Intubation systems, kits and methods for delivering tracheal catheters

Abstract

The present invention relates to a cannula system (10) for delivering a tracheal catheter (11) to a trachea of a patient. The intubation system (10) comprises a laryngoscopic lens (14) and a first sensor (20) configured to capture one or more anatomical features of the laryngoscopic lens (14) and / or the tracheal catheter (11) and / or the patient and / or configured to manipulate a position and / or orientation of a manipulation member (65) of the tracheal catheter (11). The intubation system (10) is configured to provide a first instruction for manipulating the laryngoscopic lens (14) to a first target position relative to a patient's anatomy based on data provided by the first sensor (20), and to manipulate the laryngoscopic lens (14) to a second target position once the laryngoscopic lens (14) is in the first target position. If so, a second instruction is provided for manipulating the tracheal catheter (11) and / or the manipulation member (65) to a second target position relative to the patient anatomy. The invention also relates to a kit and a method for delivering a tracheal catheter (11) to the trachea of a patient.

Description

[0001] Endotracheal intubation is considered the gold standard worldwide for establishing a safe airway for patients requiring respiratory support. Endotracheal intubation can be used, for example, during general anesthesia and / or emergency medical services (EMS) and / or intensive care.

[0002] In the most common, current-technical method of performing endotracheal intubation, an endotracheal tube is inserted into the patient's trachea while a laryngoscope is used to depress the tongue, allowing direct visual observation of the patient's glottis (which forms the entrance to the trachea). This method is known as direct laryngoscopy.

[0003] Failure to perform endotracheal intubation in a timely manner and / or improper placement of the endotracheal tube during the intubation procedure can lead to serious illness, even death from asphyxiation, hypoxemia, or pulmonary aspiration. Injuries and deaths most commonly occur in EMS situations, where endotracheal intubation is performed by a user with limited intubation experience under difficult and stressful conditions.

[0004] However, anatomical factors or general condition can make endotracheal intubation difficult, even for experienced practitioners in a hospital setting.

[0005] Therefore, alternatives have been developed in an attempt to at least alleviate some of the difficulties encountered in direct laryngoscopic endotracheal intubation. These alternatives include the use of video laryngoscopes (called indirect laryngoscopy) that provide an indirect view of the patient’s glottis, and the use of flexible endoscopes to assist the user in guiding the endotracheal tube into the patient’s trachea.

[0006] US 2016 / 206189 A1 discloses a system that provides an operator with feedback on the current position of a hinged blade and / or endotracheal tube relative to the anatomical features of a patient's oral cavity. The operator can interpret this feedback and then adjust the position, orientation, movement, etc., of the hinged blade and / or endotracheal tube.

[0007] However, there are still shortcomings in the existing technology that have not been resolved or at least not fully resolved.

[0008] For example, users may encounter difficulties when applying assistance (e.g., feedback) provided by existing systems. For instance, in the case of video laryngoscopy, the correct execution of the intubation procedure still largely depends on the user, as the user must watch the video, interpret the images in the video, and determine whether adjustments are needed based on the video.

[0009] The same may be true for the feedback received by the operator as described in US 2016 / 206189 A1. Users may have difficulty interpreting this feedback and / or applying it to laryngoscopy and intubation procedures.

[0010] This can lead to prolonged endotracheal intubation time, failure to complete the endotracheal intubation procedure, and / or errors in the endotracheal intubation procedure, such as improper placement of the endotracheal tube, which may cause serious illness or even death in the patient.

[0011] Therefore, one object of the present invention is to provide an improved device for delivering an endotracheal tube into a patient's trachea, particularly by at least partially improving one or more of the aforementioned disadvantages.

[0012] This objective is achieved by an intubation system for delivering a tracheal tube to a patient's trachea, as defined by the features of claim 1. Variations and further modifications are defined by the features of the dependent claims. The intubation system may be referred to as the intubation system according to the first aspect of this disclosure.

[0013] The intubation system may include at least one laryngoscope blade for providing access to the patient's pharynx.

[0014] The intubation system may include at least one first sensor configured to capture at least one location and / or at least one orientation of the following during operation of the intubation system: at least a portion of the laryngeal blade and / or at least a portion of the endotracheal tube and / or one or more anatomical features of the patient and / or at least a portion of at least one manipulating member configured to at least partially receive and manipulate the endotracheal tube. Alternatively or additionally, the first sensor may be configured to capture at least one location and / or at least one orientation of at least a portion of one or more other components of the intubation system during operation of the intubation system.

[0015] The intubation system may be configured to provide a user with one or more first instructions, based on data provided by the first sensor, for manipulating the laryngeal blade to a first target position relative to the patient's anatomy. The first instructions for manipulating the laryngeal blade may include one or more instructions for applying one or more forces (e.g., one or more lifting forces) to the patient's anatomy via the laryngeal blade, for example, to manipulate the shape of the patient's anatomy. For example, the first instructions may include one or more instructions for applying one or more forces to the patient's anatomy to elevate the patient's jaw thereby opening the patient's airway for intubation. The first instructions may also include one or more instructions for applying one or more forces to at least a portion of the patient's anatomy via the laryngeal blade to maintain the position of one or more sites of the patient's anatomy, for example, not moving or only minimally moving the laryngeal blade.

[0016] The intubation system can be configured to, once the laryngeal blade is substantially in the first target position, provide the user with one or more second instructions, based on data provided by the first sensor, to manipulate the endotracheal tube to a second target position relative to the patient's anatomy.

[0017] Therefore, the intubation system described herein allows the one or more first instructions (i.e., for laryngoscopy) to be provided to the user independently or at least partially independently of the one or more second instructions (i.e., for intubation). This allows the user to more easily interpret and / or more easily apply the corresponding instructions to the corresponding operation. This allows the user to focus on the corresponding action / operation, i.e., manipulating the laryngeal blade to a first target position relative to the patient's anatomy, and then manipulating the endotracheal tube to a second target position relative to the patient's anatomy, according to the corresponding instructions.

[0018] This can be advantageous because the process of delivering an endotracheal tube into a patient's trachea using a laryngeal blade can be essentially divided into at least two sub-processes. The first process may be placing the laryngeal blade in place, i.e., the first target position, for example, such that the patient's tongue is depressed, the epiglottis is retracted, and / or the patient's trachea (e.g., by exposing the laryngeal foramen) and / or the vocal cords are exposed. Once the laryngeal blade is in the target position, i.e., the first target position, the second process of inserting the endotracheal tube into the patient's trachea can begin. Each of the above processes may have one or more challenges, preferably one or more challenges that are independent of each other in each process. Therefore, the intubation system described herein can facilitate the process of delivering an endotracheal tube into a patient's trachea by focusing on each process individually and supporting the user individually in each process.

[0019] The intubation system can be configured to sequentially deliver the first and second instructions. In other words, the first instruction can be fully delivered to the user before the intubation system begins delivering the second instruction. In this regard, the phrase "once the laryngeal blade is substantially in the first target position" mentioned above may mean that the intubation system is configured to detect and / or determine that the laryngeal blade is in the first target position relative to the patient's anatomy. After the intubation system has detected and / or determined that the laryngeal blade is in the first target position relative to the patient's anatomy, the intubation system can be configured to stop delivering the first instruction and / or begin delivering the second instruction to the user.

[0020] The intubation system can be configured to provide the first and second instructions to the user partially simultaneously. In other words, the process of providing the first instruction to the user may overlap in time with the process of providing the second instruction to the user. For example, the intubation system can be configured to continue providing one or more first instructions to the user once the intubation system has begun providing the second instruction to the user, for example, if the laryngeal blade is intentionally or unintentionally displaced from the first target position and needs to be moved back to or towards the first target position.

[0021] The first sensor is configured to at least partially capture "one or more other components of the intubation system" which can be or include any component used when delivering the endotracheal tube to the patient's trachea.

[0022] The first sensor is configured to capture a portion of the laryngeal blade and / or a portion of the endotracheal tube and / or a portion of the manipulator and / or a portion of one or more other components of the intubation system, which may be any portion thereof, preferably the distal portion and / or the distal tip.

[0023] The first sensor is configured to capture one or more anatomical features that can be any anatomical feature of the patient's body. For example, the one or more anatomical features may include one or more features outside the patient's body (e.g., one or more facial features, such as one or more features of the patient's nose) and / or one or more features inside the patient's body (e.g., openings into the patient's trachea, one or more vocal cords of the patient, the patient's glottis and / or epiglottis, openings into the patient's esophagus, etc.).

[0024] The intubation system may include computing circuitry configured to process data and / or generate the first and / or second instructions. Alternatively or additionally, the computing circuitry may be provided externally, i.e., not as part of the intubation system, for example, in at least one external computing device.

[0025] The first sensor is preferably an optical sensor, and the data provided by the sensor is preferably image data related to the captured portion and / or the captured anatomical features.

[0026] The endotracheal tube can be configured as any type of tube that can be inserted into a patient's trachea, with the primary purpose of establishing and maintaining a patent airway. For example, the endotracheal tube can be an endotracheal tube, a tracheostomy tube, and / or a tracheal button.

[0027] The first sensor may be attached to the laryngeal blade and / or the endotracheal tube and / or the manipulation member. The first sensor may be disposed at and / or on the distal tip of the laryngeal blade and / or the endotracheal tube and / or the manipulation member, preferably at and / or on the most distal tip.

[0028] The first sensor may be included in and / or configured as an inertial measurement unit (IMU) and / or at least one load cell.

[0029] The first sensor may be configured to provide visual data of captured portions of the laryngeal blade and / or endotracheal tube and / or manipulation member and / or one or more other components and / or one or more anatomical features of the intubation system, preferably a live video feed. The visual data may be displayed on at least one display.

[0030] The first and / or second instructions can be any type of information based on data provided by the first sensor, and can be provided to the user in a manner that allows the user to perceive the corresponding instruction so that the instruction can be applied (e.g., audibly, visually, and / or haptically). For example, the first and / or second instructions may include at least one command for moving or further moving the laryngeal blade and / or the endotracheal tube and / or the manipulator, and / or at least one command for reducing (e.g., stopping) the movement of the laryngeal blade and / or the endotracheal tube and / or the manipulator.

[0031] Alternatively or additionally, the first instruction and / or the second instruction may include at least one command for moving one or more parts of the patient's body, such as moving to a better and / or optimal position for performing the operation. Alternatively or additionally, the second instruction may include at least one command for hinged at least a portion of the manipulator, such as hinged at least one flexible portion of the manipulator to move toward and / or reach the second target position.

[0032] The first instruction and / or the second instruction may include at least one warning that the manipulation of the laryngeal blade and / or the endotracheal tube and / or the manipulator is incorrect, and / or at least one confirmation that the manipulation of the laryngeal blade and / or the endotracheal tube and / or the manipulator is correct and / or the corresponding target position has been reached.

[0033] The endotracheal tube may include at least one scale, preferably a visible scale, associated with at least a portion of the endotracheal tube, for example, attached to at least a portion of the endotracheal tube, for example, to determine the depth of insertion of the endotracheal tube into the patient, for example, relative to the second target location. The scale may include, for example, one or more reference markers and / or at least one color code. The first sensor may be configured to at least partially capture the scale when the endotracheal tube and thus the scale are at least partially inside the patient. The first command and / or the second command may further include at least one warning that the endotracheal tube has been placed too deeply into the patient, for example, beyond the second target location.

[0034] The intubation system can be configured to generate the first instruction and / or the second instruction, preferably individually and / or based on one or more predetermined instructions. The first instruction and / or the second instruction can be provided and optionally generated based on one or more criteria of data provided by the first sensor, such as when the intubation system detects and / or does not detect one or more features (preferably predetermined features) of the laryngeal blade and / or the endotracheal tube and / or the patient's anatomy and / or one or more other components of the intubation system. The predetermined instructions can be one or more instructions stored in at least one accessible memory.

[0035] The intubation system may include the actuating member. The actuating member may be configured to receive the endotracheal tube by at least partially fitting (e.g., sliding) it onto the actuating member. When the endotracheal tube is received by the actuating member, the endotracheal tube may at least partially conform to the shape of the actuating member. The actuating member may include at least one flexible portion configured to bend in at least one degree of freedom, preferably at least two degrees of freedom, more preferably at least three degrees of freedom. The actuating member may be configured to manipulate at least a portion of the endotracheal tube by manipulating at least a portion of the actuating member, preferably by bending the actuating member through one or more flexible portions. The actuating member may be configured as a fiber optic endoscope and / or a stylet.

