WO2025004110A1

WO2025004110A1 - An endotracheal intubation tube apparatus with sensors

Info

Publication number: WO2025004110A1
Application number: PCT/IN2024/050992
Authority: WO
Inventors: Ramamoorthy SRIRANG; Bhardwaj VIMAL D; Balaramaiah Vajramuni
Original assignee: Ikanekt Biomedical Technologies Pvt Ltd
Current assignee: Ikanekt Biomedical Technologies Pvt Ltd
Priority date: 2023-06-30
Filing date: 2024-06-28
Publication date: 2025-01-02
Anticipated expiration: 2025-12-30

Abstract

The invention relates to an endotracheal intubation tube apparatus comprising: a hollow tube (200), said tube comprising, one or more vertical slots (210); at least one flexible sensor module (500) housed in one vertical slot (210), said sensor module configured to have one or more sensing means selected from the group consisting of optical sensor, conduction electrode, temperature sensor, capacitance 5 electrode, and a combination thereof; one or more holes (212) perpendicular to the surface of the hollow tube (200) for placement of the sensing means; an inflation channel (214) inside the wall of the hollow tube (200); and a cover placed over and fused to the hollow tube along with the at least one flexible sensor module. The present apparatus detects and measures obstructions, temperature, and fluid 10 presence/ volume in the tube, when in use.

Description

AN ENDOTRACHEAL INTUBATION TUBE APPARATUS WITH SENSORS

FIELD OF THE INVENTION

[001] The present invention generally relates to an endotracheal intubation tube apparatus for, including but not limited to, detecting and measuring obstructions, temperature, and fluid volume in the tube, when in use. The tube comprises one or more sensors selected from, including but not limited to, light based, temperature based, conduction based, and capacitance-based sensor.

BACKGROUND OF THE INVENTION

[002] An endotracheal tube or endotracheal intubation tube is a catheter that is inserted into the trachea for establishing and maintaining a patient airway and to ensure that adequate exchange of oxygen and carbon dioxide occurs between patients’ lungs and the ventilator. Endotracheal intubation is a medical procedure in which a tube is placed into the trachea through the mouth, nose or trachea. In most emergency situations, it is placed through the trachea and connected to the ventilator to assist in breathing for exchange of oxygen and carbon dioxide. These days the tubes are mostly made of polyvinylchloride and are single-use. The other materials that can be used to manufacture the tubes are silicon, polyurethane chloride, copper, stainless steel and rubber. These different materials offer solutions to a few of the existing deficiencies but cannot address or eliminate the most important issue of detecting.

[003] There are different types of endotracheal intubation tubes available: oral, nasal or trachea based, cuffed or uncuffed, preformed (e.g. Ring Adair and Elwyn (RAE) tube), reinforced, and double-lumened. Current issues with endotracheal intubation tubes include but are not limited to obstruction at the distal end of the tube by a blood clot or mucous plug or other secretions, kinking of the tube, herniation of the tube cuff, obstruction of the tube due to compression by surrounding tissue and partial or complete dislodging of the tube. All of these issues obstruct the flow of air. Often these obstructions go undetected by any of the existing endotracheal intubation tubes. Generally, the obstruction is detected by human visual recognition or ventilator recognition via obstruction to the positive and the negative pressure. Often the detection is late, leading to serious consequences. Introduction of any technology for obstruction detection leads to high cost on intubation for patients. Other major challenges are to incorporate the technology into the tube for obstruction detection without compromising the medical regulation restrictions such as tube size, type of material, cuff size and position, tube volume, positive pressure, negative pressure and total volume flow with speed, to contain non-obstruction components inside the tube and extra components on the tube without causing tissue damage in the trachea.

[004] Some endotracheal intubation tubes are designed to include subglottic suction capabilities to reduce the risk of ventilator-associated pneumonia (VAP) by continuously removing secretions from above the cuff. There are some prior art technologies as described below that aim to address the above issues.

