Esophageal auxiliary device for intubation

Abstract

A device and a method for using an esophageal auxiliary device for facilitating guided insertion of an endotracheal tube (104) into a subject (intubation) without the need to perform laryngoscopy and visualization of the vocal cords. In particular, the esophageal auxiliary device includes a tubular airway component (204) which is insertable in the oral pharyngeal space of a user, said tubular airway component having an expandable element configured, when deployed (304), to push the tongue base to increase the airway path. The esophageal auxiliary device further includes an endotracheal tube guiding component (206) insertable in the airway component and slidable to extend distally therefrom, said guiding component also comprising an expandable element configured, when deployed (406), to block the esophagus.

Description

[0001] ESOPHAGEAL AUXILIARY DEVICE FOR INTUBATION

[0002] TECHNICAL FIELD

[0003] The present disclosure relates generally to an esophageal auxiliary device (EAD) for introducing an endotracheal tube (ETT) into a subject. In particular, the invention relates to a tool for endotracheal tube insertion that allows inexperience user to accurately position an ETT within the trachea without Laryngoscopy.

[0004] BACKGROUND

[0005] The insertion of an endotracheal tube (ETT), known as intubation, is a critical and life-saving medical procedure, utilized widely on a global scale. In the United States, for instance, approximately 30 million in-hospital intubations are performed annually.

[0006] Intubation is frequently performed in critically injured, ill, or anesthetized patients to facilitate ventilation of the lungs, including mechanical ventilation, and to prevent the possibility of asphyxiation or airway obstruction.

[0007] The most widely used method is orotracheal intubation, in which an endotracheal tube is passed through the mouth and vocal cords into the trachea.

[0008] Intubation is typically facilitated through a Laryngoscope, a medical instrument designed to elevate and reposition the base of the tongue and epiglottis, thereby exposing the vocal cords and the entrance to the trachea.

[0009] Laryngoscopy and intubation procedures pose inherent difficulties for inexperienced clinicians, thereby contributing to a reduced likelihood of success on first attempt. Successful intubation on the first attempt is a key factor in ensuring patient safety, optimizing clinical outcomes, and effectively managing time- sensitive (emergency) medical situations, such as cardiac arrest or respiratory failure, in which time is of the essence.

[0010] Currently, there are alternative solutions in existence, including: (a) supraglottic devices (e.g., laryngeal masks and laryngeal tubes), which are not deemed as a "definitively secured airway", (b) video-laryngoscopes, which are relatively expensive. Furthermore, utilizing these devices, both supraglottic devices and video laryngoscopes, requires specific training and substantial experience.

[0011] Therefore, there is a need for improved methods and devices for facilitating a simple and safe intubation procedure, ensuring a high success rate on the first attempt even for an inexperienced clinician.

[0012] SUMMARY

[0013] Aspects of the disclosure, according to some embodiments thereof, relate to an esophageal auxiliary device (EAD) for insertion of an endotracheal tube (ETT) into a subject. In particular, some embodiments relate to a guide for endotracheal tube insertion that allows inexperience health professionals to accurately position an ETT within the Trachea.

[0014] It is noted that according to some embodiments, the ETT disclosed herein may be a standard ETT.

[0015] Inserting an esophageal tube through the esophagus is considered a routine and relatively straightforward procedure compared to inserting ETT into the trachea (intubation), which is a more critical and complex procedure. In fact, due to the anatomic structure of the pharynx and the typical head position at supine position, blindly pushing a tube down the oropharynx will get into the esophagus rather than into the trachea. Therefore, proper insertion of the ETT into the trachea, current intubation procedures require the visualization of the vocal cords (either directly by a standard laryngoscope, or indirectly, by a video laryngoscope). Thus, a higher level of expertise is required to ensure a proper placement of the ETT in the trachea and avoid misplacement in the esophagus and other related complications. Advantageously, in accordance with some embodiments, the EAD disclosed herein, or a part thereof, is configured to initially be introduced into the esophagus (e.g., as an "esophageal / gastric tube") but ultimately serves as a guide for an intubation procedure. Advantageously, in accordance with some embodiments, the EAD disclosed herein, or a part thereof, is configured to slide over an inserted gastric tube (e.g. orogastric tube) and ultimately serve as a guide for an intubation procedure. Thus, making the intubation procedure a blind (without Laryngoscopy), simple and safe procedure with a high success rate on first attempt by inexperienced healthcare professionals.

[0016] Furthermore, with an improper placement of an endotracheal tube (ETT) into the esophagus, it is impossible to ventilate the patient, which is a critical problem that can lead to death if not corrected immediately. Therefore, intubation is a life-saving procedure, and health professionals use various techniques and devices, including visualization tools and confirmation methods, to ensure the correct placement of the endotracheal tube. Advantageously, the herein disclosed EAD, in accordance with some embodiments, blocks the esophagus entrance and channels the inserted ETT to its precise placement within the trachea, eliminating the requirement for laryngoscopy and additional visualization tools, and reducing the risk of complications associated with misplacement and multiple failed intubation attempts.

[0017] Multiple failed intubation attempts pose significant risks, most importantly, inability (or prolonged delay) to provide effective respiratory support with adequate oxygenation and ventilation in cardio-pulmonary resuscitation and other medical emergencies. More intubation attempts pose a greater risk of trauma to the airway tissues with bleeding and swelling, which further decreases the odds of successful intubation. Advantageously, the herein disclosed EAD, in accordance with some embodiments, blocks the esophagus entrance and channels the inserted ETT to its precise placement within the trachea, ensuring efficient and successful intubation on first attempt, and minimizing risks associated with a delay successful intubation and mechanical ventilation. Thus, it enhances the simplicity and safety of intubation, a critical life-saving procedure, ensuring a high success rate even for clinicians with limited experience. It also saves valuable time, especially crucial in time-sensitive medical situations, ensuring prompt intervention and the initiation of lifesaving measures.

[0018] Intubation is typically facilitated through a laryngoscope, and normally, laryngoscopy poses a significant challenge for inexperienced clinicians. Advantageously, by blocking the esophagus entrance, the herein disclosed EAD, according to some embodiments, blindly guides the ETT into the trachea without laryngoscopy and vision of the vocal cords, making it a simple, low-cost and easy procedure. According to some embodiments, the herein disclosed EAD, may further include a guide wire, which blindly guides the insertion of the ETT into the trachea along its length. According to some embodiments, the herein disclosed EAD, includes blind insertion of the EAD and a gastric tube, which blindly (without Laryngoscopy) guide the insertion of the ETT into the trachea. Therefore, advantageously, an intubation using the herein disclosed EAD, according to some embodiments, can be safely performed with high success rate by an inexperience clinician, making it conducive to simplified training for healthcare professionals.

[0019] As used herein, the terms “blind insertion”, “blind intubation”, “blindly”, “blind” may interchangeably be used, and refer, according to some embodiments, to an intubation procedure which spares the need to perform a laryngoscopy and without the need of visualization of the vocal cords.

[0020] Advantageously, the herein disclosed EAD, according to some embodiments, reduces and / or delays the need for pre-laryngoscopy induction (administering the subject anesthetic agents to induce unconsciousness or sedation) currently required in the existing intubation procedures. In current intubation procedures induction is typically required at an early stage, often prior to laryngoscopy. Substantial complications are associated with pre-laryngoscopy induction, which could be mainly lower blood pressure and lack of spontaneous breathing. This risk is even higher in cases of failed intubation attempts. In contrast, the stage of insertion of the EAD to the esophagus disclosed herein according to some embodiments, does not require induction, it will only be needed at later stage of intubation procedure, when inserting the ETT, after the subject’s airway is already opened and the EAD is in the right position.

[0021] Certain embodiments of the present disclosure may include some, all, or none of the above advantages. One or more other technical advantages may be readily apparent to those skilled in the art from the figures, descriptions, and claims included herein. Moreover, while specific advantages have been enumerated above, various embodiments may include all, some, or none of the enumerated advantages.

[0022] There is provided herein, according to some embodiments, an esophageal auxiliary device (EAD) for facilitating an insertion of an endotracheal tube (ETT) into a trachea of a subject in a need thereof, the device includes: a tubular airway component including a proximal section and a curved distal section including a deployable member, wherein the curved distal section is positionable in vicinity to a tongue base, wherein the deployable member has a closed configuration, for smooth insertion of the airway component to the oral pharyngeal space of the subject, and a deployed configuration, configured to push / elevate the tongue base, thereby generate and / or increase an airway path; and an ETT guiding component including a proximal section, a distal section and an esophageal slide element at the distal section, the ETT guiding component further includes a first passage extending from a proximal section to a distal section of the ETT guiding component, configured for insertion of a gastric tube there through, wherein the ETT guiding component is configured to "ride" over the gastric tube such that the esophageal slide element is guided by the gastric tube to block the esophagus and to facilitate sliding of the ETT thereon thereby guide the insertion of the ETT into the trachea.

[0023] According to some embodiments, the ETT guiding component is insertable within the airway component and is movable distally and optionally, proximally, along the airway component.

[0024] According to some embodiments, the device has at least two configurations: a retracted configuration, wherein the proximal section of the ETT guiding component is proximally and outwardly retracted from the airway component, and the distal section of the ETT guiding component is inserted in the curved distal section of the airway component, and wherein the esophageal slide element is in a collapsed configuration within the curved distal section of the airway component, and an extended configuration, wherein the proximal section of the ETT guiding component is inserted into the airway component, and the distal section of the ETT guiding component is extended distally and outwardly from the curved distal section of the airway component, and wherein the esophageal slide element is in a deployed configuration configured to block the esophagus thereby facilitating the insertion of the ETT through the device into the trachea.

[0025] According to some embodiments, the airway component has an oval cross section.

[0026] According to some embodiments, the airway component has a longitudinal opening along at least a part of a length thereof. According to some embodiments, the airway component has an oval cross section and a longitudinal opening along at least a part of a length thereof.

[0027] According to some embodiments, the airway component includes one or more inner and / or outer longitudinal rails, recesses, tunnels, channels or any combination thereof for supporting / guiding the ETT guiding component and the gastric tube therethrough. Each possibility is a separate embodiment.

[0028] According to some embodiments, the esophageal slide element is shaped and / or includes a directional element for directing the ETT towards the trachea. Each possibility is a separate embodiment.

[0029] According to some embodiments, the directional element includes a slide, tunnel, ramp, rail, groove, pipe, tube, track, passage, recess or any combination thereof. Each possibility is a separate embodiment.

