WO2018112057A1 - Endotracheal intubation employing computer-guided tracheal targeting and on-demand endotracheal tube release - Google Patents

Endotracheal intubation employing computer-guided tracheal targeting and on-demand endotracheal tube release Download PDF

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Publication number
WO2018112057A1
WO2018112057A1 PCT/US2017/066147 US2017066147W WO2018112057A1 WO 2018112057 A1 WO2018112057 A1 WO 2018112057A1 US 2017066147 W US2017066147 W US 2017066147W WO 2018112057 A1 WO2018112057 A1 WO 2018112057A1
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WO
WIPO (PCT)
Prior art keywords
channel
ett
intubation
tube
orolaryngeal
Prior art date
Application number
PCT/US2017/066147
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French (fr)
Inventor
Axel Rosengart
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Cedars-Sinai Medical Center
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Application filed by Cedars-Sinai Medical Center filed Critical Cedars-Sinai Medical Center
Publication of WO2018112057A1 publication Critical patent/WO2018112057A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0488Mouthpieces; Means for guiding, securing or introducing the tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00002Operational features of endoscopes
    • A61B1/00004Operational features of endoscopes characterised by electronic signal processing
    • A61B1/00009Operational features of endoscopes characterised by electronic signal processing of image signals during a use of endoscope
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/005Flexible endoscopes
    • A61B1/0051Flexible endoscopes with controlled bending of insertion part
    • A61B1/0052Constructional details of control elements, e.g. handles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/005Flexible endoscopes
    • A61B1/0051Flexible endoscopes with controlled bending of insertion part
    • A61B1/0055Constructional details of insertion parts, e.g. vertebral elements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/267Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the respiratory tract, e.g. laryngoscopes, bronchoscopes
    • A61B1/2673Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the respiratory tract, e.g. laryngoscopes, bronchoscopes for monitoring movements of vocal chords
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/021Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes operated by electrical means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/50General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502User interfaces, e.g. screens or keyboards
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/50General characteristics of the apparatus with microprocessors or computers
    • A61M2205/52General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/58Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/582Means for facilitating use, e.g. by people with impaired vision by tactile feedback
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/58Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583Means for facilitating use, e.g. by people with impaired vision by visual feedback

Definitions

  • the present invention is directed to devices and methods for placing a breathing tube (endotracheal tube) into the trachea, a procedure called endotracheal intubation.
  • ETT endotracheal tube
  • the core design of most equipment used for establishing an airway is the laryngoscope that includes a handle and intubation blade.
  • the intubation blade comes in various configurations to suite both the operator's preference and the patient's anatomical characteristics.
  • the disclosed device, technology and methods describe a new laryngoscope design and intubation approach aiming at further improving both the first-attempt success rate and procedural speed of intubation.
  • a novel intubation blade which contains a separate ETT channel placed either under the laryngoscope blade convexity (outward curve) or next to it.
  • the ETT channel receives, directs and releases an ETT.
  • the disclosed ETT channel permits both controlled navigation of the ETT channel exit and on-demand ETT release from the channel.
  • a novel laryngoscope blade-like intubation device and technology is described to house and release the steerable EET channel.
  • This intubation device consists of an oval-shaped and curved intubation tube instead of the traditional laryngoscope. Inside of the tube the steerable ETT channel with quick-ETT release function is housed.
  • the disclosed grid-like intubation tube has indentations on its concave outer side to harbor and hold the tongue muscle.
  • a specific feature of the disclosed intubation device is the ability of controlled navigation of the exit position of the ETT channel.
  • the ETT channel exit segment (e.g., the last or most distal one third of its length) may be movable and steerable by the operator in a fashion similar to modern endoscopes and function independent of the overlying intubation blade.
  • the main reason of this operator-controlled function is to achieve the needed alignment of the ETT with the vocal cords, the entrance of the trachea (windpipe).
  • Such alignment is an essential step during intubation as successful alignment allows advancing the ETT through the vocal cords and into the trachea which then concludes successful intubation.
  • the intubation blade which is positioned next to the ETT channel may remain rigid in its design so it can be used to move anatomical tissue (e.g., tongue) to clear the laryngeal entrance and path to the vocal cords.
  • the core structure of the ETT channel can take on several designs. In some examples, it consists of a hollow tube which harbors and releases the ETT. In other examples, it takes on the form of a steerable shaft or half-channel to which the ETT is attached prior to is release in order to move jointly with the rod.
  • the ETT channel length may match the length of the intubation blade or, alternatively, terminate prior to the end of blade. In some examples, the cuffed end of the ETT may protrude out of the ETT channel to approximately align with its tip to the end of the rigid blade.
  • the device may use a camera or video camera to assist in aligning the ETT channel with the vocal cords.
  • the ETT channel may include a small video camera at the tip providing the operator with real-time video feedback so adjustments can be made.
  • the ETT channel may include operator-controlled manipulation.
  • the blade may include a knob on the handle (e.g., on the right side) and moving the knob towards and away from the handle could move an insertion channel tip to the left and right (or up and down). Rotating the knob clockwise and counterclockwise could move the distal channel up and down (or left and right).
  • a knob or other control mechanism could slide sideward up and down the blade handle which promotes forward and backward movement of the ETT within its channel.
  • the system may include an actuation mechanism to release the
  • ETT from the channel. For instance, pressing a button, lever, or other mechanism or electromechanical mechanism could initiate release of the ETT.
  • the disclosed computer-guided targeting has two elements. First, at any given ETT channel position it could determine the expected path of the ETT if it were advanced forward out of the channel. These expected ETT trajectories may be projected in real-time onto the operator's video display.
  • One advantage is that computer-generated, anticipated ETT trajectories reduce the need for the time consuming and cumbersome task to actually push the ETT out of the ETT channel in order to understand whether or not it is aligned with the laryngeal entrance.
  • the operator and/or software may identify and lock onto the target area of interest (i.e., laryngeal entrance and vocal cords). This can be done either by the operator manually marking the laryngeal entrance on the video screen or implementing computerized targeting software as described further below. Once the target is marked, projections of target and expected ETT channel trajectory are displayed together onto the video screen and in real-time. Navigating the ETT channel, by the operator or software, can then be guided by the video projections to correctly and quickly align the predicted ETT channel positions with the laryngeal entrance.
  • the target area of interest i.e., laryngeal entrance and vocal cords.
  • ETT channel-vocal cords targeting greatly reduces the time-consuming need of pushing the ETT forward to identify its trajectories and hence, improves the procedural speed to obtain patient ventilation.
  • ETT is released from the ETT channel in an operator-controlled fashion applying one of several mechanisms disclosed herein.
  • Intubation devices which promote an intubation channel or stylet (often used with a pre-loaded ETT) exist, both with and without a videoscopy option.
  • their clinical use is challenged by their rigid (intubation blade-like) design which may or may not 'fit' to an individual patient's orolaryngeal anatomy and do not readily adjust for differences in laryngeal morphology encountered during intubation.
  • Time and continuing training is needed with rigid intubation channel devices which reduces both first-pass success rates and procedural speed.
  • Another intubation technology promotes the use of flexible endoscopes, which are pre-loaded with an ETT and introduced into the larynx either directly or with help of conventional intubation blades.
  • endoscopes are at times 'too flexible' (i.e., unable to move the tongue out of the way or to lift the epiglottis for visualization of the vocal cords) and hence, require not only significant operator experience (restricting their use to experts hands only) but often need a second operator or intubation device to help manipulating upper airway structures for endoscope access.
  • devices, technology and methods that include an approach that may include the following steps: (1) to advance an ETT secured within or at the ETT channel through the oral cavity and towards the larynx at the same time the laryngoscope is introduced; (2) a mechanism to selectively navigate the ETT into the laryngeal entrance and trachea, with or without electronic targeting technology, allowing adjustments for anatomical differences in larynx position and anatomy (which greatly exist among individuals); and (3) to release the ETT on-demand from its channel.
  • Each of the described technology segments can be employed individually or in combination.
  • the disclosed technology focuses on improving the accuracy and speed of this procedural phase. For instance, it does so by: (1) delivering a ready-to-insert ETT together with the intubation blade into the laryngeal vault placing the ETT in a single step in proximity of the laryngeal entrance at the time the operator introduces the laryngoscope; (2) including two video cameras, one on the ETT channel, the other at the laryngoscope blade tip, that provide real-time imaging of the target structure (the laryngeal entrance) instantly orienting the operator as to the patient's specific laryngeal anatomy and entrance; (3) including video and computer-assisted targeting to support semi or fully automated alignment of the ETT channel with the laryngeal entrance (which is currently a daunting and time consuming task given the spatial complexity of the larynx); (4) operator and computer-controlled delivery of the ETT out of the ETT channel and into the trachea; and (5) operator-initiated release of the ETT from the ETT
  • a novel laryngoscope blade-like intubation device and technology houses and releases the steerable EET channel.
  • This intubation device consists of an oval-shaped and curved intubation tube ("intubation tube”) instead of the traditional laryngoscope. Inside of the tube the steerable ETT channel with quick-ETT release function is housed.
  • the dimension of the tube may change from the entry (or proximal) proximal to the exit (or distal) end.
  • the intubation tube curve downward during insertion better accommodate the oropharyngeal anatomy.
  • the concave (undersurface) side of the tube has a small axial ridge or hook.
  • the intubation tube is separated longitudinally into an upper and lower part allowing the upper part to move independently from its lower part.
  • the upper part can slide forward relative to the tube's lower part allowing the upper segment to enter the larynx more deeply.
  • the intubation tube may be made from plastic, silicone or other durable materials.
  • the proximal (entry) end of the tube has a handle for controlled insertion.
  • the upper part of the intubation tube moves forward or backward, respectively, relative to the lower tube segment.
  • the intubation tube has a hydrophilic outer coating to enhance ease of insertion.
  • the outer concave side of the tube has a groove to accommodate the tongue.
  • This concave surface may be coated with a biomedical, pressure-sensitive adhesive to create a temporary, interlocking coating between the intubation tube and tongue. This prevents the tongue muscle from moving backwards into the oropharynx as it.
  • the intubation tube may partially or completely consist of inflatable material which balloon upon oxygen insufflation.
  • the non-inflated intubation tube with its attached ETT channel is inserted into the pharynx and allowed to curve alongside the pharyngeal curvature.
  • the most distal balloon at the outer (concave) curvature of the intubation tube exit is shaped to allow simultaneous obstruction the esophageal entrance in order to minimize the risk of regurgitation of stomach content during the procedure.
  • the ETT channel is located inside the intubation tube with its distal part remaining steerable. Prior to insertion of the intubation tube into the oropharyngeal cavity, the ETT is loaded into the ETT channel. After insertion of the intubation tube into the oropharyngeal cavity the distal end of the ETT channels can be steered by the operator to appropriately place - where the ETT tube is in front of the vocal cords. Once inserted into the trachea, the ETT channel releases the ETT allowing the removal of the intubation tube while the ETT is in place, as described above.
  • the intubation tube has a build-in suction and oxygen channels.
  • Each of the channels has an outside port located at the entry side of the tube permitting connection to the respective bedside equipment.
  • the intubation tube has a build-in video system with the camera located near its exit end. Placement and targeting is video and computer-assisted as described elsewhere in this disclosure.
  • FIG. 1 illustrates a perspective view of a prior art laryngoscope with a handle and a blade
  • FIG. 2A illustrates a perspective view of an example of a laryngoscope with an
  • ETT tube channel located beneath the blade; the ETT channel is held in place by connecting attachments to the blade; however, the movable, steerable distal part of the ETT channel may have no connections to the blade;
  • FIG. 2B illustrates a perspective view of an example of a laryngoscope with an extended ETT tube channel which -in neutral (inactive) position- remains attached alongside the laryngoscope handle;
  • FIG. 2C illustrates a perspective view of an example of a laryngoscope with an extended ETT tube channel placed into active position in order to align with the ETT channel segment located under the blade; here, both the extended and the blade ETT channel segments harbor the ETT;
  • FIG. 2D illustrates a cross sectional view of examples of a channel and its fixed and movable walls for release of an ETT
  • FIGS. 2E - 2G illustrate cross section views of examples of blade walls and channel walls and their movements to open channel and release an ETT
  • FIG. 3 illustrates a perspective view of a blade portion of a laryngoscope
  • ETT channel segment which is situated beneath the blade; the arrows indicate the possible directions the distal ETT channel (and the attached ETT) can be moved into;
  • FIG. 4 illustrates a flowchart showing an example method of performing a laryngoscopy with the disclosed technology.
  • FIG. 5 illustrates a side view of an example of an intubation tube device with its overall dimensions, form and shape
  • FIG. 6 illustrates an example of a front cross sectional view of an intubation tube device showing the insertion point of the ETT.
  • the disclosed technology describes a novel device, method and technology to further improve on the goal of successful first-attempt endotracheal intubation in adults and children and addresses patients with a wide diversity of head and neck anatomies.
  • a novel intubation device and technology which primarily aims at simplifying the intubation procedure and improving the success rate and speed of first intubation attempt.
  • the described devices and methods integrates the universal form and shape of rigid laryngoscopes (namely, an intubation handle and blade with an attached light and optional video source at its tip) and introduces a novel intubation technology and procedural concepts that includes an ETT channel to retain and steer the ETT and then deploy it when properly positioned.
