Method and device for determining position of intratracheal tube

Abstract

Systems, methods, and devices are disclosed for accurately detecting the position of an endotracheal tube by sensing patient anatomy around the endotracheal tube. A system of the present disclosure includes an endotracheal tube having two or more sensors supported by the endotracheal tube configured to detect surrounding patient anatomy. The signal processing unit may receive data from the sensor and may at least one of (i) identify a detected patient anatomy, such as a vocal cord, (ii) determine a distance between the detected patient anatomy and a known point on the endotracheal tube, and (iii) verify a location of the endotracheal tube within the patient's trachea or esophageal cavity. In some embodiments, a system may include at least one expandable member that may extend along an outer surface of an endotracheal tube and support at least one sensor.

Description

[0001] Cross - reference to related applications

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 425,505, filed on November 15, 2022, entitled "Methods and Apparatus for Determining the Position of an Endotracheal Tube", which is incorporated herein by reference in its entirety.

[0003] This application also relates to U.S. Application 17 / 017,620, filed on September 10, 2020, entitled "Methods and Apparatus for Determining the Position of an Endotracheal Tube", which claims the benefit of U.S. Provisional Application 62 / 924,862, filed on October 23, 2019, entitled "Methods and Apparatus for Determining the Position of an Endotracheal Tube" and U.S. Provisional Application 63 / 054,520, filed on July 21, 2020, entitled "Methods and Apparatus for Determining the Position of an Endotracheal Tube", each of which is incorporated herein by reference in its entirety. Technical Field

[0004] Exemplary embodiments generally relate to airway management during medical procedures, and more particularly, exemplary embodiments relate to the positioning of endotracheal tubes. Background Art

[0005] The correct positioning of an endotracheal tube (ETT) facilitates pulmonary oxygenation and ventilation during medical procedures. A common problem after placing an ETT is the inability to determine the correct depth for securing the ETT. An ETT that is positioned too deeply has its lumen extending beyond the bifurcation of the trachea and the carina and communicates only with the bronchi of a single lung, which is called endobronchial intubation. According to the closed - claims project of the American Society of Anesthesiologists, endobronchial intubation accounts for 2% of adverse airway events in adults and 4% in children.

[0006] Alternatively, a shallow - positioned ETT can be secured within the lumen in the hypopharynx such that the distal end of the ETT protrudes into the trachea, but the airway occlusion cuff (AOC) (a circumferential balloon around the ETT near the distal end of the ETT) inflates above the vocal cords, creating the illusion of a functionally un - secured fixed airway. Or when the ETT is correctly positioned in the trachea, it may accidentally be pulled too shallowly or migrate upward, resulting in extubation of the ETT from the trachea. In the United States, 121,000 accidental extubations occur annually in intensive care units (ICUs), resulting in 34,000 cases of ventilator - associated pneumonia and doubling the length of ICU stays. Finally, the AOC may accidentally inflate above the vocal cords, which, if inflated continuously, may cause damage to the vocal cords. Summary of the Invention

[0007] According to an 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 further 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 the surrounding patient anatomy. The surrounding patient anatomy includes internal body cavities. The two or more sensors are further configured to detect the generated sensor signals that have interacted with the surrounding patient anatomy and send the detected sensor signals to the signal processing unit. The signal processing unit communicates signals with the two or more sensors and is configured to receive the detected sensor signals and determine position data. The position data includes the endotracheal tube position and the dimensions of the internal body cavity based on the detected sensor signals.

[0008] The sensor signals can include visible light or infrared light. The interaction of the sensor signals with the surrounding patient anatomy includes reflection, and the generated sensor signals are detected by a photodiode. The visible light can be generated by an LED or a VCSEL, and the infrared light can be generated by an LED or a VCSEL.

[0009] The endotracheal system can further 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.

[0010] The endotracheal system can further include an inflatable airway occlusion cuff positioned closer to the distal end of the endotracheal tube than to the proximal end. The two or more sensors can also be positioned proximal to the airway occlusion cuff. The two or more sensors can extend longitudinally along at least a portion of the length of the endotracheal tube.

[0011] Two or more sensors may include an interdigitated array that includes a transmitter array and a detector array such that in each row and each column of the interdigitated array, transmitters and detectors alternate. The interdigitated array may extend circumferentially around an outer surface of an endotracheal tube and longitudinally along at least a portion of the length of the endotracheal tube, wherein a distal end of the interdigitated array is proximal to an airway occlusion cuff. The transmitter array may include at least two rows each having two transmitters and at least two columns each having two transmitters. The detector array may include at least two rows each having two detectors and at least two columns each having two detectors. In non-limiting embodiments, the transmitter array may include an eight-by-eight array of transmitters. The detector array may include an eight-by-eight array of detectors. In additional non-limiting embodiments, the transmitter array and the detector array may be sized as a 6 (e.g., 6) by 9 (e.g., 9) array or a 5×10 array in its final form. In embodiments, regardless of the size of the array, the arrays may be interdigitated.

[0012] The signal processing unit may also be configured to generate position data of anatomical features using reference information about an expected profile of an internal body cavity. The signal processing unit may utilize machine learning to generate the position data.

[0013] The surrounding patient anatomy may include the larynx. The surrounding patient anatomy may include at least one vocal cord.

[0014] 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.

[0015] The endotracheal system may further include a flexible circuit disposed on the endotracheal tube between the two or more sensors and the endotracheal tube. The flexible circuit may provide signal communication between the two or more sensors and the signal processing unit.

[0016] The endotracheal system may further include a housing molded around the two or more sensors and the flexible circuit to provide encapsulation. The housing molded around the two or more sensors and the flexible circuit may serve as a lens for the two or more sensors.

[0017] According to another embodiment of the present invention, a method for defining an anatomical structure of an internal body cavity includes: providing a conduit having a proximal end and a distal end into the internal body cavity. The method further includes emitting light from two or more optical output ends supported by the conduit, detecting the intensity of the reflected light by each of two or more detectors supported by the conduit, and generating a signal in 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 further includes sending a signal from each of the two or more detectors to a signal processing unit, receiving and storing in the signal processing unit the signal from each of the two or more detectors, and using the signal processing unit to determine the position and dimensions of the internal body cavity based on the signals. The conduit may be an endotracheal conduit. The optical output ends may be light-emitting diodes (LEDs), and the detectors may be photodiodes.

[0018] The method may further include using reference information about an expected profile of the internal body cavity to generate position data of anatomical features. The method may further include determining the position of the endotracheal conduit based on the position data of the anatomical features and known points on the endotracheal conduit. The anatomical features may be vocal cords.

[0019] The method may further include receiving the position data and generating an image of the patient's anatomical structure. The signal processing unit may utilize machine learning to generate the position data.

[0020] The conduit may be an intravaginal device. The conduit may be an intrauterine device insertion needle. The conduit may be a bladder catheter. The conduit may be a pleural root. The conduit may be a pleural catheter. The conduit may be an intravascular catheter. The conduit may be a ureteral catheter. The conduit may be a gastric conduit. The conduit may be a gastric catheter.

[0021] According to one embodiment of the present invention, an endotracheal system includes an endotracheal conduit, at least one sensor supported by the endotracheal conduit, and a signal processing unit. The endotracheal conduit has a proximal end, a distal end, and a lumen extending between the proximal end and the distal end. The at least one sensor is supported by the endotracheal conduit and is configured to detect the surrounding patient's anatomical structure. The signal processing unit is configured to determine the vertical distance between the detected vertical and / or horizontal position of the surrounding patient's anatomical structure on the sensor and a known point on the endotracheal conduit.

[0022] In an illustrative embodiment, the signal processing unit is further configured to display a visual representation of the distance between the surrounding patient anatomy and a known point on the endotracheal tube. The endotracheal tube may include an inflatable balloon extending longitudinally along the outer surface of the endotracheal tube. At least one sensor may be positioned on or embedded within the inflatable elongate balloon. In some cases, the elongate balloon may be removable relative to the endotracheal tube.

[0023] The endotracheal system may further include an inflatable airway occlusion cuff positioned closer to the distal end of the endotracheal tube than to the proximal end, wherein at least one sensor is positioned proximal to the airway occlusion cuff. In some embodiments, the at least one sensor includes a sensor array that extends circumferentially around the outer surface of the endotracheal tube and longitudinally along at least a portion of the length of the endotracheal tube, wherein the distal end of the sensor array is proximal to the airway occlusion cuff.

[0024] In some embodiments, the at least one sensor is configured to detect at least one of the pressure, capacitance, impedance, acoustic, photoacoustic, ultrasound, visible light, or infrared characteristics of the surrounding patient anatomy. The at least one sensor may 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 a change in the pressure of the surrounding patient anatomy applied at or below a low pressure threshold.

[0025] According to another embodiment of the present invention, a method of positioning an endotracheal tube within a patient's trachea includes: inserting the 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 such that the distal end of the endotracheal tube is positioned within the tracheal lumen or the esophageal lumen of the patient. Inflating an airway occlusion cuff positioned towards the distal end of the endotracheal tube. The method further includes detecting the patient anatomy surrounding the endotracheal tube using at least one sensor supported by the endotracheal tube, sending data regarding the detected patient anatomy from the at least one sensor to a signal processing unit, and determining the distance between the detected surrounding patient anatomy (which is related to the two-dimensional vertical and / or horizontal position on the sensor) and a known point on the endotracheal tube.