[0030] According to some embodiments, the esophageal slide element further includes a spring / elastic element, proximally attached to the airway component, configured to exert a force forward on the esophageal slide element so as to push the esophageal slide element against the esophageal walls, thereby preventing backward dislodgement of the esophageal slide element and keeping it the right position.

[0031] According to some embodiments, the esophageal slide element is a self-inflatable soft material.

[0032] According to some embodiments, the self-inflatable soft material includes a sponge or a balloon. Each possibility is a separate embodiment.

[0033] According to some embodiments, the esophageal slide element further includes a second passage extending therethrough and configured for insertion of the gastric tube through said second passage.

[0034] According to some embodiments, the second passage is further positioned to centralize the gastric tube received from the first passage.

[0035] According to some embodiments, in a retracted configuration the gastric tube is slidable distally and outwardly from the first and second passages towards the esophagus, passed the esophageal-tracheal junction (ETJ) and into the stomach, thereby facilitating sliding of the distal section of ETT guiding component over the gastric tube until the esophageal slide element reaches the ETJ and blocks the esophagus.

[0036] According to some embodiments, the esophageal slide element is a triangle plate or has a conical shape, tapered, wedge-shaped, prismatic, triangular shape, or custom shape configured to block the esophagus. Each possibility is a separate embodiment.

[0037] According to some embodiments, the device further includes the ETT.

[0038] According to some embodiments, the cross section of the ETT may be oval for enhancing / improving the insertion of the ETT into the airway component, which, in accordance with some embodiments, also has an oval cross section. According to some embodiments, an oval ETT (as opposed to a round standard ETT) fits in the oval cross section of the airway component and thus the ETT does not protrude from the perimeter of the longitudinal opening of the airway component. This, advantageously, according to some embodiments, may reduce a risk of tissue damage.

[0039] According to some embodiments, a distal section of the ETT is more flexible than a proximal section thereof.

[0040] According to some embodiments, the distal end of the ETT is inserted within the airway component such that a distal end of the ETT contacts a proximal end of the esophageal slide element.

[0041] According to some embodiments, the device further includes the gastric tube.

[0042] According to some embodiments, the ETT further includes an ETT sensor configured to confirm positioning of the ETT in the trachea.

[0043] According to some embodiments, the ETT sensor includes a CO2 sensor, a temperature sensor, a flow sensor, impedance sensor, or any combination thereof. Each possibility is a sperate embodiment.

[0044] There is provided herein, according to some embodiments, a method for guiding insertion of an endotracheal tube (ETT) into a subject’s trachea utilizing an esophageal auxiliary device (EAD), the method includes: obtaining an EAD disclosed herein; inserting the EAD into an oral pharyngeal space of the subject, such that the curved distal section is positioned in vicinity to the tongue base, wherein the insertion is conducted while the device is in a retracted configuration and the deployable member is in a closed configuration; deploying the deployable member to push and elevate the tongue base (thereby elevates the epiglottis) thereby generating and / or increasing an airway path; sliding the gastric tube distally and outwardly through the first and second passages towards the esophagus, passed the esophageal tracheal junction (ETJ) and into the stomach; and pushing the ETT guiding component distally through the airway component, such that the distal section of the ETT guiding component slides distally over the gastric tube and extends outwardly from the curved distal section of the airway component, wherein the esophageal slide element shifts to a deployed configuration, and, upon reaching the ETJ, the esophageal slide element blocks the esophagus and directs the ETT, thereby facilitating the insertion of the ETT to the trachea.

[0045] There is provided herein, according to some embodiments, a method for guiding insertion of an endotracheal tube (ETT) into a subject’s trachea utilizing an esophageal auxiliary device (EAD), the method includes: obtaining an EAD disclosed herein; inserting the EAD into an oral pharyngeal space of the subject, such that the curved distal section is positioned in vicinity to the tongue base, wherein the insertion is conducted while the device is in a retracted configuration, the deployable member is in a closed configuration and a distal end of the ETT contacts a proximal end of the esophageal slide element; deploying the deployable member to push and elevate the tongue base (thereby elevates the epiglottis) thereby generating and / or increasing an airway path; sliding the gastric tube distally and outwardly through the first and second passages passed the esophageal tracheal junction (ETJ), through the esophagus and into the stomach; and pushing the ETT and ETT guiding component, together, distally through the airway component, such that the distal section of the ETT and the ETT guiding component slide distally over the gastric tube and extends outwardly from the curved distal section of the airway component, wherein the esophageal slide element, pushed by the distal end of the ETT, shifts to a deployed configuration, and, upon reaching the ETJ, the esophageal slide element blocks the esophagus and the ETT distal section (end) slides over the esophageal slide element and is directed into the trachea; and further inserting the ETT to the trachea of the subject.

[0046] According to some embodiments, deploying the deployable member includes inflating balloon, deploying stent, a coil or any combination thereof. Each possibility is a separate embodiment.

[0047] According to some embodiments, the esophageal slide element includes a selfinflating balloon, a sponge or a combination thereof. Each possibility is a separate embodiment.

[0048] According to some embodiments, the method further includes closing the deployable member and removing the EAD.

[0049] According to some embodiments, the method further includes keeping the ETT in the trachea and the gastric tube in place (e.g, in stomach), allowing air and other gastric content to be drained out for a better ventilation compliance.

[0050] According to some embodiments, the method is devoid of the use of a laryngoscope.

[0051] There is provided herein, according to some embodiments, a kit for guiding insertion of an endotracheal tube (ETT) into a subject’s trachea, the kit includes: the EAD disclosed herein, a gastric tube and an ETT. According to some embodiments, the ETT is the ETT disclosed herein.

[0052] There is provided herein, according to some embodiments, an esophageal auxiliary device (EAD) for facilitating insertion of an endotracheal tube (ETT) into a trachea of a subject in a need thereof, wherein the device includes an elongated body configured to be inserted through the oro / naso pharynx into the esophagus of the subject, wherein the elongated body includes: a proximal component, wherein, when the device is inserted to the esophagus, the proximal component is configured to be positioned in the oral space in vicinity to a tongue base of the subject, the proximal component has a closed configuration, for smooth insertion of the device to the oral space and / or, in according to some embodiments, the esophagus, and a deployed configuration, configured to elevate the tongue base and the epiglottis, thereby generate a void facilitating the insertion of the ETT into the trachea; and a distal component having a closed configuration, for smooth insertion of the esophageal auxiliary device to the esophagus, and a deployed configuration, wherein, the distal component is movable proximally and distally along the elongated body, wherein the deployed configuration of the distal component is configured to secure the position thereof in vicinity and distally to the Esophageal-Tracheal Junction (ETJ), to block the esophagus entrance, and to guide the insertion of the ETT into the trachea.

[0053] According to some embodiments, the elongated body may be a wire, a tube, or a rod.

[0054] According to some embodiments, the distal component may include a guiding element configured to guide the insertion of the ETT into the trachea.

[0055] According to some embodiments, the guiding element may be a guide wire, a slide, a ramp, a rail, a groove, a pipe, a tube, a track, a passage or any combination thereof.

[0056] According to some embodiments, the guide wire may be integrally formed with the esophageal auxiliary device.

[0057] According to some embodiments, the guiding element may have a retractable guide wire configured to be at least partially folded in and extended from the distal component, to advance proximally in the esophagus, and, upon reaching the ETJ, change direction to advance distally into the trachea, thereby guide the insertion of the ETT into the trachea along its length.

[0058] According to some embodiments, the guide wire may be configured to guide the insertion of the ETT by enabling the ETT to slide thereover.

[0059] According to some embodiments, the distal component and / or the guide wire may include a first sensor configured to identify the ETJ location. According to some embodiments, the first sensor may be, for example but not limited to, a touch / tactile sensor (which may sense the esophagus walls, or lack thereof, when reaching the ETJ), airflow meter / air velocity sensor (which may sense airflow upon reaching the ETJ, assuming the subject is ventilated), a static electricity sensor, magnetic field sensor or any combination thereof. Each possibility is a separate embodiment.

[0060] According to some embodiments, the guide wire may have at tip section thereof, a second sensor configured to confirm positioning thereof in the trachea. According to some embodiments, the second sensor may be a CO2 sensor, a temperature sensor, a flow sensor, or any combination thereof. Each possibility is a separate embodiment.

[0061] According to some embodiments, the deployed configuration of the distal component includes a securing member. According to some embodiments, the securing member may be an inflatable balloon, an anchor, a stent, a pillar, a coil, a pipe, a tube, a wing, or any combination thereof. Each possibility is a separate embodiment.

[0062] According to some embodiments, the proximal component, in the deployed configuration thereof, may be further configured to elevate the epiglottis to increase the void for the insertion of the ETT.

[0063] According to some embodiments, the deployed configuration of the proximal component may include a balloon, a stent a pillar, a pipe, a tube, and / or a coil, or any combination thereof to facilitate the tongue base elevation and thereby epiglottis elevation. Each possibility is a separate embodiment.

[0064] According to some embodiments, the elongated body includes a curved distal portion to facilitate insertion into the subject's Esophagus.

[0065] According to some embodiments, there is provided herein a method for guiding insertion of an endotracheal tube (ETT) into a subject’s trachea utilizing an esophageal auxiliary device (EAD), the method includes: obtaining an EAD comprising: an elongated body comprising a proximal component having a closed configuration and a deployed configuration, and a distal component having a closed configuration and a deployed configuration; inserting the EAD through the oro / naso pharynx into the esophagus of the subject, such that the proximal component is positioned in the oral / pharyngeal space in vicinity to a tongue base and the distal component is positioned in the esophagus distally to an esophageal-tracheal junction (ETJ), wherein the insertion is conducted while the proximal and distal components are in closed configuration; deploying the proximal component to elevate the tongue base (thereby elevates the epiglottis) thereby generating a void for the insertion of the ETT ; identifying the location of the ETJ utilizing a first sensor; pulling the distal component proximally along the elongated body to a position distal and in vicinity to the ETJ; and deploying the distal component thus securing the position of the distal component and blocking the esophagus entrance, and thereby facilitating guided insertion of the ETT to the trachea.

[0066] According to some embodiments, the method may further include inserting the ETT to the trachea of the subject.

[0067] According to some embodiments, the insertion of the ETT into the trachea may be facilitated by a guiding element of the distal component. According to some embodiments, the guiding element may include a slide, a ramp, a rail, a groove, a pipe, a tube, a track, a passage or any combination thereof. Each possibility is a separate embodiment.

[0068] According to some embodiments, the insertion of the ETT into the trachea may be facilitated by a retractable guide wire, and the method further includes retracting the guide wire from a partially folded configuration in the distal component, such that the guide wire advances proximally, in the esophagus, and upon reaching the ETJ, changes direction to advance distally into the trachea, thereby guiding the insertion of the ETT into the trachea along its length.

