Devices and methods for intubation

Abstract

Described herein are devices for guiding intubation procedures and methods for intubating a patient using the same. The methods and devices described herein provide systems that may be quickly and safely deployed for safe and rapid targeting and delivery of an intubation tube. For example, any of these systems may include an endotube introducer having an elongated body, a bending region, a camera at a distal end region, and a bending control device configured to vary the bending of the bending region. The endotube introducer may pre-load an intubation tube into a channel or lumen of an insertion endoscope. Also described herein are methods for using these devices to quickly and safely position and secure an endotracheal tube within a patient's trachea.

Description

[Technical Field]

[0001] Priority claims

[0001] This patent application claims priority to U.S. Provisional Patent Application No. 63 / 421,063, entitled "Devices and Methods for Intubation," filed October 31, 2022, the entire contents of which are incorporated by reference. Incorporation by Reference

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety, to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. Technical Field

[0003] The methods and devices described herein may relate to an oral endoscopy system for guiding an intubation procedure and a method of intubating a patient using an oral endoscopy system. More specifically, the methods and devices described herein may relate to an apparatus that may use a system that may be quickly and safely deployed to form a stable platform for intubation targeting and delivery. [Background technology]

[0002]

[0004] Endotracheal intubation is a common emergency procedure to provide an alternative airway for patients whose airways may be compromised or obstructed. This procedure may be performed in an operating room setting, outside of the operating room, during the course of care in an emergency room, and even in the field. Despite the fact that these procedures are performed with some frequency, endotracheal intubation remains a high-risk procedure, associated with significant incidences of respiratory complications, hemodynamic instability, and cardiac arrest. Therefore, new techniques that improve the safety and success of endotracheal intubation have a significant impact on public health and safety.

[0003]

[0005] Described herein are methods and devices (eg, systems) for performing endotracheal intubation that may improve the speed and safety of these procedures. Summary of the Invention Means to solve the problem

[0004]

[0006] The methods and apparatus (e.g., systems and devices including software, hardware, and firmware) of the present disclosure each have several innovative aspects, no one of which is solely responsible for the desirable attributes disclosed herein. Generally, these apparatus may be used to perform endotracheal intubation in a significantly faster and safer manner, in most cases, e.g., in less than 60 seconds, to prevent damage to the patient's mouth and teeth.

[0005]

[0007] One innovative aspect of the subject matter described in this disclosure can be embodied as an apparatus for intubating a patient, which may include an endotracheal introducer. Generally, the endotube introducer may be preloaded with an endotracheal tube that can be deployed distally from the endotube introducer once it is in position. The endotube introducer may include an elongate body having a bend or curve region along its length, and the bend / curvature in this region may be controllably increased, manually, automatically, or semi-automatically, to position the distal end of the endotube introducer against the epiglottis so that the preloaded endotracheal tube can extend distally into the trachea and be secured therein. Individual components or features of these systems may themselves be patentable and may include many useful improvements and advancements in the art.

[0006]

[0008] For example, the apparatus (e.g., systems and devices) described herein include an endotube introducer configured to be inserted into the tracheal region of the body through the oral cavity, the endotube introducer comprising an elongate body having a lumen extending therethrough and a bending region on the elongate body, a camera at a distal end region, and a bending control device at a proximal end region configured to change the bending of the bending region, a display configured to receive and display output from the camera, and an intubation tube pre-loaded within the lumen of an insertion endoscope, the intubation tube having an expandable anchor at a proximal end region and configured to advance distally from the endotube introducer.

[0007]

[0009] In some examples, devices (e.g., systems) described herein include an endotube introducer configured to be inserted into a tracheal region of a body through the oral cavity, the endotube introducer comprising: an elongate body having a lumen extending therethrough; and a bending region 7 cm to 20 cm from a distal end of the elongate body, the bending region configured to increase bending of the elongate body to 70 degrees or more relative to a longitudinal axis of the elongate body; a camera at a distal end region; a bending control device at a proximal end region configured to bend or straighten the elongate body at the bending region; and a display configured to receive and display output from the camera, wherein the lumen may be configured to slidably retain an intubation tube pre-loaded within the lumen of an inserting endoscope so that the intubation tube may be advanced distally from the endotube introducer.

[0008]

[0010] The elongate body of the endotube introducer may be pre-bent or curved, typically in a region approximately midway along the length of the elongate body of the endotube introducer. The location of the bend may be based on an optimal position (based on population data) such that the distal end region may be inserted into the epiglottis and guided into the trachea, allowing the endotracheal tube to extend distally into the trachea for rapid fixation. In some cases, the dimensions of the endotube introducer may be configured for a variety of different patients, and in some cases, the endotube introducers described herein may be sized for small (e.g., infants / children), medium (smaller patients), and / or large (e.g., adult) patients. In some examples, the bend region of the endotube introducer may be about 5 cm to about 25 cm (e.g., about 7 cm to about 20 cm, about 8 cm to about 18 cm, etc.) from the distal end of the endotracheal introducer. In any of these devices, the elongate body of the endotube introducer may have an initial configuration in a resting state with the bending region pre-bent between about 25 degrees and about 50 degrees, and thus the bending region may have a minimum preset bend between about 25 and 50 degrees.

[0009]

[0011] Generally, the flexion control device may be any suitable control device, including, but not limited to, a dial, knob, slider, etc. The flexion control device may be configured to increase or decrease the flexion of the flexion region, for example, the flexion control device may increase the flexion of the flexion region to about 70 degrees or more relative to the longitudinal axis of the elongate body. The flexion region may be actuated by the flexion control device by pulling one or more tendons (e.g., one or more wires, cables, etc.) to drive the flexion of the flexion region.

[0010]

[0012] In any of the endotube introducers described herein, the distal end of the endotube introducer may be configured to be driven against the laryngeal surface of the epiglottis with sufficient force to elevate the epiglottis and open the airway to allow passage of an endotracheal tube into the trachea. Thus, in any of these devices, the endotube introducer, and in particular the bending region (e.g., actuated by a bending controller), may be configured to bend the bending region against a force of 2 or more Newtons (N) (e.g., 3 N or more, 4 N or more, 5 N or more, 6 N or more, 7 N or more, 8 N or more, 9 N or more, 10 N or more, etc.).

[0011]

[0013] Generally, the distal end region of the endotube introducer may be adapted for insertion into the body and / or for applying force to the laryngeal surface of the epiglottis. For example, the distal end region of the endotube introducer may include one or more protrusions configured to atraumatically displace tissue. In some cases, the distal end region may include a tapered region formed of a relatively soft material (e.g., having a lower hardness than the more proximal region). The distal end region may have a hardness of less than 70 on the Shore A scale (e.g., less than 60, less than 50, less than 40, less than 30, less than 20, etc.). The distal end region may have curved and / or rounded edges. The distal end region may extend as a rim or ridge. In any of these devices, the bending region may bend in only one plane, e.g., the plane of the elongated body of the endotube introducer. Thus, the end region may be constrained to bend in a first plane parallel to the elongated body.

[0012]

[0014] Any of these devices may be configured to output real-time images from the distal end region of the endotube introducer, which may be useful for navigating and / or deploying the endotube introducer and / or endotracheal tube. In any of these devices, the endotube introducer may include, for example, a camera facing distally of the distal end region. In some examples, the endotube introducer may include one or more cameras configured to display visual information of the distal end region as the endotube introducer advances through the body. The device may be configured to continuously display video images looking distally from the distal end region of the device. The endotube introducer may wiredly or wirelessly connect the camera of the endotube introducer to one or more displays. The displays may be associated with the endotube introducer or may be associated with a device that communicates with the endotube introducer. In some examples, the endotube introducer may communicate with a communication device (e.g., a smartphone, tablet, laptop, etc.). In some examples, the device is configured to communicate with a dedicated display.

[0013]

[0015] Any of these devices may be configured so that once the endotracheal tube is positioned and secured within the trachea, the endotube introducer may be removed from the body and separated from the endotracheal tube. In some instances, the endotube introducer may be removed beyond the distal end of the endotracheal tube by retracting the endotube introducer proximally after securing the endotracheal tube. In any of these devices, the endotube introducer may be removed through the distal end region of the endotube introducer, such as through a channel, slit, longitudinal side opening, or the like. In some instances, the more proximal end of the endotracheal tube may have a narrower diameter than the more distal region of the endotracheal tube, so that at least partially retracting the endotube introducer proximally may allow the endotracheal tube (and in some instances, an inflation tube, e.g., a balloon, coupled to the anchor) to exit the longitudinal side opening and pass through the body to the lumen.

