Upper respiratory tract access

Abstract

Methods, devices, and systems for providing upper airway access for medical procedures. The approaches herein can provide, generate, and maintain space in the oral cavity to provide improved airway access for airway management and / or interventional procedures. The system includes a mouse traction device comprising an upper member sized and configured to engage with the upper portion of the oral cavity and a lower member sized and configured to engage with the lower portion of the oral cavity; an actuator adapted to move and adjust at least one of the upper and lower members relative to the other member in a controlled manner to increase the distance between them; a mechanism for supporting the relative positions of the two; and a tongue depressor coupled to or adapted to be coupled to the lower member.

Description

Technical Field

[0001]

[0001] This application claims priority to the following provisional application, which is incorporated herein by reference in its entirety for all purposes: 63 / 458,574, filed April 11, 2023.

[0002]

[0002] The following publications: WO2021 / 236677, WO2023 / 060241, WO / 2023 / 164434, and WO / 2023 / 201210 are hereby incorporated by reference in their entirety for all purposes.

[0003]

[0003] All publications and patent applications mentioned in this specification are hereby incorporated by reference into this specification to the same extent as if each individual publication and patent application were specifically and individually indicated to be incorporated by reference.

Background Art

[0004]

[0004] Existing mouse traction devices exist, but an alternative approach is needed that can provide more controlled and effective oral space generation and / or greater functionality for access to a patient's airway.

Summary of the Invention

[0005]

[0005] This disclosure relates to methods, devices, and systems for providing upper airway access for medical procedures. The approach herein can provide, generate, and maintain space within the oral cavity to provide improved airway access for airway management and / or invasive procedures. The systems and devices herein may be referred to as a highly stabilized and visualized platform (or "platform"), although the term does not necessarily imply the functionality required for the innovative approach herein. Further, the term "system" herein may also be used to refer to any platform of the platform herein.

[0006]

[0006] Any appropriate intraoral or airway procedure (e.g., interventional, surgical, etc.) may be performed in conjunction with the approaches herein, and any appropriate intraoral or airway procedure includes, but is not limited to, tracheal intubation, tonsillectomy, adenoidectomy, vocal cord surgery, pharyngeal surgery, vocal cord injection, oromaxillofacial, orthognathic, oromaxillofacial, plastic, and dental surgery, removal of oral / intraoral / airway tumors and other pathological tissues, other surgical and neurosurgical procedures requiring oral / intraoral access, and other upper and lower airway surgery.

[0007]

[0007] One aspect of the present disclosure is a system for generating a functional surgical space in the oral cavity.

[0008]

[0008] In this embodiment, the system optionally includes a mouse traction device. The mouse traction device optionally includes an upper member sized and configured to engage with the upper portion of the oral cavity and a lower member sized and configured to engage with the lower portion of the oral cavity.

[0009]

[0009] In this embodiment, the system optionally includes actuators that operably communicate with the upper and lower members, which are adapted to controllably adjust the distance between the upper and lower members in order to facilitate the relative movement of the maxilla and mandible when the upper and lower members engage with the upper and lower portions of the oral cavity.

[0010]

[0010] In this embodiment, the system also optionally includes a lock for maintaining a desired spacing between the upper and lower members.

[0011]

[0011] In this embodiment, the system also optionally includes a blade portion that is coupled to or can be coupled to a mouse traction device, the blade portion including a blade that is sized and configured to interface with the tongue.

[0012]

[0012] In this embodiment, the system optionally includes actuators that operably communicate with the upper and lower members, which are adapted to controllably adjust the distance between the upper and lower members in order to facilitate the application of force by the upper member to the maxilla and force by the lower member to the mandible when the upper and lower members engage with the upper and lower portions of the oral cavity, thereby resulting in controlled and gradual relative movement between the maxilla and the mandible.

[0013]

[0013] In this embodiment, the system optionally includes a blade portion that is rotatably coupled to a mouse traction device and is laterally constrained relative to the mouse traction device, the blade portion including a blade that is sized and configured to displace the tongue by applying force to the tongue as the blade portion rotates relative to the mouse traction device.

[0014]

[0014] In this embodiment, the blade portion is optionally rotatably coupled to the mouse traction device to facilitate the creation of further controlled oral and hypopharyngeal space by applying force to the tongue and displacing the tongue in addition to the space created in the oral cavity by the application of force to the upper and lower jaws by the mouse traction device.

[0015]

[0015] In this embodiment, the actuator optionally includes a scissor-type mechanism for controllingly adjusting the distance between the upper and lower members in order to facilitate the application of force to the upper and lower jaws, respectively, by the upper and lower members.

[0016]

[0016] In this embodiment, the actuator, upper member, and lower member are optionally configured and arranged such that the force on the mandible is equal to or substantially equal to the force on the maxilla.

[0017]

[0017] In this embodiment, the blade portion is optionally rotatably coupled to the lower member of the mouse traction device and is laterally constrained to the lower member.

[0018]

[0018] In this embodiment, the blade portion optionally comprises a body portion extending from the lower member in a first direction and a blade extending from the lower member in a second direction. The angle between the body portion and the blade is optionally less than 180 degrees and optionally less than 135 degrees.

[0019]

[0019] In this embodiment, the blade portion optionally comprises a coupling member extending laterally from the main body portion of the blade portion, the coupling member being coupled to the lower member such that the coupling member is rotatable about the lower member in order to facilitate rotational coupling between the blade portion and the lower member. The coupling member optionally includes first and second coupling members extending laterally from the main body portion, each of the first and second coupling members being coupled to the lower member such that the first and second coupling members are rotatable about the lower member in order to facilitate rotational coupling between the blade portion and the lower member.

[0020]

[0020] In this embodiment, the system optionally comprises one or more lateral restraint elements to facilitate lateral restraint between the blade portion and the mouse traction. Either or both of the blade portion or the mouse traction optionally comprises one or more of the one or more lateral restraint elements. The lower member optionally comprises one or more recessed areas or grooves that interface with the blade portion to resist relative lateral movement of the blade portion. One or more recessed areas optionally lies lateral to the midline of the blade portion. One or more recessed areas optionally lies lateral to the blade of the blade portion. The blade portion optionally comprises one or more couplers that are sized and configured to interface with one or more recessed areas or grooves of the lower member.

[0021]

[0021] In this embodiment, the blade portion optionally includes an elongated main body, and the blade extends from the elongated main body portion at a non-zero-degree angle and less than 180 degrees, optionally less than 135 degrees.

[0022]

[0022] In this embodiment, the blade portion optionally includes a hook at or near the first end of the elongated main body to facilitate increasing the stability of the blade portion. The hook optionally extends from the main body on the same side as the blade.

[0023]

[0023] In this embodiment, the blade portion optionally includes a handle extending from the main body, the handle extending from the main body on the side facing the blade, and the handle optionally extending from the main body on the side facing the hook.

[0024]

[0024] In this embodiment, the system optionally comprises at least one visualization device coupler fixed to the blade. The visualization device coupler optionally comprises a lumen fixed to the blade, the lumen being sized to receive a visualization device, optionally an endoscope, through the lumen. The visualization device may be adapted to be integrated with the coupler or detachable from the coupler.

[0025]

[0025] In this embodiment, the system optionally further comprises at least one of a visualization tool coupler or a visualization tool coupled to a blade to facilitate distal advancement of the visualization tool relative to the blade and positioning of the visualization rule to a certain location in order to provide an indirect view of anatomical structures on a display for operational procedural purposes, and an indirect view beyond the anatomical structures that can be seen by a direct view of the oral cavity. The system optionally is arranged to facilitate positioning of the visualization tool to a certain location in order to provide an indirect view of the hypopharynx and glottis using image data from the visualization tool shown on the display.

[0026]

[0026] In this embodiment, the system optionally further comprises a robotic system, the blade portion comprising the robotic system, and the blade being disposed in the distal region of the robotic system. The system optionally further comprises a body portion separated from the robotic system, the body portion optionally including a hook at or near the first end of the body portion. The robotic system optionally includes a hook at or near the first end to facilitate increasing the stability of the robotic system.

[0027]

[0027] In this aspect, the system optionally includes at least one of a visualization tool coupler coupled to the blade or a visualization tool to facilitate, optionally, distal advancement of the visualization tool with respect to the blade and positioning the visualization rule somewhere to provide an indirect view of the anatomical structure on the display for the surgical procedure, an indirect view that exceeds the anatomical structure visible by the direct view of the oral cavity, and optionally includes an integrated lighting element directed to provide light towards the anatomical structure. The system is optionally arranged to facilitate positioning the visualization tool somewhere to provide indirect observation of the hypopharynx and glottis using image data from the visualization tool shown on the display.

[0028]

[0028] In this aspect, the system may be an oral docking station adapted to provide a functional surgical space within the upper airway for one or more medical procedures, and may have any feature or features of any docking station herein. As an oral docking station, the docking station may include one or more medical device couplers adapted to releasably couple to a medical device such as any medical device described herein.

[0029]

[0029] One aspect of the present disclosure is a method of creating and maintaining a functional surgical space within the oral cavity for medical and surgical procedures.

[0030]

[0030] In this aspect, the method may include applying, by a device, opposing forces to the upper and lower jaws, thereby increasing the distance between the upper and lower jaws to create a first space within the oral cavity; maintaining, by a lock, the increased distance; and applying, by a blade, a force to the tongue, thereby displacing the tongue to create a further space within the oral cavity with respect to the first space and exposing one or more hypopharyngeal structures.

[0031]

[0031] This aspect may include any other step or process of this specification.

[0032]

[0032] In this aspect, the method is to apply a force to the tongue by a blade, thereby displacing the tongue and increasing the amount of directly visible upper airway anatomical structures compared to a first space generated by a mouth retractor such as any of the mouth retractors of this specification.

[0033]

[0033] In this aspect, the method may include positioning a mouth retractor in the oral cavity such that an upper member extends laterally and engages the upper part of the oral cavity and a lower member extends laterally and engages the lower part of the oral cavity.

[0034]

[0034] In this aspect, the method includes gradually applying a force to the lower jaw by the lower member and gradually applying a force to the upper jaw by the upper member, and gradually and controllably increasing the distance between the upper member and the lower member to gradually increase the distance between the upper jaw and the lower jaw by operating an actuator to generate an oral cavity space.

[0035]

[0035] In this aspect, the method may include maintaining the increased oral cavity distance.

[0036]

[0036] In this aspect, the method may include rotating a blade rotatably coupled to the lower member of the mouth retractor to displace at least a portion of the tongue. Displacing at least a portion of the tongue by the blade optionally controllably increases the oral cavity space generated by gradually increasing the distance between the upper jaw and the lower jaw, and displacing at least a portion of the tongue further exposes one or more hypopharyngeal structures.

[0037]

[0037] In this embodiment, the method may include limiting the rotational capability of the blade to the mouse traction device for a certain period of time following the rotation of the blade.

[0038]

[0038] In this embodiment, one or more hypopharyngeal structures optionally include a glottal opening.

[0039]

[0039] In this embodiment, activating the actuator may include activating the scissor-type mechanism.

[0040]

[0040] In this embodiment, the force on the mandible is optionally equal to or substantially equal to the force on the maxilla.