[0069] According to some embodiments, the method further includes identifying the ETJ location, utilizing a first sensor located in the distal component and / or the guide wire. According to some embodiments, the first sensor may be, for example but not limited to, a touch / tactile sensor (which may sense the esophagus walls, or lack thereof, when reaching the ETJ), airflow meter / air velocity sensor (which may sense airflow upon reaching the ETJ, assuming the subject is ventilated), a static electricity sensor, magnetic field sensor or any combination thereof. Each possibility is a separate embodiment.

[0070] According to some embodiments, the method further includes confirming the position of the guide wire in the trachea, utilizing a second sensor positioned at tip section of the guide wire. According to some embodiments, the second sensor may be a CO2 sensor, a temperature sensor, a flow sensor, or any combination thereof. Each possibility is a separate embodiment.

[0071] According to some embodiments, with respect to the method, deploying the proximal component includes inflating balloon, deploying stent, a pillar, a coil, a pipe, a tube, or any combination thereof. Each possibility is a separate embodiment.

[0072] According to some embodiments, the method further includes removing the guide wire after confirmation that the ETT is in the trachea.

[0073] According to some embodiments, the method further includes closing the proximal and the distal components of the EAD.

[0074] According to some embodiments, the method further includes removing the EAD, wherein the distal and proximal components are in closed configuration.

[0075] BRIEF DESCRIPTION OF THE FIGURES

[0076] Some embodiments of the disclosure are described herein with reference to the accompanying figures. The description, together with the figures, makes apparent to a person having ordinary skill in the art how some embodiments may be practiced. The figures are for the purpose of illustrative description and no attempt is made to show structural details of an embodiment in more detail than is necessary for a fundamental understanding of the disclosure. For the sake of clarity, some objects depicted in the figures are not to scale.

[0077] In the figures: FIG. 1 schematically illustrates an intubation procedure according to the prior art;

[0078] FIG. 2 schematically shows an esophageal auxiliary device (EAD), having an elongated body, a proximal component (in a closed configuration) and a distal component (in a closed configuration), inserted, respectively, in the pharynx and the esophagus of a subject, according to some embodiments;

[0079] FIG. 3 schematically shows the EAD of FIG. 2, having the proximal component in a deployed configuration, according to some embodiments;

[0080] FIG. 4 schematically shows the EAD of FIG. 3, having the distal components in a deployed configuration, and a securing member, according to some embodiments;

[0081] FIG. 5 schematically shows the EAD of FIG. 4, and an ETT guided thereby into the subject’s trachea, according to some embodiments;

[0082] FIG. 6 schematically shows an EAD, having an elongated body, a proximal component (in a closed configuration) and a distal component (in a closed configuration), inserted in the pharynx and the esophagus of a subject, and a guide wire for example, an integrated (such as built-in) guide wire, threaded through EAD and folded in at a distal section thereof, according to some embodiments;

[0083] FIG. 7 schematically shows the EAD of FIG. 6, having the proximal component in a deployed configuration, according to some embodiments;

[0084] FIG. 8 schematically shows the EAD of FIG. 7, having the guide wire in a partially folded configuration and extended partially in the esophagus and partially in the trachea of the subject, a first sensor, and a second sensor, according to some embodiments;

[0085] FIG. 9 schematically shows the EAD of FIG. 8, having a distal component in a deployed configuration, and a securing member, according to some embodiments;

[0086] FIG. 10 schematically shows the EAD of FIG. 9, having the guide wire in an extended configuration in the trachea of the subject, according to some embodiments; FIG. 11 schematically shows the EAD of FIG. 10, having an ETT guided by the extended guide wire into the subject’s trachea, according to some embodiments;

[0087] FIG. 12 shows a flow chart of a method of inserting ETT into a subject’s trachea using the EAD, according to some embodiments;

[0088] FIGS. 13A-13B schematically illustrate a first view (13A) and a second view (13B) of an esophageal auxiliary device (EAD) in a retracted configuration, having a tubular airway component with a deployable member (in a closed configuration), an ETT guiding component with an esophageal slide element (in a collapsed configuration), according to some embodiments;

[0089] FIGS. 13C-13D schematically illustrate the EAD of FIG. 13B in an extended configuration, and having the deployable member in a deployed configuration and the esophageal slide element in a deployed configuration.

[0090] FIG. 14A schematically illustrates the EAD of FIGS. 13C-13D while in use (intubation) and in an extended configuration, having a gastric tube inserted through a first and a second passages and an ETT inserted into the EAD, while the deployable member, the esophageal slide element and an ETT securing member are in a deployed configuration, according to some embodiments;

[0091] FIG. 14B an exploded view drawing of the EAD having a gastric tube inserted through a first and a second passages, and an ETT inserted into the EAD, while the deployable member and an ETT securing member are in a deployed configuration, according to some embodiments;

[0092] FIG. 15 schematically shows an EAD (in a retracted configuration) inserted in the oropharynx of a subject, having a deployable member in a closed configuration, and an esophageal slide element in a collapsed configuration (not shown), according to some embodiments;

[0093] FIG. 16 schematically shows the EAD of FIG. 15, having the deployable member in a deployed configuration, according to some embodiments; FIG. 17 schematically shows the EAD of FIG. 16, having a gastric tube inserted through a first and a second passages and positioned in the stomach, according to some embodiments;

[0094] FIG. 18 schematically shows the EAD of FIG. 17 in an extended configuration and having the ETT guiding component riding over the gastric tube and the esophageal slide element in a deployed configuration blocking the esophagus, according to some embodiments;

[0095] FIG. 19 schematically shows the EAD of FIG. 18 (or, alternatively of FIG. 25) having an (undeployed) ETT inserted through the airway component, and directed by the esophageal slide element towards the trachea, according to some embodiments;

[0096] FIG. 20 schematically shows the EAD of FIG. 19 having the (undeployed) ETT inserted into the trachea, according to some embodiments;

[0097] FIG. 21 schematically shows the EAD of FIG. 20 having a deployed ETT into the trachea, according to some embodiments;

[0098] FIG. 22 schematically shows the ETT inserted and deployed into the trachea and the gastric tube inserted into the stomach, after removing the EAD, according to some embodiments;

[0099] FIG. 23 shows a flow chart of a method of inserting ETT into a subject’s trachea using the EAD, according to some embodiments;

[0100] FIG. 24 schematically shows the EAD of FIG. 16 having the distal end of an ETT contacting a proximal end of the esophageal slide element (not shown) and a gastric tube inserted through a first and a second passages and positioned in the stomach, according to some embodiments;

[0101] FIG. 25 schematically shows the EAD of FIG. 24, having the distal section (end) of the ETT and the ETT guiding component sliding together over the gastric tube, and the esophageal slide element in a deployed configuration blocking the esophagus, according to some embodiments. FIG. 26 shows a flow chart of a method of inserting ETT into a subject’s trachea using the EAD, according to some embodiments.

[0102] DETAILED DESCRIPTION

[0103] The principles, uses, and implementations of the teachings herein may be better understood with reference to the accompanying description and figures. Upon perusal of the description and figures present herein, one skilled in the art will be able to implement the teachings herein without undue effort or experimentation. In the figures, same reference numerals refer to same parts throughout.

[0104] The present invention, in some embodiments thereof, relates to an esophageal auxiliary device (EAD) and method for insertion of an endotracheal tube (ETT) into a subject trachea without Laryngoscopy. In particular, some embodiments relate to insertion of a device into the esophagus for facilitating ETT insertion. In some embodiments, the insertion of the guide involves passing the EAD through the nose or mouth of a subject.

[0105] Reference is now made to FIG. 1, which schematically shows a standard intubation 100, according to the prior art. Standard intubation 100 involves a laryngoscope 102 and an endotracheal tube (ETT) 104 inserted in the pharynx and the trachea of a subject 106. The complexity of currently used intubation can be understood from FIG. 1 since the intubation procedure relies on a laryngoscopy procedure, which necessitates precise / accurate positioning of the laryngoscope, and head and neck, to achieve optimal visualization of the vocal cords, thereby ensuring proper ETT insertion.

[0106] Embodiments of this disclosure present a simpler and easier to use solution, blindintubation without Laryngoscopy.

[0107] FIGS. 2-5 schematically show an EAD 201, its positioning in the pharynx and the esophagus of a subject 200 and its use in simplifying a proper insertion of a tube, such as ETT 104 (shown in FIG. 1), according to some embodiments. In some embodiments, EAD 201 includes an elongated body 202 having a proximal component 204 and distal component 206. Reference is now made to FIG. 2, which schematically shows EAD 201 inserted in the pharynx and the esophagus of a subject 200, according to some embodiments. Proximal component 204 and distal component 206 are shown herein in closed configurations.

[0108] According to some embodiments, EAD 201, is configured to be inserted through the nose or mouth of the subject, pass through the oro / naso-pharynx and into the esophagus. The insertion of EAD 201 is conducted while proximal component 204 and distal component 206 are in a closed configuration, in order to facilitate smooth insertion. In some embodiments (not shown), elongated bodies of EADs, such as elongated body 202 of EAD 201, may include a curved distal portion to further facilitate the insertion into the subject’s esophagus. As shown herein, proximal component 204 of EAD 201, is configured to be positioned in the oral / pharyngeal space in vicinity to a tongue base of the subject. Distal component 206 of EAD 201, is configured to be positioned in the esophagus distally and adjacent to an esophageal-tracheal junction (ETJ) of the subject.

[0109] As used herein, the terms “esophageal-tracheal junction”, “ETJ” may interchangeably be used, and refer to specify the point where the esophagus meets the trachea and upper airways space.

[0110] After EAD 201 has been placed in the proper position in the esophagus (as depicted in FIG. 2), it needs to be secured and transformed into functional mode to guide / tunnel the insertion of the ETT.