  • the technology creates a mechanism to allow the ETT to be positioned next to the tip of the laryngoscope from the start of the procedure (that is, from the time of first laryngoscopic inspection of the throat). This is obtained by introducing an ETT channel under or next to the conventional intubation blade with its channel exit in proximity to the end of the blade.
  • the purpose of the channel is to position the ETT next to the tip of the blade, to protect it from orolaryngeal tissue (tongue movements, etc.), to control the ETT tube position, and to provide a mechanism to easily slide the ETT forward into the trachea and to release the remaining length of the ETT from its channel.
  • the operator can release the ETT from the channel once the ETT tip is introduced into the trachea. ETT release from the device allows the intubation device to be removed from the oral cavity without the need for further ETT manipulations or use of a guidewire or sheath.
  • One of the main functions of the ETT channel is to provide a mechanism for secure positioning of the ETT close to the intubation blade tip.
  • the main advantage of having the blade and ETT endings in close proximity is the immediate availability of the ETT once the blade reaches the vicinity of the laryngeal entrance during laryngoscopy.
  • the ETT channel harboring the ETT, may be a round, tube-like structure which inner luminal diameter matches or is slightly larger than the outer diameter of commercially available ETTs - for example between 8 to 15 mm.
  • the channel's total length reflects the combined laryngoscope handle, joint, and blade length ranges of, for example, 100 to 200mm, 10 to 30 mm, and 70 to 210 mm, respectively.
  • the channel comprises one continuous segment which bends to accommodate the form of the laryngoscope and the blade curve.
  • the ETT channel may be a half-channel (with the lower part remaining open) or a rod-like structure to which the ETT is connected, i.e., via quick-release connecting rings or pins.
  • the ETT channel has two segments, one placed next to the laryngoscope handle and the second under the blade. These two segments may connect with a joint-like mechanism into one single straight or curved channel once the operator releases the proximal segment from the handle and aligns it with the blade segment.
  • the ETT channel can be divided into a proximal segment, reaching from its beginning at the handle to the first one to two thirds of the blade segment; this proximal segment may consist of rigid tubing and is attached to the laryngoscope.
  • the distal or terminal segment of the ETT channel covers the last one to two thirds of the intubation blade length and can be moved in 4 main directions in order for the ETT channel exit to obtain various positons under the blade.
  • the ETT channel exit is located at the tip of the blade and may be movable and steerable. While the rigid intubation blade is held statically by the operator to secure access to the larynx, the spatial flexibility of the distal ETT channel adapts the ETT exit to individual variations in larynx anatomy in order to align the channel exit and hence the ETT tip with the laryngeal entrance. This alignment greatly simplifies the next important intubation step which is pushing the ETT out of the channel and through the vocal cords.
  • the distal or final segment of the ETT channel is anchored beneath the blade and movable and steerable within predefined boundaries similar flexible endoscopes or steerable catheters. In some examples, it comprises radial indentations in the channel wall, a large central lumen to harbor the ETT, and is partially controlled by the pulling and releasing of wire members attached to anchoring rings positioned along the length of the channel.
  • the distal ETT channel segment is anchored beneath the laryngoscope blade in a way that allows the channel exit to be navigated into various positions. For instance, the steerable exit allows the movement through angles (e.g.
  • the ETT may be inserted into the distal end of the channel until the
  • the ETT tip reaches the channel's exit or, alternatively, until the ETT cuff reaches the channel exit.
  • the ETT can rotate within the channel and/or be pushed out towards the target, the vocal cords.
  • advancing and retracting of the ETT inside the channel is accomplished using lubricants, wheels or other mechanism inside the channel.
  • the ETT channel may comprise an interconnected series of small rings or pins which are attached to a steerable rod and harbor the ETT.
  • Steering the distal channel segment into the desired alignment position is performed either manually (i.e., at the laryngoscope handle) or computer-controlled/assisted with electromechanical actuation.
  • the steering principle follows techniques employed by flexible endoscopes, steerable catheters and/or robotic systems.
  • steerability of the ETT channel is achieved by introducing a deflection apparatus into the channel body comprising the use of a deflection mechanism.
  • the deflection mechanism may include control lines, deflection wires, or push- pull wires.
  • the hub for the pull wires is located at the laryngoscope handle site; the pull wires reach through the proximal and distal ETT channel segments to their respective attachment points at the terminal channel.
  • the deflection mechanism may be manipulated to selectively deflect or straighten the intermediate and distal segments of the ETT channel.
  • two or more pull wires extending to different points along the channel length allow multiple channel segments to move in different directions.
  • a single (or multi-lumen if one would include suction or oxygen delivery subchannels) steerable ETT channel has the inner luminal diameter to harbor an ETT and incorporates pull wires in relatively small pull wire lumens to selectively deflect the distal channel segment. Examples of this are described in U.S. Pat. Nos.
  • the delivery lumen utilized in these technologies is typically defined by a delivery lumen liner formed of an elastic material such as PTFE fluoropolymer tubing as this polymer is relatively lubricious and crush resistant and has a very low coefficient of friction. It is referred to the pertinent literature.
  • a small video camera at the ETT channel exit transmits real-time positioning information to the operator and/or microprocessor for manual, semi- or fully-automated operations.
  • a suction and oxygen channel to remove secretions and to deliver oxygen directly to the laryngeal entrance, respectively, and a light channel to provide the operator with illumination of the operating field can be added to the ETT channel.
  • the ETT channel takes on the dimensions of an endoscope and resides inside the ETT. Prior to laryngoscopy, the ETT may be placed over the endoscope-like ETT-channel and secured by clipping it its proximal segment underneath the laryngoscopy blade. For intubation, the flexible and steerable EET channel is moved toward the laryngeal entrance and then the ETT is released from its anchor allowing it to be moved forward into the trachea.
  • the endoscope loaded the ETT on its outer surface may be semi-rigid not requiring anchoring to the blade.
  • a computer-assisted targeting technology which simplifies aligning the trajectory of the movable ETT channel exit with the laryngeal entrance (target).
  • the technology may display, in real-time, two dynamically moving markers (e.g. grids, targets, highlights, outlines, arrows etc.) on a video screen, one indicating the anticipated ETT trajectories at any given ETT channel position and the other representing the target laryngeal entrance, the operator steers the ETT channel to alignment to superimpose the grids. Once overlay is achieved the operator can push the ETT out of the channel and into the trachea.
  • markers e.g. grids, targets, highlights, outlines, arrows etc.
  • a video- and computer-assisted targeting technology is provided to the operator which supports or automatizes aligning the trajectory of the movable ETT channel exit with the laryngeal entrance (target: vocal cords).
  • targets vocal cords
  • Any target motion relative to the camera generates a measurable displacement deviation which is integrated to gain feedback about relative changes in vocal cords location, ETT channel exit-to-target distance, and suggested counter-movement steps to achieve ETT channel-vocal cords alignment.
  • the software-generated counter movements are quantified and projected onto the operator's video screen; for example, as recommended movement trajectories between current position and target's crosshairs. Based on this information the operator steers the ETT channel into target alignment.
  • robotic guidance allows automatic readjustments of the ETT channel exit position to project into the laryngeal entrance.
  • Feedback to the operator is delivered in clear, instinctive visual and tactile format.
  • the operator obtains contact force sensing and vibration feedback via visual and tactile display onto the laryngoscope or stand-by display.
  • an automated navigation and advisory targeting method can be applied which is based on lumen centralization.
  • An example of this is described in Gillies D, Khan G (1996) Vision based navigation system for an endoscope. Image Vis Comput 14:763- 772, the content of which is incorporated by reference herein.
  • the software searches for the darkest (dark region segmentation) and/or deepest (depth estimation) region within the image.
  • laryngoscopic visualization and targeting of the vocal cords is based on identification of the structures furthest away from the camera and recognition of the darkness of the tracheal lumen (visible in-between the cords).
  • the ETT channel wall consists of two or more longitudinal segments, each of them designed to steer the ETT channel.
  • some or all channel wall segments may retract circumferentially underneath other portions of the wall leading to partial or complete segment stacking on top of each other and creating an opening in the channel to release the ETT.
  • Such release movement of the channel wall segments can be initiated by pull wire and/or automated spring release mechanism.
  • the channel wall is partitioned into an upper and lower half or segment.
  • the upper half houses the steering mechanism together with portions of the ETT.
  • the connected lower half is not part of the steering mechanism and consists of several rings and/or short segments along the channel's longitudinal length holding the ETT. For release, a spring- supported retraction of the lower rings and/or short circular segments allows disjunction of the ETT.
  • the ETT channel may not encircle the ETT but rather have the ETT attached to its outside circumference; here the channel fulfills primarily the function of a steerable navigator moving the ETT into the desired position.
  • the ETT is housed in a separate, flexible channel which passively follows the steering channel.
  • the ETT channel may house smaller, secondary conduits, for example, to suction secretions from the blade tip area, for delivery of oxygen, cables for channel tip sensors (i.e., measuring oxygen, carbon dioxide, pressure, vibration, etc.), as well as other utilities;
  • a blade-like intubation device and technology houses and releases the steerable EET channel.
  • This intubation device consists of an oval-shaped, curved intubation tube ("intubation tube"). Inside of the tube resides the steerable ETT channel with quick-ETT release function.
  • the disclosed intubation tube has indentations on its concave outer side to harbor and hold the tongue muscle.
  • the dimension of the tube may change over the tube's length; for example, the entry end of the tube has an oval shape, about 2-4 cm in width and 1-3 cm in height, while its form changes distally to a slightly rounder exit end with a minimal inner diameter of 1.5 cm.
  • the intubation tube material allows downward curving (e.g.,., at the latter two thirds of its length) to accommodate variations in oropharyngeal anatomy.
  • accordion-like folding may be introduced into the tube wall.
  • the degree of longitudinal angle ranges between 20 to 70 degrees.
  • the concave (undersurface) side of the tube has a small axial ridge near its exit to allow intubation tube to hook into the tongue's groove at its base or behind the epiglottis.
  • the intubation tube is separated longitudinally into an upper and lower part allowing the upper part to move independently from its lower part.
  • the upper part constituting about one half to two thirds of the intubation tube's height in some examples, can slide forward relative to the tube's lower part allowing the upper segment to enter the larynx more deeply.
  • the intubation tube may be made from plastic (i.e., for single-use), silicone or other durable materials such as metal (e.g., for repeated use).
  • the proximal (entry) end of the tube has a handle for controlled insertion of the device into the oropharyngeal cavity.
  • the upper part of the intubation tube moves forward or backward, respectively, relative to the lower tube segment.
  • a spring-like mechanism may facilitate these movements.
  • the intubation tube has a hydrophilic outer coating to enhance ease of insertion and to minimize mucosal abrasions during manipulation.
  • the outer concave side of the tube has a groove to accommodate the tongue during insertion.
  • This concave surface may be coated with a biomedical, pressure-sensitive adhesive to create a temporary, interlocking coating between the intubation tube and tongue, i.e., using dihydroxyl-L-phenylalanine (DOPA; catechol). This prevents the tongue muscle from moving backwards into the oropharynx as it temporary sticks to the undersurface of the intubation tube.
  • DOPA dihydroxyl-L-phenylalanine
  • the distal two thirds of the intubation tube allows downward curving (i.e., from 10 to 70 degrees) of the upper intubation tube segment relative its longitudinal axis. This allows the distal intubation tube segment to follow the same curvature as the inside of the pharynx and larynx without collapsing in inner diameter. Curving is facilitated by material foldings within the tube wall.
  • the intubation tube may partially or completely consist of inflatable material which balloon upon oxygen insufflation.
  • the non-inflated intubation tube with its attached ETT channel is inserted into the pharynx and allowed to curve alongside the pharyngeal curvature.
  • the intubation tube balloons are inflated with oxygen to occupy and extend the oropharyngeal cavity.
  • the balloons are size-controlled to predefined inflation volumes to position the intubation tube exit (distal end) in front of the larynx (that is, bending the distal tube exit towards the laryngeal entrance).
  • the most distal balloon at the outer (concave) curvature of the intubation tube exit is shaped to allow simultaneous obstruction the esophageal entrance in order to minimize the risk of regurgitation of stomach content during the procedure. After placement and release of the ETT the balloons are deflated, and the intubation tube is withdrawn from the oral cavity.
  • the ETT channel is located inside the intubation tube with its distal part remaining steerable. Prior to insertion of the intubation tube into the oropharyngeal cavity, the ETT is loaded into the ETT channel. After insertion of the intubation tube into the oropharyngeal cavity the distal end of the ETT channels can be steered by the operator to appropriately place - where the ETT tube is in front of the vocal cords. Once inserted into the trachea, the ETT channel releases the ETT allowing the removal of the intubation tube while the ETT is in place, as described above.
  • the intubation tube has a built-in suction and oxygen channels which allow removal of secretions and oxygenation of the patient, respectively, during the intubation procedure.
  • Each of the channels has an outside port located at the entry side of the tube permitting connection to the respective bedside equipment.
  • the intubation tube may have a build-in video system with the camera located near its exit end. Placement and targeting is video and computer-assisted as described elsewhere in this disclosure.