[0026] In an illustrative embodiment, the surrounding patient anatomy is at least one vocal cord. The method may further include rotating the endotracheal tube such that a desired anterior side of the endotracheal tube faces forward, thereby aligning at least one sensor with at least one vocal cord. In some such embodiments, aligning at least one sensor with at least one vocal cord includes at least one of the following: aligning at least one sensor such that the at least one sensor is in direct contact with or in close proximity to the at least one vocal cord, or orienting the at least one sensor to a known position relative to the at least one vocal cord. Detecting the surrounding patient anatomy around the endotracheal tube may also include detecting the presence or absence of a first vocal cord and a second vocal cord.

[0027] 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 that extends longitudinally along at least a portion of the outer surface of the endotracheal tube, wherein at least one sensor is positioned on or embedded within at least one elongate balloon. In some such embodiments, the method further includes aligning at least one sensor relative to the surrounding patient anatomy, inflating at least one elongate balloon such that the at least one sensor moves toward the surrounding patient anatomy, and detecting the surrounding patient anatomy using at least one sensor as the elongate balloon inflates.

[0028] According to other embodiments of the present invention, an endotracheal system includes an elongate tube, an airway occlusion cuff, and a sensor array. The elongate tube has a proximal end, a distal end, and a lumen extending therebetween, and the airway occlusion cuff is positioned closer to the distal end of the elongate tube than to the proximal end. The sensor array is configured to detect the surrounding patient anatomy and extends circumferentially around the outer surface of the elongate tube and along the length of the elongate tube proximal to the airway occlusion cuff.

[0029] In an illustrative embodiment, the sensor array includes a flexible circuit that extends circumferentially around the outer surface of the elongate tube and a housing that surrounds the flexible circuit. In some such embodiments, the flexible circuit includes a plurality of visible light and / or infrared light emitters and a plurality of phototransistors arranged in a circular array that is mounted on or in communication with the flexible circuit.

[0030] 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 includes a unit supported by the endotracheal tube for detecting the surrounding patient anatomy and a unit for determining a distance between the detected surrounding patient anatomy and a known point on the endotracheal tube.

[0031] In some embodiments, the unit configured to detect the distance between the detected surrounding patient anatomy and a known point on the endotracheal tube is further configured to display a visual representation of the distance between the surrounding patient anatomy and the known point on the endotracheal tube. The unit for detecting the surrounding patient anatomy supported by the endotracheal tube may detect the vocal cords of the patient. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Those skilled in the art will more fully appreciate the advantages of the various embodiments of the present invention from the following "Description of Illustrative Embodiments", which is discussed with reference to the drawings outlined below.

[0033] Figure 1 FIG. schematically shows an embodiment of an endotracheal tube system according to the present disclosure;

[0034] Figure 2 FIG. schematically shows another embodiment of an endotracheal tube according to the present disclosure;

[0035] Figure 3 FIG. shows another embodiment of an endotracheal tube according to the present disclosure;

[0036] Figure 4 is a cross-section of the endotracheal tube taken along line A-A Figure 3 of the endotracheal tube;

[0037] Figure 5 FIG. shows a schematic diagram of a cross-section of an ETT, where a transmitter and a detector are positioned on the ETT while the ETT is located in the trachea;

[0038] Figure 6 FIG. shows a sensor map generated by an ETT system when measuring optical data in a cadaver trachea;

[0039] Figure 7 A shows a reproduction of Figure 6 sensor map 600 from

[0040] Figure 7 B shows the sensor map after converting the Figure 7 sensor map of A into a cylinder using a sensor interpreter;

[0041] Figure 7 C shows a 3-D modeling diagram of a tracheal slice;

[0042] Figure 7 D shows an ETT system deployed within the 3D modeling diagram of the trachea;

[0043] Figure 8Shows an additional representative embodiment of a sensor map generated by a signal processing unit according to an illustrative embodiment;

[0044] Figure 9 Shows an embodiment of a three - dimensional rendering of an endotracheal tube having an AOC created by a signal processing device;

[0045] Figure 10 Schematically shows another embodiment of an endotracheal tube according to the present disclosure;

[0046] Figure 11 Schematically shows an endotracheal tube of a system received within a patient's airway Figure 1 of another embodiment;

[0047] Figure 12 Shows an embodiment of a method of using an endotracheal tube according to the present disclosure;

[0048] Figure 13 Shows another embodiment of a method of using an endotracheal tube according to the present disclosure;

[0049] Figure 14 Shows another embodiment of a method of using an endotracheal tube according to the present disclosure;

[0050] Figure 15 Schematically shows a synthetic image of a space within a body cavity; and

[0051] Figure 16 Schematically shows a representative imaging of a patient's anatomy. Detailed Description

[0052] Illustrative embodiments provide for the 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 and reliable ETT depth position data within the airway. To this end, the endotracheal tube supports at least one sensor that, when the endotracheal tube is located within the patient's airway, detects the patient's anatomy and the conditions surrounding the endotracheal tube. For example, the sensor can detect one or more characteristics of the surrounding anatomy and send the sensed information to a signal processing unit in real - time or near real - time. The signal processing unit then determines the distances between the detected vertical and / or horizontal positions (relative to the body of the tube) of the surrounding patient anatomy and known points on the endotracheal tube.

[0053] In addition, the signal processing unit can create a visualization of the endotracheal tube placement relative to the detected patient anatomy. The anatomy detection sensor can be positioned on the surface of the endotracheal tube and / or integrated within the endotracheal tube, such as within the wall of the endotracheal tube. Additionally or alternatively, some embodiments of the endotracheal tube can include one or more elongated balloons that extend longitudinally along the outer surface of the tube, with at least one sensor disposed on or integrated within the balloon. The systems, methods, and devices of the present disclosure can achieve correct placement of the ETT and, in turn, reduce the risk of accidental extubation, which can reduce the length of time the patient needs ventilation and reduce the number of times the operator needs to readjust the ETT within the patient's airway. Details of illustrative embodiments are discussed below.

[0054] Certain exemplary embodiments are described to provide a general understanding of the principles of construction, function, manufacture, and use of the devices, systems, and methods. One or more examples of these embodiments are illustrated in the figures. The devices, systems, and methods specifically described and illustrated in the figures are non-limiting embodiments. Features shown or described in connection with one embodiment can be combined with features of other embodiments. Such modifications and variations are intended to be included within the scope of the present disclosure.

[0055] Figure 1 One embodiment of an endotracheal system 100 positioned within a patient's trachea 2 is schematically illustrated. 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 for positioning 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 outside the patient. As used herein and Figure 1 as shown, "proximal" is used to refer to the direction toward the end of the ETT 4 that extends outward from the patient when the ETT is inserted into the patient's airway, while the term "distal" is used to refer to the opposite direction. In terms of placement within the trachea 2, proximal refers to closer to the patient's mouth, and distal refers to closer to the patient's lungs.

[0056] The ETT 4 can include a tube having variable dimensions, diameter, and / or curvature, with a plastic connector 12 on the proximal end 6 of the tube 4. The plastic connector 12 can be connected to a bag-valve mask or a ventilator (not shown). In this way, the ETTs of various embodiments can maintain compatibility and usability with existing ventilator systems. In the case where the endotracheal tube 4 is 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 surgery. The ETT 4 also has one or more inflatable cuffs 14, also known as airway occlusion cuffs (AOC). When inflated, the AOC 14 can seal the trachea 2 and the lungs to prevent air leakage, form a closed pressurized system, and ensure the exchange of oxygen and carbon dioxide between the ventilator and the lungs. When the AOC 14 is positioned and inflated within the trachea 2 below or distal to the vocal cords 26, the AOC 14 creates 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 the efficacy of the ETT 4.

[0057] Typically, the endotracheal tube 4 is positioned within the patient's trachea 2. Then the AOC 14 is inflated (e.g., using a pilot balloon 16). The AOC 14 can be connected to the pilot balloon 16 through a small-diameter tube 18 that extends along the length of the ETT 4. The pilot balloon 16 can include a one-way valve to prevent air from escaping from the pilot balloon 16. To adjust the position of the AOC 14, in some cases, an operator can deflate the AOC 14, reposition it, and reinflate the AOC 14 (e.g., using the pilot balloon 16). The AOC 14 extends from a proximal end 14p to a distal end 14d and can 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.

[0058] The endotracheal tube 4 of various embodiments supports one or more sensors 20. The sensors 20 can include one or more optical outputs configured to emit light (e.g., electromagnetic radiation) and one or more optical detectors (e.g., such as a photodiode) configured to detect light. The sensors are configured to determine the position of the ETT 4 within the trachea. The optical output, such as but not limited to a light-emitting diode (LED), emits light within the body cavity. The detector measures the reflected light from the surrounding patient anatomy. As a non-limiting example, the sensors 20 can communicate with some logic (such as a signal processing unit), which can include 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 display.

