Method and apparatus for determining endotracheal tube position - Patent Application 20070122997

Abstract

Systems, methods, and devices are disclosed for accurately detecting the position of an endotracheal tube by sensing patient anatomical structures surrounding the endotracheal tube. The disclosed system includes an endotracheal tube having two or more sensors supported by the endotracheal tube configured to sense surrounding patient anatomical structures. A signal processing unit can receive data from the sensors and perform at least one of the following: (i) identify the detected patient anatomical structures, such as the vocal cords; (ii) determine the distance between the detected patient anatomical structures and a known point on the endotracheal tube; and (iii) verify the positioning of the endotracheal tube within the patient's tracheal or esophageal lumen. In some embodiments, the system can include at least one inflatable component extending along the outer surface of the endotracheal tube and capable of supporting at least one sensor.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 63 / 425,505, entitled "Methods and Devices for Determining the Position of an Endotracheal Tube," filed November 15, 2022, which is incorporated herein by reference in its entirety.

[0002] This application is also related to U.S. Patent Application No. 17 / 017,620, filed September 10, 2020, entitled "Methods and Devices for Determining a Position of an Endotracheal Tube," which claims the benefit of U.S. Provisional Patent Application No. 62 / 924,862, filed October 23, 2019, entitled "Methods and Devices for Determining a Position of an Endotracheal Tube," and U.S. Provisional Patent Application No. 63 / 054,520, filed July 21, 2020, entitled "Methods and Devices for Determining a Position of an Endotracheal Tube," each of which is incorporated herein by reference in its entirety.

[0003] The exemplary embodiments relate generally to airway management during medical procedures, and more particularly, the exemplary embodiments relate to positioning of endotracheal tubes.

[0004] Background technology Proper positioning of an endotracheal tube (ETT) aids in oxygenation and ventilation of the lungs during medical procedures. A common problem after placing an ETT is the inability to determine the correct depth to secure the ETT. If the lumen of an ETT is inserted too deeply, it may pass beyond the trachea and carina, communicating with only the bronchi of one lung; this is called endobronchial intubation. According to the Anesthesiology Society of America's Closed Claims Project, endobronchial intubation accounts for 2% of adverse respiratory events in adults and 4% in children.

[0005] Alternatively, a shallowly inserted ETT may be secured within the lumen of the hypopharynx such that the distal end of the ETT protrudes into the trachea, but the airway occlusion cuff (AOC), a circumferential balloon surrounding the ETT near its distal end, inflates over the vocal cords, creating the illusion of a functionally fixed airway. Alternatively, once correctly positioned within the trachea, the ETT may be accidentally pulled shallow or displaced upward, resulting in extubation of the ETT from the trachea. In the United States, 121,000 unintentional extubations occur in intensive care units (ICUs) annually, resulting in 34,000 cases of ventilator-associated pneumonia and doubling the length of ICU stay. Finally, the AOC may accidentally inflate over the vocal cords, potentially causing damage to the vocal cords if left inflated.

[0006] Summary of the Invention According to one embodiment of the present invention, an endotracheal system includes an endotracheal tube having a proximal end, a distal end, and a lumen between the proximal and distal ends. The endotracheal system also includes a signal processing unit and two or more sensors positioned on the endotracheal tube. The two or more sensors are configured to generate sensor signals. The generated sensor signals interact with surrounding patient anatomy. The surrounding patient anatomy includes an internal body cavity. The two or more sensors are also configured to detect the generated sensor signals interacting with the surrounding patient anatomy and transmit the detected sensor signals to the signal processing unit. The signal processing unit is in signal communication with the two or more sensors and is configured to receive the detected sensor signals and determine position data. The position data includes a position of the endotracheal tube and dimensions of the internal body cavity based on the detected sensor signals.

[0007] The sensor signal may include visible light or infrared light. Interaction of the sensor signal with the surrounding patient anatomy includes reflection, and the generated sensor signal is detected by a photodiode. The visible light may be generated by an LED or VCSEL, and the infrared light may be generated by an LED or VCSEL.

[0008] The endotracheal system may also include a display modality configured to receive the position data, generate an image of the surrounding patient anatomy, and display a visual representation of the distance between the endotracheal tube position and a known point on the endotracheal tube.

[0009] The endotracheal system may also include an inflatable airway obstruction cuff located closer to the distal end of the endotracheal tube than the proximal end. The two or more sensors may also be positioned proximal to the airway obstruction cuff. The two or more sensors may extend longitudinally along at least a portion of the length of the endotracheal tube.

[0010] The two or more sensors may include an interpenetrating array comprising an emitter array and a detector array, such that emitters and detectors alternate in each row and each column of the interpenetrating array. The interpenetrating array may extend circumferentially around the outer surface of the endotracheal tube and longitudinally along at least a portion of the length of the endotracheal tube, with the distal end of the interpenetrating array being proximal to the airway obstruction cuff. The emitter array may include at least two rows, each having two emitters, and at least two columns, each having two emitters. The detector array may include at least two rows, each having two detectors, and at least two columns, each having two detectors. In a non-limiting embodiment, the emitter array may include an 8 emitter by 8 emitter array. The detector array may include an 8 detector by 8 detector array. In further non-limiting embodiments, the emitter and detector arrays may be sized in their final form as a 6 (e.g., 6) by 9 (e.g., 9) array or a 5 by 10 array. In embodiments, regardless of the size of the arrays, the arrays may be interpenetrating.

[0011] The signal processing unit may be further configured to generate position data of the anatomical feature using reference information regarding an expected contour of the internal body cavity. The signal processing unit may utilize machine learning to generate the position data.

[0012] The surrounding patient anatomy may include the larynx. The surrounding patient anatomy may include at least one vocal cord.

[0013] The two or more sensors configured to detect the surrounding patient anatomy may be configured to detect at least one of pressure, capacitance, impedance, acoustic, photoacoustic, ultrasound, visible light characteristics, or infrared characteristics of the surrounding patient anatomy.

[0014] The endotracheal system may also include a flex circuit disposed on the endotracheal tube between the two or more sensors and the endotracheal tube. The flex circuit may provide signal communication between the two or more sensors and the signal processing unit.

[0015] The endotracheal system may also include an outer casing molded around the two or more sensors and a flex circuit to provide encasement. The outer casing and flex circuit molded around the two or more sensors may act as a lens for the two or more sensors.

[0016] According to another embodiment of the present invention, a method for defining an anatomical structure of an internal body cavity includes providing a tube having a proximal end and a distal end within the internal body cavity. The method also includes emitting light from two or more optical outputs supported by the tube, detecting the intensity of the reflected light with each of two or more detectors supported by the tube, and generating a signal at each of the two or more detectors based on the intensity of the reflected light detected by each of the two or more detectors. The method also includes transmitting a signal from each of the two or more detectors to a signal processing unit, receiving and storing the signal from each of the two or more detectors in the signal processing unit, and using the signal processing unit to determine the location and dimensions of the internal body cavity based on the signal. The tube may be an endotracheal tube. The optical outputs may be light-emitting diodes (LEDs), and the detectors may be photodiodes.

[0017] The method may further include generating position data of an anatomical feature using reference information regarding an expected contour of the internal body cavity. The method may further include determining a position of the endotracheal tube based on the position data of the anatomical feature and known points on the endotracheal tube. The anatomical feature may be the vocal cords.

[0018] The method may further include receiving the position data and generating an image of the patient's anatomy. The signal processing unit may utilize machine learning to generate the position data.

[0019] The tube may be an intravaginal device. The tube may be an intrauterine device insertion stylet. The tube may be a bladder catheter. The tube may be a pleural tube. The tube may be a pleural catheter. The tube may be an intravascular catheter. The tube may be a ureteral catheter. The tube may be an intragastric tube. The tube may be an intragastric catheter.

[0020] According to one embodiment of the present invention, an endotracheal system includes an endotracheal tube, at least one sensor supported by the endotracheal tube, and a signal processing unit. The endotracheal tube has a proximal end, a distal end, and a lumen extending between the proximal and distal ends. The at least one sensor is supported by the endotracheal tube and configured to detect surrounding patient anatomical structures. The signal processing unit is configured to determine a vertical distance between a vertical and / or horizontal position on the sensor at which the surrounding patient anatomical structures are detected and a known point on the endotracheal tube.

[0021] In an exemplary embodiment, the signal processing unit is further configured to display a visual representation of the distance between the surrounding patient anatomical structure and a known point on the endotracheal tube. The endotracheal tube may include an inflatable balloon extending longitudinally along an outer surface of the endotracheal tube. The at least one sensor may be positioned on or embedded within the inflatable elongated balloon. In some cases, the elongated balloon is detachable from the endotracheal tube.

[0022] The endotracheal system may further include an inflatable airway obstruction cuff located closer to the distal end of the endotracheal tube than the proximal end, and the at least one sensor positioned proximal to the airway obstruction cuff. In some embodiments, the at least one sensor includes a sensor array extending circumferentially around the outer surface of the endotracheal tube and longitudinally along at least a portion of the length of the endotracheal tube, the distal end of the sensor array being proximal to the airway obstruction cuff.

[0023] In some embodiments, the at least one sensor is configured to detect at least one of pressure, capacitance, impedance, acoustic, photoacoustic, ultrasound, visible light, or infrared characteristics of the surrounding patient anatomy. The at least one sensor can extend longitudinally along at least a portion of the length of the endotracheal tube. In some embodiments, the surrounding patient anatomy includes the larynx. In other embodiments, the surrounding patient anatomy includes the vocal cords. In some embodiments, the at least one sensor is configured to detect pressure fluctuations in the surrounding patient anatomy that are exerted below a low pressure threshold.

[0024] According to another embodiment of the present invention, a method for positioning an endotracheal tube within a patient's trachea includes inserting an endotracheal tube into the patient's pharynx, the endotracheal tube having a proximal end, a distal end, and a lumen between the proximal and distal ends; and moving the endotracheal tube distally so that the distal end of the endotracheal tube is positioned within the patient's tracheal lumen or the patient's esophageal lumen. An airway obstruction cuff located toward the distal end of the endotracheal tube is inflated. The method further includes detecting patient anatomical structures surrounding the endotracheal tube with at least one sensor supported by the endotracheal tube, communicating data related to the detected patient anatomical structures from the at least one sensor to a signal processing unit, and determining a distance between the detected surrounding patient anatomical structures and a known point on the endotracheal tube relative to a two-dimensional vertical and / or horizontal position on the sensor.