[005] The BreatheVision™ endotracheal intubation tube includes integrated sensors that provide real-time data on cuff pressure and temperature, helping clinicians monitor and adjust ventilation parameters more accurately.

[006] The VivaSight™ endotracheal intubation tube includes an integrated high- resolution camera, allowing continuous visualization of the airway and tube placement. This technology helps ensure correct positioning and early detection of complications like tube displacement or obstruction. The NIRSense endotracheal tube incorporates near-infrared spectroscopy to monitor the adequacy of ventilation and detect early signs of hypoxia, helping to prevent complications.

[007] iTraXS device is a smart endotracheal intubation tube that uses thin, flexible, optical fibre sensors incorporated into a standard disposable endotracheal intubation tube, which is linked to an optoelectronic monitoring and display unit. The device has a different technical aim which is to monitor contact pressure and blood supply at the cuff-trachea interface (the point where the cuff touches the windpipe lining). Also, the device is expensive.

[008] Yet another endotracheal intubation tube system comprises a microelectromechanical system (MEMS) flow sensor. The intubation tube device with the MEMS flow sensor can detect the airflow passing through the tube in real- time. Thus, it aims to judge whether the tube is inserted into an airway or esophagus during intubation by measuring the spontaneous breathing properties quantitatively just before extubation.

[009] Yet another endotracheal intubation tube system comprises a photoplethysmography endotracheal sensor to monitor pulse rate and oxygen saturation internally. In this, flexible printed circuit board technology and miniature optoelectronic components have been implemented and integrated with a custom instrumentation system.

[0010] Yet another system allows for the real-time assessment of endotracheal intubation tube placement and alerting of the clinical care team should it become displaced. The system uses a side-firing optical fiber, a near-infrared light-emitting diode, two photodetectors with an integrated amplifier, an Arduino board, and a computer loaded with a custom Lab VIEW program to monitor the position of the endotracheal tube inside the windpipe.

[0011] These prior art innovations do not effectively address the problem of detecting obstructions in the endotracheal intubation tube, due to liquids, tube compression etc. More particularly early detection is often not possible. Further, these devices are cost prohibitive. Thus, there is a need for an improved device that is low cost and yet able to effectively detect obstructions in the endotracheal intubation tube early on.

SUMMARY OF THE INVENTION

[0012] According to one embodiment, the present invention is an endotracheal intubation tube apparatus comprising: a. a hollow tube (200) having a proximal end (204) and a distal end (202) that is beveled (216), said tube comprising,

• one or more vertical slots (210) running from the proximal end to the distal end;

• at least one flexible sensor module (500) housed in one vertical slot (210), said sensor module configured to have one or more sensing means selected from the group consisting of optical sensor, conduction electrode, temperature sensor, capacitance electrode, and a combination thereof;

• one or more holes (212) perpendicular to the surface of the hollow tube (200) for placement of the sensing means; and

• an inflation channel (214) inside the wall of the hollow tube (200); and b. a cover placed over and fused to the hollow tube along with the at least one flexible sensor module.

BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Reference will be made to embodiments of the invention, examples of which may be illustrated in accompanying figures. These figures are intended to be illustrative, not limiting. Although the invention is generally described in context of these embodiments, it should be understood that it is not intended to limit the scope of the invention to these particular embodiments.

[0014] Figure la shows an embodiment of the instant hollow tube in front view [0015] Figure lb shows an embodiment of the instant hollow tube top part in sectional view

[0016] Figure 1c shows an embodiment of the instant hollow tube in top view [0017] Figure 2 shows an embodiment of the instant hollow tube in isometric section view

[0018] Figure 3a shows an embodiment of the cover tube in front view

[0019] Figure 3b shows an embodiment of the cover tube in isometric view

[0020] Figure 3c shows an embodiment of the cover tube in top view

[0021] Figure 4a shows an embodiment of the instant hollow tube with a wing

[0022] Figure 4b shows a top view of the Figure 4a embodiment

[0023] Figure 4c shows an isometric view of the Figure 4a embodiment

[0024] Figure 5a shows an embodiment of the instant flexible sensor module in isometric view