  • FIG. 1A illustrates a perspective view of a prior art laryngoscope 100 with a handle 120 and a blade 110.
  • the blade 110 can be disengaged from the handle 120.
  • FIG. 2 A illustrates a perspective view of an example of a laryngoscope 100 with an ETT tube channel 290 which is located under the convex surface of the blade 110.
  • the channel 290 may be located at the mid-center point under the primary blade 110.
  • the form, shape and design of the intubation blade 110 can vary and take on any of the currently commercially available blades, i.e., straight, curved or hyper-angulated forms.
  • a small video camera 215 at the ETT channel exit transmits real-time positioning information to the operator and/or microprocessor for manual, semi- or fully-automated operations.
  • the channel 290 may include a stationary segment 230 and a steerable segment
  • the steerable segment will include a portion of the channel 290 that is closest to the distal end of the blade 110. This section, as disclosed herein, is steerable to navigate the tip of the channel 290 to facilitate placement of the ETT through the vocal cords as disclosed herein.
  • channel 290 may be connected to the convex side of the blade
  • FIG. 2B illustrates a perspective view of an example of a laryngoscope 100 with an ETT tube channel 290.
  • the added handle 225 part of the ETT channel 290 which is in neutral position clipped onto the laryngoscope 290 handle 110 top and attached to the lower part of the handle 120 by joint 255.
  • the joint 255 allows the ETT channel 290 to open 90 degrees away from the handle 120 and to snap-connect with the blade part of the ETT channel 290.
  • the handle ETT channel part 255 may be a straight or curved structure allowing various alignment angles with the distal ETT channel once connected.
  • the handle part 225 of the ETT channel 290 may have 3 main components: (1) a wheel 235 (or other mechanism) in its wall connecting the outer channel 290 with the inner handle lumen and when turned (i.e., by the operator's thumb) that will advance and retract the ETT out of its channel 290; (2) a ring-like knob 245 located below the wheel 235 with restricted sliding movements up and down the channel 290 which induces right-left movements and (3) when the knob 245 is rotated up and down movements of the flexible ETT channel 290 (distal blade part) are induced.
  • a wheel 235 or other mechanism in its wall connecting the outer channel 290 with the inner handle lumen and when turned (i.e., by the operator's thumb) that will advance and retract the ETT out of its channel 290
  • a ring-like knob 245 located below the wheel 235 with restricted sliding movements up and down the channel 290 which induces right-left movements and (3) when the knob 245 is rotated up and down movements of the flexible ETT channel 290
  • FIG. 2C illustrates a perspective view of an example of a laryngoscope 100 with an ETT tube channel 290 with the handle part 225 of the ETT channel 290 rotated open 90 degrees.
  • the handle part 225 is now in line with the stationary segment 230 and steerable segment 240 of the channel 190. Accordingly, insertion of an ETT, or movement of the ETT will be much easier as there will not be a curve or bend at the point of connection between the stationary segment 230 and the handle part 225 of the channel 290.
  • FIG. 2D illustrates a cross sectional view of an example channel 290 that includes a fixed wall 310 and movable walls 300.
  • a mechanism such as a spring loaded release, or other mechanism is actuated by the operator or the system, at least one movable wall 300 will move to either allow an ETT to be inserted in the channel 290, or released.
  • the movable wall may retract behind or otherwise parallel with the fixed wall 310. In other examples, the movable wall(s) 300 may swing open.
  • FIG. 2E illustrates a perspective view of an additional example of the mechanics facilitating ETT release from the ETT channel 290.
  • a cross section view of an example channel 290 is illustrated that includes two channel walls 300 and blade walls 295.
  • the ETT channel 290 consists of two (complete or incomplete) half-circle channel walls 300 (or other appropriate shapes) which rotate against each other to release the ETT while the form of the laryngoscope blade remains flat and unchanged.
  • each larygoscope blade wall 295 and opposing ETT channel 290 wall 300 may constitute one piece and release of the ETT is accomplished by various (e.g., 45) degrees of folding of both walls against each other allowing channel 290 to open.
  • FIG. 3 illustrates a schematic drawing of the movements of the ETT (endotracheal tube) channel's 290 distal segment which is situated beneath the blade.
  • ETT endotracheal tube
  • FIG. 3 illustrates a schematic drawing of the movements of the ETT (endotracheal tube) channel's 290 distal segment which is situated beneath the blade.
  • the ETT channel is depicted separately from the blade 110 and not at its anticipated position beneath the blade 110.
  • the arrows indicate the main moveable directions the ETT can be moved into with the help of the steerable distal ETT channel segment: up, down, right, and left with respect to the overlying intubation blade (arrows 2 and 3), ETT rotation along its long axis (arrow 4) as well as forward and backward ETT movements within its channel (arrow 1).
  • the distal ETT channel 290 segment is anchored beneath the laryngoscope blade in a way that allows the channel exit to be oriented into various positions.
  • Orientation refers to bending the ETT channel tip (arrows 2 and 3), for example, by 60 degrees on in the direction of arrows 2 and 3. This orientation allows the operator to align the channel exit with the laryngeal entrance (vocal cords).
  • Arrow 4 indicates the ability of the ETT itself to rotate within the channel 290 and to be pushed out (arrow 1) towards the target, the vocal cords.
  • a release mechanism along the long axis of the channel allows the ETT to separate from the channel 290.
  • FIG. 4 illustrates a flow chart showing an example process for performing an intubation using the disclosed technology.
  • the ETT may be loaded 400 into the channel 290 by inserting the ETT into the distal end of the channel 290 until the ETT tip reaches the channel's 290 exit.
  • the scope 100 may be manipulated into the proper position 410 in the mouth and towards the larynx including by steering the distal portion 240 of the channel 290. Then, the laryngeal entrance will be visualized 415 either on a display transmitting video feed from a camera on the scope 100 or using visual recognition software. For instance, steering the distal channel segment into the desired alignment position 410 is performed either manually (e.g., at the laryngoscope 100 handle 120) or computer-controlled/assisted with electromechanical actuation.
  • the steering principle follows techniques employed by flexible endoscopes, steerable catheters and/or robotic systems.
  • the flexible and steerable EET channel is moved toward the laryngeal entrance to align the ETT with the vocal cords 420, and then the ETT is advanced out of the channel 290 into the trachea 430. Then, the ETT is released 440 from the channel 290 and the scope 100 is removed from the oral cavity 450.
  • FIG. 5 illustrates an example of an intubation tube 500 device that houses an ETT channel 510 that is inside the tube device 500, and is a tube within the tube device 500. Inside of the tube device 500 the ETT channel 510 is steerable, and includes an ETT 595 release function.
  • the disclosed intubation tube device 500 has indentations on its concave outer side to harbor and hold the tongue muscle.
  • Intubation tube device 500 may have an actuator 550, to steer the distal end of the ETT channel 510.
  • actuator 550 may be knobs, a slider, or other suitable electronic or mechanical system.
  • the dimensions of the tube device 500 may change from the entry (or proximal) proximal to the exit (or distal) end.
  • the entry end of the tube may have an oval shape. For instance, in some examples it may be about 2-4 cm in width and 1-3 cm in height. In some examples, its form changes distally to a slightly rounder exit end with a minimal inner diameter of 1.5 cm to allow the connector part of the ETT 595 to pass.
  • the intubation tube device 500 may be downward curved in the distal two thirds of its length to better accommodate the oropharyngeal anatomy.
  • the degree of longitudinal angle ranges between 20 to 70 degrees, in some examples.
  • the concave (undersurface) side of the tube has a small axial ridge near its exit which protrudes to the outside and enables to hook the tube into the tongue's groove at its base.
  • the intubation tube is separated longitudinally into an upper segment 515 and a lower segment 525 allowing the upper segment 515 to move independently from its lower segment 525.
  • the upper segment 515 constituting about one half to two thirds of the intubation tube's 500 height, can slide forward relative to the tube's 500 lower segment 525 allowing the upper segment 515 to enter the larynx more deeply.
  • the upper segment 515 may contain the ETT channel 510, and therefore when it slides forward it can insert the ETT housed in the ETT channel 510 closer to the delivery site.
  • the intubation tube device 500 may be made out of plastic (i.e., for single-use), silicone or other durable materials such as metal (e.g., for repeated use).
  • the proximal (entry) end of the tube has a handle 530 for controlled insertion of the device into the oropharyngeal cavity.
  • the upper segment 515 of the intubation tube device 500 may move forward or backward, respectively, relative to the lower tube segment 525.
  • the intubation tube device 500 has a hydrophilic outer coating to enhance ease of insertion.
  • the outer concave side of the tube device 500 may have a groove to accommodate the tongue during insertion.
  • This concave surface may be coated with a biomedical, pressure-sensitive adhesive to create a temporary, interlocking coating between the intubation tube and tongue, i.e., using dihydroxyl-L-phenylalanine (DOPA; catechol). This allows the tongue muscle to temporary stick to the undersurface of the intubation tube.
  • DOPA dihydroxyl-L-phenylalanine
  • the distal two thirds of the intubation tube device 500 may allow downward curving (e.g., from 10 to 50 degrees) of the upper intubation tube segment relative its longitudinal axis. This allows the distal intubation tube segment to follow the same curvature as the inside of the pharynx and larynx. However, the distal tube segment does not collapse in its inner diameter during insertion and while bending itself according to pharyngeal anatomy.
  • the intubation tube device 500 may partially or completely consist of inflatable material which balloons upon oxygen insufflation.
  • the non- inflated intubation tube with its central ETT channel 510 is inserted into the pharynx and allowed to curve alongside the pharyngeal curvature.
  • the intubation tube balloons are inflated with oxygen to occupy and extend the oropharyngeal cavity.
  • the balloons are size-controlled to predefined inflation volumes to position the intubation tube exit (distal end) in front of the larynx (that is, bending the distal tube exit towards the laryngeal entrance).
  • the most distal balloon at the outer (concave) curvature of the intubation tube exit is shaped to allow simultaneous obstruction the esophageal entrance in order to minimize the risk of regurgitation of stomach content during the procedure.
  • the balloons are deflated, and the intubation tube device 500 is withdrawn from the oral cavity.
  • the ETT channel 510 is located inside the intubation tube device 500 with its distal part remaining steerable. Prior to insertion of the intubation tube device 500 into the oropharyngeal cavity, the ETT 595 is loaded into the ETT channel 510. After insertion of the intubation tube into the oropharyngeal cavity the distal end of the ETT channels 510 can be steered by the operator to appropriately place - where the ETT tube is in front of the vocal cords. Once inserted into the trachea, the ETT channel 510 releases the ETT allowing the removal of the intubation tube while the ETT is in place, as described above.
  • the intubation tube device 500 when viewed from the side may take on a variety of angles of bending on its distal portion.
  • the distal portion will include flexible plastic.
  • the distal portion will include an accordion-folded like flexible tube that will restrict compression but bend in any direction once it reaches the temperature of a patient. This will allow the intubation tube device 500 to mold itself into the correct pharyngeal anatomy - without losing the outer diameter.
  • the tube may include embedded rings that allow the tube to be flexible but that do not allow compression.
  • FIG. 6 illustrates a front view of the intubation tube device 500 that includes entry orifice 610 and exit orifice 610. Additionally, illustrated is handle 530.
  • handle 530 may include a two-bladed handle 530 that allows sliding of the upper and lower segments against each other. Upper and lower segments may be able to slide longitudinally with respect to each other.
  • the ETT channel 510 will also extend out of the intubation tube device 500. Control knobs may be located to control the distal ETT channel 510.
  • the device 500 may include oxygen and suction channels 605. Additionally, the ETT 595 may be held in place and released by retaining mechanism 610.
  • Retaining mechanism 610 may be springs, or may be an ETT channel 510 that includes a feature that splits the ETT channel 510 open to release the ETT 595 on demand as described in further embodiments above, or other suitable mechanisms or devices as disclosed herein.
  • the disclosure herein including the steering of the ETT channel and computer-aided targeting and processing equipment may be implemented with any type of hardware and/or software, and may be a pre-programmed general purpose computing device.
  • the system may be implemented using a server, a personal computer, a portable computer, a thin client, or any suitable device or devices.
  • the disclosure and/or components thereof may be a single device at a single location, or multiple devices at a single, or multiple, locations that are connected together using any appropriate communication protocols over any communication medium such as electric cable, fiber optic cable, or in a wireless manner.
  • modules which perform particular functions. It should be understood that these modules are merely schematically illustrated based on their function for clarity purposes only, and do not necessary represent specific hardware or software. In this regard, these modules may be hardware and/or software implemented to substantially perform the particular functions discussed. Moreover, the modules may be combined together within the disclosure, or divided into additional modules based on the particular function desired. Thus, the disclosure should not be construed to limit the present invention, but merely be understood to illustrate one example implementation thereof.
  • the computing system can include clients and servers.
  • a client and server are generally remote from each other and typically interact through a communication network. The relationship of client and server arises by virtue of computer programs running on the respective computers and having a client-server relationship to each other.
  • a server transmits data (e.g., an HTML page) to a client device (e.g., for purposes of displaying data to and receiving user input from a user interacting with the client device).
  • client device e.g., for purposes of displaying data to and receiving user input from a user interacting with the client device.