[0025] In an exemplary embodiment, the surrounding patient anatomical structure is at least one vocal cord. The method may further include aligning the at least one sensor with the at least one vocal cord by rotating the endotracheal tube so that the intended front side of the endotracheal tube faces forward. In some such embodiments, aligning the at least one sensor with the at least one vocal cord includes at least one of aligning the at least one sensor so that the at least one sensor is in direct contact with or close to the at least one vocal cord, or orienting the at least one sensor in a known position relative to the at least one vocal cord. Detecting the patient anatomical structure surrounding the endotracheal tube may further include detecting the presence or absence of a first vocal cord and a second vocal cord.

[0026] The method may further include visually representing at least a portion of the endotracheal tube and the detected surrounding patient anatomy on a display. In some embodiments, the endotracheal tube further includes at least one inflatable balloon extending longitudinally along at least a portion of an outer surface of the endotracheal tube, and the at least one sensor is positioned on or embedded within the at least one elongated balloon. In some such embodiments, the method further includes aligning the at least one sensor with respect to the surrounding patient anatomy, inflating the at least one elongated balloon such that the at least one sensor moves toward the surrounding patient anatomy, and detecting the surrounding patient anatomy using the at least one sensor while the elongated balloon is inflated.

[0027] According to another embodiment of the present invention, an endotracheal system includes an elongated tube, an airway obstruction cuff, and a sensor array. The elongated tube has a proximal end, a distal end, and a lumen extending therebetween, the airway obstruction cuff being located closer to the distal end of the elongated tube than to the proximal end of the elongated tube. The sensor array is configured to detect surrounding patient anatomy and extends circumferentially around an outer surface of the elongated tube and along the length of a proximal elongated tab of the airway obstruction cuff.

[0028] In exemplary embodiments, the sensor array includes a flex circuit extending circumferentially around an outer surface of the elongated tube and an outer case surrounding the flex circuit. In some such embodiments, the flex circuit includes a plurality of visible and / or infrared light emitters and a plurality of phototransistors arranged in a circular array attached to or in communication with the flex circuit.

[0029] In yet another embodiment of the present invention, an endotracheal system includes an endotracheal tube having a proximal end, a distal end, and a lumen between the proximal and distal ends, the system further including means carried by the endotracheal tube for detecting surrounding patient anatomical structures and means for determining a distance between the detected surrounding patient anatomical structures and a known point on the endotracheal tube.

[0030] In some embodiments, the means for detecting a distance between the detected surrounding patient anatomical structure and the known point on the endotracheal tube is further configured to display a visual representation of the distance between the surrounding patient anatomical structure and the known point on the endotracheal tube. The means carried by the endotracheal tube for detecting surrounding patient anatomical structure may detect the patient's vocal cords.

[0031] Those skilled in the art will more fully appreciate the advantages of various embodiments of the present invention from the following detailed description, which is described with reference to the drawings summarized immediately below. [Brief explanation of the drawings]

[0032] [Figure 1] 1 is a schematic diagram of one embodiment of an endotracheal tube system according to the present disclosure. FIG. [Figure 2] FIG. 10 is a schematic diagram of another embodiment of an endotracheal tube according to the present disclosure. [Figure 3] 10A-10C illustrate another embodiment of an endotracheal tube according to the present disclosure. [Figure 4] FIG. 4 is a cross-sectional view of the endotracheal tube of FIG. 3 taken along line AA. [Figure 5] FIG. 1 is a schematic diagram of a cross section of an ETT with an emitter and detector positioned on the ETT while the ETT is positioned in the trachea. [Figure 6] FIG. 1 shows a sensor map generated by the ETT system while measuring optical data inside a cadaver trachea. [Figure 7A] FIG. 7 shows a reproduction of the sensor map 600 of FIG. 6. [Figure 7B] FIG. 7B shows the sensor map of FIG. 7A after being transformed into a cylindrical shape using the sensor interpreter. [Figure 7C] 3D modeling of a section of the trachea. [Figure 7D] FIG. 1 shows the ETT system deployed within a 3D modeled view of the trachea. [Figure 8] FIG. 10 illustrates a further exemplary embodiment of a sensor map generated by a signal processing unit, in accordance with an exemplary embodiment. [Figure 9] FIG. 1 illustrates one embodiment of a three-dimensional rendering of an endotracheal tube with an AOC generated by a signal processor. [Figure 10] FIG. 10 is a schematic diagram of another embodiment of an endotracheal tube according to the present disclosure. [Figure 11] 2 is a schematic diagram illustrating another embodiment of the endotracheal tube of the system of FIG. 1 received within the airway of a patient, in accordance with the present disclosure. [Figure 12] 1 illustrates one embodiment of a method of using an endotracheal tube according to the present disclosure. [Figure 13] 10A-10C illustrate another embodiment of a method of using an endotracheal tube according to the present disclosure. [Figure 14] 10A-10C illustrate another embodiment of a method of using an endotracheal tube according to the present disclosure. [Figure 15] FIG. 1 is a diagram illustrating a composite image of a space within a body cavity. [Figure 16] 1A-1C are schematic diagrams illustrating representative imaging of a patient's anatomy.

[0033] MODE FOR CARRYING OUT THE INVENTION Exemplary embodiments provide for effective and accurate placement of an endotracheal tube (ETT) within a patient's airway. Various embodiments provide rapid, accurate, frequent, and in some embodiments, continuous, reliable ETT depth position data of the ETT within the airway. To that end, the endotracheal tube carries at least one sensor that detects the patient's anatomy and surrounds the endotracheal tube when the endotracheal tube is positioned within the patient's airway. For example, the sensor can detect one or more characteristics of the surrounding anatomy and transmit the sensed information in real time or near real time to a signal processing unit. The signal processing unit then determines the distance between the vertical and / or horizontal position of the detected surrounding patient anatomy relative to the body of the tube and a known point on the endotracheal tube.

[0034] Additionally, the signal processing unit can generate a visualization of endotracheal tube placement relative to the detected patient anatomical structures. The anatomical structure detection sensor may be positioned on the surface of the endotracheal tube and / or integrated into the endotracheal tube, e.g., integrated into the wall of the endotracheal tube. Additionally or alternatively, some embodiments of the endotracheal tube can include one or more elongated balloons extending longitudinally along the outer surface of the tube, with at least one sensor disposed on or integrated within the balloon. The disclosed systems, methods, and devices can facilitate proper placement of the ETT, thereby reducing the risk of unintentional extubation, which can shorten the length of time a patient requires ventilation and reduce the number of times a physician needs to readjust the ETT within the patient's airway. Details of exemplary embodiments are described below.

[0035] Certain exemplary embodiments are described to provide a general understanding of the principles of the structure, function, manufacture, and use of devices, systems, and methods. One or more examples of these embodiments are illustrated in the accompanying drawings. The devices, systems, and methods specifically described and illustrated in the accompanying drawings are non-limiting embodiments. Features illustrated or described in connection with one embodiment may be combined with features of other embodiments. Such modifications and variations are intended to be within the scope of the present disclosure.

[0036] FIG. 1 schematically illustrates one embodiment of an endotracheal system 100 positioned within a patient's trachea 2. The ETT system 100 includes an endotracheal tube (ETT) 4 having a proximal end 6 and a distal end 8, with a lumen 10 extending from the proximal end to the distal end of the tube. The endotracheal tube 4 is inserted through the patient's mouth to position the distal end 8 of the endotracheal tube 4 within the patient's trachea 2. The proximal end 6 of the endotracheal tube 4 remains external to the patient. As used herein and as shown in FIG. 1 , "proximal" is used to refer to the direction toward the end of the ETT 4 that extends out from the patient upon insertion of the ETT into the patient's airway, and the term "distal" is used to refer to the opposite direction. With respect to placement within the trachea 2, proximal refers to near the patient's mouth, and distal refers to near the patient's lungs.

[0037] The ETT 4 can include tubing of varying sizes, diameters, and / or curvatures with a plastic connector 12 at the proximal end 6 of the tubing 4. The plastic connector 12 can be connected to a bag-valve mask or a ventilator (not shown). In this way, various ETT embodiments can maintain compatibility and usability with existing ventilation systems. With the endotracheal tube 4 positioned within the patient's trachea, the ETT 4 establishes and maintains the patient's airway to ensure adequate exchange of oxygen and carbon dioxide during surgical procedures. The ETT 4 also has one or more inflatable cuffs 14, also known as airway occlusion cuffs (AOCs). When inflated, the AOCs 14 seal the trachea 2 and lungs against air leaks, creating a closed, pressurized system to ensure the exchange of oxygen and carbon dioxide between the ventilator and the lungs. When inflated while positioned within the trachea 2 below or distal to the vocal cords 26, the AOCs 14 create a seal with the tracheal wall to form a closed air system. Therefore, proper placement of the ETT 4 within the trachea 2 is necessary to ensure its effectiveness.

[0038] Generally, the endotracheal tube 4 is positioned within the patient's trachea 2. The AOC 14 is then inflated (e.g., using the pilot balloon 16). The AOC 14 may be connected to the pilot balloon 16 via a small-diameter tube 18 that extends along the length of the ETT 4. The pilot balloon 16 may include a one-way valve to prevent air from escaping from the pilot balloon 16. To adjust the position of the AOC 14, the physician may optionally deflate the AOC 14, reposition it, and re-inflate the AOC 14 (e.g., using the pilot balloon 16). The AOC 14 may extend from a proximal end 14p to a distal end 14d and be positioned toward the distal end 8 of the ETT 4. In some embodiments, the distal end 8 of the ETT extends distally beyond the distal end 14d of the AOC 14.

