WO2025226667A1 - Automated endotracheal intubation - Google Patents
Automated endotracheal intubationInfo
- Publication number
- WO2025226667A1 WO2025226667A1 PCT/US2025/025750 US2025025750W WO2025226667A1 WO 2025226667 A1 WO2025226667 A1 WO 2025226667A1 US 2025025750 W US2025025750 W US 2025025750W WO 2025226667 A1 WO2025226667 A1 WO 2025226667A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- internal frame
- frame
- internal
- patient
- cable
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/30—Surgical robots
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/30—Surgical robots
- A61B34/32—Surgical robots operating autonomously
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/70—Manipulators specially adapted for use in surgery
- A61B34/71—Manipulators operated by drive cable mechanisms
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
- A61M16/04—Tracheal tubes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B2034/2046—Tracking techniques
- A61B2034/2065—Tracking using image or pattern recognition
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/30—Surgical robots
- A61B2034/303—Surgical robots specifically adapted for manipulations within body lumens, e.g. within lumen of gut, spine, or blood vessels
Definitions
- Endotracheal intubation is performed to access and maintain the patient's airway to facilitate safely regulated breathing.
- the process of endotracheal intubation refers to the placement of the tracheal tube in the patient’s airway.
- Common methods used clinically to place the tracheal tube include direct laryngoscopy, video laryngoscopy, and flexible intubation scope.
- Intubation may be performed in emergencies where a patient’s breathing may be unstable or in planned procedures where general anesthesia is used.
- An endotracheal intubation tube, as shown in FIG. 1, is used to route air from outside the body into the patient’s airway and/or trachea (and thus the lungs) by, for example, a mechanical ventilator.
- an automated intubation system includes an external frame, an internal frame, a flexible intubation tube, and a controller.
- the external frame includes a carriage controllably movable in at least a first direction and a second direction via at least one external actuator
- the internal frame is coupled to the carriage of the external frame.
- the internal frame includes a plurality of interlocked segments including a first segment rotatably coupled to a second segment along a longitudinal axis of the internal frame, each of the plurality of interlocked segments defining a central opening and a plurality of openings radially spaced apart from the central opening.
- the internal frame further includes a plurality of tension cables, including a first cable and a second cable, extending longitudinally from adjacent the carriage to a free end of the internal frame through the plurality of openings of the interlocked segments.
- the internal frame further includes at least one internal actuator coupled to and configured to adjust the plurality of tension cables.
- the first cable is configured to move the free end of the internal frame in a first direction and the second cable is configured to move the free end of the internal frame in a second direction.
- the flexible intubation tube defines a channel extending from a first opening to a second opening.
- the internal frame extends from the first opening through a majority of the channel, and the flexible intubation tube is configured to conform to a shape of the internal frame.
- the controller is in communication with (i) the at least one external actuator of the external frame and (ii) the at least one internal actuator of the internal frame. The controller is configured to move the internal frame to navigate an airway of a patient.
- the external frame further includes a base couplable to a rigid platform, wherein the rigid platform is adjacent to a patient surface.
- the external frame is moveable from a stowed position to an active position that is closer to the patient surface.
- the external frame includes a first linear actuator and a second linear actuator, wherein the first direction is substantially perpendicular to the second direction.
- the carriage is movable along a member of the first linear actuator and to a predefined position relative to the patient.
- the carriage is movable via the external frame to a predefined position relative to the patient.
- the carriage includes a motorized mount coupled to a fixed end of the internal frame, wherein an angle of the internal frame relative to the one or both of the external frame and the airway of the patient is adjustable via the motorized mount.
- one of the carriage or the internal frame further includes a housing containing the at least one internal actuator.
- the at least one internal actuator includes a first motor coupled to the first cable and a second motor coupled to the second cable. A length or tension of the first and second cables is adjustable to move the free end of the internal frame.
- the at least one internal actuator includes four motors and the plurality of tension cables includes four cables each coupled to a different one of the four motors for individual cable control.
- the internal frame further includes a camera disposed adjacent to the free end of the internal frame, the camera configured to send visual data to the controller.
- the camera is in electrical communication with the controller via a data and/or power cable extending through the central openings of the plurality of interlocked segments.
- the first segment of the plurality of interlocked segments is rotatable relative to the second segment by at least 4 degrees relative to the longitudinal axis.
- the plurality of interlocked segments includes at least twenty segments coupled along the longitudinal axis.
- the controller includes a processor and a memory storing instructions thereon that, when executed by the processor, cause the processor to (i) move the external frame to position the free end of the internal frame and the intubation tube thereon adjacent to the airway of the patient, and (ii) move the internal frame along with the intubation tube through the airway of the patient.
- the internal frame further includes a camera disposed adjacent to the free end of the internal frame, the camera configured to send visual data to the controller, wherein the visual data informs movement of the internal frame by the processor.
- the processor further includes an artificial intelligence model pre-trained on patient airway data including one or more anatomical landmarks.
- the processor causes the internal frame to move based on a prediction generated by the pre-trained artificial intelligence model analyzing visual data from the camera.
- the automated intubation system further includes an emergency stop button that releases tension in the plurality of tension cables, preventing further motion and enabling safe removal of the system.
- a method for automated intubation includes providing an automated intubation system.
- the automated intubation system includes an external frame including a carriage controllably movable in at least a first direction and a second direction via at least one external actuator.
- the automated intubation system further includes an internal frame coupled to the carriage of the external frame.
- the internal frame includes a plurality of interlocked segments including a first segment rotatably coupled to a second segment along a longitudinal axis of the internal frame, each of the plurality of interlocked segments defining a central opening and a plurality of openings radially spaced apart from the central opening.
- the internal frame further includes a plurality of tension cables, including a first cable and a second cable, extending longitudinally from adjacent the carriage to a free end of the internal frame through the plurality of openings of the interlocked segments.
- the internal frame further includes and at least one internal actuator coupled to and configured to adjust the plurality of tension cables, wherein the first cable is configured to move the free end of the internal frame in a first direction and the second cable is configured to move the free end of the internal frame in a second direction.
- the automated intubation system further includes a controller in communication with (i) the at least one external actuator of the external frame and (ii) the at least one internal actuator of the internal frame.
- the method further includes providing a flexible intubation tube defining a channel extending from a first opening to a second opening, wherein the internal frame extends from the first opening through a majority of the channel, and the flexible intubation tube is configured to conform to a shape of the internal frame.
- the method further includes moving the external frame to position the free end of the internal frame and intubation tube thereon adjacent to an airway of a patient.
- the method further includes moving the internal frame along with the intubation tube through the airway of the patient.
- the method further includes capturing, via a camera disposed adj acent to the free end of the internal frame, visual data of the airway.
- the method further includes sending the visual data to the controller and moving the internal frame based on the visual data from the camera.
- the method further includes analyzing, via a pre-trained artificial intelligence model, the visual data, and moving the internal frame based on a prediction generated by the pre-trained artificial intelligence model.
- an automated intubation device includes a plurality of interlocked segments, a plurality of tension cables, and at least one internal actuator.
- the plurality of interlocked segments includes a first segment rotatably coupled to a second segment along a longitudinal axis of the device.
- Each of the plurality of interlocked segments defines a central opening and a plurality of openings radially spaced apart from the central opening.
- the plurality of tension cables including a first cable and a second cable, extend longitudinally from a fixed end to a free end of the device through the plurality of openings of the interlocked segments.
- the at least one internal actuator coupled to and configured to adjust the plurality of tension cables.
- the first cable is configured to move the free end of the device in a first direction and the second cable is configured to move the free end of the device in a second direction,
- the device is configured to be disposed within a channel defined by a flexible intubation tube that is configured to conform to a shape of the device, the device being movable to navigate an airway of a patient.
- FIG. 1 shows an example of an existing endotracheal intubation process, including a standard endotracheal tube and a laryngoscope, according to one implementation.
- FIG. 2 shows a diagram of a system for automatic endotracheal intubation, according to one implementation.
- FIG. 3A shows a gantry system as an alternative for an external frame of the disclosed system, according to one implementation.
- FIG. 3B shows a linear actuator of the system of FIG. 2, according to one implementation.
- FIG. 4A shows a first portion of a housing for one or more actuators, according to one implementation.
- FIG. 4B shows a second portion of the housing couplable to the first portion in FIG. 4A, according to one implementation.
- FIG. 5A shows a portion of a system for automatic endotracheal intubation including an internal frame structure having a plurality of interlocking segments, according to one implementation.
- FIG. 5B shows a diagram of two interlocking segments and the bending motion between them, according to one implementation.
- FIG. 5C shows a diagram of an internal frame having a plurality of interlocking segments along with a cross-sectional view of one of the segments, according to one implementation.
- FIG. 6A shows an isometric view of one interlocking segment, according to one implementation.
- FIG. 6B shows a top view of the segment of FIG. 6 A.
- FIG. 6C shows a first side view of the segment of FIG. 6 A.
- FIG. 6D shows a second side view of the segment of FIG. 6A.
- FIGS. 7A-7C show various views of a camera-integrated segment that is couplable to the segment of FIG. 6 A, according to one implementation.
- endotracheal intubation refers to the insertion of an endotracheal tube into a patient’s airway. Endotracheal intubation is performed to access and maintain the patient's airway to facilitate safely regulated breathing.
- tracheal tube Common methods used clinically to place the tracheal tube include direct laryngoscopy, video laryngoscopy, and flexible intubation scope. Intubation may be performed in emergencies where a patient’s breathing may be unstable or in planned procedures where general anesthesia is used.
- An endotracheal intubation tube as shown in FIG. 1, is used to route air from outside the body by, for example, a mechanical ventilator to the trachea and thus the lungs.
- endotracheal intubation may be a straightforward process in some situations, it can often be complicated by any one of several factors.
- the setting may not provide for controlled and accurate placement of the endotracheal tube (e.g., in an ambulance or in a time-critical situation).
- differences in patient airway anatomy can reduce intubation accuracy and efficiency.
- anatomical characteristics such as short, thick necks or prominent upper incisors, as well as health conditions including obesity, airway trauma, or head and neck cancer, also increase the likelihood of a difficult airway.
- an intubation method that maximizes the first attempt success rate to ensure safe intubation of a patient.
- This disclosure provides an efficient and automated endotracheal intubation system and method.
- the disclosed system may perform intubation in 1 minute or less without human input.
- the disclosed system is further capable of human control in place of - or conjunction with - an automated system.
- the disclosed system can easily fit into an operating room, patient room, clinical setting, ambulance, or other healthcare setting that may require efficient intubation at a moment’s notice.
- the disclosed system includes an internal frame, which may be defined as the portion of the system that enters the patient.
- the disclosed internal frame may implement a pulley-tendon system along a flexible member having a plurality of interlocking segments.
- the flexible member e.g., the “internal frame” of the system
- the pulley -tendon system may be used to control the shape of the flexible member via one or more tension cables extending along the length of the member.
- the flexible member may be manipulated to approximate the shape of a laryngoscope or similar existing intubation devices.
- the flexible member is moveable in a variety of directions (e.g., x-, y-, and z-directions, or 6 degrees of freedom) relative to the patient’s airway.
- the flexible member and the endotracheal tube thereon may be coupled to an external frame configured to perform the larger-scale movements.
- the external frame may be defined as the portion of the system that does not enter the patient.
- the external frame may position the endotracheal tube near the patient’s mouth before the flexible member performs finetuned adjustments to navigate the airway.