[0025] Figure 5b shows an embodiment of the flexible sensor module of Figure 5a in front view [0026] Figure 5c shows an expanded view of the distal end of the flexible sensor module of Figure 5 a

[0027] Figure 5d shows an embodiment of the flexible sensor module of Figure 5a in top view

[0028] Figure 5e shows an expanded view of the isometric view of the flexible sensor module’s distal end

[0029] Figure 5f shows side view of the flexible sensor module embodiment of Figure 5 a

[0030] Figure 6a shows the rolled flexible sensor module in top view

[0031] Figure 6b shows the rolled flexible sensor module in isometric view

[0032] Figure 6c shows expanded view of the rolled flexible sensor module’s distal end

[0033] Figure 7a shows the connector in isometric view

[0034] Figure 7b shows the connector in top view

[0035] Figure 7c shows the connector in front view

[0036] Figure 8a shows the inflatable cuff in front view

[0037] Figure 8b shows the inflatable cuff in top view

[0038] Figure 9a shows an embodiment of the assembled form of the instant endotracheal intubation tube in front view

[0039] Figure 9b shows an embodiment of the assembled form of the instant endotracheal intubation tube in top view

[0040] Figure 9c shows an embodiment of the assembled form of the instant endotracheal intubation tube in isometric view

DETAILED DESCRIPTION OF THE INVENTION

[0041] In the following detailed description, the embodiments are described in sufficient detail to enable those skilled in the art to practice the invention and it is understood that other embodiments may be utilized and that changes may be made without departing from the scope of the invention. To avoid detail not necessary to enable those skilled in the art to practice the embodiments described herein, the description may omit certain information known to those skilled in the art. Accordingly, the description and figures are to be regarded in an illustrative rather than a restrictive sense, and all such modifications are intended to be included within the scope of the present teachings. It is to be understood that the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. It should be emphasized that the term “comprises/comprising” when used in this specification is taken to specify the presence of stated features, integers, steps or components but does not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof.

[0042] The present invention intends to meet the afore stated technical and economic disadvantages by providing an endotracheal intubation tube apparatus comprising: a hollow tube having a proximal end and a distal end that is beveled, said tube comprising, one or more vertical slots running from the proximal end to the distal end; at least one flexible sensor module housed in one vertical slot, said sensor module configured to have one or more sensing means selected from the group consisting of optical sensor, conduction electrode, temperature sensor, capacitance electrode, and a combination thereof; one or more holes perpendicular to the surface of the hollow tube for placement of the sensing means; and an inflation channel inside the wall of the hollow tube; and a cover placed over and fused to the hollow tube along with the at least one flexible sensor module.

[0043] More than one vertical slot maybe provided to house the flexible sensor module or any other part. Though multiple vertical slots are provided not all may be occupied with the sensor module or the any other part. The hollow tube and the cover can be made of material including but not limited to poly vinyl chloride, silicone or a similar flexible bio-safe material.

[0044] In one embodiment, the cover is a tube consisting of a proximal end and a distal end that is beveled, said ends corresponding to hollow tube proximal and distal ends, respectively. The inner diameter of the thin cover tube is slightly bigger than the outer diameter of the hollow tube. The thin cover tube is fused on to the surface of the hollow tube along the flexible sensor module. The distal end is the end that is inside the trachea.

[0045] In one embodiment the hollow tube has a thin wing on the outer surface extending vertically from the proximal end to the distal end, said wing being rollable along the radial surface of the hollow tube and being heat fused on to the tube outer surface along with the flexible sensor module. The wing is added during manufacturing of the hollow tube. The cover tube need not be provided when the wing is provided. The winged hollow tube embodiment avoids a separate cover tube.