[0014]

[0016] Any of the devices described herein may be configured to include software, hardware, and / or firmware and one or more processors that assist in the navigation and / or control of an endotube introducer for positioning and deploying an endotracheal tube. The devices described herein may also include a software agent trained to recommend and / or control the operation of the endotube introducer, including steering the endotube introducer. For example, any of these devices may include a trained machine learning agent that is trained to recognize the laryngeal surface of the epiglottis (e.g., from one or more camera inputs), determine the orientation of the distal end region of the endotube introducer, and determine that a flexion region should be activated to apply force from the distal end region to elevate the epiglottis and open the airway, and / or automatically (or semi-automatically, after confirmation from a user) increase the flexion angle of the flexion region and apply force to elevate the epiglottis and open the airway.

[0015]

[0017] For example, any of these devices may include one or more processors comprising a non-transitory computer-readable medium comprising instructions that, when executed by the one or more processors, cause the one or more processors to perform a method including presenting guide information on a display to guide a user to insert the endotube introducer. In some examples, the one or more processors comprise a non-transitory computer-readable medium comprising instructions that, when executed by the one or more processors, cause the one or more processors to perform a method including actuating a control device of the steerable endotube introducer to increase curvature of the elongate body such that the distal end region elevates the epiglottis. The endotracheal tube may then be advanced distally within the trachea and secured.

[0016]

[0018] Also described herein are methods of using any of these devices. For example, a method of inserting an intubation tube may include inserting a distal end region of an endotube introducer having an elongate body into a patient's mouth, the endotube introducer having an endotracheal tube preloaded therein, advancing the distal end region of the endotube introducer into the patient while positioning the distal end region below the laryngeal surface of the epiglottis while imaging an area distal to the distal end region with a camera at the distal end region, actuating a control device of the steerable endotube introducer to increase flexion of the elongate body such that the distal end region elevates the epiglottis, advancing the endotracheal tube distally from the endotube introducer into the patient's trachea, securing the endotracheal tube in the trachea, and removing the steerable endotube introducer from the patient, leaving the endotracheal tube in the trachea.

[0017]

[0019] In some examples, a method may include inserting a distal end region of an endotube introducer having an elongate body into a patient's mouth, the endotube introducer having an endotracheal tube pre-loaded therein; advancing the distal end region of the endotube introducer into the patient, positioning the distal end region below the laryngeal surface of the epiglottis while imaging an area distal to the distal end region from a camera at the distal end region; actuating a control device of the steerable endotube introducer to increase flexion of the elongate body such that the distal end region elevates the epiglottis; advancing the endotracheal tube distally from the endotube introducer into the patient's trachea; securing the endotracheal tube within the trachea; and removing the steerable endotube introducer from the patient, leaving the endotracheal tube in the trachea.

[0018]

[0020] Typically, fixation may include expanding an expandable balloon. Alternatively, fixation may include expanding a mechanical anchor (e.g., a basket, a stent, etc.). The endotracheal tube may typically be connected to an air source (e.g., an air circuit, a pump, a respirator, a ventilator, a pump, etc.) before, during, or after insertion. For example, any of these methods may include connecting the endotracheal tube to an air circuit.

[0019]

[0021] In any of these methods, the method may include actuating a controller to increase the bending of the elongate body from an angle between 25 degrees and 50 degrees relative to a longitudinal axis of the elongate body to an angle greater than 70 degrees relative to the longitudinal axis of the elongate body. Similarly, actuating a controller may include increasing the bending of the elongate body in a bending region between 7 cm and 20 cm from the distal end of the elongate body. Any of these methods may include one or more controllers for controlling assistance in controlling positioning of the distal end region using a guidance subsystem associated with the endotube introducer.

[0020]

[0022] Any of the apparatuses (e.g., systems, devices, etc.) described herein for intubating a patient may include an oral retractor ("mouth opener" or "jaw opener") that may secure the patient's jaw in an open position to allow for the safe insertion of one or more medical devices, including an intubation tube. The oral retractor may be configured to be easily and quickly deployed into the patient's oral cavity to hold the mouth open. In particular, the oral retractor may be configured to hold the mouth open so that the teeth and / or tongue are protected and injury is prevented by inserting one or more medical devices through the opening formed by the oral retractor. In some examples, a portion (e.g., a base region) of the endotube introducer may be configured as an oral retractor.

[0021]

[0023] For example, any of these devices may also include a base (e.g., an "entry base" or stand, or base region) that may be securely coupled to the oral retractor. In some examples, the base may be integral with and / or fixed to the oral retractor. In some examples, the base may be removably coupled to the oral retractor. For example, the base may be configured to couple to the oral retractor after the oral retractor is inserted into the patient's oral cavity and may snap or lock into position over the oral retractor. The base may include a support or platform portion to which additional structure (described herein) may be securely coupled. The base may include one or more openings into the patient's mouth (a central oral opening, referred to herein as a tube guide entry) that may allow for the passage of one or more medical devices, including an endotube introducer and an intubation tube, as described in more detail below. In some cases, the tube guide entry may be separate or separable and may be coupled to the base. In some examples, the tube guide entry may be formed or included as part of the base.

[0022]

[0024] The devices described herein may also include one or more displays (e.g., liquid crystal displays, or LCDs, or other displays). In some examples, the display may be configured to be removably coupled to the base so that a clinician (doctor, nurse, technician, etc.) can view the display while operating the system and intubating a patient. The display may connect to a medical device (e.g., an endotube introducer, a bougie tube, etc.) wirelessly or via one or more cables or wires to display one or more images taken by the medical device, which may assist the clinician in operating the system. In some examples, the display may also act as (or be coupled to) an input device, such as a touchscreen display. The display may also include one or more controls (input devices) for operating the display and / or other parts of the system. The display may be coupled to the base mechanically or electrically (e.g., magnetically), or both.

[0023]

[0025] As mentioned above, any of these devices may generally include an endotube introducer. The endotube introducer may include a bendable and steerable (at least in its distal region) elongate body that may be inserted into a patient's oral cavity, positioned there, and steered toward or near the trachea. The endotube introducer may be configured as a flexible endoscope with one or more (preferably two) cameras for imaging from the distal end region of the endotube introducer, one or more light sources (e.g., light-emitting diodes, LEDs), and one or more built-in suction tubes. The endotube introducer may include one or more controls for steering the distal end region of the device. For example, the endotube introducer may include one or more tendons that actuate bending of the distal end of the device from a proximal control. The bending control (also referred to herein as a proximal control) may be a knob or dial or multiple knobs or dials that control the tension of tendons articulating the distal end to steer the device.

[0024]

[0026] Generally, the endotube introducer device may be configured as a hollow tube body. The distal end of the endotube introducer is preferably normally closed but may be covered by two or more flaps or facets that may controllably open when the endotube introducer is positioned in or near the trachea. The flaps or facets may open outward, non-traumatically displacing surrounding tissue to provide space for the intubation tube and facilitate visualization and insertion of the intubation tube. The endotube introducer body may have multiple peripheral channels for holding one or more cameras, suction / vacuum lines, light sources, and / or drivers that actuate the opening of the flaps at the distal end of the endotube introducer device.

[0025]

[0027] In some examples, the endotube introducer (equivalently referred to herein simply as an endotube) may be configured to interact with the base such that the endotube introducer can be freely inserted and manipulated (rotated, tilted, advanced / retracted, etc.) through the base, but may be locked and secured in place once the endotube introducer is properly oriented in or near the trachea. For example, any of these components, including the endotube introducer, may be securely and quickly coupled (or locked) to the base by magnets, mechanical couplers, etc.

[0026]

[0028] Any of these devices may include one or more endotracheal tubes (e.g., intubation tubes). Standard or customized intubation tubes may be used. In particular, the intubation tubes described herein may have lengths greater than 24 inches (e.g., 30 inches, 32 inches, 34 inches, 36 inches, etc.). The longer (non-standard) lengths described herein may be particularly well-adapted for use with the systems described herein. The intubation tube may include air passages and / or passages for actuating an anchor (e.g., an anchor balloon) to secure the intubation tube in place. In some examples, the anchor may be an inflatable balloon.

[0027]

[0029] Any of these devices may also include tools for removing the endotube introducer or other components while leaving the intubation tube undisturbed in place. In some instances, the endotube introducer may be removed using a removal tool, referred to herein as an endoscopic bougie tube or simply a bougie. The bougie may be configured to be applied in and / or on the intubation tube and within the endotube introducer to allow removal of the endotube introducer (and base and oral retractor) without disturbing the intubation tube.

[0028]

[0030] Also described herein is a method of operating the system to insert an intubation tube. Generally, the method may be performed with the patient in a supine position (which may include placing the patient in a supine position). The patient's jaw may be held open by an oral retractor (chin retractor). The base may be pre-coupled to (or integrally attached to) the oral retractor or may be coupled after the oral retractor is attached to the patient. A display may then be coupled to the base to enable visualization from the display.