- the external frame may be active simultaneously with the flexible member for insertion and navigation along the airway.
- the disclosed system further implements a controller configured to operate and/or facilitate the operation of the system, including the motion of the internal and external frames.
- the controller may be coupled to a user interface which may include manual controls for a healthcare professional to operate the system.
- the controller may include an automated process for operating the system and performing intubation on a patient.
- the internal frame and the endotracheal tube thereon may follow a predetermined pathway and/or set of movements.
- the automated system may adjust its motion based on visual data feedback from a camera at the end of the internal frame.
- a pre-trained Al model or other visual data processor may identify and/or predict anatomical landmarks in the patient’s airway to inform adjustments of the internal frame and/or external frame.
- FIG. 2 shows an automated intubation system 10, according to one implementation.
- the system 10 includes a flexible intubation tube 30, an internal frame 100, an external frame 200, and a controller 300.
- the system 10 is configured to intubate a patient 20 positioned adjacent to the system 10 (e.g., on a hospital bed next to the system 10).
- the system 10 may be configured to automatically intubate a patient 20 (e.g., on receipt of an initiation signal from a healthcare professional or a detection system monitoring the patient 20).
- the external frame 200 includes a base 202 and a free end 204 spaced apart from the base 202.
- the external frame 200 further includes one or more arm segments 206 extending from the base 202 to the free end 204.
- the external frame 200 may include three articulable arm segments 206 each rotatably coupled to each other.
- the external frame may be a 6-axis robotic arm.
- the base 202 may be coupled to a rigid platform adjacent to the patient 20 and/or patient surface.
- the base 202 may be couplable to a side of a patient’s bed, a rollable cart placed adjacent to the patient’s bed, or a portion of a patient’s room (e.g., a wall-mounted external frame).
- the external frame 200 is generally moveable between a stowed configuration and an active configuration.
- the free end 204 of the external frame 200 is positioned further away from the patient 20 in the stowed configuration relative to the active configuration. That is, the system 10 moves the free end 204 of the external frame 200 closer to the patient 20 in the active configuration.
- the stowed configuration may include folding the one or more arm segments 206 relative to each other to form a more compact structure.
- Moving to the active configuration may include rotating the one or more arm segments 206 about the base 202 and/or each other to position the free end 204 in a desired position relative to the patient 20.
- the external frame 200 is generally configured to move the free end 204 of the external frame 200 to a desired location relative to the patient 20 and/or their airway.
- the external frame 200 includes one or more actuators (e.g., coupled to and/or internal to one or more of the arm segments 206).
- the one or more arm segments 206 may include servo motors (or similar actuators) configured to controllably move the free end 204 to a desired position.
- the external frame is configured with any one of a stepper motor, a pneumatic actuator, a hydraulic actuator, or a similar actuator configured to controllably move the arm segments.
- the external frame includes one or more arm segments moveable in at least one linear direction.
- FIG. 3A shows an external frame 200b having two arm segments moveable in a gantry-like configuration. That is, the external frame 200b includes a first member coupled to a second member, the first member being moveable along the second member in a first direction. The first member is oriented perpendicular to the second member such that the first member can move a mounting point or carriage in a second direction that is perpendicular to the first direction.
- FIG. 3B shows an image of a linear actuator 210, similar to that of FIG. 2.
- the linear actuator 210 includes a support frame 212 that is coupled to the free end 204 of the external frame 200 (e.g., to one of the arm segments 206).
- a lead screw 214 extends from one end of the support frame 212 to an opposite end.
- An external actuator 216 e.g., a servo motor or similar actuator device
- one or more potentiometers coupled to the lead screw 214 and/or the external actuator 216 may track and inform control of the position of the lead screw 214 and/or the external actuator 216.
- a carriage 220 is controllably moveable along the lead screw 214. For example, upon rotation of the lead screw 214, the carriage 220 is moved along the lead screw 214 in a first direction towards one end of the support frame 212. Rotation of the lead screw 214 in the opposite direction moves the carriage 220 in a second direction opposite to the first direction towards the opposite end of the support frame 212.
- the linear actuator 210 is generally oriented vertically (e.g., longitudinally aligned with the gravity vector). Thus, when the carriage 220 is moved towards the “lower” end of the support frame 212, the carriage 220 is moving towards a ground surface, a support surface, or a patient 20 on the support surface. The carriage 220 is moveable to a desired location along the lead screw 214 (e.g., relative to a patient’s airway).
- the external frame 200 further includes a housing 230 that is coupled to the carriage 220.
- the housing 230 is moveable with the carriage 220 in the first and second directions (e.g., the vertical directions).
- the housing 230 is further coupled to the internal frame 100.
- the housing 230 includes a first portion 232 and a second portion 234 couplable to each other (e.g., in a clamshell configuration).
- An example of the first portion 232 of the housing 230 is shown in FIG. 4A.
- An example of the second portion 234 of the housing 230 that is couplable to the first portion 232 is shown in FIG. 4B.
- the housing 230 defines a cavity 236 configured to house one or more components of the internal frame 100.
- one or more actuators e.g., motors
- the carriage 220 includes a mount coupled to the internal frame 100 and/or the carriage 220, the mount being pivotable relative to the linear actuator 210.
- the mount may be configured to tilt the internal frame 100 up, down, left, and right relative to the linear actuator 210.
- the mount may include one or more hinged couplings between the housing 230 and the internal frame 100 thereon.
- the mount and/or the linear actuator 210 may be further configured to rotate relative to the patient 20, allowing for angular adjustments to align the flexible intubation tube 30 with the patient’s airway.
- the internal frame 100 is coupled to the carriage 220 on the linear actuator 210 of the external frame 200. Specifically, the internal frame 100 is coupled to the carriage 220 via the housing 230 which includes one or more components of the internal frame 100. Thus, the internal frame 100 is generally moveable by the external frame 200 in the first and second directions (e.g., vertically) relative to the patient 20 and their airway.
- the internal frame 100 is generally configured to engage with and control the placement of a flexible intubation tube 30.
- the flexible intubation tube 30 may be a standard intubation tube (e.g., a 7mm diameter tube), as shown in FIG. 1, or a modified intubation tube configured to engage with the system 10.
- the flexible intubation tube 30 defines a channel extending from a first opening to a second opening.
- the flexible intubation tube 30 may have a curved neutral position matching the desired shape for accessing or maintaining a patient’s airway.
- the flexible intubation tube 30 includes a generally flexible material (e.g., a flexible polymer) that can conform to the shape of the internal frame 100 therein.
- the internal frame 100 is disposed at least partially within the channel of the flexible intubation tube 30.
- the internal frame 100 extends through the first opening and a majority of the channel of the flexible intubation tube 30.
- the flexible intubation tube 30 may be disposed on the internal frame 100 when the system 10 and/or the external frame 200 is in the stowed position - such that the flexible intubation tube 30 is ready for insertion into a patient’s airway upon initiation.
- the internal frame 100 changes its shape to (i) navigate the airway of the patient 20 and (ii) position the flexible intubation tube 30 properly within the patient’s airway.
- the internal frame 100 includes a plurality of interlocked segments 110 (e.g., a first and second segment rotatably coupled to each other) extending from a fixed end 102 to a free end 104 of the internal frame 100 along a longitudinal axis 101.
- a first segment may be coupled to the housing 230, and a second segment may be coupled to the first segment, closer to the free end 104.
- the plurality of segments 110 may include a number of segments in the range of 15 to 200 (e.g., between 25 and 40 interlocked segments).
- the total length of the internal frame 100, including the plurality of interlocked segments 110 may be based on the length of the flexible intubation tube 30 and/or a patient’s airway.
- FIG. 5A shows another view of the internal frame 100 that is coupled to the housing 230, the carriage 220, and the linear actuator 210.
- FIG. 5 A shows one implementation of the plurality of interlocked segments 110 including individual segments 108 coupled to each other along the longitudinal axis 101 of the internal frame 100.
- Each individual segment 108 is coupled to an adjacent segment 108 (e.g., via an interlocking structure).
- Each segment 108 is configured to rotate relative to an adjacent segment 108 (e.g., by an angle in the range of 1 to 20 degrees relative to the longitudinal axis 101).
- the entire internal frame 100 has a controllable curvature based on the movement of the plurality of interlocked segments 110.
- the plurality of interlocked segments 110 may have an entirely linear structure, or a portion of the segments 108 of the plurality of interlocked segments 110 may be angled relative to each other to form a curved shape (e.g., approximating the airway of a patient).
- the segment 108 in FIGS. 5A and 5C is only one implementation of an interlocked segment of the disclosed internal frame 100, and other variations of interlocking segments are contemplated by this disclosure.
- FIG. 5B shows a side view of two segments 107a and 107b that are substantially similar to the segments 108 of FIG. 5A.
- the segments 107a, 107b are interlocked with each other.
- the first segment 107a is axially aligned with the second segment 107b (e.g., along the longitudinal axis 101).
- the first segment 107a is rotated relative to the second segment 107b (e.g., by a specified or predetermined angle).
- the angle of rotation between the segments 107a, 107b may be limited by the structure of the segments and interference or self-contact between the segments when rotated away from the longitudinal axis 101.
- each of the segments 108 of the plurality of interlocked segments 110 defines a plurality of openings extending axially therethrough (e.g., extending substantially parallel to the longitudinal axis 101).
- each segment 108 includes four cable openings 112a, 112b, 112c, and 112d.
- the cable openings 112a- 112d are circumferentially spaced apart from each other.
- the cable openings 112a-112d are equally spaced apart from each other around the segment 108 (e.g., 90 degrees apart from each other).
- the cable openings 112a-112d are also radially spaced apart from each of the outer circumferential surface of the segment 108 and a central opening 114.
- the central opening 114 is substantially centered within the segment 108 (e.g., along the longitudinal axis 101).
- Each of the cable openings 112a-l 12d and the central opening 114 are aligned between adjacent segments 108 and are configured to retain a cable or other member therein.
- the internal frame 100 includes a plurality of tension cables 120.
- the internal frame 100 includes four tension cables 120 extending along the plurality of interlocked segments 110 from the fixed end 102 to the free end 104 of the internal frame 100.
- the segment 108 includes four tension cables 120a, 120b, 120c, and 120d extending through the corresponding cable openings 112a-l 12d. Furthermore, a central cable 122 extends through the central opening 114. Each cable 120a-120d extends longitudinally between the free end 104 and the fixed end 102 of the external frame 100. For example, the cables 120a-120d are coupled to an actuator or other portion of the housing 230. The cables 120a-120d extend through each segment 108 of the plurality of interlocked segments 110 and are coupled to a last segment on the free end 204 or another device thereon (e.g., a camera segment).
- a camera segment e.g., a camera segment
- Each cable 120a-120d is coupled to a corresponding actuator and/or spool within the housing 230.
- each cable 120a-120d may be coupled to a corresponding motor 124a, 124b, 124c, and 124d.
- Each motor 124a-124d is configured to extend or retract the corresponding cable 120a-120d.
- the motors 124a-124d may be coupled to a corresponding spool of cable such that rotation of the motor in one direction increases tension in the cable and rotation in the opposite direction decreases tension in the cable.
- the motors 124a-124d and associated spools may be disposed within the cavity 236 of the housing 230. In some implementations, fewer than four motors and/or spools may be implemented. In some implementations, more than four motors and/or spools may be implemented. In some implementations, more or less than four cables may be implemented.
