Laryngeal mask airway tube introducer and method

Abstract

A laryngeal mask airway (LMA) intubation guide for endotracheal intubation procedures and ventilation of a subject, the LMA intubation guide comprising: an elongate body defining a passageway extending between a proximal opening and a distal opening for receiving a blade portion of an intubation device; a laryngeal mask at the distal opening for covering a larynx of the subject; and a ventilation airway extending at least partially along the body, comprising: a ventilation port at a proximal end of the ventilation airway for connection to a ventilator; and a ventilation aperture at a distal end of the ventilation airway for allowing fluid communication between the ventilation airway and the passageway proximate the laryngeal mask, the LMA intubation guide configured for intubation of the subject with an endotracheal tube through the passageway while the subject is ventilated using the ventilation airway.

Description

TECHNICAL FIELD

[0001] The present invention relates to laryngeal mask airway insertion guide and method for use in endotracheal intubation procedures, particularly suitable for allowing ventilation of a subject using a laryngeal mask airway throughout the procedure. BACKGROUND

[0002] Endotracheal intubation is a procedure in which a medical professional introduces a flexible plastic tube, an endotracheal tube, into the trachea, usually through the mouth. This allows for artificial ventilation, which is required in emergency situations when respiratory capacity is compromised due to illness or injury, or during surgery when it is interfered with by medication-induced depression. It is a ubiquitous procedure and is performed in the same way all over the world.

[0003] Thousands of intubations are performed every day by different professionals, particularly anaesthetists, intensivists, emergency physicians and pre-hospital medical personnel and nursing staff. However, endotracheal intubation is a high-risk procedure that can lead to death or disability, requires a considerable level of skill and is occasionally not completed. It is often difficult and sometimes unsuccessful even for well-trained professionals. New professional instruments and advanced techniques are constantly being developed with the aim of facilitating this difficult procedure and ensuring better success rates.

[0004] The aim of the operator is to successfully pass the endotracheal tube through the mouth, pharynx and larynx and into the trachea. The oropharyngeal passageway is curved and narrow, ending at the entrance to the larynx and oesophagus. When the patient is in a supine position, the tongue tends to fall back into the pharynx, the position of the laryngeal inlet varies due to the patient's particular anatomy, the epiglottis is located above the laryngeal inlet and usually needs to be moved to expose the glottic opening.

[0005] The operator needs to identify the vocal cords at the laryngeal inlet, the epiglottis above the laryngeal inlet in a lateral view of the patient supine and the oesophagus below all the aforementioned structures in that view. This procedure requires exceptional skill; the endotracheal tube is relatively easy to follow along the path towards the oesophagus, it is usually difficult to obtain a good view of the larynx and even when a good view is obtained, it is sometimes difficult to introduce the endotracheal tube. Any delay in successfully completing the procedure is a serious complication and can be fatal.

[0006] Insertion of an endotracheal tube through all of these anatomical structures and into the trachea is referred to as endotracheal intubation, and generally requires the use of an instrument known as a laryngoscope, which includes a handle and a blade. Different shapes of blades can be used depending on a range of factors, such as the age or size of the patient and different surgical options. Laryngoscope blades are generally categorized as curved and straight, although there are many styles of curved and straight blades available on the market. Some styles of blades are designed to be placed in front of the epiglottis, while other styles of blades are designed to be placed behind the epiglottis, resulting in slightly different movements during the procedure.

[0007] During endotracheal intubation, the operator, generally standing at the top of the patient's head, introduces the blade of the laryngoscope through the mouth and into the pharynx, and manipulates anatomical structures, such as the tongue and epiglottis, to expose the entrance to the larynx, with the patient supine, depending on the particular patient and type of blade. The operator then inserts the tip of the endotracheal tube into the larynx and advances it into the trachea, with direct visualization. In traditional and common procedures, the operator generally uses the left hand to hold the handle of the laryngoscope to position the blade, and the right hand to carefully introduce the endotracheal tube, pushing it alongside the laryngoscope blade and into the visualized trachea.

[0008] Direct visualization is often difficult, despite proper technique, due to anatomical variations and challenges. In most cases, proper visualization is obtained by manipulating some of the anatomical structures. Unfortunately, in traditional laryngoscopy and traditional procedures, the operator uses both hands, and the hand used to manually introduce the endotracheal tube cannot be used to manipulate the anatomical structures to facilitate the procedure. Furthermore, a second operator cannot directly see the entrance to the larynx to assist in manipulating these structures, and would interfere with the first operator's line of sight, as the mouth opening from which the operator performing the intubation procedure generally has the best view is very limited. Video laryngoscopes can be used to eliminate the need for direct visualization, although these video laryngoscopes are generally bulkier than traditional laryngoscopes and still occupy both of the operator's hands.

[0009] Due to the difficulty of the procedure itself, combined with the severity of potential complications, this procedure can only be performed by highly skilled professionals. This difficulty and risk of severe complications also means that the procedure, and the instruments used to perform the procedure, have remained essentially unchanged for decades. Given these difficulties and risks, physicians and other professionals who perform endotracheal intubation are reluctant to use new devices or change from the traditional approach. Therefore, a new intubation device must not only offer significant procedural advantages over traditional laryngoscopes, but must also present similar features in shape and weight, and method of use, to facilitate adoption by operators who have been trained and adapted to use traditional laryngoscopes, in the often stressful context of performing an intubation procedure.

[0010] WO / 2016 / 090435A1 discloses a new intubation device that allows for an endotracheal intubation procedure to be performed using a single hand. In particular, the intubation device includes a laryngoscope blade having a tip and a base; a handle connected to the base of the blade for the intubation device to be held in the hand of a user; a channel for receiving an endotracheal tube, the channel including a blade channel portion extending along the blade substantially from the tip to the base and including an exit proximate the tip for a distal end of the endotracheal tube to be advanced from the exit, and 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 thereby 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 hand holding the intubation device, thereby allowing the user to hold the intubation device and advance the endotracheal tube using a single hand during the endotracheal intubation procedure. The entirety of WO / 2016 / 090435A1 is incorporated herein by reference.

[0011] By enabling the intubation device to be operated with a single hand for positioning the blade via the handle and advancing the endotracheal tube, the other hand of the user will be free for other uses, such as can be required to manipulate anatomical structures and / or the endotracheal tube during the endotracheal intubation procedure using another device such as a suction device or other devices such as forceps or the like.

[0012] While such a single-handed intubation device can help greatly reduce the difficulty and risk of serious complications of an endotracheal intubation procedure, a remaining problem is that there will be a period of time during the procedure when artificial ventilation is not provided to the patient. Typically, prior to the procedure, the patient will be ventilated using a mask until a sufficiently high level of blood oxygen saturation is achieved. Typically, this can involve pre-oxygenation to achieve 100% blood oxygen saturation, and optionally sedation or paralysis of the patient. When the required level of blood oxygen saturation is achieved, ventilation is stopped, the mask is removed, and the patient's mouth is exposed to allow the endotracheal intubation procedure to be performed. During the procedure, the patient will not be ventilated, and therefore it is critical that the endotracheal intubation is performed as quickly as possible so that ventilation is resumed via the endotracheal tube. If complications arise during the intubation procedure, there is a significant risk that the period of time without ventilation will be too long. In the case of a patient who is already critically ill or injured prior to the intubation procedure, this risk is exacerbated, making ventilation even more critical. It would therefore be desirable to provide a method and device to allow an endotracheal intubation procedure to be performed without interruption of ventilation.

[0013] US5964217A discloses a method and apparatus for ventilation / oxygenation during the guided insertion of an endotracheal tube. During resuscitation, an endotracheal tube can be inserted into the trachea of a patient by using a mask and a curved guide. The guide is inserted through a flexible port in the mask, with its curved distal end portion extending into the patient's mouth and hypopharynx. Air / oxygen flow is provided through the mask to initially resuscitate the patient. An optical fiber probe is inserted into the endotracheal tube at its distal end. Resuscitation, oxygenation or artificial ventilation continues uninterrupted while the optical fiber probe and endotracheal tube are inserted through the flexible port at the proximal end of the curved guide and then advanced along the guide to the patient's airway. The direction of the distal tip of the optical fiber probe can be controlled by the physician. This allows the physician to carefully guide the optical fiber probe and endotracheal tube beyond the larynx while continuing resuscitation. The optical fiber probe is then removed from the endotracheal tube and the mask is removed, while the endotracheal tube is left in place in the trachea. A cuff on the endotracheal tube is inflated and a ventilator is connected to the proximal end of the endotracheal tube to ventilate the patient. Alternatively, the patient can be manually ventilated by connecting a resuscitation bag to the proximal end of the endotracheal tube.