[0111] Reference is now made to FIG. 3, which schematically shows EAD 201 inserted in the oro / naso pharynx and the esophagus of subject 200 while proximal component 204 is in a deployed configuration 304. Although deployed configuration 304 is merely schematically demonstrated herein, according to some embodiments, it may include an inflated ballon, a stent, a pipe, a tube, a pillar, a coil, and the like, or any combination thereof, designed to elevate and support the tongue base, which lead to elevation of the epiglottis of the subject. This deployed configuration 304 of proximal component 204 clears the way for the insertion of the ETT. Distal component 206 is still in its closed configuration. Next, as depicted in FIG. 4, according to some embodiments, distal component 206 is transformed into its deployed configuration 406. As shown in FIG. 4, both proximal component 204 and distal component 206 are in their respective deployed configuration 304 and 406. According to some embodiments, deployed distal component 406 is movable proximally and optionally distally along elongated body 202. Although not shown, distal component 206 (for example, in its deployed configuration 406) may include a first sensor, configured to identify the subjects’ ETJ and optionally also to indicate / signal the site / location where the distal component 206 must move to and be deployed, and a guiding element configured to guide the insertion of the ETT into the trachea. According to some embodiments, the guiding element may include a guide wire (as exemplified and disclosed herein), a slide, a ramp, a rail, a groove, a pipe, a tube, a track, a passage, or any combination thereof. Although first sensor not shown, according to some embodiments, the first sensor may include, for example but not limited to, a touch / tactile sensor (which may sense the esophagus walls, or lack thereof, when reaching the ETJ), carbon dioxide (CO2) sensor, airflow meter / air velocity sensor (which may sense airflow upon reaching the ETJ, assuming the subject is ventilated), a static electricity sensor, magnetic field sensor or any combination thereof. Each possibility is a separate embodiment.

[0112] As noted above, with regards to proximal component 204, distal component 206 in its deployed configuration 406 may further include a securing member 407 (for example, an inflated ballon, an anchor, a stent, a pipe, a tube, a wing, a pillar, a coil, and the like, or any combination thereof), designed to secure / stabilize the position of deployed distal component 406 within the esophagus adjacent and distally to the esophageal- tracheal junction (ETJ). Optionally, securing member 407 may also be configured to support the epiglottis, block the esophagus entrance, and thereby guide and tunnel the insertion of the ETT 508 into the trachea of the subject 200 (FIG. 5).

[0113] It is noted that, in accordance with some embodiments, after EAD 201 is properly positioned in the esophagus, and proximal component 204 is deployed, the ETJ is identified, optionally using a first sensor (not shown), then distal component 206 is deployed. As depicted in FIG. 5, according to some embodiments, after both proximal component 204 and distal component 206 has been in their respective deployed configuration 304 and 406, the esophagus entrance is blocked, and the ETT is carefully guided (tunnelled) into the trachea, ensuring a smooth and successful intubation procedure 500. It can be understood from FIG. 5 that, advantageously, the intubation procedure 500 does not require a difficult procedure of laryngoscopy (as discussed hereinabove) but rather involves a blind insertion of the EAD 201 and thereafter of the ETT 508. It is noted that ETT 508 may be, for example, a commonly used ETT such as ETT 104 (shown in FIG. 1).

[0114] According to some embodiments, elongated bodies of EADs, such as elongated body 202 of EAD 201, may be a wire, rod (as shown herein), a tube or any other form appropriate for insertion to the esophagus of the subject.

[0115] Next, according to some embodiments, although not shown, both deployed proximal component 304 and distal component 406 transform to their respective closed configuration 204 and 206, thereby facilitating smooth extraction / removal of EAD 201 (including elongated body 202) from the esophagus and the subject’s larynx.

[0116] FIGS. 6-11 schematically show an EAD 601, its positioning in the oro / naso pharynx and the esophagus of a subject 200 and its use in simplifying a proper insertion of a tube, such as ETT 104 (shown in FIG. 1), according to some embodiments. In some embodiments, EAD 601 includes an elongated body 602 having a proximal component 604, a distal component 606, and a retractable guide wire 608 threaded through or extended along EAD 601. According to some embodiments, deployed distal component 606 is movable proximally and optionally distally along elongated body 602.

[0117] Reference is now made to FIG. 6, which schematically shows an EAD 601 inserted in the oro / naso pharynx and the esophagus of a subject 200, according to some embodiments. The proximal component 604 and distal component 606 are shown herein in closed configurations, and the guide wire 608 threaded through EAD 601 is shown herein in a folded configuration 610 at a distal section thereof.

[0118] According to some embodiments, EAD 601, is configured to be inserted through the nose or mouth of the subject, passed through the oro / naso pharynx and into the esophagus. The insertion of EAD 601 is conducted while proximal component 604 and distal component 606 are in a closed configuration, and guide wire 608 is in a folded configuration 610, in order to facilitate smooth insertion. As shown herein, proximal component 604 of EAD 601, is configured to be positioned in the oro / naso pharynx in vicinity to the subject’s tongue base. Distal component 606 of EAD 601, is configured to be positioned in the esophagus distally and adjacent to the subject’s ETJ.

[0119] Reference is now made to FIG. 7, which schematically shows EAD 601 inserted in the oro / naso pharynx and the esophagus of subject 200 after proximal component 604 was transformed to its deployed configuration 704. Although proximal deployed configuration 704 is merely schematically demonstrated herein, according to some embodiments, it may include an inflated ballon, a stent, a pillar, a pipe, a tube, a coil, and the like, or any combination thereof (each possibility is a separate embodiment), designed to elevate and support the tongue base which leads to elevation of the epiglottis of the subject. Deployed configuration 704 of proximal component 604 clears the way for the insertion of the ETT. As shown in FIG. 7, distal component 606 is still in its closed configuration and guide wire 608 is still in its folded configuration 610.

[0120] Next, as depicted in FIG. 8, according to some embodiments, proximal component 604 is in a deployed configuration 704, distal component is still in its closed configuration 606, and guide wire 608 (shown folded in FIG. 7) is now transformed to its partially folded configuration 808. As shown in FIG. 8, the partially folded guide wire 808 advances proximally, in the esophagus, and upon reaching the ETJ, change direction to advance distally into the trachea to extend partially in the esophagus 809a and partially in the trachea 809b. Furthermore, as shown in FIG. 8, according to some embodiments, guide wire 608 is advanced into partially folded and extended configuration 808. Also shown in FIG. 8, is that guide wire 608 includes a first sensor 810, configured to identify the subjects’ ETJ location and a second sensor 812 located at tip section thereof and configured to confirm positioning of the partially extended 808 guide wire 608 in the trachea. Although first sensor 810 and second sensor 812 are merely schematically demonstrated herein, according to some embodiments, the first sensor 810 may include, for example but not limited to, a touch / tactile sensor (which may sense the esophagus walls, or lack thereof, when reaching the ETJ), CO2 sensor, airflow meter / air velocity sensor (which may sense airflow upon reaching the ETJ, assuming the subject is ventilated), a static electricity sensor, magnetic field sensor or any combination thereof. Each possibility is a separate embodiment. The second sensor may include, for example, a CO2 sensor a temperature sensor or a flow sensor, and the like, or any combination thereof (each possibility is a separate embodiments), designed to confirm the positioning of the guide wire 808 in the trachea.

[0121] Next, as depicted in FIG. 9, according to some embodiments, once the first sensor 810 identifies the ETJ location, the distal component 606 is pulled backwards and advances proximally, in the esophagus, and upon reaching the ETJ, transformed into its deployed configuration 906, optionally, utilizing a securing member 907. Securing member 907 may be an (integral) part of the distal component of EAD 601. Guide wire 608 is still in its partially folded and extended configuration 808 and extends partially in the esophagus 809a and partially in the trachea 809b. As shown in FIG. 9, both proximal component 604 and distal component 606 are in their respective deployed configuration 704 and 906. Securing member 907 designed to secure / stabilize the position of distal component 606 of EAD 601 within the esophagus in adjacent / vicinity and distally to the ETJ, support the epiglottis, block the esophagus entrance, and thereby guide and tunnel / facilitate the insertion of the ETT 1114 into the trachea of the subject 200 (FIG. 11). Although not shown, deployed distal component 906 may further include a guiding element configured to guide the insertion of the ETT into the trachea. According to some embodiments, the guiding element may include a slide, a ramp, a rail, a groove, a pipe, a tube, a track, a passage or any combination thereof.

[0122] Securing member 907 is schematically demonstrated herein but may include an inflated ballon, an anchor, a stent, a pillar, a pipe, a coil, a tube, a wing and the like, or any combination thereof. Each possibility is a separate embodiment.

[0123] It is noted that, in accordance with some embodiments, after EAD 601 is properly positioned in the esophagus, proximal component 604 may be deployed first and then distal component 606 is deployed, or proximal component 604 and distal component 606 may be converted into their respective deployed configuration 704 and 906 simultaneously. Then, according to some embodiments, the esophageal part 809a of guide wire 608 is pulled out from the esophagus and propagates into the trachea in its extended configuration 1008 (as shown in FIG. 10).

[0124] Once, as shown in FIG. 10, both proximal component 604 and distal component 606 has shifted to their respective deployed configuration 704 and 906, securing member 907 is in position, guide wire 608 is in its extended configuration 1008 in the trachea and the esophagus entrance is blocked, EAD 601 is ready to guide (tunnel / facilitate) an ETT insertion into the trachea.

[0125] Reference is now made to FIG. 11, which schematically shows EAD 601 and ETT 1114 guided by guide wire 608 in its extended configuration 1008 into the trachea, ensuring a smooth and successful intubation procedure 1100 by enabling the ETT to slide over the wire.

[0126] It is noted that although in FIG. 11 guide wire 608 is shown threaded in ETT 1114 and thus guiding the ETT to the trachea, other embodiments of a guide wire guiding the ETT into the trachea are also covered under the scope of this disclosure. Such embodiments may include a “guide wire” in a form of a track, a ramp, a pipe, a tube, a slide, a rail, a groove, a track, a passage or any combination thereof, configured to guide the ETT into the trachea alongside, and / or along an external surface thereof.

[0127] It is noted that although ETT 1114, as shown in FIG.ll, is guided into the trachea by being threaded over guide wire 608, embodiments of this disclosure further cover the option of the ETT sliding along the guide wire, which functions as a rail.

[0128] It can be understood from FIG. 11 that, advantageously, intubation procedure 1100 does not require a procedure of laryngoscopy (as discussed hereinabove) but rather involves the blind insertion of the EAD 601 and then of the ETT 1114. It is noted that ETT 1114 may be, for example, a commonly used ETT such as ETT 104 (shown in FIG. 1).

[0129] According to some embodiments, elongated bodies of EADs, such as elongated body 602 of EAD 601, may be a wire, rod (as shown herein), a tube or any other form appropriate for insertion to the esophagus of the subject. In some embodiments, guide wires of EADs, such as guide wires 608, 610, 808, 809a, 809b and 1008 of EAD 601, may be continuous line (as shown herein in FIGS. 6- 11), composed of parts, or any combination thereof.

[0130] Reference is now made to FIG. 12, which shows a flow chart of a method of inserting ETT into a subject’s trachea using the EAD, according to some embodiments, such as but not limited to, EADs 201 (FIGS. 2-5) and 601 (FIGS. 6-11).