[0046] The flexible sensor module is uniquely designed to be placed in the hollow tube, while having the sensing means disposed thereon, such that patient obstruction is minimal or negligible. In a preferred embodiment one flexible sensor module is housed in the hollow tube. In other embodiments, more than one module may be housed in the hollow tube.

[0047] The flexible sensor module comprises, a vertical flexible strip having a distal end and a proximal end, said ends corresponding to distal and proximal ends, respectively, of the hollow tube; one or more horizontal strips attached along the length of the vertical strip starting from the distal end, wherein the horizontal strip rolls radially along the outer surface of the hollow tube; one or more sensing means selected from the group consisting of optical sensor, conduction electrode, temperature sensor, capacitance electrode, and a combination thereof, said sensing means being located on the horizontal strip, vertical strip or both; one or more reflectors being located on the flexible sensor module, the hollow tube, or both, for reflecting light to the optical sensor; and a communication pin for communication with an external device, wherein the vertical and horizontal strips are made of printed circuit board type material. The communication pin is made of metal. The vertical and horizontal strips are made of flexible printed circuit board (PCB). The material used to prepare the strips being of medical grade. The horizontal strips may be of different widths or the same width.

[0048] The sensing means may be placed on the vertical strip, on a single horizontal strip or over several horizontal strips. One type of sensing means maybe placed on one strip or a combination of sensors may be placed on one strip. The module may contain only one horizontal strip or several horizontal strips. One type of sensing means may be placed on strips of one size, whereas, other sensing means may be placed on strips of a different width or both may also be present in combination.

[0049] In a preferred embodiment the temperature sensor may be placed at the distal end of the vertical strip. In a preferred embodiment the optical sensor maybe placed at the junction of the vertical and horizontal strip. In one embodiment, the optical sensor may be placed at any other location on the horizontal strip.

[0050] The temperature sensor is used for detection or measurement of airflow in the endotracheal intubation tube which indirectly gives information about the obstruction in the tube that may be due to a liquid or compression. Multiple temperature sensors may also be provided to detect the presence of liquid before it can cause an obstruction in the air flow. Multiple temperature sensors may also detect the extent of liquid that has reached from the distal end to the proximal end of the endotracheal tube. The temperature sensors may be placed in multiple locations.

[0051] Optical sensors are for liquid and tube compression detection or measurement. Optical sensors are used for detecting/ measuring liquid obstruction in the tube, providing block location, and/or detecting compression in the tube. Light sensors measure the approximate volume of liquid that enters the tube from the trachea.

[0052] Conduction sensors/ electrodes are also used for detection or measurement of liquid obstruction or obstruction due to compression. Conduction sensor/ electrodes may also sense the entry of liquid into the tube and its distance travelled inside the endotracheal intubation tube from the distal end to the proximal end. It may also detect or measure the volume of liquid that has entered into the tube. The conduction sensor can be used for multiple purposes like temperature detection, as light reflectors or depending on location of the sensor as a standalone conduction sensor. Multiple conduction sensors may be placed in multiple locations.

[0053] The hollow tube has one or more holes perpendicular to the surface of the hollow tube, for placement of the sensing means, preferably being the conduction electrodes, the holes being placed along the vertical slot as well as repeated radially on the surface of the tube such that the holes coincide with the electrodes. The presence of the holes allows the conduction electrode to contact liquid present inside the tube. In a preferred embodiment, the holes are placed along the vertical slots at equal distance. In another embodiment, the holes may be placed at varying distances.

[0054] Capacitance sensors/ electrodes may be used alone or in combination with the other sensors disclosed herein to detect and measure the obstruction due to liquid or compression. Capacitance sensors/ electrodes may also be used for detecting or measuring liquid volume in the endotracheal intubation tube. Capacitance sensors/ electrodes can also detect the presence of liquid in or when it enters the tube. More than one capacitance sensor may be used and in multiple locations based on the requirement.