[0014] However, such apparatus is only useful in relatively straight intubations, which would not require the laryngoscope or intubation device described above. There is a need for an improved method and apparatus for ventilatory intubation under a wider range of, and more likely to be encountered in practice, conditions, preferably using an intubation device similar to those already routinely used by medical practitioners.

[0015] A laryngeal mask airway (LMA) is a medical device that can be used to provide a ventilatory airway during anaesthesia or unconsciousness. A conventional LMA design comprises a laryngeal mask connected to an airway tube. The laryngeal mask and connected airway tube are inserted through the mouth and pharynx of a subject, with the laryngeal mask located above the larynx of the subject. The laryngeal mask has a cuff which forms an airtight seal above the larynx, thereby providing a ventilatory airway directly to the larynx. The cuff can be inflatable to enable the laryngeal mask to conform to the anatomy of the subject.

[0016] The mention of any prior publication (or information derived from it) or any background art in this specification is not, and should not be taken as an acknowledgment or admission that the prior publication (or information derived from it) or background art was part of the common general knowledge in the field of endeavour to which this specification relates. SUMMARY

[0017] In one broad form, an aspect of the present technology is directed to a laryngeal mask airway (LMA) intubation guide for use in endotracheal intubation procedures and ventilation of a subject, the LMA 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; a laryngeal mask at the distal opening for covering a larynx of the subject; and a ventilation airway extending at least partially along the body, the ventilation airway comprising: a ventilation port at a proximal end of the ventilation airway for connection to a ventilator; and a ventilation aperture at a distal end of the ventilation airway for allowing fluid communication between the ventilation airway and the passageway proximate the laryngeal mask, wherein the LMA intubation guide is configured for insertion into a mouth of the subject such that the proximal opening is positioned proximate the mouth of the subject and the laryngeal mask is positioned proximate the larynx of the subject, thereby allowing the blade portion of the intubation device to be inserted into the passageway of the LMA intubation guide to allow intubation of the subject using an endotracheal tube through the passageway, while the subject is ventilated using the ventilation airway.

[0018] In one embodiment, the laryngeal mask comprises a ventilation mask cuff for forming a seal around the larynx of the subject.

[0019] In one embodiment, the ventilation mask cuff is inflatable.

[0020] In one embodiment, the ventilation aperture is located within the passageway proximate the laryngeal mask.

[0021] In one embodiment, the ventilation aperture is configured to direct a flow of ventilation gas towards the larynx of the subject.

[0022] In one embodiment, the ventilation airway is offset from the passageway.

[0023] In one embodiment, the ventilation airway is laterally offset relative to a central plane of the LMA intubation guide, the central plane being aligned with a sagittal plane of the subject when the laryngeal mask covers the larynx of the subject.

[0024] In one embodiment, the ventilation airway comprises an airway body portion extending along the body.

[0025] In one embodiment, at least the airway body portion is integrally formed with the body.

[0026] In one embodiment, the ventilation airway comprises an airway conduit portion extending away from the proximal opening.

[0027] In one embodiment, the LMA intubation guide comprises a closure for covering the proximal opening when the blade portion is not inserted through the passageway.

[0028] In one embodiment, the LMA intubation guide includes a seal covering the proximal opening, the seal being movable from a closed position to an open position when the blade portion of the intubation device is inserted through the passage.

[0029] In one embodiment, the seal includes at least one elastic membrane configured to deform in response to the blade portion abutting the seal, thereby defining an opening for receiving the blade portion.

[0030] In one embodiment, the seal includes an elastic membrane supported around a perimeter of the proximal opening, the elastic membrane including an aperture that is substantially closed in the closed position and stretched to define the opening in the open position.

[0031] In one embodiment, the aperture is a slit.

[0032] In one embodiment, the seal includes two or more elastic membranes supported around a perimeter of the proximal opening, the respective aperture of each elastic membrane being different from the apertures of the other elastic membranes in at least one of: shape; position; and orientation.

[0033] In one embodiment, the seal includes two or more elastic membranes each supported around a respective portion of a perimeter of the proximal opening, and each elastic membrane includes a respective unsupported edge, the unsupported edges at least partially overlapping in the closed position and separated to define the opening in the open position.

[0034] In one embodiment, the seal is biased toward the closed position such that the seal returns toward the closed position when the blade portion of the intubation device is removed from the passage.

[0035] In one embodiment, the seal is configured to form a partial seal around at least one of the blade portion of the intubation device and the endotracheal tube in use.

[0036] In one embodiment, the LMA intubation guide includes a removable cap for closing the proximal opening when the blade portion of the intubation device is not inserted into the passage of the LMA intubation guide.

[0037] In one embodiment, the cap includes a seal for covering the proximal opening, the seal being movable from a closed position to an open position when the blade portion of the intubation device is inserted through the passage.

[0038] In one embodiment, the LMA intubation guide includes a flange around the proximal opening.

[0039] In one embodiment, the flange is configured to prevent over-insertion of the LMA cannula guide by abutting the mouth of the subject, thereby ensuring that the proximal opening remains outside of the mouth.

[0040] In one embodiment, the LMA cannula guide is configured to break along the passage and the laryngeal mask.

[0041] In one embodiment, the body of the LMA cannula guide comprises a break line extending longitudinally along one side of the passage and the laryngeal mask, thereby allowing the LMA cannula guide to break along the break line.

[0042] In one embodiment, the break line is defined along a centre plane of the LMA cannula guide.

[0043] In one embodiment, the shape of the proximal opening is selected based on the cross-sectional shape of the blade portion of the cannula device.

[0044] In one embodiment, the size of the proximal opening is selected based on the cross-sectional size of the blade portion of the cannula device.

[0045] In one embodiment, the shape of the passage is selected based on the cross-sectional shape of the blade portion of the cannula device.

[0046] In one embodiment, the size of the passage is selected based on the cross-sectional size of the blade portion of the cannula device.

[0047] In one embodiment, the LMA cannula guide is formed from a flexible material.

[0048] In one embodiment, the LMA cannula guide is configured to expand upon receiving the blade portion.

[0049] In one embodiment, the LMA cannula guide is curved.

[0050] In one embodiment, the curvature of the LMA cannula guide is selected based on the curvature of the blade portion of the cannula device.

[0051] In one embodiment, the LMA cannula guide comprises a gastric tube conduit for allowing a gastric tube to be advanced into the oesophagus of the subject via the gastric tube conduit.

[0052] In one embodiment, the gastric tube conduit extends along the body and comprises a gastric tube conduit port at a proximal end of the gastric tube conduit and a gastric tube aperture at a distal end of the gastric tube conduit for allowing the gastric tube to be advanced into the oesophagus from the gastric tube aperture.

[0053] In one embodiment, the gastric tube aperture is located outside of the laryngeal mask and the passage.

[0054] In one embodiment, the gastric tube aperture is configured to face the oesophagus of the subject in use.

[0055] In one embodiment, the gastric tube catheter is offset from the passageway.

[0056] In one embodiment, the ventilation airway and the gastric tube catheter are offset from the passageway on opposite sides of the passageway.

[0057] In one embodiment, the LMA intubation guide is configured to allow insertion of the gastric tube independently of ongoing intubation of the subject.

[0058] In one embodiment, the LMA intubation guide is configured, in use, to at least one of: hold the tongue of the subject; and depress the tongue.

[0059] In one embodiment, the LMA intubation guide is configured to allow ventilation of the subject independently of ongoing intubation of the subject.