[0131] At step 1202, the EAD is inserted into the oro / naso pharynx of a subject when its proximal component and distal component are in closed configuration. The EAD is positioned in the esophagus such that the proximal component is positioned in the pharynx in vicinity to the tongue base, and the distal component is positioned in the esophagus distally to an esophageal-tracheal junction (ETJ). According to some embodiments, the insertion of the EAD may be an oral or a nasal insertion.

[0132] At step 1204, the proximal component is deployed to elevate (and support) the tongue base and the epiglottis, thereby generating a void for the insertion of the endotracheal tube (ETT). In some embodiments, deploying the proximal component may include inflating balloon, deploying stent, an anchor, a pillar, a coil, a pipe, a tube, a wing, or any combination thereof.

[0133] At step 1206, while the distal component is pulled backwards, it advances proximally in the esophagus along the elongated body of the EAD, to identify / locate the esophageal-tracheal junction (ETJ) and be positioned distally and in vicinity to it. The location of the ETJ is identified, optionally utilizing a first sensor, located on the distal component.

[0134] At step 1208, the distal component is deployed. In some embodiments, deploying the distal component is configured to secure / stabilize the position of the distal component of the EAD in the esophagus to a position distally and in vicinity to the ETJ and to block the esophagus entrance. In some embodiments, deploying the distal component is configured to further support the epiglottis and tunnel the entrance to the trachea. In some embodiments, deploying the distal component includes deploying a securing member. In some embodiments, deploying the securing member may include inflating balloon, deploying stent, an anchor, a pillar, a coil, a pipe, a tube, a wing, a slide or any combination thereof. Optionally, the distal component of the EAD may include a retractable guide wire extendable along EAD and folded at a distal section thereof. When such guide wire is utilized, at optional step 1210, the guide wire is extended from a folded configuration in the distal component, and advanced proximally, in the esophagus. Upon reaching and identifying the ETJ (optionally indicated by a first sensor), the direction of the guide wire is changed to advance distally into the trachea in order to guide the insertion of the ETT into the trachea along its length.

[0135] At step 1212, the insertion of the ETT into the trachea is facilitated by the distal component of the EAD (and, optionally, by the guide wire) as a guide, and its proper position in the trachea is confirmed. According to some embodiments, the EAD may include a guiding element such as a slide, a ramp, a rail, a groove, a pipe, a tube, a track, a passage or any combination thereof, to assist in guiding the ETT. According to some embodiments, confirming the proper position of the ETT in the trachea may include determining the air flow, the temperature and / or one or more parameters associated with CO2 levels in vicinity to the ETT by a second sensor at the tip section of the guide wire, if used.

[0136] At step 1216, both deployed proximal component and distal component transformed to their closed configuration, thereby facilitating smooth extraction / removal of the EAD from the esophagus and the subject’s larynx. Thereafter, the EAD is removed, and the intubation is completed and the ETT can be secured in the right place. Optionally, as depicted at step 1214, if a guide wire is utilized, it is typically removed after confirming that the ETT is in the trachea, the guide wire is removed before removal of the EAD.

[0137] Reference is now made to FIGS. 13A-13B, which schematically illustrate, in accordance with some altemative / additional embodiments, a first view (13A) and a second view (13B) of another esophageal auxiliary device (EAD) 1300. According to some embodiments, the device (EAD) has at least two configurations. According to some embodiments, the device (EAD) has a retracted configuration and an extended configuration.

[0138] EAD 1300 is depicted in a retracted configuration, and having a tubular airway component 1310 with a deployable member in a closed configuration 1316, and an ETT guiding component 1320 with an esophageal slide element in a collapsed configuration 1330, and to FIGS. 13C-13D which schematically illustrate the EAD in an extended configuration 1301, and having the deployable member in a deployed configuration 1317, and the esophageal slide element in a deployed configuration 1331.

[0139] According to some embodiments, the tubular airway component 1310 is configured to be inserted into the oropharynx of a subject. According to some embodiments, tubular airway component 1310 includes a proximal section 1312 and a curved distal section 1314 having a deployable member 1316. According to some embodiments, the proximal section of the tubular airway is adjustable. In some embodiments, deployable member 1316 has a closed configuration (shown in FIGS. 13A-13B), for smooth insertion of the airway component 1310 to the oral pharyngeal space, and a deployed configuration (shown in FIG. 13C). In some embodiments, deployable member 1316 is configured to push / elevate the tongue base, thereby generate and / or increase an airway path. In some embodiment, deployable member 1316 is movable proximally and distally along an outer wall 1315 of airway component 1310. According to some embodiments, the outer wall 1315 of airway component 1310 includes outer longitudinal rails (e.g. rail 1319), recesses, tunnels, and / or channels, or any combination thereof, for moving the deployable member 1316. Each possibility is a separate embodiment.

[0140] According to some embodiments, deployable member 1316 is connected to an inlet / outlet member 1318 configured to deploy the deployable member from a closed configuration 1316 (shown in FIGS. 13A-13B) to a deployed configuration 1317 (shown in FIGS. 13C-13D), and un-deploy the deployable member from the deployed configuration 1317 to the closed configuration 1316 (shown in FIG. 13A). According to some embodiments, the inlet / outlet member is configured to inlet / outlet air and / or fluid. Each possibility is a separate embodiment. According to some embodiments, the deployable member includes an inflating balloon, a stent, a coil or any combination thereof. Each possibility is a separate embodiment. According to some embodiments, the deployable member is a self-deployed member (e.g., self-inflated).

[0141] As used herein, the term “self-deployed” refers to a component that automatically moves and / or changes shape from a first configuration to a second configuration due to an inherent property or stored energy, without requiring active external force or actuation. According to some embodiments, the ETT guiding component 1320 is insertable within the airway component 1310 and movable proximally and distally along airway component 1310. According to some embodiments, as shown herein, the ETT guiding component 1320 comprises a proximal section 1322, and a distal section 1324 having an esophageal slide element 1330 (shown herein in a collapsed configuration). According to some embodiments, the ETT guiding component 1320 further includes a first passage 1326 extending from the proximal section 1322 to the distal section 1324 configured for insertion of a gastric tube therethrough (not shown).

[0142] As used herein, the term "passage" may refer to an internal passage or channel within the ETT guiding component, configured to accommodate the flow or passage of fluids, gases, wires, instruments, or other elements (e.g., gastric tube). The passage may be fully enclosed (e.g. lumen) or partially open. In some embodiments, the passage may function as a guiding structure, such as a rail, track, or groove, facilitating the movement or positioning of an element (e.g., gastric tube) within the ETT guiding component.

[0143] According to some embodiment, in the retracted configuration 1300, the proximal section of the ETT guiding component 1322 is proximally and outwardly retracted from the airway component 1310, and the distal section of the ETT guiding component 1324 is inserted in the curved distal section of the airway component 1314 , and the esophageal slide element 1330 is in a collapsed configuration within the curved distal section of the airway component 1314.

[0144] According to some embodiments, in an extended configuration of the EAD 1301, the proximal section of the ETT guiding component 1322 is inserted into the airway component 1310, and the distal section of the ETT guiding component 1324 is extended distally and outwardly from the curved distal section of the airway component 1314, while the esophageal slide element is in a deployed configuration 1331 configured to block the esophagus. In some embodiments the ETT may be inserted through the EAD and into the trachea of the subject. According to some embodiments, the esophageal slide element is a self-deployed member.

[0145] Reference is now made to FIGS. 14A-14B. FIG. 14A schematically illustrates the EAD of FIGS. 13C-13D while in use (intubation) 1400 and in an extended configuration 1401, having a gastric tube 1402 inserted through a first and a second passages (1426 and 1428, respectively) and an ETT 1403 inserted into the EAD, while the deployable member 1417, the esophageal slide element 1431 and an ETT securing member 1405 (typically, a balloon) are in a deployed configuration. It is noted, in accordance with some embodiments, that the ETT used herein may be a standard ETT currently available in the market. FIG. 14B shows exploded view drawings of the EAD (e.g., EAD 1300) while in use, having the gastric tube 1402 inserted through a first and a second passages (1426 and 1428, respectively) and the ETT 1403, while the deployable member, the esophageal slide element and an ETT securing member are in their deployed configuration (1417, 1431 and 1405, respectively).

[0146] According to some embodiment, the tubular airway component 1410 (which includes proximal section 1412 and distal section 1414) has a longitudinal opening 1413 along at least a part of a length thereof. In some embodiments, longitudinal opening 1413 include one or more inner and / or outer longitudinal rails, recesses, tunnels, and / or channels, or any combination thereof, for supporting and / or guiding the ETT guiding component 1420 (which includes proximal section 1422 and distal section 1424) and the gastric tube 1402 inserted through ETT guiding component 1420. Each possibility is a separate embodiment. According to some embodiments longitudinal opening 1413 facilitates the removal of airway component 1410 while keeping the ETT 1403 in place (in the trachea). According to some embodiments the tubular airway component comprises a bottom portion and a top portion configured to define an interior cavity. In one embodiment, the top portion is connected to the bottom portion via a hinge structure (e.g., an integrally formed living hinge or one or more mechanical hinge members), allowing the top portion to pivot between a closed position (i.e., where the tubular component is substantially continuous), and an open position for partial access to the interior cavity. According to some embodiment, the top portion is detachably connected to the bottom portion, thereby permitting complete removal of the top portion to provide full access to the interior cavity. In some embodiment, a latching or fastening mechanism is provided to secure the top portion in the closed position. According to some embodiments, the shape of the bottom portion of the tubular airway component is a U shape. According to some embodiments the tubular airway component is devoid of top portion. According to some embodiments, the tubular airway component is a lumen (O shape). According to some embodiments, the tubular airway component comprises a semi rigid material configured to provide both structural stability and flexibility.

[0147] According to some embodiment, deployable member 1417, is an integral part of tubular airway component 1410, or a separable part. Each possibility is a separate embodiment.

[0148] According to some embodiments, esophageal slide element 1431 is shaped and / or comprises a directional element 1432 for directing the ETT 1403 towards the trachea. According to some embodiments, directional element 1432 comprises a slide, tunnel, ramp, rail, groove, pipe, tube, track, passage, recess or any combination thereof. Each possibility is a separate embodiment. According to some embodiments, the esophageal slide element 1431 includes the second passage 1428 extending there through and configured for insertion of the gastric tube 1402 through second passage 1428. According to some embodiments, the second passage 1428 is further positioned to centralize the gastric tube 1402 received from the first passage 1426.