[0029]

[0031] In some instances where a separate tube guide entry is used, the tube guide entry may be coupled to the base. An endotube introducer may be coupled (wirelessly or by one or more wires or cords) to the display and inserted into the oral cavity through the tube guide entry. The endotube introducer may be inserted until its distal end (which in some instances may be closed by a flap or facet) is proximal to the trachea. For example, the endotube introducer may be inserted and, using visualization from the display, navigated with the proximal control until it reaches the epiglottis, and then adjusted until the tip faces the trachea. In some instances, the flap or facet may be opened to displace tissue without damaging it, making the trachea more easily visualized and / or accessible.

[0030]

[0032] The intubation tube may then be inserted through the endotube introducer until it passes the tip of the camera of the endotube introducer and is inserted into the trachea. An inflatable or expandable anchor may then be engaged. Once the patient's vitals are stabilized, the components of the system may be removed from around the intubation tube. In some instances, a tool (e.g., a bougie), optionally after being coupled to a display, may be inserted into the endotube introducer and at least a portion of and / or within the intubation tube to support the intubation tube and enable removal of the endotube introducer, base, and jaw retractor from the patient, leaving the intubation tube. The patient's vitals may be continuously monitored before, during, and after this process. In some instances, the endotube introducer may be removed without the use of a separate tool. For example, once secured in place within the trachea, the endotube introducer may be configured to retract proximally over the endotracheal tube (e.g., intubation tube), allowing the proximal region of the endotracheal tube to be removed via a channel, slot, or other opening along the length of the endotube introducer.

[0031]

[0033] In some examples described herein, the device (e.g., system) includes an oral retractor, a base connected or connectable to the oral retractor, the base including an opening leading to the oral cavity through the base, a display securely connected to the base, an endotube introducer configured to be inserted into the oral cavity through the opening and through the base, the endotube introducer including one or more cameras in communication with the display and having a steerable distal end, an intubation tube configured to be inserted through the endotube introducer, and a bougie configured to be inserted through the endotube introducer to stabilize the intubation tube while the endotube introducer, display, base, and oral retractor are removed.

[0032]

[0034] The base may be integral to the oral retractor, in some instances the base is anchored to the oral retractor, or the base is coupled to one or more connectors of the oral retractor.

[0033]

[0035] The endotube introducer may include multiple facets on a steerable distal end opening that controllably open to displace tissue. The facets may be leaflets, flaps, covers, etc., and may be atraumatic (e.g., non-sharp and / or rounded, etc.) that cover the distal end opening of the endotube introducer to prevent damage to the lumen during insertion and manipulation of the device. The facets may be flexible or rigid and may be configured to push tissue away from the distal end opening so that structures, including but not limited to the trachea, can be more easily visualized and / or accessed.

[0034]

[0036] The bougie may comprise an elongated tubular body and, in some examples, may include a camera configured to wirelessly couple the bougie to a display.

[0037] The endotube introducer may be wirelessly coupled to a display, for example, to display images and / or video from the endotube introducer on the display.

[0035]

[0038] Generally, the oral retractor may be configured to include a first mouthpiece and a second mouthpiece, each configured to enclose at least the buccal sides of the patient's teeth. In any of the oral retractors described herein, one or both of the first mouthpiece and the second mouthpiece may be adjustably coupled to the oral retractor.

[0036]

[0039] Any of these devices may include a lock, for example, a lock configured to lock the position of the endotube introducer relative to the base.

[0040] For example, the system may include an oral retractor, a base coupled or connectable to the oral retractor, the base including an opening leading to the oral cavity through the base, a display securely connected to the base, an endotube introducer configured to be inserted into the oral cavity through the opening and through the base, the endotube introducer comprising one or more cameras in communication with the display, the endotube introducer having a steerable distal end, the steerable distal end being covered with one or more facets, a control device coupled to the steerable distal end of the endotube introducer, a second control device coupled to the one or more facets and configured to actuate the one or more facets, an intubation tube configured to be inserted through the endotube introducer, and a bougie configured to be inserted through the endotube introducer to stabilize the intubation tube while the endotube introducer, display, base, and oral retractor are removed.

[0037]

[0041] Also described herein are methods, such as a method of inserting an intubation tube as described herein, that includes attaching an oral retractor and base to a patient's mouth to hold the mouth open and establish a stabilizing base, inserting a steerable endotube introducer through an opening in the stabilizing base and maneuvering a distal end of the steerable endotube introducer adjacent to the patient's trachea while displaying an image from a camera of the steerable endotube introducer on a display mounted on the stabilizing base, deploying the steerable endotube introducer to extend a facet from the distal end of the steerable endotube introducer, and inserting an intubation tube through the steerable endotube introducer and into the patient's trachea.

[0038]

[0042] Inserting the steerable endotube introducer may include protecting the patient's teeth with one or more mouthpieces of the oral retractor. Attaching the oral retractor and base may include coupling the base to the oral retractor after the oral retractor has been inserted into the patient's mouth, or the method may include inserting the base along with the oral retractor (i.e., if the base and oral retractor are pre-assembled or integrally formed). Any of these methods may include coupling the steerable endotube introducer to a display. Any of these methods may include coupling the display to a stabilizing base.

[0039]

[0043] Any of these methods may include removing the steerable endotube introducer, stabilizing base, and oral retractor, leaving the intubation tube in place. Removing may include using a bougie to remove the steerable endotube introducer, stabilizing base, and oral retractor. Deploying the steerable endotube introducer to extend the facets may include using the facets to push on tissue to expand access to the patient's trachea. Inserting the intubation tube may include expanding an anchor on the intubation tube.

[0040]

[0044] For example, a method of inserting an intubation tube may include holding the mouth open and attaching an oral retractor and base to the patient's mouth to establish a stabilizing base; coupling a display to the stabilizing base; inserting a steerable endotube introducer through an opening in the stabilizing base and maneuvering a distal end of the steerable endotube introducer adjacent to the patient's trachea; deploying the steerable endotube introducer and extending a facet from the distal end of the steerable endotube introducer; inserting an intubation tube through the steerable endotube introducer and into the patient's trachea; and removing the steerable endotube introducer, the stabilizing base, and the oral retractor, leaving the intubation tube in place.

[0041]

[0045] All of the methods and devices described herein, in any combination, are contemplated herein and can be used to achieve the advantages as described herein. [Brief explanation of the drawings]

[0042]

[0046] The novel features of the embodiments described herein are set forth with particularity in the appended claims. A better understanding of the features and advantages of the embodiments may be obtained by reference to the following detailed description that sets forth illustrative embodiments and the accompanying drawings. [Figure 1]

[0047] FIG. 1A illustrates a schematic diagram of one example of an apparatus (eg, a system) for intubating a patient, as described herein.

[0048] FIG. 1B illustrates a schematic example of a system for intubating a patient, shown engaged with the patient. [Figure 2]

[0049] FIG. 2A is a simplified diagram of a system for intubating a patient, including a base and an endotube introducer, with a display coupled to a camera of the endotube introducer.

[0050] FIG. 2B shows another simplified diagram of an example system for intubating a patient. [Figure 3]

[0051] 3A and 3B show an example of a jaw retractor prototype including a base with tube guide entries shown in side and top views, respectively. [Figure 4]

[0052] FIG. 4 shows a schematic representation of an example of the distal end region of an endotube introducer, showing the device with facets covering the deployed distal end. [Figure 5]

[0053] FIG. 5A is an example cross section through an example endotube introducer.

[0054] FIG. 5B is another example of a distal end region (tip region) of an endotube introducer showing a distal end closed by multiple facets. [Figure 6]

[0055] FIG. 6 shows a schematic diagram of one example of an oral retractor as described herein. [Figure 7]

[0056] FIG. 7 shows a schematic diagram of one example of a bougie as described herein. [Figure 8]

[0057] FIG. 8 is a schematic diagram of one example of a method for performing intubation using the devices described herein. [Figure 9]

[0058] FIG. 9 shows another example of an apparatus for intubating a patient, which is configured to quickly and safely intubate a patient. [Figure 10]

[0059] FIG. 10A shows an example of a device for intubating a patient.

[0060] 10B-10C show a side view and a side perspective view, respectively, of an example endotube introducer for intubating a patient, as described herein.

[0061] FIG. 10D shows a partial rear view of the endotube introducer shown in FIGS. 10A-10C. [Figure 11]

[0062] FIG. 11 is an exploded view of one example of an endotube introducer for intubating a patient as described herein. [Figure 12]

[0063] 12A-12H illustrate an example of a method for intubating a patient using the devices described herein. MODE FOR CARRYING OUT THE INVENTION

[0043]

[0064] Insertion of an oral endotracheal tube (also referred to herein as an intubation tube) is an important life-saving procedure that is traditionally performed in a controlled environment by highly skilled clinicians. However, there are several situations, such as rural, point-of-service (POS) locations, field hospitals, and battlefield locations, that could benefit from the insertion of an intubation tube but lack access to clinicians qualified to perform these procedures.

