished automatically. For example, but not limited to, and as set forth above, image or landmark recognition may be performed using AI or image recognition software that is configured and adapted to automatically recognize certain landmarks based on one or more images or image data received when using the system. Fig. 8A An exemplary sequence illustrating automatic image / landmark recognition is illustrated, which can then facilitate robotic control and navigation of an introducer (e.g., a flexible and / or rigid endoscope), additional details of which are described herein. In some methods and devices herein, identifying or recognizing anatomical landmarks can be performed or completed manually by medical personnel or other operators. For example, a physician can provide input (e.g., touch, audio, 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 can touch the touch screen at the location of a vocal cord identified in a displayed image or at a location to which the operator wishes the introducer to move. Figure 8B An exemplary sequence illustrating manual image / landmark recognition is illustrated, which can then facilitate robotic control and navigation of the endoscope, additional details of which are described herein. It should be understood that Fig. 8A and Figure 8BAspects of the present invention may be combined. For example, but not limited to, automatic recognition may occur (e.g., as part of a device mode), and manual confirmation of the automatic recognition aspects of the image may be required before initiating endoscopic navigation (e.g., manually touching a confirmation icon on a display).

[0207] Any system herein may include one or more processors having stored therein executable methods (e.g., software, firmware, algorithms, etc.) adapted to receive instructions or inputs based directly or indirectly on user interaction with a display (optionally touch and / or audio interaction and / or tactile feedback) when the display presents at least one image (static image or video image). The executable methods may facilitate robotic control of the movement of the introducer via an actuation member in the housing and / or a first imaging member or other member in operative communication with the introducer.

[0208] Some of the disclosures set forth above describe robotic control of movement of an introducer through the vocal cords and into the trachea.For example, some of the disclosures herein relate to automated robotic control of an introducer. Fig. 9A The diagram shows the Fig. 8A and Figure 8B ) after automatically controlling the introduction of an introducer into the trachea (or other cavity, depending on the medical procedure). For example, after one or more image recognition and / or processing steps, automatic movement of the introducer can occur using any of the actuators and / or actuation members described herein. In some cases, movement of the introducer can be at least partially manually controlled, such as (but not limited to) by a user moving an actuator (such as a joystick, wheel, slide, or other similar actuator (which can be operably connected to an internal housing actuator)) to control one or more types of movement of the introducer. Additional details regarding the types of optional movement control (e.g., distal-proximal, rotational, and / or distal-tip deflection) are described elsewhere herein. It should be understood that Fig. 9A and Fig. 9B The exemplary robot control steps in Fig. 8A and / or Figure 8B image processing and / or image recognition in combination.

[0209] The methods, devices and / or systems herein may not include automatic image processing and / or recognition. Alternatively, the methods, devices and systems herein may be adapted and configured to have a mode that does not include the use of automatic image processing and / or recognition or to be used in a manner that does not include the use of automatic image processing and / or recognition. Both of these situations may generally be referred to as manual mode herein. Figure 8BIncluded are exemplary steps that may be included in the manual mode (other steps, such as any steps herein, may obviously be included in the overall introducer navigation process). Fig. 9A and / or Fig. 9B The guide controls in (or as described elsewhere herein) may be included in the 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 to initiate the manual mode, or by touching a touch screen to identify a portion of an image. In some cases, any device herein may default to manual mode or may not be suitable for use with AI or other automatic image processing and / or recognition. In some cases, when the video quality is poor, or when the confidence in automatic navigation is below a certain threshold, or when an abnormal or unusual anatomical structure is identified, or in other cases, the device may automatically enter manual mode and / or sound, display, or vibrate an alarm.

[0210] As described herein, the methods, systems, and apparatuses herein may use or include automated modes (although it should be understood that they may also have other modes or be used in other ways). Automated modes may include automated image processing or recognition (e.g., Fig. 8A ) and automatic robotic mirror control and / or navigation (e.g. Fig. 9A ), which may optionally be performed in a continuous, closed-loop manner. In some cases, the apparatus and methods operate in an automatic mode in response to a user selection or initiation of a mode, such as by (e.g., simply) pressing an AI button on a handpiece (e.g., Figure 2C ). In some cases, the automatic mode may be the default and may run in automatic mode without user initiation. In some cases, the automatic mode may be initiated or occur after any number of modes or steps have occurred, such as in a manual control mode (e.g., Fig. 9B ), the user wishes to stop the manual control mode and return to the automatic mode. Any of the devices, systems, and methods herein may be used or have a mode in which the automatic mode continues while and as long as the medical staff continues to actuate the actuator (such as a button or switch on the handpiece). In these modes, the system may be adapted so that when the user stops actuating the actuator (e.g., releases the button or switch), the automatic mirror control and / or navigation stops. By way of example only, any "AI" button on the handpiece may be used as this type of actuator, and once released, the automatic mode may stop (e.g., a dead man's switch). This mode may be used with any other mode or method herein.

[0211] Any of the devices and systems herein may be adapted so that a user may override or stop automatic mirror control / navigation by interacting with the handpiece, including any display associated therewith. Fig.10 (Similar to Fig. 9B ) illustrates exemplary steps including manual robotic control at a time subsequent to automatic robotic control (other steps may of course be included). By way of example only, an operator may use a handheld housing actuator (e.g., a joystick, wheel, slider, etc.) to override (optionally immediately cause automatic mode to stop or pause) automatic navigation. User control may provide one or more of forward-backward (distal-proximal) and rotation. Some systems may be adapted so that automatic mode may be reactivated after a user interacts with the handpiece (e.g., presses an "AI" button). For example, in Fig.10 In the embodiment of the present invention, after manual control, the method can return to automatic control again, and can cycle back and forth according to the operator's or the device's wishes.

[0212] Any of the systems, apparatus, and methods herein may be adapted so that an operator can indicate a navigation path (or a location along a path) on a display, such as by touching a particular location on an image presented on the display, or even using a voice command, for which the system may be adapted to receive, process, and initiate an event. The system may be adapted to then automatically navigate to or toward that location. This is similar to Fig. 9A , where landmark identification in this example includes indicating locations or mid-path locations (and not necessarily specific anatomical landmarks).

[0213] like Fig. 9A As shown, any device and system herein can be adapted to automatically control the navigation of the guide (e.g., such as having a mode adapted to provide this function). Using automatic image processing and / or recognition, the system can be adapted to receive image data and determine the path of the guide (e.g., mirror). Using manual image recognition, the system can be adapted to process manual discrimination and determine the path for the mirror. Then, the onboard AI can transmit instructions to facilitate the control of the onboard actuator, thereby facilitating the intelligent, non-invasive, AI-enabled, robot-assisted navigation of the mirror into the patient's airway. This sequence can be repeated in a closed loop. As explained above, once the mirror is placed in the patient's trachea, the operator can use the mirror as a non-invasive intubation guide (similar to the guidewire in other medical procedures) to manually advance the tracheal tube on the mirror. The operator can continuously visualize the advancement of the tracheal tube on a display screen (such as a handheld or fixed monitor), optionally from both above and below the vocal cords, where a single image (optionally capable of switching between more than one image) or at least two images are displayed simultaneously.

[0214] When the term laryngoscope is used herein, it should be understood that the term can refer to a conventional laryngoscope, but the term can also refer to any type of device suitable for providing at least a video image to an operator and preferably (but not necessarily) providing a panoramic video to the operator. Generally, these are referred to as the first imaging member (or first elongated imaging member) herein. The first imaging member can be manufactured and packaged to be connected to a handheld housing, or the first imaging member can be releasably connected to the housing by the operator or assistant just before the procedure. The laryngoscope herein can generally be referred to as any one of a video guide ("VG") and an optional panoramic video guide ("PVG") and a first imaging member, and can include an image sensor (e.g., a camera) located at its distal end, as well as optical and electrical wiring and communication functions. The first imaging member can be functionally similar to the video stick of an existing video laryngoscope, and can include any of its features or functions.

[0215] It should also be understood that any video monitor (e.g., display) herein can be integrated into any handheld housing herein, or these video monitors can also be separate, independent video monitors (including as part of a detachable component that can be releasably fixed to a handpiece). As described herein, any video monitor can include a touch screen that can be adapted to respond to taps, hits, and any other type of manual commands. Any video monitor herein can also be adapted to respond to audio input (e.g., voice commands) or tactile commands. The terms display, screen, and monitor are used interchangeably herein.

[0216] In any system herein, the introducer can be an endoscope (rigid and / or flexible), which may also be simply referred to herein as a mirror. The term is understood to not necessarily be functionally limiting. 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) elongated tubular member or shaft and an optional distal camera, electrical wiring, optional optical transmission elements, or one or more elongated elements (e.g., pull wires) for articulating the distal tip. As described herein, the introducer may be adapted to be releasably fixed to any housing (indirectly or directly), optionally fixed to any housing via a connector, wherein the connection creates an operable robotic connection between the introducer and the handheld housing to facilitate robotic control of the introducer, which is described in more detail elsewhere herein.

[0217] Any of the covers herein (which may also be referred to herein as blades) may include a first elongated channel adapted to receive a first imaging member therein, and the cover may also be adapted to be releasably secured to an endotracheal tube to limit movement of the endotracheal tube relative to the cover in at least one direction. The cover may include a separate endotracheal tube lumen, or the cover may be configured with an endotracheal tube stabilizer, such as one or more clips or a partial channel, to which the endotracheal tube may be releasably secured. The cover is typically configured such that when the endotracheal tube is initially releasably secured to the cover, the position of the endotracheal tube is substantially maintained relative to the first imaging member channel and lumen, additional details of which are set forth above.

[0218] As described herein, the housing can be packaged with an introducer (e.g., endoscope) or other long endotracheal tube guide device that has been attached or coupled to the housing. In an alternative example, the introducer is not packaged to be firmly coupled to the housing, and is releasably fixed or coupled to the housing by an operator or assistant before a medical procedure. In either case, the introducer is operably connected to the housing to facilitate robotic control of the introducer, and optical data is optionally transmitted from the introducer to the housing, which optical data can be displayed on a display, as described herein. The introducer can optionally be releasably fixed to a coupling on the housing, wherein the coupling can be any suitable component or multiple components (including a separate component, such as an adapter coupled to both a handpiece and an introducer), which is sized and configured to interact or engage with the guide of the guide, and is releasably fixed to the guide of the guide. In this context, releasably fixed means that the introducer can be fixed to the housing so that both the introducer and the housing are not easily separated during normal use of the device during an intubation procedure, and can include a locking mechanism that can be additionally actuated to lock the introducer to the handpiece. For example, the locking mechanism can include an additional step or movement of the introducer to lock the introducer in place relative to the handheld housing. Figure 2A An example of an introducer 250 is shown that is releasably secured to a coupling of the housing, which coupling may be considered to include an end of the actuation member 240. Figure 2A In the example of FIG. 1 , the actuation member 240 (and other similar internally movable actuation members) can be considered a robotic extension of the introducer after the introducer is releasably secured to the coupling of the housing. That is, the actuation member and the introducer can move together and can be considered part of the same movable unit, and data can be transmitted from the introducer to the housing. Figure 2C Additional examples of housings including internal movable robotic extensions or actuation members are illustrated.

[0219] like Figure 2CAs shown in the example of , the internal movable robot extension or actuation member is at least partially disposed or arranged along and / or within a guide 217 within the housing. As described above, the guide is sized and shaped to allow the actuation member to move relative to the guide while guiding movement of the actuation member within the housing.

[0220] Fig.11 Another example of a robotic handheld device or assembly suitable for facilitating delivery of an endotracheal tube to the trachea (or other devices to a different cavity depending on the procedure) is shown. Fig.11 Any other features in the example in or appropriately modifying the example can be included, even if the text does not explain its inclusion. The device or assembly 1100 includes a handheld housing 1110, a cover or blade 1160 connected to the handheld housing 1110, and a display 1118. In this example, the handheld housing 1110 includes a universal docking station 1130, which can be disposed in the housing. The guide delivered to the patient's trachea (or other cavity) may need to be within the outer diameter limit according to the anatomical structure and / or use. For example, for pediatric patients, the mirror may need to be smaller than the guide that can be used for adult patients. According to the use of the device herein, it may be desirable to be able to releasably fix multiple flexible or rigid guides to a common (e.g., universal) handheld housing, wherein these mirrors may have different outer diameters ("OD") and sizes and / or possible different relative positions of optical transmission lines in the guide. One consideration is to ensure that the introducer can be releasably secured to the handheld housing regardless of the OD and size of the introducer, and will be in operative communication with the housing (e.g., capable of being robotically moved and optionally facilitating the transmission of optical (e.g., image) data). Thus, the handheld device includes a universal docking station or other universal connector (e.g., Fig.11 It may be beneficial to have a universal docking station or other universal coupler adapted to enable a variety of flexible and rigid introducers of different ODs and different sizes to be releasably secured to a handheld housing and to ensure operable communication with the handheld housing. The universal docking station or universal coupler may be adapted so that it can accommodate introducers of different sizes (e.g., having different circular outer cross-sectional dimensions, different introducer lengths, different locations of optional optical transmission elements, etc.). In some examples, the universal docking station may include a plurality of adapters, each sized and configured to properly engage a flexible / rigid introducer regardless of the OD and size of the introducer.

[0221] exist Fig.11In the example of FIG. 1 , a robotically controllable introducer 1150 is shown coupled to a housing 1110 and a docking station 1130, which may be within the housing. Once coupled, the introducer 1150 may be moved with an actuator within the housing in any manner described herein (e.g., distal-proximal, rotational, tip deflection in at least four different directions).

[0222] Fig.11 Also shown is an exemplary mirror or introducer guide 1117, for example, Figure 2C Compared to the internal guide 217 in FIG. 1 , the guide 1117 is associated with or proximate to an exterior region of the housing (and may extend from an exterior housing surface). Fig.11 The guide 1150 is illustrated as being stably received in a guide 1117, which in this example is disposed at a top region of the housing. This position may allow the guide to be fixed and movable relative to the top of the housing, but still have a central guide region extending through an endotracheal tube ETT. The guide 1117 may have a tubular configuration through which the guide passes before being coupled to the coupler and universal docking station 11130. Alternative guide configurations may also be used. For example, the guide 1117 may not form a complete cavity, such as if the guide has a substantially "C" shaped cross-sectional shape, as long as the guide is movable relative to the guide and the guide prevents the guide from separating from the guide.

[0223] As set forth above, in some embodiments, when the introducer is directly or indirectly releasably coupled to the handheld housing (e.g., an intubation procedure), the introducer can be robotically moved, including being advanced distally toward the trachea. In some embodiments, the assembly is optionally adapted to be capable of robotically advancing the introducer at least 10-12 cm beyond the tip of the ETT (automatic and / or manual robotic navigation) so that the introducer can be advanced to a fixed position in the trachea and sufficiently deep into the patient's trachea.

[0224] In some embodiments, the handheld assembly is configured to robotically move the introducer distally by 5 cm to 40 cm, or 5 cm to 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 distally (and thus the introducer distally) by 5 cm to 40 cm, and optionally no more than 40 cm. Alternatively, with reference to Fig.11 , the assembly may optionally be capable of moving the introducer 5 cm to 40 cm distally, or 5 cm to 60 cm distally (e.g., if the assembly does not include an actuation member or a robotic extension). In the present disclosure, the phrases actuation member, robotic extension, and introducer (or endoscope) extension may be used interchangeably.

