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WO2025034941A2 - Systèmes d'intubation supraglottique et procédés de placement - Google Patents

Systèmes d'intubation supraglottique et procédés de placement Download PDF

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Publication number
WO2025034941A2
WO2025034941A2 PCT/US2024/041414 US2024041414W WO2025034941A2 WO 2025034941 A2 WO2025034941 A2 WO 2025034941A2 US 2024041414 W US2024041414 W US 2024041414W WO 2025034941 A2 WO2025034941 A2 WO 2025034941A2
Authority
WO
WIPO (PCT)
Prior art keywords
channel
camera
tubal body
ventilating device
cuff
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/041414
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English (en)
Other versions
WO2025034941A3 (fr
Inventor
Robert Molnar
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Wm&dg Inc
Original Assignee
Wm&dg Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Wm&dg Inc filed Critical Wm&dg Inc
Publication of WO2025034941A2 publication Critical patent/WO2025034941A2/fr
Publication of WO2025034941A3 publication Critical patent/WO2025034941A3/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0402—Special features for tracheal tubes not otherwise provided for
    • A61M16/0409—Special features for tracheal tubes not otherwise provided for with mean for closing the oesophagus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments 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
    • A61B1/00131—Accessories for endoscopes
    • A61B1/00135—Oversleeves mounted on the endoscope prior to insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments 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
    • A61B1/00147—Holding or positioning arrangements
    • A61B1/00154—Holding or positioning arrangements using guiding arrangements for insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments 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
    • A61B1/012—Instruments 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 characterised by internal passages or accessories therefor
    • A61B1/015—Control of fluid supply or evacuation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments 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
    • A61B1/04—Instruments 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 combined with photographic or television appliances
    • A61B1/05—Instruments 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 combined with photographic or television appliances characterised by the image sensor, e.g. camera, being in the distal end portion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments 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
    • A61B1/267—Instruments 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0486—Multi-lumen tracheal tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0402—Special features for tracheal tubes not otherwise provided for
    • A61M16/0415—Special features for tracheal tubes not otherwise provided for with access means to the stomach
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0434—Cuffs
    • A61M16/0436—Special fillings therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0475—Tracheal tubes having openings in the tube
    • A61M16/0477—Tracheal tubes having openings in the tube with incorporated means for delivering or removing fluids

Definitions

  • This disclosure relates to the field of medical devices for airway management, including ventilating devices configured for use with a laryngoscope under visualization by one or more cameras.
  • a supraglottic airway device can be used for keeping a subject’s airway open and for ventilation while administering anesthesia and/or as a life-saving measure in a subject who is unconscious or otherwise unable to breathe unassisted.
  • this disclosure provides a ventilating device comprising a tubal body having a length between a proximal end and a distal end, the tubal body having a face surface, a back surface, and two lateral surfaces; wherein the tubal body is curved in its distal portion toward the front surface of the tubal body at an angle a configured for fitting with the curvature of the oropharynx; wherein the back surface of the tubal body extends distally from the distal end of the tubal body with a ramp which has a face surface, and a cuff being attached to at least a portion of the ramp face surface and wherein the cuff is further attached to the tubal body face surface and the cuff being configured for sealing the airway when the ventilating device is used in a subject; wherein the tubal body contains at least one ventilation channel having a proximal inlet at or near the proximal end of the tubal body, the ventilation channel passing through the tubal body for a least a portion
  • the cuff may be non-inflatable. In other preferred embodiments, the cuff may be inflatable. Some preferred embodiments include those, wherein the non-inflatable cuff has a proximal wall and two lateral walls, the proximal wall having a height above the tubal body front surface, and/or wherein the cuff is substantially U-shaped with the proximal wall of the cuff forming the base in the U-shape. Preferably, the non-inflatable cuff may have a ridge rising above the proximal wall.
  • ventilating device include those, wherein the non-inflatable cuff has at least one channel passing through the non-inflatable cuff, the cuff channel having a proximal end inlet and a distal end outlet, the cuff channel having a diameter configured for housing a camera and/or a camera sheath.
  • These ventilating devices may be further characterized by one or more of the following features:
  • the cuff channel is located in a proximal wall of the cuff
  • the cuff channel is sealed with a window at its distal outlet.
