Shielded intubation guide and method

Abstract

1. A shielded intubation guide for an endotracheal intubation procedure, the shielded intubation guide comprising: an elongated body defining a passageway extending between a proximal opening and a distal opening, the passageway being configured to receive a blade portion of an intubation device, the shielded intubation guide being configured to be inserted into a subject's mouth with the proximal opening positioned near the subject's mouth and the distal opening positioned in the subject's airway; and a shield surrounding the proximal opening and configured to substantially reduce emissions from the mouth, the shielded intubation guide enabling endotracheal intubation to be performed by inserting the blade portion of the intubation device into the passageway of the shielded intubation guide, positioning a distal end of the blade portion of the intubation device adjacent to the subject's larynx, and advancing an endotracheal tube through the passageway and along the blade portion into the subject's trachea.

Description

[Technical field]

[0001] The present invention relates to a shielded intubation guide and method for endotracheal intubation procedures, particularly those adapted to enable endotracheal intubation of a subject while substantially reducing emissions from the subject's mouth during the procedure. [Background technology]

[0002] Endotracheal intubation is a procedure in which a medical professional introduces a flexible plastic conduit, an endotracheal tube, into the windpipe, typically through the mouth, to allow artificial ventilation, which is needed in emergencies when the ability to breathe is impaired by illness or injury, or hindered by drug-induced debilitation during surgery. It is a universal procedure and is performed in the same way around the world.

[0003] Every day, thousands of intubations are performed by a variety of professionals, especially anesthesiologists, intensivists, emergency physicians, pre-hospital care workers and paramedics. However, endotracheal intubation is a high-risk procedure that requires considerable skill and, in some cases, is impossible to achieve, as it can lead to death or disability. Even for highly trained professionals, it is often difficult and sometimes unsuccessful. New specialized equipment and advanced techniques are constantly being developed with the aim of facilitating this difficult procedure and ensuring better success rates.

[0004] The operator's objective is to place the endotracheal tube into the trachea through the mouth, pharynx, and larynx. The oropharyngeal passage is curved and narrow, terminating in both the laryngeal and esophageal inlets. When the patient is in the supine position, the tongue tends to return to the pharynx, the laryngeal inlet may change in position due to the patient's particular anatomy, and the epiglottis lies above the laryngeal inlet and usually needs to be displaced to expose the glottic opening.

[0005] The operator must identify the vocal cords at the laryngeal inlet, the epiglottis above the laryngeal inlet in a lateral view with the patient supine, and the esophagus beneath all distal structures in this view. This procedure requires exceptional skill. The endotracheal tube tends to track its way down to the esophagus, and a good view of the larynx is often difficult to obtain, and even with good views, introduction of the endotracheal tube can be difficult. Any delay in successfully completing the procedure can result in serious complications, which may be fatal.

[0006] Inserting an endotracheal tube through all these anatomical structures and into the trachea is called endotracheal intubation and typically requires the use of an instrument called a laryngoscope, which has a handle and a blade. Different shaped blades may be used depending on various factors, such as the age and size of the patient and various procedure options. Laryngoscope blades are generally classified as curved or straight, although many styles of curved and straight blades are commercially available. Some styles of blades are designed to be placed anterior to the epiglottis, while others are designed to be placed posterior to the epiglottis, resulting in slightly different movements during the procedure. A light source can be provided at the tip of the blade to illuminate the area beyond it. The light source may be powered by a battery in the handle.

[0007] During endotracheal intubation, with the patient generally in a supine position, the operator stands over the patient's head and introduces the laryngoscope blade through the mouth into the pharynx, exposing the laryngeal inlet and addressing anatomical structures such as the tongue and epiglottis (depending on the specific patient and blade type). Then, under direct visualization, the operator inserts the tip of the endotracheal tube into the larynx and advances it into the trachea. In a traditional universal procedure, the operator typically uses his left hand to hold the laryngoscope by the handle to position the blade and his right hand to carefully introduce the endotracheal tube, pushing it along the laryngoscope blade into the visualized trachea.

[0008] In many cases, direct visualization is difficult due to anatomical variations and challenges, and despite proper technique. In most of these cases, adequate visualization can be obtained by manipulating some of the anatomical structures. Unfortunately, with a conventional laryngoscope and conventional procedures, the operator utilizes two hands, and the hands used to manually introduce the endotracheal tube cannot be used to manipulate the anatomical structures to facilitate the procedure. Furthermore, the second operator does not have direct visual access to the laryngeal inlet to manipulate these structures, and also interferes with the view of the first operator. The opening through which the first operator gains visibility is very limited, and the operator performing the intubation procedure is usually in an optimal viewing position. Video laryngoscopes are available to eliminate the need for direct visualization, but these are typically bulkier than conventional laryngoscopes and still occupy both hands of the operator.

[0009] Due to the degree of difficulty of the procedure itself and the seriousness of the potential complications, the procedure is only performed by highly skilled specialists. This difficulty and risk of serious complications has also meant that the procedure and the instruments used to perform it have remained essentially unchanged for decades. Physicians and other specialists who perform endotracheal intubation have been unwilling to use new devices or change their previous methods, given the difficulties and risks. Thus, new intubation devices must not only offer clear procedural advantages compared to conventional laryngoscopes, but also have similar characteristics in shape, weight, and the method of their use, to facilitate adoption by operators who are already trained and comfortable using conventional laryngoscopes in the often stressful situation of performing intubation procedures.

[0010] WO / 2016 / 090435A1 discloses a new intubation device that allows one-handed endotracheal intubation procedures. In particular, the intubation device includes a laryngoscope blade having a tip and a base, a handle attached to the base of the blade so that the intubation device can be held in a user's hand, a channel for receiving an endotracheal tube, a blade channel portion extending along the blade substantially from the tip to the base, including an outlet proximate the tip for advancing a distal end of the endotracheal tube through the outlet, a handle channel portion extending partially along the handle from the blade channel portion, and a tube movement mechanism in the handle for moving the endotracheal tube through the channel to advance the endotracheal tube, the tube movement mechanism including a thumb interface for allowing a user to operate the tube movement mechanism using the thumb of the holding hand. This allows a user to hold the intubation device and advance the endotracheal tube in an endotracheal intubation procedure with one hand. The entire contents of WO / 2016 / 090435A1 are incorporated herein by reference.

[0011] By positioning the blade via the handle and allowing for one-handed operation of the intubation device to advance the endotracheal tube, if necessary during the endotracheal intubation procedure, the user's other hand remains free for other uses, such as clearing the airway using another device, such as a suction device, or other devices, such as forceps to manipulate the anatomy and / or the endotracheal tube.

[0012] During endotracheal intubation procedures, emissions from the subject's mouth can be problematic. For example, liquids, droplets, or aerosols expelled from the subject's mouth during the procedure can expose the user of the intubation device or other nearby medical staff to infectious diseases. In particular, during the COVID-19 pandemic, the risk of viral transmission via liquids, droplets, and / or aerosols expelled from the mouth is of increasing concern. The risk of exposure to the user is particularly high due to the close proximity of the user to the subject's mouth and the increased likelihood that the subject will cough or gag during the procedure.

[0013] It would therefore be desirable to provide an apparatus and method that would allow for endotracheal intubation of a subject, ideally using intubation equipment similar to that already routinely used by physicians, while substantially reducing emissions from the subject's mouth during the procedure.

[0014] To aid in visualization, laryngoscopes and other forms of intubation devices may include a light source near the tip of the blade to provide illumination during the procedure to improve visibility of anatomical features near the larynx. Such a light source may be useful for direct visualization using a traditional laryngoscope, or for non-direct visualization using a video laryngoscope or the like. When an endotracheal intubation procedure is performed using a light source, it is sometimes referred to as light-guided endotracheal intubation.

[0015] Light-guided endotracheal intubation is useful in most scenarios, but can be essential when intubation must be performed in the dark or in poor lighting conditions. However, the use of light-guided endotracheal intubation can be problematic in situations where light leakage from the subject's mouth is undesirable. For example, when a military doctor or medic performs a light-guided endotracheal intubation in dark conditions during combat, light leakage from the subject's mouth can present an unprotected light source that can reveal their location to the enemy and make them a target.

[0016] In situations where light leakage from the subject's mouth is an issue, it may be desirable to provide devices and methods that allow for light-guided endotracheal intubation of a subject while substantially preventing light from escaping from the subject's mouth during the procedure, ideally using intubation equipment similar to that already routinely used by physicians.

[0017] Reference herein to any prior publication (or information derived therefrom) or known matter is not, and should not be considered, an acknowledgement, admission, or any form of suggestion that the prior publication (or information derived therefrom) or known matter forms part of the common general knowledge in the field of endeavor to which this specification pertains. Summary of the Invention

[0018] In one broad form, one aspect of the present invention is directed to providing a shielded intubation guide for an endotracheal intubation procedure, the shielded intubation guide comprising: an elongate body defining a passageway extending between a proximal opening and a distal opening, the passageway configured to receive a blade portion of an intubation device, the shielded intubation guide configured to be inserted into the mouth of a subject such that the proximal opening is positioned proximate the mouth of a subject and the distal opening is positioned in the airway of the subject; and a shield configured to substantially reduce emissions from the mouth of a subject, the shielded intubation guide configured to enable endotracheal intubation of a subject using the intubation device and the shielded intubation guide by inserting the blade portion of the intubation device into the passageway of the shielded intubation guide, positioning a distal end of the blade portion of the intubation device proximate the larynx of the subject, and advancing an endotracheal tube through the passageway and along the blade portion of the intubation device into the trachea of ​​the subject.

[0019] In one embodiment, the shield is configured to substantially reduce emissions from the subject's mouth of one or more of liquids, droplets, aerosols, and light emitted from a light source proximate the distal end of the blade portion of the intubation device during a light-guided endotracheal intubation procedure.

[0020] In one embodiment, the shield is configured to substantially cover the mouth of a subject when in use.

[0021] In one embodiment, the shield includes a flange extending outwardly from the body, the flange configured to substantially cover the mouth of a subject in use.

[0022] In one embodiment, the flange surrounds the proximal opening.

[0023] In one embodiment, the flange includes opposed lateral flange portions that curve toward the distal opening.

[0024] In one embodiment, the flange includes an upper edge having a recess for conforming to the subject's nose during use.

[0025] In one embodiment, the flange is configured to abut against the subject's mouth to prevent over-insertion of the shielded intubation guide and ensure that the proximal opening remains outside the mouth.

[0026] In one embodiment, the proximal opening is at least one of: proximally offset from the flange and oriented at an angle relative to the flange.

[0027] In one embodiment, the shield is configured to break along the passageway and along a section of the shield.

[0028] In one embodiment, the body of the shielded intubation guide includes a break line extending longitudinally along a side of the passage and along a section of the shield, whereby the shielded intubation guide is broken by the break line.

[0029] In one embodiment, the break line is defined along a center plane of the shielded intubation guide.