[0060] In one broad form, one aspect of the present technology is directed towards a method for an endotracheal intubation procedure, the method comprising: inserting a laryngeal mask airway (LMA) intubation guide into a mouth of a subject, the LMA intubation guide 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, the proximal opening being positioned proximate the mouth of the subject; a laryngeal mask positioned at the distal opening and positioned proximate a larynx of the subject; and a ventilation airway extending at least partially along the body, the ventilation airway comprising: a ventilation port at a proximal end of the ventilation airway for connection to a ventilator; and a ventilation aperture at a distal end of the ventilation airway for allowing fluid communication between the ventilation airway and the passageway proximate the laryngeal mask; covering the larynx of the subject with the laryngeal mask; connecting the ventilator to the ventilation port and ventilating the subject using the ventilation airway; and while continuing to ventilate the subject: inserting the blade portion of the intubation device into the passageway of the LMA 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 along the blade portion of the intubation device through the passageway into the trachea of the subject.

[0061] In one embodiment, the laryngeal mask comprises an inflatable ventilation cuff, the method comprising inflating the ventilation cuff after covering the larynx of the subject with the laryngeal mask.

[0062] In one embodiment, the method comprises, after advancing the endotracheal tube into the trachea of the subject, and while leaving the endotracheal tube in place in the trachea of the subject: withdrawing the blade portion of the intubation device from the LMA intubation guide; and removing the LMA intubation guide from the mouth of the subject.

[0063] In one embodiment, the method comprises ventilating the subject using the endotracheal tube after the endotracheal tube is advanced into the trachea of the subject and before the LMA intubation guide is removed.

[0064] In one embodiment, the LMA intubation guide is configured to break along the passage and the laryngeal mask, the method comprising breaking the LMA intubation guide to allow the LMA intubation guide to be removed while the endotracheal tube remains in place.

[0065] In one embodiment, the LMA intubation guide comprises a closure for covering the proximal opening, the method comprising removing the closure before the blade portion is inserted through the passage.

[0066] In one embodiment, the LMA intubation guide comprises a seal covering the proximal opening, the seal being normally in a closed position for sealing the proximal opening and being movable to an open position when the blade portion of the intubation device is inserted through the passage, the method comprising inserting the blade portion through the seal of the proximal opening.

[0067] In one embodiment, the seal is biased towards the closed position such that when the blade portion of the intubation device is removed from the passage, the seal returns to the closed position, the seal forming a partial seal around at least one of the blade portion of the intubation device and the endotracheal tube after insertion of the blade.

[0068] In one embodiment, ventilating the subject using the ventilation airway comprises oxygenating the subject using the ventilation airway.

[0069] In one embodiment, the LMA intubation guide comprises a gastric tube conduit, the method further comprising advancing a gastric tube into the oesophagus of the subject via the gastric tube conduit.

[0070] It will be appreciated that the general form of the application and its respective features can be used in combination, interchanged and / or independently, and that reference to individual broad forms is not meant to be limiting. BRIEF DESCRIPTION OF DRAWINGS

[0071] Various examples and embodiments of the application will now be described with reference to the accompanying drawings, in which:

[0072] Figures 1A-1J is a cross-sectional view showing steps of a first example of a ventilation endotracheal intubation procedure using a laryngeal mask airway (LMA) intubation guide on a subject;

[0073] Figure 2A and Figure 2B is Figures 1A-1J is a perspective view of the first example of an LMA intubation guide of

[0074] Figure 2C andFigure 2D is Figure 2A and Figure 2B a cross-sectional view of the LMA cannula guide of

[0075] Figure 2E and Figure 2F is Figure 2A and Figure 2B respective perspective and bottom views of the LMA cannula guide of

[0076] Figure 3A and Figure 3B is Figure 2A and Figure 2B perspective views of the LMA cannula guide of

[0077] Figure 4A is Figure 3A and Figure 3B perspective views of the LMA cannula guide, with the blade portion of the cannula device inserted into the passageway of the LMA cannula guide

[0078] Figure 4B is Figure 4A a cross-sectional view of the LMA cannula guide and the inserted blade portion of the cannula device of

[0079] Figure 5A is Figure 3A and Figure 3B a bottom view of the LMA cannula guide, with the endotracheal tube advanced through the passageway of the LMA cannula guide

[0080] Figure 5B is Figure 5A a bottom view of the LMA cannula guide and the endotracheal tube, with the LMA cannula guide broken to remove the endotracheal tube

[0081] Figures 6A-6F is a cross-sectional view showing steps of inserting a gastric tube into the esophagus of a subject using a second example of an LMA cannula guide with a gastric tube catheter

[0082] Figure 7A and Figure 7B is Figures 6A-6F perspective views of the second example of the LMA cannula guide of

[0083] Figure 8 is a perspective view of a third example of an LMA cannula guide, with a film seal for sealing the proximal opening

[0084] Figure 9 is a perspective view of a third example of an LMA cannula guide, with a separate, detachable cap seal for sealing the proximal opening; and

[0085] Figure 10A and Figure 10B is a cross-sectional view showing steps in manually advancing an endotracheal tube using a conventional laryngoscope with a LMA intubating guide of a first example. DETAILED DESCRIPTION

[0086] Reference will now be made to Figures 1A-1J Examples of a laryngeal mask airway (LMA) intubating guide 110 and corresponding methods of use thereof in a ventilated endotracheal intubation procedure will be described. The laryngeal mask airway (LMA) intubating guide 110 is particularly suited to allow intubation using a blade tipped intubating device 140 (as shown in Figures ID to IF), such as a laryngoscope or the like. For the purposes of the following examples, it is assumed that the intubating device 140 is the single handed intubating device described in WO / 2016 / 090435 Al, although it will be appreciated that other forms of intubating device can be used with appropriate adaptation of the equipment. For example, embodiments of the LMA intubating guide 110 can be configured for use with a commercially available video laryngoscope or a conventional direct vision laryngoscope.

[0087] Referring to Figure 1A , the method begins with the subject 100 being laid in a supine position in a similar manner 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 for better access to the larynx during the procedure.

[0088] At Figure 1A , the LMA intubating guide 110 is provided for insertion into the subject's mouth 102. Further details of the LMA intubating guide 110 can be found in Figures 2A-2F and Figure 3A and Figure 3B .

[0089] The LMA intubating guide 110 comprises an elongate body 111 defining a passageway 112 extending between a proximal opening 113 and a distal opening 114. The passageway 112 of the LMA intubating guide 110 is configured to receive the blade portion 142 of the intubating device 140, as shown in Figures IE and IF, and further details are shown in Figure 4A and Figure 4B .

[0090] The LMA intubating guide 110 further comprises a laryngeal mask 120 at the distal opening 114. The laryngeal mask 120 is for covering the subject's larynx and can have a similar configuration to a laryngeal mask of a conventional laryngeal mask airway device.

[0091] The LMA intubating guide 110 further comprises an airway 115 extending at least partially along the body 111. In relation to Figures 2A-2D , in particularFigure 2B and Figure 2D The ventilation airway 115 includes a ventilation port 211 at the proximal end of the ventilation airway 115 for connection to the ventilator 130 (as shown in Figures 1C-1J The ventilation airway 115 includes a ventilation port 211 at the proximal end of the ventilation airway 115 for connection to the ventilator 130 (as shown in

[0092] The LMA cannula guide 110 is then inserted into the mouth 102 of the subject 100, as shown in Figure 1B When the LMA cannula guide 110 has been correctly inserted, the laryngeal mask 120 will be positioned proximate the larynx 104 of the subject 100, and the proximal opening 113 will be positioned proximate the mouth 102 of the subject 100. The larynx 104 of the subject 100 is covered with the laryngeal mask 120.

[0093] Further details of the laryngeal mask 120 can be seen in Figures 2A-2D In this example, the laryngeal mask 120 has a ventilation cuff 223 which is configured to provide a seal around the larynx 104 of the subject 100. In some examples, the ventilation cuff 223 can be inflatable, in which case inflation gas (such as air) can be supplied into the ventilation cuff 223 via an inflation conduit 121. The inflation gas can be supplied via a syringe or other source of inflation gas in a similar manner to the inflation laryngeal mask of a conventional laryngeal mask ventilation device. It is preferred that an inflatable ventilation cuff 223 is used, as this can help to provide a seal which conforms to the subject's anatomy, but this is not essential.

[0094] Turning to Figure 1C Once the LMA cannula guide 110 has been inserted such that the larynx 104 of the subject is covered by the laryngeal mask 120, the ventilation airway 115 of the LMA cannula guide 110 can be used to ventilate the subject 100. Typically, this will involve connecting the ventilator 130 to the ventilation port 211 of the ventilation airway 115, so that ventilation gas supplied by the ventilator 130 can be delivered via the ventilation airway to a delivery point proximate the laryngeal mask 120.