[0044]

[0065] Described herein are apparatus (e.g., devices, systems, etc.) for assisting intubation tube insertion ("intubation") in a more controlled and safe manner that may avoid problems associated with insertion. In the United States, endotracheal intubations are performed approximately 15 million times in operating room settings, 650,000 times outside of operating rooms in hospitals, and 346,000 times in emergency rooms. Despite its frequency, endotracheal intubation is a high-risk procedure with significant incidences of respiratory complications, hemodynamic instability, and cardiac arrest. These complications include failed intubations (approximately 1 in 1-2,000 in elective settings, approximately 1 in 300 during rapid induction (RSI) in obstetric settings, and approximately 1 in 50-100 in emergency departments, intensive care units (ICUs), and prehospital settings). Therefore, new technologies that improve the safety and success of endotracheal intubations have a significant impact on public health and safety. The apparatus (e.g., systems) described herein may be configured to address these needs.

[0045]

[0066] For example, described herein is an oral endoscopic tube configured as an endotube introducer that guides an operator to the vocal cords. This device (e.g., system) eliminates the need for direct observation of the vocal cords with the aid of a flexible, steerable endoscopic tube, which is the current standard of care via laryngoscope. Furthermore, the distal end (including the tip) of these devices may move in one or more directions, for example, to move within the plane of the elongated and bent / curved body of the endotube introducer. Alternatively, in some instances, the endotube introducer may move beyond this plane (e.g., up, down, left, and right), significantly facilitating the operator's locating the vocal cords and directing the endotracheal tube through the vocal cords using a camera system and, in some instances, a built-in artificial intelligence agent (e.g., an AI algorithm). In some instances, the device (e.g., system) may include a mouth opener and a stabilizer. In general, the endotube introducer and / or stabilizer may be designed to protect all of the patient's teeth during the intubation process while avoiding damage to the patient's teeth or the canal. The console (display) may be an LCD or any other suitable display. The endotube introducer may include a flexible (bendable at least in the bend region or bend joint) endoscope tube with a camera, an LED light, and, in some cases, an integrated suction tube. The endotube introducer may include a built-in manipulation mechanism for bending and / or steering the device. In some examples, the endotube introducer may be configured to allow the user to move the tip in two directions (vertically and horizontally). This mechanism may be operated and guided by one or more controls (e.g., knobs, thumbwheels, tactile buttons, switches, etc.) and may optionally include one or more microcontrollers, micromotors, etc. The endotube introducer may also include a distal end region configured to prevent damage to tissue (e.g., the epiglottis) while allowing controlled displacement of the tissue.In some instances, the distal end region of the endotube introducer may include one or more petals or facets at the distal end that may extend and / or expand outward (in some cases from a first position that closes the distal end of the endotube introducer) to displace tissue or other material to allow for clearer visualization and targeting of the trachea. Additionally or alternatively, the system may include a thin endoscopic bougie with a camera that connects to a console and LCD. This bougie may be used to remove the flexible endoscopic tube while keeping the endotracheal tube in place.

[0046]

[0067] In some cases, these devices (systems, devices, etc.) may include an oral retractor or oral retractor region that couples with or even forms a stable base to which imaging and guiding may be coupled for guiding the intubation tube. Optionally, in some instances, components of the device (e.g., system) may engage with one another to form a stable base, which may be used as a reference for imaging and guiding in placing the intubation tube. The device assembly (oral retractor, base, guide tube / endotube introducer, etc.) may be specially configured to be very quickly applied to a patient without requiring training. For example, the base may be pre-attached to the oral retractor and / or configured to quickly and securely lock onto the oral retractor once applied to the patient. Similarly, the imaging (display) may be pre-coupled to the base or configured to easily engage (snap) with the base, and may be coupled wirelessly or via a quick-connect cable to the camera of the endotube introducer and / or bougie.

[0047]

[0068] The device (e.g., an endotube introducer) may be configured to be removed, leaving the intubation tube inserted, without disturbing or dislodging the intubation tube. In some instances, the bougie may be configured to stabilize the intubation tube after it has been inserted, allowing other components of the device to be removed, leaving the intubation tube.

[0048]

[0069] In some examples, these devices include one or more (or all) of an oral retractor, a base connected or connectable to the oral retractor, a display connected or connectable to the base, an endotube introducer configured to be inserted through an opening into the oral cavity through the base, optionally an intubation tube configured to be inserted through the endotube introducer, and / or a bougie configured to be inserted through the endotube introducer to stabilize the intubation tube while the endotube introducer, display, base, and oral retractor are removed.

[0049]

[0070] The base may include an opening through the base to the oral cavity, which may include or be configured to mate with a tube guide entry. The endotube introducer may include one or more cameras in communication with the display, and the endotube introducer has a steerable distal end.

[0050]

[0071] FIG. 1A shows an example of a device including at least some of these components. For example, in FIG. 1A, the device includes an oral retractor 103 portion (shown schematically from one side). The oral retractor / retractor portion may be similar to, for example, a Jennings mouth retractor and may be coated or covered with a biocompatible, autoclavable material such as silicone. The oral retractor may be reusable (e.g., sterilized). The oral retractor may include one or more attachments for connecting to a base 105. The base may be magnetically and / or mechanically coupled, for example, via one or more clips, clamps, etc. When the oral retractor is worn, the base may extend over and across the patient's mouth and may include an opening therethrough to allow access to the oral cavity. The base may include a central oral opening (e.g., a tube guide entry) that may include a tube 106 or simply be an opening through which an end tube introducer and other components may pass into the patient's mouth. 115

[0072] In FIG. 1A, a display 109 (e.g., an LCD screen, a touch screen, etc.) is shown coupled to the base. The display may be adjustable. The display may be coupled to the base before attaching the base to the oral retractor, or, in variations where the two are separate components, may be attached after the base is coupled to the oral retractor. Note that in some instances, the base and oral retractor may be integrated.

[0051]

[0073] The display may be covered with a protective cover (eg, a disposable cover such as a plastic sterile barrier that may be removed and / or replaced and / or sterilized between patients).

[0052]

[0074] FIG. 1A also illustrates an example of an endotube introducer 107, shown inserted into a base 105 through a central oral opening. In this example, the endotube introducer includes a steerable distal end that may be moved in one or more directions 127 by actuating a control, shown as a knob 117 on a proximal portion of the endotube introducer that protrudes above the base. In some examples, the endotube introducer includes multiple tendons that are actuated to pull (or, in some examples, push) the distal end region, which may be joined or hinged to enable movement for steering. The distal end region may also include one or more distally facing (and / or side-facing) cameras, light sources, and channels (e.g., irrigation channels, etc.). The endotube introducer may be coupled to a display via a cable / cord 113 or wirelessly. For example, the endotube introducer camera may be configured to display one or more video images on a display screen, either wirelessly or via a wired connection. The end tube may include on-board processing (e.g., circuitry for controlling imaging, lighting, and / or steering) and / or may store, transmit, and receive data. The end tube introducer may include on-board power, e.g., a battery, capacitor, etc., or may be configured to receive power, for example, through cabling or connection to a display or power source (not shown). In some examples, the end tube introducer is unpowered. For example, imaging may be passive (via one or more fiber optics) and illumination may be provided by one or more LEDs, which may be very low power, and / or may be provided via optical fibers / light pipes coupled to an external light source (e.g., LEDs).

[0053]

[0075] The endotube introducer 107 shown in FIG. 1A includes a plurality of expandable facets, petals, flaps, etc., located at the distal end of the endotube introducer and that may be actuated (by one or more manual or automatic controls at the proximal end of the endotube introducer) to expand outward (not shown in FIG. 1A). This expansion may aid in exposing a target tissue region, such as the trachea, to improve accuracy and precision in placing an intubation tube in a patient. The facets may, for example, be hinged (in some instances, via a living hinge, etc.) to open outward. For example, the facets may be configured to expand outward when actuated by a wire, rod, etc., or when pulled from the distal region.

[0054]

[0076] In some examples, the endotube introducer may have an inner diameter (e.g., ID) of about 8 to about 12 mm (e.g., about 10 mm), an outer diameter of about 15 to about 18 mm, and a length of about 7 to 10 inches (e.g., about 7 to 9 inches, about 8 inches, etc.).

[0055]

[0077] Optionally, any of the devices described herein may include an intubation tube 111 or may be configured to operate with an intubation tube 111. Any intubation tube may be used. In FIG. 1A, the intubation tube includes a fixed balloon 112 at its distal end (and inflation channel and inlet) and may be sufficiently flexible to be inserted along the endotube introducer once positioned. The intubation tube may be part of a system including all or some of the other components, or may be separate. For example, the intubation tube may be configured to operate with the devices described herein, including having a custom / specific length and / or proximal engagement portion to help guide the insertion and / or inflation of the device using the devices described herein. The intubation tube may include, for example, an inner diameter (ID) of 6-7 mm and have an OD smaller than the ID of the endotube introducer. The intubation tube may have a long and narrow length, for example, 20-36 inches, e.g., about 22-32 inches, about 23-37 inches, etc.

