WO2017216650A1

WO2017216650A1 - An endotracheal tube for percutaneous dilatational tracheostomy and bronchoscopy

Info

Publication number: WO2017216650A1
Application number: PCT/IB2017/052191
Authority: WO
Inventors: Khosro BARKHORDARI; Sepehr BARKHORDARI; Sepideh NIKKHAH
Original assignee: Barkhordari Khosro; Barkhordari Sepehr; Nikkhah Sepideh
Priority date: 2016-06-14
Filing date: 2017-04-18
Publication date: 2017-12-21

Abstract

The embodiments herein disclose endotracheal tube for protecting the trachea and esophagus from injury during the PDT procedure and bronchoscopy. The ET tube is fabricated with and without non-penetrable material piece. ET tube has upper and lower portions. The upper portion of the ET tube is similar to cuffed endotracheal tubes and leads to lower portion through proximal bevel. A short, thin cuff separates upper portion from the lower portion. The lower portion is U-shaped, which provides bronchoscopic visualization of the anterior wall of trachea. The non-penetrable material covers the inner surface of the ET tube with non-penetrable material piece. This layer prevents the damage to respiratory canal during PDT procedure. A distal bevel of the ET facilitates induction of the ET tube into respiratory canal. Two radiopaque lines on the mid lateral sides of the tracheal tube help for locating right position of the tube.

Description

AN ENDOTRACHEAL TUBE FOR PERCUTANEOUS

DILATATIONAL TRACHEOSTOMY AND BRONCHOSCOPY

BACKGROUND

Technical field

[0001] The embodiments herein are generally related to the field of medical appliances. The embodiments herein are particularly related to instruments for anesthesia and critical care medicine. The embodiments herein are more particularly related to an endotracheal tube designed for facilitating bronchoscopy and percutaneous dilatational tracheostomy (PDT).

Description of the Related Art

[0002] Tracheostomy is a procedure by which a tube for respiration is inserted into the trachea. The inserted tube is also connected to the ventilator. Tracheostomy may be performed using a percutaneous or an open surgical technique. The percutaneous tracheostomy (PDT) is usually performed by anesthesiologists or doctors in the intensive care unit under fiber-optic bronchoscopy guidance. PDT is a commonly used procedure, especially in patients admitted in ICU. PDT is a safe and cost-effective technique. A bronchoscope-guided procedure is the method of choice, but still in many centers PDT done without bronchoscopy.

[0003] Earlier studies have reported no significant difference in terms of complication rates or practicability in the absence of bronchoscope guidance. It is a common notion that in critical patients and those with heart disease, PDT without bronchoscopy is preferable. The PDT is often done in patients already intubated or inserted with a tube. When PDT is performed in intubated patients, usually a conventional tracheal tube is used as a path for bronchoscopy. Nowadays the use of sonography as a guiding measure has become another modality of PDT.

[0004] There are 2 main techniques for performing PDT i.e. a serial dilatational technique and a guide-wire dilating forceps (GWDF) method. Balloon dilation is another percutaneous technique. In all aforementioned techniques, the basic principle is approaching the trachea from the anterior aspect of the neck (percutaneous), and employing a Seldinger guide-wire technique for tracheostomy tube insertion. The techniques may vary slightly, depending upon the operator's preference and experience. Following infiltration with the local anesthetic, the cuff of the patient's endotracheal tube is deflated and the tube is withdrawn under direct vision (by fiber-optic bronchoscopy) until the tip is just distal to the patient's vocal cords. This removes the endotracheal tube from the operative site. Alternatively, the tube may be exchanged for a laryngeal mask airway (LMA) providing that the patient is ventilated safely using the device. Further a needle is introduced into the trachea. This may be confirmed by the ability to aspirate air through the needle. A guide wire is thereafter introduced into trachea trough the needle, but the presence of the needle and wire in the trachea must be confirmed visually via the bronchoscope before proceeding further. Depending upon the kit being used, there may be an intermediate rigid dilator, which is passed over the guidewire. Next, the curved dilator is passed over the guidewire, into the trachea (the Blue Rhino). The curved dilator is then removed and the tracheostomy tube, complete with the introducer, is inserted into the trachea over the guidewire. Alternatively, a Griggs forceps for dilation is inserted over the guide wire instead of the curved dilatator in the GWDF method.

[0005] There are some steps in the aforementioned procedures that may increase the potential risk of injury to the posterior and postero-lateral walls of the trachea and even entering the esophagus. These include: 1- when the needle is introduced, 2-when the guide wire is inserted, 3- when an intermediate rigid dilatator or Griggs forceps is introduced and 4- when a curved dilatator is introduced.

[0006] One of the early complications of PDT is pneumothorax, which is caused by the penetration of the trachea by the needle or other devices. The perforation/damage of the posterior wall of the trachea and esophagus, albeit rare, is almost always fatal. Complications like these as well as trachea- esophageal fistula, false lumen tube insertion, abrasions, and injury to the tracheal wall can be reduced by using a shield.

[0007] The tracheal tube has to be deflated and withdrawn (during the withdrawal of the tracheal tube or placement of the LMA), during this process there is a high probability of unwanted extubation and subsequent hypoxemia, especially with the non-experienced hands. The hypoxia is the most common complication of PDT. This event is very dangerous for critically ill patients.

[0008] Researchers have designed a double-lumen endotracheal tube for better visualization via fibro optic bronchoscopy instead of a regular single-lumen endotracheal tube, but still the tube has to be drawn back during the PDT procedure and there are limitations regarding the risk of unwanted extubation and consequences thereof. It does not have a protector role for trauma to the trachea and esophagus.