[0055] The communication pin is preferably located about the proximal end or at any other position on the vertical strip. The instant apparatus includes a connector. Connectors are generally present in prior art endotracheal tubes to connect the endotracheal tube to the ventilator. The instant connector has been uniquely designed for the present apparatus to have an inner cylinder which slides into the proximal end of the hollow tube, an outer cylinder which connects to a ventilator tube, and a pin holder for the communication pin to be locked in. The communication pin fits into the connector.

[0056] The instant apparatus also includes an inflatable cuff near the distal end. An inflatable cuff is typically provided in several prior art endotracheal tubes to keep the tube securely in place in the mouth after intubation. The present inflatable cuff is inflated and deflated by a cuff inflation tube that is housed in the inflation channel that runs through the wall of the hollow tube. In the present invention the inflatable cuff is fused on top of the fused thin cover tube or the thin wing. The cuff inflation tube is slidably placed into the cuff inflation channel.

[0057] As known in the field, the present apparatus is radially bent and configured to have a hole in the sidewall at about the distal end for air flow. This hole called the murphy hole is often used in tube design to enable air flow if the primary distal opening gets occluded.

[0058] The present apparatus is also provided with one or more openings including but not limited to cuts, slots etc. for insertion of the cuff inflation tube, for an inflation opening to enable cuff inflation, or for any other purpose.

[0059] The present apparatus can function with existing mechanical ventilator systems including but not limited to those available at high dependency units; home care; step down intensive care unit and intensive care units.

[0060] The present invention meets the afore states technical disadvantages by providing an advanced endotracheal intubation tube designed to enhance patient safety and improve clinical outcomes during intubation and ventilation. This invention incorporates sensors and smart technology to provide real-time monitoring and feedback, helping clinicians manage ventilation more effectively and detect complications early. The present endotracheal intubation tube can address some or all the challenges present in existing endotracheal intubation tubes that are available in the market.

[0061] One of the major prior art challenges in the existing endotracheal intubation tubes is to detect obstruction due to liquids and tube compression. The present invention includes multi-modal sensor-based technology to address these specific challenges while considering most of the medical regulations as well as keeping the cost of the multi-modal sensor based endotracheal tube as low as possible. In the present invention is incorporated multi-modal sensor-based technologies for the detection or measurement of obstruction that is caused by mucus and blood from the lungs that enter the endotracheal tube and the other obstruction by compression of the endotracheal tube due to patient’s bite or due to temperature or any other reason.

[0062] A single sensor module has been designed for multi-function for the detection or measurement of obstruction in the endotracheal tube. Light based sensor technology is used for liquid detection and measurement using the general principal of absorption and reflection methods and tube compression detection or measurement by proximity detection. Temperature based sensor technology for measuring temperature of liquid or air or for both liquid and air detection or/and indirectly measures the obstruction in tube. Other sensor technology is conduction/impedance-based methods for liquid detection, volume measurement, location of presence of the liquid and volume of liquid measurement in that particular location. Other add-on sensor technology is capacitance-based sensor method for liquid detection or measurement of location and volume.

