Device for endotracheal tube fixation and protection

Abstract

A device (100) for securing an endotracheal tube (200) comprises a tube protector (102) having an upper circular head (132) and a lower hollow cylinder (134) configured to receive the endotracheal tube (200). The tube protector (102) includes a longitudinal one-sided opening mechanism (128) for ease of insertion and removal. A tube fixer (104) with hooks and loops securely grips the endotracheal tube (200), preventing displacement. A wings flap (106) with a circular hole (112) receives the tube protector (102), while a hexagonal hole (114) accommodates a tubular member (204) of the endotracheal tube (200), connected by a notch (118). A semicircular extension wall (110) with an inner removable adhesive surface (110-2) secures the tube. A pair of straps (108-1, 108-2) attached to the wings flap (106) ensures stability. The device (100) prevents slippage, maintains proper alignment, and enhances patient safety.

Description

DEVICE FOR ENDOTRACHEAL TUBE FIXATION AND PROTECTIONTECHNICAL FIELD

[0001] The present disclosure relates, in general, to an endotracheal tube, and more specifically, relates to a device for endotracheal tube fixation and protection.BACKGROUND

[0002] Endotracheal tube is commonly used to provide mechanical ventilation and airway protection for patients in emergency medical situations or elective surgical procedures. The insertion of an endotracheal tube through the oral cavity into the trachea, known as intubation, necessitates secure fixation of the Endotracheal tube at a desired position during the procedure and following confirmation of tube position by chest X-ray. Proper fixation is critical to prevent the Endotracheal tube from slipping deeper into the trachea, which can result in ventilation of only one lung, leading to the collapse of the opposite lung and reduced oxygen saturation in the blood. Improper fixation of the tube may result in displacement from the trachea, leading to inadequate ventilation of both lungs and a consequent reduction in blood oxygen saturation.

[0003] Conventional methods for securing the endotracheal tube include cotton bandages, glued elastic straps, and various fixation devices. However, these approaches have numerous limitations:• Fixation using cotton bandages may result in inadequate tube stability, leading to slippage of the endotracheal (ET) tube from the desired position deep inside, potentially causing unilateral lung ventilation and collapse of the other lung, which reduces blood oxygen saturation.• In certain instances, the endotracheal (ET) tube may become dislodged from the trachea due to the cotton bandage, resulting in the loss of ventilation in both lungs and a subsequent reduction in blood oxygen levels.• Repeated adjustments to the tube’s position are often necessary due to the tendency of cotton bandages to loosen, causing tube displacement.• Prolonged use of cotton bandages can cause skin irritation and rashes at the angle of the mouth due to friction between the bandage and the skin.• Cotton bandages do not provide protection against accidental or unintentional biting of the tube by the patient, which can damage the ET tube, cause air leakage, and necessitate emergency reintubation.• Tooth biting of the endotracheal tube by the patient may damage the endotracheal tube which will cause air leak from endotracheal tube leads tube non-ventilation and a decrease in oxygen saturation level in the patient.• Tooth biting of the endotracheal tube by the patient may narrow the tube lumen impeding ventilation and causing ventilator alarms due to low tidal volume and high pressure in the ventilator circuit.• Tooth biting of the endotracheal (ET) tube may cause damage to the pilot line, leading to air leakage from the balloon. Deflation of the balloon may result in the entry of oral secretions or gastric contents into the lungs, potentially causing aspiration pneumonia, a life-threatening condition requiring urgent reintubation. To prevent tube biting, patients may require sedatives and paralyzing medications, which are not always desirable.• Fixation with cotton bandages can be time-consuming, as it requires knotting the tube securely in place.• Glued elastic straps, another method for securing the tube, are adhered to the skin of the cheeks, which may cause allergic reactions, skin peeling, and blistering with repeated use.• Glued elastic strap doesn’t provide protection against tube biting, tube damage, tube lumen narrowing and pilot line damage.• In emergency situations, intubation in male patients with facial hair may present difficulties, as the presence of a beard prevents effective adhesion of glued elastic straps, necessitating shaving, which is time-consuming in urgent cases.• For some patients, shaving facial hair may be objectionable for religious or cultural reasons, further complicating tube fixation.• More than one manpower required to fix the ET tube with bandage and glued elastic strap.

[0004] Therefore, it is desired to overcome the drawbacks, shortcomings, and limitations associated with existing solutions, and develop an improved fixation and protection solution for endotracheal tubes that addresses these limitations effectively.OBJECTS OF THE PRESENT DISCLOSURE

[0005] An object of the present disclosure is to provide a device for the fixation of the endotracheal tube at a desired position after intubating the patient with an endotracheal tube.

[0006] Another object of the present invention is to provide a device for preventing the endotracheal tube from slipping deep inside the trachea or becoming dislodged from the trachea.

[0007] Another object of the present disclosure is to provide a device for protecting the endotracheal tube from air leak due to damage caused by tooth bites and for preventing the narrowing of the endotracheal tube lumen due to tooth bite during mechanical ventilation.

[0008] Another object of the present invention is to provide a device for protecting the endotracheal tube pilot line from damage caused by tooth bites and preventing air leakage from the cuff balloon.

[0009] Another object of the present invention is to provide a device for preventing the use of sedative and paralyzing medication to mitigate tube damage and pilot line damage caused by tooth biting.

[0010] Another object of the present disclosure is to provide a device for protecting and securing the endotracheal tube without causing injury to the skin and angle of mouth and with consideration of the patient’s personal and religious preferences.

[0011] Another object of the present disclosure is to provide a device that is cost- effective and prevents the self-removal of the endotracheal tube by the patient.

[0012] Another object of the present disclosure is to provide a device that minimizes time consumption during the fixation of the endotracheal tube.

[0013] Yet another object of the present disclosure is to provide a device that requires minimal manpower during the fixation of the endotracheal tube.SUMMARY

[0014] The present disclosure relates in general, to an endotracheal tube, and more specifically, relates to a device for endotracheal tube fixation and protection. The main objective of the present disclosure is to overcome the drawbacks, limitations, and shortcomings of the existing device and solution, by providing a device that addresses various shortcomings associated with conventional endotracheal tube fixation, including difficulties in securing the tube, time-consuming fixation in emergency situations, risk of tube slippage deep inside trachea, risk of the endotracheal tube becoming dislodged from the trachea, potential tube damage, potential tube pilot line damage, air leak from cuff, narrowing of the endotracheal tube lumen, skin irritation and rashes, blister formation, and the undesired use of sedatives and paralyzing medications, time consuming during emergency and increasedmanpower requirement. The device comprises four primary components a tube protector, a tube fixer, wing flaps, and a strap, each configured to collaboratively.

[0015] The present disclosure provides a device for securing an endotracheal tube comprises a tube protector formed of a cylindrical structure having an upper circular head and a lower hollow cylinder, configured to receive the endotracheal tube. The tube protector includes a longitudinal one-sided opening mechanism at one portion, enabling it to be opened and closed at a longitudinal junction. The tube protector is positioned within a mouth area of a subject to cover the endotracheal tube. A tube fixer made of hooks and loops is configured to securely grip the endotracheal tube upon being received by the tube protector, holding it in a fixed position, wherein the hooks of the tube fixer engage with the loops of the tube fixer. A wings flap of a hexagonal structure comprises a circular hole configured to receive the tube protector and couple with the upper circular head part of the tube protector. A hexagonal hole is configured to receive a portion of a tubular member of the endotracheal tube, wherein the circular hole and the hexagonal hole are positioned side by side in the hexagonal structure and connected by a notch to allow the endotracheal tube to be received by the tube protector accommodated in the circular hole. A semicircular extension wall surrounds the circular hole, wherein a circular extension wall extends upwardly around the circular hole. An inner surface of the tube fixer is permanently bonded to an outer surface of the semicircular extension wall, and an inner removable adhesive surface of the semicircular extension wall comes into direct contact with the tubular member at an upper part of the endotracheal tube. A pair of straps is coupled to at least two rectangular-shaped holes located at opposite ends of the hexagonal structure of the wings flap, each of the straps having an upper end attached to the corresponding rectangular holes of the wings flap and a free end configured to secure the device at a back of a neck area of the subject. The combination of the tube protector, the tube fixer, the wings flap, and the pair of straps securely holds the endotracheal tube in position, preventing slippage and damage while ensuring proper alignment.