  • Data generated at the client device e.g., a result of the user interaction
  • Implementations of the subject matter described in this specification can be implemented in a computing system that includes a back-end component, e.g., as a data server, or that includes a middleware component, e.g., an application server, or that includes a front-end component, e.g., a client computer having a graphical user interface or a Web browser through which a user can interact with an implementation of the subject matter described in this specification, or any combination of one or more such back-end, middleware, or front-end components.
  • the components of the system can be interconnected by any form or medium of digital data communication, e.g., a communication network. Examples of communication networks include a local area network ("LAN”) and a wide area network (“WAN”), an internetwork (e.g., the Internet), and peer-to-peer networks (e.g., ad hoc peer-to-peer networks).
  • LAN local area network
  • WAN wide area network
  • Internet internetwork
  • peer-to-peer networks e
  • Implementations of the subject matter and the operations described in this specification can be implemented in digital electronic circuitry, or in computer software, firmware, or hardware, including the structures disclosed in this specification and their structural equivalents, or in combinations of one or more of them.
  • Implementations of the subject matter described in this specification can be implemented as one or more computer programs, i.e., one or more modules of computer program instructions, encoded on computer storage medium for execution by, or to control the operation of, data processing apparatus.
  • the program instructions can be encoded on an artificially-generated propagated signal, e.g., a machine-generated electrical, optical, or electromagnetic signal that is generated to encode information for transmission to suitable receiver apparatus for execution by a data processing apparatus.
  • a computer storage medium can be, or be included in, a computer-readable storage device, a computer-readable storage substrate, a random or serial access memory array or device, or a combination of one or more of them.
  • a computer storage medium is not a propagated signal, a computer storage medium can be a source or destination of computer program instructions encoded in an artificially-generated propagated signal.
  • the computer storage medium can also be, or be included in, one or more separate physical components or media (e.g., multiple CDs, disks, or other storage devices).
  • the term "data processing apparatus” encompasses all kinds of apparatus, devices, and machines for processing data, including by way of example a programmable processor, a computer, a system on a chip, or multiple ones, or combinations, of the foregoing
  • the apparatus can include special purpose logic circuitry, e.g., an FPGA (field programmable gate array) or an ASIC (application-specific integrated circuit).
  • the apparatus can also include, in addition to hardware, code that creates an execution environment for the computer program in question, e.g., code that constitutes processor firmware, a protocol stack, a database management system, an operating system, a cross-platform runtime environment, a virtual machine, or a combination of one or more of them.
  • the apparatus and execution environment can realize various different computing model infrastructures, such as web services, distributed computing and grid computing infrastructures.
  • a computer program (also known as a program, software, software application, script, or code) can be written in any form of programming language, including compiled or interpreted languages, declarative or procedural languages, and it can be deployed in any form, including as a stand-alone program or as a module, component, subroutine, object, or other unit suitable for use in a computing environment.
  • a computer program may, but need not, correspond to a file in a file system.
  • a program can be stored in a portion of a file that holds other programs or data (e.g., one or more scripts stored in a markup language document), in a single file dedicated to the program in question, or in multiple coordinated files (e.g., files that store one or more modules, sub-programs, or portions of code).
  • a computer program can be deployed to be executed on one computer or on multiple computers that are located at one site or distributed across multiple sites and interconnected by a communication network.
  • the processes and logic flows described in this specification can be performed by one or more programmable processors executing one or more computer programs to perform actions by operating on input data and generating output.
  • the processes and logic flows can also be performed by, and apparatus can also be implemented as, special purpose logic circuitry, e.g., an FPGA (field programmable gate array) or an ASIC (application-specific integrated circuit).
  • processors suitable for the execution of a computer program include, by way of example, both general and special purpose microprocessors, and any one or more processors of any kind of digital computer.
  • a processor will receive instructions and data from a read-only memory or a random access memory or both.
  • the essential elements of a computer are a processor for performing actions in accordance with instructions and one or more memory devices for storing instructions and data.
  • a computer will also include, or be operatively coupled to receive data from or transfer data to, or both, one or more mass storage devices for storing data, e.g., magnetic, magneto-optical disks, or optical disks.
  • mass storage devices for storing data, e.g., magnetic, magneto-optical disks, or optical disks.
  • a computer need not have such devices.
  • a computer can be embedded in another device, e.g., a mobile telephone, a personal digital assistant (PDA), a mobile audio or video player, a game console, a Global Positioning System (GPS) receiver, or a portable storage device (e.g., a universal serial bus (USB) flash drive), to name just a few.
  • Devices suitable for storing computer program instructions and data include all forms of non-volatile memory, media and memory devices, including by way of example semiconductor memory devices, e.g., EPROM, EEPROM, and flash memory devices; magnetic disks, e.g., internal hard disks or removable disks; magneto-optical disks; and CD-ROM and DVD-ROM disks.
  • the processor and the memory can be supplemented by, or incorporated in, special purpose logic circuitry.

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Abstract

Disclosed is a laryngeal intubation technology and device that employs a steerable endotracheal tube (ETT) channel, a targeting software to facilitate and predict ETT and vocal cords alignment, a mechanism to steer the ETT toward and into the trachea, and to release the ETT from the laryngoscope.

Description

ENDOTRACHEAL INTUBATION EMPLOYING COMPUTER-GUIDED TRACHEAL TARGETING AND ON-DEMAND ENDOTRACHEAL TUBE RELEASE
FIELD
[0001] The present invention is directed to devices and methods for placing a breathing tube (endotracheal tube) into the trachea, a procedure called endotracheal intubation.
BACKGROUND
[0002] The following description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.
[0003] There is a great and vital need in medicine to protect a patient's upper airway (the airway segment starting at the mouth/nose and reaching down to the vocal cord and entry of the trachea [windpipe]). Any compromise of airflow (e.g., from unconsciousness or traumatic injury among many others dangers) will lead within minutes to severe harm or death.
[0004] Generally, securing airflow through the upper airway is established by successful placement of a plastic tube (endotracheal tube "ETT") through the mouth and into the trachea, a process which is called tracheal intubation or simply intubation. By means of the ETT a secured airway is established avoiding the dangers of upper airway compromise and a patient's lungs are ventilated through the ETT for gas exchange. Unfortunately, no two airways are the same and significant anatomical, physiological, and pathological upper airways differences exist necessitating the use and familiarity of various intubation techniques, procedures, and equipment in addition to procedural expertise in order to successfully and quickly place an ETT.
[0005] As placing an ETT is quite uncomfortable and protected by natural airway reflexes, intubations are most commonly performed by inducing a transient, medication-induced coma, including muscular paralysis, which renders the patient's upper airway temporarily unprotected (due to airway muscle collapse) and the patient breathless (due to paralysis of the diaphragm). Therefore, a caregiver is trained to successfully place an ETT on a first attempt and within the shortest time possible, without causing damage to upper airway tissues.
[0006] The procedural swiftness to quickly intubate and restart ventilation are very important and predominate the focus and training of any caregiver responsible for airway management. Primarily, the overall goal is to improve patient safety by improving the success rate and overall procedural speed of ETT placement.
[0007] The core design of most equipment used for establishing an airway is the laryngoscope that includes a handle and intubation blade. The intubation blade comes in various configurations to suite both the operator's preference and the patient's anatomical characteristics.
SUMMARY
[0008] The disclosed device, technology and methods describe a new laryngoscope design and intubation approach aiming at further improving both the first-attempt success rate and procedural speed of intubation.
Overview
[0009] Herein, a novel intubation blade is described which contains a separate ETT channel placed either under the laryngoscope blade convexity (outward curve) or next to it. The ETT channel receives, directs and releases an ETT. In contrast to existing blades, the disclosed ETT channel permits both controlled navigation of the ETT channel exit and on-demand ETT release from the channel. These novel functions will allow 'targeted intubation' by steering the ETT towards and through the vocal cords as well as releasing the ETT from the laryngoscope. In some examples, the disclosed blade harbors, navigates, and releases the ETT on-demand during the endotracheal intubation process.
[0010] Alternatively, rather than connecting the steerable EET channel to a conventional laryngoscope blade, a novel laryngoscope blade-like intubation device and technology is described to house and release the steerable EET channel. This intubation device consists of an oval-shaped and curved intubation tube instead of the traditional laryngoscope. Inside of the tube the steerable ETT channel with quick-ETT release function is housed. In some examples, the disclosed grid-like intubation tube has indentations on its concave outer side to harbor and hold the tongue muscle.
ETT Intubation Channel
[0011] A specific feature of the disclosed intubation device is the ability of controlled navigation of the exit position of the ETT channel. The ETT channel exit segment (e.g., the last or most distal one third of its length) may be movable and steerable by the operator in a fashion similar to modern endoscopes and function independent of the overlying intubation blade. The main reason of this operator-controlled function is to achieve the needed alignment of the ETT with the vocal cords, the entrance of the trachea (windpipe). Such alignment is an essential step during intubation as successful alignment allows advancing the ETT through the vocal cords and into the trachea which then concludes successful intubation. In contrast, the intubation blade which is positioned next to the ETT channel may remain rigid in its design so it can be used to move anatomical tissue (e.g., tongue) to clear the laryngeal entrance and path to the vocal cords.
[0012] The core structure of the ETT channel can take on several designs. In some examples, it consists of a hollow tube which harbors and releases the ETT. In other examples, it takes on the form of a steerable shaft or half-channel to which the ETT is attached prior to is release in order to move jointly with the rod. The ETT channel length may match the length of the intubation blade or, alternatively, terminate prior to the end of blade. In some examples, the cuffed end of the ETT may protrude out of the ETT channel to approximately align with its tip to the end of the rigid blade.
Guidance Systems
[0013] In some examples, the device may use a camera or video camera to assist in aligning the ETT channel with the vocal cords. For instance, the ETT channel may include a small video camera at the tip providing the operator with real-time video feedback so adjustments can be made.
[0014] In some examples, the ETT channel may include operator-controlled manipulation. For instance, the blade may include a knob on the handle (e.g., on the right side) and moving the knob towards and away from the handle could move an insertion channel tip to the left and right (or up and down). Rotating the knob clockwise and counterclockwise could move the distal channel up and down (or left and right). In other examples, other combinations or iterations of levers, joysticks, control columns, knobs that are mechanically or electromechanically controlled may be employed. In some examples, a knob or other control mechanism could slide sideward up and down the blade handle which promotes forward and backward movement of the ETT within its channel.
[0015] In some examples, the system may include an actuation mechanism to release the
ETT from the channel. For instance, pressing a button, lever, or other mechanism or electromechanical mechanism could initiate release of the ETT.
Video-Assisted Targeting System
[0016] To enhance the success rate and speed of aligning the steerable ETT channel exit with the laryngeal entrance electronic, video-assisted targeting systems are disclosed. In some examples, the disclosed computer-guided targeting has two elements. First, at any given ETT channel position it could determine the expected path of the ETT if it were advanced forward out of the channel. These expected ETT trajectories may be projected in real-time onto the operator's video display. One advantage is that computer-generated, anticipated ETT trajectories reduce the need for the time consuming and cumbersome task to actually push the ETT out of the ETT channel in order to understand whether or not it is aligned with the laryngeal entrance.
[0017] Second, to achieve computer-guided/assisted ETT targeting of the vocal cords, the operator and/or software may identify and lock onto the target area of interest (i.e., laryngeal entrance and vocal cords). This can be done either by the operator manually marking the laryngeal entrance on the video screen or implementing computerized targeting software as described further below. Once the target is marked, projections of target and expected ETT channel trajectory are displayed together onto the video screen and in real-time. Navigating the ETT channel, by the operator or software, can then be guided by the video projections to correctly and quickly align the predicted ETT channel positions with the laryngeal entrance.
[0018] Once the projected images are aligned on the video screen, the operator will then move the ETT out of the channel and into the laryngeal entrance. As described above, ETT channel-vocal cords targeting greatly reduces the time-consuming need of pushing the ETT forward to identify its trajectories and hence, improves the procedural speed to obtain patient ventilation.
[0019] After placement of the ETT into the trachea (that is, successful intubation) the
ETT is released from the ETT channel in an operator-controlled fashion applying one of several mechanisms disclosed herein.
[0020] Currently, no intubation design or technology exists which has (1) an ETT channel with on-demand ETT release function, (2) incorporates a steerable ETT channel design and (3) allows computer-assisted laryngeal targeting and ETT placement. These design features aim at optimizing first-pass intubations success rates and shorten the time from begin of the intubation procedure to successful tracheal intubation.
[0021] Intubation devices which promote an intubation channel or stylet (often used with a pre-loaded ETT) exist, both with and without a videoscopy option. However, their clinical use is challenged by their rigid (intubation blade-like) design which may or may not 'fit' to an individual patient's orolaryngeal anatomy and do not readily adjust for differences in laryngeal morphology encountered during intubation. Time and continuing training is needed with rigid intubation channel devices which reduces both first-pass success rates and procedural speed.
[0022] Another intubation technology promotes the use of flexible endoscopes, which are pre-loaded with an ETT and introduced into the larynx either directly or with help of conventional intubation blades. Unfortunately, endoscopes are at times 'too flexible' (i.e., unable to move the tongue out of the way or to lift the epiglottis for visualization of the vocal cords) and hence, require not only significant operator experience (restricting their use to experts hands only) but often need a second operator or intubation device to help manipulating upper airway structures for endoscope access.