[0225] The overall length of the introducer may depend on the procedure. For example, in a bronchoscopy procedure, the introducer may optionally have a length of 50 cm-60 cm. In addition, not all procedures utilizing the handheld systems and assemblies herein require the use of the cover and / or the first imaging member (e.g., a bronchoscope), and when used in such procedures, the first imaging member and the cover may optionally be removed / disassembled from the handpiece to remove unnecessary components and simplify the procedure.

[0226] Any device herein may include an introducer distal travel limiter adapted to prevent the introducer (or robotic extension) from moving distally beyond a certain distance relative to the starting axial position. This may occur due to the construction of the assembly and certain feedback mechanisms from the AI ​​and software to the handpiece, which may inherently create a distal travel limiter when the introducer is unable to move further distally relative to the handheld housing or assembly simply due to the actuator and / or robotic extension construction. Thus, the limiter may be considered a passive or active travel limiter.

[0227] In some robotic handheld devices and assemblies herein, at least some of the robotic functionality of the device may be incorporated into a component that is removable from the handheld housing, but that may be releasably secured to the handheld housing prior to a procedure. This may allow some components to be more easily reused, while other components may be discarded after a procedure, for example. This may also allow some removable components to be able to be used with a variety of handheld devices, for example. This may also aid and / or simplify the manufacture of certain components. Fig.12 and Fig.13 An exemplary assembly having detachable components that include at least some robotic control functionality is illustrated. Fig.12A handheld housing 1200 and a removable robotic block 1270 (also referred to herein as a removable guide controller) are illustrated, which is shown as being releasably fixed to the handheld housing 1200. Blocks used in this context are not limited to any particular structure or function, but generally refer to the removable function of a component. In this example, the removable block 1270 includes an guide coupler 1222, a robotic extension or actuation member 1240 at least partially within the housing of the block 1270, and a guide 1217 within the block 1270, which guide 1217 may include any feature of any guide herein that allows the robotic extension 1240 to move, but keeps the extension 1240 in the guide or associated with the guide 1217. An actuator 1216 is also shown, which may include any function or feature of any actuator herein (e.g., a motor control that moves the extension 1240 and thereby moves the guide 1250).

[0228] In this example, the handheld housing 1210 may include a block coupler 1272 (which may also be referred to herein as an introducer controller coupler) that is sized and configured to be releasably secured to the removable block. The block 1270 may similarly include any type of suitable corresponding mating structure that is sized and configured to releasably but securely engage the block coupler 1272 on the housing 1210. The block coupler 1272 may include a variety of coupling features (e.g., press fit, female / male fit, 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, mirror movement, light transmission, video capture, mechanical actuation, distal tip articulation, etc.). Any removable "block" herein may also be referred to herein as an introducer controller, an introducer controller, or a second imaging member including the introducer.

[0229] Fig.12 Also illustrated is a removable cover 1260 having a first channel and a second channel (which may include any of the cover or blade features or functions described herein) that is releasably secured to the housing 1210 .

[0230] The handheld housing 1210 of this embodiment may include an integrated or built-in display (e.g., a touch screen) 1218, which may include any of the features or functionality of any display described herein and may be used in accordance with any of the methods or steps described herein (e.g., manual anatomical landmark identification). Alternatively, the system may have a display located on one side of the housing 1210 rather than on the other side of the housing 1210. Fig.12 A display (integrated or removable) is shown located on the top surface of the housing.

[0231] One aspect disclosed herein includes optionally utilizing preoperative information about the patient during the intubation procedure, such as preoperative images (e.g., CT, X-ray, MRI, PET scans, and / or 3D reconstructed images of the airway) or video, which can help or assist in navigating during the intubation procedure. By way of example only, it may be beneficial to utilize preoperative endoscopic video examinations to improve or enhance navigation. Optionally, patient characteristics or conditions may be incorporated into the navigation procedure. For example, if a patient's disease and / or characteristics and / or condition (all of which are generally referred to herein as "conditions") can be generally described, the operator is able to select an appropriate condition from more than one selectable condition that matches the patient's condition (e.g., from a software image library) before the procedure, and the device (e.g., via AI and / or an associated trained machine learning algorithm) will consider the condition during the intubation procedure to further improve visualization, navigation, and ETT placement, further improving the speed, success rate, accuracy, and safety of intubation. By way of example only, such an interface may include a drop-down application menu (or voice command to free up the handset for use) presented on any display or screen herein (including that of a mobile phone or computer) that would allow selection of a personalized condition for medical care for that particular patient. For example, conditions or information about the procedure may include "Laryngeal Cancer," "Base of Tongue Tumor," or "Nasal Intubation," or "Airway Exchange via Intubated LMA." Combinations of procedures and conditions may also be presented or otherwise selectable, such as "Nasal Intubation for Base of Tongue Tumor Patient." For any of these conditions and / or procedures, an image library may be retrieved from the cloud or built-in device software and optionally stored on the handpiece and used as part of the navigation.

[0232] In some embodiments, existing patient images may be delivered and stored on a handheld device (e.g., wirelessly) and utilized during navigation (e.g., via AI). For example, these images may include one or more of preoperative videos, pictures of the patient's anatomy, or reconstructed images / videos from CT / X-ray / MRI / PET scans and / or other imaging studies.

[0233] Any handheld device or component herein may also include a video record button (or other type of actuator) located on the device to allow recording of video from either or both of the VG or the mirror.

[0234] Any information from any program (e.g., video and / or image data) can also be automatically or manually transmitted to a central location (e.g., to the cloud). This data can be used to train the AI ​​to enhance the navigation capabilities of this and other systems.

[0235] Any information (e.g., video and / or image data) from any procedure may also 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 for educational purposes.

[0236] In any of the examples herein, an endotracheal tube (e.g., an ETT) may also be used as an additional manipulation tool for the flexible introducer. Moving the endotracheal tube may be beneficial in assisting in navigating and / or orienting a scope coupled to the ETT. Rotating and / or moving the endotracheal tube forward (distal) may help enhance proper introducer alignment, actuation, and advancement, whether the introducer is being navigated by an automated robot (e.g., Fig. 9A ) or when being navigated by a manual robot (e.g. Fig. 9B ). For example, the endotracheal tube can be moved anteriorly and posteriorly (distal-proximal) and / or axially rotated to optimize visualization of the introducer and / or navigation / movement of the introducer toward the target, improving the speed of intubation and first-pass success rate. In some uses, the endotracheal tube can be moved (e.g., advanced distally and / or axially rotated) prior to initiating an automated introducer navigation sequence. In some uses, the endotracheal tube can be moved (e.g., advanced distally and / or axially rotated) during an automated scope navigation sequence. In some examples, the assembly is adapted so that if the endotracheal tube is manipulated (e.g., Fig. 9A ), endotracheal tube manipulation can automatically cause the robotic interface to stop.

[0237] One aspect of the disclosure herein is related to an integrated dual video system that includes an introducer guide or guide feature. As described herein, a device (in a handpiece or a removable block portion) may include an introducer guide that allows the introducer (or robot extension) to move relative to the guide, but limits the movement to a specific or known path (e.g., within the guide and prevents the introducer from leaving the guide). As described in the above section, any guide herein may include a guide rail for a proximal portion of the introducer (or robot introducer extension) located within or outside the device housing. In addition, the guide may be sized and configured to prevent the proximal portion of the introducer (including the robot extension) from buckling. In addition, the proximal region of the introducer or the robot extension may have a stiffness suitable for preventing the mirror from buckling, wherein the stiffness may be greater than the stiffness of the mirror axis disposed outside the housing. In addition, any guide may point the introducer at a favorable angle and / or favorable trajectory and / or path within or outside the device housing. Additionally, as described above, introducer guidance may be enhanced by positioning the distal region of the introducer within the endotracheal tube to maintain endoscopic teaching due to the frictional engagement between the introducer and the endotracheal tube.

[0238] One aspect of the present disclosure relates to an introducer that, once coupled to a handheld housing (either coupled to a handpiece or via a removable block), can be robotically moved distally, and optionally, at least a certain distance. In some merely exemplary uses, the total introducer length (with or without a robotic extension) can 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, and optionally 10 cm to 40 cm, such as 10 cm to 25 cm of robotic distal introducer advancement. If the system includes a robotic extension, this can be facilitated by the travel allowed by the robotic extension in the handpiece.

[0239] In any embodiments herein, any introducer guide in the handheld housing may include a coating or other lubricating material (eg, silicone) that facilitates movement of the mirror relative to the guide and helps prevent buckling or sticking.

[0240] In any of the embodiments herein, the introducer may include one or more sensors at the distal tip for avoiding excessive steering forces during navigation (eg, during tip deflection).

[0241] In any of the embodiments herein, deflection or steering of the distal scope tip can be facilitated without the use of pull wires or other elongated tensioning structures, such as piezoelectric, alloys (bimetallic, nitinol).

[0242] In any embodiments herein, the introducer may have a stiffness that varies along its length. For example, but not limitation, the introducer herein may include one or more polymeric materials (e.g., PEBAX) that have varying stiffness (e.g., different hardnesses) along the length of the guide, and optionally provide a distal tip that is more flexible or deflectable than a proximal region of the mirror. Concepts for varying the stiffness of polymeric elongated shafts are generally known, and any concepts related thereto may be incorporated into the embodiments herein. For example, a robotic extension may include a polymeric material having a higher hardness than the introducer material at the distal end of the guide. Likewise, by way of example only, a proximal region of the guide (such as an area of ​​the guide that engages the guide on the exterior of the handpiece, such as a distal tip) may be more flexible or deflectable than a proximal region of the handpiece. Fig.11 ) can have a higher stiffness than the distal region of the introducer to help prevent buckling during distal movement.

[0243] One aspect of the disclosure herein is that the described devices and systems can be optionally but advantageously adapted and configured as a highly usable, handheld, portable, multifunctional dual video airway management platform that can be operated by a single hand of a single user. By way of example only, the handheld housing herein can be adapted for use in a variety of different airway management procedures and / or with a variety of different introducers and / or a variety of different first image components (e.g., video laryngoscopes). In these embodiments, the handheld housing can be considered a universal or common handheld housing to which a variety of different introducers and / or first imaging components can be interchangeably coupled and used. For example, it may be desirable to have a universal platform that can be coupled to an introducer sized for a pediatric patient and an introducer sized for an adult patient. Additionally or alternatively, it may 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 and usable in bronchoscopy and other airway management procedures described herein, and relatively short introducers that can be used in intubation or intubation-related airway management procedures. The platform technology may also be adapted to be able to robotically control different introducers that may be coupled to the platform, regardless of whether the airway management procedure is medical, diagnostic, or surgical. The handheld housing herein may be adapted such that one or more of the introducer, cover or blade, or first imaging member (e.g., video laryngoscope) may be releasably coupled to the handheld housing (directly or indirectly) to provide versatility. Thus, the present disclosure includes devices and systems that may be adapted to provide versatility and a wide range of uses not yet observed or provided in prior medical airway management methods.

[0244] In addition, the devices and systems herein can be adapted such that if the introducer is not required for a particular airway management procedure or portion of a procedure, the introducer can be temporarily or permanently removed (or simply not coupled to the housing). For example, if the introducer is not required for a procedure or portion of a procedure, the introducer can be not used, and if the introducer was previously coupled to the housing, it can be optionally temporarily or permanently removed from the housing. In addition, if the first imaging member is not required for a procedure or portion of a procedure, the first imaging member can be not used, and if the first imaging member was previously coupled to the housing, the first imaging member can be optionally temporarily or permanently removed from the housing. In addition, if the blade is not required for a particular procedure or portion of a procedure (e.g., bronchoscopy), the blade can be temporarily or permanently removed or not used.

[0245] Thus, the devices, assemblies, systems, and methods herein can be adapted and configured to be multifunctional, versatile, highly usable, handheld, portable platforms that are adapted to be operated by a single user to provide a number of capabilities not observed and available with existing methods, including the ability to treat a variety of patient populations in a variety of clinical scenarios and locations, and to be used in a variety of airway management procedures, and optionally while robotically controlling (e.g., using AI, smart navigation, etc.) the movement of the introducer. Furthermore, the devices herein can be quickly 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.

[0246] While the disclosure herein describes some systems and devices that can be used to generate and view two images (simultaneously on the same screen or by switching between 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 can be used without an introducer (e.g., a mirror) and with only a first imaging member. For example, this may occur if the introducer module fails or is ineffective, such as if blood and secretions in the airway interfere. The assembly can be adapted so that the operator can use the device as a conventional video laryngoscope (or VG) when the introducer is disconnected or at least not in use. The assembly can have a separate mode that includes using only the video from the first imaging member (VG).

[0247] Another exemplary scenario in which only one video or imaging device may be used includes using only the introducer video, while the first imaging member is disconnected or at least not in use. In some cases where the first imaging member can be removed from the housing, this can include disconnecting the first imaging member from the housing, or at least deactivating the first imaging member. An exemplary scenario for airway management (in which an introducer can be used without the first imaging member) is in nasal flexible endoscopic intubation, including the option of coupling the first imaging member at a later time to facilitate endoscopic manipulation when the endoscope passes through the nose to the mouth. Another exemplary scenario for airway management (in which the scope can be used without the first imaging member) is the use of an endoscope to facilitate intubation through a supraglottic airway device ("SGA"), which is a small mask positioned in the patient's mouth to provide ventilation / oxygenation of the lungs (when connected to a ventilator). When intubation is considered difficult or encounters difficulty, an SGA (e.g., a laryngeal mask airway, LMA, etc.) is often used to alleviate difficult airway situations. Another exemplary scenario of airway management (where an introducer may be used without a first imaging member) is in a diagnostic upper airway endoscopy or bronchoscopy, where the procedure may be performed with or without an indwelling endotracheal tube. Another exemplary scenario of airway management (where an introducer may be used without a first imaging member) is to confirm the correct positioning of an indwelling ETT within the patient's trachea and / or optimize the positioning of the ETT within the patient's trachea. Another exemplary scenario of airway management (where an introducer may be used without a first imaging member) is to facilitate the placement and positioning of a double-lumen endotracheal tube, which is a special type of ETT used, for example, in thoracic surgery and whose placement is often difficult. Another exemplary scenario of airway management (where an introducer may be used without a first imaging member) is to facilitate the endoscopically assisted exchange of an existing (indwelling) ETT in a patient, optionally in an operating room, ICU, emergency department, or other location. Another exemplary scenario of airway management (where an introducer may be used without a first imaging member) is to facilitate a trial of extubation. In any of these exemplary airway management procedures that may be used without the first imaging member, the cover may be detached from the handheld housing (if the blade is actually coupled to the handheld housing).

[0248] In some alternative uses, the devices or assemblies herein can be used in one or more ENT airway management procedures, such as biopsy or injection (e.g., vocal cord injection). In some alternative uses, the devices herein can be used in one or more other medical and / or surgical endoscopic procedures.

[0249] Furthermore, although the applications herein are related to medical procedures, the devices and methods herein can be used for non-medical procedures. For example, the devices herein can be used for industrial applications, for example, where an introducer may need to be "snaked" into an orifice to assess a difficult-to-access machine.