[0016] In an aspect, the tube protector has an inner diameter greater than the outer diameter of the endotracheal tube, allowing the tube protector to receive the endotracheal tube. The upper circular head includes a male extension and a female groove forming a locking mechanism, wherein the male extension and the female groove are configured to open and close upon application of minimal pressure. A triangular notch positioned on surface of the upper circular head, opposite to the male extension and the female groove, wherein the upper circular head of the tube protector permanently coupled with the circular hole of the wing flap, the upper circular head remains attached above the mouth. The lowerhollow cylinder includes a longitudinal triangular groove of the male extension on surface of the lower hollow cylinder, the longitudinal triangular groove of the male extension being configured to align with a longitudinal triangular edge of the female groove on the surface of the lower hollow cylinder in a closed position, wherein the lower hollow cylinder is positioned within the mouth area of the subject. Another longitudinal grooves are on both an inner surface and an outer surface of lower hollow cylinder of tube protector, wherein the longitudinal grooves are positioned below the triangular notch of the upper circular head and opposite to the longitudinal one-sided opening mechanism to facilitate opening and closing of the male extension and the female groove, wherein the longitudinal one-sided opening mechanism is configured to receive the endotracheal tube after the tubular member of the endotracheal tube passes through the hexagonal hole and into the circular hole via the notch of the wings flap.

[0017] In another aspect, the tube fixer comprises a middle part and two sides, wherein the inner surface of the middle part and the two sides are made of hooks, and the outer surface of the middle part and the two sides are made of loops. The inner surface of the middle part of the tube fixer is coupled to the outer surface of the semicircular extension wall and is configured to securely grip the endotracheal tube upon being received by the tube protector, holding the endotracheal tube in a fixed position. The tube fixer includes a rectangular cut hole on one side , wherein end another side of the tube fixer is configured to pass through the cut hole of the other side, and upon pulling the ends of both sides tightly, the inner removable adhesive surface of the semicircular extension wall comes into direct contact with the tubular lumen at an upper part of the endotracheal tube. The tube fixer is positioned above the mouth area of the subject, encircles the endotracheal tube received by the tube protector to prevent slippage, and ensures that the tube protector is positioned between the upper teeth and lower teeth of the subject to facilitate proper placement and stability of the endotracheal tube. The tube fixer tightly wraps around the upper part of the endotracheal tube outside the mouth, securing it in place and preventing displacement. The wings flap is positioned externally, extending laterally along the cheek area of the subject. The wings flap is made of a flexible elastomer to facilitate comfortable positioning according to the facial structure of the subject, wherein the removable adhesive on inner surface of semicircular extension wall is configured to maintain the endotracheal tube in a secure position. The pair of straps is made from soft, durable cotton or elastic material to facilitate comfortable securing and an adjustable fit around the neck area of the subject.

[0018] Various objects, features, aspects, and advantages of the inventive subject matter will become more apparent from the following detailed description of preferred embodiments, along with the accompanying drawing figures in which like numerals represent like components.BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The following drawings form part of the present specification and are included to further illustrate aspects of the present disclosure. The disclosure may be better understood by reference to the drawings in combination with the detailed description of the specific embodiments presented herein.

[0020] FIG.1A illustrates an exploded view of a device for fixation and protection endotracheal tube (ET) tube management, in accordance with an embodiment of the present disclosure.

[0021] FIG. IB illustrates an opened state of a tube protector, in accordance with an embodiment of the present disclosure.

[0022] FIG.1C illustrates a closed state of a tube protector, in accordance with an embodiment of the present disclosure.

[0023] FIG. ID illustrates a perspective view of a tube protector, in accordance with an embodiment of the present disclosure.

[0024] FIG. IE illustrates a perspective view of a device for fixation and protection endotracheal tube (ET) tube, in accordance with an embodiment of the present disclosure.

[0025] FIG.2 Illustrates an exemplary view perspective view of an endotracheal tube inserted into the device, in accordance with an embodiment of the present disclosure.

[0026] FIG. 3A illustrates an exemplary view of the ET tubes connector part is passed through the hexagonal hole and tube protector coupled with circular hole is opened through the male and female locking and longitudinal opening along with the notch, in accordance with an embodiment of the present disclosure.

[0027] FIG. 3B illustrates the device positioned on the mouth area of the user, with the tube protector receiving the ET tube, wherein the male and female locking mechanism is engaged, and the longitudinal opening is closed, in accordance with an embodiment of the present disclosure.

[0028] FIG. 3C illustrates the tube protector, coupled with wing flaps and enclosing the ET tube, positioned slightly inside the mouth and placed between the upper and lower teethof the user after receiving the endotracheal tube, in accordance with an embodiment of the present disclosure.

[0029] FIG. 3D illustrates the endotracheal tube secured tightly by the tube fixer above the mouth, with the tube protector positioned between the upper and lower teeth, in accordance with an embodiment of the present disclosure.

[0030] FIG. 3E illustrates the device secured at the back of the neck with straps after receiving the endotracheal tube, in accordance with an embodiment of the present disclosure.

[0031] FIG. 3F illustrates a longitudinal view of the device securing the endotracheal tube in the mouth area of subject, in accordance with an embodiment of the present disclosure.DETAILED DESCRIPTION

[0032] The following is a detailed description of embodiments of the disclosure depicted in the accompanying drawings. The embodiments are in such detail as to clearly communicate the disclosure. If the specification states a component or feature “may”, “can”, “could”, or “might” be included or have a characteristic, that particular component or feature is not required to be included or have the characteristic.

[0033] As used in the description herein and throughout the claims that follow, the meaning of “a,” “an,” and “the” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of “in” includes “in” and “on” unless the context clearly dictates otherwise.

[0034] The present disclosure provides a device for fixation and protecting an endotracheal tube is disclosed. The present disclosure provides a device for securing an endotracheal tube comprises a tube protector formed of a cylindrical structure having an upper circular head and a lower hollow cylinder, configured to receive the endotracheal tube. The tube protector includes a longitudinal one-sided opening mechanism on a portion of the lower hollow cylinder part, enabling it to be opened and closed along a longitudinal junction. A male-female locking mechanism is provided at the upper circular head part of the tube protector. The circular head part is coupled with the circular hole of the wing flap, with the circular head part remaining above the mouth, while the lower hollow cylinder part of the tube protector is positioned within the mouth area of a subject to cover the endotracheal tube. A tube fixer made of hooks and loops is configured to securely grip the endotracheal tube upon being received by the tube protector, holding it in a fixed position, wherein the hooks of the tube fixer engage with the loops of the tube fixer. A wings flap of a hexagonal structurecomprises a circular hole configured to receive the tube protector and couple with the upper circular head part of the tube protector. A hexagonal hole is configured to receive a portion of a tubular member of the endotracheal tube, wherein the circular hole and the hexagonal hole are positioned side by side in the hexagonal structure and connected by a notch to allow the endotracheal tube to be received by the tube protector accommodated in the circular hole. Wherein a circular extension wall extends upwardly around the circular hole, with the extension being discontinued at the notch. The circular extension wall further extends upward in a semicircular manner opposite to the connecting notch. The inner surface of the semicircular wall is coated with a removable adhesive. An inner surface of the tube fixer is permanently bonded to an outer surface of the semicircular extension wall, and an inner removable adhesive surface of the semicircular extension wall comes into direct contact with the tubular member at an upper part of the endotracheal tube. A pair of straps is coupled to at least two rectangular-shaped holes located at opposite ends of the hexagonal structure of the wings flap, each of the straps having an upper end attached to the corresponding rectangular holes of the wings flap and a free end configured to secure the device at a back of a neck area of the subject. The combination of the tube protector, the tube fixer, the wings flap, and the pair of straps securely holds the endotracheal tube in position, preventing slippage and damage while ensuring proper alignment.