[0036] The actuating member may include at least one angulation wire configured to bend the actuating member in at least one degree of freedom at least in at least one bendable portion. The movement (e.g., bending) of the angulation wire may be controlled by a user, such as manually, and / or by providing one or more inputs to at least one input device operatively connected to or operatively operable to the angulation wire. For example, the angulation wire may be moved by one or more actuators, which may be user-controlled, and / or the angulation wire may be configured to be manually moved by operating one or more manual control elements (e.g., one or more bending control knobs).

[0037] The cannulation system may include at least one control unit configured to operate the actuation member at least partially automatically, preferably at least partially based on data provided by the first sensor.

[0038] The intubation system can be configured to determine and / or indicate to the user that the laryngeal blade is substantially in the first target position and / or the endotracheal tube and / or the manipulator is substantially in the second target position. This allows the user to rely at least in part on the intubation system to determine and / or indicate that the laryngeal blade is substantially in the first target position and / or the endotracheal tube and / or the manipulator is substantially in the second target position. This can provide (further) assistance to the user during the delivery of the endotracheal tube to the patient's trachea. Once the laryngeal blade is substantially in the first target position, for example when at least one of the patient's vocal cords is visible and / or the opening into the patient's trachea is visible and / or opened to a certain extent (e.g., percentage), the intubation system can be configured to instruct the user to begin the intubation procedure, for example by advancing the endotracheal tube. For example, the intubation system can apply one or more algorithms, such as those based on artificial intelligence and / or deep learning, such as the raw output of artificial intelligence, to determine at least one view and / or at least one image captured by the first sensor, based on which the laryngoscopy procedure is considered complete.

[0039] Alternatively or additionally, the user may determine and / or confirm that the laryngeal blade is substantially in the first target position and / or the endotracheal tube and / or the manipulator is substantially in the second target position. The intubation system may include at least one input device configured to receive at least one input from the user (e.g., at least one confirmation) that the laryngeal blade is substantially in the first target position and / or the endotracheal tube and / or the manipulator is substantially in the second target position.

[0040] The intubation system may be configured to determine and / or indicate to the user at least one degree of progress in manipulating the laryngeal blade to the first target position and / or at least one degree of progress in manipulating the endotracheal tube and / or the manipulating member to the second target position. In other words, the intubation system may be configured to determine and / or indicate the status of the laryngoscopy procedure and / or intubation procedure.

[0041] The first target location may be a predetermined location and / or the second target location may be a predetermined location. For example, the first target location and / or the second target location may be predetermined relative locations, such as locations relative to the patient's anatomical structures, respectively. Alternatively or additionally, the first target location and / or the second target location are determined based on artificial intelligence. Preferably, the cannulation system is configured to determine, based on artificial intelligence, that the first target location and / or the second target location, respectively, have been reached.

[0042] The intubation system can be configured to switch from a laryngoscopy mode to an intubation mode, in which a first instruction is provided for manipulating the laryngeal blade to a first target position, and in the intubation mode a second instruction is provided for manipulating the endotracheal tube and / or the manipulator to a second target position, preferably switching occurs once the laryngeal blade is substantially in the first target position. The "switch" from laryngoscopy mode to intubation mode preferably means providing a different set of instructions; that is, a first instruction for laryngoscopy manipulation is provided in laryngoscopy mode, and a second instruction used for intubation manipulation in intubation mode is at least partially, preferably completely, replaced.

[0043] The intubation system may be configured to automatically switch from the laryngoscopy mode to the intubation mode. Alternatively or additionally, the intubation system may be configured to require at least one user input, such as at least one confirmation, before switching from the laryngoscopy mode to the intubation mode.

[0044] Alternatively or additionally, the intubation system may be configured to switch from the intubation mode to the laryngoscopy mode.

[0045] The intubation system may be configured to generate and prompt one or more warnings to the user when the user deviates from the target position and / or target orientation and / or target insertion path of the laryngeal blade and / or the endotracheal tube and / or the manipulator in the patient's body, preferably when the deviation is by a predetermined degree. The "target position" and / or "target orientation" may respectively include any position or orientation on the path leading to the first target position and / or the second target position and / or at the first target position and / or the second target position.

[0046] The intubation system may include at least one user interface having at least one manual input device configured to receive manual input commands from a user. The manual input device may include at least one button and / or at least one switch and / or at least one touchscreen and / or at least one joystick for receiving manual input commands from the user.

[0047] The intubation system may include at least one display. The intubation system may be configured to display, during operation of the intubation system, at least one image of one or more anatomical features of the patient and / or at least a portion of the laryngeal blade and / or at least a portion of the endotracheal tube and / or at least a portion of the manipulator, preferably a live feed, based on data provided by the first sensor.

[0048] For example, the user interface can be integrated into the display, for instance, by configuring the display as a touchscreen.

[0049] The intubation system can be configured to display on the display at least one target indicator representing at least one target position and / or at least one target orientation of the laryngeal blade and / or the endotracheal tube and / or the manipulation member, and at least one actual indicator representing at least one actual position and / or at least one actual orientation of the laryngeal blade and / or the endotracheal tube and / or the manipulation member. The actual position and / or actual orientation refer respectively to the current physical position and / or current physical orientation of the laryngeal blade and / or the endotracheal tube and / or the manipulation member. This simplifies the way information is conveyed to the user, for example, allowing the user to interpret the information more easily.

[0050] The intubation system can be configured to display the target indicator and / or the actual indicator in an abstract manner, for example, by using one or more relatively simple geometric shapes, such as one or more points. For instance, the target indicator and the actual indicator can each be displayed as a point, wherein the point of the actual indicator moves on the display based on the actual movement of the laryngeal blade and / or the endotracheal tube and / or the manipulator (e.g., based on data provided by one or more sensors). Therefore, a user can determine whether the laryngeal blade and / or the endotracheal tube and / or the manipulator is being moved closer to or away from the corresponding target position based on the position of the actual indicator relative to the target indicator (e.g., based on the distance of the actual indicator relative to the target indicator).

[0051] The intubation system may be configured to, during operation of the intubation system, overlay information on the display onto at least one image, preferably a real-time streaming image, of one or more anatomical features of the patient and / or at least a portion of the laryngeal blade and / or at least a portion of the endotracheal tube and / or at least a portion of the manipulator. This information may be provided for guidance and / or warning purposes.

[0052] The information may correspond to and / or represent the first and / or second instructions. The information may be any of at least one arrow, at least one piece of text, at least one symbol, and any type of indicator perceptible to the user. This allows the user to see a visual image of the laryngoscopy and / or intubation procedure, along with relevant information, on the same display. Alternatively or additionally, the information may include information about one or more anatomical features of the patient, particularly indications of the location of the one or more anatomical features. The anatomical features may include one or more of the following: the valgus, vocal cords, tracheal opening, and esophagus. This may help the user detect and / or identify the one or more anatomical features, particularly the location of the one or more anatomical features relative to at least a portion of the intubation system (e.g., the laryngeal blade and / or the endotracheal tube).

[0053] The intubation system may be configured to provide the first and / or second instructions to the user through one or more of the following means: visual, auditory, and tactile. For example, the first and / or second instructions may be provided to the user through one or more speakers and / or through one or more displays and / or through at least one resistance and / or at least one vibration (e.g., on at least one gripping portion of the intubation system configured to be gripped by the user).

[0054] The cannulation system can be configured to apply one or more algorithms (preferably one or more heuristic algorithms) to data provided by the first sensor, and generate the first and / or second instructions based at least in part on this data. The algorithms may include one or more image recognition algorithms, such as those for detecting and / or classifying one or more anatomical features of the patient. The algorithms may include one or more heuristic algorithms. The algorithms may use methods such as raw memory storage, moving array of detections, time series filtering of detections, and / or deep learning.

[0055] The intubation system may be configured, for example, by one or more algorithms, to identify whether one or more components of the intubation system (e.g., the laryngeal blade and / or the endotracheal tube and / or the manipulation member) are arranged inside (or outside) the patient and / or in one or more areas inside the patient, or at least nearby, such as near the opening of the patient's trachea and / or the opening of the patient's esophagus.

[0056] The intubation system may include at least one second sensor configured and arranged to capture one or more anatomical features of the patient's face, preferably the patient's nose. The intubation system may be configured to provide the first and / or second commands based at least in part on data provided by the second sensor. The intubation system may use one or more anatomical features of the patient's face as anchor points and / or signals for determining the status of laryngoscopy operation (e.g., the current position of the laryngeal blade) and / or intubation status (e.g., the current position of the endotracheal tube).

[0057] While the laryngeal blade and / or the endotracheal tube are being advanced into the patient, the second sensor may be configured and arranged facing away from the patient's trachea and / or the patient's oral cavity and / or the first sensor. In other words, the second sensor may be configured and arranged facing a direction substantially opposite to the direction in which the laryngeal blade and / or the endotracheal tube are advanced into the patient and / or the detection field of the first sensor. In other words, the second sensor may be configured as a rearward sensor, such as a rearward optical sensor, like a camera, and the first sensor may be a forward sensor.

[0058] The first sensor and / or the second sensor may be configured and arranged such that the angle between the detection direction of the first sensor and the detection direction of the second sensor is at least 90°, preferably at least 110°, more preferably at least 130°, more preferably at least 150°, more preferably at least 170°, and more preferably substantially 180°.

[0059] The second sensor may be configured and arranged to capture, preferably detect and / or classify and / or identify one or more facial features of the patient, particularly one or more features of the nose and / or teeth and / or lips and / or mouth.

[0060] The second sensor may be attached to the laryngeal blade and / or the endotracheal tube and / or the actuating member. The second sensor may be disposed at and / or on the distal tip of the laryngeal blade and / or the endotracheal tube and / or the actuating member, preferably at and / or on the most distal tip.

[0061] The cannulation system may include at least one communication unit configured to be communicatively connected to at least one external data storage and / or data processing unit. The communication unit may be configured to communicate with the external data storage and / or data processing unit via a wireless medium (e.g., WiFi, Bluetooth, 5G, etc.). Alternatively or additionally, the communication unit may be configured to communicate with the external data storage and / or data processing unit via a hard connection (e.g., at least one cable).

[0062] The external data storage and / or data processing unit may be included in the intubation system. Alternatively, the external data storage and / or data processing unit may not be considered part of the intubation system.

[0063] The intubation system may include at least one power storage unit configured to provide power to one or more components of the intubation system. The power storage unit may include one or more batteries, preferably having a relatively high capacity and / or being rechargeable.

[0064] The cannulation system may be configured to reduce the power consumption of one or more components of the cannulation system and / or one or more components configured to cooperate with and / or communicate with at least one component of the cannulation system according to one or more of the following criteria: When at least one extent (e.g., frequency) of the first instruction and / or the second instruction decreases; When the amount of data from the first sensor and / or the second sensor decreases; When the processing level (e.g., frequency) of at least one data source from the first sensor and / or the second sensor is reduced; When at least one degree of motion (e.g., speed) of one or more components (preferably at least the laryngeal blade and / or the endotracheal tube and / or the manipulator) decreases; When one or more anatomical features of the patient are detected or not detected; and When the user activates the reduced power consumption mode of the cannulation system.

[0065] The cannulation system may be configured to perform and / or trigger one or more power reduction measures, preferably via at least one control unit, if one or more criteria (preferably the aforementioned one or more criteria) are met and / or after one or more criteria (preferably the aforementioned one or more criteria) are met. For example, the cannulation system may be configured to adjust at least one processing frequency of processed data (e.g., data from the first sensor and / or the second sensor).

[0066] The intubation system may include one or more input devices for triggering one or more power-reduction measures. For example, the intubation system may include one or more control devices (e.g., one or more buttons) for activating and / or deactivating one or more functions of the intubation system, such as activating and / or deactivating artificial intelligence.

[0067] The intubation system may include at least one motion sensor configured to detect at least one movement of one or more components of the intubation system (preferably the laryngeal blade and / or the endotracheal tube and / or the manipulation member). The motion sensor may be configured as an inertial measurement unit (IMU) and / or included in an inertial measurement unit (IMU).

[0068] The intubation system may include the endotracheal tube. Alternatively, the endotracheal tube may not be considered a component of the intubation system.

[0069] This disclosure also relates to a kit that may include at least one intubation system according to any embodiment described herein and at least one external data receiving and processing unit, the external data receiving and processing unit being communicatively connected to the intubation system and configured to receive and process data received by the intubation system and / or send data to the intubation system.