[0250] Any system herein may be adapted so that it may optionally be used with a first imaging member such as a video laryngoscope (which may be referred to herein as VL or VG) and the system may not be coupled to an introducer, or an introducer not be used as part of the procedure.

[0251] Any of the systems herein may be used in such a manner that the 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 during the procedure, or the first imaging member may be reattached to the handheld housing at a later time during the procedure.

[0252] Any of the systems herein may be adapted to couple to multiple covers, each of which may be of at least one dimension different from the dimension of at least one other cover, which may allow, for example, different sized covers for children and adults.

[0253] Any of the systems herein may be adapted to couple to multiple introducers, which may be of different sizes and / or lengths, which may allow the handpieces herein to be used with both adults and children, for example.

[0254] Any of the systems herein may be adapted to couple to a plurality of deflectable introducers, which may be flexible or rigid, or partially flexible and partially rigid, and may have varying lengths and diameters.

[0255] Some exemplary systems or components of this paper include an introducer (e.g., a mechanical guide, a flexible endoscope, a rigid endoscope, etc.) that can be releasably fixed to a handheld housing, whereby when the introducer is fixed to the housing, the handheld housing is operably connected to the introducer, so that the handheld housing is suitable for providing controlled movement of the introducer, and the introducer is suitable for receiving and responding to such control. One aspect of the disclosure of this paper is related to an optional disposable or single-use introducer that is sized and configured to be releasably fixed to the handheld housing. After being releasably fixed (directly or indirectly) to the handheld housing, the handheld housing can be used to control the movement of the introducer. After the procedure is completed, or at a time determined by the operator, the introducer can be released from the handheld housing and can be optionally discarded. The handheld housing can be reused for the same patient, or reused after cleaning and / or disinfection.

[0256] After the intubation system is exposed to the patient, it must generally be cleaned and disinfected for reuse on a different patient. For some systems herein, it may be challenging to clean and / or disinfect one or more components that facilitate axial movement of the introducer. Therefore, in some uses, it may be desirable to have a disposable or single-use introducer that can be removed after use so that the handheld housing can be cleaned and disinfected and used with a new introducer in subsequent uses. Therefore, it may be desirable to use a disposable but affordable introducer. Any introducer herein (e.g., a flexible or rigid endoscope, etc.) may be disposable and / or may be incorporated into a disposable introducer housing assembly, any of which may be sized and configured to be releasably fixed to the handheld housing. The introducer housing assembly herein may generally be referred to as a second imaging member.

[0257] Figures 14A-14D An example of an intubation system is illustrated, which includes an exemplary handheld housing and an exemplary introducer housing assembly (also referred to as a second imaging member), wherein the handheld housing and the introducer housing assembly are sized and configured so that the introducer housing assembly can be releasably fixed to the handheld housing to create an operable connection between the handheld housing and the introducer housing assembly. In this context, the introducer housing assembly may also be simply referred to as the introducer assembly or the second imaging member. The introducer housing assembly herein may be disposable and may be easily released from the handheld housing after a procedure or as desired by the operator (such as in the event of a malfunction of the introducer assembly). When the introducer housing assembly is releasably fixed to the handheld housing, the two components together may also be referred to together as a handheld device or assembly.

[0258] In this example, the intubation system or assembly 1400 includes a handheld housing 1410, which can 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), an electronic device, one or more computer-executable methods, firmware, a microprocessor, a blade coupling, a laryngoscope or a laryngoscope coupling, etc. In some examples, the housing 1400 can include an integrated first imaging member (e.g., a laryngoscope), and in some examples, the housing 1400 includes a laryngoscope coupling adapted to be releasably secured to a laryngoscope. In some examples, the housing 1400 is coupled to a video device or includes a video device that is not necessarily considered a laryngoscope, but is adapted to provide a video image. In some examples, the handheld housing herein does not include a laryngoscope and is not adapted to be coupled to a laryngoscope.

[0259] In this example, the system 1400 optionally includes a removable cover 1460, which in this example includes a first imaging member channel 1462 defining a lumen and an endotracheal tube channel 1461. Any other suitable cover features or descriptions herein (including in any claims) may be incorporated into Figures 14A-14D In component 1400.

[0260] Assembly 1400 includes an introducer assembly 1499 (which may be referred to herein as a second imaging member) that includes an introducer housing 1490 secured to a removable guide 1450, wherein the introducer housing 1490 is sized and configured to be releasably secured to a handheld housing 1410, and wherein the introducer assembly 1499 may be disposable.

[0261] In this example, the handheld housing 1410 includes a plurality of electrical connections ( Fig. 14B ), which are adapted to be placed with corresponding electrical connectors 1495 ( Fig. 14C and Fig.14D ) is electrically connected, which can facilitate at least one type of controlled movement of the introducer, which is described below. The electrical connector of the handheld housing 1410 is connected to the onboard handheld housing controller, which can be adapted to cause movement of the introducer by facilitating the sending of an electrical signal to the electrical connector. For example, as described elsewhere herein, the onboard controller may include one or more processors and / or computer-executable methods that facilitate automatic movement of the introducer (e.g., via AI) based on automatic or manual image recognition methods. Any suitable features of any other handheld housing herein that facilitate controlled movement of the introducer can be incorporated into the handheld housing 1410.

[0262] In this example, the handheld housing 1410 includes one or more motors therein, wherein the motors are in rotational communication with or considered to be part of a motor coupling 1413, which may include a motor shaft that rotates when the motor rotates. In this example, the motors are adapted to cause axial movement of the introducer when activated, which is described below.

[0263] Fig. 14C and Fig.14D Exemplary features of the introducer housing 1490 and the introducer 1450 are illustrated. In this embodiment, the introducer housing 1490 includes an electrical connector 1495 including a plurality of electrical connectors as shown, which are adapted and positioned to establish electrical communication with the electrical connectors of the handheld housing when the introducer assembly 1499 is releasably secured to the handheld housing 1410 ( Fig. 14B). An electrical coupling between the handheld housing and the introducer housing may provide one or more types of controlled movement of the introducer. It is noted that the electrical coupling is optional, and in alternative designs, the electrical coupling may be replaced with one or more motors in the handheld housing. The electrical coupling 1495 may also include a connection for transmitting image data from the introducer to the handheld housing.

[0264] The introducer housing 1490 is adapted to be releasably coupled to the handheld housing, wherein the coupling creates operable communication between one or more controllers in the handheld housing and the introducer. In this example, the coupling creates both electrical and mechanical communication, but in other examples it may be only mechanical or only electrical. In this example, the mechanical coupling is adapted to control axial movement of the introducer, and the electrical coupling is adapted to cause axial movement of the introducer. Fig. 14C One or more types of deflection of the articulating region of the guide are shown, which can facilitate 360 ​​degrees of deflection.

[0265] In this example, the motor coupler includes a motor in the handpiece that is rotationally coupled to the shaft, such as Fig. 14B The motor shaft is sized and configured to be disposed within a motor coupler 1496, which is an introducer housing, such as Fig. 14C As shown. Fig.14D As shown, the motor shaft can be sized and configured to engage the inner surface of one of the rollers 1494a or 1494b. Thus, activation of the motor drives rotation of one of the rollers 1494a or 1494b, both of which are adapted to rotate about an axis in this example. An end region of the guide 1450 (optionally, an end of a flexible guide shaft) is fixed relative to the housing 1490 at a location 1491, while the guide and housing are adapted so that the guide can move axially relative to the housing 1490 at a region away from the location 1491. The guide 1450 is shown disposed through a hole 1493 in the housing body 1492 and through a hole 1497 in the housing body 1492.

[0266] The handheld housing can be used with different sized guides. For example, the motor shaft can be a common or universal drive element that can be sized and configured to fit within different sized rollers depending on the size of the roller and / or guide. This is an example of how a universal handpiece can be releasably secured to different guides that can have at least one size / dimension (e.g., diameter) difference. This can allow the handheld housing to be used for children as well as adults.

[0267] As used herein, the introducer housing may or may not completely surround or enclose the introducer. For example, the introducer housing may have one side open to the surrounding environment and still be considered as an introducer housing herein.

[0268] As shown, the guide 1450 is disposed between rollers or wheels 1494a and 1494b such that rotation of the rollers in opposite directions toward the guide causes axial movement of the guide, such as Fig.14D . Rotation of the roller in a first manner may result in distal movement, while rotation in an opposite manner may result in proximal movement. Any other disclosure herein related to controlled axial movement (e.g., such as an axial distance of, e.g., 10-40 cm) may be incorporated into Figures 14A-14D One or both of the rollers may have grooves or other friction interfaces, similar to Fig.14D In the upper right portion of the figure, one or more rollers may have less obvious teeth or grooves in the alternative. In the alternative, one or more of the one or more rollers may be made of polymers, plastics, to reduce the possibility of damaging the guide shaft or avoid damaging the guide shaft. The rollers may have smooth engagement surfaces, or the rollers may have non-smooth engagement surfaces.

[0269] The introducer housing of the present invention may include a body (such as housing body 1492), wherein the housing body may include one or more components, optionally including two or more components, which are fixed together (e.g., with adhesive, welding, etc.) to at least partially define the housing body.

[0270] The introducer housing assembly herein may include a plurality of electrical connectors 1495 (eg, including pins and / or through holes), each of which may be coupled to a wire ( Fig.14D ), wherein each wire can extend through the introducer shaft or be in electrical communication with a wire extending through the introducer shaft. For example, any one of the wires (e.g., four to nine) can transmit information from a camera at a distal region of the introducer (e.g., Fig. 14C) or wires can facilitate deflection control of the articulated active area of ​​the introducer, for example, such as with shape memory material (e.g., Nitinol) or bimetallic wires (e.g., 5-8 wires). The general concept of transmitting electrical signals through wires including shape memory materials to cause shaft deflection has been described, and the basic concept can be used to include one or more such wires to cause deflection of the articulated active area of ​​the introducer herein. For example, an electrical signal can be transmitted to one or more guide wires to cause their distal end sections to transition between shape memory states, which can be used to control the deflection of the introducer in one or more directions. Any wire herein may also include a bimetallic wire, which can also be used to cause deflection of the introducer by transmitting a signal to and through one or more wires. Additional electrical signals can be transmitted to the wires to cause the distal region of the wires to change shape, returning to the original, undeflected or straight shape. Electrical signals can be transmitted to any combination of wires to produce and cause any desired deflection or configuration of the articulated active area, which can be automatically controlled by, for example, AI. For example, deflection can be induced by changing the shape of any combination of the introducer's centerlines, which can be used to create a variety of shapes and configurations of the deflectable region of the introducer.

[0271] Figures 14A-14D An example of a system that uses a mechanical coupling to control axial movement of an introducer and an electrical coupling to cause deflection of a region distal to the distal end of an articulated region of the introducer is shown. Fig. 14C shown.

[0272] Any disclosure herein related to automatic and / or manual introducer control may be included in system 1400. For example, the use of one or more of a shape memory material (e.g., nitinol) or a bimetal to deflect a distal region of the introducer may be used to control the deflection of the introducer in one or more of any automatic mode and / or manual mode (including partially automatic and partially manual) described herein.

[0273] like Fig.14D It can be seen that 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 (in this embodiment, the proximal end of the introducer shaft is coupled to the introducer housing at location 1491). The force applied to the shaft to cause axial movement is applied where the introducer shaft engages the rotatable roller. Although Fig.14A1450 is not shown, but the introducer 1450 is generally suitable for guiding the advancement of an endotracheal tube, for which any relevant disclosure herein may be incorporated into this example. By controlling the axial movement (e.g., the force applied) of the introducer at a position closer to the endotracheal tube, as in this embodiment, the axial movement of the introducer is less likely to cause buckling of the introducer. For example, applying force to the introducer at a position farther from the endotracheal tube may increase the likelihood of buckling of the introducer shaft. Another exemplary advantage of controlling the axial introducer movement at one or more specific positions relatively close to the endotracheal tube is that better force feedback may be provided, if desired or required.

[0274] Any handheld housing (e.g., 1410) herein may include an encoder located on the motor to control the axial distance the introducer is moved. Additionally or alternatively, any introducer herein may include a plurality of visual markings thereon (e.g., axially spaced lines) that may be used to control the axial travel of the introducer. Additionally or alternatively, any blade herein may include an RFID tag (or EEPROM) that may be used to control initial introducer advancement and / or transmit the blade type to the system, as the blade type may affect the first visual effect.

[0275] Any component that may include an introducer housing (e.g., 1490) (which may be releasably secured to a handheld housing) may include an RFID tag (or EEPROM) that may be suitable for informing the system or controlling what type of introducer is being used, such as information relating to introducer diameter, introducer length, video resolution, and / or for enabling and disabling certain features, such as reuse.

[0276] In any of the examples herein, the introducer housing (eg, 1490 ) can be adapted to be releasably secured to a rear surface or a side surface of a handheld housing (eg, 1410 ).

[0277] exist Fig. 14CIn the embodiment of FIG. 1490 , a region of the introducer referred to in the figure as an extra loop is shown as not being enclosed in a housing (until a portion of the introducer is fed through the housing 1490). In an alternative design, this region of the introducer may be at least partially contained or disposed in a housing, which may provide protection for the introducer and potentially reduce the likelihood of objects being caught or stuck by the loop region of the introducer. Such a housing may be fixed relative to the housing 1490, or be a part of the housing 1490 so that the introducer may move relative to an additional loop housing. For example, this loop region of the introducer may be disposed in a cylindrical housing that is in a fixed relationship relative to the housing 1490. Alternatively, the loop region of the introducer may be disposed within a spiral housing or container fixed to the housing 1490, wherein the introducer may move relative to the spiral housing to facilitate axial movement.

[0278] exist Figures 14A-14D In the example of , the deflection is caused by the wires in the guide, which are adapted to change shape in response to the signal transmitted thereto. In alternatives, the deflection of the guide can be driven by another motor coupling between the handheld housing and the guide housing instead. In these alternatives, the system may include a mechanical coupling for the axial movement of the guide and the deflection of the guide. In these alternatives, the wires in the guide can be communicated with one or more motors, wherein the motor can be used to tension the wires and cause the deflection of the steerable section of the guide. For example, the system may include two or four additional motors to facilitate the deflection of the deflectable section. For example, the system may include four motors for tensioning the pull wire (or other elongated tensioning element) to cause deflection and / or to turn back to a straight configuration. Including four additional motors can help to maintain tension in the pull wire when the pull wire is tensioned at different circumferential positions to deflect the housing, which can help to deal with backlash by reducing the slack in other pull wires that are not tensioned for deflection. Having four motors may, for example, help maintain tension on all puller wires that are not tensioned to deflect at that particular location. Alternatively, the system may include two further motors, wherein the further motors may be adapted to deflect the deflectable region of the introducer.