[0059] The sensor 20 described above may also include a sensor configured to detect at least one of pressure, capacitance, impedance, acoustic, photoacoustic, ultrasonic, visible light, or infrared characteristics of the surrounding patient anatomy. In Figure 1 the illustrated embodiment, the sensor cuff 22 that supports the sensor 20 may be attached to or integrally formed with the ETT 4. In some embodiments, the sensor cuff 22 may be external to the ETT 4 and longitudinally extend along at least a portion of the length of the tube. The sensor cuff 22 may have a proximal end 22p and a distal end 22d, wherein the distal end 22d of the sensor cuff 22 is 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 a sensor cuff pilot balloon 24. In this way, in the case where the ETT 4 is inserted into a patient, the sensor cuff 22 may be inflated such that the sensor 20 is closer to or in contact with the surrounding patient anatomy, such as the patient's vocal cords 26. As described in detail below, in other embodiments, one or more sensors supported by the ETT may be supported by the ETT 4 in one or more of the following ways:

[0060] · Placed on the surface of one or more elongated balloons,

[0061] · Integrated into one or more elongated balloons,

[0062] · Placed on the surface of the ETT,

[0063] · Integrated into the ETT,

[0064] · Placed on a non-inflatable sensor cuff, or

[0065] · Integrated into a non-inflatable sensor cuff.

[0066] 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 sends it to the signal processing unit 28. Once a measurement has been made, the data controller sends the data to be stored in the non-volatile memory. The data controller retrieves data from the non-volatile memory and sends it to the central processing unit (CPU) in the signal processing unit 28. The CPU may form part of the sensor interpreter 29. The processed data locates the sensed surrounding patient anatomy and determines the distance between a known point on the ETT 4 and the sensed anatomy. For example, the signal processing unit 28 may determine the distance between the most distal point at the distal end 8 of the ETT 4 or the proximal end 14p of the AOC 14 and the detected surrounding patient anatomy (such as the vocal cords 26). To this end, and as discussed in detail below, the signal processing unit 28 may include one or more of a sensor interpreter 29 and an image processor 31. The sensor interpreter 29 determines the location of the sensed anatomy and the distance between the sensed anatomy and a known point on the ETT 4 based on the sensed data from the sensor 20 of the ETT 4. The image processor 31 generates a visual representation of the placement of the ETT 4 and may communicate with the display 33 to make the visual representation visible to the clinician in real time or near real time.

[0067] The signal processing unit 28 may use machine learning to determine the patient anatomy, as well as the distance between the air / tissue boundary and a known point on the ETT 4, and make a visual representation of the patient anatomy and the ETT.

[0068] Figure 1 An embodiment of the ETT 4 is shown, where 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 may be located within the same component or machine (such as a tablet computer, a computer, etc.). Each of these elements may be implemented as hardware (e.g., a processor), software, and / or firmware. It should be noted that Figure 1 this is only a schematic diagram showing each of these components separately. In an embodiment, 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. Thus, in Figure 1The representation of the signal processing unit 28 and other components in a single box is for simplicity purposes only. In fact, in some embodiments, the signal processing unit 28 is distributed across multiple different machines and not necessarily within the same housing or chassis.

[0069] During use, the sensor 20 detects parameters and / or characteristics of the surrounding patient anatomy. This information is transmitted to the signal processing unit 28, which differentiates the anatomy surrounding the endotracheal tube 4 and uses this information to determine the position and / or depth of the tube relative to the anatomy. 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 anatomy can be defined, mapped, and / or displayed on a screen as recognizable anatomy. More specifically, the presence or absence and location of the narrowest point within a defined space related to adjacent surrounding bounded cavity regions that can be inferred to be the vocal cords 26 along the length of the ETT 4 can be determined by using information sensed by one or more sensors 20. Alternatively, the presence of a specific pattern of a defined space or spatial shape (such as but not limited to an hourglass spatial shape, concave shape, symmetric shape, or triangular shape) can provide data that can be used to infer or define the position of the vocal cords 26.

[0070] The 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 correctly placed within the trachea 2 and not in 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 the surrounding object (i.e., the surrounding patient anatomy). The signal processing unit 28 can use the spectral data received from the sensor 20 to identify the 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 detected space and / or volume is irregular, asymmetric, discontinuous, or changes shape over a short period of time. These characteristics are unique to the esophagus and not the trachea. In this way, the signal processing unit 28 can indicate that the space does not conform to known tracheal contour standards in terms of width, diameter, or the progression of characteristics along the length of the trachea, and the signal processing unit 28 integrates the time-of-flight data to delineate the vocal cords 26 from the surrounding laryngeal structures. The spectral data can be created by the sensor 20 using a vertical cavity surface emitting laser (e.g., VCSEL) or a light emitting diode (e.g., LED) as a radiation source and employing a time-domain method of measuring the time it takes for the emitted light to reflect back from the surrounding patient anatomy to the sensor.

[0071] Then, the determined position of the vocal cords 26 can be used as an anatomical reference point (e.g., an anatomical reference) to calculate the distance from the vocal cords 26 to a known point on the ETT 4. For example, the known point can be the distal end 8 of the ETT, the proximal or distal end of the AOC 14, etc., such that determining the distances between the vocal cords 26, the anatomical reference, and the known point can indicate to the user whether the ETT 4 is correctly positioned relative to the patient's anatomy or whether an adjustment is needed. In some embodiments, the sensor 20 can detect the 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., the anatomical reference) and a known point on the endotracheal tube 4, and in some embodiments, display a visual representation thereof in real time or near real time.

[0072] Figure 2 Another embodiment of the endotracheal tube 104 in the endotracheal system 100 that can be used for Figure 1 is shown. Except as shown below, the structure, operation, and use of the endotracheal tube 104 are similar or identical to those of the endotracheal tube 4 of Figure 1 where components with the same reference numerals generally have similar features. Therefore, for the sake of brevity, the description of the structure, operation, and use of these features is omitted.

[0073] In a manner similar to Figure 1 the endotracheal tube 4, the ETT 104 has a proximal end 106 and a distal end 108, where the lumen 110 extends from the proximal end of the endotracheal tube to the distal end. When the endotracheal tube 104 is placed in the trachea 2 of the patient, the airway occlusion cuff 114 can be inflated using the pilot balloon 116 to seal the patient's airway. The endotracheal tube 104 includes an elongate balloon 101 that extends along at least a portion of the length of the endotracheal tube and supports at least one sensor 120 for detecting the surrounding patient anatomy. Although Figure 2 the illustrated embodiment of

[0074] The elongate balloon 101 supports at least one sensor 120 and aids in determining the correct placement of the endotracheal tube 104 within the patient's trachea 2. The elongate balloon 101 can be a linear balloon that extends longitudinally along the outer surface of the endotracheal tube 4 without surrounding the tube 104. For example, the elongate balloon 101 can be a single linear balloon that extends along the front or back surface of the endotracheal tube 104. In some embodiments that include multiple elongate balloons 101, the elongate balloons 101 can be positioned on multiple sides of the endotracheal tube 104. Additionally or alternatively, one or more of the elongate balloons 101 can be positioned on the same side of the endotracheal tube 104. That is, the elongate balloons 101 can be positioned at different longitudinal positions on the same side of the endotracheal tube 104. In various embodiments, the endotracheal tube 104 can include two elongate balloons 101 that face bilaterally anterolaterally. In some embodiments, the elongate balloon 101 can extend above the AOC 114 or be incorporated into the AOC 114. The elongate balloon 101 can be a separate component from the AOC 114 and can include a different inflation system (e.g., a separate pilot balloon, such as the reference sensor cuff pilot balloon 24 shown in Figure 1 for example). Alternatively, in some embodiments, the elongate balloon can be inflated by the pilot balloon 116 and can use the same inflation system as the AOC 114.

[0075] In some embodiments, the elongate balloon 101 can be incorporated into the ETT 104 (e.g., formed as a single piece with the endotracheal tube). In other embodiments, the elongate balloon 101 can be formed as a separate single piece from the endotracheal tube 104. For example, the elongate balloon 101 can be retrofitted onto an already manufactured endotracheal tube 104. To this end, the elongate balloon 101 can be part of a sleeve that is locatable on the endotracheal tube 104. The sleeve can be sterilizable and reusable.

[0076] In some embodiments, the AOC 114 can also be incorporated as part of a sleeve that also contains one or more elongate balloons 101. Additionally, a sleeve having one or more AOCs 114 and / or elongate balloons 101 can be attached to an endotracheal tube 104 that already has at least one AOC.

[0077] Although the illustrated embodiment of the endotracheal tube 104 has a circular cross-section, the cross-sectional shape of the endotracheal tube 104 can be changed. For example, when the ETT 104 is properly oriented, the ETT 104 can be changed to provide a flatter surface contact with the patient's anatomy (such as the vocal cords 26). In some embodiments, the ETT 104 has a modified cross-section with a flatter contact surface, which can provide increased sensing ability 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 can be generally triangular in shape, with two long sides and one short side. To avoid trauma to the patient's airway, the edges of the triangular cross-section can be joined by rounding. With such a configuration, when the shorter side faces backward, the two long sides can contact the patient's vocal cords 26. In some embodiments, one or more sensors 120' can be attached to or integrated into the long sides of the endotracheal tube 104.

[0078] As described above, the elongate balloon 101 can have one or more sensors 120 to assist in determining the proper placement of the endotracheal tube 104. The sensors 120 can be integrated into or on the surface of the elongate balloon 101. It should be understood that in various embodiments having multiple sensors 120, 120', the multiple sensors can be located on different surfaces. For example, as Figure 2 shown, the endotracheal tube 104 together with the elongate balloon 101 can 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 elongate balloon 101.