[0009] The biomedical researchers have also designed a similar double-lumen endotracheal tube (EZT) but with the risk of trauma by the needle and dilatators to the trachea.

[0010] Hence there is a need for an instrument that is inserted into the larynx and the trachea for providing ventilation and oxygenation for patients throughout the procedure. Also there is a need for an instrument which protects the posterior and posterolateral walls of the trachea against the penetration of the needle, guidewire, rigid dilatators, and forceps during the PDT procedure. Further there is a need for an instrument which comprises impermeable inner segment which protects the lateral and posterior wall of the trachea.

[0011] The above mentioned shortcomings, disadvantages and problems are addressed herein and which will be understood by reading and studying the following specification.

OBJECTIVES OF THE EMBODIMENTS

[0012] The primary objective of the embodiment herein is to provide a multipurpose endotracheal tube that is inserted into the larynx and the trachea for providing ventilation and oxygenation for patients throughout the procedure.

[0013] Another object of the embodiment herein is to provide an endotracheal tube designed for facilitating bronchoscopy and percutaneous dilatational tracheostomy (PDT).

[0014] Yet another object of the embodiment herein is to provide a multipurpose endotracheal tube which protects the posterior and postero-lateral walls of the trachea against the penetration of the needle, guide wire, rigid dilatators, and forceps during the PDT procedure.

[0015] Yet another object of the embodiment herein is to provide a multipurpose endotracheal tube which comprises impermeable inner segment which protects the lateral and posterior wall of the trachea.

[0016] Yet another object of the embodiment herein is to provide a multipurpose endotracheal tube which is very simple and user-friendly.

[0017] Yet another object of the embodiment herein is to provide a multipurpose endotracheal tube which does not require any special experience while handling or using on a patient.

[0018] These objects and the other advantages of the embodiments herein will become readily apparent from the following detailed description taken in conjunction with the accompanying drawings. SUMMARY

[0019] The various embodiments herein provide a multipurpose endotracheal tube that is inserted into the larynx and the trachea for providing ventilation and oxygenation for patients throughout the bronchoscopy and percutaneous dilatational tracheostomy (PDT) procedures. The multipurpose endotracheal tube which protects the posterior and postero-lateral walls of the trachea against the penetration of the needle, guidewire, rigid dilatators, and forceps during the PDT procedure. The multipurpose endotracheal tube which comprises impermeable inner segment which protects the lateral and posterior wall of the trachea.

[0020] According to one embodiment herein, the endotracheal (ET) tube for bronchoscopy and Percutaneous Dilational Tracheostomy procedure (PDT) comprises: an upper portion, a lower portion, one or more radiopaque lines provided at an inner surface of the tube in the upper portion and a pilot connected to the tube at the upper portion for inflating the cuff. The upper portion is formed in a tube shape. The lower portion comprises a cuff, a proximal bevel portion or end, a U shaped lower segment and a distal bevel portion or end. The one or more radio-opaque lines are formed parallel to each other. The one or more radio- opaque lines are blue in color. The upper portion is connected to the lower portion at the proximal bevel portion through the cuff. The cuff is designed to separate the upper portion from the lower portion. The lower segment is formed with a non-penetrable piece or coating to protect a posterior wall of trachea from a penetration of a needle, a guide wire, a rigid dilatator and forceps during a PDT procedure. [0021] According to one embodiment herein, the cuff and the proximal bevel portion or end are connected by a rectangular segment of predetermined length.

[0022] According to one embodiment herein, the distal bevel portion or end is present before a distal segment.

[0023] According to one embodiment herein, the distal segment is U-shaped segment, and an open end of the distal segment is designed to face anteriorly.

[0024] According to one embodiment herein, the non-penetrable piece or coating is provided to cover an inner layer of the endotracheal tube and the lower U-shaped segment.

[0025] According to one embodiment herein, the one or more radio- opaque lines are two radio-opaque lines. The two radio-opaque lines are arranged at two opposite sides of the tube in the upper portion. The two parallel blue radio- opaque lines are formed along a length of the tube. The two parallel blue radio- opaque lines are formed to maintain a consistency of the tube and prevent a twisting of the tube. The two parallel blue radio-opaque lines are markers for determining a correct or appropriate right position of the tube in the larynx and trachea under fluoroscopy for PDT procedure and bronchoscopy with a C-arm device. [0026] According to one embodiment herein, the non-penetrable material is selected from a group consisting of a metal or a fiber glass.

[0027] According to one embodiment herein, the length of the non- penetrable material layer is in a range of 3-4cm, and wherein the thickness of the non-penetrable material layer is 1 mm.

[0028] According to one embodiment herein, the cuff is inflatable.

[0029] According to one embodiment herein, the U-shaped segment is designed to comply with a bronchoscopic visualization of an anterior wall of the trachea.

[0030] According to one embodiment herein, the ET tube is fabricated from materials selected from a group consisting of polyvinyl chloride (PVC) or polyurethane.

[0031] According to one embodiment herein, the multipurpose endotracheal tube is fabricated in two types namely, with an un-penetrable material layer and without the un-penetrable material layer. The multipurpose endotracheal tube with the un-penetrable material layer is used in the percutaneous tracheostomy procedure. The multipurpose endotracheal tube without the un-penetrable material layer is useful in situations comprising bronchoscopy in the critically ill patients of ICU and evaluation of the trachea of patients with long-term intubation for tracheal stenosis and also other critically ill patient during bronchoscopy.