[0279] Any introducer housing herein may also include a cavity or a cavity contained therein, which cavity may be suitable as a working cavity. For example, the housing may include one or more ports communicated with one or more cavities to allow one or more substances and / or devices to be delivered into the working cavity. Fig.14DA schematic diagram of ports and cavities is shown. For example, housing 1490 can be adapted to couple to and receive a syringe to facilitate delivery of one or more substances (e.g., one or more therapeutic agents). It may be beneficial to have an agent delivery port and cavity in the housing that may be disposable and may not require cleaning. Additionally, the ports and cavities may allow for 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 different from Fig.14D The present invention also provides a method for providing a method for providing a device for the patient to be introduced in a certain manner. The method of providing a method for providing a device for the patient to be introduced in a certain manner may be described in detail in the following embodiments. The method of providing a method for providing a device for the patient to be introduced in a certain manner may be described in detail in the following embodiments. The method of providing a method for providing a device for the patient to be introduced in a certain manner may be described in detail in the following embodiments. The method of providing a method for providing a device for the patient to be introduced in a certain manner may be described in detail in the following embodiments.

[0280] As discussed above, an exemplary benefit of some embodiments of the present invention is that the distal end of the introducer and the distal end of the first imaging member can be initially positioned in the patient as a coupling unit (e.g., both are coupled to a handheld housing). This initial positioning of the introducer can allow the system to immediately fully advance the introducer distally into the patient's airway, and advance in such a way that the introducer needs a significantly shorter distance to navigate to the desired position (e.g., the laryngeal entrance). This will be contrary to the standard situation when the introducer is not coupled to the handpiece and must be advanced distally from a starting point located farther from the desired position. For example, in some uses, when the introducer is typically coupled to the first imaging member and assembly, when the introducer is inserted into its initial position, the introducer can be only about 2-7cm away from the desired position. Then, the introducer can be optionally guided to the desired position while only utilizing imaging from the first imaging member and the resulting robotic control, because even in difficult airway situations, the first imaging member is able to provide reliable and stable anatomical landmarks by viewing a larger anatomical area. One of the exemplary benefits of these examples is that the introducer and the first imaging member may be coupled to a common component in a manner such that the fields of view of the introducer and the first imaging member at least partially overlap.

[0281] An exemplary benefit of some embodiments herein that include a common handheld housing to which the introducer and the first imaging member are coupled is that the total footprint or envelope occupied by the structural device when placed within the patient's body can be smaller or at least more reliably controlled, which in the case of endotracheal intubation can further improve first-pass success rates, shorten intubation time, and reduce the risk of injury to the patient.

[0282] Any image processing herein may occur inside or outside the handheld housing. For example, the image processing may occur at least partially in a device external to the handheld housing, such as a computer with a graphics processing unit, a smart phone, etc. The handheld device may be in communication (wired or wireless) with an external device, and optionally, information related to the acquired optical information is transmitted from the handheld device to the external device for processing. The external device may also be adapted to transmit information to the handheld housing to facilitate control of the introducer, which is described in more detail herein.

[0283] Figure 17A-17G At least a portion of an exemplary cannula system 1700 is illustrated, wherein Fig.17A and Fig. 17B 1702 is an unassembled view of an exemplary integrated and handheld dual video endotracheal tube assembly, wherein this integrated assembly and other integrated assemblies may be referred to herein simply as an assembly. Any individual components of any assembly herein may be assembled together prior to the procedure to assemble and create an assembly. Figure 17C-17E The assembled assembly 1702 is illustrated. The assembly 1702 includes a housing 1710 including a first imaging member coupler 1712, a second imaging member coupler 1714, and a cover coupler 1716. The housing 1702 is configured to releasably couple to a cover 1780, a first elongated imaging member 1730 (an example of which is shown in FIG. Fig.17F and 17G )) and an optional disposable second elongated imaging member 1740. Fig.17F and Figure 17G As shown, assembly 1702' (which may include any suitable features of assembly 1702, and vice versa) includes a first elongated imaging member 1730 having a first coupling region that is sized and configured to releasably couple to a first imaging member coupler 1712. First elongated imaging member 1730 includes an elongated flexible body 1732 and a first image sensor 1734 (e.g., a camera) disposed at a distal region 1736 of elongated body 1732.

[0284] The assembly 1702 also includes a second elongated imaging member 1740 including a second coupling region 1742 sized and configured to releasably couple to a second imaging member coupler 1714 of the housing 1710. The second elongated imaging member 1740 includes a flexible and navigable elongated endotracheal tube introducer 1770 ("introducer"), at least a portion of which is deflectable. The introducer 1770 is sized to be disposed within an endotracheal tube 1790 and to allow axial movement of the endotracheal tube 1790 on the introducer 1770. The second imaging member 1740 includes a second image sensor 1773 (e.g., a camera) disposed at a distal region 1772 of the 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.

[0285] The assembly 1702 also includes a cover 1780 having a cover coupling region 1782 that is sized and configured to releasably couple to a cover coupler 1716 of the housing 1710. The cover includes an elongated channel defining an elongated cavity that is sized and dimensioned such that when the first coupling region of the first imaging member 1730 is releasably coupled to the first imaging member coupler 1712 and when the cover coupling region 1782 is releasably coupled to the cover coupler 1716, at least a portion of the elongated body 1732 of the first imaging member 1730 is disposed within the elongated cavity.

[0286] The covering 1780 also includes an endotracheal tube channel 1784 disposed on one side of the covering 1780, which is sized and dimensioned to engage with the endotracheal tube 1790 and limit movement of the endotracheal tube 1790 relative to the covering 1780 in at least one direction, as shown. The endotracheal tube channel 1784 is also configured to allow lateral movement of the endotracheal tube 1790 relative to the endotracheal tube channel 1784. In this example, the channel 1784 includes a recess or groove formed in one side of the covering 1780, which is sized and configured to engage with a portion of the outer wall of the endotracheal tube 1790, and in some embodiments, the channel 1784 can have a cross-sectional configuration that includes a surface forming a partial circle to engage with the circular outer surface of the endotracheal tube 1790.

[0287] like Fig. 17C As shown, endotracheal tube 1790 includes a lumen sized to movably receive introducer 1770 therein.

[0288] Assembly 1720 also includes one or more actuators disposed within housing 1710 and configured and positioned such that when second coupling region 1742 of disposable second elongated imaging member 1740 is releasably coupled to second imaging member coupler 1714 of housing 1710, the actuators are configured to facilitate controlled robotic movement of introducer 1770 and second image sensor 1772 (e.g., a camera) relative to first image sensor 1734 (e.g., a camera).

[0289] The 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 input information indicative of a signal received from a first image sensor (e.g., a camera) when the first image sensor is positioned in the upper airway of a patient and cause communication with an actuator within a housing (e.g., housing 1710) to control robotic movement of an introducer and a second image sensor (e.g., a camera) relative to the first image sensor and toward one or more upper airway anatomical landmarks. Details regarding exemplary methods of use are described in more detail elsewhere herein.

[0290] As described elsewhere herein, an exemplary advantage of the assemblies herein is that, once assembled, they are sized and configured so that they can be held and moved as an assembly by an operator in one hand. Assembly 1702 is an example of an assembly that is sized and configured so that when the first coupling region of first imaging member 1730 is releasably coupled to first imaging member coupler 1712, when second coupling region 1742 is coupled to second imaging member coupler 1714, when cover coupling region 1782 is releasably coupled to cover coupler 1716, and when endotracheal tube 1790 is releasably coupled to endotracheal tube channel 1784, the assembly including the first image sensor and the second image sensor can be moved as an integrated unit by an operator in one hand.

[0291] Fig. 17C The assembly view of the assembly 1702 is shown, referred to as a bottom view, in which the first image sensor and the second image sensor can be seen. The horizontal distance between the image sensors is as shown in FIG. Fig. 17C Measured in the direction marked "H".

[0292] Fig.17D A side assembled view of assembly 1702 is shown. Fig.17D As shown, the relative axial distance between the image sensors when the components are assembled as described herein is measured in the axial direction "A". It should be understood that the axial direction "A" depends on the orientation of the assembled components. For example, if Fig.17DIf the assembly in is rotated 90 degrees counterclockwise, the axial direction "A" will similarly rotate 90 degrees.

[0293] As described herein, an exemplary advantage of some of the components herein is that they are sized and configured to be held and moved by an operator in one hand. When assembled, prior to actuation of the actuator, the relative coupling between the housing, the cover, the first elongated imaging member, and the endotracheal tube holds the first image sensor at a distance from the second image sensor, an example of which is shown in Figure 17C-17E In some uses, it may be preferred that when the assembly is assembled, the first image sensor and the second image sensor are axially aligned or as close to axial alignment as possible. In some cases, the image sensors are axially aligned. In some cases, the image sensors are substantially axially aligned. In some cases, when the assembly is assembled, the first image sensor and the second image sensor are maintained within 3 cm of each other in the axial direction "A". In any of these cases, when the assembly is assembled, the horizontal distance H between the first image sensor and the second image sensor may be no greater than 2 cm. When assembled, the image sensors being maintained in close proximity can help make the overall profile or footprint of the assembly smaller, which helps make it easier and safer for a single operator to hold the dual video intubation assembly with a single hand.

[0294] Fig.17E A top view of the assembled assembly 1702 is shown with the second imaging member 1740 coupled to the housing 1710 as shown. In this top view, the first image sensor and the second image sensor are facing downward or into the page.

[0295] Fig.17F and Figure 17G A component 1702 ′ is illustrated that may include any disclosed content from component 1702 . Fig.17F and Figure 17GA first imaging member 1730 is shown that includes an elongated flexible body 1732 and a first image sensor (e.g., a camera) disposed at a distal region 1736 of the flexible body 1732. In some embodiments, the first imaging member 1730 can be integrated into and considered part of the covering, wherein the first imaging member and the covering are releasably coupled to the housing 1710 as a subassembly. In some examples, the first imaging member 1730 can be releasably coupled to the housing prior to use separate from the covering. In some examples, the housing (e.g., housing 1710) and the first imaging member (e.g., imaging member 1730) can be an integrated unit and do not need to be coupled by an operator prior to a medical procedure. Being able to remove the first imaging member from the housing and reuse the housing can be advantageous, such as if a different size first imaging member is required for a subsequent procedure (e.g., between a different patient or a pediatric patient and an adult patient), the advantages of which are described elsewhere herein. It should therefore be understood that any assembly herein may include an integrated housing and first imaging member, a cover and first imaging member integrated and coupled to the housing as a unit, or a cover and first imaging member separately releasably connected to the housing. Any component not labeled or described in system 1702' should be understood to be the same as a corresponding component or subassembly in assembly 1702.

[0296] Figures 18A-18J An exemplary housing 1710 is illustrated. It should be understood that any housing features described with respect to housing 1710 may be incorporated into any housing herein, which may be a part of any assembly herein. Figure 17A-17G Any markings on the housing 1710 may be included in Figures 18A-18J even if they are not marked in the figure.

[0297] The housing 1710 includes a communication region 1720 adapted to communicate with an optional disposable second imaging member 1740. The communication region 1720 may be configured to be releasable when the second imaging member 1740 is releasably coupled to the housing 1710 (see Figure 17C-17E) in one or more electrical, mechanical, optical, and / or video communication with the second imaging member 1740. In this example, the communication region 1720 includes a mechanical interface 1721 and a mechanical interface 1722, which are adapted to mechanically engage with the second imaging member 1740, as described in more detail below. In this example, the mechanical interfaces 1721 and 1722 are positioned and configured to mechanically engage with corresponding features on the second imaging member 1740 and cause deflection of the guide via one or more pull wires or other tensioning elements, as described below. The mechanical interfaces 1721 and 1722 can be actuated by one or more motors, for example, which can be disposed in the housing 1710. In this context, the motors can be considered to be part of a robotic control mechanism that is adapted to robotically control the movement of the guide, optionally in response to image processing as described elsewhere herein. The motor in this type of design may be considered an actuator as that term is used herein, or one or more motors may be considered to be part of an actuator, for example, where an actuator may refer to one or more individual components (e.g., a motor and drive shaft, etc.) that operate together as a mechanical and / or electrical system.

[0298] The components herein include one or more actuators 1761 (see Fig. 20 ), the actuator 1761 facilitates (directly or indirectly) the robotically controlled movement of the introducer. The motor within the housing 1710 as described in this example is an example of an actuator 1761 within the assembly. The pull wire in this exemplary embodiment is also considered an actuator, and in this example, the pull wire is disposed in the exemplary second imaging member 1740.

[0299] The communication region 1720 may further include a mechanical interface 1723 positioned to mechanically engage the second imaging member and cause or facilitate axial movement of the introducer, as will be described in more detail below. One or more motors in the housing may cause mechanical movement of the mechanical interface.

[0300] The communication area 1720 of the housing optionally includes an optical sensor 1724 adapted to optically track the axial movement and / or axial position of the introducer as the introducer moves axially relative to the optical sensor, and described in more detail elsewhere below. Other sensors may be used to track the axial movement and / or position of the introducer.

[0301] The connectivity region 1720 may also optionally include a plurality of electrical connectors 1725 (e.g., a plurality of electrical connections) that may be adapted to engage with a plurality of corresponding connectors on the second imaging member 1740 to receive data (e.g., camera signals) transmitted from the second image sensor to the housing, where the data may be processed or transmitted to an external device and / or display of the device for processing. Exemplary image processing and robotic control (automatic and / or manual robotic control) utilizing the second image sensor data is described elsewhere herein.

[0302] Figure 18G-18J Housing 1710 is illustrated with at least one housing body component removed (eg, half of a housing) to illustrate exemplary internal housing components that may be provided in any of the housings herein. Figure 18G is a side view of the housing 1710. Fig.18H is a bottom perspective view of housing 1710 . Fig.18I 17 is a bottom view of the housing 1710 . Fig.18J 1801 , which may be a camera control unit for any first image sensor herein, and which may be adapted to convert raw camera signals from the first image sensor into a USB. The housing 1710 also includes a second camera control unit 1802, which may be a camera control unit for any second image sensor herein, and which may be adapted to convert raw camera signals from the second image sensor into a USB. Position 1803 represents an exemplary position of an exemplary USB hub.

[0303] Figure 18G Also illustrated is an exemplary axial drive motor 1804 (which may be referred to herein as an axial actuation mechanism), which may include an axial drive servo mechanism and which may be adapted to facilitate axial movement of the introducer herein, as described in greater detail elsewhere herein. For example, the axial drive motor 1804 may cause rotation of the mechanical interface 1723, which is described in greater detail herein and in Fig.18J The axial drive motor 1804 is an example of an actuator as that term is used herein (and in this example is an example of an actuator disposed in a housing). Fig.18HOnly exemplary first and second deflection (or articulation) drive motors 1805 (which may be referred to herein as actuation mechanisms) are illustrated, and the first and second deflection (or articulation) drive motors 1805 may include a deflection servo mechanism, and the motors may be adapted to facilitate deflection of the introducer, which is described in more detail elsewhere herein (e.g., the motors may cause the pull wire to be tensioned). For example, the first deflection drive motor 1805 and the second deflection drive motor 1805 may cause rotation of the mechanical interfaces 1721 and 1722, respectively, which are described in more detail herein and in Fig.18J The first and second yaw (or articulation) drive motors 1805 are examples of actuators as that term is used herein (and in this example are examples of actuators disposed in a housing). Fig.18I An exemplary location of a microcontroller is shown.