[0056]

[0078] Any of these devices may further or additionally include a removal tool, referred to herein as a bougie 121 (or endoscopic bougie tube, EBT). For example, the bougie may be 25-48 inches (e.g., 30-40 inches, 34-38 inches, etc.) and may have an OD slightly smaller than the inner diameter of the intubation tube, e.g., about 1 mm. The bougie may optionally include imaging (e.g., a camera) and lighting (e.g., an LED), and may be coupled to a display 109 via a wired or wireless connection 143.

[0057]

[0079] FIG. 1B shows another example of a system for intubating a patient 150. In this example, the system includes a base 105 (e.g., a platform) connected to the upper arm of an oral retractor 103. The oral retractor includes an upper cavity for holding the upper jaw and / or teeth on a first arm and a lower cavity for holding the lower jaw and / or teeth on a second arm (shown in FIG. 6 below). The base also includes or is connected to an intermediate phase 106 that connects a display 109 (e.g., a screen and power unit) to the base. In FIG. 1B, an example of an endotube introducer 107 would also be passing through (and held in position) the base. The endotube introducer includes a control device 117 (e.g., an endotube introducer lever arm controller) that may be used to manipulate the endotube introducer.

[0058]

[0080] 2A-2B show example schematics illustrating possible operation of the devices described herein. In FIG. 2A, an oral retractor mounted on base 105 includes an opening into the patient's mouth through which endotube introducer 107 is inserted. Display 109 shows an image of the vocal cords as the endotube introducer is maneuvered into position to allow for insertion of an intubation tube, as shown in FIG. 2B.

[0059]

[0081] In any of these devices, the base may include circuitry (e.g., processor, memory, etc.) for controlling various components of the device, including imaging and / or steering / guiding the endotube introducer, etc.

[0060]

[0082] 3A and 3B show an example of a patient model with an oral retractor 105 inserted, as shown, to open the patient's jaw and hold the teeth away from the central oral opening. The base 105 in this example includes a tubular protrusion within the oral cavity and above the base, to which an endotube introducer may be movably and / or securely coupled. The base may also include a mounting for a display (not shown).

[0061]

[0083] 4 shows a schematic example of an endotube introducer 107 inserted through the mouth toward the vocal cords and steered against the vocal cords as shown. The endotube introducer also includes multiple facets 108, shown open in this schematic example, that may push against tissue to provide clear access for imaging and / or insertion of one or more additional devices, such as an intubation tube.

[0062]

[0084] Figures 5A and 5B illustrate a portion of an example of an endotube introducer described herein. In Figure 5A, a cross section through the distal end region (or distal end face in some examples) is shown. The example shown in Figure 5A includes a pair of opposing cameras, a pair of LEDs, and a pair of suction ports. One or more wire channels are also shown, which may include steering wires and / or one or more wires for opening, closing, or expanding facets at the distal end of the endotube introducer. In Figure 5B, an example distal tip region is shown including four motorized facets that may open as described herein. These facets are shown as having a pointed / pyramidal structure, but may also be atraumatic, including curved, rounded, etc. Additionally, the facets are shown closing the distal end region of the tube, and in some examples, may not close completely, allowing air and / or fluid to pass through.

[0063]

[0085] FIG. 6 shows one example of an oral retractor 103 described herein. In this example, the oral retractor includes an upper member 606 to which a first mouthpiece 602 is coupled and a lower member 608 to which a second mouthpiece 604 is coupled. The oral retractor may include one or more couplers 612, 612′ to the upper or lower (or both) members, to which a base may be coupled. The oral retractor's mouthpieces may open the upper and lower jaws and protect the patient's teeth. The mouthpieces are typically sized and shaped to include wide channels (e.g., channels having a diameter of 2 cm or more (3 cm, 4 cm, 5 cm, 6 cm, 7 cm, etc., or more)) and are configured to fit a number of different mouth configurations and sizes. In some examples, the mouthpieces may be adjustable. For example, the upper and / or lower mouthpieces may, at least initially, slide forward and backward relative to the upper and lower members to better accommodate different jaw configurations. In some examples, once the jaw retractor is locked in place and holds the patient's jaw open, the upper and lower jaws may be locked in place and prevented from further sliding. In some examples, the channel in the mouthpiece may be at least partially open on the lingual and / or occlusal sides of the mouthpiece, thereby allowing different tooth and / or jaw configurations to accommodate while protecting the buccal (anterior) surface. In some examples, only the buccal and occlusal sides of the channel are enclosed. The mouthpiece may be formed of a rigid or flexible material, or a combination of the two. For example, the mouthpiece may be formed of a flexible polymer material such as silicone. The mouthpiece may be reinforced, for example, stainless steel reinforcements may be used.

[0064]

[0086] FIG. 7 illustrates an example of a bougie 121 described herein. Generally, a bougie may include an elongated body that can be inserted onto and / or into an endotracheal tube 111 when the endotracheal tube is supported within an endotube introducer 105, as shown in FIG. 7. As described above, a bougie may be used to assist in removing the endotube introducer after the patient's vitals have been stabilized, while leaving the intubation tube intact and in place. Optionally, the bougie may include a camera that allows imaging of the position of the intubation tube, for example, so that the endotube introducer, base, and oral cavity spreader can be removed while verifying that the intubation tube remains in the correct position. Generally, a bougie may be a tubular member that fits over and supports the intubation tube. In FIG. 7, the bougie is inserted into the endotube introducer. The bougie may be solid or may include an airway passageway.

[0065]

[0087] In operation, the devices described herein may be configured to intubate a patient in need thereof. FIG. 8 is a chart illustrating an example of a method for intubating a patient, for example, using the devices described herein. The patient may be supine. The head may be flat or tilted back. Tilt of the head back is not required. Optionally, in some instances, an oral retractor may be attached, as described above, to hold the patient's teeth and jaw apart. 801 In some instances, the oral retractor may be integrated with the endotube introducer; for example, the oral retractor may already be coupled to the base, or the base may be coupled to the oral retractor after already being attached to the patient. This may form a stabilizing base. 801

[0088] A display may (optionally) be coupled to the base 803. In some examples, the display may be mounted nearby, but not on, the patient support base. The display may include a battery or may be coupled to an external power source (e.g., a wall power source, etc.).

[0066]

[0089] Generally, the endotube introducer may be introduced into the patient's mouth by being movably coupled to a base, e.g., by insertion into a central opening 805; in some instances, the endotube introducer may be inserted directly into the mouth (no separate base is required). Optionally, the endotube introducer may be coupled to a display so that a video image may be monitored as the endotube introducer is inserted and positioned (including maneuvered) within the body. The endotube introducer may be inserted through the patient's mouth until it reaches the pharyngeal region of the patient's anatomy and positioned near the patient's epiglottis; for example, the distal end of the endotube introducer may be manipulated (e.g., using a "tip-tilt" operation, e.g., by adjusting the bend of the device using a bend control) until the endotube introducer camera is pointed toward the patient's trachea. The distal end of the endotube introducer may displace the laryngeal surface of the epiglottis to expose the airway. Once in the appropriate position, the endotube introducer may optionally be secured to the base in the appropriate position. 807 Steering components may be similarly locked.

[0067]

[0090] The intubation tube may then be preloaded into the endotube introducer prior to insertion and may be advanced independently once the endotube introducer is properly positioned. 809 Alternatively, in some instances, the endotracheal tube (intubation tube) may be inserted through the endotube introducer until it passes the tip of the endotube introducer (e.g., a camera) and enters the trachea. Once properly positioned, the intubation tube may be secured, for example, by inflating a fixation balloon to secure it in place. Proper positioning may be visually confirmed using a display and camera and / or a guide agent (artificial intelligence agent). The intubation tube may be pre-connected to the air circuit 811 or may be connected to the air circuit after securing the endotracheal tube. The patient may then be intubated, and the patient's vitals may be monitored. After the patient's vitals have stabilized, the device may be removed from around the intubation tube. 813 In some instances, this may be accomplished by using a bougie to prevent the intubation tube from being dislodged when removing the endotube introducer, base, and oral retractor.

[0068]

[0091] Most of the components included in the devices described herein are sterilizable and reusable. Components may hold the patient's mouth open and provide a platform for and entry for other components. Example

[0092] The endotracheal tube introducer devices (e.g., devices and methods) described herein, when operated by a medical professional, may enable rapid and precise access to the hypopharynx to perform one or more medical procedures. As described above, these devices may be easy to use and relatively inexpensive, allowing for use in highly time-sensitive emergency situations. Furthermore, these devices may prevent trauma to the teeth and mouth, may require minimal training for use, and may prevent or reduce pressure on the cervical spine during emergency treatment, particularly compared to existing tools. Generally, these methods and devices may avoid the need for a tracheotomy. Preliminary studies have shown that these devices may provide rapid access to a patient's hypopharynx and intubate the patient without adverse outcomes in a manner more than five times faster than currently available devices.