  • the tubal body of the ventilating device may further contain at least one camera channel having a proximal inlet at or near the proximal end of the tubal body, the camera channel traversing at least a portion of the tubal body length and the camera channel merging with the ventilation channel in a distal portion for at least a portion of the tubal body length, and the camera channel having a distal outlet opening to the ramp face surface.
  • the tubal body further contains at least one camera channel having a proximal inlet at or near the proximal end of the tubal body, the camera channel traversing at least a portion of the tubal body length and the camera channel extending distally from the tubal body to the ramp face surface, and the camera channel having a distal end outlet located distally to the distal opening of the ventilation channel.
  • the distal end outlet of the camera channel may be sealed with a transparent window through which a camera positioned in the camera channel can capture images during placement and/or after the placement has been completed, the sealed window protecting the camera from exposure to bodily tissues.
  • the tubal body may further contain a gastric channel having a proximal inlet located at or near the proximal end of the tubal body, the gastric channel traversing the tubal body for at least a portion of the tubal body length and the gastric channel having a distal outlet located in a distal portion of the tubal body on the back surface of the tubal body.
  • Certain ventilating devices according to this disclosure may further comprise a connector inserted or insertable into the proximal inlet of the ventilation channel.
  • the ventilating device according to this disclosure may further comprise a sheath insertable and removable into the ventilation channel and/or the sheath insertable and removable into a camera channel when the ventilating device comprises the camera channel.
  • this disclosure provides a system for supraglottic placement, the system comprising one or more of the ventilating devices according to this disclosure and at least one laryngoscope comprising a handle attached to a blade, the blade having a front surface and a back surface, the blade being curved in its distal portion at angle [3 toward the front surface, wherein the angle [3 is the same or substantially the same as the angle a of the ventilating device, and wherein the laryngoscope is configured for being assembled with the ventilating device by placing the front surface of the tubal body of the ventilating device over the back surface of the laryngoscope blade.
  • the system may further comprise a camera, the camera being insertable into the cuff channel and removable from the cuff channel.
  • the system may further comprise one or more sheaths.
  • this disclosure provides a laryngoscope configured for being assembled with the ventilating device according to this disclosure, the laryngoscope comprising a handle attached to a blade, the blade having a front surface and a back surface, the blade being curved in its distal portion at angle [3 toward the front surface, wherein the angle [3 is the same or substantially the same as the angle a of the ventilating device, and wherein the laryngoscope is configured for being assembled with the ventilating device by placing the front surface of the tubal body of the ventilating device over the back surface of the laryngoscope blade.
  • this disclosure includes methods for supraglottic intubation, the methods comprising: a) inserting a camera into a handle of the laryngoscope according to this disclosure and extending the camera over the back surface of the blade; b) inserting the blade into the oral cavity and manipulating the handle of the laryngoscope in order to gain access to the upper airway; c) placing the front surface of the tubal body over the back surface of the blade and positioning the camera into the cuff camera channel; d) placing the ventilating device above the vocal cords and verifying the placement with the camera; e) removing the camera from the laryngoscope; and f) removing the laryngoscope from the oral cavity.
  • the methods may further comprise inserting a second camera into the ventilating device at any of steps a) through f).
  • the methods may further include inserting the camera into a sheath before placing the camera into the laryngoscope and/or into the ventilating device.
  • FIG. 1 is a perspective view of one embodiment of a ventilating device according to this disclosure.
  • FIG. 2 is a perspective view of one embodiment of a system according to this disclosure.
  • FIG. 3 is a sideview of one embodiment of a system according to this disclosure.
  • Fig. 4 is a zoomed front view focusing on a mask portion of the ventilating device of Fig. 1 .
  • Fig. 5 is a zoomed perspective view focusing on the mask portion of the ventilating device of Fig. 1.
  • FIG. 6 is a perspective view of another embodiment of a ventilating device according to this disclosure.
  • This disclosure relates to supraglottic devices including an improved ventilating device and systems useful for placing the ventilating device, as well as to airway management methods.
  • this disclosure provides an improved ventilating device and a system in which a laryngoscope is configured for placing the ventilating device, preferably under continuous visualization with at least one camera.