[0035] In an aspect, the tube protector has an inner diameter greater than the outer diameter of the endotracheal tube, allowing the tube protector to receive the endotracheal tube. The upper circular head includes a male extension and a female groove forming a locking mechanism, wherein the male extension and the female groove are configured to open and close upon application of minimal pressure. A triangular notch positioned on surface of the upper circular head, opposite to the male extension and the female groove, wherein the upper circular head of the tube protector permanently coupled with the circular hole of the wing flap, the upper circular head remains attached above the mouth. The lower hollow cylinder includes a longitudinal triangular groove of the male extension on surface of the lower hollow cylinder, the longitudinal triangular groove of the male extension being configured to align with a longitudinal triangular edge of the female groove on the surface of the lower hollow cylinder in a closed position, wherein the lower hollow cylinder is positioned within the mouth area of the subject. Another longitudinal grooves are on both an inner surface and an outer surface lower hollow cylinder part of tube protector, wherein the longitudinal groove are positioned below the triangular notch of the upper circular head and opposite to the longitudinal one-sided opening mechanism to facilitate opening and closing ofthe male extension and the female groove, wherein the longitudinal grooves are to act as hinge to facilitate opening and closing of one sided opening and closing at surface of lower hollow cylinder of tube protector is configured to receive the endotracheal tube after the tubular member of the endotracheal tube passes through the hexagonal hole and into the circular hole via the notch of the wings flap.

[0036] In another aspect, the tube fixer comprises a middle part and two sides, wherein the inner surface of the middle part and the two sides are made of hooks, and the outer surface of the middle part and the two sides are made of loops. The inner surface of the middle part of the tube fixer is coupled to the outer surface of the semicircular extension wall and is configured to securely grip the endotracheal tube upon being received by the tube protector, holding the endotracheal tube in a fixed position. The tube fixer includes a rectangular cut hole on one side, wherein end of other side of the tube fixer is configured to pass through the cut hole of the other side, and upon pulling the ends of both sides tightly, the inner removable adhesive surface of the semicircular extension wall comes into direct contact with the tubular lumen at an upper part of the endotracheal tube. The inner surface of both side of tube fixer can be attached to outer surface of middle part of tube fixer by loop and hooks. The tube fixer is positioned above the mouth area of the subject, encircles the endotracheal tube received by the tube protector to prevent slippage, and ensures that the tube protector is positioned between the upper teeth and lower teeth of the subject to facilitate proper placement and stability of the endotracheal tube. The tube fixer tightly wraps around the upper part of the endotracheal tube outside the mouth, securing it in place and preventing displacement. The wings flap is positioned externally, extending laterally along the cheek area of the subject. The wings flap is made of a flexible elastomer to facilitate comfortable positioning according to the facial structure of the subject, wherein the removable adhesive surface is configured to maintain the endotracheal tube in a secure position. The pair of straps is made from soft, durable cotton or elastic material to facilitate comfortable securing and an adjustable fit around the neck area of the subject. The present disclosure can be described in enabling detail in the following examples, which may represent more than one embodiment of the present disclosure.

[0037] The advantages achieved by the device of the present disclosure can be clear from the embodiments provided herein. The device is configured to securely stabilize an endotracheal tube, thereby preventing slippage or misalignment during use. The device is further designed to protect the endotracheal tube from damage caused by tooth bites, ensuring uninterrupted ventilation and reducing the risk of tube narrowing, where biting of the tubemay cause damage to the pilot line, leading to an air leak from the balloon. This balloon deflation can result in oral secretions or gastric content entering the lungs, potentially causing aspiration pneumonia, a life-threatening condition that necessitates urgent reintubation of the patient. Additionally, the device eliminates the need for undesired sedation or paralyzing medication to prevent tube biting, thereby minimizing potential complications associated with such medications. The device also prevents tube leakage, avoiding ventilator alarms and maintaining consistent inspiration and expiration tidal volumes. Furthermore, the device ensures patient comfort by incorporating flexible, soft, and skin-friendly wings flaps that distribute securing forces evenly across the patient’s face and neck. Moreover, the device allows for clear visualization of the tube position markers at the angle of the mouth, enabling precise monitoring of the tube’s placement. The description of terms and features related to the present disclosure shall be clear from the embodiments that are illustrated and described; however, the invention is not limited to these embodiments only. Numerous modifications, changes, variations, substitutions, and equivalents of the embodiments are possible within the scope of the present disclosure. Additionally, the invention can include other embodiments that are within the scope of the claims but are not described in detail with respect to the following description.

[0038] FIG.1A illustrates an exploded view of a device for fixation and protection endotracheal tube (ET) tube management, in accordance with an embodiment of the present disclosure.

[0039] Referring to FIG. 1A, a device 100 for fixation and protection of endotracheal tube (ET) tube management is disclosed. The device 100 is configured to overcome challenges retaining to ET tube damage, slipping, and complications due to undesired sedation or paralyzing medications. The device 100 can include a tube protector 102, a tube fixer 104, wings flap 106, and a pair of straps (108-1, 108-2) (which are collectively referred to as straps 108, herein)).

[0040] The tube protector 102 is a cylindrical structure that features an upper circular head 132 and lower hollow cylinder 134. The surface of the circular head 132 includes a male extension 126-1 and a female groove 126-2 forming a locking mechanism. Directly opposite to this locking mechanism, a triangular notch 120 is present on the surface of the circular head 132. Alongside the male extension 126-1 and female groove 126-2, a longitudinal triangular groove 130-1 is present on the surface of the lower hollow cylinder 134, which can be aligned with a longitudinal triangular edge 130-2 on the surface of the lower hollow cylinder 134. At surface of lower hollow cylinder 134 have longitudinal one-sided openingand closing mechanism 128, which may enclose the ET tube 200. On the surface of the hollow cylinder 134, there are longitudinal grooves 122 on both the inner surface 122-1 and the outer surface 122-2, positioned just below the triangular notch 120 of the upper circular head 132 and opposite to the one-sided longitudinal opening 128.

[0041] The tube fixer 104 is fabricated from a loop and hook strap, providing flexibility and elasticity, and is configured to surround the ET tube 200. The tube fixer 104 includes a middle part 104-1 and two sides (104-2, 104-3). The inner surface 104-1A of tube fixer 104 is made of hooks and outer surface 104-2A is made of loops. One side 104-3 have a rectangular cut hole 116. The tube fixer 104 is designed to surround the ET tube 200, with end of one side 104-2 passing through the rectangular hole 116 on the other side 104-3 of the tube fixer strap. Then the both end of two sides are pulled tightly then inner surface of both sides are attached to the outer surface of middle part of tube fixer by loops and hooks.