- the motors 124a-124d are configured to move the free end 104 of the internal frame 100 in one or more directions. For example, increasing tension in the first cable 120a pulls the corresponding side of the plurality of interlocked segments 110, bending the free end 104 of the internal frame 100 in that direction. Decreasing tension in the first cable 120a allows the free end 104 of the internal frame to move away from the corresponding side of the plurality of interlocked segments 110 (e.g., “pushes” the free end in the opposite direction).
- the system of cables 120a-120d and motors 124a-124d are configured to control the overall curvature, direction, and position of the internal frame 100 and the free end 104 thereof.
- the system of cables 120a-120d and motors 124a-124d are configured to position the internal frame 100 and the flexible intubation tube 30 relative to a patient’s airway.
- FIGS. 7A-7C show a camera segment 160 of the internal frame 100, according to one implementation.
- the camera segment 160 is rotatably couplable to one of the segments 108 of the plurality of interlocked segments 110.
- the camera segment 160 defines four circumferentially spaced openings and a central opening, similar to the segment 108.
- the cables 120a-120d may terminate at and attach to a portion of the camera segment 160.
- the camera segment 160 may include a camera 162 and a light source 164. Each of the camera 162 and the light source 164 are coupled to the central cable 122 extending through the central openings of each segment 108 of the plurality of interlocked segments 110 and through the central opening of the camera segment 160.
- the central cable 122 may include separate power and data cable(s) that connect to a controller, power source, or other electronic device coupled to the internal frame 100 and/or the external frame 200.
- FIGS. 6A-6D show a segment 109, according to another implementation of the internal frame 100.
- the segment 109 includes interlocking features similar to other interlocking segments described herein.
- the segment 109 includes a cylindrical outer surface 130 defining the outer diameter of the segment 109.
- the outer surface 130 is configured to match and/or engage with the inner channel of the flexible intubation tube 30.
- the segment 109 further includes a top side 132 and a bottom side 144.
- the top side 132 includes a first protrusion 134 and a second protrusion 136.
- the first protrusion 134 includes a neck 138 extending from the top side 132 and a head 140 extending from the neck 138.
- the head 140 is wider than the neck 138 and defines a shoulder at the interface between the neck 138 and the head 140.
- the head 140 has a substantially semi- circular-shaped upper surface 142.
- the second protrusion 136 is substantially similar in structure and function to the first protrusion 134.
- the first protrusion 134 is diametrically opposed to the second protrusion 136 across the top side 132.
- the bottom side 144 of the segment 109 includes opposing angled surfaces 146a, 146b.
- the angle surfaces 146a, 146b converge at a central portion of the bottom side 144.
- the bottom side 144 further defines a connection channel 148 extending along the central portion at the interface between the angled surfaces 146a, 146b.
- the connection channel 148 extends in a direction across the bottom side 144 opposite from the direction between the protrusions 134, 136 on the top side 132.
- the connection channel 148 is sized and configured to accept the first and second protrusions 134, 136 therein.
- the semi-circular-shaped upper surface 142 of the protrusions 134, 136 matches the shape of the connection channel 148.
- connection channel 148 When two of the segments 109 are coupled together, the first and second protrusions 134, 136 are disposed within the connection channel 148.
- the segments 109 are freely rotatably relative to each other about the connection channel 148 (e.g., an axis thereof).
- the angle of rotation between the two segments 109 is limited by the angle between the angled surfaces 146a, 146b and the surface of the top side 132 from which the protrusions 134, 136 extend.
- the segment 109 further includes the four cable openings and a central openings, similar to that of FIG. 5C. As shown in FIG. 6B, the segment 109 defines a first opening 150a and a second opening 150b that extend in the longitudinal direction through the segment 109 from the top side 132 to the bottom side 144, including through first protrusion 134 and the second protrusion 136, respectively. The segment 109 further defines a third opening 150c and a fourth opening 15 Od each offset 90 degrees from the first and second protrusions 134, 136. The third and fourth openings 150c, 150d extend through the segment 109 from the top side 132 to the bottom side 144, including a portion of the connection channel 148.
- the controller 300 of the system 10 is in electrical communication (e.g., wired or wireless communication) with the internal frame 100 and the external frame 200. Specifically, the controller 300 is in electrical communication with at least (i) the actuators of the one or more arm segments 206 of the external frame 200, (ii) the linear actuator 210 and the external actuator 216 thereof, (iii) the motors 124a-124d coupled to the cables 120a-120d extending through the plurality of interlocked segments 110 of the internal frame 100, and (iv) the camera segment 160 of the internal frame 100.
- the controller 300 is in electrical communication with at least (i) the actuators of the one or more arm segments 206 of the external frame 200, (ii) the linear actuator 210 and the external actuator 216 thereof, (iii) the motors 124a-124d coupled to the cables 120a-120d extending through the plurality of interlocked segments 110 of the internal frame 100, and (iv) the camera segment 160 of the internal frame 100.
- the controller 300 includes a processor 302, a memory 304, and a display and/or user interface (UI) 306.
- the memory 304 includes instructions stored thereon that, when executed by the processor 302, cause the processor 302 to move the external frame 200 and/or the internal frame 100.
- the processor 302 may move the external frame 200 to position the free end 204 in a desired position.
- the free end 204 may be moved so that the internal frame 100 and the flexible intubation tube 30 are positioned adjacent to the airway of a patient 20.
- the processor 302 may further cause the internal frame 100 to move with the flexible intubation tube 30 through the patient’s airway.
- the memory 304 may include one or more automated intubation operation instructions which, when executed by the processor 302, cause the actuators of the external frame 200 and the motors of the internal frame 100 to perform a pre-determined set of operations (e.g., motor rotations and corresponding movement of the internal frame 100 and flexible intubation tube 30).
- the camera 162 on the camera segment 160 is in electrical communication with the controller 300 via the central cable 122 extending through the plurality of interlocked segments 110.
- Visual data from the camera 162 is captured and delivered to the controller 300 in real time, which may be displayed on the user interface 306 or a connected device (e.g., a display monitor in the room).
- the controller 300 may further include controls (e.g., physical and/or incorporated into an external device) providing for human control of the system 10.
- controls e.g., physical and/or incorporated into an external device
- a healthcare professional can take over control of the system 10 when needed and control the internal frame 100 and the external frame 200 based on visual data on a display monitor.
- the controller 300 is further configured to process (e.g., via the processor 302) the visual data from the camera 162 to inform the movement of the system 10.
- the processor 302 interprets the visual data from the camera 162 to inform the movement of the external frame 200 or the internal frame 100.
- the processor 302 identifies visual landmarks of the patient 20 and their airway (e.g., anatomical landmarks) to guide the location of the internal frame 100 and the flexible intubation tube 30 thereon.
- the processor 302 of the controller 300 includes an artificial intelligence (Al) model pre-trained on patient airway data - including one or more anatomical landmarks.
- the memory 304 may include a pre-trained Al model configured to identify the mouth, throat, and airway of a human based on visual data from the camera 162.
- the internal frame 100 is caused to move based on the identification of anatomical landmarks in the visual data by the Al model.
- the internal frame 100 is caused to move based on a prediction of the anatomy generated by the Al model analyzing the visual data.
- the system 10 may include an emergency stop button on any portion of the system 10 (e.g., on the external frame 200 or the user interface 306) to halt all operations.
- the emergency stop button may release tension in the cables 120a-120d so that the internal frame 100 and flexible intubation tube 30 may be easily removed from the patient’s airway.
- a pre-defined tension scheme and/or curvature of the internal frame 100 is provided when the emergency stop is initiated.
- the system 10 is used to automatically perform endotracheal intubation on the patient 20.
- a detection system may identify when a patient 20 is unable to breathe on their own or when the patient’s airway is otherwise compromised.
- a healthcare professional may identify when a patient 20 is unable to breathe on their own or when the patient’s airway is otherwise compromised, which may include verifying a signal from the detection system. Once confirmed, the detection system and/or the healthcare professional initiates the system 10 to intubate the patient 20.
- the external frame 200 is moved from the stowed position (e.g., folded in a compact arrangement on a wall mount by the patient’s bed) to an active position closer to the patient 20.
- the processor 302 initiates movement of the one or more arm segments 206 via the one or more actuators therein to articulate the external frame 200.
- the movement of the external frame 200 may be a pre-arranged set of movements stored in the memory 304 or a dynamic movement based on in-room feedback (e.g., an external camera or the camera 162 identifying the patient’s location relative to the system 10).
- the free end 204 is moved to a desired location relative to the patient 20.
- the desired location may include the free end 204 positioned above the patient 20 by a set distance such that the bottom of the linear actuator 210 and the internal frame 100 therein are placed just above the patient’s mouth.
- the processor 302 then causes the internal frame 100 to change its overall curvature and shape, which alters the overall shape of the flexible intubation tube 30 disposed on the internal frame 100.
- the processor 302 simultaneously initiates the lowering of the internal frame 100 via the linear actuator 210 and the adjustment of the curvature of the internal frame 100 to properly insert the flexible intubation tube 30 in the patient’s airway.
- the linear actuator 210 may be activated for larger, vertical movement, while the motors 124a-124d and associated cables 120a-120d are moved for fine-tuned adjustment of the internal frame 100 and the free end 104 thereof.
- the processor 302 analyzes and interprets the visual data to inform the movement of the external frame 200, the linear actuator 210, and/or the internal frame 100.
- an Al model or preconfigured set of instructions may identify anatomical landmarks of the patient 20 to inform the next movement of the system 10.
- the internal frame 100 is retracted to leave the flexible intubation tube 30 in the airway.
- a clasp or a release mechanism may connect/disconnect the flexible intubation tube 30 from the fixed end 102 of the internal frame 100 (e.g., a clasp extending from the housing 230).
- the internal frame 100 and the plurality of interlocked segments 110 thereof may be controllably retracted to follow the exact shape of the channel of the flexible intubation tube 30 without providing a retracting force to the flexible intubation tube 30.
- the external end of the flexible intubation tube 30 may be held in place while the internal frame 100 is retracted.
- a healthcare professional may hold the flexible intubation tube 30 in place, or a stopper/extension of the internal frame 100 may engage the flexible intubation tube 30 to ensure it remains within the airway.
- the hardware and data processing components used to implement the various processes, operations, illustrative logics, logical blocks, modules and circuits described in connection with the implementations disclosed herein may be implemented or performed with a general purpose single- or multi-chip processor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein.
- DSP digital signal processor
- ASIC application specific integrated circuit
- FPGA field programmable gate array
- a general-purpose processor may be a microprocessor, or, any conventional processor, or state machine.
- a processor also may be implemented as a combination of computing devices, such as a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.
- the one or more processors may be shared by multiple circuits (e.g., the circuits of the controller 300 may comprise or otherwise share the same processor which, in some example implementations, may execute instructions stored, or otherwise accessed, via different areas of memory).
- the one or more processors may be structured to perform or otherwise execute certain operations independent of one or more co-processors.
- two or more processors may be coupled via a bus to enable independent, parallel, pipelined, or multithreaded instruction execution. All such variations are intended to fall within the scope of the present disclosure.
- the memory device may include one or more devices (e.g., RAM, ROM, Flash memory, hard disk storage) for storing data and/or computer code for completing or facilitating the various processes, layers, and modules described in the present disclosure.