[0069]

[0093] Generally, these devices may include an introducer preloaded with an endotracheal tube, a high-resolution vision system that provides guidance (e.g., via a trained machine learning agent), and on-the-fly tip adjustment that reduces or eliminates the need to clear a passage through the oropharyngeal region. These devices may be used in any suitable medical or emergency environment, including, but not limited to, emergency medical services, hospitals, operating rooms, outpatient clinics, battlefields, and airway emergency medical procedures in unmanned settings. The endotube introducers described herein may allow rapid and precise access to the hypopharynx, enabling medical professionals to perform a variety of operations.

[0070]

[0094] FIG. 9 illustrates an example of a device configured as a system that includes an endotube introducer 907, a display 909, and a connecting cable 913, and may include or be pre-loaded with an endotracheal tube 911 (visible through the elongated body of the endotube introducer in a cutout area 915). The example shown in FIG. 9 includes an endotracheal tube pre-loaded within the endotube introducer and a high-resolution vision system. The endotube introducer is configured to allow for in-situ adjustment of the distal end region (e.g., tip), which reduces the need to clear a passage through the oropharyngeal region. Generally, these devices, including the endotube introducer, are biocompatible and may be formed from materials suitable for tissue contact within the oral cavity and respiratory cavities, for example. These devices may be used as part of an intubation procedure that traditionally requires establishing a direct line of sight to the patient's trachea using a laryngoscope.

[0071]

[0095] In FIG. 9 , the endotube introducer includes a distal end 933 configured to extend distally from the elongated body of the endotube introducer. The distal end includes an extension or tongue region 934 that may be flexible but provides sufficient support to displace (e.g., elevate) the epiglottis when a tip steering control 917 (e.g., a flexion control) is actuated. In FIG. 9 , the flexion control 917 is configured to increase flexion in a flexion region 945 approximately halfway along the length of the elongated body of the endotube introducer. The endotube introducer also includes a proximal base region 905 that may be configured for only partial insertion into the mouth or oral cavity and, in some cases, may engage a separate base and / or retractor coupled to the patient's mouth. This separate base may be optional.

[0072]

[0096] In FIG. 9 , cord 913 may be directly coupled to display 909 and one or more processors 939. Or, in some examples, a camera at the distal end region of the endotube introducer, for example, may be wirelessly connected to one or more processors 939. The one or more processors may process images from one or more cameras at (or coupled to) the distal end 933 and may include video image processing and / or storage. Optionally, in some cases, the one or more processors may be configured to process images, locally or remotely, to provide guidance to a user on how to steer and / or position the distal end region of the endotube introducer so that the endotracheal tube may be positioned and secured within the trachea. Any of these devices and methods may include signal processing of the video signal so that the image is displayed with the correct contrast, brightness, etc. In any of these methods and devices, the image may be configured to be cropped, scaled, filtered, for example. In certain examples, the one or more processors may be configured to mark and / or label the image to indicate areas, such as the epiglottis, airway, etc.

[0073]

[0097] 10A-10D show another example of an apparatus configured as a system for intubating a patient, as described herein. In FIG. 10A, the system includes an endotube introducer 1007 configured to be inserted into the tracheal region of the body through an oral cavity (e.g., mouth, esophagus, etc.). The endotube introducer may generally include an elongate body 1040 having a lumen extending at least partially along its length (particularly at the distal end region) and a bending region 1045 on the elongate body. The endotube introducer may also include (or be configured to couple to) a camera (not visible in FIGS. 10A-10C) at the distal end region 1033. The endotube introducer also includes a bending control 1041 at the proximal end region configured to change the bending of the bending region.

[0074]

[0098] In Figure 10A, the system also includes a display 1009 configured to receive and display output from the camera. The system may further include one or more processors 1039. While the example shown in Figures 9 and 10A includes a processor integrated with the display 1009, the one or more processors may be part of the endotube introducer and / or may be separate from the display and / or endotube introducer. The one or more processors and / or displays may be wirelessly connected to the camera and / or endotube introducer.

[0075]

[0099] 10A, a display 1009 and a processor 1039 are shown as included parts of the apparatus. In some examples, the display and / or processor may be part of a device that may be paired with the endotube introducer and other components, such as a smartphone, pad, laptop, etc. Thus, the user may supply this component and install software for use with the endotube introducer to perform the functions described herein (e.g., display, guide, etc.).

[0076]

[0100] FIG. 10A also illustrates an example of an endotracheal tube, e.g., an intubation tube 1011, that may be used with an endotube introducer or may be pre-loaded within the endotube introducer. The endotracheal tube 1011 includes an anchor 1043, configured in FIG. 10A as an inflatable balloon. The anchor may be activated and expanded by applying fluid (e.g., saline, air, etc.) via an inflation line 1047. The endotracheal tube is generally configured to be connected to an air circuit (e.g., a ventilator, etc.) and, in some cases, may be pre-connected to the air circuit. Thus, the intubation tube 1011 may be pre-loaded within the lumen of the insertion endoscope, and the intubation tube may be configured to be advanced distally from the endotube introducer.

[0077]

[0101] 10A-10D show an example of an endotube introducer 1007 from different perspectives. The endotube introducer includes a proximally located bend control device 1041 and an elongate body 1040 extending from a proximal base region 1048 that may be gripped and / or configured to prevent injury to the patient's mouth / teeth. The elongate body in this example is pre-bent to have a resting bend angle from a bend region 1045 that is approximately midway along the length of the elongate body 1040. For example, bending of the endotube introducer may begin between about 7 cm (e.g., 8 cm, 9 cm, 10 cm, 11 cm, 12 cm, 13 cm, 14 cm, 15 cm, etc.) and about 25 cm (e.g., 24 cm, 23 cm, 22 cm, 21 cm, 20 cm, 19 cm, etc.) of the distal end region of the endotube introducer 1033. The resting bend angle (α) may be, for example, between about 25 degrees and about 50 degrees. 10B, the resting flexion angle (α) is approximately 40 degrees relative to the longitudinal axis of the elongate body in the more proximal region, which may be increased or decreased by the controller 1041 (flexion controller).

[0078]

[0102] The distal end region 1033 in this example may be formed from a different material than the elongated length and may be configured to prevent injury to the airway. For example, the distal end region may be rounded and / or formed from a softer material (e.g., a material with a lower durometer) than the elongated body 1040 of the endotube introducer. The distal end region may house or include one or more cameras facing distally and configured to view the lumen into which the endotube introducer is inserted.

[0079]

[0103] The endotube introducer 1007 shown in this example is pre-loaded with an endotracheal tube 1011 housed at least partially within the lumen of the endotube introducer. As shown in FIGS. 10C and 10D , the endotracheal tube may be inserted into an insertion region 1067, which may be part of the base 1048 of the endotube introducer. The insertion region 1067 may be funnel-shaped to guide the insertion of the endotracheal tube into the distal end region of the endotube introducer. In FIG. 10D , the elongated body of the endotube introducer includes a side opening region 1063 extending from the insertion region 1067 to the distal end of the endotube introducer. This longitudinal side opening may provide access to the lumen of the endotube introducer and may be used to remove the endotracheal tube after it has been secured and positioned. In some cases, the endotracheal tube may be pulled out of this longitudinal side opening of the endotube introducer after being secured in place. The longitudinal side opening 1063 may be closed, but may be formed of a material (e.g., a polymer) that can be displaced by pulling on the endotracheal tube. The longitudinal side opening 1063 may be a slit or notch. The longitudinal side opening may be closed or may remain closed until removal of the endotracheal tube is desired.

[0080]

[0104] FIG. 11 shows an example of an exploded view of an endotube introducer such as that shown in FIG. 9. In FIG. 11, the endotube introducer 1107 includes a distal end region 1133 that couples with a camera 1165 and is attached to the distal end of an elongate body 1140. At least a portion of the elongate body, such as a bending region, may be formed from segments 1166 (e.g., vertebrae), which may allow bending. A proximal control (e.g., dial, knob, etc.) 1159 may be connected to a cable 1167 or tendon that passes through the segment and connects to a more distal attachment 1163. The cable 1167 may be connected to a steering cable hoist rod 1161 in this example, which may be held in the base 1105 (e.g., an adjustment block) by one or more rod holders 1151 that allow the rod to rotate when the control (knob) 1159 is turned. The base 1105, controller 1159, and holder 1151 may be coupled together at the proximal end of the device by a plurality of washers 1156, 1156′, collars 1160, and screws 1155, 1158. The controller may also be connected to one or more gears 1153 and pawls 1154 that may maintain a bent position even against relatively large forces (e.g., 2N, 3N, 4N, 5N, 6N, 7N, 8N, 9N, 10N, etc.) resisting bending of the elongate body. The elongate body may be at least partially covered by a cover 1162.