[0039] The endotracheal tube 4 of various embodiments supports one or more sensors 20. The sensor 20 may include one or more optical outputs configured to emit light (e.g., electromagnetic radiation) and one or more optical detectors (e.g., photodiodes, etc.) configured to detect the light. The sensors are configured to determine the position of the ETT 4 within the trachea. The optical outputs, such as, but not limited to, light-emitting diodes (LEDs), emit light within the body cavity. The detectors measure reflected light from surrounding patient anatomical structures. As a non-limiting example, the sensor 20 may be in communication with several logics, such as a sensor interpreter configured to interpret sensor information, an image processor configured to generate an image of the interior of the patient's trachea, and / or a signal processing unit, which may include a display.

[0040] The sensor 20 described above may also include a sensor configured to detect at least one of pressure, capacitance, impedance, acoustic, photoacoustic, ultrasound, visible light, or infrared characteristics of the surrounding patient anatomy. In the illustrated embodiment of FIG. 1 , the sensor cuff 22 supporting the sensor 20 may be attached to or integrally formed with the ETT 4. In some embodiments, the sensor cuff 22 may circumscribe the ETT 4 and extend longitudinally along at least a portion of the tube's length. The sensor cuff 22 may have a proximal end 22 p and a distal end 22 d, with the distal end 22 d of the sensor cuff 22 located proximal to the AOC 14, i.e., toward the proximal end 6 of the ETT 4. In some embodiments, the sensor cuff 14 may be inflated using the sensor cuff's pilot balloon 24. In this manner, the sensor cuff 22 may be inflated with the ETT 4 inserted into the patient to bring the sensor 20 into close proximity to or contact with the surrounding patient anatomy, such as the patient's vocal cords 26. As described in more detail below, in other embodiments, the one or more sensors supported by the ETT can be supported by the ETT in one or more of the following ways: disposed on the surface of one or more elongated balloons, integrated into one or more elongated balloons, Placed on the surface of the ETT, Integrated into ETT, Placed on a non-inflatable sensor cuff, or Integrated into a non-inflatable sensor cuff.

[0041] The signal processing unit 28 receives data from the sensor 20. The signal processing unit 28 may include a data storage system (not shown). The data storage system may include a data controller that receives data collected from the sensor and transmits it to the signal processing unit 28. The data controller transmits the data to be stored in non-volatile memory as measurements are made. The data controller retrieves the data from the non-volatile memory and transmits it to a central processing unit (CPU) within the signal processing unit 28. The CPU may form part of a sensor interpreter 29. The processed data identifies the detected surrounding patient anatomical structures and determines the distance between a known point on the ETT 4 and the detected anatomical structures. For example, the signal processing unit 28 may determine the distance between the distal end 8 of the ETT 4 or the most distal point at the proximal end 14p of the AOC 14 and the detected surrounding patient anatomical structures, such as the vocal cords 26. To that end, as described in detail below, the signal processing unit 28 may include one or more of a sensor interpreter 29 that determines the location of the detected anatomical structure and the distance between the detected anatomical structure and a known point on the ETT4 based on the sensing data from the sensor 20 of the ETT4, and an image processor 31 that generates a visual representation of the ETT4 positioning and communicates with a display 33 so that the visual representation can be made visible to the clinician in real time or near real time.

[0042] The signal processing unit 28 may use machine learning to determine the distance between the patient's anatomy and air / tissue boundary and known points on the ETT 4, as well as to create a visual representation of the patient's anatomy and the ETT.

[0043] FIG. 1 illustrates one embodiment of the ETT 4, in which the display 33 is shown as a separate component in communication with the signal processing unit 28. In some embodiments, the display 33 and the signal processing unit 28 can be located within the same component or machine, such as a tablet, computer, etc. Each of these components can be embodied as hardware (e.g., a processor), software, and / or firmware. Note that FIG. 1 is merely a schematic diagram illustrating each of these components as separate. In embodiments, each of these components may be implemented in various conventional ways, such as by using hardware, software, or a combination thereof, across one or more other functional components. For example, the sensor interpreter 29 may be implemented using multiple microprocessors executing firmware. As another example, the image processor 31 may be implemented using one or more application-specific integrated circuits (e.g., “ASICS”) and associated software, or a combination of ASICs, discrete electronic components (e.g., transistors), and microprocessors. Accordingly, the representation of the signal processing unit 28 and other components within a single box in FIG. 1 is merely for simplicity. Indeed, in some embodiments, signal processing units 28 are distributed across several different machines, not necessarily in the same housing or chassis.

[0044] During use, the sensors 20 detect parameters and / or characteristics of the surrounding patient anatomy. This information is transmitted to the signal processing unit 28, which distinguishes between anatomical structures surrounding the endotracheal tube 4 and uses the information to determine the position and / or depth of the tube relative to the anatomical structures. The signal processing unit 28 generates a visual representation or image of the placement of the endotracheal tube 4 relative to the detected surrounding patient anatomy. For example, the anatomical structures may be defined, mapped, and / or displayed on a screen as recognizable anatomical structures. More specifically, the presence and location of the narrowest point within a defined space relative to the adjacent surrounding defined cavity region may be inferred to be the vocal cords 26 along the length of the ETT 4 and can be determined using information sensed by one or more sensors 20. Alternatively, the presence of a particular pattern or shape within the defined space, such as, but not limited to, an hourglass shape, a concave shape, a symmetrical shape, or a triangular shape, may provide data that can be used to infer or define the position of the vocal cords 26.

[0045] Detection and identification of the vocal cords 26 by the sensor 20 and the signal processing unit 28 can verify that the ETT 4 is properly positioned within the trachea 2 and not within the patient's esophagus. For example, in some embodiments where the sensor 20 is an infrared sensor, the signal processing unit 28 can receive time-of-flight data, i.e., a measurement of the amount of time it takes for a signal emitted from the sensor 20 to reflect back to the sensor 20. This can provide a distance measurement between the sensor 20 and surrounding objects, i.e., the surrounding patient anatomy. The signal processing unit 28 can use the spectroscopic data received from the sensor 20 to identify unique tissue components of the trachea and / or esophagus. For example, based on the sensor 20 data, the signal processing unit 28 can indicate that the space and / or volume being detected is irregular, asymmetric, discontinuous, or changes shape over a short period of time. These characteristics are specific to the esophagus and not the trachea. In this manner, signal processing unit 28 can indicate that the space does not conform to known standards for tracheal contours in terms of width, diameter, or progression of features along the length of the trachea, and signal processing unit 28 integrates the time-of-flight data to delineate vocal cords 26 from surrounding laryngeal structures. Spectroscopic data can be produced by sensor 20 using a time-domain methodology that uses a vertical cavity surface emitting laser (e.g., VCSEL) or light emitting diode (e.g., LED) as a radiation source and measures the time it takes for the emitted light to reflect back to the sensor from the surrounding patient anatomy.

[0046] The determined positions of the vocal cords 26 can then be used as anatomical reference points (e.g., anatomical references) to calculate the distance from the vocal cords 26 to a known point on the ETT 4. For example, the known point may be the distal end 8 of the ETT, the proximal or distal end of the AOC 14, etc. Determining the distance between the vocal cords 26, the anatomical reference, and the known point can indicate to the user whether the ETT 4 is properly positioned relative to the patient's anatomy or whether adjustments are needed. In some embodiments, the sensor 20 can detect surrounding patient anatomy in real time or near real time, and the signal processing unit 28 can determine the distance between the detected surrounding patient anatomy (e.g., anatomical references) and the known point on the endotracheal tube 4, and in some embodiments, can display a visual representation thereof in real time or near real time.

[0047] Figure 2 illustrates another embodiment of an endotracheal tube 104 that can be used in the endotracheal system 100 of Figure 1. Except as noted below, the structure, operation, and use of the endotracheal tube 104 are similar or identical to the structure, operation, and use of the endotracheal tube 4 of Figure 1, and like-numbered components generally have similar features. Therefore, for the sake of brevity, a description of the structure, operation, and use of such features will be omitted.

[0048] Similar to the endotracheal tube 4 of FIG. 1 , the ETT 104 has a proximal end 106 and a distal end 108 with a lumen 110 extending from the proximal end to the distal end of the endotracheal tube. A pilot balloon 116 can be used to inflate an airway occlusion cuff 114 to seal the patient's airway when the endotracheal tube 104 is positioned within the patient's trachea 2. The endotracheal tube 104 includes an elongated balloon 101 extending along at least a portion of its length and supporting at least one sensor 120 for detecting surrounding patient anatomy. While the illustrated embodiment of FIG. 2 shows a single elongated balloon 101, it will be understood that the endotracheal tube 104 can have multiple elongated balloons 101 extending along a portion of its length. Additionally or alternatively, the endotracheal tube 104 may include one or more sensors 120′ disposed on or integrated within the endotracheal tube 104. In some embodiments, the elongated balloon 101 may be omitted. The sensors 120, 120′ detect surrounding patient anatomical structures and communicate with the signal processing unit 28, which determines the distance between the detected patient anatomical structures and a known point on the endotracheal tube 104, such as the distal-most end of the endotracheal tube 104, a point on the elongated balloon 101, etc.

[0049] The elongated balloon 101 supports at least one sensor 120 to aid in determining proper placement of the endotracheal tube 104 within the patient's trachea 2. The elongated balloon 101 may be a straight balloon that extends longitudinally along the outer surface of the endotracheal tube 104 without surrounding the tube 104. For example, the elongated balloon 101 may be a single straight balloon that may extend along the anterior or posterior surface of the endotracheal tube 104. In some embodiments including multiple elongated balloons 101, the elongated balloons 101 may be positioned on multiple sides of the endotracheal tube 104. Additionally or alternatively, multiple elongated balloons 101 may be positioned on the same side of the endotracheal tube 104. That is, the elongated balloons 101 may be positioned at different longitudinal positions on the same side of the endotracheal tube 104. In various embodiments, the endotracheal tube 104 may include bilateral anterior-posterior facing elongated balloons 101. In some embodiments, the elongated balloon 101 may extend over or be incorporated into the AOC 114. The elongated balloon 101 may be a separate component from the AOC 114 and may include a different inflation system (e.g., a separate pilot balloon as shown, for example, in FIG. 1 for pilot balloon 24 of the sensor cuff). Alternatively, in some embodiments, the elongated balloon may be inflated by the pilot balloon 116 and use the same inflation system as the AOC 114.