[0095] With further details of the LMA cannula guide as shown in Figures 2A-2D The ventilator 130 can be connected to the ventilation port 211 at the proximal end of the ventilation airway 115, and ventilation gas supplied by the ventilator 130 will be delivered to the subject 100 via the ventilation hole 212 at the distal end of the ventilation airway 115. In this example, the ventilation hole 212 is located just inside the ventilation cuff 223 of the laryngeal mask 120, and can be configured to direct the ventilation gas towards the larynx 104 of the subject.

[0096] It will be appreciated that any suitable type of ventilator 130 can be used to ventilate the subject 100. In this example, a manual bag-valve ventilator 130 is used and is connected to the ventilation port 211 of the ventilation airway 115 using a suitably configured ventilator connector. The ventilator connector is typically a standard / universal connector type. The ventilator is generally located outside the subject's mouth.

[0097] Although the described example shows a ventilator 130 in the form of a manual bag-valve mask ventilator connected directly to the ventilation airway 115, the ventilator 130 may, for example, also be in the form of a powered mechanical ventilator. In some embodiments, a more remote ventilator unit can be connected to the ventilation port 211 by a length of flexible conduit or the like.

[0098] The process of ventilating the subject 100 using the ventilation airway 115 can include supplying oxygen to the subject using the ventilation airway 115, for example by supplying oxygen gas from an oxygen supply to the ventilation port. In some cases, 100% oxygen can be supplied or air can be supplied at a lower percentage of oxygen. However, it will be appreciated that oxygen supply is not essential and ventilation can be provided using air from the atmosphere without the addition of oxygen. This can depend on whether there is a separate source of pressurised oxygen, which can not be the case in some circumstances.

[0099] Ventilation of the subject 100 can continue as shown in Figure 1C It will be appreciated in this regard that the LMA intubation guide 110 can be used in a similar manner to a conventional laryngeal mask airway device. Such ventilation can continue indefinitely until the user decides to intubate the subject endotracheally. For example, the user can wish to continue ventilation until a desired level of blood oxygen saturation is achieved before intubating the subject. Alternatively, the LMA intubation guide 110 can be inserted by another user and ventilation of the subject can continue while waiting for an intubation specialist to intubate the subject.

[0100] In some embodiments, the LMA intubation guide 110 can include a closure for covering the proximal opening 113, thereby preventing ventilation gas supplied to the subject from escaping via the passageway and from the proximal opening 113 while ventilating the subject 100. In this example, the closure is provided in the form of a cap 116 which effectively seals the proximal opening 113. Typically, as Figure 1CAs shown, during initial insertion of the LMA cannula guide 110, and when ventilation is commenced and continued, the cover 116 will remain in place for sealing the proximal opening 113. However, as the ventilation gas can be supplied directly to the larynx, the use of a closure is not essential, such that it can not be important for some of the ventilation gas to escape. Other forms of closure can also be provided, such as a movable seal which will be discussed in further detail below.

[0101] Turning to Figure 1D , while the subject 100 is being ventilated, a cannulation device 140 is provided for endotracheal cannulation of the subject 100. As discussed above, in this example the cannulation device 140 is a single-handed cannulation device and comprises a handle portion 141 connected to a blade portion 142 for allowing a user to hold the cannulation device 140 and move the blade portion 142 and distal tip 143 relative to the subject's anatomy. This form of cannulation device 140 includes a passageway for receiving an endotracheal tube 150, and a tube movement mechanism in the handle portion 141 for moving the endotracheal tube 150 through the passageway to advance the endotracheal tube 150. In this case, the tube movement mechanism comprises a thumb interface 144 for allowing a user to operate the tube movement mechanism using the thumb of the hand holding the cannulation device, thereby allowing the user to hold the cannulation device 140 and advance the endotracheal tube 150 using a single hand during an endotracheal cannulation procedure.

[0102] In this example, the cover 116 is also removed prior to insertion of the blade portion 142 into the passageway 112, as also shown in Figure 1D . However, it will be appreciated that the use of a closure in the form of a removable cover 116 is not essential. In other embodiments, other forms of closure can be used. For example, other examples of LMA cannula guides 110, such as the embodiment shown in Figure 8 , can include a seal 801 covering the proximal opening 113. The seal 801 can be configured to normally be in a closed position for sealing the proximal opening 113, and to be movable to an open position upon insertion of the blade portion 142 of the cannulation device 140 into the passageway 112. Thus, the blade portion 142 can be inserted through the seal 801 of the proximal opening 113 without the need to remove the closure. In other embodiments, the closure can not be provided at all if sufficient ventilation of the subject can be achieved despite some leakage of ventilation gas from the proximal opening 113.

[0103] In preferred embodiments, the seal 801 is biased towards the closed position, such that when the blade portion 142 of the intubation device 140 is removed from the passageway 112 post-surgery, the seal 801 will return to the closed position. The seal 801 can be configured to form a partial seal around at least one of the blade portion 142 of the intubation device 140 and the endotracheal tube 150, thereby helping to reduce the escape of ventilation gas that can otherwise pass around the blade portion 142 or endotracheal tube 150 in use.

[0104] In any case, with reference to Figure 1E As ventilation of the subject 100 continues, the blade portion 142 of the intubation device 140 is inserted through the proximal opening 113 into the passageway 112 of the LMA intubation guide 110.

[0105] The blade portion 142 of the intubation device 140 is inserted through the passageway 112 of the LMA intubation guide 110 to position the distal tip 143 of the blade portion 142 proximate the larynx 104 of the subject 100. Typically, the distal tip 143 protrudes through the distal opening 114 and the laryngeal mask 120, as can be seen in Figure 4A and Figure 4B These figures provide detailed views of the positioning of the blade portion 142 of the intubation device 140 relative to the LMA intubation guide 110, as can be seen in

[0106] The specific positioning of the distal tip 143 will depend on the specific configuration of the blade, but typically the distal tip 143 will be positioned around the epiglottis 107 and moved as necessary to expose the glottis of the subject. The distal tip 143 can engage the valley within the trachea 105 of the subject. As the blade portion 142 is moved, this can result in some movement of the LMA intubation guide 110 relative to the mouth 102 and tongue 106 of the subject.

[0107] Turning now to Figure 1F Once the distal tip 143 has been moved into position to allow endotracheal intubation, the endotracheal tube 150 is advanced along the blade portion 142 of the intubation device 140, through the passageway 112 of the LMA intubation guide 110 and into the trachea 105 of the subject. It will be appreciated that the use of the single-handed intubation device 140 allows the user to use the thumb of the same hand holding the device to operate the thumb interface 144 to advance the endotracheal tube 150. However, if a different form of intubation device is used that does not facilitate single-handed intubation, the endotracheal tube 150 can be advanced manually in a generally conventional manner.

[0108] In any case, as mentioned above, the entire endotracheal intubation procedure, including insertion of the intubation device 140 and advancement of the endotracheal tube 150 into the trachea 105, can be performed while the subject 100 is being ventilated, thereby avoiding the potential risk period of no ventilation that occurs in conventional endotracheal intubation procedures. Thus, the method can be used to allow endotracheal intubation to be performed without time pressure, which medical professionals often face in conventional endotracheal intubation procedures. It will be appreciated that this can greatly improve the likelihood of successful intubation, even in traditional difficult cases.

[0109] The endotracheal tube 150 is typically a standard type of endotracheal tube, and can include a balloon cuff (not shown) that can be inflated once the endotracheal tube 150 has been advanced to the desired location. It will be appreciated that the inflated balloon cuff can assist in retaining the endotracheal tube 150 in place in the trachea 105 of the subject.

[0110] After the endotracheal tube 150 has been advanced into the trachea 105 of the subject 100 (and the balloon is inflated if there is one on the endotracheal tube 150), the intubation device 140 can be removed, while leaving the endotracheal tube 150 in place in the trachea 105, as shown in Figure 1G This can be done by withdrawing the blade portion 142 of the intubation device 140 from the LMA intubation guide 110, while the endotracheal tube 150 remains in place, as shown in Figure 1G At this stage, the LMA intubation guide 110 will remain in place, and the subject 100 will continue to be ventilated using the ventilator 130 via the ventilation airway 115 of the LMA intubation guide 110.