[0032] According to one embodiment herein, the endotracheal tube (ET) comprises two portions called an upper portion and a lower portion. The upper portion of the ET tube is similar to regular ET tubes. The lower portion of the endotracheal tube begins with a cuff. The ET tube has a high-volume, low- pressure, inflatable cuff located in the lower portion. A tiny tube connects the cuff to a pilot for inflating the cuff in the endotracheal tube. The cuff helps to reduce the risk of aspiration. During the percutaneous dilatational tracheostomy (PDT), where bronchoscopy is not possible, the cuff is pulled back to the glottis by an operator. After pulling the cuff back to the glottis, the operator observes that the cuff is positioned across the glottis and ensures that the distal segment is placed or arranged at a desirable position. The size of the cuff is shorter than that of the regular ET tube cuff. Hence the cuff is not extended far down to the cricoid cartilage. The wall of the cuff is very thin, so that the external diameter of the ET tube is not increased significantly. The main feature of the ET tube is that the cuff extended to the second distal segment by the proximal bevel portion or end facing anteriorly and a smooth curve facilitating the passage of the tube through glottis. The distal segment of the ET tube is in a semi-open condition has a U-shaped tunnel which complies with the tracheal walls. The distal segment is configured to facilitate the visualization of the trachea by a bronchoscope. This feature enables the medical practitioner for bronchoscopy. A distal bevel portion at the distal end of the lower portion of the ET tube facilitates the passing of the tube trough the glottis and trachea. The two parallel delineated radiopaque lines are arranged on both the lateral sides of the tube extending from the upper portion to the lower portion. These lines also form the upper edges of the U-shaped segment and demarcate them such that the physician ensures that the tube is in the right position, to face the anterior wall of the trachea, even without X-ray or bronchoscopy. A semi rigid band is inserted just beneath these lines for supporting the consistency of tube such that a twisting of the tube is prevented during a rotation of the tube to see/view all the walls of trachea during bronchoscopy.

[0033] According to one embodiment herein, the main characteristic of the ET tube is a layer of non-penetrable material on the inner layer, impermeable to needles or sharp instruments. The non-penetrable material is a metal piece. The non-penetrable material or layer is provided to prevent the needle, guide wire, rigid dilators, and forceps from damaging the posterior and posterolateral tracheal walls. The non-penetrable material reduces the chance of the complications. The length of non-penetrable material is varied with respect to the size of tracheal tubes and is sufficient to cover a segment of the trachea that usually is used for PDT. This layer of non-penetrable material is extended continuously in both directions as a tail and gives consistency to the tube, thereby facilitating or enabling the semi-circle or curve portion to sit in the right place. By using fluoroscopy, the markers are used along with blue radiopaque lines to define the spatial position of the tube. When PDT is performed without the guidance of the bronchoscope, the medical practitioner performs the procedure safely and efficiently with the use of markers on the metal piece. This non-penetrable layer is designed to cover the inner surface of endotracheal tube. The ET tube without a metal piece or a non-penetratable layer is suitable for use in bronchoscopy in the ICU. It has all characteristics of the tube described, except the non-penetrable layer. The endotracheal (ET) tube device is very simple and user-friendly. The ET tube does not require any special experience or skill for operation.

[0034] According to one embodiment herein, the U-shaped distal segment allows the operator to see the anterior wall of the trachea easily with a fiber optic bronchoscope. The distal segment comprises an inner layer of an impermeable material (metal piece or other composites) that prevents the piercing of the posterior tracheal wall and esophagus by the PDT needle, guide wire, and dilatators. A distal segment without a metal or layer is used in evaluating tracheal stenosis and other pathologies with bronchoscope in the patients admitted in the intensive care unit (ICU) and other wards.

[0035] According to one embodiment herein, the endotracheal (ET) tube is not withdrawn until the tracheostomy tube is not inserted to a very last stages (ultimate stage). The ET tube is designed to minimize the chances of unwanted extubation and hypoxia. The non-penetrable piece/portion is designed to cover a maximum area in danger and avoids a trauma caused to the patient due to penetration. The possibility of complications or damages or effects like pneumothorax, major bleeding, TE fistula, and tracheal and esophageal injury are reduced. The semi-open distal end of the ET tube, has adequate space for fiber optic bronchoscopy. The ET tube is simple and fabricated in general form. The junior anesthesiology residents or the trainee medical practitioners are sufficient to operate the ET tube device for bronchoscopy in the ICU. The ET tube is used in all the methods of percutaneous dilatational tracheostomy (PDT). One of the characteristics of the ET tube is the two parallel radiopaque lines with a metal stem and tails, constituting a form of radiopaque markers such that, the radiopaque lines are designed to facilitate an enhanced accuracy for PDT procedure under fluoroscopy. When the PDT is done without bronchoscopy in medical centers and situations, the ET tube provides safety to patient. When the purpose of bronchoscopy is to evaluate the stenosis or other pathologies of the trachea, the metal-less type of ET tube is used. [0036] These and other aspects of the embodiments herein will be better appreciated and understood when considered in conjunction with the following description and the accompanying drawings. It should be understood, however, that the following descriptions, while indicating preferred embodiments and numerous specific details thereof, are given by way of illustration and not of limitation. Many changes and modifications may be made within the scope of the embodiments herein without deportioning from the spirit thereof, and the embodiments herein include all such modifications. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] The other objects, features and advantages will occur to those skilled in the art from the following description of the preferred embodiment and the accompanying drawings in which:

[0038] FIG. 1 illustrates the lateral side view of the whole PF endotracheal tube illustrating the different segments/portions of this tube, according to one embodiment herein.

[0039] FIG. 2 illustrates the lateral view of the ET tube placed in the trachea, illustrating the position of the different portions/portions of the ET tube with respect to the larynx, thyroid, cricoid, and tracheal cartilages, according to one embodiment herein. [0040] FIG.3 illustrates the anterior view and superior view the ET tube illustrating the position of different segments of ET tube with respect to the vocal cords and trachea, according to one embodiment herein.