[0079] In some embodiments, the sensor 120 can be a linear sensor, and / or multiple sensors 120 can be positioned in a linear pattern into or along the surface of the elongate balloon 101. For example, Figure 2 the illustrated embodiment of includes six sensors 120 positioned linearly along the elongate balloon 101. It should be understood that more or fewer sensors 120 can be used in association with the elongate balloon. Additionally, alternative configurations of the sensors 120 are within the scope of the present disclosure. For example, multiple sensors 120 can be positioned on the elongate balloon 101 in a "V" configuration. The elongate balloon 101 can be inflated when the endotracheal tube 104 is positioned within the patient's body such that one or more sensors 120 interact with the wall of the trachea 2 or other anatomical structures (e.g., vocal cords 26) and detect information about the surrounding patient anatomy. In some embodiments, one or more sensors 120 can contact the wall of the trachea 2 or other anatomical structures (such as the vocal cords 26), while in other embodiments, one or more sensors 120 can detect information from the trachea 2 or other anatomical structures without direct contact.

[0080] The sensors of the various embodiments can be formed of a variety of materials. By way of example, materials that can change their electrical properties in response to a pressure change, such as soft materials or piezoelectric materials, can be used to form sensors 20, 120, 120'.

[0081] Sensors 20, 120, 120' can be electrical, mechanical, electromechanical, or optical in nature. In some embodiments, sensors 20, 120, 120' can utilize the piezoelectric properties of materials to convert a pressure difference into an electrical signal. For example, sensors 20, 120, 120' can detect pressure changes at discrete intervals and convert these pressure changes into signals. For example, such conversion can be effected by interrupting the transmission of light waves traveling through an optical waveguide to cause a change in the electrical properties of sensors 20, 120, 120'. Sensors 20, 120, 120' can 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 can be passive, generating their own electrical signals, or can require power from an external source and then be modified by the electrodes. For example, these electrical changes can be further modified by sensors 20, 120, 120' and sent via one or a series of wires 27 extending from sensors 20, 120, 120' to a signal processing unit 28. Alternative methods can be used to send signals from sensors 20, 120, 120' to signal processing unit 28 (e.g., a wireless connection such as RF, WiFi, etc.).

[0082] The signal processing unit 28 can be used to determine the distance between known points on the endotracheal tube and the detected patient anatomy and can be used to visualize it. The signal processing unit 28 can receive and process signals from each of one or more sensors 20, 120, 120'. Additionally, the signal processing unit 28 can communicate with a display 33 (e.g., a computer monitor or the screen of a mobile device). In some embodiments, the display 33 can be located at a position remote from the ETT 104, and the signal processing unit 28 can transmit data to the display via a wired or wireless connection to allow an operator to remotely monitor the placement of the ETT 104. For example, the communication between the signal processing unit 28 and the display 33 can occur via a network (such as a local area network, wide area network, or the Internet).

[0083] Figure 3 A separate figure shows an embodiment of the endotracheal tube 304, and Figure 4Shows a cross-sectional view of the ETT 304 along line A-A. The endotracheal tube 304 may include an optical sensor array that may extend circumferentially around the endotracheal tube along a portion of the length of the tube. In this way, the sensor can continuously determine the position of the ETT 304 relative to the vocal cords 26 within the patient's airway. The sensor may be embedded within the endotracheal tube 304.

[0084] Reference Figure 3 and Figure 4 , the sensor may consist of a series of optical devices, such as a light emitter 321 and a light detector (e.g., a photodetector) 323, which may be positioned at discrete intervals along the endotracheal tube 304. In some embodiments, the light emitter 321 and the detector 323 may be circumferentially positioned along the length of the endotracheal tube. In one embodiment, the emitter 321 is surrounded by four detectors 323 in a repeating pattern at regular intervals at a 45-degree angle to create a grid pattern, which may form a flexible circuit 325. For example, in some embodiments, the flexible circuit 325 may include a plurality of circular arrays 326, where each circular array extends circumferentially around the endotracheal tube 304. Figure 3 The embodiment shown in shows a flexible circuit 325 having 10 circular arrays 326, the 10 circular arrays 326 being placed adjacent to each other and extending along the length of the endotracheal tube 304. Figure 4 Shows a cross-section of one such circular array 326 and includes a pattern of 8 emitters 321 and 8 detectors 323 that are circumferentially arranged around the endotracheal tube 304 in an alternating manner. The circular arrays 326 may be arranged in an alternating alignment along the endotracheal tube 304 such that a grid pattern is formed, with the detectors 323 being positioned near the emitters 321. In this way, the sensor cuff 322 can detect the circumferential absorption and reflectance patterns of the patient's anatomy around the ETT 304 and can send this data to the signal processing unit 28 in the manner described above. The signal processing unit 28 may use this data to determine the absolute position of the vocal cords. Due to the unique anatomical symmetry along the anteroposterior axis of the trachea at the level of the vocal cords 26, the reflectance data collected by the sensor 320 is symmetric or nearly symmetric along this axis. Therefore, the signal processing unit 38 can identify the anteroposterior axis and match the symmetric signals to locate the vocal cord level by sequential signal comparison at 180 degrees from a fixed point on the ETT 304.

[0085] The housing 327 can be molded around the flexible circuit 325 to provide encapsulation and act as a lens. The housing 327 and the flexible circuit 325 can form a sensor pocket 322 that is disposed around the tubular body 305 of the endotracheal tube 304. The housing 327 can be a transparent plastic cover located above the flexible circuit 325. The transparent cover allows light signals to be sent from the emitter 321 to the surrounding tissue and allows the detector 323 to receive reflected signals from the surrounding tissue. The sensors (e.g., the emitter 321 and the detector 323) can be activated in a pre-programmed manner to provide local information for each emitter location. A sensor map can be created based on the sensed information. The readings from the sensors can distinguish the anatomy and its location or its absence along the length of the endotracheal tube 304 of the vocal cords.

[0086] In some embodiments, the emitter 321 and the detector 323 can be selected and designed to operate at infrared frequencies. Thus, infrared light can be used to identify laryngeal anatomy using time-of-flight in combination with emissivity and / or absorptivity measurements. The time-of-flight technique measures the time between the discharge of infrared energy and the detection of the reflected energy and can be used to determine the spatial relationship between the object emitting the infrared energy and the surrounding anatomy. The lumens above and below the vocal cords 26 allow for a longer time-of-flight from the emission of infrared light from the endotracheal tube infrared emitter 321 to the detection of the infrared light by the detector 323 compared to the time-of-flight to the closer adjacent vocal cords. Thus, the time-of-flight data collected by the sensor 320 and sent to the signal processing unit 28 provides structural definition information about the distance of the surrounding structures to the surface of the endotracheal tube 304.

[0087] By measuring the intensity of the emissivity and / or absorptivity of the reflected thermal radiation, the surrounding tissue can be characterized based on the degree of absorbed or reflected energy and the degree of light scattering or transmission through the surrounding space. Different tissue types absorb different amounts of infrared energy at specific infrared frequencies. For example, collagen absorbs infrared light at approximately 1200 nm, while water absorbs minimally at the same wavelength. The vocal cord tissue composition is different from that of the trachea and pharynx, and thus their absorption characteristics should be definable and locatable. The sensors 20, 120, 120' can include optical sensors that include optical emitters (such as LEDs and VCSELs) and detectors (such as photodiodes). For the purposes of this disclosure, the combination of an optical emitter and an optical detector can be referred to as an optical sensor. As optical sensors, the sensors 20, 120, 120' can be distributed on the ETTs 4, 104 in any layout. The optical sensors can operate in the infrared, near-infrared, and visible wavelengths.

[0088] Figure 5A schematic view showing a cross-section of the ETT 4, where while the ETT 4 is located in the trachea 2, the emitter 321 and the detector 323 are positioned on the ETT 4. The emitter 321 and the detector 323 are circumferentially positioned around the outer surface of the ETT 4. The emitter 321 and the detector 323 can be in electrical communication with a flexible circuit 5 (not shown). This flexible circuit (e.g., a flexible circuit) provides electrical communication between the emitter 321 and the detector 323 and the signal processing unit 28.

[0089] In some embodiments, the emitter 321 can be triggered (e.g., emit light) at a predetermined interval, in a predetermined order, or simultaneously. For example, the emitter can be programmed to be triggered at a time interval between 0.1 second and 20 seconds, between 0.5 second and 10 seconds, between 1 second and 5 seconds, or any other time interval between one emitter trigger and the next emitter trigger. In particular, the emitter can be pre-programmed to be triggered at intervals of 0.5, 1, 5, 10, or 20 seconds between one light emission and a subsequent light emission. The emitter 321 can include a light-emitting diode (LED) or a vertical-cavity surface-emitting laser (VCSEL) or a combination of both. In addition to being able to predetermine the time interval between successive triggers of the light emitter, the duration of a single trigger (e.g., a single emission) can be predetermined. The duration of a single emission can be, but is not limited to, between 1 millisecond (e.g., ms) and 10 seconds (e.g., s), between 100 milliseconds and 1 second, or between 200 milliseconds and 700 milliseconds.