[0023] Accordingly, disclosed are devices, technology and methods that include an approach that may include the following steps: (1) to advance an ETT secured within or at the ETT channel through the oral cavity and towards the larynx at the same time the laryngoscope is introduced; (2) a mechanism to selectively navigate the ETT into the laryngeal entrance and trachea, with or without electronic targeting technology, allowing adjustments for anatomical differences in larynx position and anatomy (which greatly exist among individuals); and (3) to release the ETT on-demand from its channel. Each of the described technology segments can be employed individually or in combination.
[0024] Currently, one of the most challenging aspects of endotracheal intubation is the manual task of aligning the ETT tip with the laryngeal entrance and then securely advancing the ETT into the trachea. If the ETT is not aligned with the laryngeal entrance it cannot be placed into the trachea and ventilation cannot be performed. Hence, the alignment step constitutes a vital phase in any intubation procedure.
[0025] The disclosed technology focuses on improving the accuracy and speed of this procedural phase. For instance, it does so by: (1) delivering a ready-to-insert ETT together with the intubation blade into the laryngeal vault placing the ETT in a single step in proximity of the laryngeal entrance at the time the operator introduces the laryngoscope; (2) including two video cameras, one on the ETT channel, the other at the laryngoscope blade tip, that provide real-time imaging of the target structure (the laryngeal entrance) instantly orienting the operator as to the patient's specific laryngeal anatomy and entrance; (3) including video and computer-assisted targeting to support semi or fully automated alignment of the ETT channel with the laryngeal entrance (which is currently a daunting and time consuming task given the spatial complexity of the larynx); (4) operator and computer-controlled delivery of the ETT out of the ETT channel and into the trachea; and (5) operator-initiated release of the ETT from the ETT channel so that the ETT remains within the trachea and the intubation device can safely be withdrawn from the oral cavity. It is envisioned that the target populations benefiting from such a device and technology include any adult or child in need of an artificial airway.
Tube Device for Intubation
[0026] In some examples, rather than connecting the steerable EET channel to a laryngoscope blade, a novel laryngoscope blade-like intubation device and technology houses and releases the steerable EET channel. This intubation device consists of an oval-shaped and curved intubation tube ("intubation tube") instead of the traditional laryngoscope. Inside of the tube the steerable ETT channel with quick-ETT release function is housed. [0027] The dimension of the tube may change from the entry (or proximal) proximal to the exit (or distal) end. The intubation tube curve downward during insertion better accommodate the oropharyngeal anatomy. The concave (undersurface) side of the tube has a small axial ridge or hook.
[0028] In some examples, the intubation tube is separated longitudinally into an upper and lower part allowing the upper part to move independently from its lower part. The upper part can slide forward relative to the tube's lower part allowing the upper segment to enter the larynx more deeply. The intubation tube may be made from plastic, silicone or other durable materials. The proximal (entry) end of the tube has a handle for controlled insertion. In addition, upon manual compression or decompression of the handle, the upper part of the intubation tube moves forward or backward, respectively, relative to the lower tube segment.
[0029] In some examples, the intubation tube has a hydrophilic outer coating to enhance ease of insertion. The outer concave side of the tube has a groove to accommodate the tongue. This concave surface may be coated with a biomedical, pressure-sensitive adhesive to create a temporary, interlocking coating between the intubation tube and tongue. This prevents the tongue muscle from moving backwards into the oropharynx as it.
[0030] In some examples, the intubation tube may partially or completely consist of inflatable material which balloon upon oxygen insufflation. In this design, the non-inflated intubation tube with its attached ETT channel is inserted into the pharynx and allowed to curve alongside the pharyngeal curvature. In some examples, the most distal balloon at the outer (concave) curvature of the intubation tube exit is shaped to allow simultaneous obstruction the esophageal entrance in order to minimize the risk of regurgitation of stomach content during the procedure.
[0031] The ETT channel is located inside the intubation tube with its distal part remaining steerable. Prior to insertion of the intubation tube into the oropharyngeal cavity, the ETT is loaded into the ETT channel. After insertion of the intubation tube into the oropharyngeal cavity the distal end of the ETT channels can be steered by the operator to appropriately place - where the ETT tube is in front of the vocal cords. Once inserted into the trachea, the ETT channel releases the ETT allowing the removal of the intubation tube while the ETT is in place, as described above.
[0032] In some examples, the intubation tube has a build-in suction and oxygen channels.
Each of the channels has an outside port located at the entry side of the tube permitting connection to the respective bedside equipment.
[0033] The intubation tube has a build-in video system with the camera located near its exit end. Placement and targeting is video and computer-assisted as described elsewhere in this disclosure.
[0034] Currently, no intubation tube design or technology exists which (1) incorporates a tube-in-tube (intubation tube housing an insertion ETT channel) laryngoscope approach and (2) an intubation tube allowing adjustment of its shape and length during ETT insertion based on anatomical needs. Additionally, other features disclosed herein are novel. These design features also allow placement of the ETT in a with semi-upright (seating) body position as preferred in acutely brain-injured patients.
BRIEF DESCRIPTION OF THE DRAWINGS
[0035] The accompanying drawings, which are incorporated in and constitute a part of this specification, exemplify the embodiments of the present invention and, together with the description, serve to explain and illustrate principles of the invention. The drawings are intended to illustrate major features of the exemplary embodiments in a diagrammatic manner. The drawings are not intended to depict every feature of actual embodiments nor relative dimensions of the depicted elements, and are not drawn to scale.
[0036] FIG. 1 illustrates a perspective view of a prior art laryngoscope with a handle and a blade;
[0037] FIG. 2A illustrates a perspective view of an example of a laryngoscope with an
ETT tube channel located beneath the blade; the ETT channel is held in place by connecting attachments to the blade; however, the movable, steerable distal part of the ETT channel may have no connections to the blade;
[0038] FIG. 2B illustrates a perspective view of an example of a laryngoscope with an extended ETT tube channel which -in neutral (inactive) position- remains attached alongside the laryngoscope handle;
[0039] FIG. 2C illustrates a perspective view of an example of a laryngoscope with an extended ETT tube channel placed into active position in order to align with the ETT channel segment located under the blade; here, both the extended and the blade ETT channel segments harbor the ETT;
[0040] FIG. 2D illustrates a cross sectional view of examples of a channel and its fixed and movable walls for release of an ETT;
[0041] FIGS. 2E - 2G illustrate cross section views of examples of blade walls and channel walls and their movements to open channel and release an ETT;
[0042] FIG. 3 illustrates a perspective view of a blade portion of a laryngoscope and the
ETT channel segment which is situated beneath the blade; the arrows indicate the possible directions the distal ETT channel (and the attached ETT) can be moved into; and
[0043] FIG. 4 illustrates a flowchart showing an example method of performing a laryngoscopy with the disclosed technology.
[0044] FIG. 5 illustrates a side view of an example of an intubation tube device with its overall dimensions, form and shape; and
[0045] FIG. 6 illustrates an example of a front cross sectional view of an intubation tube device showing the insertion point of the ETT.
[0046] In the drawings, the same reference numbers and any acronyms identify elements or acts with the same or similar structure or functionality for ease of understanding and convenience. To easily identify the discussion of any particular element or act, the most significant digit or digits in a reference number refer to the Figure number in which that element is first introduced.
DETAILED DESCRIPTION
[0047] Unless defined otherwise, technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Szycher's Dictionary of Medical Devices CRC Press, 1995, may provide useful guidance to many of the terms and phrases used herein. One skilled in the art will recognize many methods and materials similar or equivalent to those described herein, which could be used in the practice of the present invention. Indeed, the present invention is in no way limited to the methods and materials specifically described.
[0048] In some embodiments, properties such as dimensions, shapes, relative positions, and so forth, used to describe and claim certain embodiments of the invention are to be understood as being modified by the term "about."
[0049] Various examples of the invention will now be described. The following description provides specific details for a thorough understanding and enabling description of these examples. One skilled in the relevant art will understand, however, that the invention may be practiced without many of these details. Likewise, one skilled in the relevant art will also understand that the invention can include many other obvious features not described in detail herein. Additionally, some well-known structures or functions may not be shown or described in detail below, so as to avoid unnecessarily obscuring the relevant description.
[0050] The terminology used below is to be interpreted in its broadest reasonable manner, even though it is being used in conjunction with a detailed description of certain specific examples of the invention. Indeed, certain terms may even be emphasized below; however, any terminology intended to be interpreted in any restricted manner will be overtly and specifically defined as such in this Detailed Description section.
[0051] While this specification contains many specific implementation details, these should not be construed as limitations on the scope of any inventions or of what may be claimed, but rather as descriptions of features specific to particular implementations of particular inventions. Certain features that are described in this specification in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable sub-combination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a subcombination or variation of a sub-combination.
[0052] Similarly, while operations may be depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. In certain circumstances, multitasking and parallel processing may be advantageous. Moreover, the separation of various system components in the implementations described above should not be understood as requiring such separation in all implementations, and it should be understood that the described program components and systems can generally be integrated together in a single software product or packaged into multiple software products.
Overview
[0053] Patients in need of endotracheal tube (ETT) placement are often acutely threatened by oxygen deprivation, carbon dioxide build up and aspiration of throat secretions into the lungs. All these risks are associated with a significant likelihood of severe illness and death. Accordingly, procedural accuracy and speed of placing an airway (intubation) is of great essence. Therefore, many devices, equipment, intubation protocols and operator training target a high intubation success rate (i.e., placement of the ETT into the trachea on the first intubation attempt) as this improves clinical outcome by quickly restoring ventilation and simultaneously protecting secretions from entering the lungs. The disclosed technology describes a novel device, method and technology to further improve on the goal of successful first-attempt endotracheal intubation in adults and children and addresses patients with a wide diversity of head and neck anatomies. [0054] Accordingly, disclosed is a novel intubation device and technology which primarily aims at simplifying the intubation procedure and improving the success rate and speed of first intubation attempt. The described devices and methods integrates the universal form and shape of rigid laryngoscopes (namely, an intubation handle and blade with an attached light and optional video source at its tip) and introduces a novel intubation technology and procedural concepts that includes an ETT channel to retain and steer the ETT and then deploy it when properly positioned.
ETT Channel
[0055] The technology creates a mechanism to allow the ETT to be positioned next to the tip of the laryngoscope from the start of the procedure (that is, from the time of first laryngoscopic inspection of the throat). This is obtained by introducing an ETT channel under or next to the conventional intubation blade with its channel exit in proximity to the end of the blade. The purpose of the channel is to position the ETT next to the tip of the blade, to protect it from orolaryngeal tissue (tongue movements, etc.), to control the ETT tube position, and to provide a mechanism to easily slide the ETT forward into the trachea and to release the remaining length of the ETT from its channel.
[0056] The operator can release the ETT from the channel once the ETT tip is introduced into the trachea. ETT release from the device allows the intubation device to be removed from the oral cavity without the need for further ETT manipulations or use of a guidewire or sheath.
[0057] One of the main functions of the ETT channel is to provide a mechanism for secure positioning of the ETT close to the intubation blade tip. The main advantage of having the blade and ETT endings in close proximity is the immediate availability of the ETT once the blade reaches the vicinity of the laryngeal entrance during laryngoscopy.
[0058] The ETT channel, harboring the ETT, may be a round, tube-like structure which inner luminal diameter matches or is slightly larger than the outer diameter of commercially available ETTs - for example between 8 to 15 mm. The channel's total length reflects the combined laryngoscope handle, joint, and blade length ranges of, for example, 100 to 200mm, 10 to 30 mm, and 70 to 210 mm, respectively. In one example, the channel comprises one continuous segment which bends to accommodate the form of the laryngoscope and the blade curve.
[0059] In another example, the ETT channel may be a half-channel (with the lower part remaining open) or a rod-like structure to which the ETT is connected, i.e., via quick-release connecting rings or pins.
[0060] In another example, the ETT channel has two segments, one placed next to the laryngoscope handle and the second under the blade. These two segments may connect with a joint-like mechanism into one single straight or curved channel once the operator releases the proximal segment from the handle and aligns it with the blade segment.
[0061] The ETT channel can be divided into a proximal segment, reaching from its beginning at the handle to the first one to two thirds of the blade segment; this proximal segment may consist of rigid tubing and is attached to the laryngoscope. In some examples, the distal or terminal segment of the ETT channel covers the last one to two thirds of the intubation blade length and can be moved in 4 main directions in order for the ETT channel exit to obtain various positons under the blade.
Steer able ETT Channel Exit
[0062] The ETT channel exit is located at the tip of the blade and may be movable and steerable. While the rigid intubation blade is held statically by the operator to secure access to the larynx, the spatial flexibility of the distal ETT channel adapts the ETT exit to individual variations in larynx anatomy in order to align the channel exit and hence the ETT tip with the laryngeal entrance. This alignment greatly simplifies the next important intubation step which is pushing the ETT out of the channel and through the vocal cords.