[0042] The wings flap 106 is a flexible component having a hexagonal structure, with two rectangular-shaped holes (106-1,106-2) located at opposite ends of the wings flap 106. The surface of the wings flap 106 includes two holes, namely a circular hole 112 and a hexagonal hole 114, positioned side by side, with both holes being connected by a notch or cut 118. The upper circular head 132 of the tube protector 102 is permanently coupled to the circular hole 112 of the wing flap 106, wherein one side of the longitudinal opening mechanism 128 and the male and female locking mechanism at the circular head 132 of the tube protector 102 remain aligned on the same side as the connecting notch 118. The upper circular head 132 of the tube protector 102 remains attached to the circular hole 112 of the wing flap 106, while the lower hollow cylinder 134 of the tube protector 102 extends downward from the wing flap 106. Surrounding the circular hole 112 is a circular extension wall 112-1, the circular wall 112-1 is discontinued at the connecting notch 118, which extends further upward into a semicircular shape 110 opposite the notch 118. The semicircular extension wall 110 has two surfaces an inner surface 110-2 and an outer surface 110-1. The inner surface 110-2 is coated with removable adhesive and comes into direct contact with the ET tube 200, while the inner surface 104-1 A of middle part 104-1 of tube fixer 104 is permanently glued to the outer surface 110-1 of the semicircular extension wall 110. The inner surface 104-1A at the middle part 104-1 of the tube fixer 104 is permanently coupled to the outer surface 110-1 of the semicircular extension wall 110 of the wings flap 106 using permanent glue.

[0043] Further, there are pair of flexible straps (108-1,108-2) at both sides of wings flap 106. The upper ends (108-1A ,108-2A) of the pair of straps (108-1, 108-2) coupled tocorresponding rectangular-shaped holes (106-1,106-2) located at opposite ends of the wings flap 106.The other free ends (1O8-1B,1O8-2B) of the pair of straps (108-1, 108-2) are tied to back of neck of subject.

[0044] As depicted in FIG. IB to FIG. ID, the tube protector 102 is a cylindrical structure that includes the upper circular head 132 and the lower hollow cylinder 134. On the surface of the upper circular head 132, there is a male and female locking and opening mechanism. On the surface of the upper circular head 132, the locking mechanism includes the male extension 126-1 on one side and the female groove 126-2 on the other side, allowing the male extension 126-1 and female groove 126-2 to be closed or opened upon the application of minimal push or pull force. In FIG. 1C, the male extension 126-1 is inserted into the female groove 126-2 upon the application of a minimal push, wherein the locking mechanism is configured to secure the engagement in a locked state. The male and female lock is configured to disengage upon the application of the minimal pull force. Alongside the male extension 126-1 and the female groove 126-2, the longitudinal one-sided opening mechanism 128 is provided to enable the tube protector 102 to be selectively opened and closed at a longitudinal junction 124. In the closed position, the longitudinal triangular groove 130-1 on the surface of the hollow cylinder 134 is configured to align with the longitudinal triangular edge 130-2 on the surface of the hollow cylinder 134, as shown in FIG. 1C. The locking mechanism is configured to be disengaged upon the application of a minimal pull force, as shown in FIG. IB. The longitudinal one-sided opening mechanism 128 is designed to be selectively opened, as depicted in FIG. IB, and closed, as depicted in FIG. 1C, to facilitate ease of use. Opposite the male extension 126-1 and female groove 126-2 locking mechanism, the triangular notch 120 is provided on the surface of the upper circular head 132. The surface of the hollow cylinder 134 includes the longitudinal groove 122 on both the inner surface 122-1 and the outer surface 122-2, positioned below the triangular notch 120 of the upper circular head 132 and opposite the one-sided longitudinal opening 128. The inner groove 122-1 and outer groove 122-2 on the surface of the hollow cylinder 134 are configured to act as hinge facilitate the easy opening and closing of the male extension 126-1 and female groove 126-2, wherein, along with the longitudinal triangular edge 130-1 and triangular groove 130-2, they enable proper alignment during opening and closing to securely insert the ET tube 200.

[0045] The tube protector 102 fabricated from food-grade polypropylene or PVC, is configured to resist the force of a tooth bite and prevent ET tube damage or lumen narrowing. The tube protector 102 having an internal diameter larger than the outer diameter of the ETtube 200, the tube protector 102 being coupled permanently with the circular hole 112 of the wings flap 106. The circular head 132 of the tube protector 102 is permanently coupled with glue to the circular hole 112 of the wing flap 106 with proper alignment. The male extension 126-1 and female groove 126-2 of tube protector 102 is aligned with connecting notch 118 of the circular hole 112 and hexagonal hole 114 as showed in FIG IE. The internal diameter of the tube protector 102 is larger than the outer diameter of the ET tube 200 as shown in FIG. 2, allowing the ET tube 200 to remain protected without hindering airflow. The upper circular head 132 of tube protector 102 remains outside the mouth, the lower hollow cylinder 134 of tube protector 102, remains inside the mouth after covering the ET tube 200. This configuration prevents ET tube damage, pilot line damage and ET tube narrowing, ventilator alarms caused by tube leakage or irregular tidal volumes and reduces the need for sedation or paralyzing medications, thereby avoiding associated complications. In an exemplary embodiment, the tube protector 102 is made of food-grade hard polypropylene or hard PVC, configured to safeguard the ET tube from damage caused by tooth bites.

[0046] FIG. IE illustrates a perspective view of a device for fixation and protection endotracheal tube (ET) tube, in accordance with an embodiment of the present disclosure. The assembly of the device 100, as depicted in FIG. IE, includes the insertion of the tube protector 102 into the circular hole 112 of the wing flap 106, with the circular head 132 of the tube protector 102 permanently glued in proper alignment. The male and female locking mechanism of the circular head 132 is aligned on the same side as the connecting notch 118. The hollow cylinder 134 extends downward from the wing flap 106, and the longitudinal opening mechanism 128 is also aligned on the same side as the connecting notch 118. This configuration allows the tube protector 102 to be opened to receive the ET tube 200 and closed to securely cover the ET tube 200. The upper connector 202 of ET tube 200 is inserted through the hexagonal hole 114 of the wings flap 106 and then the middle part 220 of the ET passed inside the tube protector 102 through the connecting notch 118 , by opening the male extension 126-1 and female groove 126-2 of upper circular head 132 and longitudinal opening 128 at lower hollow cylinder 134 of tube protector 102. As the upper circular head 132 is permanently coupled with the circular hole 112 of the wing flap 106, opening the male and female locking mechanism at the circular head, along with the longitudinal opening 134, causes the connecting notch 118 of the wing flap 106 to widen, as it is made of a flexible material. Additionally, the longitudinal opening 128 on the surface of the lower hollow cylinder 134 of the tube protector 102 remains open. The inner surface 104-1A at the middle (104-1) of the tube fixer 104 is permanently coupled to the outer surface 110-1 of thesemicircular extension wall 110 of the wings flap 106 using permanent adhesive, wherein the tube fixer 104 is designed to surround the ET tube 200, with end of one side 104-2 passing through the rectangular hole 116 in the opposite side 104-3, then both end of both side (104- 2, 104-3) are pulled tightly , and hooks of inner surfaces (104-1 A) of both side( 104-2, 104-3) of tube fixer 104 are attached to the loops of outer surface(104-2A) of middle part (104-1) of tube fixer (104). The loops and hooks are attached to each other, ensuring that the upper portion 216 of the tubular column 204 (also referred to as the tubular member 204) of the ET tube 200, along with the connector 202, remains securely fixed outside the mouth, while the ET tube 200 remains intact. The upper ends (108-1 A, 108-2A) of the pair of straps (108-1, 108-2) are coupled to corresponding rectangular-shaped holes (106-1, 106-2) located at opposite ends of the wings flap 106, allowing the lower ends (108-1B, 108-2B) of the straps (108-1, 108-2) to be secured to the neck of the user, thereby fastening the device 100.