  • ventilating devices and systems include: 1 ) a capability for placement under visualization by one or more cameras which may reduce the risk of tissue damage and which may also decrease a time necessary for the placement procedure, resulting in ventilation being established sooner; 2) an option for a practitioner to guide the system with one hand during placement; 3) a capability to monitor for optimal ventilation and adverse reactions such as gastric aspiration and/or internal bleeding; 4) a capability to suction airway secretions and/or deliver drugs endotracheally without the need to interrupt ventilation; 5) a capability to change an endotracheal tube if necessary; 6) a capability to suction gastric aspiration; and/or 7) a capability for removing the ventilating device under continuous visualization by one or more cameras, among others.
  • distal end means the end which is introduced into the oropharynx first during examination and/or during an intubation procedure.
  • the “proximal end” is opposite to the distal end.
  • face surface means the surface which is positioned toward the subject’s front after placement is completed.
  • back surface is the opposite to the front surface.
  • FIG. 1-6 embodiments of the ventilating device and the system according to this disclosure, will now be described in more detail.
  • FIG. 1 depicts a perspective view of one embodiment of the ventilating device according to this disclosure, generally (10), which may be also referred in this disclosure as the device (10).
  • the ventilating device (10) is assembled with a laryngoscope (100) into a system, generally (200).
  • Fig. 3 depicts a side view of the system (200) of Fig. 3.
  • Figs. 4 and 5 are zoomed front and perspective views, respectively, of a distal portion of the ventilating device (10).
  • Fig. 6 depicts another embodiment of a ventilating device according to this disclosure.
  • the ventilating device (10) comprises a tubal body (12) made by a wall having a length between a proximal end (12P) and a distal end (12D).
  • the tubal body (12) has a front surface (12F) and a back surface (12B) which is the opposite to the front surface (12F) and two lateral surfaces (12L and 12R), one of which (12L) is spacing the front surface (12F) from the back surface (12B) on the left, and the other (12R) is spacing the front surface (12F) from the back surface (12B) on the right.
  • the front surface (12F) and the back surface (12B) may be substantially flat while both lateral surfaces (12L and 12R) may be somewhat convex.
  • the tubal body (12) has an oval or substantially oval cross- sectional shape in the plane perpendicular to the length of the tubal body (12).
  • a distal portion of the tubal body (12) may be rounded (arched) toward the front surface (12F) at an angle (a).
  • the arch curvature angle (a) of the tubal body (12) is configured for fitting into the oral cavity and the oropharynx, wherein the device (10) may be placed over the curvature of the tongue, reaching into the oropharynx.
  • the tubal body (12) ends with a ramp (13) which is a distal extension of the back surface wall (12B).
  • the ramp (13) has a back surface (13B) continuing from the back surface (12B) of the tubal body (12).
  • the ramp (13) has a front surface (13F) which is opposite to the back surface (13B) of the ramp (13).
  • the ramp (13) ends with a distal tip (13D) which may have a substantially round or substantially oval distal edge.
  • the ramp (13) and/or the tubal body (12) may be tapered in its distal portion such that the width of the front surface (12F) and/or the width of the front surface (13F) gradually decreases toward the distal end (12D) of the tubal body (12) and/or the distal end (13D) of the ramp (13).
  • the ramp (13) may be slopped from its proximal end (13P) toward its distal end (13D).
  • a non- inflatable cuff (14) is attached to at least a portion of the ramp (13) on the front surface (13F) of the ramp (13).
  • the length of the tubal body (12) and its curvature angle (a) are configured such that after oral placement into a subject, the cuff (14) may be placed in the upper portion of the larynx, sealing the airway while the proximal end (12P) of the device (10) remains outside the oral cavity.
  • the device (10) may be made in different sizes, including for pediatric and neonatal subjects.
  • the cuff (14) is preferably made of a soft material, e.g., silicone rubber or some other elastic rubberlike material, such that the cuff (14) can conform to the anatomy of the airway.
  • the tubal body (12) may be made of a plastic material which is sturdy enough for retaining its shape including the curvature (a) at the distal portion, but preferably also sufficiently flexible and bendable in order to fit better within the oral cavity and also to decrease the risk of damage to teeth and oral tissues.
  • the tubal body (12) may have one or more internal passages along at least a portion of its length. These passages within the tubal body (12) may be referred to in this disclosure as channels such as for example as one or more channels (16, 18 and/or 20) located within the tubal body (12). The one or more channels (passages) (16, 18 and/or 20) may traverse at least a portion of the length of the tubal body (12). [00036] In some embodiments, the channel (16) may begin with an inlet (opening) (16P) at or near the proximal end (12P) of the tubal body (12). In this disclosure, the channel (16) may be referred to as the ventilation channel (16).