[0030] In one embodiment, the shield includes cut marks configured to be cut along the passage and along the section of the shield according to the cut marks.

[0031] In one embodiment, the shape of the proximal opening is selected based on the cross-sectional shape of the blade portion of the intubation device.

[0032] In one embodiment, the size of the proximal opening is selected based on the cross-sectional size of the blade portion of the intubation device.

[0033] In one embodiment, the shape of the passageway is selected based on the cross-sectional shape of the blade portion of the intubation device.

[0034] In one embodiment, the size of the passageway is selected based on the cross-sectional size of the blade portion of the intubation device.

[0035] In one embodiment, it is made from a flexible material.

[0036] In one embodiment, the blade is configured to expand when receiving the blade.

[0037] In one embodiment, at least one wall of said body includes an expandable region.

[0038] In one embodiment, the expandable region extends longitudinally from the distal opening at least partially along the passageway to allow the body to expand circumferentially and / or extends circumferentially around the body to allow the body to expand longitudinally.

[0039] In one embodiment, the body is curved.

[0040] In one embodiment, the curvature of the body is selected based on the curvature of the blade portion of the intubation device.

[0041] In one embodiment, the device includes a seal covering the proximal opening, the seal normally in a closed position to seal the proximal opening and movable to an open position when a blade portion of the intubation device is inserted through the passageway.

[0042] In one embodiment, the seal is biased toward the closed position such that when the blade of the intubation device is removed through the passageway, the seal returns toward the closed position.

[0043] In one embodiment, the seal is configured such that, in use, it forms a partial seal surrounding at least one of the blades of the intubation device and the endotracheal tube.

[0044] In one embodiment, the intubation device includes a removable cap for closing the proximal opening when the blade is not inserted into the passageway.

[0045] In one embodiment, the cap includes a seal for covering the proximal opening, the seal normally in a closed position to seal the proximal opening, and the seal is movable to an open position when the blade portion of the intubation device is inserted through the passage.

[0046] In one embodiment, the shielded intubation guide is configured to at least one of hold the subject's tongue and depress the tongue during use.

[0047] In one embodiment, the device is configured to allow ventilation of the subject using a ventilation mask and ventilator before endotracheal intubation is performed.

[0048] In one embodiment, the shielded intubation device is configured for a light-guided endotracheal intubation procedure in which light is emitted from a light source proximate the distal end of the blade portion of the intubation device after the blade portion of the intubation device is inserted into the passage of the shielded intubation guide, and the shield is configured to substantially prevent light emitted from the light source from escaping the mouth of a subject.

[0049] In one embodiment, at least one of the optical shield is made of an opaque material and the entire shielded intubation guide is made of an opaque material.

[0050] In one embodiment, it is made from a transparent material.

[0051] In one embodiment, the shield includes a rim configured to engage a subject's face to form a seal around the subject's mouth.

[0052] In one embodiment, the body has a length selected such that the distal opening is positioned proximate to one of the subject's oral cavity, proximate to the subject's pharynx, and between the subject's tongue and palate.

[0053] In one embodiment, the shielded intubation guide includes at least one additional opening extending through the shield to facilitate access to the subject's oral cavity.

[0054] In one embodiment, the shield includes at least one suction port extending through the shield.

[0055] In one embodiment, the shield includes at least one drainage conduit extending through the shield.

[0056] In another broad form, one aspect of the invention is a method for an endotracheal intubation procedure comprising inserting a shielded intubation device into a mouth of a subject, the method comprising inserting the shielded intubation guide into a mouth of a subject, the shielded intubation guide including an elongate body defining a passageway extending between a proximal opening and a distal opening, the passageway configured to receive a blade portion of an intubation device, such that the proximal opening is positioned near the mouth of the subject and the distal opening is positioned in an airway of the subject, and a shield around the proximal opening that substantially reduces emissions from the mouth of the subject. the shielded intubation guide, performing endotracheal intubation of a subject using the intubation device and the shielded intubation guide by inserting the intubation device into the subject's mouth, inserting the blade portion of the intubation device into the passage of the shielded intubation guide, positioning a distal end of the blade portion of the intubation device adjacent to the larynx of the subject, and advancing an endotracheal tube through the passage and along the blade portion of the intubation device into the trachea of ​​the subject, wherein the shield substantially reduces emissions from the mouth of the subject during the endotracheal intubation procedure.

[0057] In one embodiment, the shield substantially reduces emissions from the subject's mouth of one or more of liquids, droplets, aerosols, and light emitted from a light source proximate the distal end of the blade portion of the intubation device during a light-guided endotracheal intubation procedure.

[0058] In one embodiment, after the blade portion of the intubation device is inserted into the passage of the intubation guide, light is emitted from a light source proximate the distal end of the blade portion of the intubation device, and the intubation device and the shielded intubation guide are used to perform light-guided endotracheal intubation of a subject, and the shield substantially prevents light emitted from the light source from escaping from the subject's mouth during the light-guided endotracheal intubation.

[0059] In one embodiment, said endotracheal intubation is performed as blind intubation.

[0060] In one embodiment, the intubation device includes a video camera positioned adjacent to the tip of the blade, and allows a user to present images captured by the video camera on a display, and the user performs the endotracheal intubation of the subject by referring to the images displayed on the display.

[0061] In one embodiment, the display is integrated with the intubation device.

[0062] In one embodiment, the display is provided in the form of goggles worn by the user.

[0063] In one embodiment, the display is surrounded by a display shield configured to allow the user to view the display and substantially prevent light emitted from the display from leaking beyond the display shield and the subject's face.

[0064] In one embodiment, when the shielded intubation guide is inserted into the mouth of a subject, the shield substantially covers the mouth of a subject.

[0065] In one embodiment, the shield includes a flange extending outwardly from the body, the flange substantially covering the mouth of a subject when the shielded intubation guide is inserted into the mouth of a subject.

[0066] In one embodiment, the method includes advancing the endotracheal tube into the subject's trachea, withdrawing the blade portion of the intubation device from the shielded intubation guide while leaving the endotracheal tube in place within the subject's trachea, and removing the shielded intubation guide from the subject's mouth.

[0067] In one embodiment, the shielded intubation guide is configured to break along the passageway and along a section of the shield, including breaking the shielded intubation guide to allow the shielded intubation guide to be removed while the endotracheal tube remains in place.

[0068] In one embodiment, this includes cutting the shielded intubation guide along the passageway and along a section of the shield to allow the shielded intubation guide to be removed while the endotracheal tube remains in place.

[0069] One embodiment includes ventilating the subject using a ventilation mask and ventilator before endotracheal intubation is performed.

[0070] In one embodiment, the shielded guide includes a seal covering the proximal opening, the seal normally in the closed position to seal the proximal opening and movable to an open position when a blade portion of the intubation device is inserted through the passage, the method including inserting the blade portion of the intubation device through the seal and into the passage of the shielded intubation device, the seal substantially reducing emissions from the mouth at least prior to insertion of the blade.

[0071] In one embodiment, the seal is biased toward the closed position such that when the blade portion of the intubation device is removed through the passageway, the seal returns toward the closed position, and the seal forms a partial seal surrounding at least one of the blade portion of the intubation device and the endotracheal tube after the blade portion is inserted.

[0072] In one embodiment, the shielded intubation guide includes a removable cap for closing the proximal opening, and the method includes inserting the shielded intubation guide into the subject's mouth with the cap sealing the proximal opening to substantially reduce emissions from the subject's mouth through the proximal opening while the cap is in place, and removing the cap prior to inserting the blade portion of the intubation device into the passage of the shielded intubation guide.

[0073] In one embodiment, the shielded intubation guide includes at least one suction port extending through the shield and includes aspiration of fluids from the subject's oral cavity via the suction port.

[0074] In one embodiment, the shielded intubation guide includes at least one drainage conduit extending through the shield and allowing fluid to drain from the subject's oral cavity via the drainage conduit.

[0075] In another broad form, one aspect of the invention is an intubation guide with a light shield for an endotracheal intubation procedure, the intubation guide with a light shield for an endotracheal intubation procedure comprising an elongate body defining a passageway extending between a proximal opening and a distal opening, the passageway being configured to receive a blade portion of an intubation device, and a light shield proximate the proximal opening, the proximal opening being positioned proximate the mouth of a subject and the distal opening being positioned in an airway of the subject, the method comprising inserting the blade portion of the intubation device into the passageway of the intubation guide with a light shield; emitting light from a light source proximate the distal end of the blade portion of the intubation device; and transmitting the light shield to the subject. and a blade portion of the intubation device configured to substantially prevent light emitted from the light source from escaping from the mouth of the subject. The objective of the present invention is to provide an intubation guide with a light shield configured for insertion into the mouth of a subject such that light-guided endotracheal intubation of a subject can be performed using the intubation device and the light shielded intubation guide by positioning a distal end of the blade portion of the intubation device proximate to the larynx of the subject and advancing an endotracheal tube along the blade portion of the intubation device through the passageway and into the trachea of ​​the subject.

[0076] In another broad form, one aspect of the invention is a method for an endotracheal intubation procedure comprising: inserting into a mouth of a subject an optically shielded intubation guide including an elongate body defining a passageway extending between a proximal opening and a distal opening, the passageway being configured to receive a blade portion of an intubation device, the proximal opening being positioned near the mouth of the subject and the distal opening being positioned in an airway of the subject; and an optical shield adjacent the proximal opening that substantially prevents light from escaping the mouth of the subject; and inserting the blade portion of the intubation device into the passageway of the shielded intubation guide. and a light shield configured to substantially prevent light emitted from the light source from escaping the mouth of the subject, the light shield being ...

[0077] It will be understood that the broad aspects of the invention and each of their features can be used in combination, interchangeably, and / or independently, and reference to separate broad aspects is not intended to be limiting. [Brief description of the drawings]

[0078] Various examples and embodiments of the present invention will now be described with reference to the accompanying drawings.

[0079] 1A through 1H are cross-sectional views illustrating steps of an endotracheal intubation procedure performed on a subject using a first example of a shielded intubation guide.

[0080] 2A and 2B are perspective views of a first example of the shielded intubation guide of FIGS. 1A through 1H.

[0081] FIG. 2C is a side view of the shielded intubation guide of FIGS. 2A and 2B.

[0082] FIG. 2D is a cross-sectional view of the shielded intubation guide of FIGS. 2A to 2C.

[0083] FIG. 3A is a perspective view of the shielded intubation guide of FIGS. 2A to 2D, with the blade portion of an intubation device inserted into the passage of the shielded intubation guide.

[0084] 3B is a cross-sectional view of the shielded intubation guide and inserted blade portion of the intubation device of FIG. 3A.

[0085] 4A and 4B are cross-sectional views illustrating the step of removing the second example shielded intubation guide after an endotracheal intubation procedure has been performed.

[0086] FIG. 5A is a bottom view of the second example shielded intubation guide of FIGS. 4A and 4B with an endotracheal tube advanced through the passageway of the shielded intubation guide.