[0047] The lower hollow cylinder 134 of the tube protector 102 is positioned between the upper and lower teeth, configured to safeguard the ET tube 200 from damage caused by tooth bites, thereby preventing ET tube leakage, pilot line damage leading to air leaks from the cuff, and structural compromise. It ensures that the ET tube 200 maintains its intended diameter, mitigating the risk of narrowing due to external biting forces. The tube protector 102 is configured to prevent ventilator alarms triggered by ET tube leakage and pilot line damage, reduced inspiration and expiration tidal volumes, or elevated pressure within the ventilator circuit. Furthermore, it eliminates the need for undesired sedation or paralyzing medications to address tube biting, thereby avoiding complications associated with such interventions. The tube protector 102 is constructed to withstand the bite force of teeth, ensuring reliable performance and durability during use.

[0048] In another embodiment, the tube fixer 104 is fabricated from loop and hook strap, providing flexibility and elasticity. The tube fixer 104 is configured to surround the endotracheal (ET) tube 200 and includes the inner surface 104-1 A of middle part 104-1 and both side (104-2 and 104-3) parts made of hooks and the outer surface 104-2A of middle part 104-1 and both side (104-2 and 104-3) parts made of loops. At one side (104-3) of the strap there have the longitudinal hole 116. The inner surface 104- 1A, at the middle (104-1) of the tube fixer 104, is permanently bonded to the outer surface 110-1 of the semicircular extension wall 110 of the wings flap 106 using glue material. The tube fixer 104 surrounds the ET tube 200, with one end 104-2 passing through the rectangular hole 116 on the other side 104-3. Both ends are tightly pulled to secure the ET tube 200 in place. Upon pulling both ends 104-2 and 104-3 of the tube fixer strap 104, the removable adhesive inner surface 110-2 of thesemicircular extension 110 comes into direct contact with the upper part 216 of the tubular surface 204 of the ET tube 2OO.The removable adhesive of inner surface 110-2 of semicircular wall extension 110 keeps the ET tube 200 secure position, which may not allow the ET tube 200, displaced from desired position. The inner surface 104-1 A hooks on both sides 104-2 and 104-3 of the tube fixer 104 strap are attached to the loops on the outer surface 104- 2A of the tube fixer 104 strap, ensuring a secure grip on the ET tube 200 to hold it in a fixed position within the airway of the subject, as shown in FIG. 2. Alternatively, the inner surface of the tube fixer 104 may be coated with removable adhesive-glue, ensuring a tight grip around the ET tube 200 to prevent slipping. In an exemplary embodiment, the tube fixer 104 is stretched manually and secured using the loop & hook strap / mechanism, maintaining the tube in a fixed position. The tube fixer 104 is configured to fixation of the ET tube 200 firmly above the mouth at the desired position, preventing any unintended slippage from the fixed placement. The tube fixer 104 ensures that the tube position marker remains clearly visible at the angle of the mouth, allowing accurate monitoring and verification of the ET tube's placement during use.

[0049] In another embodiment, the wing flap 106, made from medical-grade elastomer, is designed to be soft, flexible, and strong. It provides gentle contact with the patient's cheek area while supporting the tube protector 102 and the tube fixer 104. The wing flap 106 has two rectangular holes (106-1, 106-2) on either side, through which the upper ends (108-1 A, 108-2A) of the corresponding straps (108-1, 108-2) are attached, while the lower ends (108- 1B, 108-2B) of the straps (108-1, 108-2) are tightened at the back of the patient's neck. The wings flap 106 includes the circular hole 112 and the hexagonal hole 114 arranged side by side, with the two holes interconnected by the notch 118. The circular extension wall 112-1 surrounds the circular hole 112 and circular extension wall 112-1 separated at the connecting notch 118.The circular extension 112-1 extends further upwardly semi circularly just opposite the notch 118, forming the semicircular wall extension 110. The semicircular extension wall 110 includes the inner surface 110-2 and the outer surface 110-1, wherein the inner surface 110-2 is coated with removable adhesive and configured to engage directly with an endotracheal (ET) tube 200, and the inner surface (104-1 A) at middle of 104-1 of the tube fixer 104 is permanently coupled to the outer surface 110-1 of the semicircular extension wall 110.

[0050] In another embodiment, the pair of straps (108-1, 108-2), each of the straps having a upper end (108- 1A, 108-2A) attached to corresponding rectangular holes (106-1, 106-2) of the wings flap 106 and lower ends (108-1B, 108-2B) configured to secure thedevice at the back of the neck of the subject, where the combination of the tube protector 102, the tube fixer 104, wings flap 106, and the pair of straps (108-1, 108-2) securely holds the ET tube 200 in position, preventing slippage, damage, and ensuring proper alignment of the ET tube. The straps (108-1, 108-2) are constructed from soft, durable cotton or elastic material. It is attached to the rectangular holes (106-1, 106-2) on both sides of the wings flap 106 and secured at the back of the neck. The straps (108-1, 108-2) ensure that the wings flap 106 remains firmly in place, providing consistent support for the tube protector 102 and tube fixer 104 during use.

[0051] For example, a male or female patient with severe respiratory distress can be admitted to the intensive care unit following a motor vehicle accident, where compromised breathing necessitated intubation and connection to a mechanical ventilator to stabilize oxygen levels, and the disclosed device may be employed to securely manage the ET tube in place. The above-disclosed device is configured to protect the ET tube 200 from damage and fix the endotracheal (ET) tube 200 at proper position.

[0052] First, the patient is intubated with the ET tube 200, where the lower tip part 218 of the ET tube 200 remains inside the trachea, the middle tubular part 220 remains inside the mouth, and the upper part 216 remains outside the mouth. The connector 202 of the ET tube 200 is inserted through the hexagonal hole 114. The coupled tube protector 102 at the circular hole 112 of the wing flap 106 is then opened longitudinally at the surface of the lower hollow cylinder 134 of the tube protector 102 by pulling apart the male extension 126-1 and female groove 126-2 locking mechanism at the circular head 132. The connecting notch 118 also widens, as it is made of flexible elastomer. The coupled tube protector 102 at the circular hole 112 encloses the upper part 216 of the ET tube 200 through the widened notch 118. The male extension 126-1 and female groove 126-2 at the surface of the upper head 132 of the tube protector 102 are then closed with a gentle push, securing the male and female locking mechanism. Simultaneously, the one-sided longitudinal opening 128 at the surface of the lower hollow cylinder 134 of the tube protector 102 is also closed, aligning the longitudinal groove 130-1 with the longitudinal edge 130-2 on the surface of the hollow cylinder 134 of the tube protector 102.

[0053] The lower hollow cylinder 134 and the upper head 132 of the tube protector 102, enclosing the upper part 216 of the ET tube 200 above the mouth, slide along the ET tube 200 into the subject’s mouth. The lower hollow cylinder 134 of the tube protector 102 covers the middle part 220 of the ET tube 200 inside the mouth, positioned between the lower jaw and upper jaw. The upper circular head 132 of the tube protector 102 coupled with the circularhole 112 of the wings flap 106 remains outside the mouth. The lower hollow cylinder 134 remains inside the mouth, enclosing the middle part 220 of the ET tube 200. The tube fixer 104, coupled with the semicircular wall extension 110 of the wings flap 106, wraps around the upper part 216 of the ET tube 200 above the mouth. One end one side (104-2) of the tube fixer 104 passes through the cut hole 116 on the other side (104-3) of the tube fixer 104. Both ends of both sides (104-2, 104-3) of the tube fixer 104 are then pulled tightly. As the ends of both sides of the tube fixer 104 are pulled, the inner removable adhesive surface 110-2 of the semicircular extension wall 110 comes into direct contact with the upper part 216 of the ET tube 200. The removable adhesive surface 110-2 ensures that the ET tube 200 is held securely in place. The tube protector 102, made of food-grade polypropylene, lower hollow cylinder 134 of tube protector 102 positioned inside the patient’s mouth to shield the ET tube from damage caused by involuntary tooth biting during sedation, thereby preventing lumen narrowing or occlusion and ensuring uninterrupted airflow to the lungs. The tube fixer 104 is fabricated from the loop and hook strap. The hooks on the inner surface 104-1 A of both sides (104-2, 104-3) of the tube fixer 104 are attached to the loops on the outer surface 104-2A of the middle portion 104-1 of the tube fixer 104, which is further attached to the outer surface of the semicircular extension wall 110 of the wing flap 106. The tube fixer 104 includes an inner surface with hooks and an outer surface with loops. The strap is then tightened and secured by the loop and hook mechanism to fix the ET tube 200 in place.