[0081]

[0105] 12A-12H illustrate an example of a method for quickly and safely introducing an endotracheal tube into a patient's trachea using the devices described herein. In FIG. 12A, the patient is shown in a supine position, and the endotube introducer 1207 is inserted 1275 into the target mouth, distal end 1233 first, between the teeth, over the patient's tongue. In some examples, the elongated body of the device may be inserted straight, as shown, or in some examples, the elongated body may be pre-bent as described above. Alternatively, the bend may be controlled during insertion by a bend control (e.g., knob) 1259 at the proximal end of the device. The endotube introducer 1207 may be placed on the patient's tongue toward the oropharynx and hypopharynx, with a pre-loaded endotracheal tube already held within the lumen of the endotube introducer, as shown in FIG. 12B.

[0082]

[0106] During insertion, a camera may be used to visualize (on the display 1280) the tip (distal side) of the endotube introducer, as shown in FIG. 12C. During the procedure, the endotube introducer may be moved forward so that the tip, as viewed by the camera, is positioned below the laryngeal surface of the epiglottis, as shown in FIG. 12D. The controller 1259 may be actuated (e.g., by rotating, in this example) to bend the distal region 1233 of the endotube introducer from the bending region 1277 toward the airway 1269. In FIG. 12D, the distal end region 1233 is moved by the controller to elevate the epiglottis. For example, the endotube introducer may be advanced until the tip 1233, 1233′ of the endotube introducer, as visualized on the display, is positioned below the laryngeal surface of the epiglottis. The tip 1233 may then be rotated to elevate the epiglottis and expose the airway 1257, as shown in FIG. 12E. Once the vocal cords are visualized, for example, on the display 1280, the pre-loaded endotracheal tube 1211 may be advanced distally within the end-tube inserter such that the endotracheal tube pushes past the vocal cords and enters the trachea. The end-tube inserter may be held in place during this process. After endotracheal tube placement is confirmed (e.g., visually using the display in some instances), the endotracheal tube anchor 1243 may be expanded, e.g., inflated in some instances. This is shown in FIG. 12G. Once the endotracheal tube is secured in the trachea, the end-tube inserter may be retracted and removed from over the endotracheal tube, as shown in FIG. 12H. The endotracheal tube may be connected to an air circuit to provide air to the patient through the endotracheal tube.

[0083]

[0107] As used herein, when a feature or element is described as being on another feature or element, it may be directly on the other feature or element, or there may be intervening features and / or elements. In contrast, when a feature or element is described as being "directly on" another feature or element, there are no intervening features or elements. It is also understood that when a feature or element is described as being "connected," "attached," or "coupled" to another feature or element, it may be directly connected, attached, or coupled to the other feature or element, or there may be intervening features or elements. In contrast, when a feature or element is described as being "directly connected," "directly attached," or "directly coupled" to another feature or element, there are no intervening features or elements. Although described or illustrated with respect to one example, the features and elements so described or illustrated may also apply to other examples. It will also be understood by those skilled in the art that a reference to a structure or feature located "adjacent" to another feature may have overlapping or underlying portions with the adjacent feature.

[0084]

[0108] The terms used herein are for the purpose of describing particular examples only and are not intended to limit the present invention. For example, as used herein, the singular forms "a," "an," and "the" are also intended to include the plural forms unless the context clearly dictates otherwise. It will be further understood that, as used herein, the terms "comprises" and / or "comprising" specify the presence of stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ."

[0085]

[0109] Spatially relative terms such as "below," "belower," "lower side," "upper," and the like may be used herein to describe the relationship of one element or feature to another, as shown in the figures, for ease of description. It will be understood that spatially relative terms are intended to encompass different orientations of the device during use or operation in addition to the orientation shown in the figures. For example, if the device in the figures were inverted, an element described as "below" or "below" other elements or features would be oriented "above" the other elements or features. Thus, the exemplary term "below" can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations), and the spatially relative descriptions used herein may be interpreted accordingly. Similarly, the terms "upward," "downward," "vertical," "horizontal," and the like are used herein for descriptive purposes only, unless specifically indicated otherwise.

[0086]

[0110] The terms "first" and "second" may be used herein to describe various features / elements (including steps), but these features / elements should not be limited by these terms unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another. Thus, a first feature / element described below could be referred to as a second feature / element, and similarly, a second feature / element described below could be referred to as a first feature / element without departing from the teachings of the present invention.

[0087]

[0111] Throughout this specification and the claims that follow, unless the context otherwise requires, the word "comprises," and examples such as "comprises" and "comprising," may be used interchangeably to refer to various components in methods and articles (e.g., compositions and apparatuses, including devices and methods). For example, the term "comprising" will be understood to mean the inclusion of any stated element or step, but not the exclusion of other elements or steps.

[0088]

[0112] In general, any of the apparatus and methods described herein should be understood to be inclusive, although all or a portion of the components and / or steps may be exclusive and may be expressed as "consisting of" or "consisting essentially of" various components, steps, sub-components or sub-steps.

[0089]

[0113] As used herein in the specification and claims, including in the examples, unless expressly specified otherwise, all numbers can be read as if preceded by the word "about" or "approximately," even if the term is not explicitly visible. The phrase "about" or "approximately" may be used when describing a magnitude and / or location to indicate that the stated value and / or location is within a reasonably expected range of values ​​and / or locations. For example, a numerical value may have a value of + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated value (or range of values), etc. Numeric values ​​provided herein should be understood to include about or approximately that value unless the context indicates otherwise. For example, if the numerical value "10" is disclosed, "about 10" is also disclosed. Numerical ranges set forth herein are intended to include all subranges subsumed therein. It is also understood that when a value is disclosed, "less than or equal to" the value, "greater than or equal to" the value, and possible ranges between values ​​are also disclosed, as would be appropriately understood by one of ordinary skill in the art. For example, if a value "X" is disclosed, "less than or equal to X" and "greater than or equal to X" (e.g., where X is a number) are also disclosed. It is also understood that throughout the application, data is provided in a number of different formats, and this data represents endpoints and starting points, and ranges for any combination of the data points. For example, if a specific data point of "10" and a specific data point of "15" are disclosed, it is understood that values ​​greater than, greater than, less than, less than, and equal to 10 and 15 are considered disclosed, and ranges between 10 and 15 are also disclosed. It is also understood that each unit between two specified units is disclosed. For example, if 10 and 15 are disclosed, it is understood that 11, 12, 13, and 14 are also disclosed.

[0090]

[0114] While various illustrative examples have been described above, any of numerous modifications may be made to the various embodiments without departing from the scope of the invention as set forth in the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments, one or more method steps may be skipped entirely. Optional features of the various device and system examples may be included in some examples and not in other examples. Accordingly, the foregoing description has been provided primarily for illustrative purposes and should not be construed as limiting the scope of the invention as set forth in the claims.

[0091]

[0115] The examples and figures included herein are illustrative, not limiting, and illustrate specific examples in which the subject matter may be practiced. As described, other examples may be utilized and derived therefrom, such that structural and logical substitutions and changes may be made without departing from the scope of the present disclosure. Such examples of the inventive subject matter may be individually or collectively described herein under the term "invention" merely for convenience, and are not intended to voluntarily limit the scope of the present application to any one, if multiple inventions or inventive concepts are actually disclosed. Thus, while specific embodiments have been illustrated and described herein, any configuration calculated to achieve the same purpose may substitute for the specific embodiment shown. The present disclosure is intended to cover any and all adaptations or variations of the various embodiments. Combinations of the above-described embodiments, as well as other embodiments not specifically described herein, will be apparent to those skilled in the art upon reviewing the above description.

Claims

1. 1. A system comprising: an endotube introducer configured to be inserted through the oral cavity into a tracheal region of a body, the endotube introducer comprising: an elongate body having a lumen extending therethrough and a bending region thereon; a camera at a distal end region; and a bending control at a proximal end region configured to vary the bending of the bending region; a display configured to receive and display output from the camera; an intubation tube preloaded within the lumen of the endotube introducer, the intubation tube having an expandable anchor at a proximal end region, the intubation tube configured to be advanced distally from the endotube introducer; A system comprising:

2. The system of claim 1 , wherein the flexion control device is configured to flex the flex region greater than 70 degrees relative to a longitudinal axis of the elongate body.

3. The system of claim 1 , wherein the bend region has a minimum set bend of between about 25 degrees and 50 degrees.

4. The system of claim 1 , wherein the flexion control device is configured to flex the flex region against a force of 2 Newtons (N) or greater.

5. The system of claim 1 , wherein the bending region is 7 to 20 cm from the distal end region of the endotube introducer.

6. The system of claim 1 , wherein the distal end region of the endotube introducer comprises one or more protrusions configured to atraumatically displace tissue.