[0041]

[0041] In this embodiment, increasing the distance between the upper and lower jaws optionally occurs before the time for the blade to rotate.

[0042]

[0042] In this embodiment, rotating a blade rotatably coupled to the lower member to displace at least a portion of the tongue optionally exposes at least the hypopharyngeal and glottal structures.

[0043]

[0043] In this embodiment, the method further includes performing an interventional or surgical procedure through the oral cavity.

[0044]

[0044] In this embodiment, limiting the rotational capability of the blade relative to the mouse traction device optionally includes engaging the hook with a stabilizing device, optionally with a nearby table.

[0045]

[0045] In this embodiment, the method optionally further includes positioning a visualization tool relative to a blade and / or advancing it into the oral cavity. Positioning the visualization tool optionally provides an indirect and magnified view of the anatomical structures on the display for the surgical procedure, providing an indirect and magnified view beyond the anatomical structures that can be seen by a direct view of the oral cavity, and optionally provides an indirect and magnified view of the hypopharynx and glottis on the display.

[0046]

[0046] In this embodiment, the method may further include emitting light toward an anatomical structure to enable visualization of the anatomical structure by one or more visualization rules. [Brief explanation of the drawing]

[0047] [Figure 1]

[0047] This figure shows one view of a different view of an exemplary high-stabilization and visualization platform. [Figure 2] This figure shows one view of a different view of an exemplary advanced stabilization and visualization platform. [Figure 3] This figure shows one view of a different view of an exemplary advanced stabilization and visualization platform. [Figure 4] This figure shows one view of a different view of an exemplary advanced stabilization and visualization platform. [Figure 5]

[0048] Figure 5A shows an exemplary platform being prepared for insertion in an airway simulation manikin.

[0049] Figure 5B shows the midline insertion of the platform.

[0050] Figure 5C shows the platform where the blade is inserted into the base of the tongue and enters the hypopharynx.

[0051] Figure 5D shows a fully seated platform with the midline mandible contact point behind the upper and lower dentition. [Figure 6]

[0052] Figure 6A shows the platform from Figures 5A-5D in operation of the mouse traction device to separate the upper and lower members and the upper and lower jaws for improved upper airway access and to create surgical space inside the oral cavity. Figure 6B shows the platform from Figures 5A-5D in operation of the mouse traction device to separate the upper and lower members and the upper and lower jaws for improved upper airway access and to create surgical space inside the oral cavity. Figure 6C shows the platform from Figures 5A-5D in operation of the mouse traction device to separate the upper and lower members and the upper and lower jaws for improved upper airway access and to create surgical space inside the oral cavity. [Figure 7]

[0053] Figure 7A shows that the blade portion of the platform shown in Figures 5A-6C rotates around the traction portion to depress the tongue and create more space in the oral cavity, thereby facilitating access to all parts of the airway, including the glottis. Figure 7B shows that the blade portion of the platform shown in Figures 5A-6C rotates around the traction portion to depress the tongue and create more space in the oral cavity, thereby facilitating access to all parts of the airway, including the glottis. [Figure 8]

[0054] Figure 8A shows an exemplary embodiment of a visualization coupler for a visualization device, in this example, a platform including a lumen for a visualization scope.

[0055] Figure 8B shows the platform from Figure 8A positioned within the oral cavity. [Figure 9]

[0056] Figure 9A shows an exemplary embodiment of a platform that includes or is coupled to an intubation system.

[0057] Figure 9B shows the platform from Figure 9A positioned within the oral cavity. [Figure 10A]

[0058] This figure shows an exemplary embodiment of a platform including or coupled to an intubation system. [Figure 10B]

[0059] This figure shows the platform from Figure 10A positioned within the oral cavity. [Figure 10C]

[0060] Figures 10A and 10B show the platform positioned in the oral cavity, and the induction device was robotically (manually and / or automatically using image guidance) advanced distally into the trachea. [Figure 11]

[0061] This figure shows an exemplary embodiment of a platform supporting multiple tools. [Figure 12]

[0062] This diagram shows the platform from Figure 11 that provides stability for multiple tools. [Figure 13A]

[0063] This is a side view of an exemplary, integrated, and handheld dual-video endotracheal intubation assembly (first imaging member not shown) in an unassembled state. [Figure 13B] This is a top view of an exemplary, integrated, handheld dual-video endotracheal intubation assembly (first imaging member not shown) in an unassembled state. [Figure 13C]

[0064] This is a bottom view of an exemplary, one-piece, handheld dual-video endotracheal intubation assembly, shown in an unassembled state. [Figure 13D]

[0065] This is a side view of an exemplary, one-piece, handheld dual-video endotracheal intubation assembly, shown in an unassembled state. [Figure 13E]

[0066] This is a top view of an exemplary, one-piece, handheld dual-video endotracheal intubation assembly, shown in an unassembled state. [Figure 13F]

[0067] This is a side view of an exemplary, one-piece, handheld dual-video endotracheal intubation assembly, shown in an unassembled state. [Figure 13G]

[0068] This is a top view of an exemplary, one-piece, handheld dual-video endotracheal intubation assembly, shown in an unassembled state. [Figure 14]

[0069] This figure shows one embodiment of an exemplary disposable controller (in this example, a disposable blade) that includes an extension section equipped with control members such as magnets. [Figure 15]

[0070] This figure shows one embodiment of a disposable blade including an extension section equipped with a control member including a joystick. [Figure 16]

[0071] This figure shows an exemplary housing that may be reusable (optionally part of the introducer assembly). [Figure 17]

[0072] Figure 16 shows the blade of Figure 15 in place on the reusable introducer assembly housing, and also shows an exemplary introducer housing coupled to the reusable housing of Figure 16 (the introducer is not shown for clarity). [Figure 18]

[0073] This diagram shows details of an exemplary Hall sensor magnet interface. [Figure 19] This diagram shows details of an exemplary Hall sensor magnet interface. [Figure 20] This diagram shows details of an exemplary Hall sensor magnet interface. [Figure 21]

[0074] This figure shows details of an exemplary joystick, which may be part of a disposable blade or other disposable controller. [Figure 22] This figure shows details of an exemplary joystick, which may be part of a disposable blade or other disposable controller. [Figure 23]This figure shows details of an exemplary joystick, which may be part of a disposable blade or other disposable controller. [Figure 24]

[0075] Some of these are figures that illustrate and identify exemplary anatomical structures, as revealed by one or more aspects of the disclosure herein. [Modes for carrying out the invention]

[0048]

[0076] This disclosure relates to methods, devices, and systems for providing upper airway access for medical procedures (generally referred to herein as “approaches”). The approaches herein can provide, generate, and maintain space in the oral cavity to provide improved airway access for airway management and / or interventional procedures. The systems and devices herein may be referred to as highly stabilized and visible platforms (or “platforms”), but it is understood that this expression does not necessarily imply the required functionality for the innovative approaches herein. Furthermore, the term “system” herein may also be used to refer to any platform of the platforms herein.

[0049]

[0077] Any appropriate intraoral or airway procedure (e.g., interventional, surgical, etc.) may be performed in conjunction with the approaches herein, which include, but are not limited to, tracheal intubation, tonsillectomy, adenoidectomy, vocal cord surgery, pharyngeal surgery, vocal cord injection, orocomatofacial, mandibular, orocomatofacial, orthopedic, and dental surgery, removal of oral / intraoral / airway tumors and other pathological tissues, other surgical and neurosurgical procedures requiring oral / intraoral access, and other upper and lower airway surgery.

[0050]

[0078] Optionally, the platform herein may be used as a docking station for various devices, optionally including robotic devices, examples of which are provided herein. For example, the platform herein may be configured as a docking station for robotic devices including robotically controlled introducers and / or robotic intubation devices. It is understood that other types of robotic devices may be used with the platform herein (for example, coupled with).

[0051]

[0079] The systems and devices herein are adapted to facilitate more precise control over the creation of functionally usable oropharyngeal and hypopharyngeal spaces (e.g., upper hypopharyngeal cavity) for the operator compared to existing devices (see Figure 24). For example, the systems herein are adapted to generate more controlled jaw traction forces on the upper and lower jaws, separating them from each other (increasing oropharyngeal exposure) by the system's dedicated traction portion, while simultaneously allowing the diagnostician to focus on creating improved and functional oropharyngeal (further exposure to the exposure generated by the traction portion) and hypopharyngeal (e.g., upper hypopharyngeal, glottis, base of tongue) exposure through the tongue depressor (blade) aspect of the system (e.g., blade portion). Some past approaches, compared to using the systems herein, are adapted to make tongue depression and jaw traction more interrelated, which can result only in uncontrolled, imprecise, and undesirable preferential oral space creation. In other words, the system described herein generates a more controlled, synergistic, balanced, and reliable jaw traction force, along with a tongue-depressing force, and is adapted to expose the oropharynx, particularly the hypopharynx, and even the glottal area more efficiently and / or more easily and safely than existing devices.

[0052]

[0080] In some examples herein, the system includes a mouse traction unit (or mouse traction unit or traction unit) including an upper member sized and configured to engage with the upper portion of the oral cavity, and a lower member sized and configured to engage with the lower portion of the oral cavity. The traction unit may optionally include, or be controlled by, an actuator (e.g., a scissor-like opening configuration) adapted to move and adjust at least one of the upper and lower members relative to the other to increase the distance between them, and a mechanism (e.g., a ratchet mechanism) that maintains their relative positions. The system herein also includes a tongue depressor (e.g., a blade) coupled to or adapted to coupled to the lower member (directly or indirectly connected to one or more connecting elements), the blade being adapted to move relative to the lower member in a specific manner dedicated to displacing the tongue with the primary objective of generating further functional surgical space within the oral cavity and hypopharynx. In these examples, the actuators release the mouth by resulting in controlled relative movement of the upper and lower jaws by the upper and lower members, and the controlled movement of the tongue depressor (e.g., relative to the lower member) relative to the mouth traction device generates further functional space by displacing the tongue.

[0053]

[0081] The exemplary controlled scissor traction force that generates the capability of the system herein, in contrast to any other mouse gag (e.g., McIvor), controls and optimizes the force transmitted to the maxilla and mandible, with a primary focus of interest on simply opening the patient's mouse more widely, preferentially transmitting force to the lower mandible through an adjustable tongue blade depressor. Utilizing the system herein allows the diagnostician to apply force to the tongue blade depressor with exclusive attention to lower mandibular distraction, i.e., hypopharyngeal and even glottal exposure, rather than concentrating blade force solely to control mouse opening.

[0054]

[0082] In some cases, the tongue depressor is rotatable (swivelable) relative to the lower member to further facilitate controlled movement of the tongue while the upper and lower members maintain relative spacing between the maxilla and mandible. Relying on the upper and lower members to control jaw positioning allows for greater freedom and precision in adjusting the tongue depressor (relative to the lower member), compressing the tongue into the floor of the mouth and lifting it away from the posterior pharyngeal wall by more precise control of the force required to expose the hypopharynx.

[0055]

[0083] In these examples, the system may be described as being adapted in separate steps, such as jaw traction and tongue depressor, but the steps do not necessarily have to be performed sequentially. For example, the tongue depressor may be rotated relative to the lower member, while the lower and upper members are pulled apart by actuators.