[0090] In Figure 5 the cross-section, the emitter 321' is shown emitting light rays in a 180-degree pattern. (Although not shown, during application in an actual trachea, the light source will emit in a hemispherical pattern from the surface of the emitter.) As shown, each light ray emitted from the emitter 321 reflects multiple times from the inner surface of the trachea 2. The reflected light rays emitted from a single emitter (such as the emitter 321') are detected by one or more detectors 323.

[0091] In some embodiments, the emitter 321 and the detector 323 are pre-programmed such that for each trigger of a single emitter, all the detectors 323 make measurements. That is, a single emitter 321 generates a hemispherical light emission that reflects from the inner surface of the trachea, and each detector 323, 323’, 323” etc. (e.g., a photodetector) measures the intensity of the light signal that reaches a given photodetector. In this way, all the detectors can make a single measurement of the intensity of the light signal that reaches the detectors for each trigger of the emitter.

[0092] As a non - limiting example, the ETT system 100 can include an ETT 4 having a transmitter array that includes 64 transmitters in a circumferential array evenly distributed over the ETT 4. Additionally, the ETT system 100 can also include a detector array that includes 64 detectors distributed in a circumferential array over the ETT 4. The transmitter array and the detector array can be interpenetrating such that in each row and each column of the interpenetrating array, transmitters 321 and detectors 323 alternate. Figure 5 A non - limiting example of such an interpenetrating array disposed on the ETT 304 is shown. The cross - section of the ETT 4 having eight transmitters and eight detectors Figure 5 can show a non - limiting example of a single row of the interpenetrating array of transmitters and detectors. Figure 4 A non - limiting example of a cross - section of such an interpenetrating array disposed on the ETT 304 is shown.

[0093] As Figure 5 shown, a first light ray a is emitted from the transmitter 321' and is reflected as a reflected light ray a' from the inner surface of the trachea 2. The reflected light ray a' is then detected by the detector 323' (e.g., a photodetector). A second light ray b is also emitted simultaneously with the first light ray a from the transmitter 321'. However, due to the angle at which the light ray b reaches the inner surface of the trachea 2, the light ray b is reflected from the inner surface of the trachea 2 in a different direction as b'. The light ray b' continues to be reflected from another inner surface of the trachea 2 to continue to be reflected as a light ray b'' from another inner surface of the trachea as a light ray b'''. The light ray b''' is detected by the detector 323.

[0094] For a first approximation, compared to the optical signal b''', the optical signal a' reflected from the inner surface of the trachea 2 should be a relatively strong signal because the optical signal a' is reflected from only one surface and travels a minimum distance compared to the light ray b''' that is reflected from three surfaces and travels a greater distance. In a similar manner, each transmitter sequentially emits an optical signal, and each detector measures the reflected signal for each light emission. Each data measured by each detector 323 is transmitted to the signal processing unit 28 and is stored in the data storage system.

[0095] For the above example of two interpenetrating arrays of 64 transmitters 321 and 64 detectors 323, the data storage system can include a data register file that will include a file corresponding to 64 detectors each having 64 measurement results. In this way, the data register stores a 64 - by - 64 data set as a measurement result array.

[0096] When the data set has been collected, the sensor interpreter 29 can employ algorithms to process the data set to create a visual representation inside the trachea 2. In some embodiments, the algorithm involves averaging all the measurements for each detector 323 and then preparing an intensity map. That is, the intensity of each light signal measured by a given detector is summed over 64 data points and then divided by 64 to give the average intensity for that detector 323.

[0097] The intensity data recorded in the data registers capture the way the light signals are reflected from the surface of the trachea and are measured by detectors distributed over the tubular body 302. In some embodiments, the tubular body is approximately cylindrical. Thus, in some embodiments, the recorded data represent the spatial volume of the internal body cavity defined by the inner surface of the trachea. That is, the ETT system 100 and its interpenetrating array of emitters 321 and detectors 323 circumferentially distributed around the ETT 4 can provide a spatial map as a visual representation of the tracheal lumen.

[0098] The spatial map corresponds to a representation of the internal spatial profile of the internal body cavity constructed row by row from the sensor data, similar to how a CT (e.g., computed tomography) machine constructs a 3D image from X-ray rows. The signal processing unit 28 receives the light signal data from the detectors 323, 323’, 323”, etc., and constructs an internal spatial profile map (e.g., representation) by building a series of slices of the intensity of the light signal data row by row. That is, a 3D image of the internal body cavity can be constructed by processing the light signal data generated by the emitter 321 and the detectors 323.

[0099] Demonstration of the prototype ETT system

[0100] A prototype ETT system with two interpenetrating arrays of 64 emitters 321 and 64 detectors 323 was assembled and tested on a human cadaver to perform a proof-of-concept experiment. The interpenetrating arrays were assembled into eight rows of eight emitters and eight detectors each. In this way, an 8×8 detector array was arranged around the outer cylindrical surface of the ETT 4.

[0101] The ETT system 100 was positioned in the cadaver trachea and optical data were recorded. The signal processing unit 28 was pre-programmed such that each emitter 321 was triggered once and all the detectors measured the intensity of the light reaching each detector 323. In this way, the light intensity for each detector around the ETT 4 was measured and the data for each detector were stored. The data were stored in data registers that had 64 data points for each detector, corresponding to 64 different emitters 321 in the 8×8 emitter array.

[0102] The sensor interpreter 29 analyzes the data set using an algorithm that averages the 64 intensities for each detector in the 8×8 array, and then applies a smoothing algorithm to smooth the intensity gradients between each averaged data point.

[0103] Figure 6 Shown is a sensor map 600 generated by the ETT system 100 when measuring optical data within the trachea of the cadaver described above. The sensor map is an 8×8 array of averaged and smoothed data collected by the prototype ETT system 100. Red indicates higher intensity values, blue indicates lower intensity values, and white is in between the blue and red values. The higher intensity value (dark red) indicated by A represents a closer proximity between the emitter 321 and the inner surface of the trachea, while the lower intensity value (dark blue) indicated by B represents a greater distance between the emitter and the inner surface of the trachea. The dark blue region B corresponds to the vocal cords, providing an indication of the ETT system's position. That is, using the sensor map generated by the ETT system 100, the user can be confident that they know their position within the trachea of the subject.

[0104] Figure 6 The sensor map 600 shown in is a planar projection of data collected by the cylindrical ETT system 100 inside the tubular cadaver trachea. The flat projection can be transformed (e.g., curled) into a cylindrical representation by the sensor interpreter 29 and compared to a 3-D model of a portion of the trachea.

[0105] Figure 7 A shows a reproduction of the sensor map 600 from Figure 6 and Figure 7 B shows the sensor map 600 after transforming the sensor map 600 into a cylindrical shape using the sensor interpreter 29. Figure 7 C shows a 3-D modeling diagram of the trachea, and Figure 7 D shows the ETT system 100 deployed within the trachea.

[0106] Figure 7 B shows that the ETT system 100 can be used to provide a spatial map of the trachea, which shows the vocal cords when compared to a 3D model of the trachea as shown in Figure 7 C.

[0107] Figure 8Shows an additional representative embodiment of a sensor map generated by signal processing unit 28 according to an illustrative embodiment. As a non-limiting example, sensor 120’ can be positioned on ETT 104 located in trachea 2, as shown in slice 15. The sensor map can be a generated image slice 30 and / or three-dimensional rendering 40 of the patient anatomy sensed by sensors 20, 120, 120’. A doctor can use sensor maps 30, 40 to accurately identify and verify the positioning of the endotracheal tube. Sensor maps 30, 40 can be created in a static or dynamic setting when the endotracheal tube 104 is positioned within the patient's lumen, moved, and / or when one or more elongate balloons 101 are inflated. Sensors 20, 120, 120’ can be triggered quickly in sequence or in a combination of sequences, which can prevent sensor-to-sensor interference.

[0108] Based on signals from sensors 20, 120, 120’ (e.g., reflectance data, pressure data, time-of-flight data, etc.), signal processing unit 28 can generate an image of the sensed patient anatomy surrounding sensors 20, 120, 120’ and endotracheal tubes 4, 104. For example, using time-of-flight data or light penetration / dispersion data sensed by sensors 20, 120, 120’, the signal processing unit can generate an image slice 30 showing vocal cords 26’, epiglottis 36’, and / or cartilage 38’ surrounding tracheal lumen 2’ (where endotracheal tube 104 is positioned). The sensor map can be compared to a standardized map of the patient anatomy (e.g., larynx, pharynx, trachea, and / or esophagus map), which can be created circumferentially and longitudinally, to determine the position of endotracheal tubes 4, 104 relative to the surrounding anatomy.

[0109] In some embodiments, the generated image slice 30 can be combined with one or more additional image slices generated based on signal data from one or more additional sensors 20, 120, 120’ to create a recognizable three-dimensional rendering 40 of the patient anatomy surrounding endotracheal tubes 4, 104 and sensors 20, 120, 120’. For example, three-dimensional rendering 40 can include vocal cords 26’, tracheal lumen 2’, and cartilage 38’. Although Figure 8 not shown, three-dimensional rendering 40 can include an accurate representation of the position of endotracheal tubes 4, 104 relative to the patient anatomy.