- the memory 304 may be communicably connected to the processor 302 to provide computer code or instructions to the processor 302 for executing at least some of the processes described herein.
- the memory device 304 may be or include tangible, nontransient volatile memory or non-volatile memory. Accordingly, the memory device 304 may include database components, object code components, script components, or any other type of information structure for supporting the various activities and information structures described herein.
- the controller 300 may include any number of circuits for completing the functions described herein. For example, the activities and functionalities of the circuits of the controller 300 may be combined in multiple circuits or as a single circuit. Additional circuits with additional functionality may also be included. Further, the controller 300 may further control other activity beyond the scope of the present disclosure.
- the circuits described herein may include one or more processing circuits comprising one or more memory devices coupled to one or more processors, the one or more memory devices configured to store instructions thereon that, when executed by the one or more processors, cause the one or more processors to perform the operations performed herein and described with reference to circuits.
- the “circuits” may be implemented in machine-readable medium for execution by various types of processors, such as the processor 302.
- An identified circuit of executable code may, for instance, comprise one or more physical or logical blocks of computer instructions, which may, for instance, be organized as an object, procedure, or function. Nevertheless, the executables of an identified circuit need not be physically located together but may comprise disparate instructions stored in different locations which, when joined logically together, comprise the circuit and achieve the stated purpose for the circuit.
- a circuit of computer-readable program code may be a single instruction, or many instructions, and may even be distributed over several different code segments, among different programs, and across several memory devices.
- operational data may be identified and illustrated herein within circuits and may be implemented in any suitable form and organized within any suitable type of data structure.
- the operational data may be collected as a single data set, or may be distributed over different locations including over different storage devices, and may exist, at least partially, merely as electronic signals on a system or network.
- processor may be implemented as one or more general-purpose processors, application-specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), digital signal processors (DSPs), or other suitable electronic data processing components structured to execute instructions provided by memory.
- ASICs application-specific integrated circuits
- FPGAs field programmable gate arrays
- DSPs digital signal processors
- the one or more processors may take the form of a single core processor, multi -core processor (e.g., a dual core processor, triple core processor, quad core processor, etc.), microprocessor, etc.
- the one or more processors may be external to the apparatus, for example the one or more processors may be a remote processor (e.g., a cloud-based processor). Alternatively or additionally, the one or more processors may be internal and/or local to the apparatus. In this regard, a given circuit or components thereof may be disposed locally (e.g., as part of a local server, a local computing system, etc.) or remotely (e.g., as part of a remote server such as a cloud-based server). To that end, a “circuit” as described herein may include components that are distributed across one or more locations.
- Implementations within the scope of the present disclosure include program products comprising machine-readable media for carrying or having machine-executable instructions or data structures stored thereon.
- Such machine-readable media can be any available media that can be accessed by a general purpose or special purpose computer or other machine with a processor.
- Such machine-readable media can comprise RAM, ROM, EPROM, EEPROM, or other optical disk storage, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to carry or store desired program code in the form of machine-executable instructions or data structures and which can be accessed by a general purpose or special purpose computer or other machine with a processor. Combinations of the above are also included within the scope of machine-readable media.
- Machine-executable instructions include, for example, instructions and data which cause a general purpose computer, special purpose computer, or special purpose processing machines to perform a certain function or group of functions.
- Coupled means the joining of two members directly or indirectly to one another. Such joining may be stationary (e.g., permanent) or moveable (e.g., removable or releasable). Such joining may be achieved with the two members or the two members and any additional intermediate members being integrally formed as a single unitary body with one another or with the two members or the two members and any additional intermediate members being attached to one another.
- Coupled or variations thereof are modified by an additional term (e.g., directly coupled)
- the generic definition of “coupled” provided above is modified by the plain language meaning of the additional term (e.g., “directly coupled” means the joining of two members without any separate intervening member), resulting in a narrower definition than the generic definition of “coupled” provided above.
- Such coupling may be mechanical, electrical, or fluidic.
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Abstract
An endotracheal intubation system includes an external frame including a carriage controllably movable via at least one external actuator. An internal frame coupled to the carriage includes a plurality of interlocked segments along a longitudinal axis, each segment defining a plurality of openings. A plurality of tension cables extends longitudinally from the carriage to a free end of the internal frame through the plurality of openings of the interlocked segments. At least one internal actuator is coupled to and configured to adjust the plurality of tension cables to adjust the curvature of the plurality of interlocked segments. The internal frame extends through a channel of a flexible intubation tube that is configured to conform to a shape of the internal frame. A controller is in communication with the internal and external actuators. The controller is configured to move the internal frame to navigate an airway of a patient.
Description
AUTOMATED ENDOTRACHEAL INTUBATION
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional Patent Application No. 63/637,442, filed April 23, 2024, the entire contents of which are incorporated herein by reference.
BACKGROUND
[0002] Endotracheal intubation is performed to access and maintain the patient's airway to facilitate safely regulated breathing. The process of endotracheal intubation refers to the placement of the tracheal tube in the patient’s airway. Common methods used clinically to place the tracheal tube include direct laryngoscopy, video laryngoscopy, and flexible intubation scope. Intubation may be performed in emergencies where a patient’s breathing may be unstable or in planned procedures where general anesthesia is used. An endotracheal intubation tube, as shown in FIG. 1, is used to route air from outside the body into the patient’s airway and/or trachea (and thus the lungs) by, for example, a mechanical ventilator.
[0003] Existing systems and methods for endotracheal intubation require significant training time due in part to the diverse patient population, the wide range of personnel involved, the variety of circumstances requiring intubation, and the difficult and often outdated tools involved. For example, anatomical differences between different patients make the visualization of anatomical features more difficult, reducing the likelihood of a properly placed tracheal tube. Furthermore, in emergencies, there is a need for quick and efficient intubation to avoid unnecessary delay in oxygen to the patient.
[0004] Therefore, there is a clinical need to develop new devices, systems, and methods of placing the tracheal tube in patients that are easier to perform, more reliable, and increase the safety of the patient.
SUMMARY
[0005] According to one implementation, an automated intubation system is disclosed. The automated intubation system includes an external frame, an internal frame, a flexible intubation tube, and a controller. The external frame includes a carriage controllably movable in at least a first direction and a second direction via at least one external actuator The internal frame is coupled to the carriage of the external frame. The internal frame includes a plurality of interlocked segments including a first segment rotatably coupled to a second segment along a longitudinal axis
of the internal frame, each of the plurality of interlocked segments defining a central opening and a plurality of openings radially spaced apart from the central opening. The internal frame further includes a plurality of tension cables, including a first cable and a second cable, extending longitudinally from adjacent the carriage to a free end of the internal frame through the plurality of openings of the interlocked segments. The internal frame further includes at least one internal actuator coupled to and configured to adjust the plurality of tension cables. The first cable is configured to move the free end of the internal frame in a first direction and the second cable is configured to move the free end of the internal frame in a second direction. The flexible intubation tube defines a channel extending from a first opening to a second opening. The internal frame extends from the first opening through a majority of the channel, and the flexible intubation tube is configured to conform to a shape of the internal frame. The controller is in communication with (i) the at least one external actuator of the external frame and (ii) the at least one internal actuator of the internal frame. The controller is configured to move the internal frame to navigate an airway of a patient.
[0006] In some implementations, the external frame further includes a base couplable to a rigid platform, wherein the rigid platform is adjacent to a patient surface.
[0007] In some implementations, the external frame is moveable from a stowed position to an active position that is closer to the patient surface.
[0008] In some implementations, the external frame includes a first linear actuator and a second linear actuator, wherein the first direction is substantially perpendicular to the second direction. The carriage is movable along a member of the first linear actuator and to a predefined position relative to the patient.
[0009] In some implementations, the carriage is movable via the external frame to a predefined position relative to the patient.
[0010] In some implementations, the carriage includes a motorized mount coupled to a fixed end of the internal frame, wherein an angle of the internal frame relative to the one or both of the external frame and the airway of the patient is adjustable via the motorized mount.
[0011] In some implementations, one of the carriage or the internal frame further includes a housing containing the at least one internal actuator.
[0012] In some implementations, the at least one internal actuator includes a first motor coupled to the first cable and a second motor coupled to the second cable. A length or tension of the first and second cables is adjustable to move the free end of the internal frame.
[0013] In some implementations, the at least one internal actuator includes four motors and the plurality of tension cables includes four cables each coupled to a different one of the four motors for individual cable control.
[0014] In some implementations, the internal frame further includes a camera disposed adjacent to the free end of the internal frame, the camera configured to send visual data to the controller.
[0015] In some implementations, the camera is in electrical communication with the controller via a data and/or power cable extending through the central openings of the plurality of interlocked segments.
[0016] In some implementations, the first segment of the plurality of interlocked segments is rotatable relative to the second segment by at least 4 degrees relative to the longitudinal axis.
[0017] In some implementations, the plurality of interlocked segments includes at least twenty segments coupled along the longitudinal axis.
[0018] In some implementations, the controller includes a processor and a memory storing instructions thereon that, when executed by the processor, cause the processor to (i) move the external frame to position the free end of the internal frame and the intubation tube thereon adjacent to the airway of the patient, and (ii) move the internal frame along with the intubation tube through the airway of the patient.
[0019] In some implementations, the internal frame further includes a camera disposed adjacent to the free end of the internal frame, the camera configured to send visual data to the controller, wherein the visual data informs movement of the internal frame by the processor.
[0020] In some implementations, the processor further includes an artificial intelligence model pre-trained on patient airway data including one or more anatomical landmarks.
[0021] In some implementations, the processor causes the internal frame to move based on a prediction generated by the pre-trained artificial intelligence model analyzing visual data from the camera.
[0022] In some implementations, the automated intubation system further includes an emergency stop button that releases tension in the plurality of tension cables, preventing further motion and enabling safe removal of the system.
[0023] According to another implementation, a method for automated intubation is disclosed. The method includes providing an automated intubation system. The automated intubation system includes an external frame including a carriage controllably movable in at least a first direction and a second direction via at least one external actuator. The automated intubation system further includes an internal frame coupled to the carriage of the external frame. The internal frame includes a plurality of interlocked segments including a first segment rotatably coupled to a second segment along a longitudinal axis of the internal frame, each of the plurality of interlocked segments defining a central opening and a plurality of openings radially spaced apart from the central opening. The internal frame further includes a plurality of tension cables, including a first cable and a second cable, extending longitudinally from adjacent the carriage to a free end of the internal frame through the plurality of openings of the interlocked segments. The internal frame further includes and at least one internal actuator coupled to and configured to adjust the plurality of tension cables, wherein the first cable is configured to move the free end of the internal frame in a first direction and the second cable is configured to move the free end of the internal frame in a second direction. The automated intubation system further includes a controller in communication with (i) the at least one external actuator of the external frame and (ii) the at least one internal actuator of the internal frame. The method further includes providing a flexible intubation tube defining a channel extending from a first opening to a second opening, wherein the internal frame extends from the first opening through a majority of the channel, and the flexible intubation tube is configured to conform to a shape of the internal frame. The method further includes moving the external frame to position the free end of the internal frame and intubation tube thereon adjacent to an airway of a patient. The method further includes moving the internal frame along with the intubation tube through the airway of the patient.
[0024] In some implementations, the method further includes capturing, via a camera disposed adj acent to the free end of the internal frame, visual data of the airway. The method further includes sending the visual data to the controller and moving the internal frame based on the visual data from the camera.