[0054] The wings flap 106, constructed from a soft medical-grade elastomer, may be placed externally along the patient’s cheeks, providing dual support to ensure stability during patient movement and ventilator adjustments, while distributing securing forces evenly across the face to minimize pressure injuries and enhance comfort. The straps, made of soft elastic material, were attached to the rectangular holes of the wings flap 106 and secured at the back of the neck to hold the device firmly in position, thereby preventing ET tube dislodgement during emergency interventions, such as patient repositioning for imaging or surgery, ensuring over subsequent days that the device effectively mitigated complications such as slippage, tube damage, and ventilator alarms due to leakage or biting, allowing the patient to be weaned off the ventilator with the device being easily removed without discomfort or skin marks, thus demonstrating the efficacy and practicality of the device in critical care scenarios.

[0055] In an implementation of an embodiment, the wings flap 106 is a flexible, planar structure made of medical-grade elastomer material, configured to provide a soft and smooth surface for contact with the patient's cheeks. The wings flap 106 includes two opposing rectangular holes (106-1, 106-2) positioned laterally, enabling the attachment of straps (108-1, 108-2) for securing the device at the back of the neck of the patient. The material and structural design of the wings flap 106 ensure both flexibility and durability, accommodating patient movement while maintaining stability of the assembly.

[0056] The tube protector 102, constructed as a cylindrical structure with upper circular head 132 and lower hollow cylinder 134 with a one-sided opening mechanism with male and female locking at circular head. The circular head of the tube protector is coupled to circular hole of the wings flap 106. This coupling is achieved using a permanent adhesive glue applied to the circular head of the tube protector 102, ensuring a strong and secure bond. The coupling ensures that the tube protector 102 remains aligned so that the male n female locking at circular head and longitudinal opening 128 at hollow cylinder 134 is aligned towards the connecting notch 118 of the wings flap 106 and the upper circular head of tube protector 102 attached with circular hole 112 of wings flap 106 remains attached with mouth and lower hollow cylinder 134 of tube protector 102 remains inside the mouth in-between lower jaw and upper jaw, maintains its protective function during use.

[0057] The tube fixer 104 is positioned to surround the endotracheal tube, providing a secure grip to prevent slippage. Additionally, the tube fixer 104 remains outside (above) mouth and attached with semicircular wall extension of wings flap 106, and the upper circular head of tube protector 102 attached with circular hole 112 of wings flap 106 remains attached with mouth and lower hollow cylinder 134 of tube protector 102 remains inside the mouth in-between lower jaw and upper jaw , aligning the components and ensuring their collective stability. This coupling arrangement facilitates secure fixation of the endotracheal tube while maintaining ease of assembly and patient comfort.

[0058] FIG.2 illustrates an exemplary view perspective view of an endotracheal tube inserted into the device, in accordance with an embodiment of the present disclosure.

[0059] The endotracheal tube 200 can include an assembly that is configured for applications such as anaesthesia delivery, airway management, and mechanical ventilation. The endotracheal tube 200 can include a connector 202 positioned outside the mouth of the patient and configured to connect to an ambu bag, mechanical ventilator, or other air exchange source.

[0060] The tubular member 204 made of medical -grade Polyvinyl Chloride (PVC) or silicone, providing a passage for oxygen, anaesthetic medication, and gaseous exchange to the patient’s lungs. The lower tip 218 of ET tube 200 remains inside the trachea but above the bifurcation of trachea into right and left bronchus, the middle part 220 of ET tube 200 remains inside the mouth, the upper part 216 of ET tube 200 remains outside the mouth. Aninflatable cuff 206 is positioned around the distal portion of the tubular member 204, configured to secure the endotracheal tube 200 to the tracheal wall when inflated and prevents the oral secretion and gastric content to enter into the trachea. A one-way valve 208 configured to facilitate inflation of the cuff 206 via a syringe 212. A pilot balloon 210 and a pilot line 214, operatively connected to monitor and control the inflation of the cuff 206.

[0061] The connector 202 remains external to the mouth of the patient and serves as an interface with an oxygen source or mechanical ventilation system. The tubular member 204 allows for the delivery of oxygen and anaesthetic agents to the lungs of the patient while facilitating gaseous exchange. The inflatable cuff 206, when inflated, secures the endotracheal tube 200 to the tracheal wall, preventing displacement and ensuring proper positioning. Additionally, the inflated cuff 206 acts as a barrier to prevent gastric or oral secretions from entering the patient’s lungs and inhibits the backflow of oxygen and anaesthetic medications along the exterior of the endotracheal tube. The inflation of the cuff 206 is achieved by injecting air via the syringe 212 through the one-way valve 208, with the inflated state monitored by the pilot balloon 210 and controlled through the pilot line 214. This configuration ensures effective airway management and prevents complications associated with secretion aspiration or medication backflow.

[0062] Initially positioning the cuff 206 in a deflated state. Inserting the endotracheal (ET) tube 200 into the mouth of the patient. Introducing air through the syringe 212, wherein the air is directed through the pilot balloon 210 and controlled via the pilot line 214. Directing the air to the tubular member 204, thereby inflating the cuff 206, wherein the inflated cuff 206 engages the walls of the trachea to create a seal, with lower tip 218 portion of ET tube 200 remains inside the trachea but above the bifurcation of trachea into right and left bronchus..

[0063] The endotracheal (ET) tube inserted into the device and secured by the tube fixer 104, in accordance with an embodiment of the present disclosure. FIG. 2 illustrates an exemplary embodiment in which the endotracheal (ET) tube 200 is securely positioned within the device, with the tube fixer 104 surrounding the tube 200. The inner surface of semicircular extension wall is coated with removable adhesive, when the tube fixer 104 surrounds the ET tube, the adhesive surface inner surface of semicircular extension come direct contact with tubular lumen 204 of ET tube 200, then the tube fixer 104 surround the ET tube. The tube fixer 104, featuring an adhesive inner surface and a loop-and-hook strap, -ensures the ET tube 200 remains stable and properly positioned. The configuration of the device, as shown, isdesigned to prevent movement of the ET tube 200 while safeguarding it from potential damage.

[0064] FIG.3A to 3F illustrates an exemplary view of a device for securing an endotracheal tube 200 inside the subject, in accordance with an embodiment of the present disclosure. Referring to FIG. 3 A to 3F, the illustrated device is configured to securely position and stabilize an endotracheal (ET) tube 200 within the airway of the patient while preventing slippage, damage, or misalignment during use. The device 100 can include the tube protector 102, the tube fixer 104, the wings flap 106, and straps (108-1, 108-2), all working in conjunction to secure the ET tube 200 and ensure patient safety.