[0056]

[0084] In any embodiment of the embodiments described herein, the upper and lower members may each be a single monolithic component, or one or both may include multiple components integrated together to produce a single member. The upper and lower members described herein may each include an elongated body (the body does not need to be straight).

[0057]

[0085] An optional advantage of the systems described herein is that the system may be adapted such that the lateral movement of the tongue depressor relative to the lower member is constrained and completely prevented, which optionally helps to self-center the tongue depressor relative to the lower member and increases the stability of the tongue depressor relative to the lower member when force is applied to the tongue. The examples described herein include lateral movement constraint, but alternative systems may include a tongue depressor that can move freely laterally relative to the lower member to maximize exposure. In any system of the systems described herein, the tongue depressor may be able to move freely laterally relative to the lower member in a first state or condition, but is laterally constrained relative to the lower member in a second state or condition (e.g., by a releaseable lock).

[0058]

[0086] The platforms described herein may be used in a wide range of medical and surgical / interventional procedures that, depending on their use, are considered “docking” stations at the level of oral entry, to which other devices may be fixed or stabilized once placed in place, and which aim to take operational advantage of an enlarged and functionally usable airway anatomical structure extending into the hypopharyngeal space. For example, once the platform is fixed in place, it may not even be necessary to place hands on the platform, and the operator’s hands may be used to control other medical and surgical tools and devices, while the system maintains exposure of the oropharynx, optionally, the hypopharynx / glottis. The platforms described herein may optionally allow the procedure to be performed with fewer hands than would be required if the platform were not used. Simply as an example, one physician may be able to perform a more complex procedure that would normally require two or more people. Again, simply as an example, once the platform is placed in place (as described below), intubation may be performed hands-free, with one hand or two hands. Subsequent or separate procedures through the platform may be performed hands-free, with one hand, two hands, three hands, four hands, etc.

[0059]

[0087] The following sections provide examples of beneficial embodiments of the Platforms Specified herein, the examples of which may depend on how they are implemented and / or used. The Platforms Specified herein may offer one or more advantages over existing mouse traction devices. For example, the Platforms Specified herein may offer the advantage of integrated stabilization and visualization of the airway (including the optional use of a video camera and optional integration thereof), enabling the performance of a few-manual or even hands-free procedure (e.g., optionally including the optional use of a robot-controlled device such as an introducer), with increased precision and safety for the patient. Furthermore, for example, the Platforms Specified herein may optionally offer the advantage of applying a measurably applied and controlled scissor traction mouse release force that is essentially the same between the maxilla and mandible. Furthermore, for example, the Platforms Specified herein may optionally offer the advantage of a self-centering (lateral) mechanism for the platform. Furthermore, for example, the platform herein may optionally offer the advantage of greater precision control of scissor traction force, allowing for concentration of traction force on the tongue blade depressor with special attention to exposing the supraglottic, epiglottic, glottic, and hypopharyngeal structures. Furthermore, for example, the platform herein may offer the advantage of a greater degree of freedom option when compressing the tongue into the floor of the mouth and lifting the tongue away from the posterior pharyngeal wall, with greater control of the force required to expose the supraglottic, epiglottic / glottic, and hypopharyngeal structures, resulting in less trauma to the patient. Furthermore, for example, the platform herein may optionally offer the advantage of superior exposure of the hypopharynx and glottis / larynx as an improved tool for tracheal intubation, as well as for upper and lower airway surgery and interventional procedures in and around the patient's airway. Furthermore, for example, the platform described herein may offer the advantage of being able to use tongue blade depressors of various sizes and connect one or more medical / surgical tools and tools stabilizing devices, enabling the precise execution of procedures with fewer hands or even hands-free procedures.

[0060]

[0088] Figures 1, 2, 3, and 4 show exemplary embodiments of a system or platform 5900 configured to facilitate the more precise and controlled generation of functionally usable space. Figure 1 shows a side view of a system 5900 having an exemplary mouse traction device or traction device portion 5902 in a fully open configuration with the maxillary member 5901 and mandibular member 5903 positioned at their maximum or greatest distance "D". The traction device 5902 is an example of a traction device adapted to allow the application of a progressive scissor traction mouse release force to gradually and further separate the maxilla and mandible in a controlled manner to generate the desired functional space in the oral cavity (movement of at least one jaw relative to the other jaw). The traction unit 5902 is connected or coupled to the platform blade component or blade section 5904 (including and optionally housing the blade 5908) by a system connector or coupler 5906, which allows the blade section 5904, including the blade 5908, to rotate relative to the traction unit 5902, in this example, to rotate around the lower member 5903. The arrow "R" shown in Figure 1 indicates the direction of rotation of the blade relative to the traction unit 5902.

[0061]

[0089] The traction unit 5902 and / or the blade portion 5904 may include one or more blade portion motion limiting features sized and configured to restrict or constrain the motion of the blade portion relative to the traction unit 5902. One or more blade portion motion limiting features may be part of either or both the traction unit 5902 and the blade portion 5904. One or more blade portion motion limiting features may be configured to limit relative blade motion laterally and / or rotationally. As used in this context, “lateral” refers to the anatomically lateral direction when the platform is placed inside a mouse, as labeled in Figure 2. One or more lateral motion limiting features interface with one or more regions of the coupler 5906 and thereby include grooved, serrated, recessed or raised regions within the lower member 5903 that may be sized and configured to resist or prevent lateral motion of the blade portion relative to the lower member. In this example, the coupler 5906 includes first and second parts 5906a and 5906b, respectively, which extend laterally from the centerline of the blade portion (shown as a dashed line in Figure 2) and are fixed around or near a section of the lower member 5903, as shown in Figures 1-4. The lateral movement limiting feature prevents the coupler 5906, and therefore the blade portion, from moving laterally relative to the traction unit 5902, so that it remains laterally centered relative to the traction unit 5902.

[0062]

[0090] The blade portion 5904 comprises a blade 5908, a blade portion body 5912 including a locking mechanism 5914, and a handle 5916. The blade portion 5904 also includes an optional hook 5910. In this embodiment, the blade 5908 is adapted to slide against (optionally within) the body 5912 and can be locked in place against the body 5912 by the locking mechanism 5914, which holds the blade 5908 in place relative to the body 5912. Blades of different sizes may be used with the system, optionally with a common or universal body 5912. The hook 5910 (or other stabilizing feature) can be hooked onto a pole, railing, Mayo stand, platform, patient, or somewhere else to increase the stability of the platform 5900 (in particular, the blade portion 5904) after the platform 5900 has been placed in place within the patient's mouse.

[0063]

[0091] Alternatively or additionally, the pivot connector 5906 may rotatably lock the blade portions 5904 and blade 5908 in place after they have rotated relative to the traction device 5902, so that the blades no longer rotate relative to the traction device and thus stabilize the blade portions 5904 and blade 5908 relative to the traction device 5902 and the patient. A wide variety of rotational movement limiting features may be incorporated into one or both of the traction device or blade portions of the system to rotatably lock the blade portions of the system in place relative to the traction device.

[0064]

[0092] As shown in Figure 1, the blade portion 5904 comprises a body portion 5912 extending from the lower member 5903 in a first direction, and the blade 5908 extending from the lower member 5903 in a second direction. In this example, the angle θ between the body 5912 and the blade 5908 is less than 180 degrees. Less than 135 degrees is also an example of an angle θ between the body 5912 and the blade; similarly, angles less than that are 90 degrees, approximately 90 degrees, or exactly 90 degrees.

[0065]

[0093] Figure 2 shows the platform 5900 in a different view from the one shown in Figure 1, looking down at the length of the main body 5912 from the hook 5910 to the blade 5908. Figure 1 shows a side profile view of the platform.

[0066]

[0094] Figure 3 shows a top view of the platform 5900 with the blade body 5912 facing upward (entering and exiting the page). In Figure 3, the blade portion 5904 is shown rotated approximately 90 degrees (counterclockwise) relative to the side view shown in Figure 1. The blade locking mechanism 5914 is obscured in Figure 3 by the handle 5916.

[0067]

[0095] Figure 4 shows a top view of the platform 5900 shown in Figure 1, with the tongue depressor 5908 obscured, but facing inward in the figure. The optional hook 5910 is not shown in Figure 4.

[0068]

[0096] An exemplary benefit of platform 5900 is that, once positioned within a subject mouse, platform 5900 adapts itself as if the system were self-centering. Platform 5900 also enables visualization and / or access to various airway and anatomical structures within the patient mouse and throat that may be difficult to visualize with existing mouse traction devices, as described herein. For example, the platform may enable access to and / or visualization of the hypopharynx, base of the tongue, epiglottis, vallecula, glottal opening, larynx, vocal cords, trachea, esophagus, arytenoid cartilage, and / or other anatomical structures (see Figure 24).

[0069]

[0097] System 5900 (and other systems herein) allows the user to apply force to the blade with greater attention to hypopharyngeal and glottal exposure rather than concentrating blade force on controlling lower mandibular extension, i.e., mouth opening. The swivel / rotation motion of the blade portion of the platform herein allows for a greater degree of freedom in adjusting the blade to compress the tongue into the floor of the mouth and lift the tongue away from the posterior pharyngeal wall, enabling greater control of the force required to expose the oropharynx and hypopharynx / glottis with less trauma to the patient.

[0070]

[0098] The platform described herein may optionally allow a physician to access the throat and / or airway anatomical structures without using both hands. For example, the platform described herein may allow a physician to have one or both hands free to perform other tasks. Simply as an example, in some uses, the traction device is used to separate the upper and lower jaws, and the blade is used to displace the tongue. The blade can be held in a position where the tongue is displaced without needing to be held on the blade portion (and while the upper and lower jaws are held apart by the traction device), possibly freeing both hands of the care team user (e.g., a physician). In this sense, the platform described herein may be considered a platform whose use includes generating access, followed by active maintenance of that access (by the platform), but also passive maintenance by the user (without active maintenance by the user), so that the user can use the platform for one or more other procedures without keeping their hands on the platform.

[0071]

[0099] Figures 5A, 5B, 5C, 5D, 6A, 6B, 6C, 7A, and 7B illustrate exemplary uses of the platform 5900 of Figures 1–4 for generating and maintaining oral airway access for one or more medical / surgical procedures, demonstrating controlled generation of functionally usable space with special attention to the hypopharynx. Figure 5A is a side view similar to Figure 1, showing the platform 5900 being prepared for insertion in an airway simulation manikin, except that the system's traction device 5902 has upper and lower members 5901 and 5903 in a closer closed configuration compared to the open configuration in Figure 1.

[0072]

[0100] Figure 5B shows the midline insertion of the blade 5908 of system 5900 into the oral cavity of the subject (manikin). The upper and lower members 5901 and 5903 are still in the closed position (or at least not yet in the fully open configuration) in this example. When the distal end of the blade 5908 is inserted into the oral cavity (shown), the upper and lower members 5901 and 5903 of the traction device remain outside the oral cavity.

[0073]

[0101] Figure 5C shows that blade 5908 is further advanced distally into the oral cavity to the base of the tongue, and the traction portion is brought closer to the mouse as it enters the hypopharynx.