  • the ventilation channel (16) may be centrally located along the proximal/distal axis (12P/12D) within the tubal body (12), or the ventilation channel (16) may be positioned laterally relative to the center line of the tubal body (12).
  • the ventilation channel (16) ends with an outlet (opening) (16D) located at or near the distal end (12D) of the tubal body (12).
  • the outlet (16D) opens the channel (16) to the face surface (13F) of the ramp (13) such that when a tool, an endotracheal tube or a camera (32) is placed into the channel (16) through the inlet (16P), the tool, endotracheal tube and/or the camera (32) may extend distally from the outlet (16D) over the face surface (13F) of the ramp (13).
  • the proximal inlet (16P) of the channel (16) may be fitted with a connector (30) for connecting the ventilating device (10) to an oxygen source (not shown) such that a subject can be ventilated through the channel (16) without the need for an endotracheal tube.
  • the connector (30) may be configured for being partially insertable into the ventilation channel (16) and being permanently attached to the wall of the ventilation channel (16). In other embodiments, the connector (30) may be configured to be insertable at least partially and removable from the ventilation channel (16).
  • the device (10) may not include the connector (30).
  • the channel (16) may be made of a diameter configured for receiving an endotracheal tube.
  • the ventilating device (10) may be used for placing an endotracheal tube into a subject.
  • the channel (16) may be used in many other applications, including for placing different tools, e.g., a camera (32), forceps, and/or a suction cater, etc., including for delivering a drug to trachea, taking a biopsy, for suctioning secretion from the oral airway and/or inspecting oral airway with the camera (32).
  • the ventilating device (10) may further comprise one or more channels (18) which may be referred in this disclosure as the camera channel (18).
  • the channel (18) may begin with an inlet (opening) (18P) at or near the proximal end (12P) of the tubal body (12).
  • the channel (18) may traverse the tubal body (12) along the proximal/distal axis (12P/12D) for at least a portion of the tubal body (12) length.
  • the channel (18) may be aligned in parallel with the channel (16) such that the channels (16) and (18) are parallel aligned for at least a portion of the length of the tubal body (12).
  • the channel (18) ends with an outlet (opening) (18D) in the distal portion of the tubal body (12) to the front surface (13F) of the ramp (13).
  • the camera channel (18) and the ventilation channel (16) may be separated from each other by a wall (19) for at least a proximal portion of the tubal body (12) length.
  • the camera channel (18) may merge with the ventilation channel (16) in the distal portion of the tubal body (12) such that the outlet (18D) of the camera channel (18) may merge with the outlet (16D) of the ventilation channel (16).
  • the channel (18) is located in one of the lateral sides (12L or 12R) relative to the central line (12P/12D) of the tubal body (12) and more preferably, the channel (18) is located to the left of the channel (16), when looking at the front surface (12F) of the tubal body (12).
  • the camera (32) is a video camera with lens and more preferably the camera (32) may be a digital video camera which more preferably has anti-fog lens.
  • the camera (32) also includes a light source.
  • the camera (32) includes a flexible wand (33) ending at its distal end with the optical instrument (43) capable of taking video images in real time. The wand (33) allows for advancing the optics closer or further away, and also for extending the camera (32) distally from the channel (16 and/or 18).
  • the wand (33) may include a plastic tubing, preferably including a cable and/or a power cord by which the camera (32) may be connected to a power source and/or to a screen, preferably a computer screen and/or a smart phone screen.
  • the camera (32) may be battery-operated at least in some embodiments.
  • the camera (32) may have the capability for being connected to a screen wirelessly.
  • the camera (32) may be disposable or re-usable.
  • the camera (32) may further have a capacity to monitor sounds and heart tones. Suitable digital cameras may include CCD (charge-coupled device) and/or CMOS (complementary metal-oxide semiconductor) sensors.
  • the camera (32) may further include a sheath configured for protecting the camera (32) from damage and/or from contact with a subject’s body.
  • the ventilating device (10) may include a sheath (22) configured in length and in diameter to be insertable into the camera channel (18) and/or into the channel (16).
  • the sheath (22) is a plastic hollow tube configured for receiving the camera (32).
  • the sheath (22) may be sealed at its distal end with a transparent material - window (24).
  • the sheath (22) may extend distally from the distal end (18D) of the camera channel (18) over the face surface (13F) of the ramp (13).