[0304] Figures 19A-19K An exemplary second elongated imaging member and exemplary features thereof are illustrated. Figures 19A-19K is shown and described in the context of a second imaging member 1740, but Figures 19A-19K Any suitable aspect of the second imaging member of the present invention can be combined with any other second elongated imaging member herein, and any suitable aspect of any other second elongated imaging member herein can be combined with Figures 19A-19K For example, the second imaging member in this article Fig.14A An exemplary system 1400 is illustrated, which may also be considered an integrated component as that term is used herein. Fig.14A The system 1400 (or assembly 1400) includes an introducer assembly 1499 (which may also be considered any second imaging member herein), which includes an introducer housing 1490 (which may be considered any second imaging member housing herein) secured to a movable guide 1450, wherein the introducer housing 1490 is sized and configured to be releasably secured to a handheld housing 1410 (which may be considered any housing herein), and wherein the introducer assembly 1499 may be disposable.

[0305] Fig.19A 17 is a view of the bottom of the second imaging member 1740, which includes a housing 1744 and a guide 1770. In this example, the guide 1770 is fixed to the housing 1744 at the end (or end region) of the guide 1770 and is movable relative to the housing 1744 along a portion of the guide 1770 away from where it is fixed to the housing 1744. This is similar to the Figures 14A-14D1450 shown in . The housing 1744 includes a communication area 1746, which 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 be optionally positioned and configured to communicate with the handle mechanically, electrically, visually, and / or optically. The communication elements may be configured to transmit information (e.g., image data) and / or be operably connected to the handle to cause movement of the guide in one or more directions, as described in more detail herein.

[0306] In this exemplary embodiment, the communication region 1746 of the second imaging member 1740 includes mechanical interfaces 1741 and 1743, which are arranged relative to the housing 1744 and are configured to communicate with mechanical interfaces 1721 and 1722 in the communication region 1720 of the housing 1710 (see Fig. 18C ) are mechanically engaged. By way of example only, the mechanical interface can include a geared interaction via teeth, wherein 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) can be operably coupled to mechanical interfaces 1741 and 1743 such that rotation of interfaces 1741 and 1743 causes tensioning of the one or more pull wires, which can cause deflection of the introducer.

[0307] In this example, the communication region 1746 of the second imaging member 1740 also includes a mechanical interface 1747 disposed relative to the housing 1744 and configured to communicate with the mechanical interface 1723 in the communication region 1720 of the housing 1710 (see Fig. 18C ). By way of example only, the mechanical interface may include a gear interaction via teeth, wherein rotation of the mechanical interface 1723 of the housing 1710 (e.g., in response to activation of the housing motor) results in rotation of the mechanical interface 1747. In this example, the interface 1745 is configured to have a geared interaction with the interface 1747, such that rotation of the interface 1747 also results in rotation of 1745 (see Fig.19F The introducer passes through the housing 1744 and is disposed between the rotatable mechanical interfaces 1747 and 1745, such that rotation of the mechanical interfaces 1747 and 1745 results in axial translation (distal or proximal) of the introducer 1770, wherein Fig.19A An axial direction "A" is illustrated, which represents axial movement of the introducer 1770 relative to the housing 1744. Additional details of the communication region 1746 are described below.

[0308] Fig.19B The top of the second imaging member 1740 is illustrated, including the endotracheal tube coupler 1750 . Fig.19C A side view of the second imaging member 1740 is illustrated. Fig.19C An introducer having a curved configuration is illustrated. 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 first position to a second end or second position of the component). For example, Fig.19C The guide in can have a length extending from a first end secured to the housing 1742 and a distal-most end of the guide, wherein in this example the length of the guide can be measured along the length of the guide itself from the first secured end to the second end, even if there are one or more bend regions.

[0309] Fig.19D and Fig.19E An end view of the second imaging member 1740 is illustrated.

[0310] Fig.19F A view of the top of an exemplary second imaging member 1740 is illustrated with the top surface of the housing layer removed to illustrate exemplary internal components in the communication region 1746 of the housing 1744 . Fig.19F The view in Fig.19B The view is the same as in , but a portion of the housing is removed to illustrate the components inside the housing 1744. Fig.19A A view of the bottom of the second imaging member 1740 is illustrated. Fig.19F An exemplary geared engagement between the above-described rotatable interfaces 1745 and 1747 is illustrated. Mechanical interface 1747 can engage with rotation interface 1723 in the handle such that rotation of rotation interface 1723 (e.g., driven by a motor) causes rotation of mechanical interface 1747. The geared engagement between interfaces 1745 and 1747 causes interface 1745 to rotate in a direction opposite to the rotation of interface 1747, which causes axial movement of introducer 1770 disposed between interfaces 1745 and 1747. The geared relationship between interfaces 1745 and 1747 can amplify the forces on the introducer and help prevent slippage during axial movement of the introducer.

[0311] In some embodiments, an additional gear similar to an idler gear may be added to the handle, for example in communication with rotation interface 1723 (driven by a motor), to actively drive both rotatable interfaces 1745 and 1747 .

[0312] Fig.19FAlso illustrated are multiple electrical connectors 1749, which are arranged and configured in the housing to engage with the electrical connector 1725 in the handle and can transmit image data from the image sensor at the distal end of the guide to the housing 1710, which is described in more detail herein.

[0313] Fig.19F A window or opening 1748 is also illustrated, and as shown, is aligned with and adjacent to a portion of the introducer 1770. The window 1748 is positioned to align with a sensor 1724 (e.g., an optical sensor) in the housing so that the housing sensor can track the movement or position of the introducer as it moves in the axial direction "A". The introducer can have one or more markings on its outer surface to facilitate position tracking or sensing by the housing sensor 1724. The housing sensor 1724 can transmit the sensed information to a processor (directly or indirectly) to track the axial movement and / or position of the introducer.

[0314] Fig.19F Also illustrated are mechanical interfaces 1741 and 1743, which are positioned and configured to interact with mechanical interfaces 1721 and 1722 in housing 1710. In this example, mechanical interfaces 1741 and 1743 rotate in response to rotation of mechanical interfaces 1721 and 1722 in housing 1710, which in this example is used to cause deflection of the distal region or distal tip of the introducer in multiple directions (e.g., one or more directions of upward, downward, leftward, rightward, or a combination thereof). Fig.19F Only an example of using a first motor and a second motor within housing 1710 to cause rotation of interfaces 1741 and 1743, respectively, is illustrated. In this example, interfaces 1741 and 1743 are each connected to a first pull wire and a second pull wire, so that when interfaces 1741 and 1743 are rotated in a first direction, one of the pull wires is tensioned to cause deflection of the distal end of the introducer, and when rotated in the opposite direction, the second pull wire can be tensioned to cause deflection in a different direction (e.g., 180 degrees relative to the first direction). In one example, rotation of interface 1741 can cause deflection of the introducer in a first plane (each direction is 180 degrees relative to the other direction, for example, 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 is 180 degrees relative to the other direction, for example, up and down). Interfaces 1741 and 1743 may be independently controlled, such as with different motors in the housing, with both responsive to robotic control (automatic or manual robotic control) of introducer movement.

[0315] exist Fig.19F In the example of FIG. 1 , pull wires (e.g., exemplary and illustrative first and second pull wires 1757 are shown for clarity) can be attached to interfaces 1741 and 1743 at locations 1754 and 1753, respectively, using any of a variety of fixing techniques or fixing mechanisms. The pull wires extend from interfaces 1741 and 1743 through pull wire channels, generally labeled 1752, and then extend into introducer 1770. The pull wires can be extended through the introducer using existing pull wire routing techniques and methods and fixed in the distal region of the introducer to cause deflection of the distal tip of the introducer.

[0316] In any alternative, the housing motor may be in operative communication with only one pull wire. Fig.19F In the variation shown, housing 1710 may include four motors therein, each motor causing a separate pull wire to be tensioned.

[0317] Figure 19G-19K An exemplary second imaging member housing is illustrated, and it should be understood that any second imaging member housing herein may include Figure 19G-19K any of the exemplary features of the exemplary housing 1744 shown in Figure 19G-19K The exemplary housing 1744 shown in FIG. 1 can include any of the exemplary features of any second imaging member housing described herein. Figure 19G is a perspective view of the bottom of housing 1744. Fig.19H It is a bottom view of the housing 1744. Fig.19I is a top perspective view of housing 1744. Fig.19J 17 is the front end of the housing 1744, illustrating the first window 1755 and the second window 1756 through which the guide 1770 extends. Figure 19K A rear end view of housing 1744 is shown, including endotracheal tube coupler 1750. As described herein, a first end of the end region of the introducer can be fixed within housing 1710 and Fig.19F In the embodiment, the first end of the guide 1770 is fixed to the element 1751 in the housing 1751. Starting from the element 1751, the guide 1770 extends through the housing opening or window 1756 (see Fig.19J ) and extends from the housing. Then, the introducer 1770 forms a ring configuration as shown (for example, Fig. 17B , Fig. 17C , Fig.17E , Figure 17G , Fig.19A , Fig.19B , Fig.19E ), and then through the housing opening or window 1755 (see Fig.19J) extends back into the housing. The introducer then extends through the optional endotracheal coupler 1750 of the housing 1744, such as Fig.19F Can be seen in.

[0318] As shown, in this example, housing 1744 has a generally rectangular configuration (and in this example, housing 1744 has a generally square configuration), with a width and height greater than the thickness measured from top to bottom. The corresponding mating area of ​​housing 1710 has a similar rectangular configuration, such as Fig. 17B shown in the unassembled view.

[0319] The second imaging member 1740 includes an endotracheal tube coupler 1750, which in this example has a circular cross-section and a cylindrical configuration. Fig.17A As shown, the endotracheal tube has a first end having a coupling region 1791 as shown, which is sized and dimensioned to engage with an endotracheal tube coupling 1750 on a housing 1744 of a second imaging member 1740. The endotracheal tube 1790 also has a lumen sized to receive an introducer, such as a endotracheal tube, in the lumen when the coupling region 1791 is engaged with the endotracheal tube coupling 1750 of the housing 1744. Fig. 17C shown.

[0320] like Fig.17A As shown, the body 1711 of the housing 1710 also includes a side endotracheal tube channel 1713, which is positioned and configured so that when the cover 1780 is releasably secured to the housing 1710, the channel 1713 of the housing 1710 and the channel 1784 in the cover form a continuous channel for an endotracheal tube, as shown in FIG. Fig.17D In this case, the term "continuous" includes a small amount of minimal axial play (e.g., .01 cm-2 cm) between the two passages when the cover 1780 is coupled to the housing 1710, so long as the endotracheal tube 1790 can engage with the housing passage 1713 and the cover passage 1784. Both passages 1713 and 1784 are open on one side to allow the endotracheal tube to be removed from the passage by removing the endotracheal tube laterally or horizontally from the passage.

[0321] The housing (e.g., housing 1710) or integrated handheld assembly herein may include one or more image processors, and in some embodiments, for example, data may be transmitted to a component not integrated into the assembly where image processing occurs, such as an external computer and / or display of the system. Any type of connection may be used for data transfer, such as a USB interface.

[0322] Any component may also include one or more microcontrollers, which may optionally be disposed in a housing (e.g., housing 1710). Any component may also include one or more motor interfaces (e.g., part of the robotic control of the introducer's movement), which may optionally be disposed in a housing (e.g., housing 1710). Any component herein may also include an electronic control board that may provide power to one or more motors optionally disposed in the housing during robotic movement of the introducer.

[0323] like Fig.17D (Combined with Fig. 17C ), when the assembly is assembled, the first image sensor and the second image sensor (eg, camera) are maintained at an axial distance relative to each other. Fig.17D In the embodiment, the axial position of the first image sensor and the second image sensor is marked as L, and in this embodiment, the image sensors are within 3 cm of each other in the axial direction and can be optionally axially aligned. The horizontal distance "H" between the image sensor and the other sensors (see Fig. 17C ) is also no greater than 2 cm. When assembled, the first image sensor and the second image sensor are thus maintained at a relatively close distance from each other (in the axial direction and in the horizontal direction), the advantages of which are described herein. Thus, assembly 1702 is an example of an integrated and handheld dual video endotracheal tube assembly, wherein the assembly is configured such that when the first imaging member is coupled to the housing, when the second imaging member is coupled to the housing, when the cover is releasably coupled to the housing, and when the endotracheal tube is releasably coupled to the assembly, the assembly maintains the first image sensor at a distance from the second image sensor prior to actuation of the actuator, an example of which is Fig. 17C and Fig.17D In this example, the length and configuration of all of the endotracheal tube, introducer, cover, flexible body 1732 of first imaging member 1730, and body 1711 of housing 1710 (together and individually) allow and result in the first image sensor being maintained at a distance from the second image sensor, as well as contributing to the small overall profile and footprint of the assembly, which allows the operator to hold, move, and operate the assembly with a single hand.

[0324] Assembly 1702 is an example of an assembly that can be used in an endotracheal intubation. One of the advantages is that when the assembly is assembled, the first image sensor and the second image sensor are maintained at a relatively close axial distance (e.g., no more than 3 cm, and optionally axially aligned). When in use, the introducer typically needs to be able to be robotically moved axially by about 3-5 cm to move the introducer to or toward the glottic opening. The assembly is also adapted to be able to axially move the introducer through the glottic opening and into the trachea. Therefore, the assembly herein can robotically cause axial movement of the introducer and the second image sensor relative to the first image sensor, the axial movement being at least 3 cm, and when used for endotracheal intubation, the first image sensor remains in the upper airway.

[0325] The components herein may include a distal travel limiter configured to limit distal movement of the guide relative to the initial position and relative to the first image sensor. For example, component 1720 includes a distal travel limiter configured to limit distal movement of the guide 1770 relative to the initial position (e.g., Fig. 17C and Fig.17D ) and move distally relative to the first image sensor of the first imaging member 1730. In this example, the first end of the introducer is fixed to the housing 1744, as shown. Fig.19F As shown, the guide is allowed to move axially in a robotic manner together with the axial movement mechanism (e.g., including mechanical interfaces 1745 and 1747) within the housing 1744. By fixing the first end of the guide 1770, in this embodiment, it is possible to limit how far the guide 1770 is advanced distally. The length of the guide outside the housing 1744 between the openings 1755 and 1756 in the housing 1744 can also affect how far the guide can be advanced distally, and therefore can be considered as part of or affect the distal movement limiter. For example, if the length of the guide 1770 outside the housing 1744 between the openings 1755 and 1756 is very short, the distal movement limiter will prevent the guide from moving too far distally relative to the housing 1744.

[0326] Fig. 20Schematically illustrated is an exemplary integrated and handheld dual video assembly 2002, which can include any and all aspects of assembly 1702 and assembly 1702'. Assembly 2002 includes housing 2010, which can include any and all aspects of any housing herein (e.g., housing 1710). Assembly 2002 includes cover 2080, which can include any and all aspects of any cover herein (e.g., cover 1780). Assembly 2002 includes an optional disposable second imaging member 2040, which can include any and all aspects of any second imaging member herein (e.g., second imaging member 1740). Assembly 2002 includes endotracheal tube 2090, which can include any and all aspects of any ETT herein (e.g., endotracheal tube 1790). Component 2002 includes one or more actuators 2061, which can include any and all aspects of any of the actuators herein (e.g., one or more actuators 1761 (e.g., the actuators can be within housing 2010 and / or within second imaging member 2040)). Any component herein (e.g., 1702, 1702') can be as described above. Fig. 20 The diagram is summarized as shown in the schematic diagram.