[0041] FIG.4A and FIG.4B together illustrates both sagittal (upper most) and horizontal (middle) sections of the lower portion of tube, according to one embodiment herein.

[0042] FIG.5 illustrates a cross-section of the ET tube at a point 500 and the position of the radiopaque line markers and the proximal tapered end of the metal plate relative to the tube, according to one embodiment herein.

[0043] FIG .6 illustrates a cross-section of the ET tube at a point

600 and shows a cross-section of the metal segment and its lateral boundaries relative to the ET tube's lateral edges, according to one embodiment herein.

[0044] FIG .7 illustrates a cross-section of the ET tube at a point 700 and shows a cross-section of the distal tail of the metal segment, according to one embodiment herein.

[0045] FIG .8 illustrates a cross-section of the ET tube at a point 800 and shows the bevel of the ET tube, located at the distal end, according to one embodiment herein.

[0046] FIG. 9 illustrates the U-shaped segment of the ET tube, according to one embodiment herein. [0047] FIG.10 illustrates the metal-less version of the ET tube, according to one embodiment herein.

[0048] Although the specific features of the embodiments herein are shown in some drawings and not in others. This is done for convenience only as each feature may be combined with any or all of the other features in accordance with the embodiments herein.

DETAILED DESCRIPTION OF THE EMBODIMENTS

[0049] In the following detailed description, a reference is made to the accompanying drawings that form a portion hereof, and in which the specific embodiments that may be practiced is shown by way of illustration. The embodiments are described in sufficient detail to enable those skilled in the art to practice the embodiments and it is to be understood that the logical, mechanical and other changes may be made without departing from the scope of the embodiments. The following detailed description is therefore not to be taken in a limiting sense.

[0050] The various embodiments herein provide a multipurpose endotracheal tube that is inserted into the larynx and the trachea for providing ventilation and oxygenation for patients throughout the bronchoscopy and percutaneous dilatational tracheostomy (PDT) procedures. The multipurpose endotracheal tube which protects the posterior and postero-lateral walls of the trachea against the penetration of the needle, guidewire, rigid dilatators, and forceps during the PDT procedure. The multipurpose endotracheal tube which comprises impermeable inner segment which protects the lateral and posterior wall of the trachea.

[0051] According to one embodiment herein, the endotracheal (ET) tube for bronchoscopy and Percutaneous Dilational Tracheostomy procedure (PDT) comprises: an upper portion, a lower portion, one or more radiopaque lines provided at an inner surface of the tube in the upper portion and a pilot connected to the tube at the upper portion for inflating the cuff. The upper portion is formed in a tube shape. The lower portion comprises a cuff, a proximal bevel portion or end, a U shaped lower segment and a distal bevel portion or end. The one or more radio-opaque lines are formed parallel to each other. The one or more radio- opaque lines are blue in color. The upper portion is connected to the lower portion at the proximal bevel portion through the cuff. The cuff is designed to separate the upper portion from the lower portion. The lower segment is formed with a non-penetrable piece or coating to protect a posterior wall of trachea from a penetration of a needle, a guide wire, a rigid dilatator and forceps during a PDT procedure. [0052] According to one embodiment herein, the cuff and the proximal bevel portion or end are connected by a rectangular segment of predetermined length.

[0053] According to one embodiment herein, the distal bevel portion or end is present before a distal segment.

[0054] According to one embodiment herein, the distal segment is U-shaped segment, and an open end of the distal segment is designed to face anteriorly.

[0055] According to one embodiment herein, the non-penetrable piece or coating is provided to cover an inner layer of the endotracheal tube and the lower U-shaped segment.

[0056] According to one embodiment herein, the one or more radio- opaque lines are two radio-opaque lines. The two radio-opaque lines are arranged at two opposite sides of the tube in the upper portion. The two parallel blue radio- opaque lines are formed along a length of the tube. The two parallel blue radio- opaque lines are formed to maintain a consistency of the tube and prevent a twisting of the tube. The two parallel blue radio-opaque lines are markers for determining a correct or appropriate right position of the tube in the larynx and trachea under fluoroscopy for PDT procedure and bronchoscopy with a C-arm device. [0057] According to one embodiment herein, the non-penetrable material is selected from a group consisting of a metal or a fiber glass.

[0058] According to one embodiment herein, the length of the non- penetrable material layer is in a range of 3-4cm, and wherein the thickness of the non-penetrable material layer is 1 mm.

[0059] According to one embodiment herein, the cuff is inflatable.

[0060] According to one embodiment herein, the U-shaped segment is designed to comply with a broncho scopic visualization of an anterior wall of the trachea.

[0061] According to one embodiment herein, the ET tube is fabricated from materials selected from a group consisting of polyvinyl chloride (PVC) or polyurethane.

[0062] According to one embodiment herein, the multipurpose endotracheal tube is fabricated in two types namely, with an un-penetrable material layer and without the un-penetrable material layer. The multipurpose endotracheal tube with the un-penetrable material layer is used in the percutaneous tracheostomy procedure. The multipurpose endotracheal tube without the un-penetrable material layer is useful in situations comprising bronchoscopy in the critically ill patients of ICU and evaluation of the trachea of patients with long-term intubation for tracheal stenosis and also other critically ill patient during bronchoscopy.