[0063] The distal or final segment of the ETT channel is anchored beneath the blade and movable and steerable within predefined boundaries similar flexible endoscopes or steerable catheters. In some examples, it comprises radial indentations in the channel wall, a large central lumen to harbor the ETT, and is partially controlled by the pulling and releasing of wire members attached to anchoring rings positioned along the length of the channel. The distal ETT channel segment is anchored beneath the laryngoscope blade in a way that allows the channel exit to be navigated into various positions. For instance, the steerable exit allows the movement through angles (e.g. by deviations of 60 degrees or other angles from a centerline that runs along the longitudinal axis of the channel), as well as to change the channel exit projection, i.e., by curving the segment. Such navigation allows the operator or software program to align the channel exit (and hence, the trajectory of the ETT) with the laryngeal entrance.
Operation of the Laryngoscope with ETT Channel
[0064] For operation, the ETT may be inserted into the distal end of the channel until the
ETT tip reaches the channel's exit or, alternatively, until the ETT cuff reaches the channel exit. Once loaded within the distal channel, the ETT can rotate within the channel and/or be pushed out towards the target, the vocal cords. In some examples, advancing and retracting of the ETT inside the channel is accomplished using lubricants, wheels or other mechanism inside the channel. In some examples, the ETT channel may comprise an interconnected series of small rings or pins which are attached to a steerable rod and harbor the ETT.
[0065] Steering the distal channel segment into the desired alignment position is performed either manually (i.e., at the laryngoscope handle) or computer-controlled/assisted with electromechanical actuation. The steering principle follows techniques employed by flexible endoscopes, steerable catheters and/or robotic systems.
[0066] In some examples, steerability of the ETT channel is achieved by introducing a deflection apparatus into the channel body comprising the use of a deflection mechanism. In some examples, the deflection mechanism may include control lines, deflection wires, or push- pull wires. The hub for the pull wires is located at the laryngoscope handle site; the pull wires reach through the proximal and distal ETT channel segments to their respective attachment points at the terminal channel. The deflection mechanism may be manipulated to selectively deflect or straighten the intermediate and distal segments of the ETT channel. To increase the channel's deflection properties, two or more pull wires extending to different points along the channel length allow multiple channel segments to move in different directions.
[0067] In some examples, commercially available catheter steering technologies employ deflectable distal or intermediate segments controlled by push-pull or pull wire mechanisms. In one example, a single (or multi-lumen if one would include suction or oxygen delivery subchannels) steerable ETT channel has the inner luminal diameter to harbor an ETT and incorporates pull wires in relatively small pull wire lumens to selectively deflect the distal channel segment. Examples of this are described in U.S. Pat. Nos. 2,688,329; 3,605,725; 4,586,923; 5,030,204; 5,431, 168; 5,484,407; 5,571,085; 6,217,549; 6,251,092; and 6,371,476, the content of all of which are incorporated by reference herein in their entirety. To maximize the lumen-to-outer diameter ratio and torque transmission to the ETT channel tip tubular reinforcement or a metal wire braid reinforcement can be employed. Examples of this are disclosed in U.S. Pat. Nos. 5,738,742 and 5,964,971, the content of both of which are incorporated by reference herein in their entirety.
[0068] Many approaches to the fabrication of large diameter delivery lumen and the small diameter pull wires within the wire reinforced outer sheath have been disclosed and are commercially available. The delivery lumen utilized in these technologies is typically defined by a delivery lumen liner formed of an elastic material such as PTFE fluoropolymer tubing as this polymer is relatively lubricious and crush resistant and has a very low coefficient of friction. It is referred to the pertinent literature.
[0069] A small video camera at the ETT channel exit transmits real-time positioning information to the operator and/or microprocessor for manual, semi- or fully-automated operations.
[0070] A suction and oxygen channel to remove secretions and to deliver oxygen directly to the laryngeal entrance, respectively, and a light channel to provide the operator with illumination of the operating field can be added to the ETT channel.
[0071] In some examples, the ETT channel takes on the dimensions of an endoscope and resides inside the ETT. Prior to laryngoscopy, the ETT may be placed over the endoscope-like ETT-channel and secured by clipping it its proximal segment underneath the laryngoscopy blade. For intubation, the flexible and steerable EET channel is moved toward the laryngeal entrance and then the ETT is released from its anchor allowing it to be moved forward into the trachea. In some examples, the endoscope loaded the ETT on its outer surface may be semi-rigid not requiring anchoring to the blade. Computer Assisted Targeting Technology
[0072] A computer-assisted targeting technology is disclosed which simplifies aligning the trajectory of the movable ETT channel exit with the laryngeal entrance (target). In some examples, the technology may display, in real-time, two dynamically moving markers (e.g. grids, targets, highlights, outlines, arrows etc.) on a video screen, one indicating the anticipated ETT trajectories at any given ETT channel position and the other representing the target laryngeal entrance, the operator steers the ETT channel to alignment to superimpose the grids. Once overlay is achieved the operator can push the ETT out of the channel and into the trachea.
[0073] A video- and computer-assisted targeting technology is provided to the operator which supports or automatizes aligning the trajectory of the movable ETT channel exit with the laryngeal entrance (target: vocal cords). Different targeting methods have been described in the literature.
[0074] For example, applying visual odometry key anatomical recognition points (e.g., vocal cords) are recorded by a camera which is located at tip of the ETT channel. An example of visual odometry is described in Deguchi D, Mori K, Suenaga Y, Hasegawa J, Toriwaki J, Natori H, Takabatake H (2003) New calculation method of image similarity for endoscope tracking based on image registration in endoscope navigation. Int. Congr. Ser. 1256:460-466, the content of which is incorporated by reference herein. The target structure is identified and marked automatically by recognition software or by the operator and displayed in real-time onto the operator's video screen. Any target motion relative to the camera generates a measurable displacement deviation which is integrated to gain feedback about relative changes in vocal cords location, ETT channel exit-to-target distance, and suggested counter-movement steps to achieve ETT channel-vocal cords alignment. The software-generated counter movements are quantified and projected onto the operator's video screen; for example, as recommended movement trajectories between current position and target's crosshairs. Based on this information the operator steers the ETT channel into target alignment.
[0075] Alternatively, robotic guidance allows automatic readjustments of the ETT channel exit position to project into the laryngeal entrance. Feedback to the operator is delivered in clear, instinctive visual and tactile format. Optionally, the operator obtains contact force sensing and vibration feedback via visual and tactile display onto the laryngoscope or stand-by display.
[0076] Alternatively, an automated navigation and advisory targeting method can be applied which is based on lumen centralization. An example of this is described in Gillies D, Khan G (1996) Vision based navigation system for an endoscope. Image Vis Comput 14:763- 772, the content of which is incorporated by reference herein. Here the software searches for the darkest (dark region segmentation) and/or deepest (depth estimation) region within the image. In the described technology, laryngoscopic visualization and targeting of the vocal cords is based on identification of the structures furthest away from the camera and recognition of the darkness of the tracheal lumen (visible in-between the cords).
On Demand Release of the ETT Tube
[0077] Disclosed is a technology allowing the operator to release the ETT from its channel on-demand, a function which is needed after the ETT has been successfully inserted into the trachea.
[0078] To release an ETT from its channel several techniques can be employed.
Accordingly, after release the ETT separates from the ETT channel longitudinally for full release. In some examples, the ETT channel wall consists of two or more longitudinal segments, each of them designed to steer the ETT channel. Upon activation of the release mechanism, some or all channel wall segments may retract circumferentially underneath other portions of the wall leading to partial or complete segment stacking on top of each other and creating an opening in the channel to release the ETT. Such release movement of the channel wall segments can be initiated by pull wire and/or automated spring release mechanism.
[0079] In other examples, the channel wall is partitioned into an upper and lower half or segment. The upper half houses the steering mechanism together with portions of the ETT. The connected lower half is not part of the steering mechanism and consists of several rings and/or short segments along the channel's longitudinal length holding the ETT. For release, a spring- supported retraction of the lower rings and/or short circular segments allows disjunction of the ETT. [0080] In some other examples, the ETT channel may not encircle the ETT but rather have the ETT attached to its outside circumference; here the channel fulfills primarily the function of a steerable navigator moving the ETT into the desired position. The ETT is housed in a separate, flexible channel which passively follows the steering channel. However, optionally the ETT channel may house smaller, secondary conduits, for example, to suction secretions from the blade tip area, for delivery of oxygen, cables for channel tip sensors (i.e., measuring oxygen, carbon dioxide, pressure, vibration, etc.), as well as other utilities;
[0081] In other examples, semi- and fully automated intubation is described in which, after insertion of the laryngoscope, the operator observes on a video monitor how the ETT channel is aligned with the laryngeal solely using guidance software and once aligned, the ETT is automatically moved into the trachea using a spring-loaded or motor-driven mechanism and then released. After ETT release the laryngoscope is removed from the oral cavity.
Tube Device for Intubation
[0082] In some examples, a blade-like intubation device and technology houses and releases the steerable EET channel. This intubation device consists of an oval-shaped, curved intubation tube ("intubation tube"). Inside of the tube resides the steerable ETT channel with quick-ETT release function.
[0083] In some examples, the disclosed intubation tube has indentations on its concave outer side to harbor and hold the tongue muscle. The dimension of the tube may change over the tube's length; for example, the entry end of the tube has an oval shape, about 2-4 cm in width and 1-3 cm in height, while its form changes distally to a slightly rounder exit end with a minimal inner diameter of 1.5 cm. The intubation tube material allows downward curving (e.g.,., at the latter two thirds of its length) to accommodate variations in oropharyngeal anatomy. To allow during insertion flexible adjustments to the longitudinal intubation tube curving, accordion-like folding may be introduced into the tube wall. In some examples, the degree of longitudinal angle ranges between 20 to 70 degrees. The concave (undersurface) side of the tube has a small axial ridge near its exit to allow intubation tube to hook into the tongue's groove at its base or behind the epiglottis. [0084] In some examples, the intubation tube is separated longitudinally into an upper and lower part allowing the upper part to move independently from its lower part. The upper part, constituting about one half to two thirds of the intubation tube's height in some examples, can slide forward relative to the tube's lower part allowing the upper segment to enter the larynx more deeply.
[0085] The intubation tube may be made from plastic (i.e., for single-use), silicone or other durable materials such as metal (e.g., for repeated use). The proximal (entry) end of the tube has a handle for controlled insertion of the device into the oropharyngeal cavity. In addition, upon manual compression or decompression of the handle, the upper part of the intubation tube moves forward or backward, respectively, relative to the lower tube segment. A spring-like mechanism may facilitate these movements.
[0086] In some examples, the intubation tube has a hydrophilic outer coating to enhance ease of insertion and to minimize mucosal abrasions during manipulation. The outer concave side of the tube has a groove to accommodate the tongue during insertion. This concave surface may be coated with a biomedical, pressure-sensitive adhesive to create a temporary, interlocking coating between the intubation tube and tongue, i.e., using dihydroxyl-L-phenylalanine (DOPA; catechol). This prevents the tongue muscle from moving backwards into the oropharynx as it temporary sticks to the undersurface of the intubation tube.
[0087] To better accommodate various oropharyngeal and laryngeal anatomical differences between patients the distal two thirds of the intubation tube allows downward curving (i.e., from 10 to 70 degrees) of the upper intubation tube segment relative its longitudinal axis. This allows the distal intubation tube segment to follow the same curvature as the inside of the pharynx and larynx without collapsing in inner diameter. Curving is facilitated by material foldings within the tube wall.
[0088] In some examples, the intubation tube may partially or completely consist of inflatable material which balloon upon oxygen insufflation. In this design, the non-inflated intubation tube with its attached ETT channel is inserted into the pharynx and allowed to curve alongside the pharyngeal curvature. Next, to better visualize and target the laryngeal entrance, the intubation tube balloons are inflated with oxygen to occupy and extend the oropharyngeal cavity. The balloons are size-controlled to predefined inflation volumes to position the intubation tube exit (distal end) in front of the larynx (that is, bending the distal tube exit towards the laryngeal entrance). In some examples, the most distal balloon at the outer (concave) curvature of the intubation tube exit is shaped to allow simultaneous obstruction the esophageal entrance in order to minimize the risk of regurgitation of stomach content during the procedure. After placement and release of the ETT the balloons are deflated, and the intubation tube is withdrawn from the oral cavity.
[0089] The ETT channel is located inside the intubation tube with its distal part remaining steerable. Prior to insertion of the intubation tube into the oropharyngeal cavity, the ETT is loaded into the ETT channel. After insertion of the intubation tube into the oropharyngeal cavity the distal end of the ETT channels can be steered by the operator to appropriately place - where the ETT tube is in front of the vocal cords. Once inserted into the trachea, the ETT channel releases the ETT allowing the removal of the intubation tube while the ETT is in place, as described above.
[0090] In some examples, the intubation tube has a built-in suction and oxygen channels which allow removal of secretions and oxygenation of the patient, respectively, during the intubation procedure. Each of the channels has an outside port located at the entry side of the tube permitting connection to the respective bedside equipment.
[0091] The intubation tube may have a build-in video system with the camera located near its exit end. Placement and targeting is video and computer-assisted as described elsewhere in this disclosure.