[0074]

[0102] Figure 5D shows the blade 5908 with the distally advanced blade portion, with the lower member 5903 adjacent to the mandible and the upper member 5901 adjacent to the maxilla, as shown. Figure 5D shows the blade fully seated (distally) with the midline mandibular contact points of the upper and lower members behind the upper and lower dental arches, as shown.

[0075]

[0103] Figure 6A shows the user's hand gradually starting to actuate the scissor-like actuator 5905, controllingly moving the first and second actuating elements (in this example, the extensions of the upper and lower members) toward each other. Figure 6B shows the gradual action that causes the upper and lower members to be precisely pulled apart, thereby separating the upper and lower jaws to create functional space between them. Figure 6C shows the upper and lower members after being further pulled apart to create a larger surgical / procedural space, as shown, as well as a locking mechanism (e.g., ratchet 5907) that maintains the desired spacing between the upper and lower members.

[0076]

[0104] As described herein, an exemplary benefit of the systems and platforms herein is that the traction portion (e.g., 5902) is configured to apply safe and precise force to the upper and lower jaws (and maintain spacing between them), while the rotatable blade portion can rotate (swivel) separately relative to the traction (particularly relative to the lower member) to push the tongue down and create further functional surgical space in the oral cavity. Figure 7A shows that, by the user's fingers engaging with the handle 5916, the blade portion 5904 rotates relative to and around the upper member 5903 (swivels around the upper member 5903), thereby pulling the body 5912 out of the page, causing the blade portion to swivel around the upper member, thereby causing the blade to move toward the tongue, move the tongue, and push it down. Figure 7B shows the continued rotation or swivel of the bladed portion 5904, which allows for further tongue depression to generate a larger functional surgical space within the oral cavity, thereby providing uniquely greater exposure to the oropharynx, supraglottic, glottis, and hypopharynx. After the blade has been moved to the position shown in Figure 7B by swirling the bladed portion, the hook of the bladed portion (e.g., hook 5910) may be fixed to a table or other stabilizing structure to help stabilize the bladed portion and platform relative to the subject. Any medical procedure, such as any procedure of the herein, may then be performed, while the platform provides improved access and visibility to the oral cavity and upper airway.

[0077]

[0105] Figures 5A–7B illustrate exemplary methods of positioning, controlled and precise space generation and maintenance with reference to an exemplary platform 5900 in one or more embodiments and examples herein, but the following steps may be taken to position the platform: position the traction teeth and tongue depressor in the patient's mouse; extend the traction portion to open the jaw and enlarge the mouse opening; lock the platform traction in place to hold the jaw open; operate the bladed portion in a rotational / swiveling direction and / or translational direction so that the blade gradually compresses the tongue and allows visualization and / or access to a desired portion of the anatomical structure; lock the tongue depressor or blade in place with respect to the traction by locking a connector (which may be a pivot or other connector) between the two and / or simply, as an example, by stabilizing the blade portion hook on an object such as a table. This process can substantially stabilize the traction and blade in place with respect to the patient and the procedure. Not all of the above steps are necessarily performed in all methods, and the steps may be performed in no particular order. Any of the steps described above may be performed manually, while in some cases, parts of the steps may be performed automatically / robotically / hands-free. For example, locking the connector between the bladed section and the traction device may be performed by verbal or other non-mechanical prompts.

[0078]

[0106] After the platform has been positioned and stabilized, further steps may include adding or connecting additional tools to the platform (docking station) by additional connectors or through one or more working channels of a bladed device. Tools and / or other devices may be added and removed throughout the procedure. Tools may be robotic, manual, or a combination of both. Tools may include one or more of the following: tracheal intubation devices, tongue depressors, clamps, traction devices, lights, cameras, rigid and flexible endoscopes, lasers, forceps, injection needles, dilators, balloons, cauterizers, cutting devices, closure devices, or any other suitable tools.

[0079]

[0107] Figures 1–7B illustrate exemplary platforms and their arrangement and use, but the tongue depressor (e.g., blade) as herein is not limited to any particular blade portion. The rotatable blade as herein may be part of various other systems or devices, such as any robotically controlled system, as in other examples of parts herein. For example, Figures 8A, 8B, 9A, 10A, and 10B show alternative systems (platforms), which may include a traction device that is the same as or similar to the traction device 5902 from Figures 1–7B, and a blade portion that is an alternative to the blade portion shown in Figures 1–7B. For example, Figures 10A and 10B include a robotically controlled tracheal intubation system that includes a blade for compressing the tongue, which may also be a blade portion.

[0080]

[0108] The platform herein may also be optionally configured to provide improved visualization of anatomical structures using one or more visualization tools (e.g., one or more cameras). Visualization tools may be provided by a part of the platform, or by a device adapted for use with the platform (e.g., with a robotic system, such as any system of the system herein), which may optionally be releasably coupled to the platform for use. One or more visualization tools may provide more effective visualization than that provided by some existing mouse traction devices, which may be limited to direct visualization (the operator's view into the oral cavity). For example, the visualization system herein may provide what is referred to herein as indirect visualization, which is more effective visualization into the upper airway than that provided by direct visualization. Indirect visualization may allow “around the corner” views beyond the view that can be seen by direct visualization. Figures 8A and 8B show an alternative platform 5900, which includes a mouse traction device 5902 shown in Figures 1A–7B, and all disclosures of the alternative platform 5900 are incorporated herein by reference into the disclosures of Figures 8A and 8B. The bladed portion 5904 in Figures 8A and 8B may include any feature of the same feature of the bladed platform 5904 from Figures 1A–7B, and may also, optionally (but not limited to), an integrated visualization coupler 6302 which is a lumen for a visualization tool or device such as a visualization scope 6304 (e.g., an endoscope). The visualization coupler indirectly visualizes and magnifies a view of an anatomical structure of interest and / or uniquely enables the performance of necessary procedures in and around the patient's airway without applying undue force to the patient's tongue and / or jaw, thus minimizing patient complication and improving procedural / surgical access. The visualization coupler 6302 may be sized, configured, and positioned to interface with a visualization device to facilitate visualization of the anatomical structures of the throat and / or airway.In this example, the visualization coupler 6302 is a lumen for the scope and is incorporated into the tongue depressor or blade 5908, as shown. In this example, the coupler 6302 is positioned on the airway surface of the blade 5908, as shown (in contrast to the tongue surface). Any visualization coupler of this specification may be located on any other component of the tongue depressor and / or bladed portion. Visualization devices, such as scopes, may be used to assist in the placement of the platform and / or for visualization of anatomical structures and / or procedures after the platform has been placed in place. Visualization devices (e.g., endoscopes) may be coupled to the visualization coupler before or after the platform has been placed in place in the patient (e.g., introduced into the lumen). In an alternative example, the visualization coupler may be releasably coupled to the bladed portion. Furthermore, in an alternative example, the system may be adapted for use with two or more cameras, such as when the system includes two or more visualization couplers coupled to the bladed portion (e.g., to the blade) or releasably coupled.

[0081]

[0109] Figure 8A shows a fully open mouse traction device and a system (platform) 5900 having a bladed portion, which includes a visualization coupler (e.g., lumen) interfaced with a visualization device (e.g., endoscope) to facilitate visualization of the distal portion of the blade 5908, and a bladed portion rotatably coupled to the mouse traction device (and optionally constrained laterally relative to the mouse traction device). Figure 8B shows the system when placed in the oral cavity and after the upper and lower members have been pulled apart by the actuator, with the blade displaced to provide visualization as described elsewhere herein. Although not shown, hooks may interface with a table or other object to help stabilize the system.

[0082]

[0110] In Figures 8A and 8B, the system 5900 may also include one or more light elements that provide illumination for visualization by one or more visualization tools (e.g., a camera). The light elements may be permanently attached to the blade portion, or the blade portion may be configured for use with one or more light elements. For example, the illumination system may emit light for the visualization tool according to the blade configuration. The illumination elements may optionally extend along the blade, and optionally also extend along the body portion 5912. Optionally, the illumination system may be integrated with at least one of the blade or the blade portion 5912 to provide illumination for the procedure. Additionally or alternatively, the illumination system may be integrated with the traction portion 5902, for example, by coupling to at least one of the upper and lower members of the traction portion.

[0083]

[0111] In further or alternative examples, the system 5900 may include one or more visualization tools (e.g., cameras) incorporated within the traction frame itself, such as by being coupled to at least one of the upper and lower members.

[0084]

[0112] Figures 9A and 9B show an exemplary platform 5900 that can be adapted to be coupled to or attached (optionally, releasably coupled to or attached) to any tracheal intubation system of the tracheal intubation systems disclosed herein, such as any tracheal intubation system of the robotic controlled intubation systems described in WO2021 / 236677, WO2023 / 060241, WO / 2023 / 164434, and WO / 2023 / 201210, the robotic controlled intubation systems whose disclosure is incorporated herein by reference. Figure 9A shows an exemplary platform 5900 including a mouse traction device 5902 (including actuators and locks) and a portion 5904', the platform to be mounted to or coupled to an intubation system 900 which may be any robotic controlled intubation system of the robotic controlled intubation systems incorporated herein by reference. The intubation system 900 may be mounted to or coupled to the platform by a connector 6402. The connector 6402 may be a clamp, clip, magnet, slot, groove, diaphragm, or any other mounting device or connection method (optionally, releasable). The connector 6402 may be releasably or permanently attached to the platform and / or the intubation system 900. The platform 5900 may be connected to the handle, blade, introducer scope, and / or other components of the intubation system 900. In embodiments using the platform (or any other embodiments disclosed herein), the introduction of any of the following may be manual or automatic: introducing the blade, introducing the introducer scope, introducing the ETT. In this example, the intubation system 900 includes a handle 901 and a robotically controlled introducer 902, the exemplary details of which are described in any reference of the references incorporated herein by reference.

[0085]

[0113] The connection of the intubation device 900 to the platform 5900 may restrict the movement of the intubation device 900 relative to the platform 5900 in any axis of X, Y, Z, all axes, or regardless of the axis and / or in the rotational direction. In some embodiments, the movement of the intubation device 900 relative to the platform 5900 is restricted in all directions. In some embodiments, the movement of the intubation device 900 relative to the platform 5900 is restricted in the rotational direction. In some embodiments, the connector 6402 can first allow the movement of the intubation device 900 relative to the platform 5900 in one or more directions, and then be locked to restrict the movement of the device 900 relative to the platform 5900 in one or more directions, any example thereof described herein may be incorporated into this example.

[0086]

[0114] In the examples in Figures 9A and 9B, portion 5904' does not include a blade, as does some of the bladed portions herein. In this example, the intubation device includes a blade (tongue depressor) 903, and therefore the blade portion includes device 900, or device 900 includes the blade portion. In some embodiments, both a platform tongue depressor and a blade may be present in the intubation device.

[0087]

[0115] Device 900 may include any functionality of any of the functionalities of any of the references incorporated herein, such as robot-controlled components (manual and / or automated robot control), such as a robot-controlled introducer that can be advanced distally relative to the blade toward the trachea (and can be maneuvered in the x / y direction). Additionally or alternatively, the introducer 902 may include one or more lumens through which further tools or fluids (e.g., a gripper, a fluid for cleaning the camera, a therapeutic agent, etc.) may be delivered. Device 900 in this example may optionally include an endotracheal tube 951 which may include a distal end 904.