[0063] According to one embodiment herein, the endotracheal tube (ET) comprises two portions called an upper portion and a lower portion. The upper portion of the ET tube is similar to regular ET tubes. The lower portion of the endotracheal tube begins with a cuff. The ET tube has a high-volume, low- pressure, inflatable cuff located in the lower portion. A tiny tube connects the cuff to a pilot for inflating the cuff in the endotracheal tube. The cuff helps to reduce the risk of aspiration. During the percutaneous dilatational tracheostomy (PDT), where bronchoscopy is not possible, the cuff is pulled back to the glottis by an operator. After pulling the cuff back to the glottis, the operator observes that the cuff is positioned across the glottis and ensures that the distal segment is placed or arranged at a desirable position. The size of the cuff is shorter than that of the regular ET tube cuff. Hence the cuff is not extended far down to the cricoid cartilage. The wall of the cuff is very thin, so that the external diameter of the ET tube is not increased significantly. The main feature of the ET tube is that the cuff extended to the second distal segment by the proximal bevel portion or end facing anteriorly and a smooth curve facilitating the passage of the tube through glottis. The distal segment of the ET tube is in a semi-open condition has a U-shaped tunnel which complies with the tracheal walls. The distal segment is configured to facilitate the visualization of the trachea by a bronchoscope. This feature enables the medical practitioner for bronchoscopy. A distal bevel portion at the distal end of the lower portion of the ET tube facilitates the passing of the tube trough the glottis and trachea. The two parallel delineated radiopaque lines are arranged on both the lateral sides of the tube extending from the upper portion to the lower portion. These lines also form the upper edges of the U-shaped segment and demarcate them such that the physician ensures that the tube is in the right position, to face the anterior wall of the trachea, even without X-ray or bronchoscopy. A semi rigid band is inserted just beneath these lines for supporting the consistency of tube such that a twisting of the tube is prevented during a rotation of the tube to see/view all the walls of trachea during bronchoscopy.

[0064] According to one embodiment herein, the main characteristic of the ET tube is a layer of non-penetrable material on the inner layer, impermeable to needles or sharp instruments. The non-penetrable material is a metal piece. The non-penetrable material or layer is provided to prevent the needle, guide wire, rigid dilators, and forceps from damaging the posterior and posterolateral tracheal walls. The non-penetrable material reduces the chance of the complications. The length of non-penetrable material is varied with respect to the size of tracheal tubes and is sufficient to cover a segment of the trachea that usually is used for PDT. This layer of non-penetrable material is extended continuously in both directions as a tail and gives consistency to the tube, thereby facilitating or enabling the semi-circle or curve portion to sit in the right place. By using fluoroscopy, the markers are used along with blue radiopaque lines to define the spatial position of the tube. When PDT is performed without the guidance of the bronchoscope, the medical practitioner performs the procedure safely and efficiently with the use of markers on the metal piece. This non-penetrable layer is designed to cover the inner surface of endotracheal tube. The ET tube without a metal piece or a non-penetratable layer is suitable for use in bronchoscopy in the ICU. It has all characteristics of the tube described, except the non-penetrable layer. The endotracheal (ET) tube device is very simple and user-friendly. The ET tube does not require any special experience or skill for operation.

[0065] According to one embodiment herein, the U-shaped distal segment allows the operator to see the anterior wall of the trachea easily with a fiber optic bronchoscope. The distal segment comprises an inner layer of an impermeable material (metal piece or other composites) that prevents the piercing of the posterior tracheal wall and esophagus by the PDT needle, guide wire, and dilatators. A distal segment without a metal or layer is used in evaluating tracheal stenosis and other pathologies with bronchoscope in the patients admitted in the intensive care unit (ICU) and other wards.

[0066] According to one embodiment herein, the endotracheal (ET) tube is not withdrawn until the tracheostomy tube is not inserted to a very last stages (ultimate stage). The ET tube is designed to minimize the chances of unwanted extubation and hypoxia. The non-penetrable piece/portion is designed to cover a maximum area in danger and avoids a trauma caused to the patient due to penetration. The possibility of complications or damages or effects like pneumothorax, major bleeding, TE fistula, and tracheal and esophageal injury are reduced. The semi-open distal end of the ET tube, has adequate space for fiber optic bronchoscopy. The ET tube is simple and fabricated in general form. The junior anesthesiology residents or the trainee medical practitioners are sufficient to operate the ET tube device for bronchoscopy in the ICU. The ET tube is used in all the methods of percutaneous dilatational tracheostomy (PDT). One of the characteristics of the ET tube is the two parallel radiopaque lines with a metal stem and tails, constituting a form of radiopaque markers such that, the radiopaque lines are designed to facilitate an enhanced accuracy for PDT procedure under fluoroscopy. When the PDT is done without bronchoscopy in medical centers and situations, the ET tube provides safety to patient. When the purpose of bronchoscopy is to evaluate the stenosis or other pathologies of the trachea, the metal-less type of ET tube is used. [0067] According to one embodiment herein, the ET tube has a high-volume, low-pressure, inflatable cuff located proximal to the lower portion. This helps to reduce the risk of aspiration. In the situations where bronchoscopy is not possible by pulling it back to the glottis, the operator observes the cuff across the glottis and ensures that the position of the distal segment is desirable. The cuff is shorter than the cuff of the commonly/regular available ET tubes. The cuff does not extend far down to the cricoid cartilage. The wall of the cuff is very thin. Hence the external diameter of the ET tube is not increased significantly. The main feature of the ET tube is that the upper portion of tube leads to the lower portion by the proximal bevel portion or end facing anteriorly. The distal end of the lower portion is semi-open and comprises an U-shaped tunnel that complies with the tracheal walls. This portion facilitates the visualization of the trachea by bronchoscope. This feature enables the medical practitioner for bronchoscopy. A distal bevel portion or end of the lower portion of the ET tube facilitates the passing of the tube trough the glottis and trachea.