[0087] FIG. 5B is a bottom view of the shielded intubation guide and endotracheal tube of FIG. 5A with the shielded intubation guide broken away for removal of the endotracheal tube.

[0088] FIG. 6 is a perspective view of a third example of a shielded intubation guide having a membrane seal to seal the proximal opening.

[0089] FIG. 7A is a perspective view of a fourth example of a shielded intubation guide having a removable cap, with the cap in an open position.

[0090] 7B and 7C are perspective views of the shielded intubation guide of FIG. 7A with the cap in a closed position.

[0091] FIG. 7D is a top view of the shielded intubation guide of FIG. 7A with the cap in the closed position.

[0092] FIG. 7E is a side view of the shielded intubation guide of FIG. 7A with the cap in a closed position.

[0093] FIG. 7F is a cross-sectional view of the shielded intubation guide of FIG. 7A with the cap in a closed position.

[0094] FIG. 7G is a cross-sectional view of the shielded intubation guide of FIG. 7A with the cap in the open position.

[0095] 8 and 9 are perspective views of a fifth and sixth example, respectively, of a shielded intubation guide illustrating alternative configurations of an expandable region extending from the distal opening.

[0096] FIG. 10 is a perspective view of a seventh example of a shielded intubation guide and separate removable cap seal portion.

[0097] 11A to 11C are perspective views of an eighth example of a shielded intubation guide.

[0098] FIG. 12 is a perspective view of a ninth example of a shielded intubation guide, showing an example of a short main body configuration.

[0099] FIG. 13 is a perspective view of a tenth example of a shielded intubation guide, showing an example of a body that is extendable in the longitudinal direction.

[0100] 14A and 14B are cross-sectional views showing the steps of manually advancing an endotracheal tube using a conventional laryngoscope equipped with a first example of a shielded intubation guide. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0101] Next, an example of a shielded intubation guide for use in performing an endotracheal intubation procedure on a subject 100 will be described with reference to Figures 1A to 1H, and the use of a shielded intubation guide 110 in different steps of the procedure will be described with reference to Figures 2A to 2D, which show the shielded intubation guide 110 in more detail.

[0102] The shielded intubation guide 110 is particularly adapted to allow endotracheal intubation to be performed using a bladed intubation device 140 (as shown in Figures 1C to 1F), such as a laryngoscope. For purposes of the following examples, the intubation device 140 is assumed to be a one-handed intubation device as described in WO / 2016 / 090435A1, although it will be understood that other forms of intubation devices may be applied to the shielded intubation guide 110. For example, embodiments of the shielded intubation guide 110 may be configured for use with a commercially available video laryngoscope or a conventional direct vision laryngoscope.

[0103] Broadly, with reference to Figure 1A, shielded intubation guide 110 includes an elongated body 111 defining a passageway 112 extending between a proximal opening 113 and a distal opening 114. Passageway 112 of shielded intubation guide 110 is configured to receive a blade portion 142 of an intubation device 140, as shown in Figures 1D-1F, and more particularly in Figures 3A and 3B. Shielded intubation guide 110 also includes a shield 120 disposed near proximal opening 114.

[0104] The shielded intubation guide 110 is specifically configured for insertion into the mouth 102 of the subject 100, as shown in FIG. 1B, such that the proximal opening 113 is positioned adjacent to the mouth 102 of the subject 100 and the distal opening 114 is positioned in the subject's airway.

[0105] Different embodiments of the shielded intubation guide 110 may be configured to position the distal opening 114 in different anatomical regions of the subject. For example, the body 111 of the shielded intubation guide 110 may have a length selected such that the distal opening 114 is positioned proximate the oral cavity of the subject or proximate the pharynx of the subject. In some examples, the distal opening 114 may be positioned between the tongue and the roof of the palate of the subject, while in other examples, the distal opening 114 may be positioned behind the tongue in the oropharynx of the subject.

[0106] A shield 120, disposed about the proximal opening 113, is positioned proximate the mouth 102 of the subject 100. The shield 120 is configured to substantially reduce emissions from the mouth 102 of the subject 100. Further details of the shield 120 can be seen in Figures 2A-2D and are described below. Typically, the shield 120 is configured to substantially cover the mouth of the subject in use and includes a flange extending outwardly from the body 111, the flange substantially covering the mouth 102 of the subject 100 in use.

[0107] With the shielded intubation guide 110 inserted into the mouth 102 of the subject 100, the intubation device 140 and the shielded intubation guide 110 can be used to perform endotracheal intubation of the subject 100. A detailed example of how the shielded intubation guide 110 can be used in an endotracheal intubation procedure is described below with further reference to Figures 1A through 1H. However, in the context of describing the configuration of the shielded intubation guide 110, an endotracheal intubation procedure is performed using the shielded intubation guide 110 by inserting the blade portion 142 of the intubation device 140 into the passage 112 of the shielded intubation guide 110 (as shown in FIG. 1D), positioning the distal end 143 of the blade portion 142 of the intubation device 140 adjacent to the larynx 104 of the subject 100 (as also shown in FIG. 1D), and advancing the endotracheal tube 150 along the blade portion 142 of the intubation device 140 through the passage 112 and into the trachea 105 of the subject (as shown in FIG. 1F).

[0108] In any event, it will be appreciated that the shielded intubation guide 110 can be used to substantially reduce emissions from the subject's mouth during use, both before and during the procedure. For example, the shield 120 may be configured to substantially reduce fluid, droplet, and / or aerosol emissions from the subject's mouth 102 and thus may be used to limit exposure of the user of the intubation device 140 or other medical staff to infectious diseases that may be transmitted from the subject via these emissions from the subject's mouth. Alternatively or additionally, the shield 120 may be configured to substantially reduce emissions from the subject's mouth 102 of light emitted from a light source proximate the distal end of the blade portion of the intubation device during a light-guided endotracheal intubation procedure where light leakage from the subject's mouth may be undesirable.

[0109] An example of a method for an endotracheal intubation procedure using the shielded intubation guide 110 as described above will be described in further detail with reference to Figures 1A through 1H.

[0110] 1A, the method begins with a subject 100 in a supine position in a manner similar to a conventional endotracheal intubation procedure. The subject's head 101 can be tilted to adjust the relative positions of the subject's mouth 102, pharynx 103, and larynx 104 to allow easier access to the larynx during the procedure.

[0111] In FIG. 1A, a shielded intubation guide 110 is provided for insertion into the mouth 102 of a subject 100.

[0112] Next, the shielded intubation guide 110 is inserted into the mouth 102 of the subject 100 as shown in FIG. 1B. When the shielded intubation guide 110 is properly inserted, the proximal opening 113 is positioned proximate to the mouth 102 of the subject 100 and the distal opening 114 is positioned in the airway of the subject 100. In this example, the distal opening 114 is positioned proximate to the pharynx 103, but as described above, the location of the distal opening 114 is determined by the length of the body 111, and in other examples, the distal opening 114 may be positioned within the oral cavity, for example, between the tongue 106 and the palate of the subject 100. Additionally, the shield 120 positioned around the proximal opening 114 is positioned proximate to the mouth 102 of the subject 100 to substantially reduce emissions from the subject's mouth.

[0113] Typically, both the proximal opening 113 and the shield 120 are positioned outside the mouth 102 of the subject 100 such that the shield 120 substantially covers the mouth 102, although it will be appreciated that this is not required and alternative designs may include one or both of the shield 120 and the proximal opening 113 located at least partially inside the mouth 102. However, in this embodiment, the shield 120 includes a flange that surrounds the body 111 and covers the outside of the mouth 102, and the body 111 includes a protrusion 116 that protrudes proximally from the shield 120 such that the proximal opening 113 is located outside the mouth 102.

[0114] 1C, once the shielded intubation guide 110 is inserted, an intubation device 140 is provided to perform endotracheal intubation of the subject 100.

[0115] As mentioned above, in this example, intubation device 140 is a one-handed intubation device and includes a handle portion 141 connected to blade portion 142 to allow a user to hold intubation device 140 and move blade portion 142 and distal tip 143 relative to a subject's anatomy. This form of intubation device 140 includes a channel for receiving an endotracheal tube 150 and a tube movement mechanism in handle portion 141 for moving endotracheal tube 150 through the channel to advance endotracheal tube 150. In this case, the tube movement mechanism includes a thumb interface 144 that allows a user to operate the tube movement mechanism using the thumb of the hand holding the intubation device, thereby allowing a user to hold intubation device 140 and advance endotracheal tube 150 in a one-handed endotracheal intubation procedure.

[0116] Intubation device 140 typically includes a light source (not shown) disposed proximate the distal end of blade portion 142 to provide illumination during the endotracheal intubation procedure, in which case the procedure may be referred to as light-guided endotracheal intubation. Note that in practice, most endotracheal intubation procedures are typically performed as light-guided endotracheal intubation procedures, and therefore these terms are used interchangeably herein.

[0117] As discussed above, embodiments of the shielded intubation guide 110 may be configured to substantially reduce light emission from the subject's mouth during a light-guided endotracheal intubation procedure. In this case, the shield 120 of the shielded intubation guide 110 may be used to effectively function as a light shield and substantially prevent light emitted from the light source from escaping the subject's mouth during a light-guided endotracheal intubation procedure. Such a scenario is described in more detail below.

[0118] It should be understood that this light blocking feature may only be required in certain scenarios where light leakage from the subject's mouth may be undesirable, such as the dark conditions of a military environment, where light leakage from the subject's mouth may reveal one's location to an enemy and make one a target. However, in many other scenarios, light leakage is not an issue and the shielded intubation guide 110 does not necessarily require this light blocking feature. In any event, regardless of whether light-guided endotracheal intubation is being performed and whether a light shield is required, it is generally desirable for the shield to substantially reduce other emissions from the subject's mouth.

[0119] The intubation device 140 may be configured such that light-guided endotracheal intubation is performed as a non-direct vision intubation, i.e., the user can perform the procedure without a direct line of sight visualization of the subject's 100 larynx 104 and nearby anatomical structures while inserting the blade portion 142 of the intubation device 140.

[0120] In some examples, the intubation device 140 may further include a fiber optic viewing device (not shown) to allow the user to view the patient's internal anatomy without the need for direct observation. The fiber optic viewing device may include a flexible fiber optic bundle with a lens located at one end proximate the distal tip 143 of the blade portion 142 and an eyepiece located at the other end. The fiber optic bundle may extend along the blade portion 142 and into the handle portion 141. The eyepiece may be located on the handle portion 141 or on a suitably formed projection from the handle portion 141 to allow the user to look through the eyepiece during the procedure.

[0121] In another example, the intubation device 140 may include a video camera (not shown) positioned proximate the distal tip 143 of the blade portion 142 to provide a video image of the patient's internal anatomy during the procedure. It will be appreciated that this provides more flexible viewing options as compared to the fiber optic viewing arrangements discussed above.