[0088]

[0116] Figures 10A, 10B, and 10C show alternative platform 5900 and robot system 900, where the intubation device 900 replaces the entire blade portion 5904 in some examples herein. Any or all of the feature components disclosed herein relating to any blade portion of the blade portion may be incorporated into the robot system 900. In this example, platform 5900 includes mouse traction unit 5902 and optionally the robot system 900 may be considered to include it similarly. A pivot connector 6502 allows the robot system 900 to rotate with respect to the traction unit 5902 similar to the device shown in Figures 1-7B (as indicated by the down arrow). The robot system 900 may optionally include a hook 6504 similar to the hook 5910 shown herein, which may be used to stabilize the device after placement. The hook 6504 may be placed anywhere on the robot system 900 or any other device. Alternatively or additionally, the pivot connector 6502 may be locked after the robot system 900 has rotated relative to the traction unit 5902 so that the robot system 900 no longer rotates relative to the traction unit 5902 (an example thereof is described herein). In some embodiments, the pivot connector 6502 may include a connector 6506 (a clamp or other connector) which may allow translational or longitudinal movement of the robot system 900 relative to the traction unit 5902, as indicated by the upward arrow.

[0089]

[0117] In this example, the robotic system 900 may be any robotic endotracheal tube introduction system described in WO2021 / 236677, WO2023 / 060241, WO / 2023 / 164434, and WO / 2023 / 201210, whose disclosure is incorporated herein by reference (e.g., any dual-camera system herein). Figure 10C shows the distal region of the robotic-controlled ETT introducer 902 after it has been advanced distally and into the trachea. As described in more detail in the incorporated references, the ETT 951 may then be advanced along the ETT introducer 902 and into the trachea, after which the introducer 902 may be removed from the patient, and the ETT 951 remains in the trachea after the completion of intubation. In an exemplary use, once the robotic system is coupled to the traction portion of platform 5900, the hook 6504 may be attached to an object (e.g., a table) that may stabilize the robotic system without the user necessarily having to hold system 900. In some cases, remote control may be further used to control the robotic movement of the introducer 902 within system 900. This is another example of how the platform and its features according to this specification may enable the use of medical tools and devices with only a few hands. Furthermore, in another exemplary use of robotic system 900, system 900 may include one or more working channels, in which case, once system 900 is stabilized in place (e.g., by the hook 6504), different hands may be used to advance one or more tools (e.g., grippers, electrical tools, etc.) through one or more working channels to perform any step in a procedure. Thus, referring to Figure 10C, in a modified version of system 900, reference object 902 may be any medical tool that is advanced through the working channels in the modified version of system 900.

[0090]

[0118] As stated above, the advanced stabilization / visualization platform of this specification may enable any procedure to be performed with fewer hands than would be necessary if the advanced stabilization / visualization platform were not used. For example, one physician may be able to perform more complex procedures. Once the advanced stabilization and visualization platform is in place, (e.g.) intubation may be performed hands-free with one hand or two hands. Subsequent procedures through the advanced stabilization and visualization platform may be performed hands-free with one hand, two hands, three hands, four hands, etc. Furthermore, for example, the platform of this specification may include an automated robotic control mode (e.g., based on image analysis and automated guidance) in which the system may automatically perform one or more steps.

[0091]

[0119] Figure 11 shows a top view of a purely exemplary embodiment of a platform adapted to support one or more tools. Connector 6902 may be connected to any embodiment of the intubation device embodiments disclosed herein, or to any other intubation or visualization device. Connector 6904 may be connected to any other tool desired during the procedure. One, two, three, four, five, or more connectors may be present. Connectors may be attached to or detached from the traction component 5902 before or during the procedure. Connectors may prevent or allow rotational / translational movement of the tool. Different types of connectors may be used on a single platform. Connectors may be locked to allow movement and then prevent movement in one or more directions. Connectors may allow the device and tool to be locked in any position.

[0092]

[0120] Figure 12 shows the platform 5900 of Figure 11, securing multiple tools 1202, 1203, and 1204 by each of the different connectors 6904. The tools 1202, 1203, and 1204 include, but are not limited to, any of those described herein, each of which may include any number of individual lumens or other components, and may be any suitable medical tool or device.

[0093]

[0121] As described herein, the use of some of the platforms of the highly stabilized and visualization platforms herein facilitates the self-centering of the platform within a mouse. It also enables visualization and / or access to various airway and anatomical structures within the patient mouse and throat, for example, the highly stabilized and visualization platform may enable access to and / or visualization of the hypopharynx, base of the tongue, epiglottis, vallecula, larynx, vocal cords, glottal opening, trachea, esophagus, arytenoid cartilage, and / or other anatomical structures.

[0094]

[0122] As described herein, the advanced oral / intraoral visualization and stabilization platform may be used in conjunction with a tracheal intubation system (optionally, a robot-assisted system), which in these exemplary uses may be separate from or integrated with the intubation system. Any intubation system disclosed herein may be used with or integrated with the advanced visualization and stabilization platform herein, for example, being coupled to or attached to the platform immediately before use.

[0095]

[0123] The following examples are examples of intubation systems described in WO2021 / 236677, WO2023 / 060241, WO / 2023 / 164434, and WO / 2023 / 201210, whose disclosures are incorporated herein by reference. The following exemplary intubation systems may be coupled with any platform of the platforms herein, with or without a blade portion. That is, the following intubation systems may include a blade, and therefore, when the intubation system is coupled to a mouse traction device, the intubation system is considered to be the blade portion (tongue depressor) of the platform.

[0096]

[0124] Figures 13A–13G show at least a portion of an exemplary intubation system 1700, and Figures 13A and 13B are unassembled drawings of an integrated, handheld dual-video endotracheal intubation assembly 1702, which, as otherwise provided herein, may simply be referred to as an assembly. Any component of any individual component of any assembly of any assembly of any assembly herein may be assembled together prior to the procedure, thereby producing the assembly. Figures 13C–13E show the assembled assembly 1702. Assembly 1702 includes a housing 1710 which includes a first imaging member coupler 1712, a second imaging member coupler 1714, and a cover coupler 1716. The housing 1702 is configured to be releasably coupled to a cover 1780, a first elongated imaging member 1730 (an example of which is shown in Figures 13F and 13G), and an optional disposable second elongated imaging member 1740. Assembly 1702' (which may include any suitable feature parts of assembly 1702, and vice versa) includes a first elongated imaging member 1730 having a first coupling region sized and configured to be releasably coupled to a first imaging member coupler 1712, as shown in Figures 13F and 13G. The first elongated imaging member 1730 includes an elongated flexible body 1732 and a first image sensor 1734 (e.g., a video camera) disposed in the distal region 1736 of the elongated body 1732.

[0097]

[0125] Assembly 1702 also includes a second elongated imaging member 1740, which includes a second coupling region 1742 sized and configured to be releasably coupled to a second imaging member coupler 1714 of the housing 1710 (including the main body 1711). The second elongated imaging member 1740 includes a flexible and navigable elongated endotracheal tube introducer 1770 ("introducer"), of which at least a portion is deflectable. The introducer 1770 is disposed within the endotracheal tube 1790 (including the proximal end 1791) and is sized to allow the endotracheal tube 1790 to be moved axially along the introducer 1770. The second imaging member 1740 includes a second image sensor 1773 (e.g., a video camera) disposed in the distal region 1772 of the introducer 1770. As will be 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.

[0098]

[0126] Assembly 1702 also includes a cover 1780 having a cover coupling region 1782 that is sized and configured to be releasably coupled to a cover coupler 1716 of the housing 1710. The cover includes an elongated channel defining an elongated lumen, which is sized and configured such that at least a portion of the elongated body 1732 of the first imaging member 1730 is positioned within the elongated lumen when the first coupling region of the first imaging member 1730 is releasably coupled to the first imaging member coupler 1712 and the cover coupling region 1782 is releasably coupled to the cover coupler 1716.

[0099]

[0127] The cover 1780 further includes an endotracheal tube channel 1784 disposed on the side of the cover 1780, as shown, which interfaces with the endotracheal tube 1790 and is sized to a specific size to restrict the movement of the endotracheal tube 1790 relative to the cover 1780 in at least one direction. The endotracheal tube channel 1784 is further configured to allow the endotracheal tube 1790 to move laterally relative to the endotracheal tube channel 1784. In this example, the channel 1784 includes a recess or trough formed on the side of the cover 1780, which is sized and configured to interface with a portion of the outer wall of the endotracheal tube 1790, and in some embodiments, the channel 1784 may have a cross-sectional configuration that includes a surface that forms a partial circle to interface with the circular outer surface of the endotracheal tube 1790.

[0100]

[0128] The endotracheal tube 1790 includes a lumen that is sized to movably receive the inlet 1770, as shown in Figure 13C.

[0101]

[0129] The assembly 1720 further includes one or more actuators disposed within the housing 1710, and when the second coupling region 1742 of a disposable second elongated imaging member 1740 is releasably coupled to the second imaging member coupler 1714 of the housing 1710, the actuators are configured and positioned to facilitate the controlled robotic movement of the introducer 1770 and the second image sensor 1772 (e.g., video camera) to the first image sensor 1734 (e.g., video camera).

[0102]

[0130] System 1700 may also include one or more processors, which may or may not be part of the assembly. One or more processors may be configured to receive as input information indicating signals received from the first image sensor (e.g., a video camera) when the first image sensor is deployed in the patient's upper airway, and to provide communications to actuators within the housing (e.g., housing 1710) for controlling the robotic movement of the introducer and the second image sensor 1772 (e.g., a video camera) toward the first image sensor and toward one or more upper airway anatomical landmarks. Further details regarding exemplary uses are described in more detail elsewhere in this specification.

[0103]

[0131] As described elsewhere in this Spec., an exemplary advantage of the assemblies herein is that, once assembled, the assemblies are sized and configured such that they can be held and moved as an assembly by one hand of an operator (or, if mounted on a platform herein, without using hands). Assembly 1720 is an example of an assembly sized and configured such that an assembly including a first image sensor and a second image sensor can be moved as a single unit by one hand of an operator when the first coupling region of the first imaging member 1730 is releasably coupled to the first imaging member coupler 1712, the second coupling region 1742 is coupled to the second imaging member coupler 1714, the cover coupling region 1782 is releasably coupled to the cover coupler 1716, and the endotracheal tube 1790 is releasably coupled to the endotracheal tube channel 1784.

[0104]

[0132] Figure 13C shows an assembly diagram of assembly 1702, with reference to a bottom view in which the first and second image sensors can be seen. The horizontal distance between the image sensors is measured in direction "H" labeled in Figure 13C.

[0105]

[0133] Figure 13D shows a side view of the assembled assembly 1702. The relative axial distance between the image sensors when the assembly is assembled as described herein is measured along axial direction "A" shown in Figure 13D. It is understood that axial direction "A" depends on the orientation of the assembled assembly. For example, if the assembly in Figure 13D is rotated 90 degrees counterclockwise, axial direction "A" will also rotate 90 degrees.