[0327] It should be understood that any description including features or usage methods related to component 1702 can be integrated with component 1702 ′, and conversely, any description including features or usage methods related to component 1702 ′ can be integrated with component 1702 .

[0328] Fig.21 An exemplary method of using any of the components herein is illustrated. In the illustrated method, at step 2110, the assembled component (e.g., component 1702) is positioned within the upper airway of the patient (e.g., Fig.15). The method may include, at step 2120, causing a processor of the system to receive a signal indicative of image data from a first image sensor (e.g., a camera) of the assembly. The method may include, at step 2130, processing the signal indicative of data from the first image sensor. The method may include, at step 2140, in response to the processing step, initiating automatic or manual robotically controlled movement of an introducer of the assembly away from the first image source of the assembly and toward at least one upper airway anatomical landmark while maintaining the first image sensor in the upper airway. The method may also include, at step 2150, causing the introducer to move within the endotracheal tube and be advanced through and through 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 automatic movement of the introducer. Any additional method steps may be incorporated into Fig.21 In the exemplary method shown.

[0329] Any second elongated imaging member (eg, 1740 ) may also be referred to herein as a cartridge, as the cartridge may be releasably secured to a housing (eg, housing 1710 ).

[0330] In some variations of the embodiments herein, the system is adapted to allow a remote operator to remotely control the robotically controlled movement of the introducer herein. For example, a first operator will be with the patient and place the assembly, for example, in the patient's upper airway. The first operator activates the operation of the first image sensor and / or the second image sensor. The image data can be transmitted (e.g., wirelessly) to a remote location, where a second operator can remotely control the introducer (e.g., using a workstation). The second operator can have a display that displays video data from the first image sensor and / or the second image sensor. This type of remote control device can provide the advantages of the integrated dual video intubation assembly herein, except that the first operator in these examples will directly handle the assembly.

[0331] Any processor herein may store thereon any 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 indicate image or video data from one or more image sensors herein and determine or assist in determining a path for a guide in any number of directions, which may include causing movement of the guide such that the guide moves to or toward one or more anatomical landmarks. This type of determination or planning may be referred to herein as navigation or part of a navigation process.

[0332] It should be understood that any feature, component, or method step described in one example herein may be incorporated into any other suitable example herein, unless otherwise indicated in the description. For example, any feature or method used in any embodiment or aspect herein may be included or incorporated into any other suitable embodiment or aspect herein together with any other suitable embodiment or aspect herein.

[0333] For the purpose of explanation, the foregoing description uses specific terms to provide a comprehensive understanding of the present invention. However, it is obvious to those skilled in the art that specific details may not be required in order to practice one or more inventions herein. Therefore, for the purpose of illustration and description, the foregoing description of the specific embodiments of the invention herein is presented.

[0334] Even if not specifically indicated, one or more techniques or methods described in the present disclosure may optionally be implemented at least in part in hardware, software, firmware, or any combination thereof. For example, various aspects of a technique or component may be implemented in one or more processors, either alone or in any suitable combination, including one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), programmable logic circuits, or the like. The term "processor" or "processing circuit" may generally refer to any of the aforementioned circuits (alone or in combination with other circuits) or to any other equivalent circuit. Such hardware, software, or firmware may be implemented in the same device or in separate devices to support the various operations and functions described in the present disclosure. In addition, any of the described units, modules, or components may be implemented together or separately in discrete but interoperable logic devices. Describing different features as modules or units is intended to highlight different functional aspects, and does not necessarily mean that such modules or units must be implemented by separate hardware or software components. On the contrary, the functions associated with one or more modules or units may be performed by separate hardware or software components, or integrated in 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, and the like. The instructions (e.g., methods) may be executed by a processor to support one or more aspects of the functionality described in this disclosure.

[0335] Additional Examples A first additional example is an integrated device for robotically assisted airway management (e.g., intubation) of a patient, comprising: a handheld housing; a laryngoscope coupled to the housing and comprising a first image sensor; an actuation member movable within the housing; an endoscope extending from the actuation member, wherein the endoscope comprises a second image sensor and is configured to be removably coupled to an intubation catheter; and at least one actuator located in the housing, the at least one actuator being configured to automatically guide the endoscope via 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.

[0336] In this example, the device may also include a cover coupled to the housing, wherein the cover includes 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 and a second portion, the first portion including the first channel, the second portion including the second channel, wherein the first portion and the second portion are 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 on the patient's tongue within or near the valleculae of the patient and beneath the patient's epiglottis. The distal end of the first channel and the distal end of the second channel may be adjacent and substantially parallel. The cover may be removably coupled to the housing.

[0337] In this example, at least one of the first image sensor and the second image sensor can provide a viewing angle of at least 40 degrees in the axial plane and the horizontal plane. In the axial plane and the horizontal plane, the viewing angle can be between about 40 degrees and about 180 degrees. In the axial plane and the horizontal plane, the viewing angle can be between about 40 degrees and about 360 degrees.

[0338] This example may also include a video monitor configured to display at least one image from the first image sensor, the second image sensor, or both. The video monitor may be configured to display images from the first image sensor and the second image sensor in a split screen or picture-in-picture arrangement.

[0339] In this example, the actuation member may extend axially.The actuation member may comprise one or more interlocking rings or one or more helical elements.

[0340] In this example, the actuating member may be movable within the guide. At least a portion of the guide may be in the housing. At least a portion of the guide may be in a video monitor coupled to the housing. At least a portion of the guide may be curved. The guide may be straight. At least one actuator may be configured to automatically guide the actuating member within the guide. The actuating member may be manually moved within the guide. This example may also include a user input device aligned with the guide, the user input device coupled to the actuating member so as to enable manual control of movement of the actuating member within the guide. The actuating member may translate longitudinally within the guide to longitudinally advance and retract the endoscope. At least one actuator is configured to automatically articulate the distal end of the endoscope. At least one actuator may be configured to articulate the distal end of the endoscope in a first plane.

[0341] This example may also 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 one or more images by confirming at least one identifiable anatomical feature. The at least one processor may be configured to confirm 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.

[0342] In this example, the endoscope can be removably coupled to the actuation member.

[0343] In this example, the actuation member may be reusable and the endoscope may be disposable.

[0344] In this example, the endoscope may be integrally formed with the actuation member.

[0345] In this example, the distal end of the actuation member can be axially aligned with the proximal end of the endoscope.

[0346] In this example, the endoscope includes a flexible member, but the endoscope may include a rigid stylet with a deflectable distal end.

[0347] In this example, the device may be operated by a single user.

[0348] In this example, the length of the actuation member may be between about 10 cm and about 40 cm.

[0349] In this example, the length of the endoscope may be between about 20 cm and about 30 cm.

[0350] In this example, the length of the endoscope may be between about 20 cm and about 60 cm.

[0351] In this example, the device may be configured for use with either an adult patient or a pediatric patient.

[0352] In this example, the intubation tube may be an endotracheal tube.

[0353] In this example, the device may be configured to assist with orotracheal intubation, or the device may be configured to assist with nasotracheal intubation.

[0354] A second additional example is an integrated robotic device suitable for airway management, comprising: a handheld housing; a laryngoscope coupled to the housing and comprising a first image sensor; an actuation member movable within the housing and coupled to an introducer comprising a second image sensor; and at least one actuator located in the housing, the at least one actuator being 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.

[0355] A third additional example is an integrated robotic device suitable for airway management, comprising: a handheld housing; an actuation member movable within the housing and connectable to an introducer comprising an image sensor; and at least one actuator located in the housing, the at least one actuator being configured to automatically move the actuation member based at least in part on one or more images from the image sensor.

[0356] In some embodiments, navigation of the introducer scope (second imaging member) can be assisted by visualization through the laryngoscope (first image sensor) for navigating the introducer scope manually or automatically by a processor. For example, the outer shaft of the introducer scope may include one or more markings or indicators, wherein one or more markings or indicators on the outer shaft of the introducer scope may be visible to the laryngoscope first image sensor during the procedure. These indicators may indicate the distance from the distal tip of the introducer scope, and therefore indicate how far the introducer scope has been advanced into the anatomical structure (or beyond the laryngoscope). This can be used to prevent the introducer scope from being advanced too far or not far enough, and can prevent misplacement of the introducer scope and ultimately misplacement of the ETT.

[0357] In some embodiments, an indicator on the introducer scope can indicate a flexible or deflectable region of the introducer scope (e.g., one or more indicators can be disposed on the shaft and can indicate the position and / or location of a flexible or deflectable region of the introducer scope).

[0358] In some embodiments, one or more indicators may include one or more of a band, or a dot, or a mark, which may be black or may be colored. Different colors, thicknesses, symbols, numbers may be incorporated into the indicator to help distinguish different sections or regions along the length of the guide mirror. One or more indicators herein may include a combination of different types of indicators located on the guide mirror axis, such as, for example but not limited to, one or more of the indicators being colored, while one or more other indicators may be symbols.

[0359] In some embodiments, a light may be used as an indicator.

[0360] The indicator may span 360 degrees around the guide mirror axis, or may span only a portion of the circumference. As an example only, the indicator may span or extend 360 degrees around the guide mirror axis, while in other examples, the indicator may span or extend 180 degrees or 90 degrees around the guide mirror axis.

[0361] The outer shaft of the introducer mirror may additionally or alternatively be bright or reflective to aid in its visualization during the procedure. By way of example only, the introducer mirror shaft may include one or more reflective materials that help reflect light at least to some extent during the procedure.

[0362] Fig.34 is a block diagram of an exemplary data processing system that can be used with any embodiment of any of the inventions or embodiments described herein. Note that although Fig.34 Various components of a computer system are shown, but it is not intended to represent any particular architecture or manner of interconnecting the components; as these details are not germane to the present invention. It will also be appreciated that network computers, handheld computers, mobile devices, tablet computers, cell phones, and other data processing systems having fewer components or perhaps more components may also be used with the present invention.

[0363] like Fig.34As shown, an exemplary computer system 5100 as a form of data processing system includes a bus or interconnect 5102, which is connected to one or more microprocessors 5103 and ROM 5107, volatile RAM 5105 and non-volatile memory 5106. Microprocessor 5103 is connected to cache memory 5104. Bus 5102 connects these various components to each other, and also connects these components 5103, 5107, 5105 and 5106 to a display controller and display device 5108 and to input / output (I / O) devices 5110, which can be a mouse, keyboard, modem, network interface, printer and other devices known in the art.

[0364] Typically, input / output devices 5110 are coupled to the system via input / output controllers 5109. Volatile RAM 5105 is typically implemented as dynamic RAM (DRAM), which continuously requires power in order to refresh or maintain the data in the memory. Non-volatile memory 5106 is typically a magnetic hard drive, magnetic optical drive, optical drive, or DVD RAM, or other types of memory systems that retain data even after power is removed from the system. Typically, non-volatile memory will also be random access memory, however this is not required.

[0365] Although Fig.34 The non-volatile memory is shown as a local device directly connected to the rest of the components in the data processing system, but the present invention can utilize non-volatile memory remote from the system; such as a network storage device connected to the data processing system through a network interface (such as a modem or Ethernet interface). Bus 5102 may include one or more buses connected to each other through various bridges, controllers and / or adapters, as is known in the art. In one embodiment, I / O controller 5109 includes a USB adapter for controlling USB (Universal Serial Bus) peripheral devices. Alternatively, I / O controller 5109 may include an IEEE-1394 adapter, also known as a FireWire adapter, for controlling FireWire devices, SPI (Serial Peripheral Interface), I2C (Inter-Integrated Circuit) or UART (Universal Asynchronous Receiver / Transmitter) or any other suitable technology. Wireless communication protocols may include Wi-Fi, Bluetooth, ZigBee, near field, cellular and other protocols.

[0366] Some portions of the foregoing detailed descriptions are presented in terms of algorithms and symbolic representations of operations on data bits within a computer memory. These algorithmic descriptions and representations are the means used by those skilled in the data processing arts to most effectively convey the substance of their work to others skilled in the art. An algorithm is here, and generally, conceived to be a self-consistent sequence of operations leading to a desired result. The operations are those requiring physical manipulation of physical quantities.

[0367] It should be remembered, however, that all of these and similar terms should be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities. Unless specifically stated otherwise, as will be apparent from the following discussion, it should be appreciated that throughout this specification, discussions utilizing terms such as those set forth in the following claims refer to the actions and / or processes of a computer or computing system or similar electronic computing device that manipulates and transforms data represented as physical (electronic) quantities within the computer system's registers and / or memories into other data similarly represented as physical quantities within the computer system's memories or registers or other such information storage, transmission or display devices.

[0368] The techniques shown in the figures herein may be implemented using code (e.g., computer-executable methods, algorithms) and data stored and executed on one or more electronic devices. Such electronic devices use computer-readable media (such as non-transitory computer-readable storage media (e.g., magnetic disks; optical disks; random access memory; read-only memory; flash memory devices; phase-change memory) and transitory computer-readable transmission media (e.g., electrical, optical, acoustic or other forms of propagated signals, such as carrier waves, infrared signals, digital signals)) to store the code and data and transmit the code and data (internally and / or over a network with other electronic devices).

[0369] The processes or methods depicted in the preceding figures may be performed by processing logic including hardware (e.g., circuits, dedicated logic, etc.), firmware, software (e.g., embodied on a non-transitory computer-readable medium), or a combination of both. Although the processes or methods are described above in terms of some sequential operations, it should be appreciated that some of the operations described may be performed in a different order. Moreover, some operations may be performed in parallel rather than sequentially.

[0370] Fig. 22A "reusable" embodiment is shown, meaning that it can be sterilized and reused in a limited number of cases. In this embodiment, the introducer mirror 1770 can be completely or partially removed from the housing 1744. For example, the housing 1744 can have an opening, such as a door opening 4002. The opening can be opened to expose the introducer mirror 1770 so that the introducer mirror can be removed and cleaned and / or sterilized or replaced with a sterile introducer mirror, and the interior of the housing 1744 can be cleaned and / or sterilized. The door or opening 4002 can be only in the housing 1744, or can be in the housing and the coupler 1750. Alternatively, the coupler 1750 can be removable and can be cleaned / sterilized or replaced for the next use.

[0371] In some embodiments, the interior of housing 1744 may include a disposable sheath that separates the introducer scope from a mechanical interface, such as mechanical interfaces 1745 and 1747 disclosed herein.

[0372] Some embodiments include a cleaning tool that can be used to clean and / or disinfect the internal interface of the housing 1744. The tool can include an elongated cleaning tool that is pulled through the housing using an internal motor that drives the mechanical interface, or pulled through the housing manually or otherwise.

[0373] In some embodiments, the mechanical interface or gear is disposable and can be replaced with sterile parts. Any other parts that contact the mirror can also be disposable. Alternatively, these parts (including mechanical interfaces 1745 and 1747) can be able to be cleaned and / or sterilized.