[0110] For example, Figure 9Shows another embodiment of the three-dimensional rendering 140 created by the signal processing device 28, which includes a visual representation of the endotracheal tube 104', including a representation of the AOC 114', and the surrounding patient anatomy, such as a visual representation of the vocal cords 26'. As discussed 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 of the AOC 114p). In the case where the proximal end of the AOC 114p is used as a known point on the ETT, the distance D represents the critical distance that the ETT can travel proximally or upward in the patient's trachea 2 before the AOC 114 begins to protrude through the vocal cords 26. This information can assist the operator in determining whether adjustment of the placement of the ETT 104 is required or recommended.

[0111] The unique properties of the intralaryngeal vocal cords 26 allow the vocal cords 26 to be recognized by the sensors 20, 120, 120' (e.g., infrared sensors, visible light sensors, and / or pressure sensors) and the signal processing unit 28. In some embodiments, one or more of the sensors 20, 120, 120' can detect the 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 transmit 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 transmitted to the signal processing unit 28 and converted to show one or more of the vocal cords 26 (also known as the vocal folds), the false vocal cords (also known as the vestibular folds), and / or the lumens above, between, and below these vocal cords (also known as the supraglottic vestibule, the ventricle of the larynx, and the subglottic lumen, respectively). In some cases, data from the sensors can be transmitted to the signal processing unit 28 and converted to show the anterior surface of the esophagus. As will be discussed below, if the sensors 20, 120, 120' detect the presence of the anterior surface of the esophagus, the doctor can be alerted to improper placement of the endotracheal tube 104 within the esophagus (as opposed to the correct positioning through the patient's larynx and glottis as expected).

[0112] For example, in some embodiments where the endotracheal tube 104 includes one or more elongate balloons 101, the sensor 120 can be positioned along the length of the elongate balloon 101 such that the sensor 120 extends in the longitudinal direction of the endotracheal tube 104. In this way, when the elongate balloon 101 is inflated, the sensor 120 can contact the surrounding anatomy and can be used to detect the pressure, pressure changes, and / or pressure distribution of the surrounding anatomy. The shape of the true vocal cords and their stress-strain characteristics allow the sensors 20, 120, 120' to identify the true vocal cords as distinct from other patient anatomy by using, for example, pressure sensing techniques (e.g., resistive or capacitive touch screen sensors) and / or infrared techniques. More specifically, the true vocal cords are a layered structure composed of an inner muscular layer (thyroarytenoid muscle) with muscle fibers arranged primarily in the anteroposterior direction, a soft tissue layer of the ligamentous lamina propria, and an outermost epithelial layer. The true vocal cords are located directly caudal and medial to the false vocal cords. Each true vocal cord is approximately 11 mm to approximately 17 mm long in adult females and approximately 17 mm to approximately 25 mm long in adult males. Each true vocal cord extends through the larynx in the anteroposterior direction, attaching anteriorly to the thyroid cartilage and posteriorly to the anterolateral surface of the arytenoid cartilage. These folds are white, mainly due to their ligamentous nature. At rest, the space between these folds is narrowest at the anterior attachment (anterior commissure) and extends laterally in the transverse direction as the coronal plane moves posteriorly, almost measuring the diameter of the larynx at its widest point. These vocal cords are irregularly shaped in the coronal plane but measure approximately 0.5 mm to approximately 1 mm in depth at the surface closest to the glottis, where the total depth of the vocal cord body measures approximately 1.2 mm to approximately 1.6 mm. The shape and color of these folds and their stress-strain characteristics allow them to be identified by pressure sensing and / or infrared sensor (IR) techniques. This will be discussed in further detail below with reference to Figures 6 to 8 The IR sensing techniques associated with various embodiments of the present disclosure will be discussed in further detail.

[0113] The true vocal cords are stiffer relative to the false vocal cords. Within the true vocal cords themselves, the anterior and posterior portions of the vocal cords are stiffer than the central membranous portion, but when a stress of approximately 0 kPa to approximately 2.5 kPa is applied, the overall stiffness follows a relatively low stress-strain curve slope between approximately 20 kPa and approximately 50 kPa, but rapidly rises to a slope of approximately 200 kPa at a stress of approximately 10 kPa. The curve begins to move significantly upward at a force of approximately 2.5 kPa.

[0114] In the endotracheal tube systems 100, 104 of the present disclosure, one or more sensors 20, 120, 120' can be used to isolate the position of the true vocal cords 26 along their length. When the true vocal cords exert a pressure of about 13 kPa to about 20 kPa, one or more sensors 20, 120, 120' can detect the isolated lateral pressure exerted by each true vocal cord along a length of about 1 mm to about 1.6 mm. Because no other tissue in the anatomical regions above or below the vocal cords has such a stress-strain curve, and because no other tissue produces a signal detectable by a pressure sensor at such a low pressure threshold, the sensors 20, 120, 120' can be used to identify the true vocal cords. In some embodiments, when at least two sensors 20, 120 are expanded anterolaterally by the inflation of a component (e.g., the elongate balloon 101 or the sensor cuff 22) of the ETT 4, 104, multiple sensors 20, 120, 120' can be used to correctly identify the symmetric vocal cords. In this way, at least two sensors 20, 120 can detect substantially the same signal pattern from two symmetric vocal cords, which consist of a depression of about 1 mm to 1.6 mm at the same longitudinal position along the length of each sensor.

[0115] In addition, in certain embodiments where the endotracheal tube 104 includes one or more elongate balloons 101, an optical sensor 120 can be positioned along the length of the elongate balloon 101 such that the optical sensor 120 extends in the longitudinal direction of the endotracheal tube 104. An optical output (e.g., a transmitter) on the ETT emits light into the body cavity. Then, a detector senses the reflected light from the patient's anatomy and uses time-of-flight data, light penetration / dispersion data, or profile location data to determine the position of the ETT within the lumen.

[0116] Figure 10 Schematically shown is another embodiment of an ETT 204 according to the present disclosure that can be used in the Figure 1 ETT system 100. Except as shown below, the structure, operation, and use of the endotracheal tube 204 are similar or identical to the structure, operation, and use of the Figure 1 endotracheal tube 4, where components with the same reference numerals generally have similar features. As shown, the endotracheal tube 204 can have one or more sensors 220 positioned along the length of the surface of the endotracheal tube. As a non-limiting example, the sensor 220 can include a capacitance sensor, an impedance sensor, a visible light sensor, and / or an infrared sensor. In some embodiments, the sensor 220 of the endotracheal tube 204 includes one or more sensor antennas extending longitudinally along the endotracheal tube. The sensor 220 can extend proximally from the position of the AOC cuff 214 along the endotracheal tube 204. The AOC cuff 214 can be placed toward the distal end 208 of the endotracheal tube 204.

[0117] In some embodiments, one or more of the sensors 220 may be in the form of sensor antennas and do not need to contact a particular anatomical structure to sense and detect the presence of a particular anatomical structure. The sensor 220 may radially emit a sensor signal output 221, which may be transmitted to the signal processing unit 28 via a wireless or wired 227 connection. For example, the sensor signal output 221 may be used to sense the capacitance, impedance, visible light, and / or infrared characteristics of the tissue of the larynx and / or esophagus / pharynx anatomical structure at a distance. Different types of tissue have different capacitance, inductance, reflection, and impedance characteristics, which may allow these sensors 220 to distinguish one type of tissue from another based on the sensed information. Using the time-of-flight data and / or dispersion / light penetration data from the optical output, the sensor distinguishes the air space in the body cavity from the tissue. By distinguishing air and tissue, the sensor determines the shape of the patient's anatomical structure and the internal body cavity. This allows determination of the position of the ETT.

[0118] For example, if the endotracheal tube 204 is positioned in the esophagus, the sensor 220 will sense a signal that is not similar to the signal generated by sensing the presence of other patient anatomical structures, such as the vocal cords 26. More specifically, the anterior surface of the esophagus is a raised, non-uniform tissue surface with no significant features. A sensor 220 sensing this surface (e.g., by pressing against the surface or emitting a signal that contacts the surface) will produce a long, irregular signal pattern along a significant length of the sensor 220 (e.g., greater than about 1 cm). Because the anterior surface of the esophagus is concave, the endotracheal tube 204 naturally shifts laterally towards the center. Thus, bilaterally facing anterolateral sensors do not sense or display the same pattern. More specifically, the sensor will determine that the shape of the internal body cavity of the esophagus does not match the known shape of the space between the endotrachea and the vocal cords. These differences when sensing the vocal cords compared to the esophagus can help accurately detect the position of the sensor. Thus, since the position of the sensor 220 relative to the endotracheal tube is known, the position of the endotracheal tube 204 relative to a particular patient anatomical structure can be determined and visualized by the signal processing unit 28.

[0119] Figure 11 Another embodiment of an endotracheal tube 304 according to the present disclosure is shown, which can be used in Figure 1 the endotracheal tube system 100. Except as shown below, the structure, operation, and use of the endotracheal tube 304 are the same as Figure 1The structure, operation, and use of the endotracheal tube 4 are similar or identical, where components with the same reference numerals generally have similar characteristics. The endotracheal tube 304 includes a plurality of sensors 320. In some embodiments, the plurality of sensors 320 can form a sensor cuff 322 that can extend circumferentially around the endotracheal tube 304. Figure 11 An endotracheal tube 304 positioned within a patient's trachea 2 is shown, and the positioning of the tube relative to surrounding anatomical structures such as the vocal cords 26 and the epiglottis 36 is shown.