[0070] This disclosure also relates to an intubation system for delivering an endotracheal tube to a patient's trachea according to a second aspect of this disclosure. The intubation system may include at least one laryngeal blade for providing access to the patient's pharynx. The intubation system may include at least one first sensor. The first sensor may be configured to capture at least one location and / or at least one orientation of during operation of the intubation system: at least a portion of the laryngeal blade; and / or at least a portion of the endotracheal tube; and / or one or more anatomical features of the patient; and / or at least a portion of at least one actuating member configured to at least partially receive and manipulate the endotracheal tube. Features, embodiments, and advantages disclosed herein (e.g., above and / or below and / or with respect to the intubation system according to the first aspect of this disclosure) are applicable to or may be applicable to the intubation system according to the second aspect of this disclosure.

[0071] The features described below are applicable to intubation systems according to the first aspect of this disclosure and / or the second aspect of this disclosure.

[0072] The intubation system may include a plurality of the at least one laryngeal blade. The laryngeal blades may differ in at least one physical characteristic, preferably in shape and / or size and / or one or more dimensions. The laryngeal blades are interchangeably mounted to the mounting interface of the intubation system. This allows for the selection of a suitable and / or more appropriate laryngeal blade, for example, based on the patient and / or the patient's anatomy.

[0073] The intubation system may include an installation interface configured to be interchangeably operatively coupled to any of a plurality of different laryngeal blades. The laryngeal blades may differ in at least one physical characteristic, preferably in shape and / or size and / or one or more dimensions. This provides the user with a choice of different laryngeal blades, allowing selection of a suitable blade, for example, based on the patient and / or the patient's anatomy. For example, the user may select a laryngeal blade based on various factors and / or characteristics, such as the patient's age, patient size, comorbidities, etc.

[0074] The intubation system can be configured to detect when and / or whether one of the laryngeal blades has been installed into the mounting interface and / or which of the plurality of laryngeal blades has been installed into the mounting interface. Alternatively or additionally, this feature can be implemented for any device that can be installed into and / or can be mounted into the intubation system (e.g., a fiber optic endoscope, etc.). This can provide a means of automatically detecting installed devices (e.g., laryngeal blades). This can facilitate laryngoscopy procedures, such as determining whether the most suitable laryngeal blade for a particular procedure and / or patient has been installed and / or applied. Furthermore, this can allow the intubation system to select one and / or a suitable AI model from multiple different artificial intelligence (AI) models, for example, for generating and / or providing instructions to the user (e.g., the first instruction and / or the second instruction). Additionally, this can reduce the risk of errors during laryngoscopy procedures and / or intubation procedures.

[0075] Specifically, the intubation system may be configured to apply automated detection algorithms, such as AI algorithms, preferably using a video feed of a corresponding device (e.g., a laryngeal blade) installed in the intubation system, to determine which device (e.g., a laryngeal blade) is installed. Once the device (e.g., a laryngeal blade) is determined, the intubation system may be configured to apply the AI ​​algorithm and generate and / or provide instructions related to the determined and / or detected device (e.g., a laryngeal blade).

[0076] The above configuration can be implemented as an example: 1. Connection detection: The intubation system can detect when a new device (e.g., a laryngeal blade) is connected and / or installed into the intubation system.

[0077] 2. Initial Device Verification: The cannulation system then acquires the raw video stream from the connected device and samples the incoming frames of the raw video stream. These frames can be processed by an AI algorithm to predict which device classification they are suitable for.

[0078] 3. Repeated detection until statistical certainty: The cannulation system can track which device was predicted in step 2 until the prediction history reaches a point of statistical certainty, such as a predetermined point.

[0079] 4. Disable the AI ​​algorithm and / or the processor configured to apply the AI ​​algorithm until another device is connected to the intubation system. Once statistical determinism is achieved, the intubation system may cease operation and / or application of the AI ​​algorithm until it detects a new device connected to the intubation system.

[0080] The cannulation system may include at least one processor configured to execute and / or run AI algorithms, such as the AI ​​algorithms described above and / or any AI algorithms described herein.

[0081] One or more components may be removably mounted to one or more mounting ports of the cannulation system. Preferably, the cannulation system is configured to detect when and / or whether at least one of the one or more components is mounted to the mounting port. This can provide means for automatically detecting the one or more components, such as ensuring that all necessary components are mounted and / or determining whether the component best suited for a particular procedure and / or patient is being applied.

[0082] The intubation system may be configured to detect one or more features of the laryngeal blade and / or one or more components of the intubation system that may be attached to the intubation system and optionally removable from the intubation system.

[0083] The one or more features may include one or more of the following: the type or category of the laryngeal blade or the component, one or more dimensions of the laryngeal blade or the component, or the suitability of the laryngeal blade or the component for a particular operation and / or a particular patient.

[0084] The intubation system can be configured to detect one or more features based on images or videos (preferably live images or live video streams) of the laryngeal blade and / or corresponding components, preferably wherein the images or videos (preferably live images or live video streams) are generated based on data provided by the first sensor.

[0085] The intubation system can be configured to detect one or more features based on the image or video (preferably the real-time image or real-time video stream) by applying at least one algorithm (preferably at least one artificial intelligence algorithm).

[0086] The one or more components may include one or more optical fibers and / or one or more cores.

[0087] The cannulation system can be configured to determine and / or select the first instruction and / or the second instruction (preferably selected from multiple different sets of first instructions and / or second instructions) and / or adjust the first instruction and / or the second instruction based on one or more detected features.

[0088] The intubation system can be configured to generate a rating and / or report on the user's performance during the intubation process after the user performs the intubation procedure, and to generate feedback to the user including and / or based on the rating and / or report. This allows for the automatic provision of a report on the performance of the laryngoscopy and / or intubation procedures upon completion of the procedure. The intubation system can be configured to communicate the report to the user either by saving the report to a file (e.g., in the storage device of the intubation system and / or an external storage device) or by displaying the report (e.g., on the display of the intubation system, such as directly after the procedure). The intubation system can be configured to convey the report to the user visually and / or audibly and / or tactilely. This can improve the efficiency of the laryngoscopy and / or intubation procedures. Existing practices heavily rely on experienced users providing feedback personally or via video reports, which consumes significant resources and limits the frequency and availability of such feedback. Automated performance reporting can enhance learning, reduce errors, and improve patient outcomes, particularly by providing immediate and / or consistent feedback.

[0089] The cannulation system can be configured to record operational data, identify one or more performance indicators, and / or provide feedback related to patient risk.

[0090] The above configuration can be implemented as an example: 1. Data processing: The cannulation system can process incoming data from one or more sensors (in particular one or more image sensors, such as the first sensor), extract information from the patient's anatomical structures detected by the one or more sensors, and generate information and / or one or more warnings based on the data using an AI algorithm.

[0091] 2. Real-time performance analysis: The intubation system can maintain a list of errors and achievements detected during laryngoscopy and / or intubation procedures, particularly when events occur, including the time of occurrence. This list can be continuously updated as the procedure progresses. The list may include: • Time to tracheal intubation. • Number of attempts • Percentage of glottal opening. • Number of esophageal intubations • Visualization grade • Respect for tissue. • The smoothness of the operation (flow of procedure). • etc.

[0092] 3. Completion of Procedure: The intubation system can detect whether the laryngoscopy and / or intubation procedure has been successfully completed based on previous events (e.g., the intubation system can detect that the endotracheal tube has entered the patient's trachea, and then the intubation system can detect that the device is currently outside the patient's body, indicating that the procedure has been completed). 4. Saving Performance Reports: The intubation system can then compile and save performance reports from real-time performance analysis, for example, in a unique format for each specific attempt, which may include appropriate metadata, including patient, user, and system information (if available). These reports are readily accessible to the user.

[0093] 5. Display Performance Report: Upon detection of the completion of a laryngoscopy procedure and / or intubation procedure, the intubation system may display a performance report to the user. This may be a new window or field displayed on the intubation system's monitor. It also includes viewing older reports or multiple reports from previous procedures, and providing comparisons and statistical analyses of all procedures to assess performance over a period of time.

[0094] The rating may be based on the degree of deviation and / or conformity between the user's performance and the first and / or second instructions.

[0095] The rating may be based on one or more of the following: endotracheal intubation time, number of endotracheal intubation attempts, POGO percentage, number of esophageal intubations, visualization level, tissue protection, smoothness of operation, and patient risk during user performance.

[0096] The intubation system may be configured to predict the location of one or more anatomical features of a patient (e.g., the location of the opening into the patient's trachea) and / or the location of one or more medical instruments (e.g., one or more medical instruments used with and / or by the intubation system) that are not detected or undetectable by the intubation system (particularly by the intubation system's sensors, such as the first sensor), or are not fully detected or not fully detected, or have not yet been (fully) detected or are not (fully) detected, particularly not optically detected or not optically detectable. In other words, the intubation system may be configured to predict the location of one or more anatomical features of a patient that are obscured from the field of view of the intubation system (e.g., obscured from the field of view of the intubation system's sensors, such as the first sensor). This may allow for the prediction and / or estimation of the location (e.g., approximate location) of anatomical features and / or medical devices (e.g., airway management tools), even when they are not visible or not yet visible or not yet fully visible, such as when the anatomical features are partially or completely obscured.

[0097] During laryngoscopy and intubation, the user's ability to accurately locate anatomical features is crucial for successful outcomes. Visualization of key anatomical landmarks, such as the vallecula, tracheal opening, and esophageal opening, guides the user in the correct placement of laryngeal blades, endotracheal tubes, and / or any other airway management tools, which is essential for ensuring airway and patient safety. Many comorbidities and user errors can lead to difficult airways, typically characterized by limited or obstructed visualization of the patient's anatomical features. This can cause the user to misunderstand and / or misinterpret the patient's anatomy, resulting in failed intubation attempts and increasing the risk of morbidity and mortality. Such situations can also cause user panic, stiffness, and / or excessive focus on obtaining a clear view, distracting their attention from the overall procedure and potentially jeopardizing patient safety. Therefore, the configuration described above can alleviate one or more of these problems. This predictive guidance helps the user orient themselves, reduces anxiety, and maintains focus on the overall procedure.

[0098] The cannulation system can be configured to continuously refine its predictive model based on real-time partial and / or complete detection of the target anatomical structure, which can improve accuracy and / or reliability over time.

[0099] The intubation system can be configured to overlay predicted target anatomical structures (e.g., vallecula, vocal cords, tracheal opening, and esophagus) onto the video stream.

[0100] The above configuration can be implemented as an example: 1. Data processing: The cannulation system can process incoming data from sensors (e.g., image sensors) and extract information from patient anatomical features and possible patient condition classifications that may indicate difficult cannulation.

[0101] 2. Predictive modeling of target anatomical structures based on complete occlusion: The cannulation system can acquire real-time anatomical features and comorbidities, and use these to predict the location of target anatomical structures. These predictive metrics can be stored internally within the cannulation system.

[0102] 3. Predictive modeling of partially occluded target anatomical structures: The intubation system can acquire real-time information from step 2, and if any target anatomical structure becomes partially visible during the procedure, the intubation system can update its prediction metrics to match the current input, and the intubation system can further predict the location of the entire target anatomical structure based on a partial view of the target anatomical structure.

[0103] 4. Update predictive modeling using unobstructed target anatomy: The cannulation system can acquire information from steps 2 and 3, and if the user obtains a completely unobstructed view of the target anatomy, the cannulation system can further update its predictive metrics to match the current input.

[0104] 5. Visual overlay: The intubation system can acquire the predicted output of steps 2-4 and visually display the predicted output to the user through the display of the intubation system.

[0105] According to a further aspect that can be implemented in conjunction with any of the above-described intubation systems, the intubation system can be configured to detect one or more anatomical features of the mannequin and associate the detected anatomical features of the mannequin with one or more anatomical features of the human body corresponding to the one or more anatomical features of the mannequin.

[0106] When the intubation system detects one or more anatomical features of a mannequin associated with the anatomical features of a human body, the intubation system can be configured to display images of one or more anatomical features of the human body to the user. This can simulate a realistic anatomical view when the user performs laryngoscopy and / or intubation procedures on the mannequin.