[0374] One aspect of the present disclosure relates to medical devices and systems that include a robotically controllable medical device (e.g., a controllable endoscope, a medical tool, a surgical tool, an articulatable catheter, etc.) and a user-actuated disposable controller adapted to be attached / detached or coupled / disconnected (directly or indirectly) to the robotically controllable medical device, and wherein the user-actuated controller may be adapted to be disposable (non-reusable), while one or more parts of the robotically controllable medical device may be reusable. An exemplary and non-limiting benefit of such a system is that more expensive parts of the system may be reused, optionally without resterilization, while less expensive parts with which a user interacts (e.g., physically contacts) to control the more expensive robotically controllable medical device parts may be discarded (not reused) after a medical procedure and replaced with new sterile user-controllable parts.

[0375] It should be understood that the reusable "controllable" portion of the system as described herein is not limited to a mechanically movable controllable portion (e.g., an articulated shaft, a movable working distal end of a tool, etc.). For example, a reusable controllable medical device may refer to a reusable electronic device, such as in Fig.33 In the example shown.

[0376] Non-limiting exemplary embodiments of this aspect are in the field of endotracheal intubation, where a robotically controllable ETT introducer and / or introducer actuator (e.g., a motor) can be reused with a replaceable user-actuated controller, examples of which are provided herein. In some embodiments, the replaceable user-actuated controller includes an integrated intubation blade. Any and all of the above (including in the accompanying drawings) disclosures may be optionally incorporated by reference into embodiments herein that include a disposable user-actuated controller and a reusable robotically controllable medical device and / or medical device actuator.

[0377] In some intubation embodiments, one or more user interface devices or control members (i.e., joysticks, wheels, sliders, buttons, voice-activated controllers or other similar actuatable members) controlled by a user (which may include physical contact or non-contact, such as a voice-activated controller (e.g., a microphone)) and actuated to control the articulation and / or advancement / retraction of the introducer (mirror) may be part of a reusable controller that is fully or partially disposable or non-reusable. By way of example only, a control member may be incorporated into a disposable blade of an intubation system. One or more control members may be incorporated into a rigid or flexible extension of the blade (e.g., where the blade and extension are integrated, and may optionally be integral (integral means formed of the same material so that they are not two connected and integrated together)), such that when the reusable housing is at least partially disposed within the disposable blade, the blade extension covers or surrounds at least a portion of the reusable body or housing of the system (which may be referred to herein as an "introducer assembly"). The extension of the blade is typically sized and configured to be handheld, which is described in more detail elsewhere herein. The introducer assembly of the system may be reusable and include one or more introducer actuators, such as motors and / or other controls, to cause and control robotic articulation and / or advancement / retraction of the introducer (which is considered part of the introducer assembly, even though the introducer may be decoupled from the reusable housing). Exemplary introducer actuators (e.g., motors, etc.) are described elsewhere herein.

[0378] The disposable blade herein may include a portion containing one or more control members (such as a joystick) that controls the motor and / or other introducer actuators in the reusable housing or body via a control member interface (the control member interface has one or more control member interface elements as part of the reusable housing or body). The control member interface may be disposable and sterile outside the user's contact, and may be operably connected to the control member interface element in the reusable housing inside. The user control member may be sealed and separated from the inner housing via a sterile barrier. In this way, the control member interface element remains sterile (not contaminated) during use, and the reusable housing that may include the motor and / or other introducer controller may be reusable without the need to be sterilized. It should be understood that in this context, the reusable housing may include or be similar to any one of the "housings" herein (such as housing 1710) and any one of the "second imaging members" herein (such as second elongated imaging members 1740). Thus, it should be understood that in this context, a reusable introducer assembly may include an introducer that is detachable from a reusable housing (such as introducer 1770 as part of second imaging member 1740), examples of which are described in greater detail herein. Fig.26 A portion of a secondary imaging member (introducer shaft not shown for clarity) is shown, such as housing 1744, which is releasably coupled to Fig.25 Therefore, it should be understood that Fig.25 and Fig.26 All may be considered to illustrate an "introducer assembly" herein, even when the removable introducer is not secured to a housing that includes one or more actuators (eg, motors) internally. It should also be understood that Fig.25 An exemplary "reusable housing" is shown that optionally includes one or more control member interface elements and at least one EET introducer actuator (eg, motor).

[0379] Fig.23 An exemplary embodiment of a disposable controller is shown, in which example, the disposable controller includes a disposable blade, and the disposable controller includes an extended area or extension that incorporates at least one control member (a magnet in this example) that is sensed by a Hall sensor in a reusable introducer assembly. In any of the embodiments herein, the blade and extension can be integrated, as shown, and optionally integrally formed, or formed of the same material (not two parts coupled together). Fig.23The disposable controller shown in the embodiment of the present invention includes a disposable blade 4102, which includes a distal region (which may have a curved configuration as shown) that is sized and configured to be positioned in the oral cavity of a subject, and a blade extension 4104 extending away from the distal region, wherein the disposable controller also includes a control member 4106, which includes a magnet in this example, and the movement of the magnet (when actuated by a user) is suitable for being sensed by a Hall sensor in a reusable guide assembly or a reusable housing. The Hall sensor (or other type of sensor) is also operably connected to one or more guide actuators (e.g., motors), so that the one or more guide actuators facilitate robotic control of the guide in response to user actuation of the disposable control member. In this example, the control member 4106 is integrated into the extension 4104 and includes a Hall sensor magnet incorporated into a flexible and movable member, which may include a flexible material, such as silicone (or other suitable material), which allows the user to move the magnet by moving the flexible material. Movement of the magnet is sensed by a Hall sensor in the introducer assembly housing, which is located near and below the magnet. While this example includes a Hall sensor, the sensor / mechanism (between the disposable control member and the reusable control member interface element) can be any type of suitable sensor suitable for sensing motion, proximity, positioning, speed, acceleration, current, etc.

[0380] In any of the examples herein relating to cannula controllers, the extension or body can be sized and configured to be held in the hand of an operator, and the controller can be configured to be manually controlled by one or more fingers when the extension is grasped or gripped by the hand.

[0381] Blade 4102 also includes a cavity 4107 therein that is sized and configured to receive at least a portion of an introducer assembly therein, such as Fig.25 43. The distal region of the housing 4302 is shown in . In this example, the cavity 4107 is generally elongated and extends along at least a portion of the length of the extension 4104.

[0382] Fig.24 Another example of a disposable controller suitable for use with a robotically controllable medical device is shown, in which the disposable controller includes a disposable blade 4102 and is similar to Fig.23 The leaves from Fig.23 Any relevant disclosures of Fig.24. The blade 4102 includes a curved distal region suitable for placement in the oral cavity, an extension 4104 extending away from the curved distal region. The extension 4104 includes a control member 4202, which includes a movable joystick in this example, as shown. The joystick is incorporated into or integrated into the control member 4202, and the control member 4202 is suitable for allowing a user to move the joystick. The control member 4202 can also include a flexible material, such as silicone. The joystick can be embedded in the sterile barrier or completely below the flexible sterile barrier, and additional details thereof are described herein. Fig.24 The blade 4102 in the embodiment also includes a cavity 4107 therein that is sized and configured to receive at least a portion of an introducer assembly housing or body therein, such as Fig.25 The distal region of the housing 4302 is shown in .

[0383] Fig.25 At least a portion of a reusable housing (or body) of an exemplary introducer assembly is shown that is adapted to engage with a disposable controller, such as a disposable blade herein. The reusable housing 4302 of the introducer assembly includes at least one control member interface element 4304 (shown generally) positioned and adapted in / on the housing 4302 to be disposed in the cavity 4107 of the disposable blade and positioned relative to at least the control member to be in operably connected to at least one control member in the blade and to be responsive to manual movement of the at least one control member when at least a portion of the housing is disposed in the cavity 4107. The housing 4302 may include one or more actuators, such as motors and / or other controllers, to cause and control robotic movement of the introducer, additional details of which are described herein. The housing or body 4302 also includes a control member interface element 4304 that includes one or more mechanisms adapted to engage with and be responsive to a control member of the blade, which control member may include a magnet or a joystick, such as only a control member. Fig.23 and Fig.24 As shown. By way of example only, the control member interface element 4304 may include a Hall sensor responsive to movement of a magnet in the disposable blade. In the case of a blade joystick, the control member interface element 4304 may include a plurality of metal contact areas, such as copper segments that may be electrically connected to a housing component to initiate activation of a motor. The control member interface element 4304 is also adapted to communicate with a motor and / or other actuator within a reusable housing to facilitate robotic movement of the introducer (or other controllable medical device). In this manner, a control member (or other disposable controller) on the disposable blade controls an actuator (e.g., a motor) within the reusable housing.

[0384] Fig.26Shown is placed Fig.25 Reusable housing Fig.24 In other words, Fig.25 The distal region of the housing 4302 of the introducer assembly has been placed Fig.24 In the cavity 4107 of the blade 4102. Fig.23 , Fig.24 and Fig.25 All public contents of Fig.26 In this position, the joystick 4202 is in operable communication (in this case electrical communication) with a control member interface element 4304 (not visible) of the housing 4302, and indirectly and ultimately with a motor and / or other controller mechanism suitable for enabling the robot to control the guide / mirror. Fig.23 The blade in (or any other disposable blade herein) can also be Fig.26 In this example, the operable communication between the control member interface element and the control member on the blade is a Hall sensor communication or a magnetic communication, rather than an electrical communication. However, as explained herein, other types of sensors can be used to create an operable communication between the disposable controller and the reusable housing or body. Fig.26 Also shown is an introducer housing 1744 (described in greater detail herein) securely coupled to housing 4302. Although not shown, the introducer can be coupled to housing 1744. Coupling housing 1744 (and the introducer) to housing 4302 creates operable and controllable communication between one or more actuators (e.g., motors) in 4302 and the introducer, which allows for robotically controllable movement of the introducer when a user actuates a control member of the disposable blade.

[0385] Fig. 27 , Fig.28 and Fig.29 Only details of an exemplary interface between a disposable control member including a magnet and a reusable control member interface element including a Hall sensor are shown. This may be referred to herein as a Hall sensor magnet interface. Fig. 27 Only shown Fig.23, which includes a control member including a flexible member 4506, which in this example includes a ridge 4502 formed therein. Flexible member 4506 may include a flexible material, such as silicone (or other flexible sterilizable material). Ridge 4502 or other means allows the user to move contact 4504 in any direction. Magnet 4702 is embedded or coupled to flexible member 4506 or under center piece 4504, and the user's movement of the magnet is sensed by a Hall sensor on the reusable introducer assembly housing, which then controls an actuator that controls the robotic movement of the introducer. Contact 4504 can move laterally in any direction (in the x-direction and / or y-direction) and optionally in the z-direction. For example, the x- and y-directions can control the introducer scope articulation, while the z-direction can control the introducer scope to advance distally / retract proximally.

[0386] Fig.28 Shows Fig. 27 A side view of a control member (of a disposable controller) shown in perspective view.

[0387] Fig.29 A cross-sectional view of the Hall sensor-magnet interface is shown after the introducer assembly housing has been positioned in the cavity of the disposable blade. The interface includes a flexible member 4706 (with ridges 4502), contacts 4504, and magnets 4702. The magnet is moved by the user, which helps to robotically control the introducer. When the magnet moves, its movement / positioning is sensed by the Hall sensor in the housing 4704, and the output of the Hall sensor controls one or more introducer actuators (e.g., motors). Flexible member 4706 engages with blade extension 4708 to form a sterile barrier. Control member interface 4710 is an interface between the disposable blade portion control member and the reusable handle portion control member interface element (the interface can be a contact or non-contact interface).

[0388] Fig.30 , Fig.31 and Fig.32 Details of an exemplary control member and interface including a joystick 4202 are shown. Any relevant disclosure from any other example herein may be incorporated by reference Figure 30-Figure 32 in the public content.

[0389] Fig.30Only exemplary control members are shown, which include a joystick 4802, which includes a joystick shaft 4804. A joystick enclosure 4806 is also shown. The joystick enclosure allows the user to move the joystick 4802 in any direction. Electrical contacts (such as spring pins) are located below the joystick 4802, and the user's movement of the joystick is transmitted to one or more metal parts on the reusable shell, which then communicates and controls the introducer actuator, which controls the robotic movement of the introducer (or other controllable medical device). The joystick can move laterally in any direction (in the x-direction and / or y-direction) and optionally in the z-direction. For example, the x- and y-directions can control the joint movement of the introducer mirror, while the z-direction can control the advancement / retraction of the introducer mirror.

[0390] Fig.31 Shows Fig.30 A side view of the control member (including the joystick) shown in perspective view.

[0391] Fig.32 Shown include Fig.30 and Fig.31 A cross-sectional view of the joystick interface is shown. Fig.32 Joystick 4802 and electrical connector 5002 are shown. The electrical connector contacts one or more metal (such as copper) parts in the reusable housing 5004. The joystick is actuated (moved in this case) by the user to robot-control the movement of the guide mirror. When the joystick is moved, electrical signals are transmitted to the reusable guide assembly housing through the metal parts. These signals are transmitted (directly or indirectly) to the motor and / or other actuators in the reusable housing to cause and control the movement of the guide in one or more directions (e.g., x, y and / or z). The joystick housing 4806 interfaces with the blade extension area 4708 to form a sterile barrier. The control member interface 5006 is an interface between a disposable part (disposable blade in this case) and a reusable part. In some embodiments, the joystick can be completely below the flexible sterile barrier.

[0392] In any of the embodiments herein, at least one control member may be adapted to have at least a first control mode and a second control mode, which may be optionally used to switch between x / y movement control and a second mode suitable only for z movement control (forward / backward). By way of example only, a joystick may include a top button that is adapted to be pressed once and kept pressed (in the down state) if in the "up" state, or to be pushed to return it to the up state if in the down / pressed state. Depending on the state of the button (or other actuator), movement of the control member (e.g., joystick) will cause x / y movement or z movement. By way of example only, if the button is in a first state (e.g., up), it will cause x / y movement, and if the button is in a second state (e.g., down), it will cause z movement (or conversely, if the button is in a first state (e.g., up), it will cause z movement, and if the button is in a second state (e.g., down), it will cause x / y movement). The joystick is used only as an example, and other control members may be adapted to have different states that cause different types of motion.

[0393] In some embodiments, one or more control members of the disposable controller are incorporated or integrated into a rigid disposable blade. In some embodiments, the sterile barrier includes both a rigid portion and a flexible portion, the rigid portion being, for example, an integrated blade and a blade extension (which may optionally be at least partially integral (same component)), and a flexible portion being, for example, an area of ​​a flexible material (e.g., silicone or other flexible material) directly surrounding the control member. In some embodiments, the control member interface is on the handheld system, rather than being far away from the system. In some embodiments, the sterile barrier is primarily rigid, so that the user can operate the control member directly on the sterile barrier to control the guide mirror, while the movement of the control member area relative to the handle is minimized or not substantially moved. In some embodiments, the blade including the blade extension incorporating the control member is adapted to snap into place (mechanical integration) with the guide assembly housing. The connection / coupling may be rigid, without significant play or movement between the two components. In some cases, the user can control the system by placing their hands directly on the system within the sterile field. In other words, the control member for controlling the articulation / advancement / retraction of the guide mirror is located on a device rigidly connected to the guide mirror. This may allow the system to be operated with one hand, as described in more detail herein.