[0122] The video camera may be connected to a display (not shown) to present images from the video camera in real time or near real time during the procedure. Although a small display may be integrated with the intubation device 142, it may be preferable to have a separate larger display to present a magnified image of the internal anatomical structures at a more convenient viewing location for the user. The connection to the display may be achieved via a cable extending from the intubation device 140 or via a wireless communication connection that may avoid interference with user movements by the cable. In some examples, the display may be provided in the form of goggles worn by the user. It will be appreciated that this allows the user to conveniently view the images presented from the video camera regardless of the position of the user's body and head. The display may occupy the entire viewing area of ​​the goggles or only a portion of it, depending on the implementation.

[0123] In any of the above options comprising a display, the display may be surrounded by a display shield (not shown) and may be configured to allow the user to view the display while substantially preventing light emitted from the display from leaking beyond the display shield and the user's face. For example, in the above example of a display integrated with the intubation device 142, the display shield may be in the form of an extended hood that surrounds the display, which engages with the user's face around the user's eyes to substantially prevent light leakage. In the case of a display comprised in goggles worn by a user, the goggles may include a surrounding shield in the form of an opaque, preferably flexible, covering that can conform to the face around the user's eyes to substantially prevent light leakage.

[0124] In any event, with reference to Figure 1D, endotracheal intubation is initiated by inserting the blade portion 142 of the intubation device 140 into the passageway 112 of the shielded intubation guide 110 through the proximal opening 113. The blade portion 142 of the intubation device 140 passes through the passageway 112 of the shielded intubation guide 110 to position the distal tip 143 of the blade portion 142 adjacent the larynx 104 of the subject 100. Typically, the distal tip 143 protrudes through the distal opening 114, as seen in Figures 3A and 3B for a detailed view of the position of the blade portion 142 of the intubation device 140 relative to the shielded intubation guide 110.

[0125] Light-guided endotracheal intubation is typically initiated by activating the light source of the intubation device 140 while inserting the blade portion 142 of the intubation device 140 into the passageway 112 of the shielded intubation guide 110 .

[0126] The following discussion describes the steps involved in performing a light-guided endotracheal intubation procedure to facilitate further explanation of how the shielded intubation guide 110 comprises a light shield, thereby substantially preventing light emitted from the light source during a light-guided endotracheal intubation procedure from escaping from the subject's mouth.

[0127] It will be appreciated that endotracheal intubation is typically guided by light, but light leakage from the subject's mouth may not be considered a problem in many practical scenarios. In many cases, protection from liquids, droplets, and aerosols is more important. Thus, it should be understood that while embodiments of the shielded intubation guide 110 may require light blocking functionality only for certain scenarios, embodiments of the shielded intubation guide 110 are generally expected to be used to reduce other emissions from the subject's mouth 102, such as fluids, droplets, and aerosols, in most practical scenarios.

[0128] Preferably, the light source is activated only after the distal tip 143 of the blade portion 142 (and thus the light source, if provided on the intubation device 140, is typically positioned proximate thereto) is initially inserted into the passageway 112. As such, light is emitted only from the light source inside the passageway 112 to guide the insertion of the distal tip 143 through the passageway and into the desired position relative to the subject's anatomy.

[0129] The particular positioning of the distal end 143 will depend on the particular configuration of the blade, but typically the distal tip 143 is positioned around the epiglottis 107 and moved as necessary to expose the subject's glottis. The distal tip 143 may engage the vallecula in the subject's trachea 105. As the blade portion 142 is moved, there may be some movement of the shielded intubation guide 110 relative to the subject's mouth 102 and tongue 106.

[0130] 1E illustrates, in dashed lines, areas within the patient's airway that may be illuminated by the light source if activated during insertion of the blade portion 142, particularly when the distal tip 143 is in place. Note that different areas may be illuminated depending on the particular configuration of the intubation device 140, particularly the location of the light source. In any case, the light source will typically be configured to illuminate surrounding anatomical structures, such as the larynx 104 and epiglottis 107, such that the user can move the distal tip 143 relative to these anatomical structures under the guidance of the light.

[0131] Typically, there will also be some illumination beyond these target areas, which may include some light emitted up the pharynx 103 toward the mouth 102, as shown in Figure IE. However, it will be appreciated that the shield 120 of the shielded intubation guide 110 can substantially prevent this light from escaping the mouth 102 of the subject 100 by obstructing the light emitted toward the mouth 102. It will be appreciated that if this light blocking function is desired, the shield 120 should be formed from an opaque material to substantially prevent the transmission of light through the shield 120 itself.

[0132] As discussed above, the shield 120 preferably substantially covers the mouth 102 of the subject 100, and in examples where the shield 120 includes a flange extending outwardly from the body 111, it is the flange that substantially covers the mouth 102 of the subject 100. It will be appreciated that a properly configured shield 120 with sufficient coverage of the mouth 102 can be used to effectively prevent light leakage from the mouth during a light-guided endotracheal intubation procedure.

[0133] It will be appreciated that while some light may be able to leak through the passages 112, light emitted towards the passages 112 is significantly impeded by the blades 142 in the passages 112. Additionally, as discussed in more detail below, the body 111 and the passages 112 defined therein are often curved, and this curvature of the body 111 may help prevent light rays from being emitted directly along the passages 112.

[0134] Additionally, in some embodiments, the shielded intubation guide 110 may include a seal for covering the proximal opening 113 to help prevent light from escaping from the proximal opening 113 through the passageway 112 while a light-guided endotracheal intubation procedure is being performed. FIG. 6 illustrates an example of a shielded intubation guide 610 including a seal 601 covering the proximal opening 113. The seal 601 may be configured to be normally in a closed position to seal the proximal opening and movable to an open position when the blade portion 142 of the intubation device 140 is inserted through the passageway 112. Thus, the blade portion 142 may be inserted through the seal 601 in the proximal opening 113 while the seal can help block light emitted from a light source at the distal tip 143 of the blade portion 142.

[0135] It will also be appreciated that a seal as described above may be useful in reducing other emissions of fluids, droplets, and / or aerosols from the subject's mouth or airways via passageway 112 before and during an endotracheal procedure.

[0136] 1F, once the distal tip 143 has been moved into the appropriate position, the endotracheal tube 150 is advanced along the blade portion 142 of the intubation device 140 through the passageway 112 of the shielded intubation guide 110 to insert the endotracheal tube tip 151 into the subject's trachea 105. It will be appreciated that use of a one-handed intubation device 140 allows the endotracheal tube 150 to be advanced by the user manipulating the thumb interface 144 using the thumb of the same hand that is holding the device. However, if a different form of intubation device is used that does not facilitate one-handed intubation, the endotracheal tube 150 may be advanced manually in a generally conventional manner.

[0137] In any case, an endotracheal intubation procedure, including inserting the intubation device 140 and advancing the endotracheal tube 150 into the trachea 105, can be performed under the guidance of light emitted from the light source, with the shield 120 substantially preventing light from escaping from the mouth 102 of the subject 100. Thus, in this manner, the shielded intubation guide 110 can be used to perform light-guided endotracheal intubation without the problem of light leakage.

[0138] For example, this method may allow a military physician or medic to perform a light-guided endotracheal intubation procedure in the dark conditions of a combat scenario without light escaping from the subject's mouth, risking revealing the physician or medic's location to an enemy and making him or her a target, as will be appreciated, thereby expanding the options available to a military physician or medic to allow for emergency intubation, such as in a combat scenario.

[0139] However, as discussed above, the shielded intubation guide 110 may be suitably used to reduce emissions from the subject's mouth in all scenarios, regardless of whether this light-blocking function is required, and may help to avoid the transmission of infectious diseases from the subject to the user or other medical staff via droplet or aerosol emissions from the subject's mouth, for example.

[0140] The endotracheal tube 150 is typically a standard endotracheal tube and may include a balloon cuff (not shown) that may be inflated once the endotracheal tube 150 has been advanced to a desired location. It will be appreciated that the inflated balloon cuff may help to hold the endotracheal tube 150 in place within the subject's trachea 105.

[0141] After the endotracheal tube 150 has been advanced into the trachea 105 of the subject 100 (and after a balloon cuff, if provided with the endotracheal tube 150, has been inflated), the light source may be deactivated (if used as part of a light-guided tracheal intubation procedure). As shown in FIG. 1G, the intubation device 140 may be removed, leaving the endotracheal tube 150 in place within the trachea 105. This may be done by withdrawing the blade portion 142 of the intubation device 140 from the shielded intubation guide 110, leaving the endotracheal tube 150 in place, as shown in FIG. 1G. At this stage, the shielded intubation guide 110 remains in place.

[0142] The endotracheal tube 150 can then be coupled to a ventilation source and used to provide ventilation to the subject 100. Typically, this involves connecting a ventilation source (not shown) to a connector 152 at the proximal end of the endotracheal tube 150 such that ventilation is provided via the endotracheal tube 150.

[0143] It will be appreciated that any suitable type of ventilation source may be used to ventilate the subject 100. For example, a manual bag valve type ventilator may be used by connecting to the connector 152 of the endotracheal tube 150 using a suitably configured ventilator connector. The ventilator connector is typically a standard / universal connector type. The ventilator is typically placed outside the subject's mouth. Alternatively, the ventilation source may be in the form of a powered mechanical ventilator, for example. In some embodiments, a more remote ventilator unit may be connected to the connector 152 of the endotracheal tube 150 by a flexible tube or the like.

[0144] Once ventilation via the endotracheal tube 150 has been established, the shielded intubation guide 110 may be removed from the mouth 102 of the subject 100, leaving the endotracheal tube 150 in position for continued ventilation, as shown in FIG. 1H.

[0145] In some embodiments, shielded intubation guide 110 may be configured to break along passageway 112 and along sections of shield 120 to allow for its removal. Additional steps for breaking and removing the second example of shielded intubation guide 410 are shown in Figures 4A and 4B.

[0146] For example, an exemplary shielded intubation guide 410 may include a break line 117 in a section of the body 111 and shield 120, typically extending between the passageway 112 and an edge of a flange that comprises the shield 120. When using such a shielded intubation guide 410, the method may include breaking the shielded intubation guide 410 as in Figure 4A to allow the shielded intubation guide 110 to be removed while the endotracheal tube 150 remains in place as shown in Figure 4B.

[0147] 5A and 5B show detailed views of the shielded intubation guide 410 before and after rupture with the endotracheal tube 150 extending through the passageway 112, thereby illustrating how the shielded intubation guide 110 can be removed leaving the endotracheal tube 150 in the deployed position.

[0148] It will be appreciated that this approach to breaking the shielded intubation guide 110 may avoid the need to thread the shielded intubation guide 110 over the connector 152 attached to the proximal end of the intubation tube 150 and the need to remove the proximal end of the endotracheal tube 150 from the ventilator, which would unintentionally interrupt ventilation of the subject using the endotracheal tube 150. This may also avoid the risk of unintentionally moving the endotracheal tube 150 from its reach and potentially losing sight of a safe airway during removal of the shielded intubation guide 110.