[0107] In other words, the intubation system can detect and locate the anatomical features of the mannequin, and then overlay real human anatomical images on these detected features. This allows for the simulation of one or more obstacles, such as trauma, blood, mucus, mist, and vomit, to simulate challenging clinical conditions. Effective training is crucial for medical professionals performing laryngoscopy and intubation procedures. Mannequins are widely used for training purposes because their tissues feel realistic and are easy to manipulate, but they often lack the realistic visual feedback needed to adequately prepare users for actual clinical conditions. Current-level mannequins provide realistic anatomical features and can simulate comorbidities to create difficult intubations via actuators, pumps, fluids, and control circuitry. The high cost of advanced mannequins limits their adoption, making many training programs inaccessible. Furthermore, the materials used in these mannequins are often fragile, reducing their usability and requiring frequent replacements. Additionally, the variety of simulated environments offered by these mannequins may be limited, potentially restricting the range of training scenarios available to users. Therefore, the configuration described above can provide a more cost-effective alternative for practicing laryngoscopy and / or intubation procedures on more advanced and complex mannequins, which can improve the accessibility of high-quality training. This feature improves the training experience by providing more realistic and diverse training scenarios, and better prepares healthcare professionals for real-world operations.

[0108] The above configuration can be implemented as an example: 1. Select training scenario: Users can choose from a variety of training scenarios.

[0109] 2. Data processing: The cannulation system can process incoming data from one or more sensors of the cannulation system (e.g., one or more image sensors, such as the first sensor) and extract information from the anatomical features of the human model detected by the sensors.

[0110] 3. Generating Human Images: The intubation system may use one or more algorithms (e.g., one or more AI algorithms) to generate realistic human anatomical images based on the selected training scenario and the output of data processing. Generating these images may include methods such as: • Generative AI models • Stable diffusion AI model, • Overlay pre-saved images onto the segmented anatomical structures of the human body model. • And / or use the selected training scenario, detection and localization of human model anatomical features as conditional controls for any of the above methods.

[0111] 4. Visual overlay: The intubation system can acquire the output of step 3 and visually display the generated human body image to the user through the display of the intubation system.

[0112] The cannulation system may be configured to display at least one image (preferably a real-time stream) of one or more anatomical features of the human model on a display, preferably based on data provided by the first sensor. The cannulation system may be configured to overlay images of associated human anatomical features on the display.

[0113] According to a further aspect that can be implemented in conjunction with any of the aforementioned intubation systems, the intubation system can be configured to determine the patient's oxygen saturation (SpO2), for example, based on data provided by the first sensor, such as hue shift analysis based on the patient's mucosa. For example, the intubation system can be configured to estimate the patient's SpO2 using a visual feed of the laryngoscopy and / or intubation procedures. The intubation system can apply an AI model trained for detecting and / or determining the patient's SpO2. Alternatively or additionally, the AI ​​model of the intubation system can be configured to select anatomical features from which patient SpO2 analysis can be performed.

[0114] According to a further aspect that can be implemented in conjunction with any of the aforementioned intubation systems, the intubation system can be configured to determine and / or detect patient conditions and / or comorbidities and / or ailments that pose a risk when the intubation procedure is performed on the patient via the intubation system, and / or patient conditions and / or comorbidities that pose a risk when the intubation procedure is performed on the patient via the intubation system. This allows the intubation system to classify and / or detect whether the patient has one or more conditions associated with difficult intubation, such as neck trauma, a high Mallampati grade, obesity, etc. An AI model of the intubation system can be trained to detect patient conditions and / or comorbidities and / or ailments.

[0115] The condition and / or comorbidities and / or discomfort may include neck trauma, Mallampati classification (especially a Mallampati classification at and / or above a certain threshold, such as Mallampati grade 3 or higher), obesity, etc.

[0116] The intubation system can be configured to generate a user-perceptible warning when the intubation procedure is not completed within a predetermined time period, and / or instruct the user to provide oxygen to the patient by means other than intubation when one or more conditions are met (particularly when the predetermined duration is exceeded). This can provide a timer and / or detection that the operation is not performed as planned and / or that the patient's health is at risk if oxygen is not provided to the patient soon. In the case of tracheotomy, the intubation system can be configured to generate an alarm to notify trained and / or authorized and / or designated personnel to perform the tracheotomy. Alternatively or additionally, the intubation system can be configured to instruct the user to use different components or instruments of the intubation system, such as different laryngeal blades and / or different endotracheal tubes, particularly laryngeal blades and / or endotracheal tubes of different sizes and / or shapes from the current laryngeal blades and / or endotracheal tubes, particularly laryngeal blades and / or endotracheal tubes of more suitable or appropriate sizes. This can assist the user in applying the most appropriate component, particularly according to the corresponding patient and / or corresponding situation.

[0117] The "methods other than intubation" may include bag ventilation, direct oxygen supply and / or tracheotomy.

[0118] The cannulation system can be configured to display (preferably automatically) a pre- and / or post-operation checklist. This checklist may include a set of predetermined steps and / or checks that the user should perform.

[0119] The intubation system can be configured to detect fluid in the patient's pharynx and / or oral cavity, and optionally generate a user-perceptible warning that fluid has been detected.

[0120] The cannulation system can be configured to generate instructions to the user to remove the liquid and how to remove it.

[0121] The intubation system may be configured to generate a virtual representation, particularly a digital model, of the laryngeal blade, the endotracheal tube, and optionally the patient's anatomical structures during operation of the intubation system. Preferably, the intubation system is configured to display the virtual representation on at least one display, and preferably, the intubation system is configured to move and / or orient the virtual representation on the display to correspond to the movement and / or orientation of the intubation system during operation. This can provide a real-time external view of the orientation of the laryngeal blade, endotracheal tube, and / or other devices relative to the patient's anatomy, such as one or more outputs based on an artificial intelligence (AI) model. The intubation system may be configured to display one or more instructions (e.g., the first instruction and / or the second instruction) and / or one or more warnings, along with the virtual representation.

[0122] The intubation system can be configured to adjust (preferably rotate, preferably flip) the orientation of at least one image (preferably a live stream image) based on at least one standard during operation of the intubation system. This image is generated based on data provided by the first sensor and displayed on at least one display. This can facilitate laryngoscopy and / or intubation procedures. For example, if the intubation system detects that an operation (e.g., laryngoscopy and / or intubation) is being performed inverted (e.g., relative to a normal or reference orientation), the intubation system can be configured to automatically flip or invert the image, particularly automatically aligning it with the user and the intubation system, more specifically, with at least one component of the intubation system (e.g., a laryngeal blade).

[0123] The criteria may include the orientation of the user and / or the intubation system relative to the patient (particularly the patient's trachea).

[0124] This disclosure also relates to a kit that may include at least one intubation system according to any embodiment described herein and at least one endotracheal tube.

[0125] The aforementioned objective is also achieved by a method for delivering an endotracheal tube into a patient's trachea, preferably by an intubation system according to any embodiment described herein.

[0126] The features, implementation schemes, and advantages of the cannulation system described in this article are applicable accordingly to the method described.

[0127] The method may include inserting a laryngeal blade into a patient's mouth, the laryngeal blade being configured to provide access to the patient's pharynx.

[0128] The method may include capturing at least one of the following positions and / or at least one orientation via at least one first sensor: At least a portion of the laryngeal blade; and / or At least a portion of the endotracheal tube; and / or One or more anatomical features of the patient; and / or At least a portion of at least one actuating member, the actuating member being configured to at least partially receive and actuate the endotracheal tube.

[0129] The method may include providing a user with one or more first instructions, based on data provided by the first sensor, for manipulating the laryngeal blade to a first target position relative to the patient's anatomy. The method may include manipulating the laryngeal blade to the first target position, particularly based on the first instructions. The method may include, once the laryngeal blade is substantially in the first target position, providing the user with one or more second instructions, based on data provided by the first sensor, for manipulating the endotracheal tube and / or the manipulating member to a second target position relative to the patient's anatomy. The method may include manipulating the endotracheal tube and / or the manipulating member to the second target position, particularly based on the second instructions.

[0130] The described method steps are not limited to a specific order and can be performed in any technically feasible order.

[0131] The aforementioned objective is also achieved by a further method for delivering an endotracheal tube into a patient's trachea, preferably using an intubation system according to any embodiment described herein. The features, embodiments, and advantages of the intubation system described in detail herein apply accordingly to the method.

[0132] The method may include: A laryngeal blade is inserted into the patient's mouth, the laryngeal blade being configured to provide access to the patient's pharynx.

[0133] The method may include: The endotracheal tube is inserted into and / or enters the patient's trachea through the oral cavity.

[0134] The method may include: The following at least one position and / or at least one orientation is captured by at least one first sensor: At least a portion of the laryngeal blade; and / or At least a portion of the endotracheal tube; and / or One or more anatomical features of the patient; and / or At least a portion of at least one actuating member, the actuating member being configured to at least partially receive and actuate the endotracheal tube.

[0135] The steps described in the method are not limited to a specific order and can be performed in any technically feasible order.

[0136] The following list provides preferred embodiments of this disclosure: 1. An intubation system for delivering an endotracheal tube to a patient's trachea, the intubation system comprising: At least one laryngeal blade, said laryngeal blade being used to provide access to the patient's pharynx; and At least one first sensor, configured to capture at least one of the following positions and / or at least one orientation during operation of the cannulation system: At least a portion of the laryngeal blade; and / or At least a portion of the endotracheal tube; and / or One or more anatomical features of the patient; and / or At least a portion of at least one actuating member, the actuating member being configured to at least partially receive and actuate the endotracheal tube; The intubation system is configured (preferably based on data provided by the first sensor) to provide the user with one or more first commands for manipulating the laryngeal blade (preferably manipulating it to a first target position relative to the patient's anatomy); and / or The intubation system is configured to, preferably once the laryngeal blade is substantially in place, preferably substantially in the first target position, provide the user with one or more second commands (preferably based on data provided by the first sensor) for manipulating the endotracheal tube and / or the manipulator (preferably manipulating it to a second target position relative to the patient's anatomy).

[0137] 2. The intubation system according to aspect 1, comprising the actuating member, wherein the actuating member is configured to receive the endotracheal tube by at least partially fitting the endotracheal tube onto the actuating member, wherein when the endotracheal tube is received by the actuating member, the endotracheal tube at least partially conforms substantially to the shape of the actuating member, wherein the actuating member includes at least one flexible portion configured to bend in at least one degree of freedom, preferably at least two degrees of freedom, more preferably at least three degrees of freedom, wherein the actuating member is configured to manipulate at least a portion of the endotracheal tube by manipulating at least a portion of the actuating member, preferably by bending the actuating member in one or more flexible portions of the actuating member, wherein preferably the actuating member is configured as a fiber optic endoscope.

[0138] 3. The intubation system according to any one of the foregoing aspects, wherein the intubation system is configured to determine and / or indicate to the user that the laryngeal blade is substantially in the first target position and / or the endotracheal tube and / or the manipulator is substantially in the second target position.

[0139] 4. The intubation system according to any one of the foregoing aspects, wherein the intubation system is configured to determine and / or indicate to the user at least one degree of progress in manipulating the laryngeal blade to the first target position and / or at least one degree of progress in manipulating the endotracheal tube and / or the manipulating member to the second target position.

[0140] 5. The cannulation system according to any one of the foregoing aspects, wherein: The first target location is a predetermined location and / or the second target location is a predetermined location; and / or The first target position and / or the second target position are determined based on artificial intelligence, preferably wherein the cannulation system is configured to determine, based on artificial intelligence, that the first target position and / or the second target position have been reached respectively.

[0141] 6. The intubation system according to any one of the foregoing aspects, wherein the intubation system is configured to switch between a laryngoscopy mode and an intubation mode, wherein in the laryngoscopy mode a first instruction is provided for manipulating the laryngeal blade to a first target position, and in the intubation mode a second instruction is provided for manipulating the endotracheal tube and / or the manipulating member to a second target position, preferably switching is performed once the laryngeal blade is substantially in the first target position.

[0142] 7. The intubation system according to any one of the foregoing aspects, wherein the intubation system is configured to generate and prompt one or more warnings to the user, preferably when the user deviates from the target position and / or target orientation and / or target insertion path of the laryngeal blade and / or the endotracheal tube and / or the manipulator in the patient's body, preferably when the deviation is a predetermined degree of deviation.

[0143] 8. The intubation system according to any one of the foregoing aspects, comprising at least one user interface having at least one input device configured to receive input commands from a user, wherein the input device includes at least one button and / or at least one switch and / or at least one touchscreen and / or at least one joystick for receiving input commands from the user.

[0144] 9. The intubation system according to any one of the foregoing aspects, further comprising at least one display, preferably wherein the intubation system is configured to display, during operation of the intubation system, at least one image of one or more anatomical features of the patient and / or at least a portion of the laryngeal blade and / or at least a portion of the endotracheal tube and / or at least a portion of the manipulator based on data provided by the first sensor, preferably a real-time streaming image.