[0120] Usage method

[0121] Figure 12 An embodiment of a method 500 of using an endotracheal tube 4 according to an illustrative embodiment of the present invention is shown. It should be noted that this process substantially simplifies the longer processes typically used. Thus, the method can have many steps that those skilled in the art might use. Additionally, some steps can be performed in a different order than shown, or simultaneously. Thus, those skilled in the art can modify the method appropriately. Regarding Figure 2 the embodiment of the endotracheal tube 104 shown in describes the method 500. However, it should be understood that the method 500 can be implemented with any of the devices and systems described herein.

[0122] Method 500 begins at step 502, which positions the endotracheal tube 104 into the patient's glottis or esophageal lumen. As previously described, the endotracheal tube 104 can include one or more elongate balloons 101 having one or more sensors 120. Additionally or alternatively, the endotracheal tube 104 can have one or more sensors 120' positioned along the surface of the endotracheal tube 104. The endotracheal tube 104 can then be rotated within the lumen such that the intended front side of the endotracheal tube 104 is facing the forward direction (step 504). To this end, a marker can be positioned on the proximal end 106 of the endotracheal tube 104 outside the patient to indicate which side of the endotracheal tube 104 is the intended front side. The tube 104 is rotated to align one or more sensors 120, 120' to correctly detect the presence or absence of the vocal cords. In some embodiments, aligning sensors 120, 120' can include setting the sensor 120 located on the elongate balloon 101 such that the sensor can directly contact or interact with the vocal cords after the elongate balloon 101 is inflated. Other embodiments align sensors 120, 120' by placing the sensors 120, 120' such that they can interact with the vocal cords or other surrounding patient anatomy without direct contact, such as using the infrared sensing techniques described above. Aligning sensors 120, 120' can include setting the sensors in a known position relative to the vocal cords (e.g., setting sensors 120, 120' such that they face the direction of the vocal cords).

[0123] Then, the AOC 114 can 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 elongate balloons 101, the balloons 101 can be inflated such that one or more sensors 120 of the elongate balloons 101 contact the patient's anatomy (step 508). In cases where multiple elongate balloons 101 are used in conjunction 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. A sensor array or sensor cuff of one or more sensors 120, 120' can contact or interact with the surrounding tissue (step 510). For example, the sensor 120 on the surface of the balloon 101 can contact the vocal cords 26 or the anterior surface of the esophagus when the balloon is inflated. In some embodiments, the deformation of the vocal cords 26 (or the anterior surface of the esophagus if the endotracheal tube 104 is positioned within the esophagus) caused by the inflated elongate balloon 101 allows the sensor 120 to detect the surrounding patient anatomy to create a sensor map. In some embodiments that include one or more sensors 120' located on the surface of the endotracheal tube 104, the sensor 120' and / or the sensed signals of the sensors 120, 120' can detect the surrounding patient anatomy, for example, using the infrared sensing technique described above (step 510), without direct contact and / or without the need for inflation of the balloon 101.

[0124] As described above, one or more sensors 120, 120' can send sensor data to the signal processing unit 28 for further processing (step 512). Then, the signal processing unit 28 can process the signals from one or more sensors 120, 120' and convert the data (e.g., pressure readings, time-of-flight data, etc.) into representative image data for visualization on the display 33. For example, the above-described sensor maps 30, 40, 40' can be generated by the signal processing unit 28. The signal processing unit 28 can send the image data to the display 33 such that the sensor data can be displayed to the user as an image in an identifiable manner.

[0125] If the sensor detects the presence of the vocal cords (step 514), the image on the display screen 33 will show the appropriate and recognizable anatomical structures, such as the vocal cords, false vocal cords, etc. As described above, the signal processing unit 28 may include a sensor interpreter that can calculate the distance between the vocal cord signal and a known point. 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 identified patient anatomical structure) and the known point (e.g., AOC 114) can be calculated by the signal processing unit and displayed to the operator (step 516). The distance calculation and / or the image of the sensed patient anatomical structure can be used to accurately verify the position of the endotracheal tube 104, and if necessary, the depth of the endotracheal tube 104 can be adjusted for optimal placement (step 518). For example, the doctor can ensure that the endotracheal tube 104 is not positioned within the bronchus by moving the endotracheal tube 104 proximally within the lumen such that the distance between the AOC 114 and the vocal cords 26 (as measured from the distal ends of the most distal sensors 120, 120') is less than about 1 cm. The optimal placement of the endotracheal tube 104 may include positioning the endotracheal tube 104 at a depth within the lumen of the trachea 2 to achieve oxygenation and ventilation of both lungs of the patient. In some embodiments, adjusting the depth of the endotracheal tube 104 may 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.

[0126] If, in step 512, the displayed image of the patient anatomical structure sensed by one or more sensors 120, 120' (120) does not show or indicate the presence of the vocal cords 26 (step 513), this may alert the doctor 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 can be removed (step 515) and repositioned within the patient (step 502) with the aim of positioning the endotracheal tube 104 within the lumen of the trachea. Then the steps of method 500 can be repeated to verify the position of the endotracheal tube within the lumen, as described above.

[0127] Figure 13 Another embodiment of a method 900 of using an endotracheal tube 4 in accordance with an illustrative embodiment of the present invention is shown. It should be noted that this process substantially simplifies the longer process typically used. Accordingly, the method may have many steps that a person skilled in the art may use. Additionally, some steps may be performed in a different order than shown, or simultaneously. Accordingly, a person skilled in the art may modify the method appropriately. Regarding Figure 2The embodiment of the endotracheal tube 104 shown in [Figure] describes method 900. However, it should be understood that method 900 can be implemented with any of the devices and systems described herein.

[0128] The process begins at step 902, initial intubation, where the ETT is inserted into the patient. At step 904, the clinician positions the ETT at an initial position within the patient. After the initial positioning, the optical output on the ETT emits light (e.g., visible light and / or infrared light) into the body cavity (step 906). The light reflects off the surrounding patient anatomy, and the reflected light is detected by a sensor on the ETT (step 908).

[0129] The sensor generates sensor data, such as information about the vocal cords. Then, the sensor generates position data / signals and sends the signal to a signal processing unit (step 910).

[0130] After receiving the position signal from the sensor, the signal processing unit processes the sensor data into position data (step 912). The position data can include the position of the ETT relative to the sensed patient anatomy. The signal processing unit can display the position data received from the signal processing unit; i.e., display the position of the sensed patient anatomy and / or the ETT.

[0131] The signal processing unit can automatically determine the position of the ETT relative to the sensed patient anatomy based on the signal containing the sensor data (step 912). In some embodiments, the signal processing unit uses machine learning to determine the position of the ETT.

[0132] 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 be properly placed within the patient (step 914).

[0133] 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.

[0134] Returning to step 914, if the depth of the ETT is optimal, the ETT does not need to be adjusted, and the process loops back to step 906 to continuously monitor the ETT position during the medical procedure.

[0135] Figure 14Another embodiment 1400 of a method of visualizing an anatomical structure that defines an internal body cavity is shown. In step 1410, a tube is provided into the internal body cavity. The tube has a proximal end and a distal end. In some embodiments, the tube is 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 for positioning 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 outside the patient. As used herein and Figure 1 as shown, "proximal" is used to refer to the direction toward the end of the ETT 4 that extends outward from the patient when the ETT is inserted into the patient's airway, while the term "distal" is used to refer to the opposite direction. In terms of placement within the trachea 2, the proximal end refers to being closer to the patient's mouth, and the distal end refers to being closer to the patient's lungs.

[0136] In step 1420, light is emitted from two or more optical output ends supported by the tube. The emitted light is reflected from various surfaces of the internal body cavity. The optical output can be a light-emitting diode (LED) and / or a vertical cavity surface emitting laser (VCSL). Two or more detectors can be circumferentially arranged on the tube as an array. The array can be an eight (8) × eight (8) array.

[0137] The two or more optical outputs can be triggered (e.g., emitted) simultaneously or at a pre-programmed interval between successive emissions. In some embodiments, the emitter 321 can be triggered (e.g., emit light) at a predetermined interval, in a predetermined order, or simultaneously. For example, the emitter can be programmed to be triggered at a time interval between 0.1 second and 20 seconds, between 0.5 second and 10 seconds, between 1 second and 5 seconds, or any other time interval between one emitter trigger and the next emitter trigger.

[0138] In step 1430, each of the two or more detectors supported by the tube detects the intensity of the reflected light. Each ray of light emitted from the emitter 321 is reflected multiple times from the surfaces inside the trachea 2. The reflected rays of light emitted from a single emitter (such as emitter 321') are detected by one or more detectors 323.

[0139] In step 1440, a signal is degraded in each of two or more detectors based on the intensity of the reflected light detected by each of the two or more detectors. The optical detector can be a photodiode. In some embodiments, the emitter 321 and the detectors 323 are pre-programmed such that for each trigger of a single emitter, all the detectors 323 make measurements. That is, a single emitter 321 generates a hemispherical light emission reflected from the inner surface of the trachea, and each detector 323, 323', 323", etc. (e.g., a photodetector) measures the intensity of the light signal reaching a given photodetector. In this way, all the detectors can make a single measurement of the intensity of the light signal reaching the detectors for each trigger of the emitter.

[0140] In step 1450, a signal from each of two or more detectors is sent to a signal processing unit. The signal can be sent over a wire or can be sent wirelessly. Wireless transmission can be via radio, Bluetooth, WiFi, or any other wireless transmission protocol.