[0092] Currently, no intubation tube design or technology exists which (1) incorporates a tube-in-tube (intubation tube housing an insertion ETT channel) laryngoscope approach and (2) an intubation tube allowing adjustment of its shape and length during ETT insertion based on anatomical needs. Additionally, other features disclosed herein are novel. These design features also allow placement of the ETT in a with semi-upright (seating) body position as preferred in acutely brain-injured patients. EXAMPLES
[0093] The following examples are provided to better illustrate the claimed invention and are not intended to be interpreted as limiting the scope of the invention. To the extent that specific materials or steps are mentioned, it is merely for purposes of illustration and is not intended to limit the invention. One skilled in the art may develop equivalent means or reactants without the exercise of inventive capacity and without departing from the scope of the invention.
[0094] FIG. 1A illustrates a perspective view of a prior art laryngoscope 100 with a handle 120 and a blade 110. For practical purposes (sterilization, etc.) the blade 110 can be disengaged from the handle 120.
[0095] FIG. 2 A illustrates a perspective view of an example of a laryngoscope 100 with an ETT tube channel 290 which is located under the convex surface of the blade 110. In some examples, the channel 290 may be located at the mid-center point under the primary blade 110. The form, shape and design of the intubation blade 110 can vary and take on any of the currently commercially available blades, i.e., straight, curved or hyper-angulated forms. In some examples, a small video camera 215 at the ETT channel exit transmits real-time positioning information to the operator and/or microprocessor for manual, semi- or fully-automated operations.
[0096] The channel 290 may include a stationary segment 230 and a steerable segment
240. The steerable segment will include a portion of the channel 290 that is closest to the distal end of the blade 110. This section, as disclosed herein, is steerable to navigate the tip of the channel 290 to facilitate placement of the ETT through the vocal cords as disclosed herein.
[0097] Additionally, the channel 290 may be connected to the convex side of the blade
110 through a support structure 285. In some examples, the support structure may be a solid plastic, metal or other mechanism or may be any other mechanical connection between the channel and the blade 110. In some examples, the channel 290 will be directly attached to the convex surface of the blade 110 except for the distal portion which will have freedom of movement where the convex surface of the blade 110 tapers away from the channel 290. In some examples, the ETT channel may be shorter in length than the laryngoscope blade. [0098] FIG. 2B illustrates a perspective view of an example of a laryngoscope 100 with an ETT tube channel 290. Particularly, depicted is the added handle 225 part of the ETT channel 290 which is in neutral position clipped onto the laryngoscope 290 handle 110 top and attached to the lower part of the handle 120 by joint 255. The joint 255 allows the ETT channel 290 to open 90 degrees away from the handle 120 and to snap-connect with the blade part of the ETT channel 290. The handle ETT channel part 255 may be a straight or curved structure allowing various alignment angles with the distal ETT channel once connected.
[0099] The handle part 225 of the ETT channel 290 may have 3 main components: (1) a wheel 235 (or other mechanism) in its wall connecting the outer channel 290 with the inner handle lumen and when turned (i.e., by the operator's thumb) that will advance and retract the ETT out of its channel 290; (2) a ring-like knob 245 located below the wheel 235 with restricted sliding movements up and down the channel 290 which induces right-left movements and (3) when the knob 245 is rotated up and down movements of the flexible ETT channel 290 (distal blade part) are induced.
[00100] FIG. 2C illustrates a perspective view of an example of a laryngoscope 100 with an ETT tube channel 290 with the handle part 225 of the ETT channel 290 rotated open 90 degrees. In this example, the handle part 225 is now in line with the stationary segment 230 and steerable segment 240 of the channel 190. Accordingly, insertion of an ETT, or movement of the ETT will be much easier as there will not be a curve or bend at the point of connection between the stationary segment 230 and the handle part 225 of the channel 290.
[00101] FIG. 2D illustrates a cross sectional view of an example channel 290 that includes a fixed wall 310 and movable walls 300. As illustrate, a mechanism, such as a spring loaded release, or other mechanism is actuated by the operator or the system, at least one movable wall 300 will move to either allow an ETT to be inserted in the channel 290, or released. For instance, as illustrated, the movable wall may retract behind or otherwise parallel with the fixed wall 310. In other examples, the movable wall(s) 300 may swing open.
[00102] FIG. 2E illustrates a perspective view of an additional example of the mechanics facilitating ETT release from the ETT channel 290. In this example, a cross section view of an example channel 290 is illustrated that includes two channel walls 300 and blade walls 295. Accordingly, the ETT channel 290 consists of two (complete or incomplete) half-circle channel walls 300 (or other appropriate shapes) which rotate against each other to release the ETT while the form of the laryngoscope blade remains flat and unchanged. As illustrated in FIG. 2F, each larygoscope blade wall 295 and opposing ETT channel 290 wall 300 may constitute one piece and release of the ETT is accomplished by various (e.g., 45) degrees of folding of both walls against each other allowing channel 290 to open. As illustrated in Figure 2G, downward rotation and folding of one intubation blade wall 295 and its connected, opposite ETT channel 290 wall 300 may release the ETT while the opposite intubation blade wall 295 remains unchanged in position In some examples, to appropriately account for the curvature of the blade a multiple of small release segments arranged in series can be utilized. Release can conveniently be initiated by spring-load relaxation or other suitable methods.
[00103] FIG. 3 illustrates a schematic drawing of the movements of the ETT (endotracheal tube) channel's 290 distal segment which is situated beneath the blade. For simplicity the ETT channel is depicted separately from the blade 110 and not at its anticipated position beneath the blade 110. The arrows indicate the main moveable directions the ETT can be moved into with the help of the steerable distal ETT channel segment: up, down, right, and left with respect to the overlying intubation blade (arrows 2 and 3), ETT rotation along its long axis (arrow 4) as well as forward and backward ETT movements within its channel (arrow 1).
[00104] The distal ETT channel 290 segment is anchored beneath the laryngoscope blade in a way that allows the channel exit to be oriented into various positions. Orientation refers to bending the ETT channel tip (arrows 2 and 3), for example, by 60 degrees on in the direction of arrows 2 and 3. This orientation allows the operator to align the channel exit with the laryngeal entrance (vocal cords).
[00105] Arrow 4 indicates the ability of the ETT itself to rotate within the channel 290 and to be pushed out (arrow 1) towards the target, the vocal cords. A release mechanism along the long axis of the channel allows the ETT to separate from the channel 290.
[00106] FIG. 4 illustrates a flow chart showing an example process for performing an intubation using the disclosed technology. For operation, the ETT may be loaded 400 into the channel 290 by inserting the ETT into the distal end of the channel 290 until the ETT tip reaches the channel's 290 exit.
[00107] Next, the scope 100 may be manipulated into the proper position 410 in the mouth and towards the larynx including by steering the distal portion 240 of the channel 290. Then, the laryngeal entrance will be visualized 415 either on a display transmitting video feed from a camera on the scope 100 or using visual recognition software. For instance, steering the distal channel segment into the desired alignment position 410 is performed either manually (e.g., at the laryngoscope 100 handle 120) or computer-controlled/assisted with electromechanical actuation. The steering principle follows techniques employed by flexible endoscopes, steerable catheters and/or robotic systems.
[00108] For intubation, the flexible and steerable EET channel is moved toward the laryngeal entrance to align the ETT with the vocal cords 420, and then the ETT is advanced out of the channel 290 into the trachea 430. Then, the ETT is released 440 from the channel 290 and the scope 100 is removed from the oral cavity 450.
Tube Device for Intubation
[00109] FIG. 5 illustrates an example of an intubation tube 500 device that houses an ETT channel 510 that is inside the tube device 500, and is a tube within the tube device 500. Inside of the tube device 500 the ETT channel 510 is steerable, and includes an ETT 595 release function. In some examples, the disclosed intubation tube device 500 has indentations on its concave outer side to harbor and hold the tongue muscle. Intubation tube device 500 may have an actuator 550, to steer the distal end of the ETT channel 510. In some examples, actuator 550 may be knobs, a slider, or other suitable electronic or mechanical system.
[00110] The dimensions of the tube device 500 may change from the entry (or proximal) proximal to the exit (or distal) end. The entry end of the tube may have an oval shape. For instance, in some examples it may be about 2-4 cm in width and 1-3 cm in height. In some examples, its form changes distally to a slightly rounder exit end with a minimal inner diameter of 1.5 cm to allow the connector part of the ETT 595 to pass. The intubation tube device 500 may be downward curved in the distal two thirds of its length to better accommodate the oropharyngeal anatomy. The degree of longitudinal angle ranges between 20 to 70 degrees, in some examples. The concave (undersurface) side of the tube has a small axial ridge near its exit which protrudes to the outside and enables to hook the tube into the tongue's groove at its base.
[00111] In some examples, the intubation tube is separated longitudinally into an upper segment 515 and a lower segment 525 allowing the upper segment 515 to move independently from its lower segment 525. The upper segment 515, constituting about one half to two thirds of the intubation tube's 500 height, can slide forward relative to the tube's 500 lower segment 525 allowing the upper segment 515 to enter the larynx more deeply. The upper segment 515 may contain the ETT channel 510, and therefore when it slides forward it can insert the ETT housed in the ETT channel 510 closer to the delivery site.
[00112] The intubation tube device 500 may be made out of plastic (i.e., for single-use), silicone or other durable materials such as metal (e.g., for repeated use). The proximal (entry) end of the tube has a handle 530 for controlled insertion of the device into the oropharyngeal cavity. In addition, upon manual compression or decompression of the handle 530, knobs or other mechanical devices known, the upper segment 515 of the intubation tube device 500 may move forward or backward, respectively, relative to the lower tube segment 525.
[00113] In some examples, the intubation tube device 500 has a hydrophilic outer coating to enhance ease of insertion. The outer concave side of the tube device 500 may have a groove to accommodate the tongue during insertion. This concave surface may be coated with a biomedical, pressure-sensitive adhesive to create a temporary, interlocking coating between the intubation tube and tongue, i.e., using dihydroxyl-L-phenylalanine (DOPA; catechol). This allows the tongue muscle to temporary stick to the undersurface of the intubation tube.
[00114] To better accommodate various oropharyngeal and laryngeal anatomical differences between patients, the distal two thirds of the intubation tube device 500 may allow downward curving (e.g., from 10 to 50 degrees) of the upper intubation tube segment relative its longitudinal axis. This allows the distal intubation tube segment to follow the same curvature as the inside of the pharynx and larynx. However, the distal tube segment does not collapse in its inner diameter during insertion and while bending itself according to pharyngeal anatomy. [00115] In some examples, the intubation tube device 500 may partially or completely consist of inflatable material which balloons upon oxygen insufflation. In this design, the non- inflated intubation tube with its central ETT channel 510 is inserted into the pharynx and allowed to curve alongside the pharyngeal curvature. Next, to better visualize and target the laryngeal entrance, the intubation tube balloons are inflated with oxygen to occupy and extend the oropharyngeal cavity. The balloons are size-controlled to predefined inflation volumes to position the intubation tube exit (distal end) in front of the larynx (that is, bending the distal tube exit towards the laryngeal entrance). In some examples, the most distal balloon at the outer (concave) curvature of the intubation tube exit is shaped to allow simultaneous obstruction the esophageal entrance in order to minimize the risk of regurgitation of stomach content during the procedure. After placement and release of the ETT, the balloons are deflated, and the intubation tube device 500 is withdrawn from the oral cavity.
[00116] The ETT channel 510 is located inside the intubation tube device 500 with its distal part remaining steerable. Prior to insertion of the intubation tube device 500 into the oropharyngeal cavity, the ETT 595 is loaded into the ETT channel 510. After insertion of the intubation tube into the oropharyngeal cavity the distal end of the ETT channels 510 can be steered by the operator to appropriately place - where the ETT tube is in front of the vocal cords. Once inserted into the trachea, the ETT channel 510 releases the ETT allowing the removal of the intubation tube while the ETT is in place, as described above.
[00117] The intubation tube device 500 when viewed from the side may take on a variety of angles of bending on its distal portion. In some examples the distal portion will include flexible plastic. In some examples the distal portion will include an accordion-folded like flexible tube that will restrict compression but bend in any direction once it reaches the temperature of a patient. This will allow the intubation tube device 500 to mold itself into the correct pharyngeal anatomy - without losing the outer diameter. In other examples the tube may include embedded rings that allow the tube to be flexible but that do not allow compression.
[00118] FIG. 6 illustrates a front view of the intubation tube device 500 that includes entry orifice 610 and exit orifice 610. Additionally, illustrated is handle 530. In some examples, handle 530 may include a two-bladed handle 530 that allows sliding of the upper and lower segments against each other. Upper and lower segments may be able to slide longitudinally with respect to each other. In this example, the ETT channel 510 will also extend out of the intubation tube device 500. Control knobs may be located to control the distal ETT channel 510. In some examples, the device 500 may include oxygen and suction channels 605. Additionally, the ETT 595 may be held in place and released by retaining mechanism 610. Retaining mechanism 610 may be springs, or may be an ETT channel 510 that includes a feature that splits the ETT channel 510 open to release the ETT 595 on demand as described in further embodiments above, or other suitable mechanisms or devices as disclosed herein.