[0394] In alternative examples, the reusable portion (e.g., any of the reusable introducer assemblies herein) optionally includes a screen or display, and the disposable controller (e.g., any of the disposable blades with a controller herein) is optionally sized and configured to cover at least a portion of the screen. The interface facilitates the user to actuate the disposable controller (rather than directly actuating the screen), so there is no need to clean the screen between patients / users. In these alternative examples, the interface can be configured with capacitive or resistive touch functionality.

[0395] Although some examples herein describe and illustrate disposable control members as part of a laryngoscope blade (in other words, a disposable blade including at least one control member), similar disposable controllers or other disposable controllers may be used in conjunction with and with other devices / systems, such as, but not limited to, colonoscopes, bronchoscopes, esophagoscopes, articulated laparoscopes, other endoscopes, articulated surgical tools, feeding tube systems, articulated catheters, laparoscopic devices, bone surgical devices, any handheld controllable device, any controllable device, other devices useful for such surgery, etc. Existing systems and devices may need to be modified to be controllable via a disposable controller. Systems and devices may be rigid or flexible, or partially rigid and partially flexible. By way of example only, any device / method of use including an articulated camera (e.g., a colonoscope, esophagoscope, ureteroscope, intrauterine or similar scope, hysteroscope, etc.).

[0396] The disposable controller concept herein can optionally be used in the field of single-port laparoscopy, which is typically performed with large robots (e.g., the da Vinci system) or small hand tools, which can be uncomfortable to use. The disposable controller concept herein can be combined and used with a handheld robot or a set of handheld robotic tools (such as graspers, scissors, etc.). There are many robotic tools that can benefit from being partially disposable and partially reusable.

[0397] Fig.33Only an exemplary laparoscopic handheld robot system 3300 is shown, which includes a reusable part and a part intended to be disposable. In this example, the system 3300 includes a tool end 3301, which may only include one or more of a gripper, a scissors, a camera, etc., for example. The system 3300 also includes an optional articulated shaft portion 3302, a handle 3304, an optional control member 3303 (in this example, a trigger and / or a button control), an optional control member 3305 (in this example, a joystick and / or additional controls) and a reusable electronic device 3306. All devices except the electronic device 3306 can be suitable for disposable use, while more expensive electronic devices are reusable. Alternatively, one or more parts of the shaft are also optionally reusable. The system 3300 can be adapted so that the electronic device 3306 can be disconnected from the disposable component to facilitate their reuse. Optional triggers, joysticks, buttons and / or other actuable control members can be operably connected to the tool portion and / or the articulated portion 3302 of the shaft.

[0398] In any of the embodiments herein, the interface between at least one control member and the control member interface element may include a mechanical interface or communication. By way of example only, the disposable controller may include a button that, when pressed against the button on the reusable portion by a user actuation, causes and controls at least a portion of the reusable portion (which may include a robotically controllable medical device) to be actuated.

[0399] In any of the embodiments herein, the interface between at least one control member and the control member interface element may include an optical interface or communication. By way of example only, any of the control members may be optionally configured as or similar to a trackball, wherein an optical sensor senses the positioning / movement of the control member.

[0400] As a variation of the concepts herein, for any of the systems that include a disposable controller, the disposable controller may alternatively be reusable. In these variations, the portion with the controller is adapted to be sterilizable, especially by harsh methods such as autoclaving. This method can keep the electronics / optics safe while allowing the patient contact portion to be clean. An exemplary precedent for this is a battery pack for orthopedic drills and saws.

[0401] In some embodiments, a portion of the control member is disposable and a portion is reusable. For example, a portion of the control member can be on a disposable blade and a portion of the control member can be on a reusable handle. The control member is a user interface that controls a motor and / or mechanism in the introducer assembly housing, which in turn controls the introducer mirror articulation and / or advancement / retraction. In some embodiments, the entire control member is disposable.

Claims

1. An intubation system, comprising: A disposable blade, comprising: a distal region sized and configured to be positioned in the oral cavity, an extension extending from the distal region and configured and dimensioned to be hand-held, the extension comprising at least one control member adapted to be manually actuated by an operator and the extension comprising a cavity; A reusable introducer assembly ("assembly"), at least a portion of which is sized and configured to be disposed within the lumen, the assembly comprising: at least one control member interface element adapted to be disposed in the cavity, positioned in operable communication with the at least one control member, and responsive to manual actuation of the at least one control member when at least a portion of the assembly is disposed in the cavity, --ETT introducer ("Introducer"), and and at least one guide actuator operably connected to the at least one control member interface element and to the guide to cause controlled robotic movement of the guide in at least one direction of motion in response to user actuation of the at least one control member.

2. The system according to claim 1, wherein: The at least one control member interface element is adapted and positioned to sense one or more of motion, proximity, position, velocity, acceleration, or current.

3. The system according to claim 1, wherein: The at least one control member comprises a magnet and the at least one control member interface element comprises a Hall sensor.

4. The system according to claim 1, wherein: The at least one control member comprises a joystick and the at least one control member interface element comprises one or more metallic contact surfaces.

5. The system according to claim 1, wherein: The at least one control member and the at least one control member interface element are in at least one of electrical, magnetic, mechanical or optical operable communication.

6. The system according to claim 1, wherein: The at least one control member comprises a flexible material.

7. The system according to claim 1, wherein: The extension comprises a rigid material.

8. The system according to claim 1, wherein: The at least one control member comprises a rigid, moveable material.

9. The system according to claim 8, wherein: The at least one control member comprises a movable joystick.

10. The system according to claim 1, wherein: The at least one control member comprises one or more pogo pins.

11. The system according to claim 1, wherein: The assembly comprises a housing including the at least one control member interface element and the at least one introducer actuator, and wherein the introducer is adapted to be releasably coupled to the housing to facilitate operable communication between the at least one introducer actuator and the introducer when the introducer is releasably coupled to the housing.

12. The system of claim 1, wherein: The disposable blade includes an endotracheal tube side channel.

13. The system of claim 1, wherein: The at least one introducer actuator comprises a motor.

14. The system of claim 1, wherein: The at least one control member is operable in a first mode and a second mode, wherein when in the first mode actuation of the control member causes a first type of movement of the guide, and when in the second mode actuation of the control member causes a second type of movement of the guide.

15. The system of claim 14, wherein: When in the first mode, actuation of the control member causes movement of the guide in the x / y direction, and when in the second mode, actuation of the control member causes movement of the guide in the z direction.

16. The system of claim 14, wherein: The at least one control member comprises a depressible button, and wherein the at least one control member is in a first mode when the depressible button is in a first state, and wherein the at least one control member is in a second mode when the depressible button is in a second state.

17. An intubation system, comprising: A disposable blade, comprising: a distal region sized and configured to be positioned in the oral cavity, an extension extending from the distal region and configured and dimensioned to be hand-held, the extension comprising at least one control member adapted to be manually actuated by an operator and the extension comprising a cavity; a reusable housing, at least a portion of which is sized and configured to be disposed within the cavity of the disposable blade, the reusable housing comprising: at least one control member interface element adapted to be disposed in the cavity, positioned in operable communication with the at least one control member, and responsive to manual actuation of the at least one control member when at least a portion of the assembly is disposed in the cavity, and at least one endotracheal tube introducer actuator in operative communication with the at least one control member interface element and adapted to be in operative communication with the endotracheal tube introducer to cause controlled robotic movement of the introducer in at least one direction of motion in response to user actuation of the at least one control member.

18. The system of claim 17, wherein: The at least one control member interface element is adapted and positioned to sense one or more of motion, proximity, position, velocity, acceleration, or current.

19. The system of claim 17, wherein: The at least one control member comprises a magnet and the at least one control member interface element comprises a Hall sensor.

20. The system of claim 17, wherein: The at least one control member comprises a joystick and the at least one control member interface element comprises one or more metallic contact surfaces.

21. The system of claim 17, wherein: The at least one control member and the at least one control member interface element are in at least one of electrical, magnetic, mechanical or optical operable communication.

22. The system of claim 17, wherein: The at least one control member comprises a flexible material.

23. The system of claim 17, wherein: The extension comprises a rigid material.

24. The system of claim 17, wherein: The at least one control member comprises a rigid, moveable material.

25. The system of claim 24, wherein: The at least one control member comprises a movable joystick.

26. The system of claim 17, wherein: The at least one control member comprises one or more pogo pins.

27. The system of claim 17, further comprising an endotracheal tube introducer adapted to be releasably coupled to the reusable housing to facilitate operable communication between the at least one introducer actuator and the introducer when the endotracheal tube introducer is releasably coupled to the reusable housing.

28. The system of claim 17, wherein: The disposable blade includes an endotracheal tube side channel.

29. The system of claim 17, wherein: The at least one introducer actuator comprises a motor.

30. The system of claim 17, wherein: The at least one control member is operable in a first mode and a second mode, wherein when in the first mode actuation of the control member causes a first type of movement of the guide, and when in the second mode actuation of the control member causes a second type of movement of the guide.

31. The system of claim 30, wherein: When in the first mode, actuation of the control member causes movement of the guide in the xy direction, and when in the second mode, actuation of the control member causes movement of the guide in the z direction.

32. The system of claim 30, wherein: The at least one control member comprises a depressible button, and wherein the at least one control member is in a first mode when the depressible button is in a first state, and wherein the at least one control member is in a second mode when the depressible button is in a second state.

33. A kit comprising an intubation system, the kit comprising: a disposable blade and a reusable introducer assembly, the disposable blade and the reusable introducer assembly being uncoupled and not in operative communication; The disposable blade comprises: a distal region sized and configured to be positioned in the oral cavity, an extension extending from the distal region and configured and dimensioned to be hand-held, the extension comprising a cavity and at least one control member adapted to be manually actuated by a user; At least a portion of the reusable introducer assembly ("assembly") is sized and configured to be disposed within the cavity, the reusable introducer assembly comprising: at least one control member interface element adapted to be disposed in the cavity, positioned in operable communication with the at least one control member, and responsive to manual actuation of the at least one control member when the disposable blade is releasably secured to the reusable introducer assembly, --ETT introducer ("Introducer"), and and at least one guide actuator operably connected to the at least one control member interface element and to the guide to cause controlled robotic movement of the guide in at least one degree of freedom of motion in response to user actuation of the at least one control member.

34. A kit comprising a disposable controller for an intubation system, comprising: A disposable blade, comprising: a distal region sized and configured to be positioned in the oral cavity, an extension extending from the distal region and configured and dimensioned to be hand-held, the extension comprising a cavity and at least one control member adapted to be actuated by a user, Therein, the kit comprises neither an endotracheal tube introducer nor an endotracheal tube introducer actuator.

35. A method of intubating a patient, comprising: positioning at least a portion of a reusable introducer assembly ("assembly") into a cavity of a disposable blade, whereby said positioning step positions a control member of the disposable blade proximate a control member interface element of the assembly such that the control member interface element is responsive to manual user control of the control member, The assembly further includes an endotracheal tube introducer ("introducer") and at least one introducer actuator in operable communication with the at least one control member interface element and in operable communication with the introducer; manually moving the control member to cause controlled robotic movement of the introducer in at least one direction of movement; and The assembly is removed from the disposable blade such that the control member interface element is no longer responsive to manual user movement of the control member.

36. The method of claim 35, wherein: The removing step occurs at a time after the endotracheal tube has been advanced over the introducer and into the trachea.

37. A disposable handheld intubation controller, comprising: a distal blade region sized and configured to be positioned in the oral cavity; and an extension extending from the distal blade region, the extension being configured and dimensioned to be hand-held, The extension includes a cavity and at least one control member adapted for manual actuation by a user.

38. The disposable controller of claim 37, wherein: The at least one control member is offset 180 degrees from a distal end of the distal blade region.

39. The disposable controller of claim 37 packaged in a kit and not coupled to an endotracheal tube introducer and not coupled to an endotracheal tube introducer actuator.

40. A controllable medical system including a disposable controller, comprising: A disposable controller, comprising: a body comprising at least one control member adapted to be actuated by a user, and A robotically controllable medical device ("medical device"), at least a portion of which is sized and configured to interface with the subject, the medical device comprising: at least one control member interface element adapted to be positioned in operable communication with the at least one control member and to be responsive to actuation of the at least one control member, a controllable member, at least a portion of which is movable in at least one direction, and - at least one controllable member actuator in operative communication with the at least one control member interface element and in operative communication with the controllable member to cause controlled robotic movement of the controllable member in response to user actuation of the at least one control member.

41. The system of claim 40, wherein: The controllable member includes an endoscope.

42. The system of claim 40, wherein: The controllable member includes a controllable catheter.

43. The system of claim 40, wherein: The controllable member includes a surgical tool.

44. The system of claim 40, wherein: The controllable member includes an endotracheal tube introducer.

45. A system according to any one of claims 40-44, further comprising any other appropriately combinable features described herein, including in any of the claims, figures, examples and embodiments.

46. ​​A disposable controller for a controllable medical system, comprising: A disposable controller, comprising: - A body comprising at least one control member adapted to be actuated by a user.

47. The disposable controller of claim 46, wherein: The body includes a cavity therein.

48. The disposable controller of claim 46, wherein: The disposable controller has an articulatable tool at its distal end.

49. The disposable controller of claim 46, wherein: The disposable controller includes an articulatable shaft at a distal region thereof.

50. The disposable controller of claim 46, wherein: The disposable controller is adapted to couple and decouple with a reusable electronics kit.

51. A method of performing a medical procedure on a subject using a disposable controller, comprising: positioning at least a portion of a reusable, robotically controllable medical device ("medical device") into a cavity of a disposable controller, whereby said positioning step positions a control member of said disposable controller proximate a control member interface element of said medical device such that said control member interface element is responsive to user actuation of said control member, The reusable medical device further comprises a controllable member and one or more controllable member actuators, the at least one controllable member actuator being in operable communication with the at least one control member interface element and in operable communication with the controllable member; manually moving the control member to cause controlled robotic movement of the controllable member in at least one direction of movement; and The reusable medical device is removed from the disposable controller such that the control member interface element of the reusable medical device no longer responds to manual user movement of the control member of the disposable controller.

52. The method of claim 51, wherein: The positioning step positions a control member of the disposable controller within at least one of mechanical proximity, electrical proximity, magnetic proximity, or optical proximity of a control member interface element.

53. An intubation system, comprising: A disposable controller, comprising: a body configured and dimensioned to be hand-held, at least one control device integral with the body for actuation by an operator, and -- cavity; A reusable introducer assembly ("assembly"), at least a portion of which is sized and configured to be disposed within the lumen, the assembly comprising: a responsive control device for responding to actuation of the at least one control member when at least a portion of the assembly is disposed in the cavity, and - at least one guide actuator device operably connected to the at least one response control device for causing the guide to respond in response to user actuation of the at least one control device and operably connected to the guide to cause controlled robotic movement of the guide in at least one degree of freedom of movement.

54. The system of claim 53, wherein: The disposable controller includes a distal blade region sized and configured to be positioned in the oral cavity.

55. The system of claim 54, wherein: The body of the disposable controller is initially formed with the distal blade region.

56. The system of claim 54, further comprising a camera disposed in the distal blade region.

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