[0065] FIG. 3A illustrates the placement of the device on the mouth part of the user, the subject is intubated with ET tube 200, the lower tip 218 of ET tube 200 remains inside the trachea and just above the bifurcation of trachea, the middle portion 220 of the ET tube 200 remains inside of mouth, the upper portion 216 of the ET tube 200 remains outside mouth. The ballon 210 is inflated by pushing air through the syringe 212 to the one way valve 208, air goes through the pilot ballon 210 and pilot line 214 to inflate the cuff 206. The inflated cuff 206 is attached to the wall of trachea. The device 100 includes the assembled, the tube protector 102 permanently coupled by adhesive inside the circular hole 112 of the wings flap 106, with the tube fixer 104 attached with semicircular wall 110 of the wings flap 106, where the upper ends (108-1 A, 108-2A) of both straps (108-1, 108-2) coupled to the rectangular holes (106-1, 106-2) of the wings flaps 106. The assembled device 100 is attached to the mouth by positioning it close to the mouth and inserting the connector 202 of the ET tube 200 through the hexagonal cut hole 114 of the wing flap. The tube protector 102 is opened on one side longitudinally 128 and at the circular head 132, with the male extension 126-1 and female groove 126-2 opening along with the connecting notch 118, which is widened to enclose the upper part 216 of the tubular member 204 of the ET tube 200.

[0066] FIG. 3B illustrates the placement of the device on the mouth part of the user, wherein, upon receiving the endotracheal (ET) tube 200, the tube protector 102 enclosed the ET tube 200 at the upper part 216 of ET tube 200 above the mouth. The male extension 126-1 is inserted into the female groove 126-2 at the circular head 132 of the tube protector 102. Upon applying mild force, the male extension 126-1 and female groove 126-2 at the upper head surface 132 of the tube protector 102 securely lock together. Simultaneously, the onesided longitudinal opening 128 on the surface of the lower hollow cylinder 134 of the tube protector 102 is also closed, aligning the longitudinal groove 130-1 with the longitudinal edge 130-2. The lower hollow cylinder 134 and the upper head 132 of the tube protector 102enclose the upper part 216 of the ET tube 200 above the mouth. The tube protector 102 then slides along the ET tube 200 into the subject's mouth. The ET tube 200 is positioned between the upper and lower teeth of the subject, in accordance with an embodiment of the present disclosure.

[0067] FIG 3C illustrates the placement of the device on the mouth part of the user , wherein the device 100 along with tube protector 102 which is coupled with circular hole 112 of wings flap 106 enclosing the upper part 216 of ET tube 200 above mouth slided through the ET tube 200 into inside the mouth to cover middle part 220 of ET tube. The closed hollow cylindrical 134 of tube protector 102 remains inside the mouth between upper tooth and lower tooth. The circular head 132 of tube protector 102 coupled with circular hole 112 of wings flap 106 remains outside the mouth.

[0068] FIG. 3D illustrates the placement of the device on the mouth part of the user, wherein the endotracheal (ET) tube is secured by the tube fixer 104, and the tube protector 102 is positioned between the upper teeth and lower teeth of the subject, in accordance with an embodiment of the present disclosure. The upper head 132 of the tube protector 102 remains outside the mouth, coupled with the circular hole 112 of the wing flap 106. The tube fixer 104, coupled with the semicircular wall extension 110 of the wing flap 106, wraps around the upper part 216 of the ET tube 200 above the mouth. One end 104-2 of the tube fixer 104 passes through the cut hole 116 on the other end 104-3 of the tube fixer 104. When both ends (104-2, 104-3) of the tube fixer 104 are pulled tightly, the inner removable adhesive surface 110-2 of the semicircular wall extension 110 comes into direct contact with the tubular lumen / member 204 at the upper part 216 of the ET tube 200. The removable adhesive surface 110-2 secures the ET tube 200 in position. The inner hooks (104-1 A) on both ends (104-2, 104-3) of the tube fixer 104 attach to the loops on the outer surface (104- 2A) at the middle section (104-1) of the tube fixer 104, ensuring a firm wrap around the upper part 216 of the ET tube 200 outside the mouth. Finally, the lower ends (108-1B, 108- 2B) of the straps (108-1, 108-2) are attached at the back of the subject’s neck.

[0069] FIG. 3E illustrates the placement of the device on the mouth part of the subject, wherein, upon receiving the endotracheal (ET) tube, the tube protector 102 is positioned between the upper teeth and lower teeth of the subject and is fixed at the back of the neck with straps, in accordance with an embodiment of the present disclosure. The pair of straps (108-1, 108-2) of the upper ends (108-1 A, 108-2A) are coupled to corresponding rectangular-shaped holes (106-1, v 106-2) located at opposite ends of the wings flap 106,allowing the straps (108-1, 108-2) of the lower ends (108-1B ,108-2B) to be secured knotted to the back neck of the user, thereby fastening the device 100.

[0070] FIG. 3F illustrates a longitudinal view of the placement of the device on the mouth part of the subject, wherein, upon receiving the endotracheal (ET) tube, the upper circular head 132 remains attached above mouth with circular hole 112 of wings flap 106, the lower hollow cylinder 134 of the tube protector 102 is positioned between the upper teeth and lower teeth of the user, in accordance with an embodiment of the present disclosure. The inner surface 110-1 of semicircular extension 110, remains attached to the tubular member 204 of ET tube 200. Initially positioning the cuff 206 in the deflated state. Inserting the endotracheal (ET) tube 200 into the mouth of the patient. Introducing air through the syringe 212, wherein the air is directed through the pilot balloon 210 and controlled via the pilot line 214. Directing the air to the tubular member 204, thereby inflating the cuff 206, wherein the inflated cuff 206 engages the walls of the trachea to create a seal, with one half portion of the tubular member 204 positioned inside the mouth and the other half portion positioned outside the mouth.

[0071] The combined action of the tube protector 102, wings flap 106, tube fixer 104 and pair of straps (108-1, 108-2) ensures that the ET tube 200 is held securely in its desired position within the trachea. The inflated cuff 206 prevents backflow of oxygen and anaesthesia and blocks gastric or oral secretions from entering the lungs. The straps (108-1, 108-2) maintain the external components, including the wings flap 106, in a stable position, distributing the securing forces evenly across the patient’s head and neck. This configuration ensures that the ET tube 200 remains properly positioned, minimizing the risk of complications during ventilation or anaesthesia.

[0072] Thus, the present invention overcomes the drawbacks, shortcomings, and limitations associated with existing solutions, and provides a device for securely stabilizing an endotracheal tube, preventing slippage or misalignment during use. The device protects the endotracheal tube from damage caused by tooth bites, ensuring uninterrupted ventilation and reducing the risk of tube narrowing. It eliminates the need for undesired sedation or paralyzing medication to prevent tube biting, thereby reducing potential complications associated with such medications. Additionally, the device prevents tube leakage, thereby avoiding ventilator alarms and maintaining consistent inspiration and expiration tidal volumes. The device ensures patient comfort with flexible, soft, and skin-friendly wings flaps that distribute securing forces evenly across the patient’s face and neck. Furthermore, thedevice allows clear visualization of the tube position markers at the angle of the mouth, enabling precise monitoring of the tube’s placement.

[0073] It will be apparent to those skilled in the art that the device 100 of the disclosure may be provided using some or all of the mentioned features and components without departing from the scope of the present disclosure. While various embodiments of the present disclosure have been illustrated and described herein, it will be clear that the disclosure is not limited to these embodiments only. Numerous modifications, changes, variations, substitutions, and equivalents will be apparent to those skilled in the art, without departing from the spirit and scope of the disclosure, as described in the claims.ADVANTAGES OF THE PRESENT INVENTION

[0074] The present disclosure provides a device that securely stabilizes an endotracheal tube, preventing slippage or misalignment during use.