[0050] In some embodiments, the elongated balloon 101 may be incorporated into the ETT 104 (e.g., formed integrally with the endotracheal tube). In other embodiments, the elongated balloon 101 may be formed as a separate, integral piece from the endotracheal tube 104. For example, the elongated balloon 101 may be retrofitted onto an already manufactured endotracheal tube 104. To that end, the elongated balloon 101 may be provided as part of a sleeve that can be positioned over the endotracheal tube 104. The sleeve may be sterilizable and reusable.

[0051] In some embodiments, the AOC 114 may also be incorporated as part of a sleeve that also includes one or more elongated balloons 101. Additionally, a sleeve with one or more AOCs 114 and / or elongated balloons 101 may be incorporated onto an endotracheal tube 104 that already has at least one AOC.

[0052] While the illustrated embodiment of the endotracheal tube 104 has a circular cross-section, the cross-sectional shape of the endotracheal tube 104 may be modified. For example, the ETT 104 may be modified to provide a flatter surface contact with the patient's anatomical structures, such as the vocal cords 26, when the ETT 104 is properly oriented. In some embodiments, the ETT 104 has a modified cross-section with a flatter contact surface, which can provide increased sensing capability or better vocal cord contact or interaction between the sensors 120, 120′ and the vocal cords 26. For example, the modified cross-section of the ETT 104 may be approximately triangular, having a cross-section with two long sides and one short side. Rounded points may join the sides of the endotracheal tube with the triangular cross-section to avoid causing trauma to the patient's airway. This configuration allows the two long sides to contact the patient's vocal cords 26 when the short sides are facing backward. In some embodiments, one or more sensors 120′ may be attached to or integrated into the long sides of the endotracheal tube 104.

[0053] As described above, the elongated balloon 101 may have one or more sensors 120 to aid in determining proper endotracheal tube 104 placement. The sensors 120 may be integrated into or on the surface of the elongated balloon 101. It will be appreciated that in various embodiments having multiple sensors 120, 120′, the multiple sensors may be positioned on different surfaces. For example, as shown in FIG. 2, an endotracheal tube 104 having an elongated balloon 101 may include one or more sensors 120′ located on the surface of the endotracheal tube 104 and / or one or more sensors 120 located on the surface of the elongated balloon 101.

[0054] In some embodiments, the sensor 120 may be a linear sensor, and / or multiple sensors 120 may be positioned in a linear pattern within or along the surface of the elongated balloon 101. For example, the illustrated embodiment of FIG. 2 includes six sensors 120 positioned linearly along the elongated balloon 101. It will be understood that a greater or lesser number of sensors 120 may be used in conjunction with the elongated balloon. Additionally, alternative configurations of sensors 120 are within the scope of the present disclosure. For example, multiple sensors 120 may be positioned in a "V"-shaped configuration on the elongated balloon 101. The elongated balloon 101 may be inflated while the endotracheal tube 104 is positioned within the patient such that one or more sensors 120 interact with the walls of the trachea 2 or other anatomical structures (e.g., vocal cords 26) and detect information of the surrounding patient anatomy. In some embodiments, one or more sensors 120 may contact the walls of the trachea 2 or other anatomical structures, such as the vocal cords 26, and in other embodiments, one or more sensors 120 may detect information from the trachea 2 or other anatomical structures without direct contact.

[0055] The sensors of various embodiments can be formed from a number of materials. For example, sensors 20, 120, 120' can be formed using materials that can change their electrical properties in response to changes in pressure, such as flexible or piezoelectric materials.

[0056] The sensor 20, 120, 120' may be electrical, mechanical, electromechanical, or optical in nature. In some embodiments, the sensor 20, 120, 120' may use the piezoelectric properties of a material to convert pressure differences into an electrical signal. For example, the sensor 20, 120, 120' may detect pressure changes at discrete intervals and convert these pressure changes into a signal. Such conversion may be achieved by, for example, causing a change in the electrical properties of the sensor 20, 120, 120' by interrupting the transmission of light waves through an optical waveguide. The sensor 20, 120, 120' may capture changes in voltage or current generated in response to pressure changes at multiple discrete points along the surface of the elongated balloon 101 (e.g., using electrodes) or the surface of the endotracheal tube 104. The electrodes may be passive and generate their own electrical signal, or may require electricity from an external source, which is then modified by the electrodes. For example, these electrical changes may be further modified in the sensor 20, 120, 120' and transmitted by a wire or series of wires 27 extending from the sensor 20, 120, 120' to the signal processing unit 28. Alternative methods may be used to transmit signals from the sensor 20, 120, 120' to the signal processing unit 28 (e.g., wireless connection such as RF, WiFi, etc.).

[0057] The signal processing unit 28 can be used to determine the distance between a known point on the endotracheal tube and a detected patient anatomical structure and can also be used to visualize it. The signal processing unit 28 can receive and process signals from each of the one or more sensors 20, 120, 120′. In addition, the signal processing unit 28 can communicate with a display 33 (e.g., a computer monitor or a mobile device screen). In some embodiments, the display 33 can be located remotely from the ETT 104, and the signal processing unit 28 can transmit data to the display via a wired or wireless connection to enable remote monitoring of the placement of the ETT 104 by a physician. For example, communication between the signal processing unit 28 and the display 33 can occur via a network, such as a local area network, a wide area network, or the Internet.

[0058] Figure 3 shows an isolated view of one embodiment of an endotracheal tube 304, and Figure 4 shows a cross-sectional view of the ETT 304 along line AA. The endotracheal tube 304 may include an array of optical sensors that may extend circumferentially around the endotracheal tube along a portion of the tube's length. In this manner, the sensors may continuously determine the position of the ETT 304 within the patient's airway relative to the vocal cords 26. The sensors may be implanted within the endotracheal tube 304.

[0059] 3 and 4, the sensor may be comprised of a series of optical devices, such as optical emitters 321 and optical detectors (e.g., photodetectors) 323, which may be positioned at discrete intervals along the endotracheal tube 304. In some embodiments, the optical emitters 321 and detectors 323 may be positioned circumferentially along the length of the endotracheal tube. In one embodiment, the emitters 321 may be surrounded by four detectors 323 at regular intervals and at 45-degree angles in a repeating pattern to form a grid pattern, forming a flex circuit 325. For example, in some embodiments, the flex circuit 325 may include multiple circular arrays 326, each extending circumferentially around the endotracheal tube 304. The embodiment shown in FIG. 3 illustrates a flex circuit 325 having ten circular arrays 326 positioned adjacent to one another extending along the length of the endotracheal tube 304. FIG. 4 shows a cross-section of such a circular array 326, including a pattern of eight emitters 321 and eight detectors 323 circumferentially alternating around the endotracheal tube 304. The circular array 326 can be arranged in an alternating alignment along the endotracheal tube 304, with the detectors 323 positioned adjacent to the emitters 321 forming a grid pattern. In this manner, the sensor cuff 322 can detect the circumferential absorbance and reflectance patterns of the patient's anatomy surrounding the ETT 304, and this data can be transmitted to the signal processing unit 28 in the manner described above. The signal processing unit 28 can use the data to determine the absolute position of the vocal cords. Due to the inherent anatomical symmetry along the anterior-posterior axis of the trachea at the level of the vocal cords 26, the reflectance data collected by the sensor 320 is symmetrical or nearly symmetrical along this axis. Thus, the signal processing unit 38 can identify the anterior-posterior axis and collate symmetric signals to determine the vocal cord level by sequential signal comparisons over 180 degrees from a fixed point on the ETT 304.

[0060] The outer casing 327 can be molded around the flex circuit 325 to provide encasement and act as a lens. The outer casing 327 and flex circuit 325 can form a sensor cuff 322 that is placed around the tubular body 305 of the endotracheal tube 304. The outer casing 327 can be a transparent plastic cover positioned over the flex circuit 325. This transparent cover allows optical signals to be transmitted from the emitter 321 to the surrounding tissue and reflected signals to be received from the surrounding tissue by the detector 323. The sensors, e.g., the emitter 321 and the detector 323, can be triggered in a preprogrammed manner to provide local information for each emitter location. A sensor map can be created based on the sensed information. Readings from the sensors can distinguish the anatomy and location or absence of vocal cords along the length of the endotracheal tube 304.

[0061] In some embodiments, the emitter 321 and detector 323 may be selected and designed to operate at infrared frequencies. Thus, infrared light may be used to identify laryngeal anatomical structures using time-of-flight combined with emissivity and / or absorptivity measurements. Time-of-flight techniques measure the time between the emission of infrared energy and the detection of reflected energy and can be used to determine the spatial relationship between the object emitting the infrared energy and the surrounding anatomical structures. The lumens above and below the vocal cords 26 may have a longer time-of-flight between the emission from the endotracheal tube's infrared emitter 321 and the detection of infrared light by the detector 323 than the time-of-flight of closer adjacent vocal cords. Thus, the time-of-flight data collected by the sensor 320 and transmitted to the signal processing unit 28 provides a structure defining information regarding the distance of surrounding structures to the surface of the endotracheal tube 304.

[0062] By measuring the emissivity and / or absorptivity intensity of reflected thermal radiation, it is possible to characterize surrounding tissue based on the degree of absorbed or reflected energy and the degree to which light disperses or travels through the surrounding space. Different tissue types absorb different amounts of infrared energy at specific infrared frequencies. For example, collagen absorbs infrared light well at approximately 1200 nm, while water absorbs minimally at the same wavelength. The composition of vocal cord tissue differs from that of the trachea and pharynx; therefore, their absorption identities must be definable and localizable. The sensor 20, 120, 120' may include an optical sensor with an optical emitter (such as an LED or VCSEL) and a detector (such as a photodiode). For purposes of this disclosure, the combination of an optical emitter and an optical detector may be referred to as an optical sensor. As an optical sensor, the sensor 20, 120, 120' may be distributed on the ETT 4, 104 in any configuration. The optical sensor may operate at infrared, near-infrared, and visible wavelengths.