[0145] 10. The intubation system according to aspect 9, wherein the intubation system is configured to display on the display at least one target indicator representing at least one target position and / or at least one target orientation of the laryngeal blade and / or the endotracheal tube and / or the manipulation member, and at least one actual indicator representing at least one actual position and / or at least one actual orientation of the laryngeal blade and / or the endotracheal tube and / or the manipulation member.

[0146] 11. The intubation system according to aspect 9 or 10, wherein the intubation system is configured to, during operation of the intubation system, overlay information on the display at least one image, preferably a real-time streaming image, of one or more anatomical features of the patient and / or at least a portion of the laryngeal blade and / or at least a portion of the endotracheal tube and / or at least a portion of the manipulator.

[0147] 12. The intubation system according to aspect 11, wherein the information includes information about one or more anatomical features of the patient, and in particular an indication of the location and / or presence of one or more anatomical features on the image.

[0148] 13. The intubation system according to any one of the foregoing aspects, wherein the intubation system is configured to provide the first instruction and / or the second instruction to the user in one or more of the following ways: visual, auditory, and tactile.

[0149] 14. The intubation system according to any one of the foregoing aspects, wherein the intubation system is configured to apply one or more algorithms, preferably one or more heuristic algorithms, to data provided by the first sensor, and to generate the first instruction and / or the second instruction based at least in part on the data.

[0150] 15. The intubation system according to any one of the foregoing aspects, further comprising at least one second sensor, wherein the intubation system is configured to provide the first command and / or the second command based at least in part on data provided by the second sensor, preferably wherein the second sensor is preferably configured and arranged to capture one or more anatomical features of the patient’s face, preferably the patient’s nose.

[0151] 16. The intubation system according to any one of the foregoing aspects further includes at least one communication unit configured to be communicatively connected to at least one external data storage and / or data processing unit.

[0152] 17. The intubation system according to any one of the foregoing aspects, further comprising at least one power storage unit configured to provide power to one or more components of the intubation system.

[0153] 18. The intubation system according to any one of the foregoing aspects, wherein the intubation system is configured to reduce the power consumption of one or more components of the intubation system and / or one or more components configured to cooperate with and / or communicate with at least one component of the intubation system according to one or more of the following criteria: When at least one degree of the first instruction and / or the second instruction is reduced; When the amount of data from the first sensor and / or the second sensor decreases; When the processing level of at least one of the data from the first sensor and / or the second sensor is reduced; When the degree of movement of one or more components, preferably at least the laryngeal blade and / or the endotracheal tube and / or the manipulator, decreases; When one or more anatomical features of the patient are detected or not detected; and When the user activates the low-power mode of the cannulation system.

[0154] 19. The intubation system according to any one of the foregoing aspects, wherein the first sensor and / or the second sensor is an optical sensor, preferably an image sensor.

[0155] 20. The intubation system according to any one of the foregoing aspects, further comprising the endotracheal tube.

[0156] 21. An intubation system for delivering an endotracheal tube to a patient's trachea, the intubation system comprising: At least one laryngeal blade, said laryngeal blade being used to provide access to the patient's pharynx; and At least one first sensor, configured to capture at least one of the following positions and / or at least one orientation during operation of the cannulation system: At least a portion of the laryngeal blade; and / or At least a portion of the endotracheal tube; and / or One or more anatomical features of the patient; and / or At least a portion of at least one actuating member, the actuating member being configured to at least partially receive and actuate the endotracheal tube.

[0157] 22. The intubation system according to any one of the foregoing aspects, comprising a plurality of the at least one laryngeal blades, wherein the laryngeal blades differ in at least one physical characteristic, preferably differing in shape and / or size and / or one or more dimensions of the laryngeal blades, wherein the laryngeal blades are interchangeably mounted to the mounting interface of the intubation system.

[0158] 23. The intubation system according to any one of the foregoing aspects, wherein the intubation system includes an installation interface configured to be interchangeably operatively coupled to any of a plurality of different laryngeal blades, wherein the laryngeal blades differ in at least one physical feature, preferably differing in shape and / or size and / or one or more dimensions of the laryngeal blades.

[0159] 24. The cannulation system according to aspect 22 or 23, wherein the cannulation system is configured to detect: When and / or whether one of the laryngeal blades has been installed into the mounting interface; and / or Which of the plurality of laryngeal blades has been installed into the mounting interface.

[0160] 25. The intubation system according to any one of the foregoing aspects, wherein one or more components are removably mounted to one or more mounting interfaces of the intubation system, preferably wherein the intubation system is configured to detect when and / or whether at least one of the one or more components is mounted to the mounting interface.

[0161] 26. The intubation system according to any one of the foregoing aspects, wherein the intubation system is configured to detect one or more features of the laryngeal blade and / or one or more components of the intubation system that can be attached to and optionally removed from the intubation system.

[0162] 27. The intubation system according to aspect 26, wherein one or more features include one or more of the following: the type or category of the laryngeal blade or the component, one or more dimensions of the laryngeal blade or the component, or the suitability of the laryngeal blade or the component for a particular operation and / or a particular patient.

[0163] 28. The intubation system according to aspect 26 or 27, wherein the intubation system is configured to detect one or more features based on an image or video, preferably a real-time image or real-time video stream, of the laryngeal blade and / or corresponding components, preferably wherein the image or video, preferably a real-time image or real-time video stream, is generated based on data provided by the first sensor.

[0164] 29. The intubation system according to aspect 28, wherein the intubation system is configured to detect one or more features based on the image or video, preferably the real-time image or real-time video stream, by applying at least one algorithm, preferably at least one artificial intelligence algorithm.

[0165] 30. The cannulation system according to any one of aspects 25 to 29, wherein the one or more components comprise one or more optical fibers and / or one or more tube cores.

[0166] 31. The cannulation system according to any one of aspects 26 to 30, wherein the cannulation system is configured to determine and / or select the first instruction and / or the second instruction based on one or more detected features, preferably selecting from a plurality of different sets of first instructions and / or second instructions, and / or adjusting the first instruction and / or the second instruction.

[0167] 32. The intubation system according to any one of the foregoing aspects, wherein the intubation system is configured to generate a performance score of the user during the intubation process after the user performs the intubation process through the intubation system, and to generate feedback to the user including and / or based on the score.

[0168] 33. The intubation system according to aspect 32, wherein the scoring is based on the degree of deviation and / or conformity of the user's performance from the first instruction and / or the second instruction.

[0169] 34. The intubation system according to aspect 32 or 33, wherein the scoring is based on one or more of the following: endotracheal intubation time, number of endotracheal intubation attempts, glottic opening percentage, number of esophageal intubations, visualization level, tissue protection, fluency of operation, and patient risk during the user performance.

[0170] 35. The intubation system according to any one of the foregoing aspects, wherein the intubation system is configured to predict the location of one or more anatomical features of the patient that are not detected or not fully detected or undetectable or incompletely detected by the intubation system, particularly the first sensor, especially those that are not optically detected or not optically detected or incompletely optically detected.

[0171] 36. The cannulation system according to any one of the preceding aspects, wherein the cannulation system is configured to detect one or more anatomical features of a human model and associate the detected anatomical features of the human model with one or more anatomical features of a human body corresponding to the one or more anatomical features of the human model.

[0172] 37. The intubation system according to aspect 36, wherein the intubation system is configured to display an image of the one or more anatomical features of the human body to the user when the intubation system detects the one or more anatomical features of the human body model associated with the anatomical features of the human body.

[0173] 38. The cannulation system according to aspect 36 or 37, wherein the cannulation system is configured to display on a display at least one image of one or more anatomical features of the human model, preferably a real-time streaming image, preferably based on data provided by the first sensor, and wherein the cannulation system is configured to overlay the associated image of the human anatomical feature on the display.

[0174] 39. The cannulation system according to any one of the preceding aspects, wherein the cannulation system is configured to determine the patient's blood oxygen saturation, particularly based on data provided by the first sensor, particularly based on hue shift analysis of the patient's mucosa.

[0175] 40. The cannulation system according to any one of the foregoing aspects, wherein the cannulation system is configured to determine and / or detect: The patient’s condition and / or comorbidities and / or discomfort that pose a risk when the intubation procedure is performed on the patient via the intubation system; and / or The patient’s condition and / or comorbidities pose a risk when the intubation procedure is performed on the patient using the intubation system.

[0176] 41. The cannulation system according to any one of the foregoing aspects, wherein the cannulation system is configured to: If the intubation process is not completed within the predetermined time period, a user-perceptible warning is generated; and / or Instruct the user to use a different laryngeal blade and / or a different endotracheal tube, especially a laryngeal blade and / or endotracheal tube of a different size and / or shape from the current laryngeal blade and / or endotracheal tube, especially a laryngeal blade and / or endotracheal tube of a more suitable size; and / or When one or more conditions are met, particularly when a predetermined duration is exceeded, the user is instructed to provide oxygen to the patient by means other than intubation.

[0177] 42. The intubation system according to any one of the foregoing aspects, wherein the intubation system is configured to detect fluid in the patient's pharynx and / or oral cavity, and optionally generate a user-perceptible warning of detected fluid.

[0178] 43. The cannulation system according to aspect 42, wherein the cannulation system is configured to generate instructions instructing the user to remove the liquid and how to remove the liquid.

[0179] 44. An intubation system according to any one of the foregoing aspects, wherein the intubation system is configured to generate, in particular a digital model, a virtual representation of the laryngeal blade and the endotracheal tube, and optionally the anatomical structures of the patient, during operation of the intubation system, preferably wherein the intubation system is configured to display the virtual representation on at least one display, preferably wherein the intubation system is configured to move and / or orient the virtual representation on the display to correspond to the movement and / or orientation of the intubation system during operation.

[0180] 45. The intubation system according to any one of the foregoing aspects, wherein the intubation system is configured to, during operation of the intubation system, adjust, preferably rotate, preferably flip, at least one image, preferably a real-time streaming image, based on at least one standard, the image being generated based on data provided by the first sensor and displayed on at least one display.

[0181] 46. ​​The intubation system according to aspect 45, wherein the criteria include the orientation of the user and / or the intubation system relative to the patient, particularly the patient's trachea.

[0182] 47. A kit comprising at least one intubation system according to any one of the preceding aspects and at least one external data receiving and processing unit, the external data receiving and processing unit being communicatively connected to the intubation system and configured to receive and process data received by the intubation system and / or transmit data to the intubation system.

[0183] 48. A kit comprising at least one intubation system according to any one of aspects 1 to 46 and at least one endotracheal tube.

[0184] 49. A method for delivering an endotracheal tube into a patient's trachea, said method preferably performed using an intubation system according to any one of aspects 1 to 46, said method comprising: A laryngeal blade is inserted into the patient's mouth, the laryngeal blade being configured to provide access to the patient's pharynx; The following at least one position and / or at least one orientation is captured by at least one first sensor: At least a portion of the laryngeal blade; and / or At least a portion of the endotracheal tube; and / or One or more anatomical features of the patient; and / or At least a portion of at least one actuating member, the actuating member being configured to at least partially receive and actuate the endotracheal tube; Based on the data provided by the first sensor, the user is given one or more first commands for manipulating the laryngeal blade (preferably manipulating it to a first target position relative to the patient's anatomical structure); Manipulate the laryngeal blade, preferably manipulating it to the first target position; Preferably, once the laryngeal blade is substantially in place, preferably at the first target position, the user is provided with one or more second commands based on data provided by the first sensor for manipulating the endotracheal tube and / or the manipulator (preferably manipulating it to a second target position relative to the patient's anatomy); and Manipulate the endotracheal tube and / or the manipulation member, preferably manipulating it to the second target position.

[0185] 50. A method for delivering an endotracheal tube into a patient's trachea, the method preferably performed using an intubation system according to any one of aspects 1 to 46, the method comprising: A laryngeal blade is inserted into the patient's mouth, the laryngeal blade being configured to provide access to the patient's pharynx; The endotracheal tube is inserted into the patient's trachea through the oral cavity; The following at least one position and / or at least one orientation is captured by at least one first sensor: At least a portion of the laryngeal blade; and / or At least a portion of the endotracheal tube; and / or One or more anatomical features of the patient; and / or At least a portion of at least one actuating member, the actuating member being configured to at least partially receive and actuate the endotracheal tube.

[0186] Preferred embodiments of the invention are further illustrated below with reference to the accompanying drawings. The described embodiments are merely exemplary and do not limit the invention as defined by the claims and their equivalents.