  • the camera (32) may be placed into the sheath (22).
  • the sheath (22) caring the camera (32) may be then advanced distally from the distal outlet (18D) of the camera channel (18) such that the camera (32) can take images distally from the distal end (12D) of the device (10).
  • the sheath (22) comprises the window (24)
  • the camera (32) is protected by the transparent window (24) from coming into contact with subject’s tissues.
  • the sheath (22) may be removable from the channel (18) such that the sheath (22) can be extended distally from the device (10) on demand when in use, and then be retrieved back into the channel (18) and taken out from the device (10) through the proximal inlet (18P).
  • the sheath (22) may be made of a plastic material which protects the camera (32).
  • the ventilating device (10) may comprise a stopper, lid or cap (26) configured for closing the inlet (18P) in order to prevent air leakage through the channel (18) when the channel (16) is used for ventilation.
  • the stopper, lid or cap (26) may be attached to the tubal body (12) with a loop (27).
  • the stopper (26) is attached to the tubal body (12) with a loop (27) such that the stopper (26) remains connected to the tubal body (12) even when the stopper (26) is not closing the channel (18).
  • the ventilating device (10) may further comprise a channel (20) which may be referred in this disclosure as the gastric channel (20).
  • the channel (20) may begin with an inlet (opening) (20P) at or near the proximal end (12P) of the tubal body (12).
  • the channel (20) may be periferally located along the proximal/distal axis (12P/12D) and be aligned in parallel with the channel (16) for at least a portion of the channel (20) length.
  • the channel (20) is separated from the channel (16) by a wall (21 ).
  • the channel (20) is located in one of the lateral sides (12L or
  • the channel (20) ends with an outlet (opening) (20D) on the back surface (12B) of the tubal body (12) in the distal portion of the tubal body (12).
  • the channel (20) may have a recess (slit) (23) along at least a portion of the channel (20) length.
  • the recess (23) may open the channel (20) to the back surface (12B) and/or to the lateral surface (12L or 12R).
  • a diameter of the channel (20) is configured such that a suction catheter or the camera (32) can be placed in the channel (20).
  • the ventilating device (10) may not have the channel (20), or the channel (20) may have a second distal outlet (20D) which may open on the face surface (13F) of the ramp (13).
  • the cuff (14) may be inflatable, non-inflatable or having at least one inflatable portion and at least one non-inflatable portion.
  • the cuff (14) is non-inflatable, including the embodiments shown in Figs. 1-5.
  • the non-inflatable cuff (14) may be made of a soft material, e.g., silicon rubber or some other synthetic rubber-like material, such that the cuff (14) is flexible enough to conform with the anatomy of the oropharynx during placement.
  • the cuff (14) is attached to at least a portion of a rim on the face surface (13F) of the ramp (13).
  • the cuff (14) is also attached to the face surface (12F) of the tubal body (12), forming a cushion around the distal outlets (16D and/or 18D) of the ventilation channel (16).
  • the cuff (14) has a proximal wall (14P) rising above the front surface (12F) of the tubal body (12) and attached to the front surface (12F) of the tubal body (12).
  • the cuff (14) is U-shaped or substantially U-shaped with the proximal wall (14P) of the cuff (14) forming the base of the U-chape.
  • the proximal wall (14P) extends into a left lateral wall (14L) and a right lateral wall (14R).
  • the left lateral wall (14L) is attached at least a portion of the left lateral rim of the ramp (13) and the right lateral wall (14R) is attached to at least a portion of the right lateral rim of the ramp (13).
  • the left lateral wall (14L) and the right lateral wall (14R) rise above the ramp front surface (13F).
  • the lateral walls (14L and 14R) form the two arms of the U-shape.
  • the cuff (14) may cover the distal portion of the ramp face surface (13F), forming a soft surface on the distal tip (13D) of the ramp
  • the height of cuff (14) above the tubal body face surface (12F) may gradually decrease (slop down) through the lateral walls (14L and 14R) toward the distal tip (13D) of the ramp (13), for example as is shown in the embodiment of Fig. 3, such that the cuff (14) may not have a height or may only have a minimal height in a distal portion of the ramp (13) over the ramp face surface (13F).
  • the cuff (14) may be tapered at its distal tip (14D).
  • the shape and size of the cuff (14) are configured to fit within the supraglottic portion of the larynx such that after oral placement into a subject, the cuff (14) may seal the subject’s upper airway above the glottic aperture and vocal cords in order to permit ventilation through the ventilation channel (16).