[0025] In some implementations, the method further includes analyzing, via a pre-trained artificial intelligence model, the visual data, and moving the internal frame based on a prediction generated by the pre-trained artificial intelligence model.
[0026] According to another implementation, an automated intubation device is disclosed. The automated intubation device includes a plurality of interlocked segments, a plurality of tension cables, and at least one internal actuator. The plurality of interlocked segments includes a first segment rotatably coupled to a second segment along a longitudinal axis of the device. Each of the plurality of interlocked segments defines a central opening and a plurality of openings radially spaced apart from the central opening. The plurality of tension cables, including a first cable and a second cable, extend longitudinally from a fixed end to a free end of the device through the plurality of openings of the interlocked segments. The at least one internal actuator coupled to and configured to adjust the plurality of tension cables. The first cable is configured to move the free end of the device in a first direction and the second cable is configured to move the free end of the device in a second direction, The device is configured to be disposed within a channel defined by a flexible intubation tube that is configured to conform to a shape of the device, the device being movable to navigate an airway of a patient.
[0027] This summary is illustrative only and is not intended to be in any way limiting. Other aspects, features, and advantages of the devices or processes described herein will become apparent in the detailed description set forth herein, taken in conjunction with the accompanying figures, wherein like reference numerals refer to like elements.
BRIEF DESCRIPTION OF DRAWINGS
[0028] The systems, methods, and devices are explained in even greater detail in the following drawings. The drawings are merely exemplary and certain features may be used singularly or in combination with other features. The drawings are not necessarily drawn to scale.
[0029] FIG. 1 shows an example of an existing endotracheal intubation process, including a standard endotracheal tube and a laryngoscope, according to one implementation.
[0030] FIG. 2 shows a diagram of a system for automatic endotracheal intubation, according to one implementation.
[0031] FIG. 3A shows a gantry system as an alternative for an external frame of the disclosed system, according to one implementation.
[0032] FIG. 3B shows a linear actuator of the system of FIG. 2, according to one implementation.
[0033] FIG. 4A shows a first portion of a housing for one or more actuators, according to one implementation.
[0034] FIG. 4B shows a second portion of the housing couplable to the first portion in FIG. 4A, according to one implementation.
[0035] FIG. 5A shows a portion of a system for automatic endotracheal intubation including an internal frame structure having a plurality of interlocking segments, according to one implementation.
[0036] FIG. 5B shows a diagram of two interlocking segments and the bending motion between them, according to one implementation.
[0037] FIG. 5C shows a diagram of an internal frame having a plurality of interlocking segments along with a cross-sectional view of one of the segments, according to one implementation.
[0038] FIG. 6A shows an isometric view of one interlocking segment, according to one implementation.
[0039] FIG. 6B shows a top view of the segment of FIG. 6 A.
[0040] FIG. 6C shows a first side view of the segment of FIG. 6 A.
[0041] FIG. 6D shows a second side view of the segment of FIG. 6A.
[0042] FIGS. 7A-7C show various views of a camera-integrated segment that is couplable to the segment of FIG. 6 A, according to one implementation.
DETAILED DESCRIPTION
[0043] Following below are more detailed descriptions of concepts related to, and implementations of, methods, apparatuses, and systems for automated endotracheal intubation. The figures illustrate exemplary implementations in detail and the present disclosure is not limited to the details or methodology set forth in the description or illustrated in the figures. The terminology used herein is for the purpose of description only and should not be regarded as limiting.
[0044] In general, endotracheal intubation refers to the insertion of an endotracheal tube into a patient’s airway. Endotracheal intubation is performed to access and maintain the patient's airway to facilitate safely regulated breathing. Common methods used clinically to place the tracheal tube include direct laryngoscopy, video laryngoscopy, and flexible intubation scope. Intubation may be performed in emergencies where a patient’s breathing may be unstable or in planned procedures where general anesthesia is used. An endotracheal intubation tube, as shown in FIG. 1, is used to route air from outside the body by, for example, a mechanical ventilator to the trachea and thus the lungs.
[0045] While endotracheal intubation may be a straightforward process in some situations, it can often be complicated by any one of several factors. For example, in an emergency situation, the setting may not provide for controlled and accurate placement of the endotracheal tube (e.g., in an ambulance or in a time-critical situation). Furthermore, differences in patient airway anatomy can reduce intubation accuracy and efficiency. For example, anatomical characteristics, such as short, thick necks or prominent upper incisors, as well as health conditions including obesity, airway trauma, or head and neck cancer, also increase the likelihood of a difficult airway. There is a need for an intubation method that maximizes the first attempt success rate to ensure safe intubation of a patient.
[0046] This disclosure provides an efficient and automated endotracheal intubation system and method. The disclosed system may perform intubation in 1 minute or less without human input. In some implementations, the disclosed system is further capable of human control in place of - or conjunction with - an automated system. The disclosed system can easily fit into an operating room, patient room, clinical setting, ambulance, or other healthcare setting that may require efficient intubation at a moment’s notice.
[0047] The disclosed system includes an internal frame, which may be defined as the portion of the system that enters the patient. The disclosed internal frame may implement a pulley-tendon system along a flexible member having a plurality of interlocking segments. The flexible member (e.g., the “internal frame” of the system) may be placed within a standard endotracheal tube to manipulate the location and shape of the endotracheal tube. The pulley -tendon system may be used to control the shape of the flexible member via one or more tension cables extending along the length of the member. The flexible member may be manipulated to approximate the shape of a laryngoscope or similar existing intubation devices. Thus, the flexible member is moveable in a
variety of directions (e.g., x-, y-, and z-directions, or 6 degrees of freedom) relative to the patient’s airway.
[0048] The flexible member and the endotracheal tube thereon may be coupled to an external frame configured to perform the larger-scale movements. The external frame may be defined as the portion of the system that does not enter the patient. For example, the external frame may position the endotracheal tube near the patient’s mouth before the flexible member performs finetuned adjustments to navigate the airway. The external frame may be active simultaneously with the flexible member for insertion and navigation along the airway.
[0049] The disclosed system further implements a controller configured to operate and/or facilitate the operation of the system, including the motion of the internal and external frames. The controller may be coupled to a user interface which may include manual controls for a healthcare professional to operate the system. In other implementations, the controller may include an automated process for operating the system and performing intubation on a patient. For example, the internal frame and the endotracheal tube thereon may follow a predetermined pathway and/or set of movements. The automated system may adjust its motion based on visual data feedback from a camera at the end of the internal frame. For example, a pre-trained Al model or other visual data processor may identify and/or predict anatomical landmarks in the patient’s airway to inform adjustments of the internal frame and/or external frame.
[0050] Referring to the figures generally, the various implementations disclosed herein relate to systems, apparatuses, and methods for automated endotracheal intubation.
Example System and Device
[0051] FIG. 2 shows an automated intubation system 10, according to one implementation. The system 10 includes a flexible intubation tube 30, an internal frame 100, an external frame 200, and a controller 300. The system 10 is configured to intubate a patient 20 positioned adjacent to the system 10 (e.g., on a hospital bed next to the system 10). The system 10 may be configured to automatically intubate a patient 20 (e.g., on receipt of an initiation signal from a healthcare professional or a detection system monitoring the patient 20).
[0052] As shown in FIG. 2, the external frame 200 includes a base 202 and a free end 204 spaced apart from the base 202. The external frame 200 further includes one or more arm segments 206 extending from the base 202 to the free end 204. For example, the external frame 200 may include
three articulable arm segments 206 each rotatably coupled to each other. In some implementations, the external frame may be a 6-axis robotic arm.
[0053] The base 202 may be coupled to a rigid platform adjacent to the patient 20 and/or patient surface. For example, the base 202 may be couplable to a side of a patient’s bed, a rollable cart placed adjacent to the patient’s bed, or a portion of a patient’s room (e.g., a wall-mounted external frame).
[0054] The external frame 200 is generally moveable between a stowed configuration and an active configuration. The free end 204 of the external frame 200 is positioned further away from the patient 20 in the stowed configuration relative to the active configuration. That is, the system 10 moves the free end 204 of the external frame 200 closer to the patient 20 in the active configuration. The stowed configuration may include folding the one or more arm segments 206 relative to each other to form a more compact structure. Moving to the active configuration may include rotating the one or more arm segments 206 about the base 202 and/or each other to position the free end 204 in a desired position relative to the patient 20.
[0055] The external frame 200 is generally configured to move the free end 204 of the external frame 200 to a desired location relative to the patient 20 and/or their airway. Thus, the external frame 200 includes one or more actuators (e.g., coupled to and/or internal to one or more of the arm segments 206). For example, the one or more arm segments 206 may include servo motors (or similar actuators) configured to controllably move the free end 204 to a desired position. In some implementations, the external frame is configured with any one of a stepper motor, a pneumatic actuator, a hydraulic actuator, or a similar actuator configured to controllably move the arm segments.
[0056] In other implementations, the external frame includes one or more arm segments moveable in at least one linear direction. For example, FIG. 3A shows an external frame 200b having two arm segments moveable in a gantry-like configuration. That is, the external frame 200b includes a first member coupled to a second member, the first member being moveable along the second member in a first direction. The first member is oriented perpendicular to the second member such that the first member can move a mounting point or carriage in a second direction that is perpendicular to the first direction.
[0057] As shown in FIG. 2, the free end 204 of the external frame 200 is coupled to a linear actuator 210. FIG. 3B shows an image of a linear actuator 210, similar to that of FIG. 2. The linear
actuator 210 includes a support frame 212 that is coupled to the free end 204 of the external frame 200 (e.g., to one of the arm segments 206). A lead screw 214 extends from one end of the support frame 212 to an opposite end. An external actuator 216 (e.g., a servo motor or similar actuator device) is coupled to the lead screw 214 and configured to controllably rotate the lead screw 214. For example, one or more potentiometers coupled to the lead screw 214 and/or the external actuator 216 may track and inform control of the position of the lead screw 214 and/or the external actuator 216.
[0058] A carriage 220 is controllably moveable along the lead screw 214. For example, upon rotation of the lead screw 214, the carriage 220 is moved along the lead screw 214 in a first direction towards one end of the support frame 212. Rotation of the lead screw 214 in the opposite direction moves the carriage 220 in a second direction opposite to the first direction towards the opposite end of the support frame 212.
[0059] The linear actuator 210 is generally oriented vertically (e.g., longitudinally aligned with the gravity vector). Thus, when the carriage 220 is moved towards the “lower” end of the support frame 212, the carriage 220 is moving towards a ground surface, a support surface, or a patient 20 on the support surface. The carriage 220 is moveable to a desired location along the lead screw 214 (e.g., relative to a patient’s airway).
[0060] The external frame 200 further includes a housing 230 that is coupled to the carriage 220. The housing 230 is moveable with the carriage 220 in the first and second directions (e.g., the vertical directions). The housing 230 is further coupled to the internal frame 100. The housing 230 includes a first portion 232 and a second portion 234 couplable to each other (e.g., in a clamshell configuration). An example of the first portion 232 of the housing 230 is shown in FIG. 4A. An example of the second portion 234 of the housing 230 that is couplable to the first portion 232 is shown in FIG. 4B. The housing 230 defines a cavity 236 configured to house one or more components of the internal frame 100. For example, as further described herein, one or more actuators (e.g., motors) may be disposed within the cavity 236 of the housing 230.