[0106]

[0134] As described herein, an exemplary advantage of some of the assemblies herein is that the assemblies are made to a specific size and configuration so that they can be held and moved with one hand by an operator. When assembled, the relative coupling between the housing, the cover, the first elongated imaging member, and the endotracheal tube maintains the first image sensor at a certain distance from the second image sensor before the actuator is operated, an example of which is shown in Figures 13C-13E. In some uses, it may be preferable that, when the assembly is assembled, the first and second image sensors are aligned axially or as close to axially aligned as possible. In some cases, the image sensors are aligned axially. In some cases, the image sensors are substantially aligned axially. In some cases, when the assembly is assembled, the first and second image sensors are maintained so that, when the assembly is assembled, they are within 3 cm of each other axially. In any of these cases, the horizontal distance H between the first and second image sensors may be as little as 2 m when the assembly is assembled. The maintained proximity of the image sensors when assembled may help provide a smaller overall profile or footprint of the assembly, which helps make it easier and safer for a single operator to hold the dual video intubation assembly with one hand.

[0107]

[0135] Figure 13E shows a top view of the assembled assembly 1702, in which the second imaging member 1740 is coupled to the housing 1710 as shown. The first and second image sensors are oriented downwards or inwards in this top view.

[0108]

[0136] Figures 13F and 13G show an assembly 1702' which may include any disclosure of the disclosure from assembly 1702. Figures 13F and 13G show a first imaging member 1730 which includes an elongated flexible body 1732 and a first image sensor (e.g., a video camera) disposed in the distal region 1736 of the flexible body 1732. In some embodiments, the first imaging member 1730 may be integrated with a cover and considered as part thereof, and the first imaging member and cover are releasably coupled to the housing 1710 as a partial assembly. In some examples, the first imaging member 1730 may be releasably coupled to the housing separately from the cover before use. In some examples, the housing (e.g., housing 1710) and the first imaging member (e.g., imaging member 1730) may be a single unit and do not need to be coupled by the operator before the medical procedure. In cases where different sized first imaging members are required for subsequent procedures (e.g., between different patients or between pediatric and adult patients), it may be advantageous to be able to remove the first imaging member from the housing and reuse the housing, the advantages of which are described elsewhere in this specification. Therefore, it is understood that any assembly of the assemblies described herein may include an integrated housing and first imaging member, and a cover and first imaging member integrated and coupled to the housing as a unit, or a cover and first imaging member separately and releasably coupled to the housing. Any component in system 1702' that is not labeled or described is understood to be the same as the corresponding component or sub-assembly in assembly 1702.

[0109]

[0137] The following examples provide further merely exemplary intubation systems that may be coupled to and used with any platform of the Platforms of this Specification. In some embodiments of intubation, one or more user interface devices or control members (i.e., joysticks, wheels, sliders, buttons, voice-activated controllers, or other similarly operable members) that are controlled (including physically or non-contactly, such as voice-activated controllers (e.g., microphones)) and operated by the user to control the articular movement and / or forward / backward movement of the introducer (scope) may be part of a reusable controller that is either completely or partially disposable or non-reusable. Simply as an example, the control members may be incorporated into a disposable blade of the intubation system. One or more control members may be incorporated into the blade extension (rigid or flexible) (for example, the blade and extension may be integrated and optionally unitary (unitary meaning formed from the same material so as to be integrated together rather than two joined parts)), thereby 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 the “introducer assembly”), where the reusable housing is at least partially disposed within the disposable blade. The blade extension is sized and configured as a whole to be handheld, which is described in more detail elsewhere herein. The introducer assembly of the system is reusable and may include one or more introducer actuators, such as motors and / or other controls, to produce and control the robotic joint movement and / or forward / backward movement of the introducer (which are considered part of the introducer assembly even if the introducer can be separated from the reusable housing). Exemplary introducer actuators (e.g., motors) are described elsewhere herein.

[0110]

[0138] The disposable blade (tongue depressor) described herein may include a portion comprising one or more control members (such as a joystick) that control a motor and / or other introducer actuator within a reusable housing or body via a control member interface having one or more control member interface elements that are part of the reusable housing or body. The control member interface is disposable, may be sterile on the outside to which the user comes into contact, and may operably communicate with the control member interface elements within the inner reusable housing. The user control members may be sealed from the inner housing by a sterile barrier. Thus, the control member interface elements remain sterile (uncontaminated) during use, and the reusable housing, which may include the motor and / or other introducer controller, can be reused without the need for sterilization. In this context, it is understood that the reusable housing may include or be similar to any housing of the “housing” described herein (e.g., housing 1710) and any member of the “second imaging member” described herein, such as the second elongated imaging member 1740. Therefore, it is understood that a reusable introducer assembly in this context may include an introducer detachable from a reusable housing (such as introducer 1770, which is part of a second imaging member 1740), the examples of which are described in more detail herein. For example, Figure 17 shows a portion of a second imaging member, such as housing 1744 (an introducer shaft not shown for clarity), which is releasably coupled to the reusable housing shown in Figure 16. Therefore, it is understood that Figures 16 and 17 may be considered together to represent an “introducer assembly” as described herein, even when the detachable introducer is not fixed to a housing containing one or more actuators (e.g., motors) inside. It is also understood that Figure 16 shows an exemplary “reusable housing” which optionally includes one or more control member interface elements and at least one EET introducer actuator (e.g., a motor).

[0111]

[0139] Figure 14 shows an exemplary embodiment of a disposable controller, which in this example includes a disposable blade and an extension area or extension, the extension area or extension incorporating at least one control member, in this example a magnet, which is detected by a Hall sensor located within a reusable introducer assembly. In any embodiment of the embodiments herein, the blade and extension may be integrated as shown, optionally formed in a single unit, or formed from the same material (not two components joined together). The disposable controller shown in Figure 14 includes a disposable blade 4102 including a distal region (which may have a curved configuration as shown) sized and configured to be positioned within a subject mouse, a blade extension 4104 extending outward from the distal region, and the disposable controller further includes a control member 4106, in this example a magnet, the movement of the control member 4106 (when activated by the user) adapted to be detected by a Hall sensor located within a reusable introducer assembly or reusable housing. The Hall sensor (or other type of sensor) also operably communicates with one or more introducer actuators (e.g., motors), which then facilitate robotic control of the introducer in response to user operation of a disposable control member. In this example, the control member 4106 includes a Hall sensor magnet integrated into the extension 4104 and incorporated within a flexible and movable member, the flexible and movable member may include a flexible material such as silicone (or other suitable material), the flexible material allowing the user to move the magnet by moving the flexible material. The movement of the magnet is detected by a Hall sensor located in close proximity to and beneath the magnet within the introducer assembly housing. While this example includes a Hall sensor, the sensor / mechanism (between the disposable control member and the reusable control member interface element) may be any type of suitable sensor adapted to detect motion, proximity, positioning, velocity, acceleration, current, etc.

[0112]

[0140] In any example of the examples herein relating to an intubation controller, the extension or body may be sized and configured to be held in the operator's hand, and the controller may be arranged to be manually controllable by one or more fingers while the extension is grasped or held by the hand.

[0113]

[0141] The blade 4102 also includes an internal cavity 4107, which is sized and configured to receive at least a portion of the introducer assembly, such as the distal region of the housing 4302 shown in Figure 16. In this example, the cavity 4107 is generally elongated and extends along at least a portion of the length of the extension 4104.

[0114]

[0142] Figure 15 shows another example of a disposable controller adapted for use with a robotically controllable medical device, which in this example includes a disposable blade 4102, similar to the blade in Figure 14. Any relevant disclosures from Figure 14 are incorporated by reference into the disclosures of Figure 15. The blade 4102 includes a curved distal region adapted for placement within a mouse, and an extension 4104 extending outward from the curved distal region. The extension 4104 comprises a control member 4202, which in this example includes a movable joystick, as shown. The joystick is incorporated into or integrated with the control member 4202, which is adapted to allow a user to move the joystick. The control member 4202 may further include a soft material such as silicone. The joystick may be embedded within a sterile barrier or completely beneath a soft sterile barrier, further details of which are described herein. The blade 4102 in Figure 15 also includes a cavity 4107 inside, which is sized and configured to receive at least a portion of the introducer assembly housing or body, such as the distal region of the housing 4302, as shown in Figure 16.

[0115]

[0143] Figure 16 shows at least a portion of a reusable housing (or body) of an exemplary introducer assembly adapted to interface with a disposable controller, such as a disposable blade, as described herein. The reusable housing 4302 of the introducer assembly includes at least one control member interface element 4304 (shown overall), which is positioned and adapted within / on the housing 4302 to be disposed within the cavity 4107 of a disposable blade, and when at least a portion of the housing is disposed within the cavity 4107, it operably communicates with and is positioned relative to the at least one control member in the blade to respond to manual movement of the at least one control member. The housing 4302 may include one or more actuators, such as motors and / or other controllers, to produce and control the robotic motion of the introducer, further details of which are described herein. The housing or body 4302 further comprises a control member interface element 4304 which includes one or more mechanisms adapted to interface with and respond to a control member of the blade, which may include, as an example, a magnet or a joystick, as shown in Figures 14 and 15. As an example, the control member interface element 4304 may include a Hall sensor that responds to the movement of a magnet in the disposable blade. In the case of a blade joystick, the control member interface element 4304 may include multiple metal contact areas, such as copper segments, which can electrically communicate with the housing component to initiate motor startup. The control member interface element 4304 is also adapted to communicate with a motor and / or other actuator in the reusable housing to facilitate the robotic movement of the introducer (or other controllable medical device). Thus, the control member on the disposable blade (or other disposable controller) controls the actuator (e.g., a motor) in the reusable housing.

[0116]

[0144] Figure 17 shows the disposable blade of Figure 15 in place on the reusable housing of Figure 16. In other words, the distal region of the housing 4302 of the introducer assembly from Figure 16 is located within the cavity 4107 of the blade 4102 in Figure 15. All disclosures from Figures 14, 15, and 16 are incorporated by reference into the disclosure of Figure 17. In this position, the joystick 4202 is operably (in this case, electrically) communicating with the control member interface element 4304 (invisible) of the housing 4302 and, indirectly and ultimately, with the motor and / or other controller mechanism adapted to bring about robotic control of the introducer / scope. The blade of Figure 14 (or any other disposable blade of this specification) may also be used and positioned as shown in Figure 17. In that example, the operable communication between the control member interface element and the control member on the blade is not electrical communication but Hall sensor or magnetic communication. However, as described herein, other types of sensors may be used to generate operable communication between the disposable controller and the reusable housing or body. Figure 17 also shows an introducer housing 1744 (described in more detail herein) securely coupled to housing 4302. Although not shown, an introducer may also be coupled to housing 1744. Coupling housing 1744 (and introducer) to housing 4302 generates operable and controllable communication between one or more actuators (e.g., motors) within 4302 and the introducer, enabling robotic and controllable motion of the introducer when the user activates the control member for the disposable blade.