[0111] The endotracheal tube 150 can then be coupled to a ventilation source, and used instead to provide ventilation to the subject 100, as shown in Figure 1H The ventilation source can be the same ventilation source that was used to provide ventilation using the ventilation airway 115, or can be a different ventilation source. In this case, the ventilator 130 is disconnected from the ventilation airway 115, and immediately connected to the connector 152 at the proximal end of the endotracheal tube 150, in order to provide ventilation via the endotracheal tube 150, with minimal disruption.

[0112] In some cases, it is preferred that ventilation using endotracheal tube 150 is established prior to stopping ventilation using ventilation airway 115 to ensure continuous ventilation of the subject, which can require the use of a second ventilation source. In some examples, it is desirable that effective ventilation using endotracheal tube 150 is confirmed prior to disconnecting ventilator 130 from ventilation airway 115, and if this is not the case, ventilation using ventilation airway 115 can be continued while the user repositions endotracheal tube 150 so as to achieve effective ventilation. However, this can not be necessary, particularly if the operator is able to confirm in other ways that endotracheal tube 150 has been correctly deployed, and the time without ventilation when switching from ventilation via ventilation airway 115 to ventilation via endotracheal tube 150 is kept to a minimum.

[0113] Once ventilation via endotracheal tube 150 has been established, as Figure 1H illustrated, LMA intubation guide 110 can be removed from mouth 102 of subject 100, leaving endotracheal tube 150 in place to continue ventilation. In embodiments where LMA intubation guide 110 has laryngeal mask 120 with inflatable ventilation cuff 223, ventilation cuff 223 can be selectively deflated at this stage.

[0114] In some embodiments, LMA intubation guide 110 can be configured to break away along passageway 112 and laryngeal mask 120 to allow its removal, as Figure 1I illustrated. For example, in the case of exemplary LMA intubation guide 110 as Figures 2A-2F illustrated, this can be facilitated by defining a break line 117 in body 111, further details of which will be described in due course. In this embodiment, laryngeal mask 120 includes ventilation cuff 223, and a partition 224 can also be provided in ventilation cuff 223 as an effective extension of break line 117. It will be appreciated that when ventilation cuff 223 is of the inflatable type, this partition 224 can represent an airtight end wall of the inflatable volume of ventilation cuff 223.

[0115] In any case, when using such an LMA intubation guide 110, the method can comprise breaking away LMA intubation guide 110, as Figure 1I illustrated, to cause LMA intubation guide 110 to be removed while endotracheal tube 150 remains in place, as Figure 1J illustrated. Figure 5A and Figure 5B detailed views of LMA intubation guide 110 before and after it has been broken away, with endotracheal tube 150 extending through passageway 112 to thereby illustrate how this will allow LMA intubation guide 110 to be removed while leaving endotracheal tube 150 in its deployed position.

[0116] It will be appreciated that this method of breaking the LMA cannula guide 110 can avoid the need to pass the cannula guide 110 through the tube joint at the proximal end of the cannula 150, and can avoid the need to break the proximal end of the endotracheal tube 150, which would undesirably interrupt ventilation of the subject using the endotracheal tube 150. It can also avoid the risk of inadvertently dislodging the endotracheal tube 150 from its delivery position and potentially losing a secure airway during removal of the LMA cannula guide 110.

[0117] In an alternative example, the LMA cannula guide 110 can comprise a cutting mark (not shown) and be configured to be cut along the passage 112 by following the cutting mark. It will be appreciated that this would facilitate similar functionality to that discussed above for facilitating removal of the LMA cannula guide 110, without the need to provide a breakable portion in the construction of the LMA cannula guide 110, but with the added requirement of using a cutting tool.

[0118] The LMA cannula guide 110 can be designed to fit the passage 112 to the blade portion 142 of the cannula device 140 without having to create a margin for the tube fit. As will be discussed further in due course, this can help to reduce the leakage of ventilation gas around the blade portion 142 during the procedure.

[0119] It will be appreciated that the above method provides a new technique for allowing endotracheal intubation of a subject while providing a temporary airway using the LMA cannula guide 110. In the event of intubation difficulties, the LMA cannula guide 110 can be inserted to establish a temporary airway and ventilate the subject for the required time to stabilise the subject's condition before actually performing the endotracheal intubation procedure. In some cases, the LMA cannula guide 110 can be used to provide a temporary airway for a longer period of time until a suitably skilled person is available to perform the endotracheal intubation procedure.

[0120] In any case, given the above description of the method, it will be appreciated that the ability to perform a ventilated intubation procedure will be achieved by the specific design of the LMA cannula guide 110, which will now be described in further detail with reference to the following examples. Figures 2A-2F which will be described in further detail.

[0121] As described above, the LMA intubation guide 110 comprises an elongate body 111 defining a passageway 112 extending between a proximal opening 113 and a distal opening 114. The passageway 112 is configured to receive the blade portion 142 of the intubation device 140. The LMA intubation guide 110 further comprises a laryngeal mask 120 at the distal opening 114. The laryngeal mask 120 is for covering the larynx 104 of the subject 100. The LMA intubation guide 110 further comprises a ventilation airway 115 extending at least partially along the body 111. The ventilation airway 115 comprises a ventilation port 211 at a proximal end of the ventilation airway 115 for connection to a ventilator 130, and a ventilation hole 212 at a distal end of the ventilation airway 115 for allowing fluid communication between the ventilation airway 115 and the passageway 112 proximal to the laryngeal mask 120.

[0122] As described previously, the LMA intubation guide 110 is configured for insertion into the mouth 102 of the subject 100 so that the proximal opening 113 is positioned proximal to the mouth 102 of the subject and the laryngeal mask 120 is positioned proximal to the larynx 104 of the subject, thereby allowing the blade portion 142 of the intubation device 140 to be inserted into the passageway 112 of the LMA intubation guide for intubation of the subject 100 using the endotracheal tube 150 through the passageway, while the subject 100 is ventilated using the ventilation airway 115.

[0123] It will be appreciated that, after insertion of the LMA intubation guide 110 and prior to endotracheal intubation, the LMA intubation guide 110 allows ventilation of the subject 100 via the ventilation airway 115. Such ventilation can include oxygenation and can continue for a significant period of time if required. In some cases, the LMA intubation guide 110 can be used for ventilation only, or can be used for ventilation until the point at which it is decided that endotracheal intubation is required. It will therefore be appreciated that the LMA intubation guide can be configured to allow ventilation of the subject independently of intubation of the subject being performed.

[0124] The elongate body 111 of the LMA intubation guide 110 can be curved as described in the examples of Figures 2A-2F Such a curved configuration can be provided so that the LMA intubation guide 110 can better conform to the mouth 102 and airway anatomy of the subject 100 in use. However, it is not essential that the LMA intubation guide 110 be curved.

[0125] The LMA intubation guide 110 can be formed from different materials having different degrees of flexibility, as required. For example, embodiments of the LMA intubation guide 110 can be formed from a relatively flexible material, which can allow the LMA intubation guide 110 to be at least partially deformed to conform to the natural curvature of the mouth 102 and airway anatomy of the subject, in use. On the other hand, embodiments of the LMA intubation guide 110 can be formed from a relatively inflexible material, in which the curvature of the body 111 would need to be selected to conform to the anatomy of the subject, without relying on substantial deformation of the intubation guide 110.

[0126] It will be appreciated that the LMA intubation guide 110 can serve to allow the blade portion 142 of the intubation device 140 to be inserted into the airway of the subject 100 without interfering with the tongue and other anatomical structures of the subject, which can otherwise obstruct the insertion of the blade portion 142, in use. This is particularly advantageous, as the LMA intubation guide 110 can prevent direct visibility during the insertion of the blade portion 142. It will be appreciated that the LMA intubation guide 110 will generally serve to hold the tongue of the subject, and will generally depress the tongue, i.e. urge the tongue downwards. This can depend on the particular shape and configuration of the LMA intubation guide 110, including the curvature and flexibility discussed above.