[0149] In an alternative example, shielded intubation guide 110 may include cut marks (not shown) and be configured to be cut along passageway 112 and along sections of shield 120 by following the cut marks. It will be appreciated that this facilitates similar functionality to facilitate removal of shielded intubation guide 110 as described above, without the additional requirement of using a cutting tool, without frangible parts in the structure of shielded intubation guide 110.

[0150] The shielded intubation guide 110 may be designed such that the passageway 112 attaches to the blades 142 of the intubation device 140 without incorporating a tube attachment allowance. This may help to reduce leakage of light emitted from the light source around the blades 142 and through the passageway 112 during a light-guided endotracheal intubation procedure. This may likewise help to reduce other emissions such as fluids, droplets, and / or aerosols passing through the passageway 112 during a light-guided or any other form of endotracheal intubation procedure.

[0151] In some examples of the methods described above, the shielded intubation guide 110 may be inserted into the mouth 102 of the subject 100 as shown in Figure 1B, and the subject 100 may be ventilated using a ventilation mask and / or ventilator while the shielded intubation guide 110 is in place before endotracheal intubation is performed. It will therefore be appreciated that the shielded intubation guide 110 is preferably configured to allow this to occur, for example by being designed to fit under a standard ventilation mask.

[0152] As described above for ventilation using an endotracheal tube, it will be appreciated that any suitable type of ventilator may be used to ventilate a subject using a ventilation mask. Typically the ventilator will be in the form of a manual bag-valve-mask ventilator connected to a ventilation mask, but may alternatively be in the form of, for example, a powered mechanical ventilator.

[0153] Ventilating the subject using a ventilation mask may include supplementing the subject with oxygen using a ventilation mask, such as by providing oxygen gas from an oxygen source to a ventilation port. In some cases, 100% oxygen may be provided, or air may be provided with a lower percentage of oxygen. Nevertheless, it will be appreciated that supplemental oxygen is not required and ventilation may be provided using ambient air without the addition of oxygen. This may depend on the availability of a separate source of pressurized oxygen, which may not be the case in some circumstances.

[0154] In any event, if ventilation is performed following insertion of the shielded intubation guide 110, this may continue indefinitely until the user decides to proceed with endotracheal intubation of the subject. For example, the user may wish to continue ventilation until a desired blood oxygen saturation level is achieved before intubating the subject. Alternatively, the shielded intubation guide 110 may be inserted by another user, and the subject may be ventilated while waiting for an intubation professional to perform endotracheal intubation on the subject.

[0155] It will be appreciated that the above method provides a new technique for enabling endotracheal intubation to be performed on a subject using the shielded intubation guide 110, with the shield 120 substantially reducing emissions from the subject's mouth during use. In view of the above method, it will be appreciated that the ability to perform an endotracheal intubation procedure is made possible by the particular design of the shielded intubation guide 110, which will be described in further detail with respect to Figures 2A-2D.

[0156] As mentioned above, the shielded intubation guide 110 includes an elongated body 111 defining a passageway 112 extending between a proximal opening 113 and a distal opening 114. The passageway 112 is configured to receive a blade portion 142 of an intubation device 140. The shielded intubation guide 110 also includes a shield 120 at the distal opening 114. As mentioned above, the shield 120 is for substantially reducing emissions from the subject's mouth during use.

[0157] As previously described, the shielded intubation guide 110 is configured for insertion into the mouth 102 of the subject 100 with the proximal opening 113 positioned proximate the subject's mouth 102 and the distal opening positioned proximate the subject's pharynx 103. This allows endotracheal intubation of the subject to be performed using the intubation device 140 and the shielded intubation guide 110.

[0158] As described above, the endotracheal intubation procedure generally involves inserting the blade portion 142 of the intubation device 140 into the passage 112 of the shielded intubation guide 110, positioning the distal end 143 of the blade portion 142 of the intubation device 140 adjacent to the larynx 104 of the subject 100, and advancing the endotracheal tube 150 along the blade portion 142 of the intubation device 140 through the passage 112 and into the trachea 105 of the subject 100.

[0159] Further optional and / or preferred features of the shielded intubation guide 110 will now be described with respect to Figures 2A through 2D.

[0160] As mentioned above, the shield 120 is typically configured to substantially cover the mouth 102 of the subject 100 during use. In this example, the shield 120 includes a flange extending outwardly from the body, as shown in Figures 2A-2D, which is configured to substantially cover the mouth 102 of the subject 100 during use. Typically, the flange surrounds the proximal opening 113.

[0161] In this example, the flange with the shield 120 has a generally rectangular shape including top and rear edges 221, 222 and side edges 223, 224. In this case, the flange includes opposed lateral flange portions that curve toward the distal opening 114. In other words, the lateral flange portions are curved to at least partially wrap around the face of the subject 100. This curved flange arrangement can assist in blocking light emitted toward the subject's mouth 102 during a light-guided endotracheal intubation procedure. This can also help reduce other emissions from the subject's mouth 102 by minimizing a gap between the flange with the shield 120 and the face of the subject 100 through which fluids, droplets, aerosols, etc. may be transmitted.

[0162] In this embodiment, the flange carrying the shield 120 includes an upper edge 221 having a recess 225 that conforms to the nose of the subject 100 during use. However, alternative embodiments of the shielded intubation guide 110 may include different configurations of the shield 120 while still providing properties that substantially reduce emissions from the subject's mouth 102.

[0163] The flange may also be configured with additional features to aid in correct insertion of the shielded intubation guide 110. In particular, the flange can help prevent over-insertion of the shielded intubation guide 110 by abutting the subject's mouth 102, thereby ensuring that the proximal opening 113 remains disposed outside of the mouth 102.

[0164] In some embodiments, the shielded intubation guide 110 may include straps or other suitable means for securing the shielded intubation guide 110 in place relative to the subject's mouth 102 after insertion. For example, the straps may be attached to the side edges 223, 224, or may include loops for wrapping around the subject's ears, or may extend around the back of the subject's head. It will be appreciated that any means for securing the shielded intubation guide 110 to the subject may be used in a manner similar to that used to secure an oxygen mask or other device worn on the subject's face.

[0165] The proximal opening 113 may be offset proximally from the flange and / or oriented at an angle relative to the flange. With reference to Figures 2A-2D, it can be seen that the proximal opening 113 is provided at the end of a protrusion 116 that protrudes proximally from the shield 120 such that the proximal opening 113 is located outside the mouth 102. In this case, the proximal opening 113 is offset from the flange and oriented at an angle relative to the flange. In particular, the upper proximal opening edge 211 is offset further away from the flange compared to the rear proximal opening edge 212.

[0166] In this case, the upper proximal opening edge 211 is substantially straight and leads into a substantially flat side of the body 111 terminating in a substantially straight upper distal opening edge 213. On the other hand, the rear proximal opening end 212 is curved and leads into a substantially flat side of the body 111 which terminates in a curved rear distal opening end 210. It will be understood that the shapes of these edges and corresponding sides of the body 111 will generally be selected depending on the shape of the blade portion 142 of the intubation device 140, as will be discussed in more detail below.

[0167] As mentioned above, in some examples, the shielded intubation guide 110 may be configured to allow ventilation of the subject 100 using a ventilation mask and ventilator after insertion and before induced endotracheal intubation is performed. To facilitate this, the shielded intubation guide 110 may be designed to fit under a standard ventilation mask or to allow the use of a ventilation mask in combination with the inserted shielded intubation guide 110.

[0168] The elongated body 111 of the shielded intubation guide 110 may be curved, as shown in the examples of Figures 2A-2D. Such a curved configuration may be provided to allow the shielded intubation guide 110 to better conform to the anatomy of the mouth 102 and airways of the subject 100 during use. Additionally, as discussed above, the curvature may help prevent light from escaping through the passageway 112 around the blade portion 142 of the intubation device 140 during a light-guided endotracheal intubation procedure. It will be appreciated that it is not necessary for the shielded intubation guide 110 to be curved, but whether it is curved and the degree of curvature will depend, at least in part, on the blade type of the intubation device 140.

[0169] The shielded intubation guide 110 may be formed from different materials having different levels of flexibility depending on requirements. For example, embodiments of the shielded intubation guide 110 may be formed from a relatively flexible material such that the shielded intubation guide 110 may be able to at least partially deform during use to conform to the natural curvature of the mouth 102 and airway anatomy of a subject.

[0170] On the other hand, embodiments of the shielded intubation guide 110 may be formed from a relatively inflexible material, and the curvature of the body 111 should be selected to conform to the subject's anatomy without causing substantial deformation of the intubation guide 110.

[0171] Also, while the use of a flexible material to form the shield 120 may be beneficial to enable the shield 120 to conform to the subject's face around the subject's mouth 102, this is not required and a more rigid material may be used.

[0172] The shielded intubation guide 110 is typically made from a suitable medical grade plastic material. In embodiments intended to provide a light-blocking function as described above, at least the shield 120 should be made from an opaque material to ensure that light does not penetrate the light shield 120 and escape from the mouth 102 of the subject 100 during the light-guided endotracheal intubation procedure. In a preferred embodiment, the entire shielded intubation guide 110 may be made from the same opaque material. On the other hand, it should be understood that if a light-blocking function is not required, it is not necessary to use an opaque material to form the shield 120 or other parts of the intubation guide 110, and in fact it may be desirable to make these parts transparent to facilitate visualization of the subject's oral cavity and pharynx during the endotracheal intubation procedure.

[0173] It will be appreciated that the shielded intubation guide 110 acts to allow the blade portion 142 of the intubation device 140 to be inserted into the airway of the subject 100 without interference with the subject's tongue or other anatomical structures that may impede the insertion of the blade portion 142 during use. This is particularly beneficial since some embodiments of the shielded intubation guide 110 may prevent direct visualization during insertion of the blade portion 142. However, it should be appreciated that other embodiments of the shielded intubation guide 110 may be configured to allow intubation under direct visualization. In any event, it should be appreciated that the shielded intubation guide 110 typically acts to hold the subject's tongue, typically depressing the tongue, i.e., urging the tongue downward. This may depend on the particular shape and configuration of the shielded intubation guide 110, including its curvature and flexibility as discussed above.

[0174] The proximal opening 113 of the shielded intubation guide 110 is configured to allow the blade portion 142 to be inserted into the passage 112 of the intubation guide 110 via the proximal opening 113. Preferably, the shielded intubation guide 110 is designed to fit the intubation device 140, particularly its blade portion 142. The intubation device 140 and the endotracheal tube 150 used in the procedure do not necessarily have to be specifically adapted for the artificial ventilation endotracheal intubation procedure as described above. Thus, the shielded intubation guide 110 may be separately equipped for the intubation device 140 and the endotracheal tube 150, provided that the correct type of intubation device 140 and the respective blade portion 142 are selected for the shielded intubation guide 110.