7. The system of claim 1 , wherein the endotube introducer is wirelessly coupled to the display.

8. The system of claim 1 , further comprising a longitudinal side opening through the body and into the lumen.

9. The system of claim 1 , wherein the distal end region is constrained to bend in a first plane parallel to the elongate body.

10. 10. The system of claim 1, further comprising one or more processors, the one or more processors comprising a non-transitory computer-readable medium comprising instructions that, when executed by the one or more processors, cause the one or more processors to perform a method comprising presenting guide information on the display to guide a user to insert the endotube introducer.

11. The system of claim 1 , wherein the flexure control device comprises a dial.

12. 1. A system comprising: an endotube introducer configured to be inserted through the oral cavity into a tracheal region of a body, the endotube introducer comprising: an elongate body having a lumen extending therethrough; a bending region 7 cm to 20 cm from a distal end of the elongate body, the bending region configured to increase bending of the elongate body to 70 degrees or more relative to a longitudinal axis of the elongate body; a camera at the distal end region; and a bending control device at the proximal end region configured to bend or straighten the elongate body at the bending region; a display configured to receive and display output from the camera; Equipped with the lumen is configured to slidably retain an intubation tube pre-loaded within the lumen of the endotube introducer such that the intubation tube may be advanced distally from the endotube introducer. system.

13. The system of claim 12 , wherein the bend region is pre-bent to an initial angle of between about 25 degrees and 50 degrees relative to the longitudinal axis of the elongate body.

14. The system of claim 12, wherein the bend region has a minimum set bend of between about 25 degrees and 50 degrees.

15. The system of claim 12 , wherein the flexion control device is configured to flex the flex region against a force of 2 Newtons (N) or greater.

16. The system of claim 12, wherein the bending region is 7 to 20 cm from the distal end of the endotube introducer.

17. The system of claim 12 , wherein the distal end region of the endotube introducer comprises one or more protrusions configured to atraumatically displace tissue.

18. The system of claim 12 , wherein the endotube introducer is wirelessly coupled to the display.

19. The system of claim 12 , further comprising a longitudinal side opening through the body and into the lumen.

20. The system of claim 12 , wherein the distal end region is constrained to bend in a first plane parallel to the elongate body.

21. 13. The system of claim 12, further comprising one or more processors, the one or more processors comprising a non-transitory computer-readable medium comprising instructions that, when executed by the one or more processors, cause the one or more processors to perform a method comprising presenting guide information on the display to guide a user to insert the endotube introducer.

22. The system of claim 12 , wherein the flexure control device comprises a dial.

23. 1. A method of inserting an intubation tube, comprising: inserting a distal end region of an endotube introducer having an elongated body into a patient's mouth, the endotube introducer having an endotracheal tube preloaded therein; advancing the distal end region of the endotube introducer within the patient to position the distal end region below the laryngeal surface of the epiglottis while imaging an area distal to the distal end region with a camera at the distal end region; activating a control device of the endotube introducer to increase bending of the elongate body such that the distal end region elevates the epiglottis; advancing the endotracheal tube distally from the endotube introducer into the patient's trachea; securing the endotracheal tube to the trachea; removing the endotube introducer from the patient, leaving the endotracheal tube in the trachea; A method comprising:

24. 24. The method of claim 23, wherein the securing comprises expanding an expandable balloon.

25. 24. The method of claim 23, further comprising connecting the endotracheal tube to an air circuit.

26. 24. The method of claim 23, wherein actuating the control device comprises increasing the bending of the elongate body from an angle between 25 degrees and 50 degrees relative to a longitudinal axis of the elongate body to an angle of greater than 70 degrees relative to the longitudinal axis of the elongate body.

27. 24. The method of claim 23, wherein actuating the control device comprises increasing the bending of the elongate body in a bending region between 7 cm and 20 cm from the distal end of the elongate body.

28. 24. The method of claim 23, further comprising using a guide subsystem associated with the endotube introducer to help control positioning of the distal end region.

29. 1. A method of inserting an intubation tube, comprising: inserting a distal end region of an endotube introducer having an elongated body into a patient's mouth, the endotube introducer having an endotracheal tube preloaded therein; advancing the distal end region of the endotube introducer within the patient to position the distal end region below the laryngeal surface of the epiglottis while imaging an area distal to the distal end region from a camera at the distal end region, and controlling a control device of the endotube introducer to increase bending of the elongate body such that the distal end region elevates the epiglottis; advancing the endotracheal tube distally from the endotube introducer into the patient's trachea; securing the endotracheal tube to the trachea; removing the endotube introducer from the patient, leaving the endotracheal tube in the trachea; A method comprising:

30. 1. A system comprising: an oral retractor; a base connected or connectable to the oral retractor, the base including an opening through the base to the oral cavity; a display securely coupled to the base; an endotube introducer configured to be inserted through the opening and through the base into the oral cavity, the endotube introducer including one or more cameras in communication with the display, the endotube introducer having a steerable distal end; an intubation tube configured to be inserted through the endotube introducer; a bougie configured to be inserted through the endotube introducer to stabilize the intubation tube during removal of the endotube introducer, the display, the base, and the oral retractor; A system comprising:

31. 31. The system of claim 30, wherein the base is integral to the oral retractor.

32. 31. The system of claim 30, wherein the base is anchored to the oral retractor.

33. 31. The system of claim 30, wherein the endotube introducer comprises a plurality of facets on the steerable distal end opening that controllably open to displace tissue.

34. 31. The system of claim 30, wherein the bougie comprises a camera configured to wirelessly couple the bougie to the display.

35. 31. The system of claim 30, wherein the endotube introducer is wirelessly coupled to the display.

36. 31. The system of claim 30, wherein the oral retractor comprises a first mouthpiece and a second mouthpiece configured to enclose at least the buccal sides of the patient's teeth.

37. 37. The system of claim 36, wherein one or both of the first mouthpiece and the second mouthpiece are adjustably coupled to the oral retractor.

38. The system of claim 30, further comprising a lock configured to lock the position of the endotube introducer relative to the base.

39. 1. A system comprising: an oral retractor; a base connected or connectable to the oral retractor, the base including an opening through the base to the oral cavity; a display securely coupled to the base; an endotube introducer configured to be inserted through the opening and through the base into the oral cavity, the endotube introducer comprising one or more cameras in communication with the display, the endotube introducer having a steerable distal end, the steerable distal end covered by one or more facets; a control device coupled to the steerable distal end of the endotube introducer; and a second control device coupled to the one or more facets and configured to actuate the one or more facets; an intubation tube configured to be inserted through the endotube introducer; a bougie configured to be inserted through the endotube introducer to stabilize the intubation tube during removal of the endotube introducer, the display, the base, and the oral retractor; A system comprising:

40. 1. A method of inserting an intubation tube, comprising: attaching an oral retractor and base to the patient's mouth to hold the mouth open and establish a stabilizing base; inserting the steerable endotube introducer through an opening in the stabilizing base and maneuvering a distal end of the steerable endotube introducer adjacent to the patient's trachea while displaying an image from a camera of the steerable endotube introducer on a display mounted on the stabilizing base; deploying the steerable endotube introducer to extend facets from a distal end of the steerable endotube introducer; inserting an intubation tube through the steerable end tube introducer into the patient's trachea; A method comprising:

41. 41. The method of claim 40, wherein inserting the steerable endotube introducer includes protecting the patient's teeth with one or more mouthpieces of the oral retractor.

42. 41. The method of claim 40, wherein attaching the oral retractor and the base comprises connecting the base to the oral retractor after the oral retractor is inserted into the patient's mouth.

43. 41. The method of claim 40, further comprising coupling the steerable endotube introducer to the display.

44. 41. The method of claim 40, further comprising coupling the display to the stabilizing base.

45. 41. The method of claim 40, further comprising removing the steerable endotube introducer, the stabilizing base, and the oral retractor, leaving the intubation tube in place.

46. 46. ​​The method of claim 45, wherein removing comprises removing the steerable endotube introducer, the stabilizing base, and the oral retractor with a bougie.

47. 41. The method of claim 40, wherein deploying the steerable endotube introducer to extend facets comprises using the facets to push on tissue to expand access to the patient's trachea.

48. 41. The method of claim 40, wherein inserting the intubation tube includes expanding an anchor of the intubation tube.

49. 1. A method of inserting an intubation tube, comprising: attaching an oral retractor and base to the patient's mouth to hold the mouth open and establish a stabilizing base; coupling a display to the stabilizing base; inserting a steerable endotube introducer through the opening in the stabilizing base and maneuvering a distal end of the steerable endotube introducer adjacent the patient's trachea; deploying the steerable endotube introducer to extend facets from a distal end of the steerable endotube introducer; inserting an intubation tube through the steerable end tube introducer into the patient's trachea; removing the steerable endotube introducer, the stabilizing base, and the oral retractor, leaving the intubation tube in place; A method comprising:

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