[0127] The proximal opening 113 of the LMA intubation guide 110 is configured to allow the blade portion 142 to be inserted through the proximal opening 113 into the passageway 112 of the intubation guide 110. Preferably, the LMA intubation guide 110 will be designed to fit the intubation device 140, in particular the blade portion 142 thereof. The intubation device 140 and endotracheal tube 150 used in the procedure do not necessarily need to provide any particular adaptability for the ventilation endotracheal intubation procedure described above. Thus, the LMA intubation guide 110 can be provided separately to the intubation device 140 and endotracheal tube 150, provided that the correct type of intubation device 140 and corresponding blade portion 142 is selected for the LMA intubation guide 110.

[0128] As previously mentioned, the laryngeal mask 120 at the distal opening 114 of the LMA intubation guide 110 is configured to cover the larynx 104 of the subject 100. The ventilation airway 115 includes a ventilation port 211 at the proximal end of the ventilation airway 115 for connection to a ventilator, and a ventilation hole 212 at the distal end of the ventilation airway 115 for allowing fluid communication between the ventilation airway 115 and the passageway 112 proximal to the laryngeal mask 120.

[0129] Further preferred or optional features of the LMA intubation guide 110, and the associated advantages thereof, will now be described.

[0130] The LMA cannula guide 110 will generally be formed from a suitable medical grade plastic material, and in some embodiments can be transparent so as to enable the subject's anatomy to be seen in use. However, if a laryngoscope with video capability is used, it can not be necessary to use a transparent material.

[0131] The basic configuration of the laryngeal mask 120 can be similar to a conventional laryngeal mask of a known laryngeal mask airway device. The laryngeal mask 120 generally includes a ventilation mask cuff 223 that forms a seal around the subject's larynx 104. The cuff will generally encircle the proximal opening 113 of the LMA cannula guide 110.

[0132] As mentioned previously, the ventilation mask cuff 223 can be inflatable, in which case the ventilation mask cuff 223 will generally include an air-tight chamber formed from a flexible material. The ventilation mask cuff 223 can be inflated using an inflation conduit 121 that can be connected to the chamber of the ventilation mask cuff 123 via an inflation port 222, and can include an inflation connector 221 that is suitably configured for connection to an inflation source, such as an air-filled syringe, an external air supply line, or the like. The inflation conduit 121 can be formed from a thin tube that is of a length that can extend from the laryngeal mask 120, through the subject's pharynx 103 and mouth 102, so as to allow the inflation connector 221 to be accessed at a convenient location outside the mouth 102 after the LMA cannula guide 110 has been inserted, for example as shown in Figure 1B

[0133] The ventilation aperture 212 of the ventilation airway 115 will generally be located within the passageway, proximate the laryngeal mask 120. In some examples, the ventilation aperture 212 can be provided directly within the laryngeal mask 120, or otherwise proximate the distal opening 114 of the LMA cannula guide 110. In this case, the ventilation aperture 212 is located proximate the ventilation mask cuff 223 of the laryngeal mask 120, which can enable the ventilation gas to be supplied proximate the subject's larynx 104.

[0134] The ventilation airway 115 can be offset from the passageway 112 of the LMA cannula guide 110. In this case, the ventilation airway 115 is laterally offset relative to a central plane of the LMA cannula guide 110 that is aligned with the subject's sagittal plane when the laryngeal mask 120 covers the subject's larynx 104. However, this positioning is not essential, and different embodiments can have different ventilation airway 115 positions relative to other features of the LMA cannula guide 110.

[0135] In some embodiments, the ventilation aperture 212 can be specifically configured to direct the flow of ventilation gas towards the subject's larynx 104. This can help to ensure that the ventilation gas is less likely to escape from the proximal opening 113 of the LMA cannula guide 110 in the event of imperfect closure or sealing, or in the absence of a closure member. ​

[0136] With reference to Figures 2A-2F In the example shown, the ventilation airway 115 can comprise an airway body portion 214 extending along the body 111, and can further comprise an airway conduit portion 213 extending away from the proximal opening 113. Preferably, at least the airway body portion 214 is integrally formed with the body 111. Thus, the ventilation airway 115 can extend alongside the passageway in a closely parallel arrangement.

[0137] Preferably, the LMA cannula guide 110 will be configured to allow ventilation of the subject 100 using the ventilation airway 115 without allowing escape of ventilation gases from the proximal opening 113 prior to and during insertion of the blade portion 142 of the cannula device 140. In some embodiments, this can be achieved by providing the proximal opening 113 with a closure for covering the proximal opening 113, which can be left in place during ventilation but removed prior to insertion of the blade portion 142 through the proximal opening 113.

[0138] Following insertion, the blade portion 142 can be sufficient to substantially prevent escape of gases from the proximal opening 113. Once the cannulation procedure is complete, ventilation can continue via the endotracheal tube. Thus, the closure can be provided in the form of a removable cap or plug which can be applied to the proximal opening 113 using a range of different possible interfaces (such as a threaded connection, an interference fit, etc.) as required. Alternatively, the closure can be provided in the form of a movable cover, such as a hingedly attached barrier which can be pushed out of the way upon insertion of the blade portion 142.

[0139] In the present embodiment, as Figure 1D shown, the closure is provided in the form of a movable cap 116 which covers the proximal opening 113 and can be removed to allow insertion of the blade portion 142 through the proximal opening 113 as required. In this case, the cap 116 is engaged with the rim 201 surrounding the proximal opening 113 in an interference fit. The cap 116 can comprise a pull tab 202 or similar feature for allowing an operator to remove the cap 116 by grasping and pulling the tab 201. Figure 3A and Figure 3B Further views of the LMA cannula are shown with the cap 116 removed.

[0140] In some embodiments, for example in the example of the LMA cannula guide 810 shown in Figure 8 the LMA cannula guide 810 can comprise a seal 801 covering the proximal opening 113. The seal 801 can be configured to normally be in a closed position for sealing the proximal opening 113, and to be movable to an open position when the blade portion 142 of the cannula device 140 is inserted through the proximal opening 113. Returning to Figure 1EIt will be appreciated that when the blade portion 142 of the intubation device 140 is first inserted into the proximal opening 113, this can cause the seal 801 in the proximal opening 113 to move from a closed position to an open position, thereby allowing the blade portion 142 to pass through the proximal opening 113.

[0141] As noted above, when the blade portion 142 of the intubation device 140 is inserted through the proximal opening 113, the seal 801 can move from a normally closed position (e.g., as shown in Figure 8 In some embodiments, the seal 801 can include at least one resilient membrane configured to deform in response to the blade portion 142 abutting the seal 801, thereby defining an opening for receiving the blade portion 142.

[0142] In one example, the seal 801 can include two or more resilient membranes, each supported around a respective portion of the perimeter of the proximal opening 113, and each including a respective unsupported edge 802. The respective unsupported edges 802 can at least partially overlap in the closed position, and separate to define the opening in the open position. Although overlapping edges 802 are preferred for more effective sealing, in some examples the edges 802 can abut in the closed position without any overlap.

[0143] In other examples, the seal 801 can include two or more resilient membranes supported around the perimeter of the proximal opening 113. The respective apertures of each resilient membrane can differ in shape, position, or orientation from the apertures of the other resilient membranes. In other words, the seal 801 can include a plurality of fully supported membranes having misaligned or overlapping apertures (e.g., slits) to provide an enhanced sealing effect.

[0144] In another example, the seal 801 can include a single resilient membrane supported around the perimeter of the proximal opening 113. The single resilient membrane can include an aperture that is substantially closed in the closed position and stretched to define the opening in the open position. For example, in some embodiments the aperture can be a slit. In other embodiments, the aperture can be a pinhole, or can have any other geometry selected to allow a suitable opening to be formed to receive the blade portion 142 of the intubation device 140. For example, the aperture can be cruciform or H-shaped.

[0145] The at least one resilient membrane can be formed from any suitable membrane material, although typically a thin, flexible polymeric material will be used. It can also be desirable to form the membrane from a transparent material, as noted above with respect to the LMA intubation guide 110.

[0146] It will be appreciated that when the blade portion 142 is received in the proximal opening 113 (e.g., as shown in Figure 4A andFigure 4B As shown, the seal 801 can be in an open configuration, but can still provide an effective seal around the blade portion 142 to substantially prevent the escape of ventilation gas around the blade portion 142 during intubation procedures. The degree of sealing or leakage will depend on the design of the seal 801, as well as the design of the blade portion 142. For example, if the seal 801 is configured to stretch around the blade portion 142 in the open position, a substantially airtight seal can be formed even when the blade portion 142 extends through the proximal opening 113.