[0063] Figure la shows an embodiment of the instant hollow tube in front view. Figure lb shows an embodiment of the instant hollow tube top in sectional view. Figure 1c shows an embodiment of the instant hollow tube in top view. Figure 2 shows an embodiment of the instant hollow tube in isometric section view. In Figures la to 1c, the hollow tube (200) which is one major part of the present endotracheal tube apparatus has multiple vertical slots (210) along the outer surface of the tube running from the proximal end (204) to the distal end (202), which is part of manufacturing and is designed to align the flexible sensor module’s (500) vertical strip (502) into the 210 vertical slots. The distal end (202) is beveled (216). The hollow tube (200) also has cylindrical holes (212) perpendicular to the surface of the tube for conduction electrode (514, 516) alignment. The holes (212) are placed radially at equal distance and repeated vertically at equal distance starting from the distal end (202) of the hollow tube (200) to the proximal end (204). There is an additional hole (208) near the beveled end for air flow. In one embodiment, the temperature sensor (520), which can measure temperature of the liquid and body temperature, may be located in or about the hole 208. The hollow tube also has a vertical inflation channel (214) inside the wall running from the proximal end (204) to the distal end (202); this channel is added at the manufacturing stage. This channel is cut (206) open to the outer surface of the hollow tube at the place where the inflatable cuff (800) is located on the hollow tube (200) and when air passes through this channel the cuff inflates (Figure 1c). The cut (206) is preferably provided mid-way on the hollow tube. For explanation purposes the tube is shown as straight but a skilled person is aware that it is radially bent to a certain degree which is part of the manufacturing. [0064] In one embodiment, the hollow tube has a thin cover tube (300). Figure 3a shows an embodiment of the front view of the cover tube. Figure 3b shows an embodiment of the isometric view of the cover tube. Figure 3c shows an embodiment of the top view of the cover tube. The inner diameter of the thin cover tube (300) is slightly bigger than the outer diameter of the hollow tube (200). This thin cover tube (300) will be fused on to the surface of the tube 200 along with the flexible PCB sensor module 500. One end of the thin cover tube 300 is beveled.

[0065] Figure 4a shows an embodiment of the instant hollow tube with a wing. Figure 4b shows top view of the Figure 4a embodiment. Figure 4c shows isometric view of the Figure 4a embodiment. The hollow tube embodiment shown in Figures 4a-4c has a vertical thin wing (402) along the outer surface of the tube and this is part of manufacturing of the tube. This thin wing (402) is easily rollable along the radial surface of the tube and can be heat fused on to the tube outer surface along with the flexible PCB sensor module (500). In the winged embodiment, a cover tube is replaced by the wing which rolls over the hollow tube as a cover.

[0066] Figure 5a shows isometric view of an embodiment of the instant flexible sensor module. Figure 5b shows front view of the embodiment of the flexible sensor module of Figure 5a. Figure 5c shows an expanded view of the distal end of the flexible sensor module of Figure 5a. Figure 5d shows top view of the embodiment of the flexible sensor module of Figure 5a. Figure 5e shows an expanded view of the isometric view of the flexible sensor module’s distal end. Figure 5f shows side view of the flexible sensor module embodiment of Figure 5a.

[0067] This preferable embodiment of the thin flexible PCB sensor module (500) is integrated with optical sensors, temperature sensor, conduction sensors and optical reflectors to detect the block and measure liquid secretions inside the tube. However, the module may comprise only of a single type of sensing means or a combination of the sensing means. The invention is not limited to the embodiment depicted in the drawings. The module (500) has a flexible PCB vertical strip (502) and alternating small width horizontal strips 504 and big width horizontal strips 504 starting at the distal end 508 of the PCB vertical strip. The reflectors are placed on the big width strips in this embodiment, but it is understood that the location can be on any other strip or part of the sensor module. The reflectors reflect the light from the optical sensor back to the optical sensor.

[0068] In this embodiment, optical sensors (518) are placed at the mid-junction of the vertical (502) and horizontal strips (504, 506) in multiple locations along the vertical strip. In a preferred embodiment the big width horizonal strips (506) are designed to act like a reflector for the optical sensors (518). The optical sensor measures or detects the block in the tube due to respiratory secretion that enters the tube. Optical sensors at multiple locations detect the block location and the quantity. Optical sensors can align with 210 or have a separate slot or be flush with the surface of the tube.

[0069] Each of the horizontal strips (504, 506) have multiple conduction electrodes (514, 516) which align with the cylindrical holes (212) on the hollow tube. These electrodes (514, 516) use the impedance and conduction method to detect the presence of liquid in the tube and measure the volume. The location and length of liquid presence in the tube will also be detected and measured. There is a temperature sensor (520) placed at the tip of the distal end of the vertical strip (502) to measure the temperatures.