[0061] In some implementations, the carriage 220 includes a mount coupled to the internal frame 100 and/or the carriage 220, the mount being pivotable relative to the linear actuator 210. For example, the mount may be configured to tilt the internal frame 100 up, down, left, and right relative to the linear actuator 210. Thus, the mount may include one or more hinged couplings between the housing 230 and the internal frame 100 thereon. The mount and/or the linear actuator
210 may be further configured to rotate relative to the patient 20, allowing for angular adjustments to align the flexible intubation tube 30 with the patient’s airway.
[0062] As shown in FIG. 2, the internal frame 100 is coupled to the carriage 220 on the linear actuator 210 of the external frame 200. Specifically, the internal frame 100 is coupled to the carriage 220 via the housing 230 which includes one or more components of the internal frame 100. Thus, the internal frame 100 is generally moveable by the external frame 200 in the first and second directions (e.g., vertically) relative to the patient 20 and their airway.
[0063] The internal frame 100 is generally configured to engage with and control the placement of a flexible intubation tube 30. The flexible intubation tube 30 may be a standard intubation tube (e.g., a 7mm diameter tube), as shown in FIG. 1, or a modified intubation tube configured to engage with the system 10. The flexible intubation tube 30 defines a channel extending from a first opening to a second opening. The flexible intubation tube 30 may have a curved neutral position matching the desired shape for accessing or maintaining a patient’s airway. The flexible intubation tube 30 includes a generally flexible material (e.g., a flexible polymer) that can conform to the shape of the internal frame 100 therein.
[0064] As shown in FIG. 2, the internal frame 100 is disposed at least partially within the channel of the flexible intubation tube 30. For example, the internal frame 100 extends through the first opening and a majority of the channel of the flexible intubation tube 30. The flexible intubation tube 30 may be disposed on the internal frame 100 when the system 10 and/or the external frame 200 is in the stowed position - such that the flexible intubation tube 30 is ready for insertion into a patient’s airway upon initiation. During use, the internal frame 100 changes its shape to (i) navigate the airway of the patient 20 and (ii) position the flexible intubation tube 30 properly within the patient’s airway.
[0065] The internal frame 100 includes a plurality of interlocked segments 110 (e.g., a first and second segment rotatably coupled to each other) extending from a fixed end 102 to a free end 104 of the internal frame 100 along a longitudinal axis 101. For example, a first segment may be coupled to the housing 230, and a second segment may be coupled to the first segment, closer to the free end 104. The plurality of segments 110 may include a number of segments in the range of 15 to 200 (e.g., between 25 and 40 interlocked segments). The total length of the internal frame 100, including the plurality of interlocked segments 110, may be based on the length of the flexible intubation tube 30 and/or a patient’s airway.
[0066] FIG. 5A shows another view of the internal frame 100 that is coupled to the housing 230, the carriage 220, and the linear actuator 210. FIG. 5 A shows one implementation of the plurality of interlocked segments 110 including individual segments 108 coupled to each other along the longitudinal axis 101 of the internal frame 100. Each individual segment 108 is coupled to an adjacent segment 108 (e.g., via an interlocking structure). Each segment 108 is configured to rotate relative to an adjacent segment 108 (e.g., by an angle in the range of 1 to 20 degrees relative to the longitudinal axis 101).
[0067] As shown in FIG. 5 A, the entire internal frame 100 has a controllable curvature based on the movement of the plurality of interlocked segments 110. Thus, the plurality of interlocked segments 110 may have an entirely linear structure, or a portion of the segments 108 of the plurality of interlocked segments 110 may be angled relative to each other to form a curved shape (e.g., approximating the airway of a patient). The segment 108 in FIGS. 5A and 5C is only one implementation of an interlocked segment of the disclosed internal frame 100, and other variations of interlocking segments are contemplated by this disclosure.
[0068] For example, FIG. 5B shows a side view of two segments 107a and 107b that are substantially similar to the segments 108 of FIG. 5A. The segments 107a, 107b are interlocked with each other. In the first panel of FIG. 5B, the first segment 107a is axially aligned with the second segment 107b (e.g., along the longitudinal axis 101). In the second panel of FIG. 5B, the first segment 107a is rotated relative to the second segment 107b (e.g., by a specified or predetermined angle). The angle of rotation between the segments 107a, 107b may be limited by the structure of the segments and interference or self-contact between the segments when rotated away from the longitudinal axis 101.
[0069] As shown in FIG. 5C, each of the segments 108 of the plurality of interlocked segments 110 defines a plurality of openings extending axially therethrough (e.g., extending substantially parallel to the longitudinal axis 101). For example, each segment 108 includes four cable openings 112a, 112b, 112c, and 112d. The cable openings 112a- 112d are circumferentially spaced apart from each other. For example, the cable openings 112a-112d are equally spaced apart from each other around the segment 108 (e.g., 90 degrees apart from each other).
[0070] The cable openings 112a-112d are also radially spaced apart from each of the outer circumferential surface of the segment 108 and a central opening 114. The central opening 114 is substantially centered within the segment 108 (e.g., along the longitudinal axis 101). Each of the
cable openings 112a-l 12d and the central opening 114 are aligned between adjacent segments 108 and are configured to retain a cable or other member therein.
[0071] To control the curvature of the internal frame 100 and the plurality of interlocked segments 110 thereof, the internal frame 100 includes a plurality of tension cables 120. For example, as shown in FIG. 5 A, the internal frame 100 includes four tension cables 120 extending along the plurality of interlocked segments 110 from the fixed end 102 to the free end 104 of the internal frame 100.
[0072] As shown in FIG. 5C, the segment 108 includes four tension cables 120a, 120b, 120c, and 120d extending through the corresponding cable openings 112a-l 12d. Furthermore, a central cable 122 extends through the central opening 114. Each cable 120a-120d extends longitudinally between the free end 104 and the fixed end 102 of the external frame 100. For example, the cables 120a-120d are coupled to an actuator or other portion of the housing 230. The cables 120a-120d extend through each segment 108 of the plurality of interlocked segments 110 and are coupled to a last segment on the free end 204 or another device thereon (e.g., a camera segment).
[0073] Each cable 120a-120d is coupled to a corresponding actuator and/or spool within the housing 230. For example, each cable 120a-120d may be coupled to a corresponding motor 124a, 124b, 124c, and 124d. Each motor 124a-124d is configured to extend or retract the corresponding cable 120a-120d. For example, the motors 124a-124d may be coupled to a corresponding spool of cable such that rotation of the motor in one direction increases tension in the cable and rotation in the opposite direction decreases tension in the cable. The motors 124a-124d and associated spools may be disposed within the cavity 236 of the housing 230. In some implementations, fewer than four motors and/or spools may be implemented. In some implementations, more than four motors and/or spools may be implemented. In some implementations, more or less than four cables may be implemented.
[0074] In use, the motors 124a-124d are configured to move the free end 104 of the internal frame 100 in one or more directions. For example, increasing tension in the first cable 120a pulls the corresponding side of the plurality of interlocked segments 110, bending the free end 104 of the internal frame 100 in that direction. Decreasing tension in the first cable 120a allows the free end 104 of the internal frame to move away from the corresponding side of the plurality of interlocked segments 110 (e.g., “pushes” the free end in the opposite direction). Thus, the system of cables 120a-120d and motors 124a-124d are configured to control the overall curvature,
direction, and position of the internal frame 100 and the free end 104 thereof. For example, the system of cables 120a-120d and motors 124a-124d are configured to position the internal frame 100 and the flexible intubation tube 30 relative to a patient’s airway.
[0075] As shown in FIG. 5C, a camera segment 160 is disposed on the free end 104 of the internal frame 100. FIGS. 7A-7C show a camera segment 160 of the internal frame 100, according to one implementation. The camera segment 160 is rotatably couplable to one of the segments 108 of the plurality of interlocked segments 110. The camera segment 160 defines four circumferentially spaced openings and a central opening, similar to the segment 108. The cables 120a-120d may terminate at and attach to a portion of the camera segment 160.
[0076] The camera segment 160 may include a camera 162 and a light source 164. Each of the camera 162 and the light source 164 are coupled to the central cable 122 extending through the central openings of each segment 108 of the plurality of interlocked segments 110 and through the central opening of the camera segment 160. The central cable 122 may include separate power and data cable(s) that connect to a controller, power source, or other electronic device coupled to the internal frame 100 and/or the external frame 200.
[0077] Other variations of interlocking segments beyond that of FIGS. 5A-5C are contemplated by this disclosure. For example, FIGS. 6A-6D show a segment 109, according to another implementation of the internal frame 100. The segment 109 includes interlocking features similar to other interlocking segments described herein.
[0078] The segment 109 includes a cylindrical outer surface 130 defining the outer diameter of the segment 109. The outer surface 130 is configured to match and/or engage with the inner channel of the flexible intubation tube 30. The segment 109 further includes a top side 132 and a bottom side 144.
[0079] The top side 132 includes a first protrusion 134 and a second protrusion 136. Specifically, the first protrusion 134 includes a neck 138 extending from the top side 132 and a head 140 extending from the neck 138. The head 140 is wider than the neck 138 and defines a shoulder at the interface between the neck 138 and the head 140. The head 140 has a substantially semi- circular-shaped upper surface 142. The second protrusion 136 is substantially similar in structure and function to the first protrusion 134. The first protrusion 134 is diametrically opposed to the second protrusion 136 across the top side 132.
[0080] The bottom side 144 of the segment 109 includes opposing angled surfaces 146a, 146b. The angle surfaces 146a, 146b converge at a central portion of the bottom side 144. The bottom side 144 further defines a connection channel 148 extending along the central portion at the interface between the angled surfaces 146a, 146b. The connection channel 148 extends in a direction across the bottom side 144 opposite from the direction between the protrusions 134, 136 on the top side 132. The connection channel 148 is sized and configured to accept the first and second protrusions 134, 136 therein. For example, the semi-circular-shaped upper surface 142 of the protrusions 134, 136 matches the shape of the connection channel 148.
[0081] When two of the segments 109 are coupled together, the first and second protrusions 134, 136 are disposed within the connection channel 148. The segments 109 are freely rotatably relative to each other about the connection channel 148 (e.g., an axis thereof). The angle of rotation between the two segments 109 is limited by the angle between the angled surfaces 146a, 146b and the surface of the top side 132 from which the protrusions 134, 136 extend.
[0082] The segment 109 further includes the four cable openings and a central openings, similar to that of FIG. 5C. As shown in FIG. 6B, the segment 109 defines a first opening 150a and a second opening 150b that extend in the longitudinal direction through the segment 109 from the top side 132 to the bottom side 144, including through first protrusion 134 and the second protrusion 136, respectively. The segment 109 further defines a third opening 150c and a fourth opening 15 Od each offset 90 degrees from the first and second protrusions 134, 136. The third and fourth openings 150c, 150d extend through the segment 109 from the top side 132 to the bottom side 144, including a portion of the connection channel 148.
[0083] As shown in FIG. 2, the controller 300 of the system 10 is in electrical communication (e.g., wired or wireless communication) with the internal frame 100 and the external frame 200. Specifically, the controller 300 is in electrical communication with at least (i) the actuators of the one or more arm segments 206 of the external frame 200, (ii) the linear actuator 210 and the external actuator 216 thereof, (iii) the motors 124a-124d coupled to the cables 120a-120d extending through the plurality of interlocked segments 110 of the internal frame 100, and (iv) the camera segment 160 of the internal frame 100.