[0063] 5 is a schematic diagram of a cross section of an ETT 4 with an emitter 321 and a detector 323 positioned on the ETT 4 while the ETT 4 is positioned in the trachea 2. The emitter 321 and the detector 323 are positioned circumferentially around the outer surface of the ETT 4. The emitter 321 and the detector 323 may be in electrical communication with a flexible circuit 5 (not shown). The flexible circuit (e.g., a flex circuit) provides electrical communication between the emitter 321 and the detector 323 and the signal processing unit 28.

[0064] In some embodiments, the emitters 321 may fire (e.g., emit light) at predetermined intervals, in a predetermined sequence, or simultaneously. For example, the emitters may be programmed to fire at time intervals of 0.1 seconds to 20 seconds, at time intervals of 0.5 seconds to 10 seconds, at time intervals of 1 second to 5 seconds, or at any other time interval between one emitter firing and the next. In particular, the emitters may be preprogrammed to fire at intervals of 0.5 seconds, 1 second, 5 seconds, 10 seconds, or 20 seconds between one emission and a subsequent emission. The emitters 321 may comprise light-emitting diodes (LEDs), vertical-cavity surface-emitting lasers (VCSELs), or a combination thereof. In addition to being able to predetermine the time interval between successive firings of the light emitters, the duration of a single firing (e.g., a single emission) may also be predetermined. The duration of a single release may be, but is not limited to, 1 millisecond (eg, millisecond) to 10 seconds (eg, second), or 100 milliseconds to 1 second, or 200 milliseconds to 700 milliseconds.

[0065] Emitter 321' is shown emitting light rays over a 180-degree pattern in the cross section of Figure 5. (Although not shown, during actual tracheal application, the light source would emit from the surface of the emitter in a hemispherical pattern.) As shown, each of the light rays emitted from emitter 321 reflects multiple times off the inner surface of trachea 2. The reflected light rays emitted from a single emitter, such as emitter 321', are detected by one or more of detectors 323.

[0066] In some embodiments, the emitters 321 and detectors 323 are pre-programmed so that for each firing of a single emitter, all of the detectors 323 make a measurement. That is, the single emitter 321 generates a hemispherical emitted light that is reflected from the inner surface of the trachea, and all of the detectors 323, 323', 323'', etc. (e.g., photodetectors) measure the intensity of the optical signal that reaches a given photodetector. In this way, all of the detectors can make a single measurement of the intensity of the optical signal that reaches the detector for each firing of the emitter.

[0067] As a non-limiting example, the ETT system 100 may include an ETT 4 having an emitter array including 64 emitters evenly distributed in a circumferential array on the ETT 4. Additionally, the ETT system 100 may further include a detector array including 64 detectors distributed in a circumferential array on the ETT 4. The emitter array and detector array may be interpenetrating, such that emitters 321 and detectors 323 alternate in each row and each column of the interpenetrating array. A non-limiting example of such an interpenetrating array disposed on the ETT 304 is shown in FIG. 5. The cross-section of the ETT 4 of FIG. 5, having eight emitters and eight detectors, may illustrate a non-limiting example of a single row of an interpenetrating array of emitters and detectors. A non-limiting example of a cross-section of such an interpenetrating array disposed on the ETT 304 is shown in FIG. 4.

[0068] As shown in FIG. 5, a first light ray a is emitted from emitter 321′ and is reflected from the inner surface of trachea 2 as reflected light ray a′. The reflected light ray a′ is then detected by detector 323′ (e.g., a photodetector). A second light ray b is also emitted at the same time as the first light ray a from emitter 321′. However, due to the angle at which light ray b reaches the inner surface of trachea 2, light ray b is reflected from trachea 2 as b′ in a different direction than a′. Light ray b′ travels and reflects from another inner surface of trachea 2, travels as light ray b″, and is reflected again from another inner surface of trachea 2 as light ray b′′. Light ray b′′ is detected by detector 323.

[0069] To a first approximation, the optical signal a' reflected from the inner surface of the trachea 2 should be a relatively strong signal compared to the optical signal b''', because it is reflected from only one surface and has traveled a minimal distance compared to the light ray b''', which has traveled farther after being reflected from three surfaces. Similarly, each emitter then emits an optical signal, and all detectors measure the reflected signal for each emission. Each data measurement by each detector 323 is communicated to the signal processing unit 28 and stored in the data storage system.

[0070] In the above example of two interpenetrating arrays of 64 emitters 321 and 64 detectors 323, the data storage system may include a data register file that would contain files corresponding to the 64 detectors, each with 64 measurements. In this way, the data registry stores a 64x64 data set as an array of measurements.

[0071] Once the data set is collected, the sensor interpreter 29 may process the data set using an algorithm to create a visual representation of the interior of the trachea 2. In some embodiments, the algorithm includes averaging all of the measurements of each detector 323 and then preparing an intensity map. That is, the intensity of each of the optical signals measured by a given detector is summed over 64 data points and then divided by 64 to obtain the average intensity for that detector 323.

[0072] The intensity data recorded in the data register captures how the optical signal is reflected from the surface of the trachea and measured by detectors distributed on the tubular body 302. In some embodiments, the tubular body is approximately cylindrical. Thus, in some embodiments, the recorded data represents the spatial volume of the internal body cavity defined by the inner surface of the trachea. That is, the ETT system 100, having an interpenetrating array of emitters 321 and detectors 323 distributed circumferentially around the ETT 4, can provide a spatial map that is a visual representation of the internal cavity of the trachea.

[0073] The spatial map corresponds to an internal spatial contour representation of the internal body cavity constructed row by row of sensor data, similar to how a CT (e.g., computed tomography) machine constructs a 3D image from a row of X-rays. Signal processing unit 28 receives optical signal data from detectors 323, 323', 323'', etc. and constructs the internal spatial contour map (e.g., representation) by constructing a series of slices of the intensity of the optical signal data row by row. That is, by processing the optical signal data generated by emitter 321 and detector 323, a 3D image of the internal body cavity can be constructed.

[0074] Demonstration of a prototype ETT system A prototype ETT system with two interpenetrating arrays of 64 emitters and 64 detectors was assembled and tested on a human cadaver to demonstrate proof of concept. The interpenetrating arrays were assembled with eight rows of eight emitters and eight detectors per row. This resulted in an 8 x 8 detector array arranged around the outer cylindrical surface of the ETT.

[0075] The ETT system 100 was positioned in the cadaver trachea and optical data was recorded. The signal processing unit 28 was preprogrammed to fire each emitter 321 once and measure the intensity of light reaching each detector 323. In this manner, light intensity was measured for each detector around the entire perimeter of the ETT 4, and data was stored for each. The data was stored in a data registry with 64 data points for each detector, corresponding to the 64 different emitters 321 in the 8x8 emitter array.

[0076] The data set was analyzed by the sensor interpreter 29 using an algorithm that took the average of 64 intensities for each detector in the 8 × 8 array, and then applied a smoothing algorithm to smooth the intensity gradient between each averaged data point.

[0077] FIG. 6 shows a sensor map 600 generated by the ETT system 100 while measuring the optical data in the cadaver trachea described above. The sensor map is an 8x8 array of averaged and smoothed data collected by the prototype ETT system 100. Red represents higher intensity values, blue represents lower intensity values, and white is between the blue and red values. Higher intensity values ​​(dark red), indicated by A, represent closer proximity between the emitter 321 and the inner surface of the trachea, while lower intensity values ​​(dark blue), indicated by B, represent greater distance between the emitter and the inner surface, in the case of the trachea. The dark blue region B corresponds to the vocal cords and provides an indication of the ETT system's location. That is, using the sensor map generated by the ETT system 100, a user can be confident that they know where they are located in the subject's trachea.

[0078] 6 is a planar projection of data collected by a cylindrical ETT system 100 inside a tubular cadaver trachea. The planar projection can be converted (e.g., curled) into a cylindrical representation by the sensor interpreter 29 and compared to a 3D model of a section of the trachea.

[0079] Figure 7A shows a reconstruction of the sensor map 600 from Figure 6, and Figure 7B shows the sensor map 600 after being converted to a cylindrical shape using sensor interpreter 29. Figure 7C shows a 3D modeled view of the trachea, and Figure 7D shows ETT system 100 deployed within the trachea. Figure 7B shows that ETT system 100 can be used to provide a spatial map of the trachea showing the vocal cords when compared to the 3D model of the trachea, as shown in Figure 7C.

[0080] FIG. 8 illustrates a further representative embodiment of a sensor map generated by the signal processing unit 28, according to an exemplary embodiment. As a non-limiting example, a sensor 120′ may be positioned on the ETT 104 located in the trachea 2, as shown in slice 15. The sensor map may be a generated image slice 30 and / or a three-dimensional rendering 40 of the patient's anatomy sensed by the sensors 20, 120, 120′. A physician can use the sensor map 30, 40 to accurately identify and verify the positioning of the endotracheal tube. The sensor map 30, 40 may be created in a static or dynamic setting as the endotracheal tube 104 is positioned and moved within the patient's lumen and / or as one or more elongated balloons 101 are inflated. The sensor map may be created by rapidly triggering the sensors 20, 120, 120′ in a sequence or combination of sequences that can prevent sensor-to-sensor interference.

[0081] Based on signals from the sensors 20, 120, 120′ (e.g., reflectance data, pressure data, time-of-flight data, etc.), the signal processing unit 28 can generate images of the sensed patient anatomy surrounding the sensors 20, 120, 120′ and the endotracheal tube 4, 104. For example, using the time-of-flight data or optical transmission / scattering data sensed by the sensors 20, 120, 120′, the signal processing unit can generate image slices 30 showing the vocal cords 26′, epiglottis 36′, and / or cartilages 38′ surrounding the tracheal lumen 2′ in which the endotracheal tube 104 is positioned. The sensor map can be compared to standardized maps of the patient anatomy, such as larynx, pharynx, trachea, and / or esophagus maps, which can be created circumferentially and longitudinally to determine the position of the endotracheal tube 4, 104 relative to the surrounding anatomy.

[0082] In some embodiments, the generated image slice 30 can be combined with one or more additional generated image slices based on signal data from one or more additional sensors 20, 120, 120′ to create a recognizable three-dimensional rendering 40 of the patient's anatomy surrounding the endotracheal tube 4, 104 and the sensors 20, 120, 120′. For example, the three-dimensional rendering 40 can include the vocal cords 26″, the tracheal lumen 2″, and the cartilage 38″. Although not shown in FIG. 8 , the three-dimensional rendering 40 can include an accurate representation of the position of the endotracheal tube 4, 104 relative to the patient's anatomy.