  • the cuff (14) may be positioned above the vocal cords while the tip (13D) of the ramp (13) may rest against the upper esophageal sphincter, which may help with preventing gastric aspiration.
  • the cuff (14) may have a ridge (28) rising above the proximal wall (14P) and preferably also over a portion of the lateral walls (14L and 14R).
  • the ridge (28) can be made of a soft material such as for example as silicon rubber and preferably, the ridge (28) is made of the same material as the cuff
  • the purpose of the ridge (28), when present, is to improve a seal in the upper airway and to prevent the device (10) from sliding down the airway after the device (10) has been placed.
  • the cuff (14) may have one or more channels (34) passing through a thickness of the proximal wall (14P), one embodiment of which is shown in Fig. 3, or the channel (34) may be passing through a thickness of the lateral wall (14L or 14R).
  • the channel (34) may be referred in this disclosure as the cuff channel (34).
  • the cuff channel (34) is a passage through the thickness of the cuff (14).
  • Th cuff channel (34) has a proximal end inlet (34P) and a distal end outlet (34D). In some embodiments, the distal end outlet (34D) may be sealed with a transparent window (35).
  • a diameter of the cuff channel (34) is configured for receiving the camera (32) with or without the sheath (22).
  • the cuff channel (34) may be positioned above the distal outlet (16D) of the ventilation channel (16) and/or the distal outlet (18D) of the camera channel (18) such that when the camera (32) is placed into the cuff channel (34), the camera (32) may assist in placement of the device (10) by providing images in real time of the upper airway, glottic aperture and vocal cords.
  • a ventilating device may comprise an inflatable cuff (314) in communication with means (315) for inflating the cuff (314).
  • the ventilating device (300) has essentially the same structure as the ventilating device (10).
  • the device (300) comprises a tubal body (312) having a length between a proximal end (312P) and a distal end (312D).
  • Tubal body (312) has a front surface (312F) and the opposite back surface (not shown in Fig. 6).
  • the ramp (313) extends distally from the distal end (312D) of the tubal body back surface (312B).
  • the inflatable cuff (314) is attached to the rim of the ramp (313) on the face surface (313F) of the ramp (313).
  • the cuff (314) is also attached to the distal edge of the tubal body front surface (312F). After placement is completed, the cuff (314) may be inflated with means (315), forming a seal in the upper airway.
  • the ventilating device (300) contains a ventilation channel (316) having a length between a proximal inlet (316P) and a distal end outlet (316D), the ventilation channel (316) traversing at least a portion of the tubal body length (312).
  • the distal end (316D) opens onto the face surface of the ramp (313).
  • the tubal body (312) contains one or more camera channels (318) traversing at least a portion of the tubal body (312) length.
  • the camera channel (318) has a proximal inlet (318P) and a distal outlet (318D).
  • the distal end (318D) of the camera channel (318) may extend distally from the distal outlet (316D) of the ventilation channel (316).
  • the camera distal end (318D) may be sealed with a transparent window (319). In other embodiments, the camera channel may not have the window (319).
  • the camera channel (318) may be separated from the ventilation channel (316) for at least a portion of the tubal body (312) length.
  • the camera channel (318) may then merge with the ventilation channel (316) at the distal portion of the tubal body (312).
  • the distal portion of the camera channel (318) extends distally from the distal opening (316D) of the ventilation channel (316) and above the ramp front surface (313F).
  • the distal portion (318D) of the camera channel (318) may be made of a flexible plastic material such that the camera (32) may be placed in the camera channel (318) and capture images at the distal end (318D) of the camera channel (318).
  • the camera (32) can take images behind the window such that the camera (32) does not come in contact with subject’s body.
  • the ventilating device (300) may further comprise a gastric channel (320) with structure and functions similar to those described for the gastric channel (20).
  • the gastric channel (320) traverses through the tubal body (312) for at least a portion of its length.
  • the gastric channel (32) has a length between a distal end outlet (320D) and a proximal end inlet (320P).
  • the distal end outlet (320D) opens onto the back surface (312B) of the tubal body (312) or into one of the lateral surfaces above the cuff (314).
  • the ventilating device (10 or 300) may be placed with assistance of a laryngoscope, one embodiment of which, generally (100) is shown in Figs. 2 and 3.