[0149] FIGS. 15-22 schematically show an EAD in its retracted or extended configurations (1500 and 1801, respectively), its positioning in the oropharynx of a subject 200 and its use in simplifying a proper insertion of a tube, such as ETT 1403 (shown in FIG. 14B), according to some embodiments. In some embodiments, EAD 1500 (and EAD 1801) includes a tubular airway 1510 and an ETT guiding component 1520. In some embodiments, tubular airway 1510 includes a proximal section 1512 and a curved distal section 1514 which includes a deployable member 1516. In some embodiments, the ETT guiding component 1520 includes a proximal section 1522, a distal section 1824 (shown in FIG. 18) and an esophageal slide element (shown in FIG. 18 in a deployed configuration 1831).

[0150] Reference is now made to FIG. 15, which schematically shows EAD 1500 inserted in the oropharynx of a subject 200, according to some embodiments. Deployable member 1516 is shown herein in a closed configuration and esophageal slide element is in a collapsed configuration (not shown).

[0151] According to some embodiments, tubular airway 1510 of EAD 1500 is configured to be inserted into an oral pharyngeal space (into the oropharynx) of the subject 200 such that the curved distal section 1514 of tubular airway 1510 is positioned in vicinity to a tongue base. The insertion of tubular airway 1510 is conducted while deploy able member 1516 is in a closed configuration in order to facilitate smooth insertion of the airway component 1510 to the oral pharyngeal space of the subject 200. The insertion of tubular airway 1510 is conducted while EAD 1500 is in a retracted configuration. In the retracted configuration of EAD 1500 the proximal section 1522 of the ETT guiding component 1520 is proximally and outwardly retracted from the airway component 1510, and the distal section (not shown) of the ETT guiding component 1522 is inserted in the curved distal section 1514 of the airway component 1514, and the esophageal slide element is in a collapsed configuration (not shown) within the curved distal section 1514 of the airway component 1510. In some embodiments, the curved shape of curved distal section 1514 further facilitates smooth insertion of EAD 1500 into the subject’s oropharynx.

[0152] After EAD 1500 has been placed in the proper position in the subj ect’ s oropharynx (i.e., curved distal section 1514 of tubular airway 1510 is positioned in vicinity to a tongue base) (as depicted in FIG. 15), it needs to be secured and transformed into functional mode to guide / tunnel the insertion of the ETT.

[0153] Reference is now made to FIG. 16, which schematically shows EAD 1500 inserted into the oropharynx of the subject 200 while the deployable member is in a deployed configuration 1617. The esophageal slide element is still in a collapsed configuration (not shown), and the EAD is still in a retracted configuration.

[0154] According to some embodiments, the deployable member (shown herein in a deployed configuration 1617) is configured to push / elevate the tongue base, thereby generate and / or increase an airway path. In some embodiments, deployable member 1617 may include an inflating balloon, a stent, a coil or any combination thereof, designed to push / elevate the tongue base, thereby generate and / or increase an airway path. According to some embodiments, the deployable member 1617 is a self-deployed member (e.g., selfinflated). According to some embodiments, the deployable member 1617 is further configured to secure the position of the tubular airway 1510 in vicinity to a tongue base and to secure the EAD 1500 in the subject’s oropharynx.

[0155] In some embodiments, deployable member 1617 is connected to an inlet / outlet member 1618 configured to deploy the deployable member from a closed configuration 1516 (shown in FIG. 15) to a deployed configuration 1617 (shown herein in FIG. 16), and un-deploy the deployable member from the deployed configuration 1617 to the closed configuration 1516 (shown in FIG. 15).

[0156] According to some embodiments, for proper pushing / elevating the tongue base of a subject, the location of the deployable member is adjustable such that the deployable member is movable proximally and distally along an outer wall of the airway component (shown in FIG. 13D). In such case, according to some embodiments, the outer wall of the airway component includes outer longitudinal rails, recesses, tunnels, and / or channels, or any combination thereof, designed for moving the deployable member (shown in FIG. 13D).

[0157] Next, as depicted in FIG. 17, according to some embodiments, a gastric tube 1702 is inserted through a first passage 1726 of ETT guiding component 1520 and a second passage (not shown) of the esophageal slide element (in a collapsed configuration, not shown) and positioned in the stomach of the subject 200. According to some embodiments, first passage 1726 is extending from the proximal section 1522 to the distal section (shown in FIG. 14B) of ETT guiding component 1520, configured for insertion of a gastric tube there through (shown in FIG. 14B). According to some embodiments, the esophageal slide element (not shown) includes the second passage (shown in FIG. 14B) extending there through and configured for insertion of the gastric tube 1702 through the second passage (shown in FIG. 14B). According to some embodiments, the second passage is further positioned to centralize the gastric tube 1702 received from the first passage 1726. According to some embodiments, gastric tube 1702 is inserted through the first passage 1726 and the second passage (not shown), while deployable member 1617 is in a deployed configuration and EAD 1500 is in a retracted configuration.

[0158] As shown in FIG. 17, while EAD is in its retracted configuration 1500 the (inserted) gastric tube 1702 is slidable distally and outwardly from the first passage 1726 of ETT guiding component 1520 and the second passage (not shown) of the esophageal slide element (not shown, in collapsed configuration) towards the esophagus, passed the esophageal-tracheal junction (ETJ) and into the stomach, thereby facilitating sliding of the distal section (not shown) of ETT guiding component 1520 over the gastric tube 1702 until the esophageal slide element reaches the ETJ and blocks the esophagus (shown in

[0159] FIG. 18).

[0160] According to some embodiments, gastric tube 1702 allows air and other gastric content to be drained out of the subject’s stomach thereby allowing a better ventilation compliance.

[0161] Thereafter, as depicted in FIG. 18, according to some embodiments, EAD 1500 in its retracted configuration (shown in FIG. 17) is shifted (or transformed) to its extended configuration 1801 (deploy able member 1617 is still in a deployed configuration), and the esophageal slide element 1831 in its deployed configuration blocks the esophagus. According to some embodiments, in an extended configuration 1801, the proximal section 1522 of the ETT guiding component (shown in FIG. 14B) is inserted into the airway component 1510, and the distal section 1824 of the ETT guiding component (shown in FIG. 14B) is extended distally and outwardly from the curved distal section 1514 of the airway component 1510, and the esophageal slide element 1831 is in a deployed configuration.

[0162] According to some embodiments, esophageal slide element 1831 in its deployed configuration is configured to block the esophagus thereby facilitating the insertion of an ETT (shown, for example, in FIG. 19) through EAD 1801 into the trachea. According to some embodiments, as the EAD transforms from its retracted configuration (shown, for example, in FIG. 17) to its extended configuration 1801 (esophageal slide element 1831 is in its deployed configuration), the ETT guiding component (shown as proximal section 1522 and distal section 1824) “rides" over the (inserted) gastric tube 1702 such that esophageal slide element 1831 is guided by gastric tube 1702 to block (upon reaching the ETJ) the esophagus (entrance) and to facilitate sliding of the ETT over esophageal slide element 1831 thereby guiding the insertion of the ETT into the trachea of subject 200.

[0163] According to some embodiments, esophageal slide element 1831 is shaped and / or comprises a directional element (not shown) for directing the ETT towards the trachea. According to some embodiments, the esophageal slide element 1831 is a self-deployed (e.g. self-inflated) element. According to some embodiments, esophageal slide element 1831 includes a self-inflated soft material (e.g., foam-based self-inflating materials) which can expand, fill a void, and fully or partially block the esophagus (in vicinity to the ETJ). According to some embodiments, the self-inflatable soft material includes a sponge, a balloon, or any combination thereof. Each possibility is a separate embodiment.

[0164] According to some embodiments, esophageal slide element 1831 further includes a spring or an elastic element (not shown), proximally attached to the airway component 1510, and configured to exert a force foreword on the esophageal slide element 1831 so as to push the esophageal slide element 1831 against the esophageal walls, thereby preventing backward dislodgement of the esophageal slide element 1831 and keeping it the right position.

[0165] According to some embodiments, the esophageal slide element 1831 (shown herein in its deployed configuration) has a triangle plate shape, conical shape, tapered shape, wedge-shaped, prismatic shape, triangular shape, custom shape, or any other shape configured to block the esophagus. Each possibility is a separate embodiment. According to some embodiments, the esophageal slide element 1831 (shown herein in its deployed configuration), is shaped and / or includes a directional element (e.g., shown in FIG. 14B) for directing the ETT towards the trachea. According to some embodiments, the directional element includes a slide, tunnel, ramp, rail, groove, pipe, tube, track, passage, recess or any combination thereof. Each possibility is a separate embodiment.

[0166] According to some embodiments, the esophageal slide element 1831 further includes a location sensor (e.g., depth sensor) at a tip section thereof, configured to indicate / signal the position and / or site / location of esophageal slide element 1831. Each possibility is a separate embodiment.

[0167] According to some embodiments, the distal section 1824 of the ETT guiding component (shown in FIG. 14B) further includes a location sensor (e.g., depth sensor) at a tip section thereof, configured to indicate / signal the position and / or location / site of distal section 1824. Each possibility is a separate embodiment.

[0168] According to some embodiments, deployable member 1617 includes a status sensor configured to identify its status and / or its configuration. Each possibility is a separate embodiment.

[0169] Once, as depicted in FIGS. 19-20, the esophagus (entrance) has been blocked by esophageal slide element 1831 in its deployed configuration (EAD in its extended configuration 1801 and deploy able member 1617 is in its deployed configuration), an ETT 1903 is pushed through airway component 1510 of EAD 1801 and carefully directed by esophageal slide element 1831 towards the trachea (FIG. 19) and inserted into the trachea (FIG. 20), ensuring a smooth and successful intubation procedure 1900, in accordance with some embodiments.

[0170] It is noted, in accordance with some embodiments, that the ETT used herein may be a standard ETT currently available in the market. According to some embodiments, as depicted herein, ETT 1903 includes an ETT securing member 1904 (typically a balloon), configured to secure the position of the ETT 1903 in the trachea of subject 200. According to some embodiments, while the ETT 1903 is pushed through airway component 1510 of EAD 1801 and directed towards the trachea, securing member 1904 of ETT 1903 is undeployed (deflated) (as shown in FIGS. 19-20). According to some embodiments, when the ETT securing member 1904 shifts to its deployed (inflated) configuration (e.g., ETT in FIG. 21), the ETT 1903 is secured. According to some embodiments, ETT securing member 1904 is connected to an inlet / outlet ETT member 1910 configured to inflate securing member 1904 (shown in FIGS. 21-22, thereby secure the position of ETT 1903.