[0083] For example, FIG. 9 shows another embodiment of a three-dimensional rendering 140 created by the signal processing unit 28, including a visual representation of the endotracheal tube 104″, including a representation of the AOC 114″, and a visual representation of the surrounding patient anatomy, e.g., the vocal cords 26″. As described in detail below, the signal processing unit 28 determines the absolute position of the vocal cords 26 and the distance D between the vocal cords and a known point on the ETT 104, e.g., the proximal end 114p of the AOC. With the proximal end 114p of the AOC as the known point on the ETT, the distance D represents a critical distance the ETT can move proximally or superiorly within the patient's trachea 2 before the AOC 114 begins to herniate through the vocal cords 26. This information can help a physician determine whether adjustments to the placement of the ETT 104 are necessary or recommended.

[0084] The unique characteristics of the vocal cords 26 within the larynx allow the sensors 20, 120, 120', such as infrared sensors, visible light sensors, and / or pressure sensors, and the signal processing unit 28 to identify the vocal cords 26. In some embodiments, one or more of the sensors 20, 120, 120' can detect pressure characteristics of the surrounding patient anatomy. The signal processing unit 28 can amplify and / or filter each signal received from the sensors 120, 120' and forward each signal or a processed version of the signal to the display 33, where it can be converted into a visualization including color and / or intensity. For example, data from the sensors 20, 120, 120' can be forwarded to the signal processing unit 28 and converted to indicate one or more of the vocal cords 26 (also called vocal folds), false vocal cords (also called vestibular folds), and / or the cavities above, between, and below the vocal cords (also called the supraglottic vestibule, laryngeal ventricle, and subglottic space). In some cases, data from the sensor can be transferred to signal processing unit 28 and converted to indicate the anterior surface of the esophagus. As described below, if sensor 20, 120, 120' detects the presence of the anterior surface of the esophagus, it can alert the physician to improper placement of endotracheal tube 104 within the esophagus (as opposed to proper positioning through the patient's larynx and glottis, as intended).

[0085] For example, in certain embodiments in which the endotracheal tube 104 includes one or more elongated balloons 101, the sensor 120 can be positioned along the length of the elongated balloon 101 so that the sensor 120 extends longitudinally of the endotracheal tube 104. In this manner, upon inflation of the elongated balloon 101, the sensor 120 can contact the surrounding anatomical structures and be used to detect pressure, pressure changes, and / or pressure profiles of the surrounding anatomical structures. The shape of the true vocal cords and their stress-strain characteristics allow the sensors 20, 120, 120' to distinguish them from other patient anatomy, for example, by using pressure-sensing techniques (e.g., resistive or capacitive touchscreen sensors) and / or infrared techniques. More specifically, the true vocal cords are layered structures consisting of an inner muscle layer (thyroarytenoid muscle) with muscle fibers aligned primarily along the anterior-posterior direction, a soft tissue layer of the lamina propria, which is a ligament, and an outermost epithelial layer. The true vocal cords are located immediately posterior and medial to the false vocal cords. The length of each true vocal fold is approximately 11 mm to 17 mm in adult females and approximately 17 mm to 25 mm in adult males. Each true vocal fold spans the larynx in the anterior-posterior direction, attaching anteriorly to the thyroid cartilage and posteriorly to the anterior-lateral surface of the arytenoid cartilage. These folds are white in color, primarily due to their ligamentous nature. At rest, the space between these folds is narrowest at the anterior attachment (anterior commissure) and expands laterally as the coronal plane moves posteriorly, reaching approximately the diameter of the larynx at its widest point. These folds are irregularly shaped in the coronal plane, but are approximately 0.5 mm to 1 mm deep at the surface closest to the glottis, with the total depth of the vocal fold body being approximately 1.2 mm to 1.6 mm. The shape and color of these folds, as well as their stress-strain characteristics, allow them to be identified using pressure-sensing and / or infrared (IR) sensor technology. IR sensing technology relevant to various embodiments of the present disclosure is described in further detail below in connection with Figures 6-8.

[0086] The true vocal folds are stiffer than the false vocal folds. Within the true vocal folds themselves, the anterior and posterior portions are stiffer than the central membranous portion, but the overall stiffness follows a stress-strain curve gradient that is relatively low between about 20 kPa and about 50 kPa when stresses of about 0 kPa to about 2.5 kPa are applied, but rises rapidly to a slope of about 200 kPa at a stress of about 10 kPa. The curve begins to move significantly upward at a force of about 2.5 kPa.

[0087] In the endotracheal tube system 100, 104 of the present disclosure, one or more sensors 20, 120, 120' can be used to isolate the location of the true vocal cords 26 along their length. The one or more sensors 20, 120, 120' can detect the isolated lateral pressure exerted by each true vocal cord along a length of approximately 1 mm to approximately 1.6 mm when the true vocal cord exerts a pressure of approximately 13 kPa to approximately 20 kPa. Because other tissues in the anatomical regions above or below the vocal cords do not have such stress-strain curves, and other tissues do not produce detectable signals by pressure sensors at such low pressure thresholds, the sensors 20, 120, 120' can be used to identify the true vocal cords. In some embodiments, multiple sensors 20, 120, 120' can be used to properly identify symmetrical vocal cords when at least two sensors 20, 120 are expanded anteriorly and posteriorly outward by inflation of a component of the ETT 4, 104, such as the elongated balloon 101 or the sensor cuff 22. In this way, at least two sensors 20, 120 can detect nearly identical signal patterns from two symmetrical vocal folds consisting of depressions of approximately 1 mm to 1.6 mm at the same longitudinal position along the length of each sensor.

[0088] Additionally, in certain embodiments in which the endotracheal tube 104 includes one or more elongated balloons 101, the optical sensor 120 can be positioned along the length of the elongated balloon 101 such that the optical sensor 120 extends longitudinally of the endotracheal tube 104. An optical output (e.g., an emitter) on the ETT emits light within the body cavity. A detector then senses the reflected light from the patient's anatomy and determines the position of the ETT within the lumen using time-of-flight data, optical transmission / scattering data, or contour positioning data.

[0089] FIG. 10 schematically illustrates another embodiment of an ETT 204 according to the present disclosure that can be used with the ETT system 100 of FIG. 1. Except as noted below, the structure, operation, and use of the endotracheal tube 204 are similar or identical to those of the endotracheal tube 4 of FIG. 1, and like-numbered components generally have similar features. As illustrated, the endotracheal tube 204 can have one or more sensors 220 positioned along the length of the surface of the endotracheal tube. By way of non-limiting example, the sensors 220 can include capacitive, impedance, visible light, and / or infrared sensors. In some embodiments, the sensors 220 of the endotracheal tube 204 include one or more sensor antennas extending longitudinally along the endotracheal tube. The sensors 220 can extend proximally along the endotracheal tube 204 from the location of the AOC cuff 214. The AOC cuff 214 can be positioned toward the distal end 208 of the endotracheal tube 204.

[0090] In some embodiments, one or more of the sensors 220 may be in the form of a sensor antenna and do not need to contact a particular anatomical structure to sense and detect its presence. The sensors 220 may radially emit a sensor signal output 221 that can be communicated to the signal processing unit 28 via a wireless or wired 227 connection. The sensor signal output 221 may be used to sense, for example, the capacitance, impedance, visible light, and / or infrared characteristics of tissue in the laryngeal and / or esophageal / pharyngeal anatomical structures at a distance. Different types of tissue have different capacitance, inductive, reflective, and impedance characteristics, and these sensors 220 can distinguish one type of tissue from another based on the sensed information. The sensors utilize time-of-flight data and / or scattering / optical transmission data from the optical output to distinguish air space from tissue within the body cavity. By distinguishing air from tissue, the sensors determine the patient's anatomy and the shape of the internal body cavity. This allows the position of the ETT to be determined.

[0091] For example, when the endotracheal tube 204 is positioned within the esophagus, the sensor 220 detects signals that are dissimilar to signals generated by detecting the presence of other patient anatomical structures, such as the vocal cords 26. More specifically, the anterior surface of the esophagus is a convex, uneven tissue surface without any distinguishing features. Sensor 220 detecting this surface (e.g., by pressing against the surface or by transmitting a signal that contacts the surface) generates a long, irregular signal pattern along a significant length of the sensor 220 (e.g., greater than approximately 1 cm). Because the anterior surface of the esophagus is concave, the endotracheal tube 204 naturally displaces outward from the center. Therefore, sensors facing anterior-posterior on both sides do not detect or display the same pattern. More specifically, the sensor determines that the shape of the internal body cavity of the esophagus does not match the known shape of the space within the trachea and between the vocal cords. These differences when detecting the vocal cords compared to the esophagus can help accurately detect the sensor's location. Thus, because the position of the sensor 220 relative to the endotracheal tube is known, the position of the endotracheal tube 204 relative to the anatomy of a particular patient may be determined, and can be determined and visualized, by the signal processing unit 28.

[0092] FIG. 11 illustrates another embodiment of an endotracheal tube 304 according to the present disclosure that can be used with the endotracheal tube system 100 of FIG. 1. Except as noted below, the structure, operation, and use of the endotracheal tube 304 are similar to or identical to the structure, operation, and use of the endotracheal tube 4 of FIG. 1, and like-numbered components generally have similar features. The endotracheal tube 304 includes multiple sensors 320. In some embodiments, the multiple sensors 320 can form a sensor cuff 322 that can extend circumferentially around the endotracheal tube 304. FIG. 11 illustrates the endotracheal tube 304 positioned within a patient's trachea 2, illustrating the positioning of the tube relative to surrounding anatomical structures, such as the vocal cords 26 and epiglottis 36.

[0093] How to use FIG. 12 illustrates one embodiment of a process 500 for using an endotracheal tube 4 in accordance with an exemplary embodiment of the present invention. Note that this process is substantially simplified from the more lengthy processes typically used. Thus, the process may have many steps that one skilled in the art would likely use. Additionally, some of the steps may be performed in a different order than shown or simultaneously. Thus, one skilled in the art may modify the process accordingly. Process 500 is described with respect to the embodiment of endotracheal tube 104 shown in FIG. 2. However, it will be understood that process 500 may be implemented with any of the devices and systems described herein.