[0175] As mentioned above, some embodiments of the shielded intubation guide may include a seal, such as the example shown in Figure 6. In that example, the shielded intubation guide 610 includes a seal 601 that covers the proximal opening 113. The seal 601 may normally be in a closed position to seal the proximal opening 113 and may be movable to an open position when the blade portion 142 of the intubation device 140 is inserted through the passageway 112. The seal 601 may assist in reducing emissions from the subject's mouth or airway through the passageway 112.

[0176] Returning to FIG. 1D, it will be appreciated that when the blade portion 142 of the intubation device 140 is initially inserted into the proximal opening 113, the seal 601 of the proximal opening 113 may be moved from a closed position to an open position to allow the blade portion 142 to pass through the proximal opening 113.

[0177] In a preferred embodiment, the seal 601 is biased towards the closed position and returns towards the closed position when the blades 142 of the intubation device 140 are removed from the passageway 112 after the procedure. The seal 601 may be configured to form a partial seal surrounding at least one of the blades 142 of the intubation device 140 and the endotracheal tube 150 to reduce or prevent emissions that may otherwise pass around the blades 142 or endotracheal tube 150 during use.

[0178] As mentioned above, the seal 601 may be movable from a normally closed position (shown in FIG. 6 ) to an open position when the blades 142 of the intubation device 140 are inserted through the proximal opening 113. In some embodiments, the seal 601 may include at least one elastic membrane configured to deform in response to the blades 142 being urged against the seal 601, thereby defining an opening for receiving the blades 142.

[0179] In one example, the seal 601 may include two or more elastic membranes, each supported around a respective portion of the periphery of the proximal opening 113, and each including a respective unsupported edge 602. Each unsupported edge 602 may at least partially overlap in the closed position and be separated to define an opening in the open position. Although overlapping edges 602 are preferred for more effective sealing, in some examples the edges 602 may abut in the closed position without overlapping.

[0180] In other examples, the seal 601 may include two or more elastic membranes supported around the periphery of the proximal opening 113. Each opening in each elastic membrane may differ in shape, location, or orientation from the openings in the other elastic membranes. In other words, the seal 601 may include multiple fully supported membranes with openings, such as slits, that do not align or overlap, thereby providing an enhanced sealing effect.

[0181] In another example, the seal 601 may include a single elastic membrane supported around the periphery of the proximal opening 113. The single elastic membrane may include an opening that is substantially closed in the closed position and extends to define the opening in the open position. For example, in some embodiments, the opening may be a slit. In other embodiments, the opening may be a pinhole or have any other shape selected to allow an appropriate opening to be formed to receive the blade portion 142 of the intubation device 140. For example, the opening may be cross-shaped or H-shaped.

[0182] The at least one elastic membrane may be formed from any suitable membrane material, but typically a thin, flexible polymeric material is used. Preferably, the membrane is formed from an opaque material to ensure that no light leaks out, as described above for the shielded intubation guide 110.

[0183] It will be appreciated that when blade portion 142 is received in proximal opening 113 (e.g., as shown in FIGS. 3A and 3B ), seal 601 may be in an open configuration and still provide an effective seal around blade portion 142 to substantially prevent light leakage around blade portion 142 during a light-guided intubation procedure and / or to substantially reduce emissions of fluids, droplets, aerosols, etc., around blade portion 142 during an endotracheal intubation procedure. This depends on the design of seal 601 as well as the design of blade 142. For example, if seal 601 is configured to extend around blade portion 142 in the open position, it may form a substantially airtight seal even when blade portion 142 extends through proximal opening 113.

[0184] It is also noted that the example of the shielded intubation guide 610 shown in FIG. 6 illustrates an alternative configuration of the body 111 and shield 120 compared to the examples described above. In this case, the proximal opening 113 is provided at the end of the longer protrusion 116. The shield 120 includes longer lateral flanges with lateral edges 223, 224 that more effectively wrap around the subject's face, while the upper and rear edges 221, 222 are located closer to the body 111. The portion of the body 111 that is inserted into the subject's mouth 102 is also shorter than the examples described above. Thus, it should be understood that suitable embodiments of the shielded intubation guide 610 may include significant variations to the configuration of the body 111 and shield 120 while providing similar functionality to those described above.

[0185] It will be appreciated that embodiments of the shielded intubation guide 110 can move relative to the subject's anatomy as the blade portion 142 of the intubation device 140 is inserted through the passageway 112, specifically when the distal tip 143 is moved to an appropriate position where the endotracheal tube 150 can be inserted through the larynx 104 and into the subject's trachea 105.

[0186] Returning to the detailed example of shielded intubation guide 110 shown in Figures 2C and 2D, it can be seen that elongated body 111 may be defined as a thin-walled body for defining passageway 112. Body 111 and light shield 120 may be formed from rigid, semi-rigid, or flexible materials, such as suitable medical grade plastic materials. As mentioned above, where light blocking is required, it is desirable to form at least light shield 120, and preferably the entire shielded intubation guide 110, using an opaque material.

[0187] As mentioned above, it may be desirable to provide the shielded intubation guide 110 that is configured to break along the passageway 112 and along a section of the optical shield 120 to facilitate removal of the shielded intubation guide 110 while the endotracheal tube 150 remains in place.

[0188] In the example of shielded intubation guide 410 shown in Figures 4A and 4B and Figures 5A and 5B, body 111 of shielded intubation guide 410 includes a break line 117 that extends longitudinally along the side of passageway 112 and a section of shield 120. This allows shielded intubation guide 410 to be broken along break line 117. In this case, break line 117 extends along a section of shield 120 from passageway 112 to rear edge 222 of the flange forming shield 120.

[0189] The break line 117 can be formed by providing an area of ​​material that is significantly thinner than the material making up the walls of the body 111 and shield 120, which is breakable when opposing sides of the body 111 and optical shield 120 are forced apart. A hinge line may be provided on opposite sides of the passageway 112 to allow the intubation guide 110 to split into two hinged sections to facilitate removal while the endotracheal tube 150 remains in place.

[0190] In this case, it can be seen that the break line 117 is defined along the central plane of the shielded intubation guide 110. This break line 117 is aligned with the sagittal plane of the subject 100 during use. However, it will be understood that the particular configuration of the break line 117 in the illustrated configuration is not required and the shielded intubation guide 110 may include different configurations that allow it to be broken to facilitate its removal.

[0191] The proximal opening 113 and passageway 112 of the shielded intubation guide 110 typically have a cross-section selected to receive the blades 142 of the intubation device 140. It will be understood, therefore, that the particular cross-sectional shape will depend on the design of the intubation device 140. The proximal opening 113 and passageway 112 correspond to the cross-sectional shape of the blades 142 as shown in FIG. 3B. However, the shape may vary depending on the particular shape of the blades 142 at different points along its length.

[0192] Thus, the shape of proximal opening 113 and passageway 112 may be selected based on the cross-sectional shape of blade portion 142 of intubation device 140. As mentioned above, shielded intubation guide 110 may be curved, and if so, the curvature of shielded intubation guide 110 may be selected based on the curvature of blade portion 142 of intubation device 140.

[0193] The degree of curvature may also be determined by a range of other factors, including the flexibility of the material used to form the body 111 and the anatomy of the subject's airway. For example, as discussed above, the use of a more flexible material may allow a straight or relatively non-curved body 111 to deform during use and conform to the blades 142 and / or the subject's airway. It will be appreciated that the curvature of the body 111 may be less critical if it is formed from a relatively flexible material. However, it should be noted that there are practical limits to the flexibility of the shielded intubation guide 110 to prevent collapse when inserted into the subject's mouth.

[0194] Additionally, the use of a relatively more flexible material to form the body 111 of the shielded intubation guide 110 may allow for accommodating blade portions 142 of different sizes and shapes, whereas the use of a relatively more rigid material may limit the range of blade types, as different shielded intubation guides 110 may need to be selected for blade portions 142 of different sizes and shapes.

[0195] It should be noted that a variety of different shapes and sizes of shielded intubation guides 110 may be used with intubation devices to accommodate patients having different ages, sizes, and anatomical configurations. For example, different shielded intubation guides 110 may be provided for use with pediatric, adult, or obese subjects, selected to correspond with the blade selected for the particular subject.

[0196] However, some of the techniques described above, such as the use of flexible materials to form the shielded intubation guide 110, may allow a similar shielded intubation guide 110 to be used with a series of different blades.

[0197] The size of the proximal opening 113 and the passageway 112 may be selected based on the cross-sectional size of the blades 142 of the intubation device 140. In some instances, the proximal opening 113 of the shielded intubation guide 110 may be purposefully constructed to be smaller in size than the corresponding cross-sectional size of the blades 142 of the intubation device 140. Similarly, the passageway 112 of the shielded intubation guide 110 may be purposefully constructed to be smaller in size than the corresponding cross-sectional size of the blades 142 of the intubation device 140. In this regard, it will be appreciated that the shielded intubation guide 110 may be configured to expand when receiving the blades 142. Thus, forming the shielded intubation guide 110 from an expandable material allows the blades 142 to be more tightly enclosed within the shielded intubation guide 110 during use.

[0198] A further example of a shielded intubation guide 710 is shown in Figures 7A through 7G. It will be understood that this shares many common features with the above example, and the same reference numbers will be used to refer to the common features. However, this example illustrates some optional structural features that will now be described.

[0199] In this example, the shielded intubation guide 710 may include a removable cap 730 that closes the proximal opening 113 when the blade portion 142 of the intubation device 140 is not inserted into the passage 112 of the shielded intubation guide 110.

[0200] In this case, the cap 730 is provided as an integral part of the shielded intubation guide 710 and is coupled to the shield 120 by a retaining member 731 extending from one of the side edges 224 of the shield 120. FIG. 7A shows the cap 730 removed from the proximal opening 113 so that the blade portion 142 of the intubation device 140 can be inserted into the open passageway 112. FIG. 7B, on the other hand, shows the cap 730 in a closed position for sealing the proximal opening 113. When the cap 730 is in the closed position, the cap 730 can fit inside the proximal opening 113 or engage with a rim surrounding the proximal opening 113. The cap 730 may include a tab 732, as seen in FIG. 7B, allowing the user to remove the cap 730 by grasping and pulling the tab 732.

[0201] Further details of cap 730 in the closed position can be seen in the cross-sectional view of FIG. 7F, while the structure of proximal opening 113 can be better observed with cap 730 removed, as shown in the cross-sectional view of FIG. 7G.

[0202] Typically, the cap 730 remains in place to seal the proximal opening 113 during insertion of the shielded intubation guide 110 into the user's mouth, thereby substantially reducing emissions from the proximal opening while the cap is in place. The cap 730 may then be removed prior to inserting the blade portion 142 of the intubation device 140 into the passageway 112 of the shielded intubation guide 110.