[0068] According to one embodiment herein,the two parallel delineated radiopaque lines are present on both the lateral sides of the ET tube extending from the upper portion of the ET tube to the lower portion of the ET tube. The two parallel delineated radiopaque lines also form the upper edges of the U-shaped segment and demarcate them such that the physician ensures that the tube is in the right position, facing the anterior wall of the trachea, even without X-ray or bronchoscopy. The main characteristic of this ET tube is a layer of non-penetrable material (a metal piece) on the inner layer. The layer of non-penetrable material (a metal piece) is impermeable to needles or sharp instruments. This segment of layer of non-penetrable material (a metal piece) prevents the needle, guide wire, rigid dilators, and forceps from hitting the posterior and posterolateral tracheal walls, thus reducing the chance of the complications. The length of the layer of non-penetrable material (a metal piece) piece varies with the size of tracheal tubes and is sufficient to cover a segment of the trachea that usually is used for PDT procedure. This layer continues in both directions of the ET tube as a tail and gives consistency to the tube, helping the semi-circle portion of the ET tube to sit in the right place. The layer of non-penetrable material and the two parallel delineated radiopaque lines are markers which guide the medical practitioner for fluoroscopy and bronchoscopy. In fluoroscopy, the markers are used along with blue radiopaque lines to define the spatial position of the ET tube. In cases or situations when PDT procedure is done without the guidance of the bronchoscope, by using the markers (the two parallel delineated radiopaque lines and the metal piece) on the ET tube the medical practitioner can perform the PDT procedure safely without any complications. The metal-less version of the ET tube is suitable for bronchoscopy in the ICU. The device is very simple and user-friendly, and does not require any special experience.

[0069] According to one embodiment herein, the bevel is portion of the ET tube which ends to U shaped segment of the ET tube. The ET tube comprises two bevels i.e. proximal bevel portion or end and distal bevel portion or end. Through the U-shaped segment all walls of tracheal tube are seen/observed by little rotation of tube and bronchoscope together.

[0070] According to one embodiment herein, the non-penetrable material has a length of 3-4 cm. The thickness of non-penetrable material is thin layer and about 1-mm thick embedded in the posterior wall of the ET tube. The non-penetrable material layer is fabricated from materials selected from a group comprising a metal, a fiber glass and the like.

[0071] According to one embodiment herein, the ET tube is fabricated from polyvinyl chloride (PVC) or polyurethane.

[0072] According to one embodiment herein, the ET tube need not be withdrawn until the very last stages of inserting the tracheostomy tube. Thus the chances of unwanted extubation and hypoxia are reduced. The non- penetrable material or the metal piece covers most of the area in danger of penetrating trauma. Hence the possibility of complications like pneumothorax, major bleeding, TE fistula, and tracheal and esophageal injury are avoided. Because of the semi-open distal end of the ET tube, the room for fiberoptic bronchoscopy is adequate. Beneath these radiopaque lines is a thin band of semi-rigid material that helps consistency of the ET tube. This makes the ET tube resistance to twisting when the ET tube is rotated for observing all walls of trachea during bronchoscopy. The lower portion (half) of the ET tube is straight. The simplicity and general form of the ET tube is one of its important advantages. Even junior anesthesiology residents can use the ET tube for bronchoscopy in the ICU. The ET tube can be used in all of the methods of PDT. The ET tube comprises two parallel radiopaque lines with a metal stem and tail, constituting a form of radiopaque markers such that it would afford enhanced accuracy in the use of PDT under fluoroscopy. In addition, in centers and situations where PDT is done without bronchoscopy, it confers safety. If the purpose of bronchoscopy is to evaluate the stenosis or other pathologies of the trachea, the metal-less type of ET tube is used.

[0073] FIG. 1 is the lateral view of the whole PF endotracheal tube illustrating the different segments/portions of this tube, according to one embodiment herein. The ET tube is fabricated from polyvinyl chloride (PVC) material. The ET tube has a curvature and design like other regular endotracheal tubes at upper portion. In lower portion of the ET tube a high-pressure and low- volume cuff 101 is located. This cuff is connected to a pilot 107 by a tiny tube for inflation. The lower portion of this endotracheal tube is straighter relative to the commonly available ET tubes. The cuff 102 is shorter with a thin wall of blue color, located proximal to the U-shaped distal segment 102. The operator/medical practitioner can draw back the tube to locate the position below the vocal cords within subglottic region without using the bronchoscope. Between the cuff and the distal U-shaped segment of the ET tube is a small segment of the regular ET tube for the attachment of the cuff 101. The tube leads to the distal segment with a slight curve as a proximal bevel portion 103. Two radiopaque blue lines 104 at both lateral portion of the tracheal tube. The two radiopaque lines continue down to the upper margin of the U-shaped distal segment 102 and provide the clue both visually and radiologically for the operator to define the correct position of the tube in the trachea. Beneath this line is a band of semi-rigid material, maintaining the consistency during rotation of tube. The U-shaped distal segment 102 of the tube is U-shaped with an open portion facing anteriorly and superiorly toward the tracheal rings. This enables the operator to have a clear bronchoscopic view during percutaneous dilational tracheostomy (PDT) procedure without need to draw back the endotracheal tube. This segment is straighter than regular/commonly available endotracheal tubes. The metal piece (or metal piece coating) 105 is present in the lumen of the U-shaped distal segment 102 with two thin proximal and distal tails. The proximal tail is embedded in predetermined length (in centimeters) into the inferior wall of the tube. The metal piece (or metal piece coating) forms the inner layer of the U-shaped distal segment of the tracheal tube. The distal tail of the metal piece, similar to the proximal tail, extends into the inferior wall of the tube up to the bevel portion of the tube. These extensions of the metal piece provide consistency to the tube and prevent the ET tube from wrapping and twisting the U-shaped distal segment 102. The distal bevel 106 of the distal U-shaped distal segment 102 of the ET tube is without metal to reduce any probable trauma to the glottis and other surrounding tissues.