[0117]

[0145] Figures 18, 19, and 20 illustrate just illustrative interface details between a disposable control member including a magnet and a reusable control member interface element including a Hall sensor. This may be referred to herein as a Hall sensor-magnet interface. Figure 18 shows only a portion of a disposable controller (e.g., a blade) shown in Figure 14, which in this example includes a control member including a flexible member 4506 with a protrusion 4502 formed inside. The flexible member 4506 may include a flexible material such as silicone (or other flexible, sterilizable material). The protrusion 4502 or other means allows the user to move the contact portion 4504 in any direction. The magnet 4702 is embedded in or coupled to the flexible member 4506 or is located beneath the centerpiece 4504, and the user's movement of the magnet is detected by a Hall sensor on the reusable introducer assembly housing, which then controls actuators that control the robotic movement of the introducer. The contact portion 4504 may move laterally in any direction (in the x and / or y directions) and optionally in the z direction. For example, the x and y directions may control the joint movement of the probe, while the z direction may control distal advancement / proximal retraction of the probe.

[0118]

[0146] Figure 19 shows a side view of the control component (of the disposable controller) shown in the perspective view of Figure 18.

[0119]

[0147] Figure 20 shows a cross-sectional view of the Hall sensor magnet interface after the introducer assembly housing has been positioned within the cavity of the disposable blade. The interface includes a flexible member 4706 (having a raised portion 4502), a contact portion 4504, and a magnet 4702. The magnet is moved by the user to facilitate robotic control of the introducer. As the magnet moves, its motion / position is detected by a Hall sensor in the housing 4704, and its output controls one or more introducer actuators (e.g., motors). The flexible member 4706 interfaces with the blade extension portion 4708 to form a sterile barrier. The control member interface 4710 is an interface (which may be a contact or non-contact interface) between the disposable blade portion control member and the reusable handle portion control member interface element.

[0120]

[0148] Figures 21, 22, and 23 show details of exemplary control members and interfaces, including the joystick 4202. Any relevant disclosures from any other examples herein may be incorporated by reference into the disclosures of Figures 21–23.

[0121]

[0149] Figure 21 shows a purely illustrative control member including a joystick 4802 with 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 pogo pins, are located beneath the joystick 4802, and the user's movement of the joystick is communicated to one or more metal components on the reusable housing, which then communicate with and control actuators that control the robotic movement of the inducer (or other controllable medical device). The joystick may be moved laterally in any direction (in the x and / or y directions) and optionally in the z direction. For example, the x and y directions may control the articulation joint movement of the inducer scope, while the z direction may control the advancement / reverse movement of the inducer scope.

[0122]

[0150] Figure 22 shows a side view of the control component (including the joystick) shown in the perspective view of Figure 21.

[0123]

[0151] Figure 23 shows a cross-sectional view of the interface including the joystick shown in Figures 21 and 22. Figure 23 shows the joystick 4802 and the electrical connector 5002. The electrical connector contacts one or more metal (such as copper) components within the reusable housing 5004. The joystick is actuated (in this case, moved) by the user to robotically control the movement of the introducer scope. As the joystick moves, electrical signals are transmitted through the metal components to the reusable introducer assembly housing. These signals are communicated (directly or indirectly) to motors and / or other actuators within the reusable housing to bring about and control the movement of the introducer in one or more (e.g., x, y, and / or z) directions. The joystick enclosure 4806 interfaces with the blade extension area 4708 to form a sterile barrier. The control member interface 5006 is the interface between the disposable part (in this case, the disposable blade) and the reusable part. In some embodiments, the joystick may be entirely under a soft sterile barrier.

[0124]

[0152] In any embodiment of the embodiments described herein, at least one control member may be adapted to have at least first and second control modes and may optionally be used to switch between x / y motion control and a second mode adapted only for z motion control (forward / backward). Simply as an example, a joystick may have an upper button which may be adapted to be pressed down once and remain pressed down (in a down state) when in an "up" state, or pressed back to an up state when in a down / pressed state. Depending on the state of the button (or other actuator), the motion of the control member (e.g., joystick) will result in either x / y motion or z motion. Simply as an example, the button may result in x / y motion when in a first (e.g., up) state and z motion when in a second (e.g., down) state (or vice versa). The joystick is used merely as an example, and other control members may be adapted to have different states that result in different types of motion.

[0125]

[0153] In some embodiments, one or more control members of a disposable controller are incorporated into or integrated with a rigid disposable blade. In some embodiments, the sterile barrier comprises both a rigid portion, e.g., an integrated blade and blade extension (optionally, at least partially unified (same component)) and a flexible portion, e.g., an area of ​​flexible material (e.g., silicone or other flexible material) surrounding the control members in close proximity. In some embodiments, the control member interface is located on the handheld system and not separated from the system. In some embodiments, the sterile barrier is primarily rigid so that the user can directly manipulate the control members on the sterile barrier to control the introducer scope, with minimal or no movement of the control member area relative to the handle. In some embodiments, the blade, including the blade extension incorporating the control members, is fitted to snap into the introducer assembly housing (mechanical integration). This connection / coupling may be rigid with no significant play or movement between the two components. The user may control the system by placing their hand directly on the system, or in some cases, within a sterile field. In other words, the control members that control the joint movement / advancement / retraction of the induction scope are located on a device firmly connected to the induction scope. This may also allow the system to be operated with one hand, which will be described in more detail herein.

[0126]

[0154] In these alternative examples, the reusable portion (e.g., any assembly of the reusable introducer assembly herein) may optionally include a screen or display, and the disposable controller (e.g., any disposable blade of the disposable blade having the controller herein) may optionally be sized and configured to cover at least a portion of the screen. The interface facilitates the user operating the disposable controller (rather than directly on the screen), so that the screen does not need to be cleaned between patient / user. In these alternative examples, the interface may be configured to have capacitive or resistive touch capabilities.

[0127]

[0155] While some examples herein describe and illustrate disposable control members that are part of a laryngoscope blade (in other words, a disposable blade including at least one control member), similar or other disposable controllers may be incorporated into and used with other devices / systems, such as, for example, colonoscopes, bronchoscopes, esophagoscopes, articulating laparoscopes, other endoscopes, articulating surgical tools, feeding tube systems, articulating catheters, laparoscopic devices, bone surgery devices, any handheld devices, any controllable devices, and other devices that may be used in such procedures. Existing systems and devices may need to be modified to be controllable by disposable controllers. Systems and devices may be rigid or flexible, or partially rigid and partially flexible. As merely an example, any device / method of use includes articulating cameras (e.g., colonoscopes, esophagoscopes, ureteroscopes, endoscopes or similar scopes, hysteroscopies, etc.).

[0128]

[0156] The concept of disposable controllers as described herein may, optionally, be used in the field of single-port laparoscopy, which is typically performed by large robots (e.g., the da Vinci system) or small hand tools, which may be uncomfortable for the user. The concept of disposable controllers as described herein may be incorporated into and used with a handheld robot or a set of handheld robotic tools such as grippers, scissors, etc. Many robotic tools exist that can benefit from being partially disposable and partially reusable.

[0129]

[0157] The examples shown in Figures 13A–23 are understood to be exemplary robotic devices and exemplary intubation systems that may be coupled to or mounted on any platform of the platform described herein. It is also understood that any concept, feature, method step, method of use, or embodiment of any example herein may be combined with any other appropriately combinable concept, feature, method step, method of use, or embodiment from any example herein.

[0130]

[0158] Figure 24 shows and identifies exemplary anatomical structures, some of which are revealed by one or more aspects of the disclosure herein.

Claims

1. A system for creating a functional surgical space inside the oral cavity, Upper member, sized and configured to engage with the upper part of the oral cavity. Includes a lower member that is sized and configured to engage with the lower portion of the oral cavity, Mouse traction device, Actuators that are operable and communicate with the upper and lower members, adapted to controllably adjust the distance between the upper and lower members in order to facilitate the application of force by the upper member to the maxilla and force by the lower member to the mandible when the upper and lower members engage with the upper and lower portions of the oral cavity, thereby resulting in controlled and gradual relative movement between the maxilla and the mandible. A lock, which is fitted and positioned to maintain a desired spacing between the upper member and the lower member, The mouse traction device is rotatably coupled to the mouse traction device and comprises a blade portion that is laterally constrained relative to the mouse traction device, wherein the blade portion includes a blade that is sized to apply force to the tongue and displace the tongue when the blade portion rotates relative to the mouse traction device and when the upper and lower members apply force to the upper and lower jaws, The blade portion is rotatably coupled to the mouse traction device, and the system facilitates the creation of further controlled oral and hypopharyngeal spaces by applying force to the tongue and displacing the tongue in relation to the space created inside the oral cavity by the application of force to the upper and lower jaws by the mouse traction device.

2. The system according to claim 1, wherein the actuator includes a scissor-type mechanism for controllably adjusting the distance between the upper member and the lower member in order to facilitate the application of force to the upper jaw and the lower jaw, respectively, by the upper and lower members.

3. The system according to claim 1, wherein the actuator, the upper member, and the lower member are configured and arranged such that the force on the lower jaw is equal to or substantially equal to the force on the upper jaw.

4. The system according to claim 1, wherein the blade portion is rotatably coupled to the lower member of the mouse traction device and is restrained laterally with respect to the lower member.

5. The system according to claim 1, wherein the blade portion comprises a main body portion extending from the lower member in a first direction and the blade extending from the lower member in a second direction.

6. The system according to claim 5, wherein the angle between the main body portion and the blade is less than 180 degrees.

7. The system according to claim 6, wherein the angle between the main body portion and the blade is less than 135 degrees.

8. The system according to claim 1, wherein the blade portion comprises a connecting member extending laterally with respect to the main body portion of the blade portion, and the connecting member is coupled to the lower member such that the connecting member is rotatable around the lower member in order to facilitate rotational coupling between the blade portion and the lower member.

9. The system according to claim 8, wherein the connecting member includes first and second connecting members that extend in different lateral directions relative to the main body portion, and each of the first and second connecting members is coupled to the lower member such that the first and second connecting members are rotatable around the lower member in order to facilitate the rotational coupling between the blade portion and the lower member.

10. The system according to claim 1, further comprising one or more lateral restraint elements for facilitating lateral restraint between the blade portion and the mouse traction device.

11. The system according to claim 10, wherein one or both of the blade portion or the mouse traction device comprises one or more of the one or more lateral restraint elements.

12. The system according to claim 11, wherein the lower member comprises one or more recessed areas or grooves that interface with the blade portion in order to resist the relative lateral movement of the blade portion.

13. The system according to claim 12, wherein the one or more recessed areas are lateral to the center line of the blade portion.

14. The system according to claim 12, wherein the one or more recessed areas are located laterally to the blade of the blade portion.

15. The system according to claim 12, wherein the blade portion comprises one or more couplers configured to be sized to interface with one or more recessed areas or grooves of the lower member.

16. The system according to claim 1, wherein the blade portion includes an elongated main body, and the blade extends from the elongated main body portion at a non-zero-degree angle and less than 180 degrees.

17. The system according to claim 1, wherein the blade portion is provided with a hook at or near the first end of the elongated main body in order to facilitate increasing the stability of the blade portion.

18. The system according to claim 17, wherein the hook extends from the main body on the same side as the blade.

19. The system according to claim 1, wherein the blade portion comprises a handle extending from the main body, and the handle extends from the main body on the side facing the blade.