[0075] The present disclosure provides a device that protects the endotracheal tube from damage due to tooth bites, ensuring uninterrupted ventilation and reducing the risk of tube lumen narrowing.

[0076] The present disclosure provides a device that eliminates the need for undesired sedation or paralyzing medication to prevent ET tube biting, thereby reducing potential complications associated with such medications.

[0077] The present disclosure provides a device that prevents ET tube leakage, thereby avoiding ventilator alarms and maintaining consistent inspiration and expiration tidal volumes.

[0078] The present disclosure provides a device securing ET tube, wherein the device prevents ET tube leakage and damage, thereby avoiding the need for reintubation with a new ET tube.

[0079] The present disclosure provides a device that prevents damage to the ET tube pilot line, which could otherwise cause cuff deflation, leading to the entry of saliva secretions into both lungs, thereby preventing aspiration-related complications and avoiding reintubation with a new ET tube.

[0080] The present disclosure provides a device that ensures patient comfort with flexible, soft, and skin-friendly wings flaps that distribute securing forces evenly across the patient’s face and neck.

[0081] The present disclosure provides a device that allows clear visualization of the tube position markers at the angle of the mouth, enabling precise monitoring of the tube’s placement.

[0082] The present disclosure provides a device that required less manpower to fix the the ET tube.

[0083] The present disclosure provides a devices that can fix the ET tube at in emergency situation with patient having beard or without hurting the religious sentiment.

Claims

aim:

1. A device (100) for securing an endotracheal tube (ET) tube (200), the device comprising: a tube protector (102) formed of a cylindrical structure having an upper circular head (132) and a lower hollow cylinder (134), configured to receive the endotracheal tube (200), wherein the tube protector (102) comprises a longitudinal one-sided opening mechanism (128) at one portion of the tube protector (102) to enable the tube protector to be opened and closed at a longitudinal junction (124), the tube protector being positioned within a mouth area of a subject to cover the ET tube; a tube fixer (104) made of hooks and loops, configured to securely grip the ET tube (200) upon being received by the tube protector (102), holding the ET tube in a fixed position, wherein the hooks of the tube fixer (104) engage with the loops of the tube fixer (104); a wings flap (106) of a hexagonal structure comprising: a circular hole (112) configured to receive the tube protector (102) and be coupled with the upper circular head (132) of the tube protector (102); a hexagonal hole (114) configured to receive a portion of a tubular member (204) of the endotracheal tube (200), wherein the circular hole (112) and the hexagonal hole (114) are positioned side by side in the hexagonal structure and connected by a notch ( 118) to allow the endotracheal tube (200) to be received by the tube protector (102) accommodated in the circular hole (112); and a circular extension wall (112-1) surrounding the circular hole (112), wherein the circular extension wall (112-1) is configured to extend further in a semicircular manner upwardly, forming a semicircular extension wall (110), wherein an inner surface (104-1A) of the tube fixer (104) is permanently bonded to an outer surface (110-1) of the semicircular extension wall (110) and an inner removable adhesive surface (110-2) of the semicircular extension wall (110) comes into direct contact with the tubular member (204) at an upper part (216) of the endotracheal tube (200); and a pair of straps (108-1, 108-2) coupled to at least two rectangularshaped holes (106-1, 106-2) located at opposite ends of the hexagonal structure of the wings flap (106), each of the straps (108-1, 108-2) having anupper end (108-1 A, 108-2A) atached to the corresponding rectangular holes (106-1, 106-2) of the wings flap (106) and a free end (108-1B, 108-2B) configured to secure the device (100) at a back of a neck area of the subject, wherein combination of the tube protector (102), the tube fixer (104), the wings flap (106), and the pair of straps (108, 109) securely holds the endotracheal tube (200) in position, preventing slippage and damage, and ensuring proper alignment of the endotracheal tube (200).

2. The device as claimed in claim 1, wherein the tube protector (102) have an inner diameter greater than the outer diameter of the ET tube (200), allowing the ET tube to be received by the tube protector (102).

3. The device as claimed in claim 1, wherein the upper circular head (132) comprises: a male extension (126-1) and a female groove (126-2) forming a locking mechanism, wherein the male extension (126-1) and the female groove (126-2) are configured to open and close upon application of minimal pressure; a triangular notch (120) positioned on surface of the upper circular head, opposite to the male extension (126-1) and the female groove (126-2), wherein the upper circular head (132) of the tube protector (102) permanently coupled with the circular hole (112) of the wing flap (106), the upper circular head (132) remains atached above the mouth area;4. The device as claimed in claim 3, wherein the lower hollow cylinder (134) comprises: a longitudinal triangular groove (130-1) of the male extension (126-1) on surface of the lower hollow cylinder (134), the longitudinal triangular groove (130-1) of the male extension (126-1) being configured to align with a longitudinal triangular edge (130-2) of the female groove (126-2) on the surface of the lower hollow cylinder (134) in a closed position, wherein the lower hollow cylinder (134) is positioned within the mouth area of the subject; a longitudinal groove (122) on both an inner surface (122-1) and an outer surface (122-2) positioned below the triangular notch (120) of the upper circular head (132) and opposite to the longitudinal one-sided opening mechanism (128) to act as hinge to facilitate opening and closing of the male extension (126-1) and the female groove (126-2), wherein the longitudinal groove (122) is operated to receive the endotracheal tube (200) after the tubular member (204) of the endotracheal tube (200) passesthrough the hexagonal hole (114) and into the circular hole (112) via the notch (118) of the wings flap (106).

5. The device as claimed in claim 1, wherein the tube fixer (104) comprises: a middle part (104-1) and two sides (104-2 ,104-3), wherein the inner surface (104-1A) of the middle part (104-1) and the two sides (104-2, 104-3) of the tube fixer (104) made of hooks; and an outer surface (104-2A) of the middle part (104-1) and the two sides (104-2 ,104-3) made of loops, wherein the inner surface (104-1 A) of the middle part (104-1) of the tube fixer (104) is coupled to the outer surface (110-1) of the semicircular extension wall (110) and is configured to securely grip the endotracheal tube (200) upon being received by the tube protector (102), holding the endotracheal tube (200) in a fixed position.

6. The device as claimed in claim 1, wherein the tube fixer (104) comprises a cut hole (116) of rectangular shape on one side (104-3) of the tube fixer (104), wherein an end of the opposite side (104-2) is configured to pass through the cut hole (116) of the one side (104-3), wherein upon pulling ends of both sides (104-2, 104-3) of the tube fixer (104) tightly, the inner removable adhesive surface (110-2) of the semicircular extension wall (110) comes into direct contact with the tubular member (204) at the upper part (216) of the endotracheal tube (200).

7. The device as claimed in claim 1, wherein the tube fixer (104) is configured to: position above the mouth area of the subject; encircle the ET tube (200) received by the tube protector (102) to prevent slippage, such that the tube protector (102) is positioned between upper teeth and lower teeth of the subject to facilitate proper placement and stability of the ET tube; and tightly wrap around the upper part (216) of the endotracheal tube (200) outside the mouth, securing the endotracheal tube (200) in place and preventing displacement.

8. The device as claimed in claim 1, wherein the wings flap (106) is positioned externally, extending laterally along cheek area of the subject.

9. The device as claimed in claim 1, wherein the wings flap (106) is made of a flexible elastomer to facilitate comfortable positioning to facial structure of the subject, wherein the upper circular head (132) of the tube protector (102) remains attached to the circular hole (112) of the wing flap (106), and the lower hollow cylinder (134) of the tube protector (102) extends downward from the wing flap (106).

10. The device as claimed in claim 1, wherein the pair of straps (108-1, 108-2) are made from soft, durable cotton or elastic material to facilitate comfortable securing and adjustable fit around the neck area of the subject.

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