[0094] Process 500 begins at step 502, in which an endotracheal tube 104 is positioned within the patient's glottic or esophageal lumen. As previously described, the endotracheal tube 104 may include one or more elongated balloons 101 having one or more sensors 120. Additionally or alternatively, the endotracheal tube 104 may have one or more sensors 120' positioned along the surface of the endotracheal tube 104. The endotracheal tube 104 may then be rotated within the lumen (step 504) so ​​that the intended front side of the endotracheal tube 104 faces forward. To that end, a mark may be positioned on the proximal end 106 of the endotracheal tube 104 that is external to the patient to indicate which side of the endotracheal tube 104 is the intended front side. The tube 104 is rotated to align the one or more sensors 120, 120' to properly detect the presence or absence of vocal cords. In some embodiments, aligning the sensor 120, 120' can include positioning the sensor 120 located on the elongated balloon 101 such that the sensor can directly contact or interact with the vocal cords after the elongated balloon 101 is inflated. Other embodiments align the sensor 120, 120' by positioning the sensor 120, 120' such that it can interact with the vocal cords or other surrounding patient anatomical structures without direct contact, for example, using the infrared sensing techniques described above. Aligning the sensor 120, 120' can include positioning the sensor in a known position relative to the vocal cords (e.g., positioning the sensor 120, 120' to face toward the vocal cords).

[0095] The AOC 114 can then be inflated to occlude the patient's airway (step 506). Inflating the AOC 114 can include inflating one or more AOCs. In some embodiments where the endotracheal tube 104 includes one or more elongated balloons 101, the balloons 101 can be inflated so that one or more sensors 120 of the elongated balloons 101 contact the patient's anatomy (step 508). When multiple elongated balloons 101 are used in connection with a single endotracheal tube 104, the multiple balloons 101 can be fluidly connected such that each of the multiple balloons 101 can be inflated in a single step. The sensor array or sensor cuff of one or more sensors 120, 120′ can contact or interact with surrounding tissue (step 510). For example, the sensors 120 on the surface of the balloon 101 can contact the vocal cords 26 or the anterior surface of the esophagus upon balloon inflation. In some embodiments, deformation of the vocal cords 26 (or the anterior surface of the esophagus if the endotracheal tube 104 is positioned within the esophagus) by the inflated elongated balloon 101 allows the sensor 120 to detect surrounding patient anatomy to create a sensor map. In some embodiments including one or more sensors 120′ located on the surface of the endotracheal tube 104, the sensor 120′ and / or the sensor signals of the sensors 120, 120′ can detect surrounding patient anatomy without direct contact and / or without requiring inflation of the balloon 101, for example, using infrared sensing techniques described above (step 510).

[0096] The one or more sensors 120, 120′ may transmit sensor data to the signal processing unit 28 for further processing (step 512), as described above. The signal processing unit 28 may then process the signals from the one or more sensors 120, 120′ and convert the data, such as pressure readings, time-of-flight data, etc., into representative image data for visualization on the display 33. For example, the sensor maps 30, 40, 40′ described above may be generated by the signal processing unit 28. The signal processing unit 28 may transmit the image data to the display 33 so that the sensor data may be displayed as an image recognizable to a user.

[0097] If the sensor detects the presence of vocal cords (step 514), the image on the display screen 33 shows appropriate, recognizable anatomical structures, such as vocal cords, false vocal cords, etc. The signal processing unit 28 may include a sensor interpreter capable of calculating the distance between the vocal cord signal and a known point, as described above. As a non-limiting example, the known point may be the AOC 114 or the distal end 108 of the endotracheal tube 104. As described above, the distance between the vocal cords 26 (or other recognized patient anatomical structures) and the known point (e.g., the AOC 114) may be calculated and displayed to the physician by the signal processing unit (step 516). The position of the endotracheal tube 104 may be accurately verified using the distance calculation and / or the image of the detected patient anatomical structures, and the depth of the endotracheal tube 104 may be adjusted, if necessary, for optimal placement (step 518). For example, a physician can ensure that the endotracheal tube 104 is not positioned intrabronchially by moving the endotracheal tube 104 proximally within the lumen so that the distance between the AOC 114 and the vocal cords 26 is less than about 1 cm, as measured from the distal end of the most distal sensor 120, 120′. Optimal placement of the endotracheal tube 104 can include positioning the endotracheal tube 104 at a depth within the lumen of the trachea 2 to achieve oxygenation and ventilation of both of the patient's lungs. In some embodiments, adjusting the depth of the endotracheal tube 104 can include deflating the AOC 114, repositioning the endotracheal tube within the lumen, reinflating the AOC, and repeating some or all of the steps of method 500.

[0098] If, in step 512, the displayed image of the patient's anatomy as sensed by one or more sensors 120, 120' does not indicate the presence of vocal cords 26 (step 513), this may alert the physician that the endotracheal tube 104 has been positioned within the lumen of the esophagus rather than the intended lumen of the trachea 2. Accordingly, the endotracheal tube 104 may be removed (step 515) and repositioned within the patient with the intent of positioning it within the lumen of the trachea (step 502). The steps of method 500 may then be repeated to verify the position of the endotracheal tube within the lumen, as described above.

[0099] FIG. 13 illustrates another embodiment of a process 900 for using an endotracheal tube 4 in accordance with an exemplary embodiment of the present invention. Note that this process is substantially simplified from a more lengthy process typically used. Thus, the process may have many steps that one skilled in the art would likely use. Additionally, some of the steps may be performed in a different order than shown or simultaneously. Thus, one skilled in the art may modify the process accordingly. Process 900 is described with respect to the embodiment of an endotracheal tube 104 shown in FIG. 2. However, it will be understood that process 900 may be implemented with any of the devices and systems described herein.

[0100] The process begins with initial intubation, step 902, where the ETT is inserted into the patient. In step 904, the clinician positions the ETT within the patient in an initial position. After initial positioning, an optical output on the ETT emits light (e.g., visible and / or infrared light) into the body cavity (step 906). The light is reflected from the surrounding patient anatomy, and the reflected light is detected by a sensor on the ETT (step 908).

[0101] The sensor generates sensor data, for example, information about the vocal cords, etc. The sensor then generates position data / signals and communicates the signals to the signal processing unit (step 910).

[0102] After receiving the position signal from the sensor, the signal processing unit processes the sensor data into position data (step 912). The position data may include the ETT position relative to the sensed patient anatomy. The signal processing unit may display the position data received from the signal processing unit, i.e., display the sensed patient anatomy and / or the position of the ETT.

[0103] The signal processing unit may automatically determine the position of the ETT relative to the sensed patient anatomy based on the signal including the sensor data (step 912). In some embodiments, the signal processing unit uses machine learning to determine the position of the ETT.

[0104] After determining the position of the ETT relative to the sensed patient anatomy, the signal processing unit determines whether the ETT should be adjusted to ensure proper placement within the patient (step 914).

[0105] If the depth of the ETT needs to be adjusted, the process loops back to step 904, where the clinician positions the ETT within the patient based on the position data from step 912. The process continues from step 904.

[0106] Returning to step 914, if the ETT depth is optimal, no adjustment of the ETT is necessary and the process loops back to step 906 for continuous monitoring of the ETT position during the medical procedure.

[0107] FIG. 14 illustrates yet another embodiment 1400 of a method for defining the anatomy of an internal body cavity. In step 1410, a tube is provided within the internal body cavity. The tube has a proximal end and a distal end. In some embodiments, the tube includes an endotracheal tube (ETT) 4 having a proximal end 6 and a distal end 8, with a lumen 10 extending from the proximal end to the distal end of the tube. The endotracheal tube 4 is inserted through a patient's mouth to position the distal end 8 of the endotracheal tube 4 within the patient's trachea 2. The proximal end 6 of the endotracheal tube 4 remains external to the patient. As used herein and as shown in FIG. 1 , "proximal" is used to refer to the direction toward the end of the ETT 4 that extends outward from the patient upon insertion of the ETT into the patient's airway, and the term "distal" is used to refer to the opposite direction. With respect to placement within the trachea 2, proximal refers to near the patient's mouth, and distal refers to near the patient's lungs.

[0108] In step 1420, light is emitted from two or more optical outputs supported by the tube. The emitted light is reflected off various surfaces of the internal body cavity. The optical outputs may be light emitting diodes (LEDs) and / or vertical cavity surface emitting lasers (VCSLs). Two or more detectors may be circumferentially arranged on the tube as an array. The array may be an 8x8 array.

[0109] The two or more light outputs may fire (e.g., emit) simultaneously or with a preprogrammed interval between successive emissions. In some embodiments, the emitters 321 may fire (e.g., emit light) at predetermined intervals, in a predetermined sequence, or simultaneously. For example, the emitters may be programmed to fire at time intervals of 0.1 seconds to 20 seconds, at time intervals of 0.5 seconds to 10 seconds, at time intervals of 1 second to 5 seconds, or any other time interval between one emitter firing and the next.

[0110] In step 1430, the intensity of the reflected light is detected by each of two or more detectors supported by the tube. Each light beam emitted from emitter 321 is reflected multiple times off the inner surface of trachea 2. Reflected light beams emitted from a single emitter, such as emitter 321′, are detected by one or more of detectors 323.

[0111] In step 1440, the signal is degraded at each of the two or more detectors based on the intensity of the reflected light detected by each of the two or more detectors. The photodetectors may be photodiodes. In some embodiments, the emitter 321 and detectors 323 are preprogrammed so that all of the detectors 323 make a measurement for each firing of a single emitter. That is, the single emitter 321 generates a hemispherical emission of light that is reflected from the inner surface of the trachea, and all of the detectors 323, 323′, 323″, etc. (e.g., photodetectors) measure the intensity of the optical signal reaching a given photodetector. In this way, all of the detectors may make a single measurement of the intensity of the optical signal reaching the detector for each firing of the emitter.