[0187] Figure 1 An intubation system according to one embodiment of the present disclosure is shown schematically and with perspective illustration; Figure 2 It is shown in schematic and perspective diagrams Figure 1 The intubation system; Figure 3 It is shown in schematic and perspective diagrams Figure 1 and Figure 2 The intubation system; Figure 4It is shown in schematic and perspective diagrams Figures 1 to 3 Modifications to the intubation system; Figure 5 It is shown in schematic and perspective diagrams Figures 1 to 3 The intubation system; Figure 6 It is shown in schematic and perspective diagrams Figures 1 to 3 and Figure 5 The intubation system; Figure 7 Showing Figures 1 to 6 A flowchart of the intubation system's actions and judgments; Figure 8 It is shown in schematic and perspective diagrams Figures 1 to 6 An exemplary configuration of the cannulation system; Figure 9 It is shown in schematic and perspective diagrams Figures 1 to 6 An exemplary configuration of the cannulation system.

[0188] Figures 1 to 6 The illustration shows an intubation system 10 and a procedure for delivering an endotracheal tube 11 (e.g., an intratracheal tube) to the trachea of ​​a patient 12. The intubation system 10 may include at least one laryngeal blade 14 for providing access to the pharynx of the patient 12. The laryngeal blade 14 may be configured to be inserted into the oral cavity of the patient 12 through the user's mouth 15.

[0189] It should be noted that some components may not be shown in every drawing and / or indicated by reference marks, for example, for clarity and / or because some components may be hidden / covered in some drawings.

[0190] The intubation system 10 may include at least one first sensor 20, the first sensor being configured to capture at least one location and / or at least one orientation of the following during operation of the intubation system 10: at least a portion of the laryngeal blade 14 and / or at least a portion of the endotracheal tube 11 and / or one or more anatomical features of the patient 12 and / or at least one manipulator 65 (see Figure 4 At least a part of ).

[0191] The first sensor 20 can be attached to a component of the intubation system 10, for example, to the laryngeal blade 14. Figures 1 to 6 In this configuration, the first sensor 20 is placed inside the patient's body. Therefore, in... Figure 1 and Figure 2 In the diagram, the first sensor 20 is represented by a dashed line.

[0192] The intubation system 10 may include at least one second sensor 21, which is preferably configured and arranged to capture one or more anatomical features of the patient 12’s face, such as the patient 12’s nose 23. The intubation system 10 may be configured to provide the first command and / or the second command based at least in part on the data provided by the second sensor 21.

[0193] like Figure 1 and Figure 2 As shown, when the laryngeal blade 14 and / or the endotracheal tube 11 are being advanced into the patient's body, the second sensor 21 may be configured and arranged facing away from the patient's trachea and / or the patient's oral cavity and / or the first sensor 20. In other words, the second sensor 21 may be configured and arranged in a direction substantially opposite to the direction in which the laryngeal blade and / or the endotracheal tube 11 are advanced into the patient's body and / or the detection direction or detection field of the first sensor 20. In other words, the second sensor 21 may be configured as a rearward sensor, such as a rearward optical sensor, such as a camera, and the first sensor 20 may be a forward sensor.

[0194] The first sensor 20 and / or the second sensor 21 may be configured as optical sensors, for example to provide visual data of the corresponding captured features / elements, preferably real-time video streams, such as captured anatomical features of the patient's body and / or captured portions of the laryngeal blade 14 and / or captured portions of the endotracheal tube 11 and / or captured portions of the manipulator 65 and / or captured portions of one or more other components of the intubation system 10.

[0195] The cannulation system 10 can be configured to apply one or more algorithms (preferably one or more heuristic algorithms, such as algorithms based on artificial intelligence and / or deep learning) to the data provided by the first sensor 20 and / or the second sensor 21, and generate the first instruction and / or the second instruction based at least in part on the data provided by the first sensor 20 and / or the second sensor 21.

[0196] The intubation system 10 may further include at least one handle 24 configured to be gripped by a user. The handle 24 may be connected to the laryngeal blade 14 to allow the user to manipulate the laryngeal blade 14 by gripping and moving the handle 24.

[0197] The intubation system 10 may further include at least one display 28. The display 28 may be connected to the handle 24. The intubation system 10 may be configured to display, at least one image of one or more anatomical features of the patient 12 and / or at least a portion of the laryngeal blade 14 and / or at least a portion of the endotracheal tube 11 and / or at least a portion of the manipulator 65, preferably a real-time streaming image, based at least in part on data provided by the first sensor 20 and / or the second sensor 21. Figures 1 to 6 View 32 of display 28 is shown, which is visible to the user when performing laryngoscopy and / or intubation procedures. As shown in view 32 of display 28, the first sensor 20 and / or the second sensor 21 can capture various anatomical features of the patient 12, which can be displayed to the user on display 28. For example, the opening 38 into the patient's trachea can be at least partially captured by the first sensor 20 and displayed to the user via display 28. The opening 38 is located between the vocal cords 42. The opening 38 and the vocal cords 42 are part of the glottis. The opening 46 into the patient's esophagus can also be captured by the first sensor 20 and / or the second sensor 21 and displayed to the user via display 28. This helps the user prevent the laryngeal blade 14 from entering the opening 38 of the patient's trachea and / or the opening 46 of the patient's esophagus, which could cause serious damage.

[0198] The features / elements captured by the first sensor 20 and / or the second sensor 21 can serve as indications and / or markers of the intubation system 10 to determine whether the laryngeal blade 14 is in the first target position and / or whether the laryngeal blade 14 is moving toward the first target position and / or whether the position and / or orientation of the laryngeal blade 14 may pose a danger to the patient 12.

[0199] The display 28 may display video and / or live stream images of the images captured by the first sensor 20 and / or the second sensor 21. Alternatively or additionally, the display 28 may display one or more individual frames or still images of elements / features captured by the first sensor 20 and / or the second sensor 21.

[0200] Capturing and displaying the anatomical features of the patient 12 to the user can help the user manipulate the laryngeal blade 14 and / or the endotracheal tube 11.

[0201] The intubation system 10 can be configured to provide a user with one or more first commands, based on data provided by the first sensor 20 and / or the second sensor 21, for manipulating the laryngeal blade 14 to a first target position relative to the anatomical structure of the patient 12. Once the laryngeal blade 14 is substantially in the first target position, the intubation system 10 can be configured to provide a user with one or more second commands, based on data provided by the first sensor 20 and / or the second sensor 21, for manipulating the endotracheal tube 11 and / or the manipulator 65 to a second target position relative to the anatomical structure of the patient. The first target position may be a predetermined position and / or the second target position may be a predetermined position. Preferably, the first target position and / or the second target position are determined based on artificial intelligence. Preferably, the intubation system is configured to determine, based on artificial intelligence, that the first target position and / or the second target position have been reached, respectively.

[0202] Therefore, capturing corresponding features / elements, such as one or more anatomical features of the patient 12 and / or at least a portion of the laryngeal blade 14 and / or at least a portion of the endotracheal tube 11 and / or at least a portion of the manipulation member 65, by the first sensor 20 and / or the second sensor 21, can be used to provide and preferably also generate the first command and / or the second command.

[0203] The first instruction and / or the second instruction may be provided to the user in the following ways: visually, for example through the display 28; auditorily, for example through one or more speakers (e.g., on or within the handle 24); and / or tactilely, for example through one or more vibrations and / or resistance provided to the handle 24. The cannulation system 10 may be configured to provide the first instruction to the user in the same manner as the second instruction (e.g., visually, auditorily, and / or tactilely) or in a different manner.

[0204] The intubation system 10 may be configured to overlay information 50 onto and / or alongside at least one image on the display 28 during operation of the intubation system 10. The information 50 may be provided for guidance and / or warning purposes. The information 50 may correspond to and / or represent the first instruction and / or the second instruction. The information 50 may be any of at least one arrow, at least one piece of text, at least one symbol, and any type of indicator perceptible to the user. As an example, the first instruction (i.e., information 50) may be displayed on the display 28 as one or more arrows to guide the user, for example, in the direction in which the laryngeal blade 14 should be manipulated toward a first target position.

[0205] like Figure 1As shown, the information 50 (e.g., arrows) enables the user to manipulate the laryngeal blade 14 based on the information 50. Figure 1 In this context, the user can use the information 50 to make adjustments in one or more directions 52 (in...) Figure 1 (Depicted as a dashed arrow in the middle) manipulates the laryngeal blade 14.

[0206] The intubation system 10 may be configured to determine and / or indicate to the user that the laryngeal blade 14 is substantially in the first target position. The intubation system 10 may be configured to determine and / or indicate to the user (e.g., via the display 28) at least one degree of progress in manipulating the laryngeal blade 14 to the first target position.

[0207] Once the laryngeal blade 14 is substantially in the first target position, the intubation system 10 can be configured to switch from a laryngoscopy mode to an intubation mode, in which a first command is provided to manipulate the laryngeal blade 14 to the first target position, and in the intubation mode, a second command is provided to manipulate the endotracheal tube 11 and / or the manipulator 65 to the second target position. This is in Figure 2 The text "Start endotracheal intubation" displayed on the display 28 is indicated in an exemplary manner.

[0208] Switching from laryngoscopy mode to intubation mode can be based on one or more features / elements captured by the first sensor 20 and / or the second sensor 21, such as any features / elements described above.

[0209] Therefore, once Figure 2 As shown, when the laryngeal blade 14 is in the first target position, the user can begin inserting the endotracheal tube 11, as follows. Figure 3 As shown. Figure 2 As shown, with Figure 1 Compared to the scenario shown, a greater portion (i.e., most) of the opening 38 and / or vocal cords 42 entering the patient's trachea can be captured by the first sensor 20 and optionally displayed to the user via the display 28. Specifically, capturing one or more features (e.g., a proportion and / or portion) of the opening 38 and / or vocal cords 42 entering the patient's trachea can be an indication to the intubation system 10 and / or the user that the first target location has been reached; for example, this could allow and / or trigger the intubation system 10 to begin providing the second instruction to the user. For example, in Figure 2 In this process, the sensor 20 captures a larger portion of the epiglottis 58, vocal cords 42, and opening 38, which is consistent with... Figure 1 Conversely, this can be interpreted as an instruction to the cannulation system 10 and / or the user that the first target location has been reached.

[0210] The intubation system 10 may be configured to provide a user with a second instruction, based on data provided by the first sensor 20 and / or the second sensor 21, for manipulating the endotracheal tube 11 and / or the manipulator 65 to a second target position relative to the patient's anatomy, preferably in the intubation mode, preferably only in the intubation mode, i.e. when the laryngeal blade is substantially in the first target position.

[0211] The features / elements captured by the first sensor 20 and / or the second sensor 21 can serve as indicators and / or markers of the intubation system 10 for determining whether the endotracheal tube 11 and / or the manipulator 65 are in the second target position and / or whether the endotracheal tube 11 and / or the manipulator 65 are moving toward the second target position and / or whether the position and / or orientation of the endotracheal tube 11 and / or the manipulator 65 may pose a danger to the patient 12.

[0212] Similar to a laryngoscopy procedure, the intubation system 10 may overlay information 64 (e.g., one or more arrows and / or text and / or symbols and / or any type of indication perceptible to the user) onto and / or alongside at least one image on the display 28 during intubation. The information 64 may be provided for guidance and / or warning purposes. The information 64 may correspond to and / or represent the second instruction. As an example, the second instruction (i.e., information 64) may be displayed on the display 28 as one or more arrows to guide the user, for example, in the direction the endotracheal tube 11 should be manipulated toward a second target position.

[0213] like Figure 3 As shown, the information 64 (e.g., arrows) enables the user to manipulate the laryngeal blade 14 and / or the endotracheal tube 11 based on the information 64. Figure 3 In this context, the user can use the information 64 to make adjustments in one or more directions 68 (in...) Figure 3 (Depicted as a dashed arrow in the middle) manipulates the endotracheal tube 11.

[0214] like Figures 1 to 3 As shown, a user can grasp and manipulate the endotracheal tube 11. Alternatively or additionally, the intubation system 10 may include at least one manipulation member 65 (e.g., a stylet and / or bougie and / or fiber optic endoscope) configured to receive the endotracheal tube 11, for example by at least partially mounting the endotracheal tube 11 onto the manipulation member 65 (e.g., its shaft). Figure 4As shown. The manipulation member 65 may be configured to be manipulated and / or actuated (e.g., bent) by a user, such as by the user grasping and manipulating the manipulation member 65, and / or by one or more actuators included in the cannulation system 10, for example, the actuators may be controlled by one or more user inputs provided via at least one user interface (e.g., at least one joystick).