[0074] FIG. 2 is the lateral view of the ET tube placed in the trachea, illustrating the position of the different portions/portions of the ET tube with respect to the larynx, thyroid, cricoid, and tracheal cartilages, according to one embodiment herein. The blue radiopaque line 104 demarcates both upper borders of the distal segment and the midline of the lateral aspect of the ET tube. The tracheal cuff 10 lis located just below the vocal cords 202, under the thyroid 203 and the cricoid cartilages 204. The proximal bevel portion or end 103 of the tube begins at the level of the proximal border of the first tracheal cartilage ring 201. The body of the metal piece 105 begins at proximal bevel portion or end 103 and ends at the distal bevel portion or end 106. The metal piece (or metal piece coating) is a portion of the inner ET tube wall and extends distally up to 4-5 tracheal rings. The metal piece (or metal piece coating) 105 is a shield and avoids the injury to the body tissues by the protruding needle underneath the posterior wall of the tracheal tube and anterior wall of the esophagus.

[0075] FIG.3 is the anterior view and superior view the ET tube illustrating the position of different segments of ET tube with respect to the vocal cords and trachea, according to one embodiment herein. FIG.3 illustrates the glottis 202, the anterior aspect of the U-shaped distal segment 102, with blue lines 104. The pilot 107 is connected by a tiny tube for inflating the cuff. The bronchoscope tip is positioned to visualize the trachea while performing tracheostomy or evaluating the trachea for post-intubation stenosis and other pathological conditions. The metal piece covers the inner layer of the tube from the cricoid cartilage to the tracheal ring 4-5. This helps to prevent piercing of the posterior wall of the trachea and esophagus by needle and other instruments which are used during PDT procedure. Even without bronchoscopy, when the needle accidentally hits this portion, it gives the operator a sign that the needle should be pulled back. The bevel of the tracheal tube is seen from above at the tip of the tracheal tube.

[0076] FIG.4 and FIG.4B together illustrates both sagittal (upper most) and horizontal (middle) sections of the lower portion of tube, according to one embodiment herein.

[0077] FIG.4A illustrates the lateral and superior-anterior (sagittal and coronal sections) ET tube. FIG.4A illustrates the side view of the lower portion of the ET tube. The lower portion of ET tube, illustrates cuff 101, proximal bevel portion or end 103, distal U-shaped segment 102 and distal bevel portion or end 106. The metal piece 105 covers the inner layer of the tube at portionicular length, it ends 1-2 millimeter to upper margin of distal U shaped segment 102 laterally.

[0078] FIG.4B illustrates coronal cross sections (lower) of the tube at different points, which are depicted separately in following figures (FIG 5, FIG.6, FIG. 7 and FIG. 8). At the middle there is horizontal section of the invention seen from above, with four cross sectional points (500, 600, 700 and 800 respectively). The details of these cross sections are discussed at following figures (FIG 5, FIG.6, FIG. 7 and FIG. 8).

[0079] FIG.5 illustrates a cross-section of the ET tube at a point 500 and the position of the radiopaque line markers and the proximal tapered end of the metal plate relative to the tube, according to one embodiment herein. Two blue lines depicts the radiopaque lines, just beneath them is a band of semirigid material to add consistency to tube. FIG.5 is a cross-sectional view of an embodiment of the instrument at the cuff level, reference to point 500 in Fig.4B.The tube has a very thin cuff 101 at the outer surface, with an insignificant increase in the outer circumference of the ET tube. It enables the operator to choose a larger tube size (adjusting to the patient) to cover a larger portion on the trachea. The proximal tail 502 of the metal piece is embedded in the posterior wall of the ET tube. The 2 radiopaque lines 104 are located beneath the cuff continuing proximally at the middle of the lateral walls of the ET tube, enabling the operator to recognize the right position of the trachea at the glottis and in the trachea. Under these lines 104 two bands 501 of semi-rigid PVC or other material are embedded in the wall of the tube.

[0080] FIG .6 illustrates a cross-section of the ET tube at a point 600 and shows a cross-section of the metal segment and its lateral boundaries relative to the ET tube's lateral edges, according to one embodiment herein. FIG.6 shows a cross-sectional view at point 600 in Fig. 4B. It illustrates the position of the non-penetrable piece 301 in relation to the tube. The non- penetrable piece has a tunnel-like shape adjusting to the ET tube. It forms the inner layer of the tube without increasing the wall thickness of the tube. At this level, the internal diameter of the ET tube has not changed, hence there is no restriction for the bronchoscope and nor does it impede the passage of it. The outer layer of this portion of the ET tube is the continuation of the regular layer or the tube, which makes this portion of the tube as soft as the outer portions and reduces the possibility of trauma caused by the metal piece to tissues. The upper edges of the U-shaped segment of the tracheal tube do not contain the metal piece. This is to reduce the chance of trauma caused by the metal piece to the larynx and trachea, and also makes it softer. The radiopaque lines 104 are located at the upper margin of lower segment. The semi-rigid bands 501 are located beneath the radiopaque lines. These structures help consistency of the tube.