[0171] It can be understood from FIGS. 19-20 that, advantageously, the intubation procedure 1900 does not require a procedure of laryngoscopy (as discussed hereinabove) but rather involves a blind insertion of the EAD 1500 (shown herein in its extended configuration 1801), a blind insertion of the gastric tube 1702 and there after blind insertion of the ETT 1903. It is noted that ETT 1903 may be, for example, a commonly used ETT such as ETT 104 (shown in FIG. 1).

[0172] According to some embodiments, a distal section 1906 of the ETT 1903 is more flexible than a proximal section 1908 of the ETT 1903. According to some embodiments, one or more sections of the ETT are more flexible than one or more other sections of the ETT. According to some embodiments, the distal section 1906 of the ETT 1903 includes a floppy material. According to some embodiments, the distal section 1906 of the ETT 1903 is flexible and / or soft and / or floppy (for example, compared to the proximal section of ETT 1903) and configured to undergo a backwards deflection to the esophagus direction. Each possibility is a separate embodiment. In some embodiments, the cross section of the ETT (e.g. ETT 1903) may be oval for enhancing / improving the insertion of the ETT into the airway component (e.g., airway component 1510). According to some embodiments, the airway component has an oval cross section. According to some embodiments, an oval ETT (as opposed to a round standard ETT) fits in the oval cross section of the airway component and thus the ETT does not protrude from the perimeter of the longitudinal opening of the airway component. This, advantageously, according to some embodiments, may reduce a risk of tissue damage.

[0173] According to some embodiments, the distal section 1906 of the ETT 1903 further includes a location sensor (e.g., depth sensor) at a tip section thereof, configured to indicate / signal the position and / or location / site of distal section 1906. Each possibility is a separate embodiment.

[0174] According to some embodiments, the ETT 1903 further includes at a distal end thereof an ETT sensor (not shown) configured to confirm proper position of the ETT 1903 in the trachea. According to some embodiments, confirming the proper position of the ETT in the trachea may include determining the air flow, the temperature and / or one or more parameters associated with CO2 levels in vicinity to the ETT. Each possibility is a separate embodiment.

[0175] It is noted that, in accordance with some embodiments, after EAD 1500 (shown in its extended configuration 1801) is properly positioned in the oral pharyngeal space, and the gastric tube 1702 is inserted there through to the stomach, deployable member 1516 (shown herein in its deployed configuration 1617) may be deployed first and then

[0176] EAD 1500 shifted to its extended configuration 1801 thereby esophageal slide element shifts (transforms) to its deployed configuration 1831, or vice versa (first EAD 1500 shifts to its extended configuration and then deploy able member 1516 is deployed), or deploy able member 1516 and EAD 1500 shifts to its extended configuration 1801 (thereby esophageal slide element shifts / transforms to its deployed configuration 1831) simultaneously. Each possibility is a separate embodiment.

[0177] Next, as shown in FIG. 21, according to some embodiments, after ETT 1903 is inserted into the trachea, in its undeployed configuration (i.e., ETT securing member is in its un-deployed configuration 1904, shown in FIGS. 19-20), then ETT securing member 1904 of ETT 1903 is being deployed and shifted to its deployed (inflated configuration, thereby deploying ETT 1903. EAD in its extended configuration 1801 is still in the oropharynx of subject 200, deployable member is in its deployed configuration 1617 esophageal slide element 1831 is in its deployed configuration, and gastric tube 1702 is in the stomach.

[0178] Optionally, next, as depicted in FIG. 22, according to some embodiments, EAD 1801 (shown in FIG. 21) is removed from the oropharynx of subject 200 keeping both the ETT 1903 in its deployed configuration (ETT securing member is in its deployed (inflated) configuration) inserted into the trachea and the gastric tube 1702 inserted into the stomach. According to some embodiments, the deployable member is shifted to its closed configuration before removing the EAD from the oropharynx of subject 200. According to some embodiments, the EAD is shifted to its retracted configuration before removing the EAD from the oropharynx of subject 200.

[0179] According to some embodiments, keeping gastric tube 1702 in the stomach allows air and other gastric content to be drained out of the subject’s stomach thereby allowing a better ventilation compliance.

[0180] Reference is now made to FIG. 23, which shows a flow chart of a method of inserting ETT into a subject’s trachea using the EAD, according to some embodiments, such as but not limited to, EAD 1500 (in its retracted configuration in FIGS. 15-20, and in its extended configuration 1801 in FIGS. 21-22).

[0181] At step 2302, the EAD is inserted into an oral pharyngeal space of the subject, such that the curved distal section of the EAD is positioned in vicinity to the tongue base. The insertion is conducted while the device (EAD) is in a retracted configuration and the deployable member is in a closed configuration.

[0182] At step 2304, a deployable member of the curved distal section of the EAD is deployed to push and elevate the tongue base (thereby elevating the epiglottis) thereby generating and / or increasing an airway path for the subject. In some embodiments, deploying the deployable member may include inflating balloon, deploying stent, an anchor, a wing, or any combination thereof. At step 2306, a gastric tube inserted / slides distally and outwardly through a first passage of the ETT guiding component and a second passage of the esophageal slide element (of the EAD) towards the esophagus, such that a distal end of the gastric tube is positioned in the esophagus passed the esophageal tracheal junction (ETJ) (through the esophagus) and into the stomach of the subject.

[0183] At step 2308, the ETT guiding component is pushed distally through the airway component (the EAD is shifted to its extended configuration) such that the distal section of the ETT guiding component slides distally over the gastric tube and extends outwardly from the curved distal section of the airway component, the esophageal slide element shifts to a deployed configuration (esophageal slide element is deployed), and, upon reaching the ETJ, the esophageal slide element blocks the esophagus and directs the ETT, thereby facilitating the insertion of the ETT to the trachea. According to some embodiments the esophageal slide element comprises a self-inflating balloon, a sponge or a combination thereof. Each possibility is a separate embodiment.

[0184] At step 2310, an ETT is inserted to the trachea of the subject (intubating). According to some embodiments, the insertion of the ETT to the trachea includes confirming the position of the ETT in the trachea, utilizing an ETT sensor positioned at tip section (distal end / section) of the ETT. According to some embodiments the ETT sensor comprises a CO2 sensor, a temperature sensor, a flow sensor, or any combination thereof. Each possibility is a separate embodiment. The ETT may then be secured by inflating a ballon.

[0185] Optionally, at step 2312, the deployable member is closed, and the EAD is removed, keeping the ETT in the trachea and the gastric tube in place (in stomach). In some embodiments, prior to its removal, the EAD is shifted to its retracted configuration.

[0186] Reference is now made to FIGS. 24-25, which may optionally serve as schematic alternatives to FIGS. 17-18, respectively, described above, according to some embodiments.

[0187] As shown, in FIG. 24, according to some embodiments, EAD 1500 in its retracted configuration is contacting an ETT 1703 such that a distal end (section) 1712 of an ETT 1703 contacts a proximal end of the esophageal slide element (not shown). According to some embodiments, a gastric tube 1702 is inserted through a first passage 1726 of ETT guiding component 1520 and a second passage (not shown) of the esophageal slide element (in a collapsed configuration, not shown) and positioned in the stomach of the subject 200. According to some embodiments, first passage 1726 is extending from the proximal section 1522 to the distal section (shown in FIG. 14B) of ETT guiding component 1520, configured for insertion of a gastric tube there through (shown in FIG. 14B). According to some embodiments, the esophageal slide element (not shown) includes the second passage (shown in FIG. 14B) extending there through and configured for insertion of the gastric tube 1702 through the second passage (shown in FIG. 14B).

[0188] According to some embodiments, deployable member 1516 in its collapsed configuration (shown in FIG. 15) shifts to its deployed configuration 1617 before or after the inserting of the gastric tube through the first passage 1726 of ETT guiding component 1520 and the second passage (not shown) of the esophageal slide element. Each possibility is a separate embodiment.

[0189] Next, according to some embodiments, as depicted in FIG. 25, while pushing an ETT 1803 and ETT guiding component 1520 (shown in FIG. 24), together, distally through the airway component 1510, the distal section 1812 of the ETT 1703 and the ETT guiding component 1520 slide distally over the gastric tube 1702 and extends outwardly from the curved distal section 1514 of the airway component 1510, and the esophageal slide element in its collapsed configuration (nit shown), pushed by the distal end 1812 of the ETT 1803, shifts to a deployed configuration 1831, and, upon reaching the ETJ, the esophageal slide element 1831 blocks the esophagus and the ETT distal section (end) 1812 slides over the esophageal slide element 1831 and is directed into the trachea.

[0190] Reference is now made to FIG. 26, which shows a flow chart of a method of inserting ETT into a subject’s trachea using the EAD, according to some embodiments, such as but not limited to, EAD 1500 (in its retracted configuration in FIGS. 15-16, and 24 and in its extended configuration 1801 in FIGS. 25 and 19-22).

[0191] At step 2602, the EAD is inserted into an oral pharyngeal space of a subject, such that the curved distal section of a tubular airway component is positioned in vicinity to the tongue base, and the insertion is conducted while the device (EAD) is in a retracted configuration, a deployable member is in a closed configuration and a distal end of the ETT contacts a proximal end of the esophageal slide element.

[0192] At step 2604, the deployable member of a curved distal section of the EAD is deployed to push and elevate the tongue base (thereby elevates the epiglottis) thereby generating and / or increasing an airway path (for the subject).

[0193] At step 2606, the gastric tube slides distally and outwardly through a first passage of the ETT guiding component and a second passage of the esophageal slide element, passed the esophageal tracheal junction (ETJ), through the esophagus and into the stomach of the subject.

[0194] At step 2608 the ETT and ETT guiding component, are pushed together, distally through the airway component, such that the distal section of the ETT and the ETT guiding component slide distally over the gastric tube and extends outwardly from the curved distal section of the airway component, the esophageal slide element, pushed by the distal end of the ETT, shifts to a deployed configuration, and, upon reaching the ETJ, the esophageal slide element blocks the esophagus and the ETT distal section (end) slides over the esophageal slide element and is directed into the trachea.

[0195] At step 2610, an ETT is inserted to the trachea of the subject (intubating). According to some embodiments, the insertion of the ETT to the trachea includes confirming the position of the ETT in the trachea, utilizing an ETT sensor positioned at tip section (distal end / section) of the ETT. According to some embodiments the ETT sensor comprises a CO2 sensor, a temperature sensor, a flow sensor, or any combination thereof. Each possibility is a separate embodiment. The ETT may then be secured by inflating a ballon.

