IL311566B2

IL311566B2 - Esophageal auxiliary device for intubation

Info

Publication number: IL311566B2
Application number: IL311566A
Authority: IL
Inventors: Bar Amir
Original assignee: Health Corp Of Tzafon Medical Center R A; Bar Amir
Priority date: 2024-03-19
Filing date: 2024-03-19
Publication date: 2025-02-01
Also published as: WO2025196669A1; IL311566B1; IL311566A

Description

ESOPHAGEAL AUXILIARY DEVICE FOR INTUBATION TECHNICAL FIELD 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 guide for endotracheal tube insertion that allows inexperience user to accurately position an intubation device within the airway.

BACKGROUND 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.

ETT 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.

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

Intubation is typically facilitated through a laryngoscope, a medical instrument designed to elevate and reposition the epiglottis, thereby exposing the vocal cords and the entrance to the trachea.

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.

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.

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.

SUMMARY 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 intubation device within the airway.

Inserting a 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, to avoid improper insertion of the ETT into the esophagus, 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 mistakenly placing it in the esophagus and other related complications. Advantageously, the EAD disclosed herein, in accordance with some embodiments, is configured to initially be introduced into the esophagus as an "esophageal tube" but ultimately serves as a guide for an intubation procedure. Thus, making the intubation procedure a blind, simple and safe procedure with a high success rate on first attempt by inexperienced health professionals.

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 30 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 additional visualization tools, and reducing the risk of complications associated with misplacement and multiple failed intubation attempts.

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.

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. 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.

As used herein, the terms "blind insertion", "blind intubation", "blindly", "blind" may interchangeably be used, and refer to an intubation procedure which spares the need to perform a laryngoscopy with visualization of the vocal cords.

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 risk 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, and even if ultimately mild sedation will be used, it will only be needed at later stage of intubation procedure, after the subject’s airway is already opened and the EAD is in the right position.

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.

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/pharyngeal 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 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 ETJ, to block the esophagus entrance, and to guide the insertion of the ETT into the trachea.

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

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

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

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

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.

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

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.

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 CO 2 sensor, a temperature sensor, a flow sensor, or any combination thereof. Each possibility is a separate embodiment.

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.

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.

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.

According to some embodiments, the elongated body includes a curved distal potion to facilitate insertion into the subject's esophagus.

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.

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

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 ramp, a rail, a groove, a pipe, a tube, a track, a passage or any combination thereof. Each possibility is a separate embodiment.

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.

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.

According to some embodiments, the method further includes confirming the 20 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 CO sensor, a temperature sensor, a flow sensor, or any combination thereof. Each possibility is a separate embodiment.

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.

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

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

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

BRIEF DESCRIPTION OF THE FIGURES 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.

In the figures: FIG. 1 schematically illustrates an intubation procedure according to the prior art; FIG. 2 schematically shows a 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; FIG. 3 schematically shows the EAD of FIG. 2, having the proximal component in a deployed configuration, according to some embodiments; 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; FIG. 5 schematically shows the EAD of FIG. 4, and an ETT guided thereby into the subject’s trachea, according to some embodiments; 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; FIG. 7 schematically shows the EAD of FIG. 6, having the proximal component in a deployed configuration, according to some embodiments; 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; 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; 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; and FIG. 12 shows a flow chart of a method of inserting ETT into a subject’s trachea using the EAD, according to some embodiments.

DETAILED DESCRIPTION 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.

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. In particular, some embodiments relate to insertion of a guide 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.

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 to achieve optimal visualization of the vocal cords, thereby ensuring proper ETT insertion.

Embodiments of this disclosure present a simpler and easier to use solution.

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.

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.

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.

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.

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 2is 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 2clears 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 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), 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.

As noted above, with regards to proximal component 204, distal component 2in 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).

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 30 ETT 508. It is noted that ETT 508 may be, for example, a commonly used ETT such as ETT 104 (shown in FIG. 1).

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.

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 2(including elongated body 202) from the esophagus and the subject’s larynx.

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.

Reference is now made to FIG. 6, which schematically shows an EAD 6inserted 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.

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.

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 6was 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.

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), 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 carbon dioxide (CO 2) 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.

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 ramp, a rail, a groove, a pipe, a tube, a track, a passage or any combination thereof.

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.

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 6may be converted into their respective deployed configuration 704 and 9simultaneously.

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).

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 30 the esophagus entrance is blocked, EAD 601 is ready to guide (tunnel/facilitate) an ETT insertion into the trachea.

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.