[0147] It can be appreciated that some leakage can still occur via the passage 401 extending through the blade portion 142 to allow for the delivery of the endotracheal tube 150, particularly in the open passage design described. In some examples, the intubation device 140 can be designed to include a passage seal described in WO / 2016 / 090435 Al (not shown). Such a passage seal can be used to prevent the escape of gas from the ventilation port 122 along the passage 401. However, this is not necessary, and in some designs of the intubation device 140, the endotracheal tube 150 can fit within the passage 401 so as to not provide a significant leakage path, and the seal 801 can sufficiently conform to the blade portion to prevent substantial leakage.

[0148] Figure 9 Another embodiment of the LMA intubation guide 110 is shown in which a separate removable cap seal component 901 can be provided in place of the cap 116 to provide a similar seal 801 as shown previously. The cap seal component 901 can also have a slightly different design compared to the previous cap 116, particularly in that the cap seal component 901 can have a removal tab 902 extending to one side of the cap seal component 901 to allow for removal with a peeling action rather than a pulling action.

[0149] In addition, the cap seal component 901 can include an integral seal 801 for covering the proximal opening 113 that is normally in a closed position for sealing the proximal opening 113, and is movable to an open position when the blade portion 142 of the intubation device 140 is inserted through the proximal opening 113 to function in a similar manner to the seal 801 of the earlier described embodiments of the shielded intubation tube 810 in WO / 2016 / 090435 Al. Figure 8 The seal 801 of the cap seal component 901 can include a seal membrane having one or more slits 802 or other apertures formed therein to allow for the insertion of the blade portion 142 in a similar manner to the seal 801 of the earlier described embodiments of the shielded intubation tube 810 in WO / 2016 / 090435 Al.

[0150] As with the lid 116 and seal 801 described above, the lid sealing member 901 is intended to prevent escape of ventilation gas from the proximal opening 113 when ventilating the subject 100. Preferably, this can be achieved by partially sealing the proximal opening 113 around any inserted objects, even when a laryngoscope blade and endotracheal tube are located within the proximal opening 113. If the laryngoscope blade and endotracheal tube are removed, the seal will return to its original closed position, thereby reforming a complete seal.

[0151] It will be appreciated that by providing the seal 801 in a separate lid sealing member 902, this enables the lid sealing member 902 to be formed from a suitable resilient material, such as silicone or rubber, whereas the LMA insertion guide 910 can be formed from a different material. This can greatly simplify the manufacture of the LMA insertion guide 910.

[0152] It will also be appreciated that the use of a detachable lid can be particularly desirable for use with video or direct vision laryngoscopes, thereby allowing the user to have unobstructed line of sight into the proximal opening 113 and through the passage 112.

[0153] It will be appreciated that when the blade portion 142 of the intubation device 140 is inserted through the passage 112, particularly when the distal tip 143 is moved into position to allow the endotracheal tube 150 to be advanced through the larynx 104 to the subject's trachea 105, this can allow the LMA insertion guide 110 to move relative to the subject's anatomy.

[0154] With reference to Figure 2C and Figure 2D With reference to the detailed example of the LMA insertion guide 110 shown, it can be seen that the elongate body 111 can be defined as a thin-walled body to define the passage 112. The body 111 is typically formed from a rigid, semi-rigid or flexible material, such as a suitable medical grade plastic material. As mentioned above, transparency can be a desirable quality, but is not essential.

[0155] In some alternative examples, the LMA insertion guide 110 can comprise a flange (not shown) around the proximal opening 113. This flange can be configured to help correctly insert the LMA insertion guide 110 by abutting the subject's mouth 102, thereby ensuring that the proximal opening 113 remains positioned outside the mouth. However, if such a flange is provided, it should not prevent full insertion of the LMA insertion guide 110, thereby allowing the laryngeal mask 120 to be positioned correctly to provide a seal over the larynx 104 of the subject 100.

[0156] As mentioned above, it is desirable to provide an LMA intubation guide 110 which is configured to break along the passageway 112 and the laryngeal mask 120 to facilitate removal of the LMA intubation guide 110 whilst the endotracheal tube 150 remains in situ.

[0157] In this particular example, the body 111 of the LMA intubation guide 110 includes a break line 117 extending longitudinally along one side of the passageway 112 to thereby allow the LMA intubation guide 110 to break along the break line 117.

[0158] The break line 117 can be formed by providing a region of material which is significantly thinner than the material from which the wall of the body 111 is manufactured, such that when the opposing sides of the body 111 are forcibly pulled apart, the thinner region will be broken. Hinge lines can be defined on opposing sides of the passageway 112 such that the intubation guide 110 can break into two hingedly connected parts to assist in removal whilst the endotracheal tube 150 remains in situ.

[0159] In this case, it will be seen that the break line 117 is defined along the central plane of the intubation guide 110. This break line 117 will align with the sagittal plane of the subject in use. However, it will be appreciated that the particular configuration of the break line 117 in the configuration described is not essential and that the LMA intubation guide 110 can include different arrangements to allow it to break to facilitate its removal.

[0160] As mentioned above, the break line 117 can extend through the ventilation cuff 223 in the form of a partition 224 in the ventilation cuff 223, which can be seen in use in Figure 5A and Figure 5B Thus, when the body 111 of the LMA intubation guide 110 is split to allow removal of the LMA intubation guide 110 whilst leaving the endotracheal tube 150 in situ, the ventilation cuff 223 of the laryngeal mask 120 will open at the partition 224.

[0161] The proximal opening 113 and the passageway 112 of the LMA intubation guide 110 will generally have a cross-sectional shape selected to receive the blade portion 142 of the intubation device 140. Thus, it will be appreciated that the particular cross-sectional shape will depend on the design of the intubation device 140. The proximal opening 113 and the passageway 112 will accommodate the cross-sectional shape of the blade portion 142 as shown in Figure 4B However, this shape can vary depending on the particular shape of the blade portion 142 at different points along its length.

[0162] Accordingly, the shape of the proximal opening 113 and the passage 112 can be selected based on the cross-sectional shape of the blade portion 142 of the intubation device 140. As noted above, the LMA intubation guide 110 can be curved, and if so, the curvature of the LMA intubation guide 110 can be selected based on the curvature of the blade portion 142 of the intubation device 140.

[0163] The degree of curvature can also depend on a range of other factors, including the flexibility of the material used to form the body 111 and the airway anatomy of the subject. For example, as noted above, the use of a more flexible material can allow a straight or relatively uncurved body 111 to deform and conform to the blade portion 142 and / or the airway of the subject in use. It will be appreciated that if the body 111 is formed from a relatively flexible material, its curvature can be less important. However, it should be noted that in order to prevent the LMA intubation guide 110 from collapsing when inserted into the mouth of the subject, its flexibility will have a practical limit.

[0164] Furthermore, the use of a relatively more flexible material to form the body 111 of the intubation guide 110 can allow different sizes and shapes of blade portion 142 to be accommodated, whereas the use of a relatively more rigid material can limit the range of blade types, such that different LMA intubation guides 110 can need to be selected for different sizes and shapes of blade portion 142.

[0165] It should be noted that a range of different shapes and sizes of LMA intubation guide 110 can be provided to accommodate a range of different types, shapes and sizes of blade that can be used with the intubation device, to suit patients of different ages, sizes and anatomies. For example, different LMA intubation guides 110 can be provided for use with children, adults or obese subjects, and will be selected to correspond to the selected blade of the particular subject.

[0166] However, some of the techniques described above, such as the use of a flexible material to form the LMA intubation guide 110, can allow the same LMA intubation guide 110 to be used with a range of different blades.

[0167] The size of the proximal opening 113 and the passageway 112 can be selected based on the cross-sectional dimension of the blade portion 142 of the cannula device 140. In some examples, the proximal opening 113 of the LMA cannula guide 110 can be deliberately configured to be smaller in size than the corresponding cross-sectional dimension of the blade portion 142 of the cannula device 140. Similarly, the passageway 112 of the LMA cannula guide 110 can be deliberately configured to be smaller in size than the corresponding cross-sectional dimension of the blade portion 142 of the cannula device 140. Providing a proximal opening 113 and / or passageway 112 of smaller size can ensure a tight fit, which helps to seal against gas escaping around the blade portion 142 at the interface of the blade portion 142 with the proximal opening 113 and passageway 112.