[0112] In step 1450, the signals from each of the two or more detectors are transmitted to a signal processing unit. The signals may be transmitted over wires or wirelessly. The wireless transmission may be via radio, Bluetooth, WiFi, or any other wireless transmission protocol.

[0113] In step 1460, signals from each of the multiple detectors are received and stored in the signal processing unit. The signals include data that the controller may send to store in non-volatile memory once measurements have been made. The data controller retrieves the data from non-volatile memory and sends it to a central processing unit (CPU) within the signal processing unit 28.

[0114] In step 1470, the position and dimensions of the internal body cavity are determined based on the signals using a signal processing unit. The signal processing unit 28 may include one or more of a sensor interpreter 29 that determines the positions of sensed anatomical structures and distances between the sensed anatomical structures and known points on the ETT 4 based on sensed data from the sensors 20 of the ETT 4, and an image processor 31 that generates a visual representation of the ETT 4 placement and communicates with a display 33 to make the visual representation visible to the clinician in real time or near real time. The signal processing unit 28 may use machine learning to determine the patient's anatomical structures and distances between the air / tissue boundary and known points on the ETT 4, as well as to create the visual representation of the patient's anatomical structures and the ETT.

[0115] An exemplary generated image of a patient's anatomy is shown in FIG. 15. In an exemplary embodiment, a sensor detects how light spreads throughout the patient's airway. As light spreads from the optical output, some light penetrates the surrounding tissue and some light reflects back to the sensor. The sensor collects light reflectance data and communicates the data to a signal processing unit. The signal processing unit generates a light transmission map representing the surrounding tissue and internal body cavity space surrounding the ETT. In the exemplary image of FIG. 15, red areas represent areas of low light transmission (high reflectance) or tissue, and blue areas represent areas of high light transmission (low reflectance) or empty body cavity space. Vocal cord level can be determined by comparing the exemplary image to known shapes of the patient's anatomy. For example, the vocal cords may be located at the top of the image where the blue and red areas meet at the tissue / body cavity boundary. The location of the ETT within the lumen is determined from measuring known points on the ETT relative to the vocal cords. In some embodiments, machine learning can be utilized to generate the image and / or determine the ETT position.

[0116] In another embodiment, the sensor cuff may be attached to or integrated into an intravaginal device or intrauterine device (IUD) insertion stylet. In this case, the surrounding tissue is the vaginal wall and the insertion reference point is the cervix. The sensor detects the air / tissue interface of the cervix, and the resulting image is compared to the known shape of the patient's anatomy. This allows for more accurate placement of the IUD.

[0117] In another embodiment, the sensor cuff may be attached to or integrated into an intravaginal device that monitors the progression of cervical dilation and contractions during labor. The sensor detects the air / tissue interface of the cervix, and the resulting image is compared to known progression stages of cervical dilation / contraction during labor before the baby is born. This allows for more accurate and continuous monitoring of the progression of labor.

[0118] A representation of the laryngeal anatomy detected by the sensor is shown in FIG. 16. As described above, the optical output emits light (e.g., visible and / or infrared light) within the lumen. As shown in FIG. 16, an image of the patient's anatomy can be generated utilizing the optical transmission data. The air / tissue boundary at the top of the trachea, the glottis, represents the vocal cords. The position of the ETT can be determined based on the known reference points of the ETT and the location of the vocal cords. This allows the clinician to determine whether the ETT is positioned in the trachea, or if it is positioned too low, beyond the carina and into the bronchus, or too high, requiring extubation.

[0119] Mapping of the patient's anatomy and locating the ETT may be performed in real time, allowing for constant monitoring of the ETT's position within the patient. As described above, an internal spatial contour representation of the trachea can be constructed, leading to a 3D image of the trachea and portions of the carina and bronchi. By enabling constant real-time monitoring, the likelihood of extubation or intubation is reduced. This allows for safer and more effective intubation of the patient. A surprising consequence of real-time monitoring is that the ETT system 100 can prevent extubation or intubation. The ETT system is unique in that it can determine an internal spatial contour representation of a body cavity, such as the trachea. Therefore, reducing extubation increases the safety of procedures performed with the ETT system 100.

[0120] Additionally, the ETT system 100 can provide a physician with knowledge of changes in the position of the ETT 104, 304 during use. For example, a physician can remotely monitor the position of the ETT 104, 304 and detect changes in the position and / or orientation of the ETT 104, 304 due to patient movement rather than active movement or repositioning by the physician. Movement of the ETT 104, 304 not initiated by the physician may indicate that the patient is moving while sedated, and movement of a sedated patient may indicate a decrease in the patient's sedation level. That is, detection of unintended patient movement during a procedure while the patient is sedated is possible through the use of the ETT system 100 and can provide the physician with important information that can be used to reduce the potential risk to the patient coming out of sedation prematurely. Thus, the physician's ability to detect a patient's level of sedation, thereby increasing the safety of procedures performed through the use of the ETT system 100, is another surprising result of the real-time monitoring provided by the ETT system 100.

[0121] The above-described embodiments of the present invention are intended to be merely exemplary, and numerous variations and modifications will be apparent to those skilled in the art. Such variations and modifications are intended to be within the scope of the present invention as defined by any of the appended claims.

Claims

1. an endotracheal tube having a proximal end, a distal end, and a lumen between the proximal end and the distal end; a signal processing unit; two or more sensors positioned on the endotracheal tube, generating a sensor signal, the generated sensor signal interacting with a surrounding patient anatomy, the surrounding patient anatomy including an internal body cavity; Detecting the generated sensor signal interacting with the surrounding patient anatomy; transmitting the detected sensor signal to the signal processing unit; two or more sensors configured as follows:

1. An endotracheal system comprising: the signal processing unit is in signal communication with the two or more sensors; receiving the detected sensor signal; Endotracheal tube position; a size of the internal body cavity based on the detected sensor signal; determining location data, including It is configured as follows: Endotracheal system.

2. the sensor signal comprises visible light or infrared light; the interaction of the sensor signal with the surrounding patient anatomy includes reflection; the generated sensor signal is detected by a photodiode; The system of claim 1 .

3. the visible light is generated by an LED or a VCSEL; The infrared light is generated by an LED or a VCSEL. The system of claim 2 .

4. receiving the location data; generating an image of the surrounding patient anatomy; displaying a visual representation of the distance between an anatomical reference and a known point on the endotracheal tube; Display modality configured as follows: The system of claim 1 further comprising:

5. The system of claim 1 , wherein the two or more sensors extend longitudinally along at least a portion of the length of the endotracheal tube.

6. The system comprises: an inflatable airway-occlusion cuff located closer to the distal end of the endotracheal tube than to the proximal end; Furthermore, the two or more sensors are positioned proximal to the airway obstruction cuff; The system of claim 1 .

7. the two or more sensors comprise an interpenetrating array comprising an emitter array and a detector array, the emitters and the detectors alternating in each row and each column of the interpenetrating array; the interpenetrating array extends circumferentially around an outer surface of the endotracheal tube and longitudinally along at least a portion of the length of the endotracheal tube, a distal end of the interpenetrating array being proximal to the airway obstructing cuff. The system of claim 5.

8. the emitter array includes at least two rows each having two emitters and at least two columns each having two emitters; the detector array includes at least two rows each having two detectors and at least two columns each having two detectors; The system of claim 7.

9. The system of claim 7 , wherein the signal processing unit is further configured to generate position data of anatomical features using reference information regarding an expected contour of the internal body cavity.

10. The system of claim 1 , wherein the signal processing unit utilizes machine learning to generate the location data.

11. The system of claim 1 , wherein the surrounding patient anatomy includes the larynx.

12. The system of claim 8 , wherein the surrounding patient anatomical structure includes at least one vocal cord.

13. 10. The system of claim 1, wherein the two or more sensors configured to detect the surrounding patient anatomy are configured to detect at least one of pressure, capacitance, impedance, acoustic, photoacoustic, ultrasound, visible light characteristics, or infrared characteristics of the surrounding patient anatomy.

14. a flex circuit disposed on the endotracheal tube between the two or more sensors and the endotracheal tube, the flex circuit providing signal communication between the two or more sensors and the signal processing unit. The system of claim 1 further comprising:

15. an outer case molded around the two or more sensors and the flex circuit to provide encasement; The system of claim 14 further comprising:

16. The system of claim 15 , wherein the outer case molded around the two or more sensors and the flex circuit acts as a lens for the two or more sensors.

17. 1. A method for defining the anatomical structure of an internal body cavity, the method comprising: providing a tube having a proximal end and a distal end to an internal body cavity; emitting light from two or more light outputs supported by said tube; detecting an intensity of the reflected light by each of two or more detectors supported by the tube; generating a signal at each of the two or more detectors based on the intensity of the reflected light detected by each of the two or more detectors; transmitting the signal from each of the two or more detectors to a signal processing unit; receiving and storing a signal from each of the two or more detectors in the signal processing unit; determining a location and size of the internal body cavity based on the signals using the signal processing unit; A method comprising:

18. 18. The method of claim 17, wherein the tube is an endotracheal tube.

19. generating position data for anatomical features using reference information regarding the expected contour of the internal body cavity; 20. The method of claim 17, further comprising:

20. determining a position of the endotracheal tube based on the position data of the anatomical features and known points on the endotracheal tube; 20. The method of claim 19, further comprising:

21. 20. The method of claim 19, wherein the anatomical feature is a vocal cord.

22. receiving the location data; generating an image of the patient's anatomy; 20. The method of claim 19, further comprising:

23. the light output is a light emitting diode (LED); the detector is a photodiode; 18. The method of claim 17.

24. The method of claim 19 , wherein the signal processing unit utilizes machine learning to generate the location data.

25. 18. The method of claim 17, wherein the tube is an intravaginal device.

26. 18. The method of claim 17, wherein the tube is an intrauterine device insertion stylet.

27. 18. The method of claim 17, wherein the tube is a bladder catheter.

28. 18. The method of claim 17, wherein the tube is a pleural tube.

29. 18. The method of claim 17, wherein the tube is an intravascular catheter.

30. 18. The method of claim 17, wherein the tube is a ureteral catheter.

31. 18. The method of claim 17, wherein the tube is an intragastric catheter.

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