It is noted that although in FIG. 11 guide wire 608 is shown threaded in ETT 11and 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.

It is noted that although ETT 1114, as shown in FIG.11, 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.

It can be understood from FIG. 11 that, advantageously, intubation procedure 1100 does not require a difficult 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 1(shown in FIG. 1).

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.

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).

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.

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.

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.

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, 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.

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 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 CO 2 levels in vicinity to the ETT by a second sensor at the tip section of the guide wire, if used.

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.

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.

As used herein, the indefinite articles "a" and "an" mean "at least one" or "one or more" unless the context clearly dictates otherwise.

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 30 forth herein. Other embodiments may be practiced, and an embodiment may be carried out in various ways.

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.

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.

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.

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 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 30 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. 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.

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.

Claims

- 21 - CLAIMS What we claim is:

1. An esophageal auxiliary device for facilitating an insertion of an endotracheal tube (ETT) into a trachea of a subject in a need thereof, the device comprising: an elongated body configured to be inserted through the oro/naso pharynx into the esophagus of the subject, the elongated body comprises: a proximal component, wherein, when the device is inserted to the esophagus, the proximal component is configured to be positioned in the oral/pharyngeal 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 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 ETJ, to block the esophagus entrance, and to guide the insertion of the ETT into the trachea.

2. The device of claim 1, wherein the elongated body is a wire, a tube, or a rod.

3. The device of any one of claims 1-2, wherein the distal component comprises a guiding element configured to guide the insertion of the ETT into the trachea.

4. The device of claim 3, wherein the guiding element comprises a guide wire, a ramp, a rail, a groove, a pipe, a tube, a track, a passage or any combination thereof.

5. The device of claim 4, wherein the guide wire is an integrally formed with the esophageal auxiliary device. - 22 -

6. The device of any one of claims 3-5, wherein the guiding element comprises 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.

7. The device of claim 6, wherein the guide wire is configured to guide the insertion of the ETT by enabling the ETT to slide thereover.

8. The device of any one of claims 1-7, wherein the distal component and/or the guide wire comprise a first sensor configured to identify the ETJ location.

9. The device of any one of claims 5-8, wherein the guide wire comprises, at tip section thereof, a second sensor configured to confirm positioning thereof in the trachea.

10. The device of claim 9, wherein the second sensor comprises a CO 2 sensor, a temperature sensor, a flow sensor, or any combination thereof.

11. The device of any one of claims 1-10, wherein the deployed configuration of the distal component comprises a securing member.

12. The device of claim 11, wherein the securing member comprises an inflatable balloon, an anchor, a stent, a pillar, a coil, a pipe, a tube, a wing, or any combination thereof.

13. The device of any one of claims 1-12, wherein the proximal component, in the deployed configuration thereof, is further configured to elevate the epiglottis to increase the void for the insertion of the ETT.

14. The device of any one of claims 1-13, wherein the deployed configuration of the proximal component comprises 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.

15. The device of any one of claims 1-14, wherein the elongated body comprises a curved distal potion to facilitate insertion into the subject's esophagus. - 23 -

16. 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 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; 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.

17. The method of claim 16, further comprising inserting the ETT to the trachea of the subject.

18. The method of any one of claims 16-17, wherein the insertion of the ETT into the trachea is facilitated by a guiding element of the distal component, wherein the guiding element comprises a ramp, a rail, a groove, a pipe, a tube, a track, a passage or any combination thereof.

19. The method of any one of claims 16-17, wherein the insertion of the ETT into the trachea is facilitated by a retractable guide wire, and wherein the method further comprises retracting the guide wire from a partially folded configuration in the distal component, - 24 - 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.

20. The method of any one of claims 16-19, further comprising identifying the ETJ location, utilizing a first sensor located in the distal component and/or the guide wire.

21. The method of any one of claims 19-20, further comprising confirming the position of the guide wire in the trachea, utilizing a second sensor positioned at tip section of the guide wire.

22. The method of claim 21, wherein the second sensor comprises a CO 2 sensor, a temperature sensor, a flow sensor, or any combination thereof.

23. The method of any one of claims 16-22, wherein deploying the proximal component comprises inflating balloon, deploying stent, a pillar, a coil, a pipe, a tube, or any combination thereof.

24. The method of any one of claims 19-23, further comprising removing the guide wire after confirmation that the ETT is in the trachea.

25. The method of any one of claims 16-24, further comprising closing the proximal and the distal components of the EAD.

26. The method of claims 16-25, further comprising removing the EAD, wherein the distal and proximal components are in closed configuration.