  • this disclosure relates to a laryngoscope configured to be assembled with the ventilating device (10 or 300).
  • the laryngoscope (100) has a handle (102) attached to a blade (104).
  • the handle (102) may be a substantially tubal structure having a length between a proximal end (102P) and a distal end (102D), but any other shapes typically used in handles can be also suitable.
  • the length and shape of the handle (102) are configured for a comfortable grip by a hand, which is necessary for manipulations during placement.
  • the handle (102) may be a substantially tubal body which may be hollow.
  • the handle (102) has a front surface (102F), the opposite back surface (102B) and two lateral surfaces, a left lateral surface (102L) and a right lateral surface (102R).
  • the left lateral surface (102L) separates the handle front surface (102F) from the handle back surface (102B) on the left.
  • the right lateral surface (102R) separates the handle front surface (102F) from the handle back surface
  • the handle (102) contains one or more channels (passages) (106) traversing through at least a portion of the length of the handle (102).
  • the channel (106) may have an inlet (opening) (106P) located at or near the proximal end (102P) of the handle (102).
  • the channel (106) ends with an outlet (opening) (106D) which may be located at or near the distal end (102D) of the handle (102).
  • a diameter for the channel (106) is configured such that the camera (32) with or without the sheath (22) can be placed in the channel (106) through the inlet (106P) and then be extended from the outlet (106D) of the handle (102).
  • the handle (102) may be a hollow body that has an inlet (opening) at the proximal end (102P) and an outlet (opening) at the distal end (102D) such that the camera (32) can be placed in the handle (102) and then be extended from the distal end (102D) of the handle (102) without being placed in the channel (106) and therefore, some of the embodiments do not include the channel (106).
  • the handle (102) may contain one or more additional channels (106) suitable for holding in place various instruments, including a suction catheter and the camera (32).
  • the handle (102) is attached to a blade (104).
  • the handle (102) may be attached to the blade (104) detachably.
  • the handle (102) and its blade (104) may be formed, for example by molding, into a one-piece laryngoscope during manufacturing.
  • the blade (104) has a proximal end (104P) with which it is attached to at least at the handle distal end (102D) on the handle front surface (102F).
  • the blade (104) has a distal end (104D) and a length between the proximal end (104P) and the distal end (104D).
  • the blade (104) has a front surface (104F) and the opposite back surface (104B). In some preferred embodiments, the blade (104) is flat or substantially flat.
  • the blade (104) is a distal extension of the handle front surface (102F) such that the distal outlet (106D) of at least one channel (106) and/or the distal outlet (102D) of the handle (102) may open to the back surface (104B) of the blade (104) when the handle (102) is hollow or substantially hollow.
  • the blade (104) may have one or more channels and/or grooves traversing at least some of the blade back surface (104B) length and/or at least some of the blade front surface (104F) length.
  • the channel (106) may extend from the distal end (102D) of the handle (102) along the blade back surface (104B) for a least a portion of the blade (104) length.
  • the blade (104) is curved in its distal portion at an angle ([3) toward the blade front surface (104F).
  • the curvature of the angle ([3) is configured to fit with the contour of a human larynx such that the blade (104) can be used for lifting the epiglottis.
  • a healthcare professional may grasp the handle (102) and insert the blade (104) into the oropharynx in order to gain access to the subject’s airway.
  • angles ([3) and the length of the blade (104) are configured such that the ventilating device (10 or 300) which has the curvature of angle (a) may be assembled with the laryngoscope (100) into an assembly, including as shown in embodiments of Figs. 2 and 3.
  • angles (a) and ([3) are the same or substantially the same.
  • substantially the same means plus/minus 5% of the value, e.g., substantially the same as 90-degree angle means 90 ⁇ 4.5 degree angels.
  • this disclosure relates to a system for supraglottic placement, generally (200).
  • the system (200) comprises the laryngoscope (100), one or more the ventilating devices (10 and/or 300) and optionally one or more cameras (32) and further optionally one or more sheaths (22).
  • the system (200) may be assembled into an assembly, one embodiment of which is shown in Figs. 2 and 3, wherein the tubal body face surface (12F) of the ventilating device (10 or 300) is positioned over the back surface (104B) of the blade (104) with the distal end (13D or ) of the ventilating device (10) extending distally.