[0203] It is noted that in this example of shielded intubation guide 110, the flanges comprising shield 120 are laterally curved to conform to the shape of the subject's face during use, as best seen in Figures 7D and 7E. Note further with respect to these figures that this example of shielded intubation guide 110 has a significantly reduced protrusion 116 as compared to the previous examples.

[0204] Returning to FIG. 7C, it can be seen that the body 111 of the shielded intubation guide 710 is curved as discussed in the examples above. In this case, the walls of the body 111 include respective expandable regions 701 that extend longitudinally from the distal opening 114 at least partially along the passageway 112. These expandable regions 701 allow the body 111 to expand circumferentially during use. These expandable regions 701 may be provided by forming longitudinal grooves in the walls of the body 111 that are normally in a collapsed state as shown in FIG. 7C, but which can expand to accommodate the blades 142 of the intubation device 140 inserted through the passageway 112 and the distal opening 114. Details of these expandable regions can be seen in the cross-sectional views of FIGS. 7F and 7G.

[0205] Two more examples of shielded intubation guides 810 and 910 are shown in Figures 8 and 9, respectively, which are essentially the same as shielded intubation guide 710 described above, but provide different examples of possible configurations of the expandable region 701 that extends longitudinally from the distal opening 114 at least partially along the passageway 112.

[0206] In the first example shown in FIG. 8, one expandable region 701 is provided on each side wall of the body 111, but in contrast to the previous example, no expandable region 701 is provided on the upper and lower walls of the body 111.

[0207] In a second example shown in Figure 9, two expandable regions 701 are provided on each sidewall of the body 111. The provision of multiple longitudinal grooves improves expandability and ensures that the body 111 typically has a flatter profile that facilitates insertion of the shielded intubation guide 910 while still allowing insertion of the blade portion 142 of the intubation device 140. This may help reduce damage to the balloon cuff of the endotracheal tube during the procedure.

[0208] Since it is generally desirable to avoid pushing the tongue backwards during an endotracheal intubation procedure, ideally the tongue position should be maintained without significant movement. In the example shielded intubation guide 910 of FIG. 9, the substantially flat configuration of the distal end of the body 111 resulting from the use of multiple expandable regions 701 allows this portion of the shielded intubation guide 910 to more easily traverse the tongue and palp without pushing the tongue backwards or touching the pharynx, and thus avoiding eliciting a gag reflex in the subject.

[0209] While the expandable regions 701 described above are shown in the form of longitudinal grooves in the walls of the body 111, it will be appreciated that this is merely an example of a suitable construction technique for providing an expandable region for circumferential expansion of the body, and that many other techniques are available to those skilled in the art. For example, a suitable expandable region may be formed using a relatively flexible material compared to the remainder of the body 111, or by providing overlapping walls that can slide over one another to facilitate circumferential expansion of the body 111.

[0210] Another example of a shielded intubation guide 1010 is shown in Figure 10. In this case, instead of the one-piece cap 730 shown above, a separate, removable cap seal portion 1030 is provided. The cap seal portion 1030 of this example also has a slightly different design than the one-piece cap 730 described above, particularly in that the cap seal portion 1030 engages the protruding portion 116 in which the proximal opening 113 is defined and has a removal tab 1031 extending to the side of the cap seal portion 1030 to allow removal with a peeling action as opposed to a pulling action.

[0211] Additionally, in this example, the cap seal 1030 includes an integral seal 1032 for covering the proximal opening 113, the seal 1032 normally in a closed position to seal the proximal opening 113 and movable to an open position when the blades 142 of the intubation device 140 are inserted through the proximal opening 113, thereby functioning in a manner similar to the seal 601 of the previously described embodiment of the shielded intubation guide 600 of FIG. 6. The cap seal 1030 may include a sealing membrane 1032 having one or more slits 1033 or other orifices formed therein to accommodate the blades 142 upon insertion.

[0212] According to seal 601 described above, by partially sealing the proximal opening 113 around the inserts, the cap seal 1030 is intended to provide improved protection from fluids, aerosols or droplets even while the laryngoscope blade and endotracheal tube are positioned inside the proximal opening 113. Once the laryngoscope blade and endotracheal tube are removed, the sealing membrane 1032 returns to its original closed position, thereby re-establishing a complete seal.

[0213] It will be appreciated that providing the seal 1032 in a separate cap seal portion 1030 allows the cap seal portion 1030 to be formed from a suitable resilient material, such as a silicone or rubber material, while the shielded intubation guide 1010 is formed from an entirely different material. This can greatly simplify the manufacture of the shielded intubation guide 1010.

[0214] It will also be appreciated that the use of a removable cap may be particularly desirable for use with a non-visual or direct vision laryngoscope, thereby allowing the user to have a clear line of sight through the proximal opening 113 and passageway 112.

[0215] Another example of a shielded intubation guide 1110 is shown in Figures 11A through 11C. The shielded intubation guide 1110 includes a separate removable cap seal portion 1030, like the above example of the shielded intubation guide 1010 shown in Figure 10, but in this case the shielded intubation guide 1110 also includes several additional optional features incorporated into the shield 120 and body 111.

[0216] In this example, the shielded intubation guide 1110 includes additional openings through the shield 120 of different types, apart from the main passageway 112, to facilitate access to the subject's oral cavity for various purposes. In this particular example, the shielded intubation guide 1110 includes a pair of suction ports 1140 and a pair of drainage fluid conduits 1150 located on either side of the proximal opening 114.

[0217] Suction ports 1140 may be provided to facilitate aspiration of fluids, such as saliva, blood, or vomit, prior to or during intubation. Each suction port 1140 includes an opening through the shield 120 through which a suction tube or other suitable suction device can be inserted to allow for aspiration of fluids from the subject's oral cavity. In this example, the opening of each suction port 1140 is defined at an angle relative to the shield 120 such that the suction tube or suction device is directed toward the body 111 when inserted through the suction port 1140. As a result, the suction tube or suction device can conform to the side wall of the body toward the subject's pharynx when inserted through the suction port 1140, which can assist in proper positioning of the tip of the suction tube / device during use.

[0218] In this example, the suction port 1140 may also include a port seal 1141 for closing the suction port opening. The port seal 1141 preferably functions in a similar manner as described above for the seals 601, 1032 in the previous examples, but is configured to allow insertion of a suction tube / device during use (as opposed to the blade portion 142 of the intubation device 140). Thus, it will be appreciated that each port seal 1141 may be configured such that it is normally in a closed position to seal the suction port 1140, and is movable to an open position when a suction tube / device is inserted through the suction port 1140. Preferably, the port seal 1141 may be configured to form a partial seal surrounding the suction tube / device during use. It will be appreciated that the port seal 1141 may help reduce emissions from the subject's mouth that may otherwise leak through the suction port 1140.

[0219] The embodiment of the shielded intubation guide 1110 shown in Figures 11A through 11C further includes drainage conduits 1150 disposed on either side of the proximal opening 113 (covered in this example by the cap seal 1030). The drainage conduits are provided to allow evacuation of fluids, including air with suspended droplets or aerosols, from the subject's oral cavity.

[0220] As seen in the front view of the shielded intubation guide 1110 in Figure 11A, each drainage conduit 1150 extends along the shield 120 from a respective conduit opening 1151 through the shield 120 disposed adjacent the proximal opening 113 (covered by the cap seal 130 in this example) to a proximal conduit opening 1151 near the side edges 223, 224 of the shield 120. Turning to the rear views of the shielded intubation guide 1110 in Figures 11B and 11C, each drainage conduit 1150 extends partially along the body 111 in a parallel arrangement and includes a conduit body portion 1152 with a distal conduit opening 1153 that is disposed within the subject's oral cavity when the body 111 of the shielded intubation guide 1110 is inserted into the subject's mouth.

[0221] It will be appreciated that when the subject is lying on a bed, operating table, etc., the proximal conduit opening 1151 of the drainage conduit 1150 faces downwards towards both side edges of the shield 120, and the distal conduit opening 1153 faces the pharynx on each side of the body 111 and its internal passageway 112 inside the subject's mouth. A catheter or tube may be connected to the proximal opening 1151 of the drainage conduit 1150. The other end is connected to a suction source or other form of airflow with a viral / bacterial filter to capture any microorganisms, thereby allowing drainage via the drainage conduit 11150 without exposing the user to fluid, droplet or aerosol emissions. The diameter of the proximal conduit opening 1151 should be standard for connection with standard tubing. However, even if no suction or airflow suction catheter is added, the aerosol outflow (if any) will be directed towards the floor (not the user). The proximal conduit openings 1151 may be closed with respective conduit caps (not shown) when they are not being used for drainage, thereby preventing emissions from leaking through the drainage conduits.

[0222] In this example, the shield 120 includes a rim 1160 configured to engage the subject's face, thereby forming a seal around the subject's mouth. In this example, the rim 1160 extends around the circumference of the shield 120, but this is not required and in some examples, the rim may be located inside the edge of the shield 120. The rim 1160 may include foam or an inflatable cuff, as in a typical ventilation mask, to provide an enhanced sealing effect. It will be appreciated that the rim 1160 can further reduce emissions from the subject's mouth both before and during an endotracheal intubation procedure.

[0223] In this particular embodiment, the body 111 includes a thickened region 1170 surrounding the body 111 near the shield. This thickened region 1170 can help protect the subject's teeth from the blades 142 of the intubation device 140 during insertion and can also help protect the body 111 from injury if the subject bites down with their teeth. The body 111 may further include teeth protrusions 1181, 1182 that project outwardly from the body 111 and are offset from the shield 120. The teeth protrusions 1181, 1182 are configured to engage the inner surfaces of the subject's teeth during use and help secure the shielded intubation guide 1110 in the mouth after the body 111 is inserted.

[0224] 12 and 13 show further examples of shielded intubation guide embodiments, illustrating some potential variations on the design of the body 111, as discussed below.

[0225] 12 shows an example of a shielded intubation guide 1210 having a relatively short body configuration compared to the previous example. In this case, the length of the body 111 is selected such that when the shielded intubation guide 1210 is inserted into the subject's mouth, the distal opening 114 is positioned within the subject's oral cavity, specifically between the tongue and the roof of the subject's palate. This short body configuration may help to avoid coughing or gag reflexes prior to endotracheal intubation, particularly when performing endotracheal intubation in an awake subject.

[0226] 13 illustrates another example of a shielded intubation guide 1310 having a longitudinally expandable body 111. In this example, the body includes a longitudinally expandable region 1301 that extends circumferentially around the body 111 and allows the body 111 to expand longitudinally during use. The shielded intubation guide 1310 may include the longitudinally expandable region 1301 when the body 111 is initially in a relatively short configuration for insertion into a subject's mouth, typically in a collapsed state.

[0227] When the shielded intubation guide 1310 is inserted into the subject's mouth, the distal opening 114 may be positioned within the subject's oral cavity, specifically between the subject's tongue and palate. When the blade portion 142 of the intubation device 140 is then introduced into the passageway 112, the longitudinally expandable region 1301 expands, thereby longitudinally expanding the body 111.