[0070] This flexible PCB vertical strip (502) aligns with one of the vertical slots (210) on the hollow tube and the horizontal strips (504, 506) are rolled radially along the outer surface of the hollow tube (200). The appearance of the rolled flexible PCB sensor module on the hollow tube (200) surface looks like that shown in Figures 6a to 6c. Figure 6a shows the rolled flexible sensor module in top view. Figure 6b shows the rolled flexible sensor module in isometric view. Figure 6c shows expanded view of the rolled flexible sensor module top view. The number of horizontal strips, electrodes, vertical slots and optical sensors are not limited to the representations in the figures given here.

[0071] The sensor module has a communication pin (510) at the proximal end (512) of the flexible vertical PCB sensor module for communication with external devices. The external devices being for data collection and monitoring and being configured to connect to the communication pin via a cable or any other suitable means. The pin can exit the tube at the proximal end or at any other location between the proximal end and the middle of the tube. Each of these optical sensors (518), temperature sensor (520), conduction or capacitance sensors/ electrodes, horizontal strips (504, 506) are electrically connected to the communication pin (510) in order to communicate to the external devices. The external devices being configured to inform the caretakers of a potential block or issue, detected by the sensor module via alarms. The communication pin (510) is slidably placed in a pin holder that is part of the connector (700), according to one embodiment. The communication pin may be held in the connector or in any other alternate means. [0072] The instant connector (700) has an inner cylinder (706) which slides into the hollow tube at the proximal end (204) of the tube to provide a firm connection. The connector has an outer cylinder which connects to the ventilator tube. The connector also has a communication pin holder. The communication pin is slidably placed into the pin holder (710) and backward sliding is prevented by the pin holder lock (712) that locks to hold the pin primly in the pin holder. Figure 7a shows isometric view of the connector. Figure 7b shows the connector in top view. Figure 7b shows the connector in front view. However, it is understood that the connector of Figure 7 is one embodiment and that a skilled person may easily modify the connector structure and still be within the scope of this invention.

[0073] Figure 8a shows the inflatable cuff in front view. Figure 8b shows the inflatable cuff in top view. In Figures 8a and 8b the inflatable cuff is already inflated for representation and explanation purposes only. The device is not limited to this appearance. The top and bottom portion of the inflatable cuff (800) is fused on top of the thin cover tube (300) or the thin wing (402) while leaving the center portion of the inflatable cuff unfused to the hollow tube (200). Cuts (206) are provided on the hollow tube (200) for access to the inflation channel (214) and let air into the inflatable cuff. An inflation tube (900) is provided in the cuff inflation channel (214) to inflate and deflate the cuff. The tube (900) slides into the inflation channel (214) and is fused. In one embodiment, the tube (900) enter the hollow tube (200) at approximately the center of the tube. However, the entrance may be located elsewhere too. [0074] Figures 9 shows an embodiment of the device in assembled format. This embodiment is one that has the cover tube. Figure 9a shows an embodiment of the instant endotracheal intubation tube apparatus in front view. Figure 9b shows an embodiment of the instant endotracheal intubation tube apparatus in top view. Figure 9c shows an embodiment of the instant endotracheal intubation tube apparatus in isometric view. The flexible PCB sensor module (500) is placed in such way that the 502 vertical strip is aligned into the vertical slots (210) of plain hollow tube (200) and then all the horizontal strips 504 and 506 are radially folded onto the outer surface of the plain hollow tube (200). At this point all the electrodes (514, 516) on the horizontal strips (504, 506) slide into the respective cylindrical holes (212), optical sensors (518) face the inner plain hollow tube (200), and the temperatures sensor (520) slides into the hole (208) at the beveled (216) end of the plain hollow tube (200).

[0075] After placing the flexible PCB sensor module (500) onto the tube outer surface, the thin tube cover (300) is slidably placed on the rolled flexible PCB sensor module and hollow tube and fused by glue or heat. After heat fusion, cuts (206) are made at two locations, one being at the point where the cuff inflation tube (900) is inserted and another one at the inflatable cuff’ s location.