[0196] Optionally, at step 2612, the deployable member is closed, and the EAD is removed, keeping the ETT in the trachea and the gastric tube in place (in stomach). In some embodiments, prior to its removal, the EAD is shifted to its retracted configuration.

[0197] It is appreciated that certain features of the disclosure, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the disclosure, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination or as suitable in any other described embodiment of the disclosure. No feature described in the context of an embodiment is to be considered an essential feature of that embodiment, unless explicitly specified as such.

[0198] As used herein, the indefinite articles “a” and “an” mean “at least one” or “one or more” unless the context clearly dictates otherwise.

[0199] Although the disclosure is described in conjunction with specific embodiments thereof, it is evident that numerous alternatives, modifications and variations that are apparent to those skilled in the art may exist. Accordingly, the disclosure embraces all such alternatives, modifications and variations that fall within the scope of the appended claims. It is to be understood that the disclosure is not necessarily limited in its application to the details of construction and the arrangement of the components and / or methods set forth herein. Other embodiments may be practiced, and an embodiment may be carried out in various ways.

[0200] The phraseology and terminology employed herein are for descriptive purpose and should not be regarded as limiting. Citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the disclosure. Section headings are used herein to ease understanding of the specification and should not be construed as necessarily limiting.

[0201] As used herein, the term “about” may be used to specify a value of a quantity or parameter (e.g., the length of an element) to within a continuous range of values in the neighborhood of (and including) a given (stated) value. According to some embodiments, “about” may specify the value of a parameter to be between 80 % and 120 % of the given value. According to some embodiments, “about” may specify the value of a parameter to be between 90 % and 110 % of the given value. According to some embodiments, “about” may specify the value of a parameter to be between 95 % and 105 % of the given value.

[0202] In the description and claims of the application, each of the words “comprise” “include” and “have”, and forms thereof, are not necessarily limited to members in a list with which the words may be associated. In the description and claims of the application the expression “at least one of A and B”, (e.g. wherein A and B are elements, method steps, claim limitations, etc.) is equivalent to “only A, only B, or both A and B”. In particular, the expressions “at least one of A and B”, “at least one of A or B”, “one or more of A and B”, and “one or more of A or B” are interchangeable.

[0203] Throughout this application, various embodiments of this invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range. Whenever a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integral) within the indicated range. The phrases “ranging / ranges between” a first indicate number and a second indicate number and “ranging / ranges from” a first indicate number “to” a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numerals therebetween.

[0204] It is appreciated that certain features of the disclosure, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the disclosure, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination or as suitable in any other described embodiment of the disclosure. No feature described in the context of an embodiment is to be considered an essential feature of that embodiment, unless explicitly specified as such.

[0205] Although steps of methods according to some embodiments may be described in a specific sequence, methods of the disclosure may include some or all of the described steps carried out in a different order. A method of the disclosure may include a few of the steps described or all of the steps described. No particular step in a disclosed method is to be considered an essential step of that method, unless explicitly specified as such. The phraseology and terminology employed herein are for descriptive purpose and should not be regarded as limiting. Citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the disclosure. Section headings are used herein to ease understanding of the specification and should not be construed as necessarily limiting.

Claims

CLAIMSWhat we claim is:

1. An esophageal auxiliary device (EAD) for facilitating an insertion of an endotracheal tube (ETT) into a trachea of a subject in a need thereof, the device comprising: a tubular airway component comprising a proximal section and a curved distal section comprising a deployable member, wherein the curved distal section is positionable in vicinity to a tongue base, wherein the deployable member has a closed configuration, for smooth insertion of the airway component to the oral pharyngeal space of the subject, and a deployed configuration, configured to push / elevate the tongue base, thereby generate and / or increase an airway path; and an ETT guiding component comprising a proximal section, a distal section and an esophageal slide element at the distal section, the ETT guiding component further comprises a first passage extending from a proximal section to a distal section of the ETT guiding component, configured for insertion of a gastric tube therethrough, wherein the ETT guiding component is configured to "ride" over the gastric tube such that the esophageal slide element is guided by the gastric tube to block the esophagus and to facilitate sliding of the ETT thereon thereby guide the insertion of the ETT into the trachea.

2. The device of claim 1 , wherein the ETT guiding component is insertable within the airway component and is movable distally and optionally, proximally, along the airway component.

3. The device of any one of claims 1-2, wherein the device has at least two configurations: a retracted configuration, wherein the proximal section of the ETT guiding component is proximally and outwardly retracted from the airway component, and the distal section of the ETT guiding component is inserted in the curved distal section of theairway component, and wherein the esophageal slide element is in a collapsed configuration within the curved distal section of the airway component, and an extended configuration, wherein the proximal section of the ETT guiding component is inserted into the airway component, and the distal section of the ETT guiding component is extended distally and outwardly from the curved distal section of the airway component, and wherein the esophageal slide element is in a deployed configuration configured to block the esophagus thereby facilitating the insertion of the ETT through the device into the trachea.

4. The device of any one of claims 1-3, wherein the airway component has a longitudinal opening along at least a part of a length thereof.

5. The device of any one of claims 1-4, wherein the airway component comprises one or more inner and / or outer longitudinal rails, recesses, tunnels, channels or any combination thereof for supporting / guiding the ETT guiding component and the gastric tube therethrough.

6. The device of any one of claims 1-5, wherein the esophageal slide element is shaped and / or comprises a directional element for directing the ETT towards the trachea.

7. The device of claim 6, wherein the directional element comprises a slide, tunnel, ramp, rail, groove, pipe, tube, track, passage, recess or any combination thereof.

8. The device of any one of claims 1-7, wherein the esophageal slide element further comprises a spring / elastic element, proximally attached to the airway component, configured to exert a force forward on the esophageal slide element so as to push the esophageal slide element against the esophageal walls, thereby preventing backward dislodgement of the esophageal slide element and keeping it the right position.

9. The device of any one of claims 1-8, wherein the esophageal slide element is a self- inflatable soft material.

10. The device of claim 9, wherein the self-inflatable soft material comprises a sponge or a balloon.

11. The device of any one of claims 1-10, wherein the esophageal slide element further comprises a second passage extending therethrough and configured for insertion of the gastric tube through said second passage.

12. The device of claim 11, wherein the second passage is further positioned to centralize the gastric tube received from the first passage.

13. The device of any one of claims 1-12, wherein in a retracted configuration the gastric tube is slidable distally and outwardly from the first and second passages towards the esophagus, passed the esophageal-tracheal junction (ETJ) and into the stomach, thereby facilitating sliding of the distal section of ETT guiding component over the gastric tube until the esophageal slide element reaches the ETJ and blocks the esophagus.

14. The device of any one of claims 1-13, wherein the esophageal slide element is a triangle plate or has a conical shape, tapered, wedge-shaped, prismatic, triangular shape, or custom shape configured to block the esophagus.

15. The device of any one of claims 1-14, further comprising the ETT.

16. The device of claim 15, wherein a distal section of the ETT is more flexible than a proximal section thereof.

17. The device of any one of claims 15-16, wherein a cross section of the ETT is oval for improving the insertion of the ETT into the airway component.

18. The device of any one of claims 1-17, wherein the distal end of the ETT is inserted within the airway component such that a distal end of the ETT contacts a proximal end of the esophageal slide element.

19. The device of any one of claims 1-18, further comprising the gastric tube.

20. The device of any one of claims 1-19, wherein the ETT further comprising an ETT sensor configured to confirm positioning of the ETT in the trachea.

21. The device of claim 20, wherein the ETT sensor comprises a CO2 sensor, a temperature sensor, a flow sensor, impedance sensor, or any combination thereof.

22. A method for guiding insertion of an endotracheal tube (ETT) into a subject’s trachea utilizing an esophageal auxiliary device (EAD), the method comprising: obtaining an EAD according to any one of claims 1-21; inserting the EAD into an oral pharyngeal space of the subject, such that the curved distal section is positioned in vicinity to the tongue base, wherein the insertion is conducted while the device is in a retracted configuration and the deployable member is in a closed configuration; deploying the deployable member to push and elevate the tongue base (thereby elevates the epiglottis) thereby generating and / or increasing an airway path; sliding the gastric tube distally and outwardly through the first and second passages towards the esophagus, passed the esophageal tracheal junction (ETJ) and into the stomach; and pushing the ETT guiding component distally through the airway component, such that the distal section of the ETT guiding component slides distally over the gastric tube and extends outwardly from the curved distal section of the airway component, wherein the esophageal slide element shifts to a deployed configuration, and, upon reaching the ETJ, the esophageal slide element blocks the esophagus and directs the ETT, thereby facilitating the insertion of the ETT to the trachea.

23. A method for guiding insertion of an endotracheal tube (ETT) into a subject’s trachea utilizing an esophageal auxiliary device (EAD), the method comprising: obtaining an EAD according to any one of claims 1-21; inserting the EAD into an oral pharyngeal space of the subject, such that the curved distal section is positioned in vicinity to the tongue base, wherein the insertion is conducted while the device is in a retracted configuration, the deployable member is in a closed configuration and a distal end of the ETT contacts a proximal end of the esophageal slide element;deploying the deployable member to push and elevate the tongue base (thereby elevates the epiglottis) thereby generating and / or increasing an airway path; sliding the gastric tube distally and outwardly through the first and second passages passed the esophageal tracheal junction (ETJ), through the esophagus and into the stomach; pushing the ETT and ETT guiding component, together, distally through the airway component, such that the distal section of the ETT and the ETT guiding component slide distally over the gastric tube and extend outwardly from the curved distal section of the airway component, wherein the esophageal slide element, pushed by the distal end of the ETT, shifts to a deployed configuration, and, upon reaching the ETJ, the esophageal slide element blocks the esophagus and the ETT distal section (end) slides over the esophageal slide element and is directed into the trachea; and further inserting the ETT to the trachea of the subject.

24. The method of any one of claims 22-23, wherein deploying the deployable member comprises inflating balloon, deploying stent, a coil or any combination thereof.

25. The method of any one of claims 22-24, wherein the esophageal slide element comprises a self-inflating balloon, a sponge or a combination thereof.

26. The method of any one of claims 22-25, further comprising closing the deployable member and removing the EAD.

27. The method of any one of claims 22-26, further comprising keeping the ETT in the trachea and the gastric tube in place, allowing air and other gastric content to be drained out for a better ventilation compliance.

28. A kit for guiding insertion of an endotracheal tube (ETT) into a subject’s trachea, the kit comprises: the EAD of any one of claims 1-14, and 18, a gastric tube and an ETT.

29. The kit of claim 28, wherein the ETT is the ETT of any one of claims 16, 17, 20 and 21.

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