[0228] It will be appreciated that this effectively lengthens the body 111 such that the distal opening 114 is moved deeper into the subject's airway, such as beyond the subject's tongue and palate in the pharynx. The particular location of the distal opening 114 during use will, of course, depend on the configuration of the shielded intubation guide 1310, and particularly the body 111 and the longitudinally expandable region 1301. In any event, the lengthening of the body 111 aids in guiding the endotracheal tube during an endotracheal intubation procedure.

[0229] 13, the longitudinally expandable region 1301 may be provided in an accordion-like structure, preferably formed from a relatively flexible material and / or having a relatively thin thickness to facilitate expandability. However, it will be appreciated that alternative construction techniques may be used to provide the longitudinally expandable region 1301. For example, a suitable longitudinally expandable region 1301 may be provided using a telescoping body portion.

[0230] In any event, the longitudinally expanding nature of the body 111 allows the shielded intubation guide 1310 to be used across the continuum from awake to paralyzed subjects. Using a shielded intubation guide with a relatively long, fixed body length in a non-paralyzed subject can pose a risk of eliciting a cough or gag reflex.

[0231] In this example, insertion of the blade portion 142 into the passageway 112 will expand the longitudinally expandable region 1301 as the other circumferentially expandable expansion region 701 configuration near the distal opening 114 forms a relatively tight fit around the blade portion 142, causing the blade portion 142 to exert pressure on the distal end of the body 111, thereby causing the normally folded longitudinally expandable region 1301 to expand. It will be appreciated that this requires each of the expandable regions 701, 1301 to be configured such that the longitudinally expandable region 1301 expands before the circumferentially expandable region 701 expands to allow the blade portion 142 to pass through the distal opening 114. It will be appreciated that the expansion may alternatively be caused by an externally activated expansion mechanism or the like.

[0232] Figures 14A and 14B are cross-sectional views illustrating the steps of manually advancing an endotracheal tube using a conventional laryngoscope with a first example of a shielded intubation guide 110. It will be appreciated that the steps illustrated in Figures 14A and 14B effectively replace the steps illustrated in Figures 1E and 1F of the method described with reference to Figures 1A to 1H, but using a conventional laryngoscope as intubation device 140 instead of the one-handed version of the intubation device illustrated above. It will be appreciated that the conventional laryngoscope in this example may be either a direct or video laryngoscope.

[0233] The blade portion 142 of the intubation device 140 is inserted into the passageway 112 of the shielded intubation guide 110, generally as in Figure ID, and it is envisioned that the light source may be activated during insertion, as described above. However, with reference to Figure 14A, in this case, an endotracheal tube 150 is provided separately from the intubation device 140. Looking to Figure 14B, the endotracheal tube 150 is manually advanced along the blade portion 142 of the intubation device 140 through the passageway 112 to introduce the tip 151 of the endotracheal tube 150 into the subject's trachea 105. The remainder of the method may then continue generally as described above with reference to Figures 1G-1H.

[0234] It will be appreciated that when a conventional laryngoscope is used as an intubation device 140 in this manner, the user will typically hold the handle 141 of the intubation device 140 with one hand and manually advance the endotracheal tube 150 with the other hand.

[0235] In any event, it will be appreciated that the different embodiments of the shielded intubation guide described above allow for endotracheal intubation to be performed while substantially reducing oral emissions throughout the procedure.

[0236] Throughout this specification and the claims that follow, unless the context requires otherwise, the word "comprise" and variations such as "comprises" or "comprising" are understood to mean the inclusion of a stated integer or group of integers or steps, and not the exclusion of other integers or groups of integers. As used herein and unless otherwise specified, the term "approximately" means ±20%.

[0237] It should be noted that as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to a "support" includes a plurality of supports. In this specification and in the claims that follow, reference will be made to a number of terms, which shall be defined to have the following meanings unless a contrary intention is apparent.

[0238] Of course, it is to be understood that the foregoing is illustrative of the present invention and that all other modifications and variations of this invention as would be apparent to those skilled in the art are deemed to be within the broad scope and periphery of the invention as defined herein.

Claims

1. 1. A shielded intubation guide for an endotracheal intubation procedure, comprising: a) an elongate body defining a passageway extending between a proximal opening and a distal opening, the passageway configured to receive a blade portion, the blade portion being a laryngoscope blade of an intubation device, the shielded intubation guide configured to be inserted into the mouth of a subject such that the proximal opening is positioned proximate the mouth of the subject and the distal opening is positioned in the airway of the subject; b) a shield including a flange around the proximal opening and extending outwardly from the body, the flange being configured to surround the proximal opening and cover the exterior of the mouth of the subject in use, thereby substantially reducing emissions from the mouth of the subject, the flange including opposed lateral flange portions that are curved to wrap partially around the face of the subject in use; i) inserting the blade portion of the intubation device into the passage of the shielded intubation guide; ii) positioning a distal end of the blade portion of the intubation device adjacent to the larynx of the subject; iii) A shielded intubation guide configured to enable endotracheal intubation of a subject using the intubation device and the shielded intubation guide by advancing an endotracheal tube through the passage and along the blade portion of the intubation device into the subject's trachea.

2. The shield is a) a liquid; b) a droplet; and c) an aerosol; and and d) light emitted from a light source proximate the distal end of the blade portion of the intubation device during a light-guided endotracheal intubation procedure.

3. 3. The shielded intubation guide of claim 2, wherein the flange includes an upper edge having a recess for conforming to the subject's nose during use.

4. The shielded intubation guide according to any one of claims 1 to 3, characterized in that the flange is configured to abut against the subject's mouth to prevent over-insertion of the shielded intubation guide and to keep the proximal opening positioned outside the mouth.

5. The shielded intubation guide according to any one of claims 1 to 4, wherein the proximal opening is disposed proximally offset from the flange.

6. The shielded intubation guide according to any one of claims 1 to 5, characterized in that it is configured to be broken along the passage and along the section of the shield.

7. 7. The shielded intubation guide of claim 6, wherein the body of the shielded intubation guide includes a break line extending longitudinally along a side of the passage and along a section of the shield, whereby the shielded intubation guide is broken by the break line.

8. The shielded intubation guide according to claim 7, wherein the break line is defined along a central plane of the shielded intubation guide.

9. The shielded intubation guide according to any one of claims 1 to 5, further comprising a cutting mark, and configured to be cut along the passage and along the section of the shield according to the cutting mark.

10. The shielded intubation guide according to any one of claims 1 to 9, characterized in that it is made of a flexible material.

11. The shielded intubation guide according to claim 10, wherein the shielded intubation guide is configured to expand when receiving the blade portion.

12. 12. The shielded intubation guide of claim 11, wherein at least one wall of the body includes an expandable region.

13. The expandable area is a) extending longitudinally from the distal opening at least partially along the passageway to allow the body to expand circumferentially; 13. The shielded intubation guide of claim 12, wherein said first and second ends extend circumferentially about said body to permit said body to expand longitudinally.

14. The shielded intubation guide according to any one of claims 1 to 13, wherein the main body is curved.

15. The shielded intubation guide of any one of claims 1 to 14, further comprising a seal covering the proximal opening, the seal being normally in a closed position to seal the proximal opening and movable to an open position when a blade portion of the intubation device is inserted through the passage.

16. 16. The shielded intubation guide of claim 15, wherein the seal is biased toward the closed position such that when the blade portion of the intubation device is removed through the passageway, the seal returns toward the closed position.

17. 17. The shielded intubation guide of claim 16, wherein the seal is configured such that, in use, it forms a partial seal surrounding at least one of the blades of the intubation device and the endotracheal tube in use.

18. 18. The shielded intubation guide of any one of claims 1 to 17, further comprising a removable cap for closing the proximal opening when the blade portion of the intubation device is not inserted into the passageway.

19. 20. The shielded intubation guide of claim 18, wherein the cap includes a seal for covering the proximal opening, the seal normally in the closed position to seal the proximal opening, and the seal is movable to an open position when the blade portion of the intubation device is inserted through the passageway.

20. The shielded intubation guide, during use, a) holding the subject's tongue; The shielded intubation guide according to any one of claims 1 to 19, characterized in that it is configured to perform at least one of the following: b) depressing the tongue.

21. 21. The shielded intubation guide of any one of claims 1 to 20, characterized in that it is configured to fit under a standard ventilation mask to allow ventilation of the subject using a standard ventilation mask and ventilator before endotracheal intubation is performed.

22. The shielded intubation guide according to any one of claims 1 to 21, characterized in that the shielded intubation device is configured for a light-guided endotracheal intubation procedure in which light is emitted from a light source proximate the distal end of the blade portion of the intubation device after the blade portion of the intubation device is inserted into the passage of the shielded intubation guide, and the shield is configured to substantially prevent light emitted from the light source from escaping from the mouth of a subject.

23. a) the shield is formed of an opaque material; 23. The shielded intubation guide according to claim 22, wherein the shielded intubation guide is entirely made of an opaque material.

24. a) the shield is i) a liquid; ii) a droplet; and iii) configured to substantially reduce emissions from the mouth of a subject, the emissions being one or more of: aerosols; The shielded intubation guide according to claim 1, characterized in that it is made of a transparent material.

25. 25. The shielded intubation guide of any one of claims 1 to 24, wherein the shield includes a rim configured to engage a subject's face to form a seal around the subject's mouth.

26. When the intubation guide is inserted into the mouth of the subject, The distal opening is a) the oral cavity of a subject; b) the subject's pharynx; and c) the body has a length such that it is positioned between the tongue and palate of a subject.

27. 27. The shielded intubation guide of any one of claims 1 to 26, characterized in that the shielded intubation guide includes at least one additional opening extending through the shield to facilitate access to the subject's oral cavity.

28. 28. The shielded intubation guide of claim 27 including at least one suction port extending through the shield.

29. 29. A shielded intubation guide as claimed in claim 27 or 28, including at least one drainage conduit extending through the shield.

30. 1. An intubation guide with light shield for an endotracheal intubation procedure, comprising: a) an elongate body defining a passageway extending between a proximal opening and a distal opening, the passageway being configured to receive a blade portion of an intubation device; b) a light shield proximate the proximal opening; the proximal opening is positioned near the mouth of the subject and the distal opening is positioned in the airway of the subject; i) inserting the blade portion of the intubation device into the passage of the light-shielded intubation guide; ii) emitting light from a light source proximate the distal end of the blade portion of the intubation device, the light shield being configured to substantially prevent light emitted from the light source from escaping the mouth of a subject; iii) positioning a distal end of the blade portion of the intubation device adjacent to the larynx of the subject; iv) a light-shielded intubation guide configured for insertion into the mouth of a subject so as to enable light-guided endotracheal intubation of a subject to be performed using the intubation device and the light-shielded intubation guide by advancing an endotracheal tube through the passage and along the blade portion of the intubation device into the subject's trachea,

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