[0141] In step 1460, a signal from each of two or more detectors is received and stored in the signal processing unit. The signal includes data that the controller can send to be stored in non-volatile memory once the measurement has been made. The data controller retrieves the data from non-volatile memory and sends it to the central processing unit (CPU) in the signal processing unit 28.

[0142] In step 1470, the signal processing unit is used to determine the position and dimensions of the internal body cavity based on the signal. The signal processing unit 28 can include one or more of a sensor interpreter 29 and an image processor 31. The sensor interpreter 29 determines the position of the sensed anatomical structure and the distance between the sensed anatomical structure and a known point on the ETT 4 based on the sensed data from the sensor 20 of the ETT 4. The image processor 31 generates a visual representation of the placement of the ETT 4 and can communicate 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 can use machine learning to determine the distances between the patient's anatomical structure and the air / tissue boundary and known points on the ETT 4, and to create a visual representation of the patient's anatomical structure and the ETT.

[0143] Figure 15 An exemplary generated image of the patient's anatomical structure is shown. In an exemplary embodiment, the sensor detects how light propagates through the patient's entire airway. When light propagates from the optical output, some light penetrates the surrounding tissue and some light is reflected back to the sensor. The sensor collects the light reflection data and transmits the data to the signal processing unit. The signal processing unit generates a light penetration map representing the surrounding tissue and the internal body cavity space around the ETT. In Figure 15In an exemplary image, the red regions represent areas or tissues with low light penetration (high reflectance), while the blue regions represent areas or empty body cavity spaces with high light penetration (low reflectance). The vocal cord level can be determined by comparing the exemplary image with the known shape of the patient's anatomical structure. For example, the vocal cords can be located at the top of the image, where the blue and red regions meet at the tissue / body cavity boundary. The position of the ETT within the lumen is determined by 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.

[0144] In another embodiment, the sensor cuff can be attached to or integrated with a vaginal device or an intrauterine device (IUD) insertion needle. In this case, the surrounding tissue is the vaginal wall, and the insertion reference point will be the cervix. The sensor detects the air / tissue boundary of the cervix and compares the generated image with the known shape of the patient's anatomy. This will allow for more precise placement of the IUD.

[0145] In another embodiment, the sensor cuff can be attached to or integrated with a vaginal device that monitors the progress of cervical dilation and cervical effacement during childbirth. The sensor detects the air / tissue boundary of the cervix and, prior to delivering the baby, compares the generated image with the known stages of cervical dilation / effacement during childbirth. This will allow for more precise and continuous monitoring of the progress of childbirth.

[0146] Figure 16 A representation of the laryngeal anatomy detected by the sensor is shown. As described above, the optical output end emits light (e.g., visible light and / or infrared light, etc.) within the lumen. As Figure 16 shown, light penetration data can be utilized to generate an image of the patient's anatomy. The air / tissue boundary of the glottis at the top of the trachea represents the vocal cords. The position of the ETT can be determined based on the known reference point of the ETT and the position of the vocal cords. This allows the clinician to determine whether the ETT is positioned within the trachea, or positioned too low, beyond the carina and into the bronchus, or too high resulting in extubation.

[0147] Mapping of the patient's anatomy and detection of the position of the ETT can be done in real time, allowing for continuous monitoring of the ETT position within the patient. As described above, a representation of the internal space profile of the trachea can be constructed, resulting in a 3D image of the trachea and portions of the carina and bronchi. By allowing continuous, real-time monitoring, the likelihood of extubation or intubation into the bronchus is reduced. This allows for safer and more effective intubation of the patient. The surprising result of real-time monitoring is that the ETT system 100 can prevent extubation or intubation into the bronchus. The ability to determine a representation of the internal space profile of an internal body cavity (e.g., the trachea) differentiates the ETT system. Thus, the reduction in extubation increases the safety of the procedures performed with the ETT system 100.

[0148] In addition, the ETT system 100 can provide the operator with knowledge of the positional changes of the ETTs 104, 304 during use. For example, a doctor can remotely monitor the positions of the ETTs 104, 304 and detect that the position and / or orientation of the ETTs 104, 304 has changed due to patient movement rather than being actively moved or repositioned by the doctor. Movement of the ETTs 104, 304 that is not initiated by the operator can indicate that the patient is moving while in a sedated state, and movement of a sedated patient can indicate a decrease in the patient's level of sedation. That is, by using the ETT system 100, it is possible to detect unexpected movement of the patient during the course of the patient being in a sedated state, and important information can be provided to the operator that can be used to reduce the potential risks to the patient of emerging prematurely from the sedated state. Thus, another surprising result of the real-time monitoring provided by the ETT system 100 is that the operator can detect the patient's level of sedation, thereby increasing the safety of procedures performed using the ETT system 100.

[0149] The embodiments of the invention described above are intended to be merely exemplary; many variations and modifications will be apparent to those skilled in the art. These variations and modifications are intended to fall within the scope of the invention as defined by any appended claims.

Claims

1. An endotracheal system, comprising: An endotracheal tube having a proximal end, a distal end, and a lumen therebetween; A signal processing unit; Two or more sensors positioned on the endotracheal tube and configured to: Generate sensor signals that interact with the surrounding patient anatomy, the surrounding patient anatomy including an internal body cavity; Detect the generated sensor signals that have interacted with the surrounding patient anatomy; And Send the detected sensor signals to the signal processing unit; and 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 including: The endotracheal tube position; And The dimensions of the internal body cavity based on the detected sensor signals.

2. The system according to claim 1, wherein: The sensor signals include visible light or infrared light; The interaction of the sensor signals with the surrounding patient anatomy includes reflection; and The generated sensor signals are detected by a photodiode.

3. The system according to claim 2, wherein: The visible light is generated by an LED or a VCSEL; and The infrared light is generated by an LED or a VCSEL.

4. The system according to claim 1, further comprising: 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 an anatomical reference and a known point on the endotracheal tube.

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

6. The system according to claim 1, further comprising: An inflatable airway occlusion cuff positioned closer to the distal end of the endotracheal tube than to the proximal end; And Wherein the two or more sensors are positioned proximal to the airway occlusion cuff.

7. The system according to claim 5, wherein: The two or more sensors include an interpenetrating array including a transmitter array and a detector array such that in each row and each column of the interpenetrating array, transmitters and detectors alternate; and The interpenetrating array circumferentially extends around the outer surface of the endotracheal tube and longitudinally extends along at least a portion of the length of the endotracheal tube, wherein the distal end of the interpenetrating array is proximal to the airway occlusion cuff.

8. The system according to claim 7, wherein: The transmitter array includes at least two rows each having two transmitters and at least two columns each having two transmitters; and The detector array includes at least two rows each having two detectors and at least two columns each having two detectors.

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

10. The system according to claim 1, wherein The signal processing unit uses machine learning to generate the position data.

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

12. The system according to claim 8, wherein, The surrounding patient anatomy includes at least one vocal cord.

13. The system according to 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, acoustics, photoacoustics, ultrasound, visible light characteristics, or infrared characteristics of the surrounding patient anatomy.

14. The system according to claim 1, the system further comprising: A flexible circuit disposed on the endotracheal tube between the two or more sensors and the endotracheal tube, the flexible circuit providing signal communication between the two or more sensors and the signal processing unit.

15. The system according to claim 14, the system further comprising: A housing molded around the two or more sensors and the flexible circuit to provide encapsulation.

16. The system according to claim 15, wherein, The housing molded around the two or more sensors and the flexible circuit acts as a lens for the two or more sensors.

17. A method of an anatomical structure defining an internal body cavity, the method comprising: Providing a tube having a proximal end and a distal end into the internal body cavity; Emitting light from two or more optical outputs supported by the tube; Detecting the intensity of the reflected light by each of two or more detectors supported by the tube; Generating a generated signal in each of the two or more detectors based on the intensity of the reflected light detected by each of the two or more detectors; Sending the signal from each of the two or more detectors to a signal processing unit; Receiving and storing in the signal processing unit the signals from each of the two or more detectors; And Using the signal processing unit to determine the position and size of the internal body cavity based on the signals.

18. The method according to claim 17, wherein, The tube is an endotracheal tube.

19. The method according to claim 17, the method further comprising: Using reference information about an expected profile of the internal body cavity to generate position data of anatomical features.

20. The method according to claim 19, the method further comprising: Determining the position of the endotracheal tube based on the position data of the anatomical features and known points on the endotracheal tube.

21. The method according to claim 19, wherein The anatomical feature is a vocal cord.

22. The method according to claim 19, the method further comprising: Receiving the position data; And Generating an image of the patient anatomy.

23. The method according to claim 17, wherein: The optical output is a light emitting diode LED; and The detector is a photodiode.

24. The method according to claim 19, wherein, The signal processing unit uses machine learning to generate the position data.

25. The method according to claim 17, wherein The tube is a vaginal device.

26. The method according to claim 17, wherein The tube is an intrauterine device insertion needle.

27. The method according to claim 17, wherein The tube is a bladder catheter.

28. The method according to claim 17, wherein The tube is a pleural tube.

29. The method according to claim 17, wherein, The tube is an intravascular catheter.

30. The method according to claim 17, wherein, The tube is a ureteral catheter.

31. The method according to claim 17, wherein The tube is a gastric catheter.

Images