[0215] When the endotracheal tube 11 is received by the actuating member 65, the endotracheal tube 11 can at least partially conform to the shape of the actuating member 65. The actuating member 65 may include at least one flexible portion configured to bend in at least one degree of freedom, preferably at least two degrees of freedom, more preferably at least three degrees of freedom. The actuating member 65 may be configured to manipulate at least a portion of the endotracheal tube 11 by manipulating at least a portion of the actuating member 65, preferably by bending the actuating member 65 in one or more flexible portions. Preferably, the actuating member 65 is configured as a fiber optic endoscope or a video endoscope (e.g., a CCD endoscope).

[0216] The operating member 65 may include one or more control elements 66 (e.g., one or more control knobs) for user control / adjustment, such as by rotating a knob (in... Figure 4 (represented by dashed line 69) to manipulate one or more portions of the manipulation member 65, such as the distal end or distal portion 67 of the manipulation member 65, thereby manipulating one or more portions of the endotracheal tube 11.

[0217] The intubation system 10 may be configured to overlay user-understandable information 68 (e.g., one or more arrows and / or text and / or symbols and / or any type of indicator, such as at least one command to bend the manipulator 65, for example, to bend the distal end or distal portion 67 of the manipulator 65 upwards) onto and / or alongside at least one image on the display 28 during intubation. The information 68 may be provided for guidance and / or warning purposes. The information 68 may correspond to and / or represent the second instruction.

[0218] Figure 1 and Figure 2 The sensor 20 shown and / or at least one additional sensor may be attached to a portion of the actuation member 65, for example, to the distal end or distal portion 67 of the actuation member 65.

[0219] The cannulation system 10 can be configured to determine and / or check (and optionally indicate to the user) that the cannulation operation has been completed, which in Figure 5 The text "Tracheal intubation completed" displayed on the display 28 is indicated in an exemplary manner.

[0220] The intubation system 10 may be configured to determine and / or check (and optionally instruct the user) whether the endotracheal tube 11 is in the opening 46 of the patient's esophagus, as described above, which could cause serious injury. If the intubation system 10 determines that the endotracheal tube 11 is in the patient's esophagus, the intubation system 10 may be configured to provide a second instruction, such as one or more warnings and / or directions, for removing the endotracheal tube 11 from the patient's esophagus. This is in Figure 6 The text "esophageal intubation" and arrow 78 displayed on the monitor 28 are used to indicate this in an exemplary manner. Figure 6 As shown, the information (e.g., text 74 and arrow 78) enables the user to manipulate the endotracheal tube 11 based on the information (e.g., text 74 and arrow 78). Figure 6 In this context, the user can use the information 74, 78 to operate in one or more directions 80 (in... Figure 6 (Depicted as a dashed arrow in the middle) manipulates the endotracheal tube 11.

[0221] The intubation system 10 may include at least one user interface (not shown) having at least one input device configured to receive input commands from a user. The input device may include at least one button and / or at least one switch and / or at least one touchscreen and / or at least one joystick for receiving input commands from the user. For example, the user interface may be integrated into the display 28, for instance, by configuring the display 28 as a touchscreen.

[0222] like Figures 1 to 6 As shown, providing the first and second instructions to the user via display 28 is merely exemplary. The intubation system 10 may be configured to provide the first and / or second instructions in any manner (e.g., auditory, visual, and / or tactile) so that the user can perceive the corresponding instruction to apply it.

[0223] Figure 7 The intubation system 10 is shown to be used to complete the entire process of delivering the endotracheal tube 11 to the patient's trachea (including laryngoscopy and intubation procedures). Figure 7 The actions and decisions / determinations performed by the intubation system / device are shown, identified by rectangles and diamonds with solid lines, respectively. Figure 7 The user actions are further shown, indicated by rectangles with dashed lines.

[0224] After the user activates the intubation system 10, the system can read sensors (e.g., the first sensor 20 and / or the second sensor 21) and determine the status of the laryngoscopy (operation) and intubation (operation). The intubation system 10 can determine whether the laryngeal blade 12 is inside the patient (i.e., within the patient's body) based on the sensor readings.

[0225] If the intubation system 10 determines that the laryngeal blade 12 is inside the patient, Figure 7 The use of "yes" indicates that the intubation system 10 can be set to determine the maximum frequency of laryngoscopy operation status, for example, to improve performance and / or accuracy. If the intubation system 10 determines that the laryngeal blade 12 is not in the patient's body, Figure 7 If "No" is used to indicate that the intubation system 10 can reduce the frequency of determining the status of the laryngoscopy operation, for example, to reduce power consumption.

[0226] The intubation system 10 can determine and / or check whether the laryngoscopy (procedure) has been completed. If the laryngoscopy (procedure) is determined to be completed, in Figure 7 The use of "Yes" indicates that the intubation system 10 can proceed to the next check and / or determination, and / or can instruct the user to begin the intubation procedure. If the laryngoscopy (procedure) is determined to be incomplete, in Figure 7 If indicated by "No", the intubation system 10 can provide (e.g., via the display 28) the first instruction, which may include warnings and / or directions to guide the user through the laryngoscopy (procedure).

[0227] The intubation system 10 can determine and / or check whether the endotracheal tube 11 is in the patient's body. If the intubation system 10 determines that the endotracheal tube 11 is in the patient's body, Figure 7 If indicated by "Yes", the intubation system 10 may proceed to the next check and / or determination, and / or provide further instructions. If the intubation system 10 determines that the endotracheal tube 11 is not in the patient's body, the intubation system 10 may instruct (e.g., via the display 28) the user to begin and / or continue the intubation (procedure).

[0228] The intubation system 10 can determine and / or check whether the endotracheal tube 11 is in the patient's esophagus, which, as mentioned above, can cause serious injury. If the intubation system 10 determines that the endotracheal tube 11 is in the patient's esophagus, in Figure 7 If "yes" is used, the intubation system 10 can provide instructions, such as one or more warnings and / or directions, to remove the endotracheal tube 11 from the patient's esophagus. If the intubation system 10 determines that the endotracheal tube 11 is not in the patient's esophagus, Figure 7If "No" is used to indicate that the intubation system 10 can proceed to the next check and / or determination and / or further instructions.

[0229] The intubation system 10 can determine and / or check whether the endotracheal tube 11 is in the patient's trachea. If the intubation system 10 determines that the endotracheal tube 11 is in the patient's trachea, Figure 7 If "yes" is used, the intubation system 10 can proceed to the next check and / or determination and / or further instructions. If the intubation system 10 determines that the endotracheal tube 11 is not in the patient's trachea, Figure 7 If "No" is used to indicate that the intubation system 10 can provide instructions including one or more warnings to guide the user to complete the intubation (process).

[0230] The intubation system 10 can determine and / or check whether the endotracheal tube 11 is too deep in the patient's trachea. If the intubation system 10 determines that the endotracheal tube 11 is too deep in the patient's trachea, Figure 7 If indicated by "Yes", the intubation system 10 can provide instructions, such as one or more warnings and / or directions, for retracting the endotracheal tube 11, for example, to a target depth in the patient's trachea. If the intubation system 10 determines that the endotracheal tube 11 is not too deep in the patient's trachea, Figure 7 If "No" is used to indicate that the intubation system 10 can indicate / inform the user that the intubation (process) has been completed.

[0231] The user can then remove the laryngeal blade 12 from the patient and close the intubation system 10.

[0232] The intubation system 10 may be configured to predict the location or site of one or more anatomical features of the patient (e.g., the location or site of the opening into the patient's trachea) and / or the location or site of one or more medical instruments (e.g., one or more medical instruments used with and / or by the intubation system 10), the location or site of which is not detected or is undetectable by the intubation system 10 (e.g., by the first sensor 20), particularly not optically detected or not optically detectable, or not fully detected or not fully detectable, or not yet (fully) detected or not (fully) detectable. Figure 8As illustrated, the intubation system 10 can be configured to process data provided or generated by at least one sensor (e.g., at least the first sensor 20) (i.e., the intubation system 10 can read the sensor) and determine an operational state, such as the current position of one or more components of the intubation system 10 (e.g., the laryngeal blade 14) and / or the endotracheal tube 11, particularly relative to the patient's anatomy. Based on the determined operational state, the intubation system 10 can be configured to predict the location or position of one or more anatomical features of the patient and / or one or more medical instruments, even if the one or more anatomical features of the patient and / or the one or more medical instruments may not be fully detectable and / or fully visible, for example because the one or more anatomical features of the patient and / or the one or more medical instruments may be hidden or obscured, for example, by a portion of the patient's anatomy 89. The predicted location or position of one or more anatomical features of the patient and / or one or more medical instruments can be indicated (e.g., visually) to the user, for example, through view 32 of the display 28. This indication is in Figure 8 The bottom is schematically shown as a box 90. For example, based on Figure 8 As shown in view 32, the opening into the patient's trachea may not be visible, for example, because the opening may be hidden or obscured, such as by part of the patient's anatomy 89 and / or by medical instruments (e.g., the medical instruments of the intubation system 10). The intubation system 10 may assist the user in indicating the location or site of the opening into the patient's trachea via indicator 90.

[0233] like Figure 9 As illustrated, the intubation system 10 can be configured to generate a user (e.g., after the user performs the intubation procedure through the intubation system 10) Figure 9 The intubation system 10 can generate a rating and / or report 91 for the performance of the fictional user "Jane Doe" during the intubation procedure, i.e., the user's performance during the intubation procedure, and generate feedback to the user including and / or based on the rating and / or report 91. The intubation system 10 can be configured to determine (preferably automatically) that the intubation procedure has been completed, for example based on data provided or generated by the first sensor 20 (i.e., the intubation system 10 can read the corresponding sensor), for example by detecting that the endotracheal tube 11 is at or located at the opening 38 into the patient's trachea. The intubation system 10 can be configured to compile data, such as program data and / or historical data related to the user's performance in previous one or more intubation procedures (e.g., the most recent 10 intubation procedures), such as... Figure 9As exemplarily illustrated, the intubation system 10 can be configured to generate a score and / or report 91 based on compiled data. The score and / or report 91 can be displayed to or viewed by a user, for example, on the display 28. At least a portion of the program data and / or historical data 92 can also be displayed to or viewed by the user, for example, on the display 28.

[0234] The scoring and / or reporting 91 may be based on one or more of the following: (tracheal) intubation time, POGO percentage, number of (tracheal) intubation attempts, number of esophageal intubations, visualization level, tissue protection, fluency of operation, Cormack-Lehane classification or categorization (CL grade), and patient risk during user performance.

Claims

1. An intubation system (10) for delivering an endotracheal tube (11) to a patient (12) via the endotracheal duct, said intubation system (10) comprising: At least one laryngeal blade (14) for providing access to the patient's pharynx; as well as At least one first sensor (20) is configured to capture at least one of the following positions and / or at least one orientation during operation of the cannulation system (10): At least a portion of the laryngeal blade (14); and / or At least a portion of the endotracheal tube (11); and / or One or more anatomical features of the patient (12); and / or At least a portion of at least one actuating member (65), the actuating member (65) being configured to at least partially receive and actuate the endotracheal tube (11). The intubation system (10) is configured to provide a user with one or more first commands, based on data provided by the first sensor (20), to manipulate the laryngeal blade (14) to a first target position relative to the anatomy of the patient (12); and The intubation system (10) is configured to, once the laryngeal blade (14) is substantially in the first target position, provide the user with one or more second instructions, based on data provided by the first sensor (20), to manipulate the endotracheal tube (11) and / or the manipulator (65) to a second target position relative to the patient's anatomy.

2. The intubation system (10) according to claim 1, comprising the actuating member (65), wherein the actuating member (65) is configured to receive the endotracheal tube (11) by at least partially fitting the endotracheal tube (11) onto the actuating member (65), wherein when the endotracheal tube (11) is received by the actuating member (65), the endotracheal tube (11) at least partially substantially conforms to the shape of the actuating member (65), wherein the actuating member (65) includes at least one flexible portion configured to be flexible in at least one degree of freedom, preferably at least two degrees of freedom, more preferably at least three degrees of freedom, wherein the actuating member (65) is configured to manipulate at least a portion of the endotracheal tube (11) by manipulating at least a portion of the actuating member (65), preferably by bending the actuating member (65) through one or more flexible portions of the actuating member (65), preferably wherein the actuating member (65) is configured as a fiber optic endoscope.

3. The intubation system (10) according to any one of the preceding claims, wherein the intubation system (10) is configured to determine and / or indicate to the user that the laryngeal blade (14) is substantially in the first target position and / or the endotracheal tube (11) and / or the manipulator (65) is substantially in the second target position.