Computer & Hardware Implementation of Disclosure
[00119] It should initially be understood that the disclosure herein, including the steering of the ETT channel and computer-aided targeting and processing equipment may be implemented with any type of hardware and/or software, and may be a pre-programmed general purpose computing device. For example, the system may be implemented using a server, a personal computer, a portable computer, a thin client, or any suitable device or devices. The disclosure and/or components thereof may be a single device at a single location, or multiple devices at a single, or multiple, locations that are connected together using any appropriate communication protocols over any communication medium such as electric cable, fiber optic cable, or in a wireless manner.
[00120] It should also be noted that the disclosure is illustrated and discussed herein as having a plurality of modules which perform particular functions. It should be understood that these modules are merely schematically illustrated based on their function for clarity purposes only, and do not necessary represent specific hardware or software. In this regard, these modules may be hardware and/or software implemented to substantially perform the particular functions discussed. Moreover, the modules may be combined together within the disclosure, or divided into additional modules based on the particular function desired. Thus, the disclosure should not be construed to limit the present invention, but merely be understood to illustrate one example implementation thereof.
[00121] The computing system can include clients and servers. A client and server are generally remote from each other and typically interact through a communication network. The relationship of client and server arises by virtue of computer programs running on the respective computers and having a client-server relationship to each other. In some implementations, a server transmits data (e.g., an HTML page) to a client device (e.g., for purposes of displaying data to and receiving user input from a user interacting with the client device). Data generated at the client device (e.g., a result of the user interaction) can be received from the client device at the server.
[00122] Implementations of the subject matter described in this specification can be implemented in a computing system that includes a back-end component, e.g., as a data server, or that includes a middleware component, e.g., an application server, or that includes a front-end component, e.g., a client computer having a graphical user interface or a Web browser through which a user can interact with an implementation of the subject matter described in this specification, or any combination of one or more such back-end, middleware, or front-end components. The components of the system can be interconnected by any form or medium of digital data communication, e.g., a communication network. Examples of communication networks include a local area network ("LAN") and a wide area network ("WAN"), an internetwork (e.g., the Internet), and peer-to-peer networks (e.g., ad hoc peer-to-peer networks).
[00123] Implementations of the subject matter and the operations described in this specification can be implemented in digital electronic circuitry, or in computer software, firmware, or hardware, including the structures disclosed in this specification and their structural equivalents, or in combinations of one or more of them. Implementations of the subject matter described in this specification can be implemented as one or more computer programs, i.e., one or more modules of computer program instructions, encoded on computer storage medium for execution by, or to control the operation of, data processing apparatus. Alternatively or in addition, the program instructions can be encoded on an artificially-generated propagated signal, e.g., a machine-generated electrical, optical, or electromagnetic signal that is generated to encode information for transmission to suitable receiver apparatus for execution by a data processing apparatus. A computer storage medium can be, or be included in, a computer-readable storage device, a computer-readable storage substrate, a random or serial access memory array or device, or a combination of one or more of them. Moreover, while a computer storage medium is not a propagated signal, a computer storage medium can be a source or destination of computer program instructions encoded in an artificially-generated propagated signal. The computer storage medium can also be, or be included in, one or more separate physical components or media (e.g., multiple CDs, disks, or other storage devices).
[00124] The operations described in this specification can be implemented as operations performed by a "data processing apparatus" on data stored on one or more computer-readable storage devices or received from other sources.
[00125] The term "data processing apparatus" encompasses all kinds of apparatus, devices, and machines for processing data, including by way of example a programmable processor, a computer, a system on a chip, or multiple ones, or combinations, of the foregoing The apparatus can include special purpose logic circuitry, e.g., an FPGA (field programmable gate array) or an ASIC (application-specific integrated circuit). The apparatus can also include, in addition to hardware, code that creates an execution environment for the computer program in question, e.g., code that constitutes processor firmware, a protocol stack, a database management system, an operating system, a cross-platform runtime environment, a virtual machine, or a combination of one or more of them. The apparatus and execution environment can realize various different computing model infrastructures, such as web services, distributed computing and grid computing infrastructures.
[00126] A computer program (also known as a program, software, software application, script, or code) can be written in any form of programming language, including compiled or interpreted languages, declarative or procedural languages, and it can be deployed in any form, including as a stand-alone program or as a module, component, subroutine, object, or other unit suitable for use in a computing environment. A computer program may, but need not, correspond to a file in a file system. A program can be stored in a portion of a file that holds other programs or data (e.g., one or more scripts stored in a markup language document), in a single file dedicated to the program in question, or in multiple coordinated files (e.g., files that store one or more modules, sub-programs, or portions of code). A computer program can be deployed to be executed on one computer or on multiple computers that are located at one site or distributed across multiple sites and interconnected by a communication network. [00127] The processes and logic flows described in this specification can be performed by one or more programmable processors executing one or more computer programs to perform actions by operating on input data and generating output. The processes and logic flows can also be performed by, and apparatus can also be implemented as, special purpose logic circuitry, e.g., an FPGA (field programmable gate array) or an ASIC (application-specific integrated circuit).
[00128] Processors suitable for the execution of a computer program include, by way of example, both general and special purpose microprocessors, and any one or more processors of any kind of digital computer. Generally, a processor will receive instructions and data from a read-only memory or a random access memory or both. The essential elements of a computer are a processor for performing actions in accordance with instructions and one or more memory devices for storing instructions and data. Generally, a computer will also include, or be operatively coupled to receive data from or transfer data to, or both, one or more mass storage devices for storing data, e.g., magnetic, magneto-optical disks, or optical disks. However, a computer need not have such devices. Moreover, a computer can be embedded in another device, e.g., a mobile telephone, a personal digital assistant (PDA), a mobile audio or video player, a game console, a Global Positioning System (GPS) receiver, or a portable storage device (e.g., a universal serial bus (USB) flash drive), to name just a few. Devices suitable for storing computer program instructions and data include all forms of non-volatile memory, media and memory devices, including by way of example semiconductor memory devices, e.g., EPROM, EEPROM, and flash memory devices; magnetic disks, e.g., internal hard disks or removable disks; magneto-optical disks; and CD-ROM and DVD-ROM disks. The processor and the memory can be supplemented by, or incorporated in, special purpose logic circuitry.
CONCLUSION
[00129] The various methods and techniques described above provide a number of ways to carry out the invention. Of course, it is to be understood that not necessarily all objectives or advantages described can be achieved in accordance with any particular embodiment described herein. Thus, for example, those skilled in the art will recognize that the methods can be performed in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other objectives or advantages as taught or suggested herein. A variety of alternatives are mentioned herein. It is to be understood that some embodiments specifically include one, another, or several features, while others specifically exclude one, another, or several features, while still others mitigate a particular feature by inclusion of one, another, or several advantageous features.
[00130] Furthermore, the skilled artisan will recognize the applicability of various features from different embodiments. Similarly, the various elements, features and steps discussed above, as well as other known equivalents for each such element, feature or step, can be employed in various combinations by one of ordinary skill in this art to perform methods in accordance with the principles described herein. Among the various elements, features, and steps some will be specifically included and others specifically excluded in diverse embodiments.
[00131] Although the application has been disclosed in the context of certain embodiments and examples, it will be understood by those skilled in the art that the embodiments of the application extend beyond the specifically disclosed embodiments to other alternative embodiments and/or uses and modifications and equivalents thereof.
[00132] In some embodiments, the terms "a" and "an" and "the" and similar references used in the context of describing a particular embodiment of the application (especially in the context of certain of the following claims) can be construed to cover both the singular and the plural. The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (for example, "such as") provided with respect to certain embodiments herein is intended merely to better illuminate the application and does not pose a limitation on the scope of the application otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the application. [00133] Certain embodiments of this application are described herein. Variations on those embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. It is contemplated that skilled artisans can employ such variations as appropriate, and the application can be practiced otherwise than specifically described herein. Accordingly, many embodiments of this application include all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the application unless otherwise indicated herein or otherwise clearly contradicted by context.
[00134] Particular implementations of the subject matter have been described. Other implementations are within the scope of the following claims. In some cases, the actions recited in the claims can be performed in a different order and still achieve desirable results. In addition, the processes depicted in the accompanying figures do not necessarily require the particular order shown, or sequential order, to achieve desirable results.
[00135] All patents, patent applications, publications of patent applications, and other material, such as articles, books, specifications, publications, documents, things, and/or the like, referenced herein are hereby incorporated herein by this reference in their entirety for all purposes, excepting any prosecution file history associated with same, any of same that is inconsistent with or in conflict with the present document, or any of same that may have a limiting affect as to the broadest scope of the claims now or later associated with the present document. By way of example, should there be any inconsistency or conflict between the description, definition, and/or the use of a term associated with any of the incorporated material and that associated with the present document, the description, definition, and/or the use of the term in the present document shall prevail.
[00136] In closing, it is to be understood that the embodiments of the application disclosed herein are illustrative of the principles of the embodiments of the application. Other modifications that can be employed can be within the scope of the application. Thus, by way of example, but not of limitation, alternative configurations of the embodiments of the application can be utilized in accordance with the teachings herein. Accordingly, embodiments present application are not limited to that precisely as shown and described.

Claims

1. An orolaryngeal intubation device for combining laryngoscope function with a steerable intubation channel, the device comprising: a laryngoscope comprising a handle and a blade; a channel comprising: at least one movable wall; and a mechanism configured to manipulate the at least one movable wall to retain and release an endotracheal tube.
2. The orolaryngeal intubation device of claim 1, further comprising a steering mechanism which allows movement of a distal portion of the channel.
3. The orolaryngeal intubation device of claim 2, wherein the steering mechanism comprises a knob connected to wires attached to the channel.
4. The orolaryngeal intubation device of claim 3, wherein the wires are contained inside wire lumens in the channel.
5. The orolaryngeal intubation device of claim 4, wherein the knob is configured to move the wires through rotation and sliding.
6. The orolaryngeal intubation device of claim 1, wherein the at least one movable wall comprises two moveable walls configured to open and close around hinges.
7. The orolaryngeal intubation device of claim 1, wherein the at least one movable wall is configured to retract behind a stationary wall of the channel.
8. The orolaryngeal intubation device of claim 1, wherein the channel is a tubular shape sized approximately the size of a standard endotracheal tube.
9. The orolaryngeal intubation device of claim 1, wherein the endotracheal tube is fully enclosed by the channel when retained by the at least one movable wall.
10. The orolaryngeal intubation device of claim 1, wherein the channel further comprises: a handle segment connected to the laryngoscope handle; and a blade segment connected to a convex side of the blade, wherein the proximal and distal segment are connected by a movable joint.
11. The orolaryngeal intubation navigation system, comprising: a display a memory containing machine readable medium comprising machine executable code having stored thereon instructions for performing a method of guiding the alignment of an endotracheal tube during an intubation procedure; at least one processor coupled to the memory, the at least one processor configured to execute the machine executable code to cause the processor to: receive, from at least one camera connected to a laryngoscope, video data; process the video data to identify a location of a laryngeal entrance on the video data; determine, by processing the video data, a trajectory of a channel connected to the laryngoscope relative to the laryngeal entrance; process a set of frames of video data to superimpose the trajectory of the channel and the laryngeal entrance; and display the set of frames on the display.
12. The navigation system of claim 11, wherein the channel comprises a proximal portion that is moveable using an electromechanical system.
13. The navigation system of claim 12, wherein the at least one processor further caused to: send instructions to the electromechanical system to move the proximal portion until the trajectory of the channel intersects with the laryngeal entrance.
14. A method of performing an orolaryngeal procedure, the method comprising: providing a laryngoscope with a channel, wherein the channel comprises at least one movable wall; inserting an endotracheal tube in the channel, and actuating a mechanism on the laryngoscope to connect to the endotracheal tube; insert the laryngoscope inside a patient's mouth and line up the channel with the patient's laryngeal entrance; and actuating the mechanism to open the movable wall and to release the ETT.
15. The method of claim 14, further comprising actuating a second mechanism to extend the endotracheal tube from the channel.
16. The method of claim 15, wherein the second mechanism is a knob.
17. The method of claim 15, wherein the second mechanism is a dial.
18. The method of claim 15, wherein the channel comprises rollers.
19. An orolaryngeal intubation tube device comprising: a tube with a handle and an actuator; and an ETT channel contained at least partially inside the tube configured to removably hold an ETT, and wherein actuating the actuator releases the ETT.
20. The orolaryngeal intubation tube device of claim 19, wherein the tube is comprised of plastic and configured to bend to a patient's anatomy.
21. The orolaryngeal intubation tube device of claim 19, wherein the tube has a top segment and a bottom segment that slide longitudinally with respect to each other.
22. The orolaryngeal intubation tube device of claim 19, wherein the ETT channel may be move longitudinally with an actuator with respect to the tube.
23. The orolaryngeal intubation tube device of claim 19, wherein the distal portion of the tube includes rings.
24. The orolaryngeal intubation tube device of claim 19, wherein the outer walls of the tube contain inflatable balloons to center and fixate the intubation tube within the oropharyngeal anatomy.
PCT/US2017/066147 2016-12-13 2017-12-13 Endotracheal intubation employing computer-guided tracheal targeting and on-demand endotracheal tube release WO2018112057A1 (en)

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