[0081] FIG .7 illustrates a cross-section of the ET tube at a point 700 and shows a cross-section of the distal tail of the metal segment, according to one embodiment herein. FIG.7 is a cross-sectional view of the tube at the level of 700 point of FIG 4B.The distal tail 701 of the metal piece is embedded in the inferior wall of the endotracheal tube (ET) tube, as discussed in Fig.5, for the proximal tail. The two parallel blue radiopaque lines or markers 104 are located on the superior border of the U-shaped segment. These two parallel blue radiopaque lines markers 104 along with the distal tail 701 of the metal piece are used to guide the insertion of the needle and guide wire under fluoroscopy in situations when bronchoscopy is contraindicated or is hazardous. The semirigid bands 501 are located beneath the radiopaque lines at upper border of distal segment of the tube. [0082] FIG .8 illustrates a cross-section of the ET tube at a point 800 and shows the bevel of the ET tube, located at the distal end, according to one embodiment herein. FIG.8 illustrates a cross-sectional view of the ET tube at the distal end of the tube in accordance with point 800 of Fig.4B. The tail of the non-penetrable piece and the semi-rigid thin bands 501 is not seen because they end at 5-10 millimeters to the end of the ET tube. The blue line markers are seen on the upper margin of this segment. The distal bevel portion or end is located at the distal end of the ET tube is located and is seen.

[0083] FIG. 9 illustrates the U-shaped segment of the ET tube, according to one embodiment herein. FIG.9 illustrates the superior view of the U- shaped segment of the tube. The non-penetrable material covers the surface of the lower wall of the endotracheal (ET) tube, preventing the penetration of this layer as well as posterior tracheal wall and esophagus by needle and other devices during PDT procedure. The body of the non-penetrable piece (metal piece) 105 also complies with the shape of the distal end of regular tubes. The distal tail 701 of the metal piece ends before the ending of the ET tube.

[0084] FIG.10 illustrates the metal-less version of the ET tube, according to one embodiment herein. FIG.10 illustrates the metal-less form of the ET tube. The different sections of the device are visible. There is no difference between the ET tube with metal plate or coating and ET tube without metal plate or coating except that the metal-less type does not have the metal piece. The radio opaque line 104 demarcates mid lateral of the tube. The radio opaque line 104 continues distally to upper border of lower portion of the ET tube. The tiny cuff 101 places down to glottis 202. The radio opaque lines 104 continue at upper edges of distal segment or portion. The semi-rigid band 501 are located just beneath radio opaque lines down to 2-3 millimeters of tip the tracheal tube.

[0085] The foregoing description of the specific embodiments will so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without deportioning from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments.

[0086] It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the appended claims. [0087] Although the embodiments herein are described with various specific embodiments, it will be obvious for a person skilled in the art to practice the invention with modifications. However, all such modifications are deemed to be within the scope of the claims.

[0088] It is also to be understood that the following claims are intended to cover all of the generic and specific features of the embodiments described herein and all the statements of the scope of the embodiments which as a matter of language might be said to fall there between.

Claims

CLAIMS What is claimed is:

1. An endotracheal (ET) tube for bronchoscopy and Percutaneous Dilational Tracheostomy procedure (PDT) comprises:

an upper portion, and wherein the upper portion is formed in a tube shape;

a lower portion, and wherein lower portion comprises a cuff, a proximal bevel portion or end, a U shaped lower segment and a distal bevel portion or end;

one or more radiopaque lines provided at an inner surface of the tube in upper portion, and wherein the one or more radiopaque lines are formed parallel to each other, and wherein the one or more radiopaque lines are blue in color; and

a pilot connected to the tube at the upper portion for inflating the cuff;

wherein the upper portion is connected to the lower portion at the proximal bevel portion through the cuff, and wherein the cuff is designed to separate the upper portion from the lower portion, and wherein the lower segment is formed with a non-penetrable piece or coating to protect a posterior wall of trachea from a penetration of a needle, a guide wire, a rigid dilatator and forceps during a PDT procedure.

2. The endotracheal (ET) tube according to claim 1, wherein the cuff and the proximal bevel portion or end are connected by a rectangular segment of predetermined length.

3. The endotracheal (ET) tube according to claim 1, wherein the distal bevel portion or end is present before a distal segment.

4. The endotracheal (ET) tube according to claim 1, wherein the distal segment is U-shaped segment, and wherein an open end of the distal segment is designed to face anteriorly.

5. The endotracheal (ET) tube according to claim 1, wherein the non- penetrable piece or coating is provided to cover an inner layer of the endotracheal tube and the lower U-shaped segment.

6. The endotracheal (ET) tube according to claim 1, wherein the one or more radiopaque lines are two radiopaque lines, and wherein the two radiopaque lines are arranged at two opposite sides of the tube in the upper portion, and wherein the two parallel blue radiopaque lines are formed along a length of the tube, and wherein the two parallel blue radiopaque lines are formed to maintain a consistency of the tube and prevent a twisting of the tube, and wherein the two parallel blue radiopaque lines are markers for determining a correct or appropriate right position of the tube in the larynx and trachea under fluoroscopy for PDT procedure and bronchoscopy with a C-arm device.

7. The endotracheal (ET) tube according to claim 1, wherein the non- penetrable material is selected from a group consisting of a metal or a fiber glass.

8. The endotracheal (ET) tube according to claim 1, wherein the length of the non-penetrable material layer is in a range of 3-4 cm, and wherein the thickness of the non-penetrable material layer is 1 mm.

9. The endotracheal (ET) tube according to claim 1, wherein the cuff is inflatable.

10. The endotracheal (ET) tube according to claim 1, wherein the U-shaped segment is designed to comply with a bronchoscopic visualization of an anterior wall of the trachea.

11. The endotracheal (ET) tube according to claim 1, wherein the ET tube is fabricated from materials selected from a group consisting of polyvinyl chloride (PVC) or polyurethane.