[0076] After the cut is made, the inflatable cuff (800) is slidably placed on to the fused thin cover tube (300) close to the distal (202) end of the hollow tube. The cuff inflation tube (900) is slidably placed into inflation channel 216 at the sleeve cut (206) location and then fused by glue or heat.

[0077] Next the inner cylinder (706) of the tube connector (700) is slidably placed into the plain hollow tube (200) at the proximal end (204) which provides a firm connection and the communication pin is slidably placed into the pin holder (710) and backward sliding is prevented by the pin holder lock (712).

[0078] Initial proof of principle experiments have shown successful monitoring of secretion levels, block percentage, location of block, improved safety by reduced risk of VAP and ability to alert health care provider about a potential block. The design features and sensors used in the present apparatus are considered keeping in mind overall cost of the endotracheal intubation tube to be as low as possible while addressing some or all the challenges of the existing endotracheal intubation tubes available in the market as well as medical regulations. The present invention in endotracheal tubes has a significant advancement in critical care, offering improved patient outcomes through enhanced monitoring and proactive management of ventilation-related complications. It requires less training for healthcare staff, is highly cost effective, needs no change in intubation method, and is compatible with traditional ventilator machines.

[0079] While the present invention has been described with respect to certain embodiments, it will be apparent to those skilled in the art that various changes and modifications may be made without departing from the scope of the invention as defined in the following claims.

Claims

We Claim:

1. An endotracheal intubation tube apparatus comprising: a. a hollow tube (200) having a proximal end (204) and a distal end (202) that is beveled (216), said tube comprising,

2. The apparatus as claimed in claim 1, wherein the flexible sensor module (500) comprises,

• a vertical flexible strip (502) having a distal end (508) and a proximal end (512), said ends corresponding to hollow tube ends 202 and 204, respectively;

• one or more horizontal strips attached along the length of the vertical strip starting from the distal end (508), wherein the horizontal strip rolls radially along the outer surface of the hollow tube (200);

• the one or more sensing means being located on the horizontal strip, vertical strip or both;

• one or more reflectors being located on the flexible sensor module, the hollow tube, or both, for reflecting light to the optical sensor; and

• a communication pin (510) for communication with an external device, wherein the vertical and horizontal strips are made of printed circuit board type material.

3. The apparatus as claimed in claim 1, wherein the cover is a tube (300) consisting of a proximal end (306) and a distal end (302) that is beveled (304), said ends corresponding to hollow tube ends 204 and 202, respectively.

4. The apparatus as claimed in claim 1, wherein the cover is as a thin wing (402) extending vertically on the outer surface of the hollow tube (200), from the proximal end to the distal end, said wing being rollable along the radial surface of the hollow tube and being fused on to the tube outer surface along with the flexible sensor module (502).

5. The apparatus as claimed in claim 2, wherein the horizontal strips are of different widths (504, 506) or the same width.

6. The apparatus as claimed in claim 2, wherein the temperature sensor (520) is placed at the distal end (508) of the vertical strip.

7. The apparatus as claimed in claim 2, wherein the optical sensor is placed at the junction of the vertical and horizontal strip or at any other location on the horizontal strip.

8. The apparatus as claimed in claim 2, wherein the communication pin (510) is preferably located about the proximal end (512) or at any other position on the vertical strip.

9. The apparatus as claimed in claim 1, wherein the one or more holes (212) perpendicular to the surface of the hollow tube (200) are for placement of the sensing means being conduction electrodes, the holes being placed along the vertical slot (210) as well as repeated radially on the surface of the tube such that the holes coincide with the electrodes.

10. The apparatus as claimed in claim 1 including a connector (700) which has an inner cylinder (709) which slides into the proximal end of the hollow tube, an outer cylinder (706) which connects to a ventilator tube, and a holder (710) for a communication pin (510) to be locked in.

11. The apparatus as claimed in claim 1, including an inflatable cuff (800) near the distal end, wherein the cuff is inflated and deflated by a cuff inflation tube (900) that is housed in the inflation channel (214).