[0084] The controller 300 includes a processor 302, a memory 304, and a display and/or user interface (UI) 306. The memory 304 includes instructions stored thereon that, when executed by the processor 302, cause the processor 302 to move the external frame 200 and/or the internal
frame 100. Specifically, the processor 302 may move the external frame 200 to position the free end 204 in a desired position. For example, the free end 204 may be moved so that the internal frame 100 and the flexible intubation tube 30 are positioned adjacent to the airway of a patient 20.
[0085] The processor 302 may further cause the internal frame 100 to move with the flexible intubation tube 30 through the patient’s airway. For example, the memory 304 may include one or more automated intubation operation instructions which, when executed by the processor 302, cause the actuators of the external frame 200 and the motors of the internal frame 100 to perform a pre-determined set of operations (e.g., motor rotations and corresponding movement of the internal frame 100 and flexible intubation tube 30).
[0086] The camera 162 on the camera segment 160 is in electrical communication with the controller 300 via the central cable 122 extending through the plurality of interlocked segments 110. Visual data from the camera 162 is captured and delivered to the controller 300 in real time, which may be displayed on the user interface 306 or a connected device (e.g., a display monitor in the room).
[0087] The controller 300 may further include controls (e.g., physical and/or incorporated into an external device) providing for human control of the system 10. For example, a healthcare professional can take over control of the system 10 when needed and control the internal frame 100 and the external frame 200 based on visual data on a display monitor.
[0088] The controller 300 is further configured to process (e.g., via the processor 302) the visual data from the camera 162 to inform the movement of the system 10. In some implementations, the processor 302 interprets the visual data from the camera 162 to inform the movement of the external frame 200 or the internal frame 100. The processor 302 identifies visual landmarks of the patient 20 and their airway (e.g., anatomical landmarks) to guide the location of the internal frame 100 and the flexible intubation tube 30 thereon.
[0089] According to some implementations, the processor 302 of the controller 300 includes an artificial intelligence (Al) model pre-trained on patient airway data - including one or more anatomical landmarks. For example, the memory 304 may include a pre-trained Al model configured to identify the mouth, throat, and airway of a human based on visual data from the camera 162. In some implementations, the internal frame 100 is caused to move based on the identification of anatomical landmarks in the visual data by the Al model. In some
implementations, the internal frame 100 is caused to move based on a prediction of the anatomy generated by the Al model analyzing the visual data.
[0090] Finally, the system 10 may include an emergency stop button on any portion of the system 10 (e.g., on the external frame 200 or the user interface 306) to halt all operations. The emergency stop button may release tension in the cables 120a-120d so that the internal frame 100 and flexible intubation tube 30 may be easily removed from the patient’s airway. In other implementations, a pre-defined tension scheme and/or curvature of the internal frame 100 is provided when the emergency stop is initiated.
[0091] In use, the system 10 is used to automatically perform endotracheal intubation on the patient 20. For example, a detection system may identify when a patient 20 is unable to breathe on their own or when the patient’s airway is otherwise compromised. Furthermore, a healthcare professional may identify when a patient 20 is unable to breathe on their own or when the patient’s airway is otherwise compromised, which may include verifying a signal from the detection system. Once confirmed, the detection system and/or the healthcare professional initiates the system 10 to intubate the patient 20.
[0092] First, the external frame 200 is moved from the stowed position (e.g., folded in a compact arrangement on a wall mount by the patient’s bed) to an active position closer to the patient 20. The processor 302 initiates movement of the one or more arm segments 206 via the one or more actuators therein to articulate the external frame 200. The movement of the external frame 200 may be a pre-arranged set of movements stored in the memory 304 or a dynamic movement based on in-room feedback (e.g., an external camera or the camera 162 identifying the patient’s location relative to the system 10).
[0093] The free end 204 is moved to a desired location relative to the patient 20. For example, the desired location may include the free end 204 positioned above the patient 20 by a set distance such that the bottom of the linear actuator 210 and the internal frame 100 therein are placed just above the patient’s mouth.
[0094] Next, the processor 302 then causes the internal frame 100 to change its overall curvature and shape, which alters the overall shape of the flexible intubation tube 30 disposed on the internal frame 100. The processor 302 simultaneously initiates the lowering of the internal frame 100 via the linear actuator 210 and the adjustment of the curvature of the internal frame 100 to properly insert the flexible intubation tube 30 in the patient’s airway. For example, the linear actuator 210
may be activated for larger, vertical movement, while the motors 124a-124d and associated cables 120a-120d are moved for fine-tuned adjustment of the internal frame 100 and the free end 104 thereof.
[0095] The camera 162 on the free end 104 of the internal frame 100 and its plurality of interlocked segments 110 feed visual data of the patient’s airway back to the controller 300. The processor 302 analyzes and interprets the visual data to inform the movement of the external frame 200, the linear actuator 210, and/or the internal frame 100. For example, an Al model or preconfigured set of instructions may identify anatomical landmarks of the patient 20 to inform the next movement of the system 10.
[0096] Once the flexible intubation tube 30 is properly positioned in the patient’s airway, the internal frame 100 is retracted to leave the flexible intubation tube 30 in the airway. For example, a clasp or a release mechanism may connect/disconnect the flexible intubation tube 30 from the fixed end 102 of the internal frame 100 (e.g., a clasp extending from the housing 230). The internal frame 100 and the plurality of interlocked segments 110 thereof may be controllably retracted to follow the exact shape of the channel of the flexible intubation tube 30 without providing a retracting force to the flexible intubation tube 30. In other implementations, the external end of the flexible intubation tube 30 may be held in place while the internal frame 100 is retracted. For example, a healthcare professional may hold the flexible intubation tube 30 in place, or a stopper/extension of the internal frame 100 may engage the flexible intubation tube 30 to ensure it remains within the airway.
Conclusion
[0097] The hardware and data processing components used to implement the various processes, operations, illustrative logics, logical blocks, modules and circuits described in connection with the implementations disclosed herein (e.g., the processor 302) may be implemented or performed with a general purpose single- or multi-chip processor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. A general-purpose processor may be a microprocessor, or, any conventional processor, or state machine. A processor also may be implemented as a combination of computing devices, such as a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction
with a DSP core, or any other such configuration. In some implementations, the one or more processors may be shared by multiple circuits (e.g., the circuits of the controller 300 may comprise or otherwise share the same processor which, in some example implementations, may execute instructions stored, or otherwise accessed, via different areas of memory). Alternatively or additionally, the one or more processors may be structured to perform or otherwise execute certain operations independent of one or more co-processors. In other example implementations, two or more processors may be coupled via a bus to enable independent, parallel, pipelined, or multithreaded instruction execution. All such variations are intended to fall within the scope of the present disclosure.
[0098] The memory device (e.g., memory 304, memory unit, storage device) may include one or more devices (e.g., RAM, ROM, Flash memory, hard disk storage) for storing data and/or computer code for completing or facilitating the various processes, layers, and modules described in the present disclosure. The memory 304 may be communicably connected to the processor 302 to provide computer code or instructions to the processor 302 for executing at least some of the processes described herein. Moreover, the memory device 304 may be or include tangible, nontransient volatile memory or non-volatile memory. Accordingly, the memory device 304 may include database components, object code components, script components, or any other type of information structure for supporting the various activities and information structures described herein.
[0099] It should be understood that the controller 300 may include any number of circuits for completing the functions described herein. For example, the activities and functionalities of the circuits of the controller 300 may be combined in multiple circuits or as a single circuit. Additional circuits with additional functionality may also be included. Further, the controller 300 may further control other activity beyond the scope of the present disclosure. In some implementations, the circuits described herein may include one or more processing circuits comprising one or more memory devices coupled to one or more processors, the one or more memory devices configured to store instructions thereon that, when executed by the one or more processors, cause the one or more processors to perform the operations performed herein and described with reference to circuits.
[0100] As mentioned above and in one configuration, the “circuits” may be implemented in machine-readable medium for execution by various types of processors, such as the processor 302. An identified circuit of executable code may, for instance, comprise one or more physical or logical
blocks of computer instructions, which may, for instance, be organized as an object, procedure, or function. Nevertheless, the executables of an identified circuit need not be physically located together but may comprise disparate instructions stored in different locations which, when joined logically together, comprise the circuit and achieve the stated purpose for the circuit. Indeed, a circuit of computer-readable program code may be a single instruction, or many instructions, and may even be distributed over several different code segments, among different programs, and across several memory devices. Similarly, operational data may be identified and illustrated herein within circuits and may be implemented in any suitable form and organized within any suitable type of data structure. The operational data may be collected as a single data set, or may be distributed over different locations including over different storage devices, and may exist, at least partially, merely as electronic signals on a system or network.
[0101] While the term “processor” is briefly defined above, the term “processor” and “processing circuit” are meant to be broadly interpreted. In this regard and as mentioned above, the “processor” may be implemented as one or more general-purpose processors, application-specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), digital signal processors (DSPs), or other suitable electronic data processing components structured to execute instructions provided by memory. The one or more processors may take the form of a single core processor, multi -core processor (e.g., a dual core processor, triple core processor, quad core processor, etc.), microprocessor, etc. In some implementations, the one or more processors may be external to the apparatus, for example the one or more processors may be a remote processor (e.g., a cloud-based processor). Alternatively or additionally, the one or more processors may be internal and/or local to the apparatus. In this regard, a given circuit or components thereof may be disposed locally (e.g., as part of a local server, a local computing system, etc.) or remotely (e.g., as part of a remote server such as a cloud-based server). To that end, a “circuit” as described herein may include components that are distributed across one or more locations.
[0102] Implementations within the scope of the present disclosure include program products comprising machine-readable media for carrying or having machine-executable instructions or data structures stored thereon. Such machine-readable media can be any available media that can be accessed by a general purpose or special purpose computer or other machine with a processor. By way of example, such machine-readable media can comprise RAM, ROM, EPROM, EEPROM, or other optical disk storage, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to carry or store desired program code in the form of
machine-executable instructions or data structures and which can be accessed by a general purpose or special purpose computer or other machine with a processor. Combinations of the above are also included within the scope of machine-readable media. Machine-executable instructions include, for example, instructions and data which cause a general purpose computer, special purpose computer, or special purpose processing machines to perform a certain function or group of functions.
[0103] For purposes of this description, certain advantages and novel features of the aspects and configurations of this disclosure are described herein. The described methods, systems, and apparatus should not be construed as limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed aspects, alone and in various combinations and sub-combinations with one another. The disclosed methods, systems, and apparatus are not limited to any specific aspect, feature, or combination thereof, nor do the disclosed methods, systems, and apparatus require that any one or more specific advantages be present or problems be solved.
[0104] Although the figures and description may illustrate a specific order of method steps, the order of such steps may differ from what is depicted and described, unless specified differently above. Also, two or more steps may be performed concurrently or with partial concurrence, unless specified differently above. Such variation may depend, for example, on the software and hardware systems chosen and on designer choice. All such variations are within the scope of the disclosure. Likewise, software implementations of the described methods could be accomplished with standard programming techniques with rule-based logic and other logic to accomplish the various connection steps, processing steps, comparison steps, and decision steps.
[0105] Features disclosed in this specification (including any accompanying claims, abstract, and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive. The claimed features extend to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract, and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.