20. The system according to claim 19, wherein the handle extends from the main body on the side opposite to the hook.

21. The system according to claim 1, further comprising at least one visualization device coupler fixed to the blade.

22. The visualization device coupler comprises a lumen fixed to the blade, the lumen being sized to receive a visualization device, optionally an endoscope, through the lumen, according to claim 21.

23. The system according to claim 1, which provides an indirect view of an anatomical structure on a display for surgical procedures, further comprising at least one of a visualization tool coupler or a visualization tool connected to the blade to facilitate distal advancement of the visualization tool relative to the blade and positioning of the visualization tool in a certain location, in order to provide an indirect view beyond the anatomical structure that can be seen by a direct view of the oral cavity.

24. The system according to claim 23, wherein the visualization tool is positioned to facilitate positioning of the visualization tool at the location in order to provide indirect observation of the hypopharynx and glottis using image data from the visualization tool displayed on a display.

25. The system according to claim 1, further comprising a robotic system, wherein the blade portion constitutes the robotic system, and the blade is disposed within the distal region of the robotic system.

26. The system according to claim 25, further comprising a main body portion separated from the robot system, wherein the main body portion includes a hook at or near a first end of the main body portion.

27. The robot system according to claim 25, wherein the robot system includes a hook at or near the first end to facilitate increasing the stability of the robot system.

28. A method for creating and maintaining a functional surgical space within the oral cavity for medical and surgical procedures, The mouse traction device is positioned inside the oral cavity such that the upper member extends laterally and engages with the upper part of the oral cavity, and the lower member extends laterally and engages with the lower part of the oral cavity. The lower member gradually applies force to the lower jaw, the upper member gradually applies force to the upper jaw, and the actuator is activated to gradually increase the distance between the upper and lower jaws in a controllable manner in order to generate oral space, thereby gradually increasing the distance between the upper and lower jaws. Maintaining the aforementioned increased distance, Rotating a blade rotatably coupled to the lower member in order to displace at least a portion of the tongue, Displacing at least a portion of the tongue with the blade increases the oral cavity space generated by gradually increasing the distance between the maxilla and the mandible, and displacing at least a portion of the tongue further exposes one or more hypopharyngeal structures, rotates, A method comprising limiting the rotational capability of the blade to the mouse traction device for a certain period of time following the rotation of the blade.

29. The method according to claim 28, wherein one or more hypopharyngeal structures are provided with a glottal opening.

30. The method according to claim 28, wherein activating the actuator includes activating a scissor-type mechanism.

31. The method according to claim 28, wherein the force applied to the mandible is equal to or substantially equal to the force applied to the maxilla.

32. The method according to claim 28, wherein increasing the distance between the upper jaw and the lower jaw occurs before the time for rotating the blade.

33. The method according to claim 28, wherein rotating the blade, which is rotatably coupled to the lower member, in order to displace at least a portion of the tongue, exposes at least the hypopharyngeal and glottal structures.

34. The method according to claim 28, further comprising performing an interventional or surgical procedure through the oral cavity.

35. The method according to claim 34, wherein performing the interventional or surgical procedure optionally includes using one or more clamping devices to secure one or more procedural tools to at least one of the upper member, the lower member, or the blade.

36. The method of claim 28, wherein limiting the rotational capability of the blade with respect to the mouse traction device includes engaging the hook with a stabilizing device, optionally, a nearby table.

37. The method according to claim 28, wherein limiting the rotational capability of the blade with respect to the mouse traction device includes engaging a lock to prevent rotation between the lower member and the blade.

38. The method according to claim 28, further comprising advancing the visualization tool into the oral cavity relative to the blade.

39. The method according to claim 38, wherein advancing the visualization tool includes advancing the visualization tool relative to a visualization tool coupler, the visualization tool coupler restricts the movement of the visualization tool in at least one non-axial direction.

40. The method according to claim 39, wherein advancing the visualization tool relative to the visualization tool coupler includes advancing the scope through the lumen.

41. The method of claim 38, further comprising advancing the visualization tool distally to a certain location in order to provide an indirect and magnified view of an anatomical structure on a display for a surgical procedure, which goes beyond the anatomical structure that can be seen by a direct view of the oral cavity.

42. The method according to claim 41, wherein advancing the visualization tool distally includes advancing the visualization tool to a certain location to provide an indirect and magnified view of the hypopharynx and glottis on the display.

43. The method according to claim 28, further comprising directly or indirectly coupling the robotic system to the mouse traction device, wherein the blade is located inside the distal region of the robotic system.

44. The method according to claim 43, further comprising robotically advancing the introducer of the robotic system distally into the inside of the trachea.

45. The method according to claim 43, wherein coupling the robot system to the mouse traction device includes coupling the robot system to the lower member.

46. The method according to claim 28, further comprising directly or indirectly connecting the intubation system to the lower member, wherein the blade is located inside the distal region of the intubation system.

47. The method according to claim 46, further comprising advancing the introducer of the intubation system distally into the trachea.

48. A system for creating a functional surgical space inside the oral cavity, It is a mouse traction device, Upper member, sized and configured to engage with the upper part of the oral cavity. A mouse traction device including a lower member sized and configured to engage with the lower portion of the oral cavity, Actuators that are operable and communicate with the upper and lower members, adapted to controllably adjust the distance between the upper and lower members in order to facilitate the application of force by the upper member to the maxilla and force by the lower member to the mandible when the upper and lower members engage with the upper and lower portions of the oral cavity, thereby resulting in controlled and gradual relative movement between the maxilla and the mandible. A lock, which is fitted and positioned to maintain a desired spacing between the upper member and the lower member, A blade portion rotatably coupled to the mouse traction device and restrained laterally with respect to the mouse traction device, the blade portion including a blade sized to apply force to the tongue and displace the tongue when the blade portion rotates with respect to the mouse traction device and when the upper and lower members apply force to the upper and lower jaws, A system for providing an indirect view of anatomical structures on a display for surgical procedures, comprising a visualization tool coupler or at least one of a visualization tool connected to the blade, to provide an indirect view beyond the anatomical structures that can be seen by a direct view of the oral cavity, and to optionally facilitate distal advancement of the visualization tool relative to the blade and positioning of the visualization rule in a certain location.

49. The system according to claim 48, wherein the visualization tool is positioned to facilitate positioning of the visualization tool at the location in order to provide indirect observation of the hypopharynx and glottis using image data from the visualization tool displayed on a display.

50. A method for creating and maintaining a functional surgical space within the oral cavity for medical and surgical procedures, The mouse traction device is positioned inside the oral cavity such that the upper member extends laterally and engages with the upper part of the oral cavity, and the lower member extends laterally and engages with the lower part of the oral cavity. The lower member gradually applies force to the lower jaw, the upper member gradually applies force to the upper jaw, and the actuator is activated to controllably and gradually increase the distance between the upper member and the lower member, thereby gradually increasing the distance between the upper jaw and the lower jaw. Maintaining the increased distance between the upper jaw and the lower jaw, Rotating a blade rotatably coupled to the lower member in order to engage with at least a portion of the tongue and displace the portion thereof, Displacing at least a portion of the tongue with the blade allows for a controllable increase in the oral space relative to the space generated within the oral cavity as the distance between the maxilla and the mandible increases, and displacing at least a portion of the tongue increases the direct view of the oral cavity, as well as rotation. The rotational capability of the blade is limited to the mouse traction device for a certain period of time following the rotation of the blade, An indirect view of anatomical structures on a display for surgical procedures, providing an indirect view beyond the anatomical structures that can be seen by a direct view of the oral cavity, by positioning a visualization rule at a certain location relative to the blade, A method comprising emitting light toward the anatomical structure in order to enable visualization of the anatomical structure by the aforementioned visualization rules.

51. The method according to claim 50, wherein advancing the visualization tool distally includes advancing the visualization tool to a certain location to provide an indirect view of the hypopharynx and glottis on the display.

52. A method for creating and maintaining a functional surgical space within the oral cavity for medical and surgical procedures, The device applies opposing forces to the upper and lower jaws, thereby increasing the distance between the upper and lower jaws and creating a first space within the oral cavity. The lock maintains the increased distance, A method comprising applying force to the tongue with a blade, thereby displacing the tongue, creating a further space within the oral cavity relative to the first space, and exposing one or more hypopharyngeal structures.

53. A method for creating and maintaining a functional surgical space within the oral cavity for medical and surgical procedures, The device applies opposing forces to the upper and lower jaws, thereby increasing the distance between the upper and lower jaws and creating a first space within the oral cavity. The lock maintains the increased distance, A method comprising applying force to the tongue with a blade, thereby displacing the tongue and increasing the amount of upper airway anatomical structure that can be directly visualized compared to the first space.

54. An oral docking station adapted to provide a functional surgical space inside the upper airway for one or more medical procedures, It is a mouse traction device, Upper member, sized and configured to engage with the upper part of the oral cavity. A mouse traction device including a lower member sized and configured to engage with the lower portion of the oral cavity, Actuators that are operable and communicate with the upper and lower members, adapted to controllably adjust the distance between the upper and lower members in order to facilitate the application of force by the upper member to the maxilla and force by the lower member to the mandible when the upper and lower members engage with the upper and lower portions of the oral cavity, thereby resulting in controlled and gradual relative movement between the maxilla and the mandible. A lock, which is fitted and positioned to maintain a desired spacing between the upper member and the lower member, The mouse traction device is rotatably coupled to the mouse traction device and comprises a blade portion that is laterally constrained relative to the mouse traction device, wherein the blade portion includes a blade that is sized to apply force to the tongue and displace the tongue when the blade portion rotates relative to the mouse traction device and when the upper and lower members apply force to the upper and lower jaws, Oral docking station, wherein the blade portion is rotatably coupled to the mouse traction device, facilitating the creation of a further controlled oral space by applying force to the tongue to displace the tongue, in addition to the space created inside the oral cavity by the application of force to the upper and lower jaws by the mouse traction device.

55. The oral docking station according to claim 54, further comprising one or more medical device couplers adapted to be releasably coupled to a medical device.

56. The oral docking station according to claim 55, configured to be releasably coupled to a robotic device adapted for robot-assisted applications, and optionally releasably coupled to the docking station, the robotic device may be used for one or more medical procedures without requiring a hand to hold the robotic device.

57. The oral docking station according to claim 55, wherein the one or more medical device couplers are optionally adapted to stabilize the robotic device so as to be releasably coupled to the robotic device, and to provide hands-free use of the robotic device (i.e., no hands are required to stabilize the device).

58. The oral docking station according to claim 55, wherein one or more medical device couplers are adapted to be releasably coupled to an endoscope, optionally an elongated tool.

59. The oral docking station according to claim 55, wherein the one or more medical device couplers are adapted to be releasably coupled to a surgical tool.

60. The oral docking station according to claim 55, wherein the one or more medical device couplers are adapted to be releasably coupled to an interventional tool.

61. The oral docking station according to claim 55, wherein one or more medical device couplers are adapted to be releasably coupled to a visualization tool.

62. The oral docking station according to claim 55, wherein one or more medical device couplers are adapted to be releasably coupled to a light-emitting tool.

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