4. The intubation system (10) according to any one of the preceding claims, wherein the intubation system (10) is configured to determine and / or indicate to the user at least one degree of progress in manipulating the laryngeal blade (14) to the first target position and / or at least one degree of progress in manipulating the endotracheal tube (11) and / or the manipulating member (65) to the second target position.

5. The cannulation system (10) according to any one of the preceding claims, wherein: The first target location is a predetermined location and / or the second target location is a predetermined location; and / or The first target position and / or the second target position are determined based on artificial intelligence, preferably wherein the cannulation system (10) is configured to determine based on artificial intelligence that the first target position and / or the second target position have been reached respectively.

6. The intubation system (10) according to any one of the preceding claims, wherein the intubation system (10) is configured to switch from a laryngoscopy mode to an intubation mode, wherein in the laryngoscopy mode a first instruction is provided for manipulating the laryngeal blade (14) to the first target position, and in the intubation mode a second instruction is provided for manipulating the endotracheal tube (11) and / or the manipulator (65) to the second target position, preferably the switching is performed once the laryngeal blade (14) is substantially in the first target position.

7. The intubation system (10) according to any one of the preceding claims, wherein the intubation system (10) is configured to generate and prompt one or more warnings to the user when the user deviates from the target position and / or target orientation and / or target insertion path of the laryngeal blade (14) and / or the endotracheal tube (11) and / or the manipulator (65) in the patient's body, preferably when the deviation is at a predetermined degree.

8. The intubation system (10) according to any one of the preceding claims, further comprising at least one display (28), preferably wherein the intubation system (10) is configured to display, during operation of the intubation system (10), at least one image of one or more anatomical features of the patient (12) and / or at least a portion of the laryngeal blade (14) and / or at least a portion of the endotracheal tube (11) and / or at least a portion of the manipulator (65) based on data provided by the first sensor (20), preferably a real-time streaming image.

9. The intubation system (10) according to claim 8, wherein the intubation system (10) is configured to display on the display (28) at least one target indicator representing at least one target position and / or at least one target orientation of the laryngeal blade (14) and / or the endotracheal tube (11) and / or the manipulation member (65), and at least one actual indicator representing at least one actual position and / or at least one actual orientation of the laryngeal blade (14) and / or the endotracheal tube (11) and / or the manipulation member (65).

10. The intubation system (10) according to claim 8 or 9, wherein the intubation system (10) is configured to, during operation of the intubation system (10), overlay information (50, 51, 64, 68, 70, 74, 78) on the display (28) at least one image, preferably a real-time streaming image, of one or more anatomical features of the patient (12) and / or at least a portion of the laryngeal blade (14) and / or at least a portion of the endotracheal tube (11) and / or at least a portion of the manipulator (65).

11. The cannulation system (10) of claim 10, wherein the information includes information about one or more anatomical features of the patient, and in particular an indication of the location and / or presence of one or more anatomical features on the image.

12. The intubation system (10) according to any one of the preceding claims, wherein the intubation system (10) is configured to apply one or more algorithms, preferably one or more heuristic algorithms, to data provided by the first sensor (20) and to generate the first instruction and / or the second instruction based at least in part on the data.

13. The intubation system (10) according to any one of the preceding claims, further comprising at least one second sensor (21) configured and arranged to capture one or more anatomical features of the patient’s face, preferably the patient’s nose (23), wherein the intubation system (10) is configured to provide the first command and / or the second command based at least in part on the data provided by the second sensor (21).

14. The intubation system (10) according to any one of the preceding claims, wherein the intubation system (10) is configured to reduce the power consumption of one or more components of the intubation system (10) and / or one or more components configured to cooperate and / or communicate with at least one component of the intubation system (10) according to one or more of the following criteria: When at least one degree of the first instruction and / or the second instruction is reduced; When the amount of data from the first sensor (20) and / or the second sensor (21) decreases; When the processing level of at least one of the data from the first sensor (20) and / or the second sensor (21) is reduced; When the degree of movement of one or more components, preferably at least the laryngeal blade (14) and / or the endotracheal tube (11) and / or the manipulator (65) decreases; When one or more anatomical features of the patient (12) are detected or not detected; and When the user activates the low-power mode of the cannulation system (10).

15. The intubation system (10) according to any one of the preceding claims, comprising a plurality of the at least one laryngeal blade (14), wherein the laryngeal blades (14) differ in at least one physical feature, preferably differing in shape and / or size and / or one or more dimensions of the laryngeal blades (14), wherein the laryngeal blades (14) are interchangeably mounted to the mounting interface of the intubation system (10).

16. The intubation system (10) according to any one of the preceding claims, wherein the intubation system (10) includes an installation interface configured to be interchangeably operatively coupled to any of a plurality of different laryngeal blades (14), wherein the laryngeal blades (14) differ in at least one physical feature, preferably differing in shape and / or size and / or one or more dimensions of the laryngeal blades (14).

17. The cannulation system (10) according to claim 15 or 16, wherein the cannulation system (10) is configured to detect: When and / or whether one of the laryngeal blades (14) has been installed into the mounting interface; and / or Which of the plurality of laryngeal blades has been installed into the mounting interface.

18. The intubation system (10) according to any one of the preceding claims, wherein one or more components are removably mounted to one or more mounting interfaces of the intubation system (10), preferably wherein the intubation system (10) is configured to detect when and / or whether at least one of the one or more components is mounted to the mounting interface.

19. The intubation system (10) according to any one of the preceding claims, wherein the intubation system (10) is configured to detect one or more features of the laryngeal blade (14) and / or one or more components of the intubation system (10) that may be attached to the intubation system (10) and optionally removable from the intubation system (10).

20. The intubation system (10) of claim 19, wherein one or more of the features include one or more of the following: the type or category of the laryngeal blade or the component, one or more dimensions of the laryngeal blade or the component, or the suitability of the laryngeal blade or the component for a particular operation and / or a particular patient.

21. The intubation system (10) according to claim 19 or 20, wherein the intubation system (10) is configured to detect one or more features based on an image or video, preferably a real-time image or a real-time video stream, of the laryngeal blade (14) and / or corresponding components, preferably wherein the image or video, preferably a real-time image or a real-time video stream, is generated based on data provided by the first sensor.

22. The intubation system (10) of claim 21, wherein the intubation system (10) is configured to detect one or more features based on the image or video, preferably the real-time image or real-time video stream, by applying at least one algorithm, preferably at least one artificial intelligence algorithm.

23. The cannulation system (10) according to any one of claims 18 to 22, wherein the one or more components comprise one or more optical fibers and / or one or more tube cores.

24. The cannulation system (10) according to any one of claims 19 to 23, wherein the cannulation system (10) is configured to determine and / or select the first instruction and / or the second instruction based on one or more detected features, preferably from a plurality of different sets of first instructions and / or second instructions, and / or adjust the first instruction and / or the second instruction.

25. The intubation system (10) according to any one of the preceding claims, wherein the intubation system (10) is configured to generate a performance score of the user during the intubation process after the user performs the intubation process through the intubation system (10), and to generate feedback to the user including and / or based on the score.

26. The intubation system (10) of claim 25, wherein the scoring is based on the degree of deviation and / or conformity of the user's performance from and / or with the first instruction and / or the second instruction.

27. The intubation system (10) according to claim 25 or 26, wherein the scoring is based on one or more of the following: endotracheal intubation time, glottic opening percentage, number of endotracheal intubation attempts, number of esophageal intubations, visualization level, tissue protection, smoothness of operation, and patient risk during the user performance.

28. The intubation system (10) according to any one of the preceding claims, wherein the intubation system (10) is configured to predict (90) the location of one or more anatomical features of the patient that are not detected or not fully detected or cannot be detected or not fully detected by the intubation system, particularly the first sensor (20), especially that are not optically detected or not optically detected or not optically detected or not fully optically detected.

29. The intubation system (10) according to any one of the preceding claims, wherein the intubation system (10) is configured to detect one or more anatomical features of a human model and associate the detected anatomical features of the human model with one or more anatomical features of a human body corresponding to the one or more anatomical features of the human model.

30. The cannulation system (10) of claim 29, wherein the cannulation system (10) is configured to display an image of the one or more anatomical features of the human body to the user when the cannulation system (10) detects the one or more anatomical features of the human body model associated with the anatomical features of the human body.

31. The cannulation system (10) according to claim 29 or 30, wherein the cannulation system (10) is configured to display on a display at least one image of one or more anatomical features of the human model (12), preferably a real-time streaming image, preferably based on data provided by the first sensor (20), and wherein the cannulation system (10) is configured to overlay the associated images of the human anatomical features on the display.

32. The intubation system (10) according to any one of the preceding claims, wherein the intubation system (10) is configured to determine the patient’s blood oxygen saturation, particularly based on data provided by the first sensor (20), particularly based on hue shift analysis of the patient’s mucosa.

33. The cannulation system (10) according to any one of the preceding claims, wherein the cannulation system (10) is configured to determine and / or detect: The patient’s condition and / or comorbidities and / or discomfort pose a risk when the intubation procedure is performed on the patient via the intubation system (10); and / or The patient’s condition and / or comorbidities pose a risk when the intubation procedure is performed on the patient via the intubation system (10).

34. The cannulation system (10) according to any one of the preceding claims, wherein the cannulation system (10) is configured to: If the intubation process is not completed within the predetermined time period, a user-perceptible warning is generated; and / or Instruct the user to use a different laryngeal blade and / or a different endotracheal tube, especially a laryngeal blade and / or endotracheal tube of a different size and / or shape from the current laryngeal blade and / or endotracheal tube, especially a laryngeal blade and / or endotracheal tube of a more suitable size; and / or When one or more conditions are met, particularly when a predetermined duration is exceeded, the user is instructed to provide oxygen to the patient by means other than intubation.

35. The intubation system (10) according to any one of the preceding claims, wherein the intubation system (10) is configured to detect fluid in the patient's pharynx and / or oral cavity, and optionally generate a user-perceptible warning of detected fluid.

36. The cannulation system (10) of claim 35, wherein the cannulation system (10) is configured to generate instructions instructing the user to remove the liquid and how to remove the liquid.

37. The intubation system (10) according to any one of the preceding claims, wherein the intubation system (10) is configured to generate, in particular a digital model, a virtual representation of, the laryngeal blade (14) and the endotracheal tube (11) and optionally the anatomical structures of the patient during operation of the intubation system (10), wherein preferably the intubation system (10) is configured to display the virtual representation on at least one display, and preferably wherein the intubation system (10) is configured to move and / or orient the virtual representation on the display to correspond to the movement and / or orientation of the intubation system (10) during operation.

38. The intubation system (10) according to any one of the preceding claims, wherein the intubation system (10) is configured to, during operation of the intubation system (10), adjust, preferably rotate, preferably flip at least one image, preferably a real-time streaming image, based on at least one criterion, the image or real-time streaming image being generated based on data provided by the first sensor (20) and displayed on at least one display.

39. The intubation system (10) according to claim 38, wherein the criteria include the orientation of the user and / or the intubation system (10) relative to the patient, particularly the patient's trachea.

40. The intubation system (10) according to any one of the preceding claims, wherein the intubation system (10) includes at least one processor configured to execute and / or run and / or apply AI algorithms, in particular any AI algorithms applicable to the intubation system (10).

41. A kit comprising at least one intubation system (10) according to any one of claims 1 to 40 and at least one endotracheal tube (11).

42. A method for delivering an endotracheal tube (11) to the trachea of ​​a patient (12), said method preferably performed using an intubation system (10) according to any one of claims 1 to 40, said method comprising: A laryngeal blade (14) is inserted into the oral cavity of the patient (12), the laryngeal blade (14) being configured to provide access to the pharynx of the patient (12); The following at least one position and / or at least one orientation is captured by at least one first sensor (20): At least a portion of the laryngeal blade (14); and / or At least a portion of the endotracheal tube (11); and / or One or more anatomical features of the patient (12); and / or At least a portion of at least one actuating member (65), the actuating member being configured to at least partially receive and actuate the endotracheal tube (11). Based on the data provided by the first sensor (20), the user is provided with one or more first instructions for manipulating the laryngeal blade (14) to a first target position relative to the anatomical structure of the patient (12); Manipulate the laryngeal blade (14) to the first target position; Once the laryngeal blade (14) is substantially in the first target position, the user is given one or more second instructions based on the data provided by the first sensor (20) to manipulate the endotracheal tube (11) and / or the manipulator (65) to a second target position relative to the anatomy of the patient (12). as well as Manipulate the endotracheal tube (11) and / or the manipulation member (65) to the second target position.

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