[0106] As used in the specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise. Ranges may be expressed herein as from “about” one particular value, and/or to “about” another particular value.
When such a range is expressed, another aspect includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about”, it will be understood that the particular value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint. The terms “about” and “approximately” are defined as being “close to” as understood by one of ordinary skill in the art. In one non-limiting aspect the terms are defined to be within 10%. In another non-limiting aspect, the terms are defined to be within 5%. In still another non-limiting aspect, the terms are defined to be within 1%.
[0107] The terms “coupled”, “connected”, and the like as used herein mean the joining of two members directly or indirectly to one another. Such joining may be stationary (e.g., permanent) or moveable (e.g., removable or releasable). Such joining may be achieved with the two members or the two members and any additional intermediate members being integrally formed as a single unitary body with one another or with the two members or the two members and any additional intermediate members being attached to one another. If “coupled” or variations thereof are modified by an additional term (e.g., directly coupled), the generic definition of “coupled” provided above is modified by the plain language meaning of the additional term (e.g., “directly coupled” means the joining of two members without any separate intervening member), resulting in a narrower definition than the generic definition of “coupled” provided above. Such coupling may be mechanical, electrical, or fluidic.
[0108] Certain terminology is used in the following description for convenience only and is not limiting. The words “right”, “left”, “lower”, and “upper” designate the direction in the drawings to which reference is made. The words “inner” and “outer” refer to directions toward and away from, respectively, the geometric center of the described feature or device. The words “distal” and “proximal” refer to directions taken in the context of the item described and, with regard to the instruments herein described, are typically based on the perspective of the practitioner using such instrument, with “proximal” indicating a position closer to the practitioner and “distal” indicating a position further from the practitioner. The terminology includes the above-listed words, derivatives thereof, and words of similar import.
[0109] Throughout the description and claims of this specification, the word “comprise” and variations of the word, such as “comprising” and “comprises”, means “including but not limited to”, and is not intended to exclude, for example, other additives, components, integers or steps.
“Exemplary” means “an example of’ and is not intended to convey an indication of a preferred or ideal aspect. “Such as” is not used in a restrictive sense, but for explanatory purposes.
[0110] The corresponding structures, materials, acts, and equivalents of all means or step plus function elements in the claims below are intended to include any structure, material, or act for performing the function in combination with other claimed elements as specifically claimed. The description of the present disclosure has been presented for purposes of illustration and description but is not intended to be exhaustive or limited to the form disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the present disclosure.
Claims
1. An automated intubation system, comprising: an external frame comprising a carriage controllably movable in at least a first direction and a second direction via at least one external actuator; an internal frame coupled to the carriage of the external frame, the internal frame comprising: a plurality of interlocked segments including a first segment rotatably coupled to a second segment along a longitudinal axis of the internal frame, each of the plurality of interlocked segments defining a central opening and a plurality of openings radially spaced apart from the central opening; a plurality of tension cables, including a first cable and a second cable, extending longitudinally from adjacent the carriage to a free end of the internal frame through the plurality of openings of the interlocked segments; and at least one internal actuator coupled to and configured to adjust the plurality of tension cables, wherein the first cable is configured to move the free end of the internal frame in a first direction and the second cable is configured to move the free end of the internal frame in a second direction; a flexible intubation tube defining a channel extending from a first opening to a second opening, wherein the internal frame extends from the first opening through a majority of the channel, and the flexible intubation tube is configured to conform to a shape of the internal frame; and a controller in communication with (i) the at least one external actuator of the external frame and (ii) the at least one internal actuator of the internal frame, the controller configured to move the internal frame to navigate an airway of a patient.
2. The automated intubation system of claim 1, wherein the external frame further comprises a base couplable to a rigid platform, wherein the rigid platform is adjacent to a patient surface.
3. The automated intubation system of claim 2, wherein the external frame is moveable from a stowed position to an active position that is closer to the patient surface.
4. The automated intubation system of any of claims 1-3, wherein the external frame comprises a first linear actuator and a second linear actuator, wherein the first direction is substantially perpendicular to the second direction, and wherein the carriage is movable along a member of the first linear actuator and (ii) to a predefined position relative to the patient.
5. The automated intubation system of any of claims 1-4, wherein the carriage is movable via the external frame to a predefined position relative to the patient.
6. The automated intubation system of any of claims 1-5, wherein the carriage comprises a motorized mount coupled to a fixed end of the internal frame, wherein an angle of the internal frame relative to the one or both of the external frame and the airway of the patient is adjustable via the motorized mount.
7. The automated intubation system of any of claims 1-6, wherein one of the carriage or the internal frame further includes a housing containing the at least one internal actuator.
8. The automated intubation system of any of claims 1-7, wherein the at least one internal actuator comprises a first motor coupled to the first cable and a second motor coupled to the second cable, wherein a length or tension of the first and second cables is adjustable to move the free end of the internal frame.
9. The automated intubation system of claim 8, wherein the at least one internal actuator comprises four motors and the plurality of tension cables includes four cables each coupled to a different one of the four motors for individual cable control.
10. The automated intubation system of any of claims 1-9, wherein the internal frame further comprises a camera disposed adjacent to the free end of the internal frame, the camera configured to send visual data to the controller.
11. The automated intubation system of claim 10, wherein the camera is in electrical communication with the controller via a data and/or power cable extending through the central openings of the plurality of interlocked segments.
12. The automated intubation system of any of claims 1-11, wherein the first segment of the plurality of interlocked segments is rotatable relative to the second segment by at least 4 degrees relative to the longitudinal axis.
13. The automated intubation system of any of claims 1-12, wherein the plurality of interlocked segments includes at least twenty segments coupled along the longitudinal axis.
14. The automated intubation system of any of claims 1-13, wherein the controller comprises a processor and a memory storing instructions thereon that, when executed by the processor, cause the processor to (i) move the external frame to position the free end of the internal frame and the intubation tube thereon adjacent to the airway of the patient, and (ii) move the internal frame along with the intubation tube through the airway of the patient.
15. The automated intubation system of any of claims 1-14, wherein the internal frame further comprises a camera disposed adjacent to the free end of the internal frame, the camera configured to send visual data to the controller, wherein the visual data informs movement of the internal frame by the processor.
16. The automated intubation system of any of claims 1-15, wherein the processor further comprises an artificial intelligence model pre-trained on patient airway data including one or more anatomical landmarks.
17. The automated intubation system of any of claims 1-16, wherein the processor causes the internal frame to move based on a prediction generated by the pre-trained artificial intelligence model analyzing visual data from the camera.
18. The automated intubation system of any of claims 1-17, further comprising an emergency stop button that releases tension in the plurality of tension cables, preventing further motion and enabling safe removal of the system.
19. A method for automated intubation, the method comprising:
(i) providing an automated intubation system comprising:
an external frame comprising a carriage controllably movable in at least a first direction and a second direction via at least one external actuator; an internal frame coupled to the carriage of the external frame, the internal frame comprising: a plurality of interlocked segments including a first segment rotatably coupled to a second segment along a longitudinal axis of the internal frame, each of the plurality of interlocked segments defining a central opening and a plurality of openings radially spaced apart from the central opening; a plurality of tension cables, including a first cable and a second cable, extending longitudinally from adjacent the carriage to a free end of the internal frame through the plurality of openings of the interlocked segments; and at least one internal actuator coupled to and configured to adjust the plurality of tension cables, wherein the first cable is configured to move the free end of the internal frame in a first direction and the second cable is configured to move the free end of the internal frame in a second direction; and a controller in communication with (i) the at least one external actuator of the external frame and (ii) the at least one internal actuator of the internal frame;
(ii) providing a flexible intubation tube defining a channel extending from a first opening to a second opening, wherein the internal frame extends from the first opening through a majority of the channel, and the flexible intubation tube is configured to conform to a shape of the internal frame;
(iii) moving the external frame to position the free end of the internal frame and intubation tube thereon adjacent to an airway of a patient; and
(iv) moving the internal frame along with the intubation tube through the airway of the patient.
20. The method of claim 19, further comprising: capturing, via a camera disposed adjacent to the free end of the internal frame, visual data of the airway; sending the visual data to the controller; and moving the internal frame based on the visual data from the camera.
21. The method of any of claims 19-20, further comprising:
analyzing, via a pre-trained artificial intelligence model, the visual data; and moving the internal frame based on a prediction generated by the pre-trained artificial intelligence model.
22. An automated intubation device, comprising: a plurality of interlocked segments including a first segment rotatably coupled to a second segment along a longitudinal axis of the device, each of the plurality of interlocked segments defining a central opening and a plurality of openings radially spaced apart from the central opening; a plurality of tension cables, including a first cable and a second cable, extending longitudinally from a fixed end to a free end of the device through the plurality of openings of the interlocked segments; and at least one internal actuator coupled to and configured to adjust the plurality of tension cables, wherein the first cable is configured to move the free end of the device in a first direction and the second cable is configured to move the free end of the device in a second direction, wherein the device is configured to be disposed within a channel defined by a flexible intubation tube that is configured to conform to a shape of the device, the device being movable to navigate an airway of a patient.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202463637442P | 2024-04-23 | 2024-04-23 | |
| US63/637,442 | 2024-04-23 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2025226667A1 true WO2025226667A1 (en) | 2025-10-30 |
Family
ID=97490901
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US2025/025750 Pending WO2025226667A1 (en) | 2024-04-23 | 2025-04-22 | Automated endotracheal intubation |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2025226667A1 (en) |
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| US20020153008A1 (en) * | 2001-04-19 | 2002-10-24 | Richard Schwartz | Endotracheal intubation device |
| US20200030575A1 (en) * | 2018-07-25 | 2020-01-30 | Intuitive Surgical Operations, Inc. | Systems and methods for use of a variable stiffness flexible elongate device |
| US20200297442A1 (en) * | 2017-08-16 | 2020-09-24 | Intuitive Surgical Operations, Inc. | Systems and methods for monitoring patient motion during a medical procedure |
| US20210220594A1 (en) * | 2018-07-25 | 2021-07-22 | Universität Zürich | Video-endoscopic intubation stylet |
| WO2023212085A1 (en) * | 2022-04-26 | 2023-11-02 | Ohio State Innovation Foundation | Automated endotracheal intubation device |
| US20230372032A1 (en) * | 2020-09-21 | 2023-11-23 | The Brigham And Women's Hospital, Inc. | Robotic artificial intelligence nasal/oral/rectal enteric tube |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20020153008A1 (en) * | 2001-04-19 | 2002-10-24 | Richard Schwartz | Endotracheal intubation device |
| US20200297442A1 (en) * | 2017-08-16 | 2020-09-24 | Intuitive Surgical Operations, Inc. | Systems and methods for monitoring patient motion during a medical procedure |
| US20200030575A1 (en) * | 2018-07-25 | 2020-01-30 | Intuitive Surgical Operations, Inc. | Systems and methods for use of a variable stiffness flexible elongate device |
| US20210220594A1 (en) * | 2018-07-25 | 2021-07-22 | Universität Zürich | Video-endoscopic intubation stylet |
| US20230372032A1 (en) * | 2020-09-21 | 2023-11-23 | The Brigham And Women's Hospital, Inc. | Robotic artificial intelligence nasal/oral/rectal enteric tube |
| WO2023212085A1 (en) * | 2022-04-26 | 2023-11-02 | Ohio State Innovation Foundation | Automated endotracheal intubation device |
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