  • the tubal body face surface (12F) of the ventilating device (10 or 300) is positioned over the back surface (104B) of the blade (104) with the distal end (13D or ) of the ventilating device (10) extending distally.
  • some distal portion of the tubal body (12), more preferably at least the distal portion (13D) of the ramp (13) and at least a portion of the cuff (14) extend distally from the distal end (104D) of the blade (104) as can be seen for example, in Fig. 3.
  • the system (200) may further include at least one camera (32) insertable and removable into the handle (102), preferably the camera (32) is insertable and removable into the channel (106).
  • the camera (32) may be extended from the distal outlet (106D) by manipulating the camera wand (33).
  • the camera (32) can be then positioned through the cannel (34) of the ventilating device (10) such that the camera (32) can collect images and provide visualization of the upper airway, glottic aperture and vocal cords.
  • Using one camera (32) positioned in the channel (34) and then preferably also using a second camera (32) positioned in the channel (18) and/or (16) allows a healthcare professional to observe the vocal cords and the glottis while attempting to gain access to the subject’s airway, improving accuracy of placement, reducing a placement time and preventing the risk of tissue trauma.
  • the healthcare professional has a technical advantage of using a laryngoscope in combination with a supraglottic device. This provides the opportunity for less invasive supraglottic intubation even for a difficult to intubate airway, where obtaining access to the airway without a laryngoscope may be problematic.
  • the camera (32) can be removed from the channels (34 and 106 or 106 and 318), while the system (200) remains assembled and positioned in place. This provides additional flexibility in using one camera in several different applications and/or locations.
  • the laryngoscope (100) may be removed without disturbing the device (10).
  • this disclosure provides methods for supraglottic placement, the methods may include the following steps: a) inserting the camera (32) into the laryngoscope handle (102), preferably into the channel (106) and extending the camera (32) over the back surface (104B) of the blade (104); b) inserting the blade (104) into the oral cavity and manipulating the handle (102) of the laryngoscope (100) in order to gain access to the upper airway; c) placing the front surface (12F or 312F) of the tubal body (12 or 312) over the back surface (104B) of the blade (104) and positioning the camera (32) in the cuff camera channel (34) if present; d) placing the ventilating device (10 or 300) above the vocal cords and verifying the placement with the camera (32); e) removing the camera (32) from the laryngoscope (100); f) removing the laryngoscope (100) from the oral cavity; and g) optionally connecting the connector (30) to a ventilator.
  • the method may further comprise inserting a second camera (32) into the channel (18) at any of steps a) through g). In some further embodiments, the methods may further comprise inserting the camera (32) into the sheath (22) before placing it into the channel (106) and/or the channel (18 or 318).
  • Present devices, systems and methods provide a technical advantage of supraglottic intubation for patients who otherwise may not receive this procedure in part because their airway is difficult to access without a laryngoscope and conventional laryngeal masks are commonly cannot be used with a laryngoscope. This improves the efficiency of intubation, shortens the time needed for intubation and minimizes the risk of trauma.
  • the ventilating device (10 or 300) may be used specifically with the laryngoscope (100), it will be appreciated that the ventilating device (10) may be also used without the laryngoscope (100).
  • a subject can be monitored continuously with the camera (32) positioned in the ventilating device (10 or 300) for adverse reactions, including for obstruction and/or gastric aspiration.

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Abstract

L'invention concerne un dispositif de ventilation conçu pour être assemblé avec un laryngoscope et comprenant un corps tubaire ayant une longueur entre une extrémité proximale et une extrémité distale, le corps tubaire ayant une surface frontale, une surface arrière et deux surfaces latérales ; la surface arrière du corps tubaire s'étendant de manière distale à partir de l'extrémité distale du corps tubaire avec une rampe qui a une surface frontale, et un ballonnet étant fixé à au moins une partie de la surface frontale de rampe et à la surface frontale de corps tubaire ; le corps tubaire contenant un canal de ventilation ayant une entrée proximale au niveau ou à proximité de l'extrémité proximale du corps tubaire et traversant le corps tubaire sur au moins une partie de la longueur de corps tubaire et le canal de ventilation se terminant par une sortie distale qui débouche sur la surface frontale de rampe.
PCT/US2024/041414 2023-08-09 2024-08-08 Systèmes d'intubation supraglottique et procédés de placement Pending WO2025034941A2 (fr)

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US202363531629P 2023-08-09 2023-08-09
US63/531,629 2023-08-09

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