[0168] This sealing effect can be more pronounced if a flexible material is used to form the LMA cannula guide 110, as this can result in the proximal opening and / or passageway 112 being significantly smaller in size than the corresponding cross-sectional dimension of the blade portion 142, and stretching to accommodate the blade portion 142 in use. In this regard, it will be appreciated that the LMA cannula guide 110 can be configured to expand upon receipt of the blade portion 142. Thus, forming the LMA cannula guide 110 from an expandable material can allow the blade portion 142 to be more tightly enclosed in the LMA cannula guide 110 in use.

[0169] In some embodiments, the LMA cannula guide can additionally comprise a gastric tube conduit, thereby enabling the gastric tube to be additionally advanced into the oesophagus of the subject via the gastric tube conduit, using a method as shown in Figures 6A-6F

[0170] Referring to Figure 6A , in a similar manner to the method of ventilation endotracheal intubation using the LMA cannula guide 110 described above, the method begins with the subject 100 lying in a supine position. Again, the head 101 of the subject can be tilted to adjust the relative positions of the mouth 102, pharynx 103 and larynx 104 of the subject, in order to better access the larynx during the procedure.

[0171] In Figure 6A , the LMA cannula guide 610 is provided for insertion into the mouth 102 of the subject 100, but in this case the LMA cannula guide 610 further comprises a gastric tube conduit 611. Further details of this example of the LMA cannula guide 110 can be seen in Figure 7A and Figure 7B .

[0172] ​This version of LMA intubation guide 610 can have substantially the same construction as the previously described versions of LMA intubation guide 110, except for the additional inclusion of a gastric tube conduit 611. Thus, LMA intubation guide 610 will generally comprise an elongate body 111 defining a passageway 112 extending between a proximal opening 113 and a distal opening 114, a laryngeal mask 120 positioned at the distal opening 114, and a ventilation conduit 115 extending at least partially along the body 111.

[0173] As with the previous ventilation intubation methods, as Figure 6B shown, the LMA intubation guide 610 is inserted into the mouth 102 of the subject 100. When the LMA intubation guide 610 is correctly inserted, the laryngeal mask 120 will be positioned proximate the larynx 104 of the subject 100, and the proximal opening 113 will be positioned proximate the mouth 102 of the subject 100. The larynx 104 of the subject 100 will be covered by the laryngeal mask 120. If the inflatable ventilation mask cuff 223 is provided, it can be inflated to form a seal around the larynx 104.

[0174] With regard to Figure 6C , once the LMA intubation guide 610 has been inserted such that the larynx 104 of the subject is covered by the laryngeal mask 120, the subject 100 can be ventilated using the ventilation conduit 115 of the LMA intubation guide 610. As described above, this can involve connecting the ventilator 130 to the ventilation conduit 115 such that ventilation gas can be supplied via the ventilation conduit to a delivery point proximate the laryngeal mask 120.

[0175] Ventilation of the subject 100 can continue as Figure 6C shown, and in this regard it will be appreciated that the LMA intubation guide 610 can be used in a manner similar to a conventional laryngeal mask ventilation conduit device.

[0176] Turning to Figure 6D , while the subject 100 is being ventilated, the gastric tube 620 can be fed through the gastric tube conduit 611.

[0177] With regard to Figure 7A and Figure 7B , it will be seen that the gastric tube conduit 611 can extend along the body 111 and comprise a gastric tube conduit port 701 at the proximal end of the gastric tube conduit 611 and a gastric tube aperture 702 at the distal end of the gastric tube conduit. The gastric tube aperture 702 is generally configured to allow a gastric tube to be advanced from the gastric tube aperture 702 into the oesophagus. In this example, the gastric tube aperture 702 is positioned outside of the laryngeal mask 120 and the passageway 112, but this positioning will depend on the design of the laryngeal mask and the position of the gastric tube aperture 702 relative to the oesophagus 601. The gastric tube aperture 702 is preferably positioned proximate the distal most end of the laryngeal mask 120 so as to place the gastric tube as close to the oesophagus as possible.

[0178] Then, the distal end 621 of the gastric tube 620 can be advanced from the gastric tube 611 through the gastric tube opening 702 and into the esophagus 601 of the object 100, as... Figure 6E As shown. The gastric tube orifice 702 is preferably configured to be an object-oriented esophagus 601 in use, thereby helping to guide the gastric tube tip 621 into the esophagus 601.

[0179] Finally, as Figure 6F As shown, the gastric tube 620 can then be connected to the catheter 630, which in turn can be connected to an aspiration source or other medical device for use as needed.

[0180] according to Figures 6A-6F The sequence of steps shown indicates that the endotracheal intubation method described above can be followed in a similar manner. Figures 1D-1J The manner shown and described is as follows.

[0181] It is understood that the LMA intubation guide 610 can be configured to allow the insertion of the gastric tube 620 independently of ongoing intubation of the subject. Furthermore, it should be understood that the LMA intubation guide 610 can be configured to still allow ventilation of the subject independently of ongoing intubation. Therefore, the gastric tube 611 will preferably be disposed separately from the access 112 to allow the insertion of the gastric tube 620 without interfering with other ventilation and endotracheal intubation functions of the LMA intubation guide 610 as described above.

[0182] Turn again Figure 7A and Figure 7B It will be observed that the gastric tube 611 can be offset from the access route 112 in a manner similar to that of the ventilation airway 115. The gastric tube 611 can also be laterally offset relative to the central plane of the LMA cannulation guide 110. In some examples, the ventilation airway 115 and the gastric tube 611 can be offset from the access route 112 on opposite sides. Furthermore, the gastric tube 611 can be integrally formed with the body 111 of the LMA cannulation guide in a manner similar to the airway body portion 214 of the ventilation airway 115 extending along the body 111. However, this positioning is not mandatory, and different embodiments may have different positions of the gastric tube 611 relative to other features of the LMA cannulation guide 110.

[0183] Figure 10A and Figure 10B This is a cross-sectional view illustrating the steps of manually advancing an endotracheal tube using a conventional laryngoscope with an LMA intubation guide 110 of the first example. It should be understood that... Figure 10A and Figure 10B The steps described in the text effectively replace the reference. Figures 1A-1J The described method is in Figure 1E andFigure 1F The steps described herein are performed, but a conventional laryngoscope is used as the intubation device 140 instead of the previously shown single-handed intubation device version. It is understood that the conventional laryngoscope in this example can be a direct-view laryngoscope or a video laryngoscope.

[0184] Assuming the viewing section 142 of the cannulation device 140 is inserted into the passage 112 of the LMA cannulation guide 110, roughly as described above... Figure 1E As described. However, just... Figure 10A In this case, the endotracheal tube 150 is provided separately from the intubation device 140. (Continue to...) Figure 10B The endotracheal tube 150 is manually advanced along the viewing section 142 of the intubation device 140 and through the passage 112 to introduce the tip 151 of the endotracheal tube 150 into the subject's trachea 105. The remainder of the method can then be continued, generally as previously described with reference to Figures 1G to 1G. Figure 1J As stated above.

[0185] Understandably, when using a conventional laryngoscope as an intubation device 140 in this manner, the user will typically hold the handle 141 of the intubation device 140 with one hand while manually advancing the endotracheal tube 150 with the other hand.

[0186] In any case, it is understood that the above-described methods and different embodiments of the LMA intubation guide can allow endotracheal intubation in which ventilation is provided via the laryngeal mask airway throughout the procedure to reduce the associated risk of loss of ventilation during the procedure, while using familiar intubation devices.

[0187] In this specification and the appended claims, unless the context otherwise requires, the word "comprising" and variations such as "including" shall be understood to mean including the said integer or set of integers or steps, but not excluding any other integer or set of integers. As used herein, unless otherwise stated, the term "about" means ±20%.

[0188] It is important to note that, as used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural references unless the context clearly indicates otherwise. Thus, for example, a reference to “a support” includes multiple supports. In this specification and the following claims, several terms will be referenced and will be defined as having the following meanings unless there is a clear intention to the contrary.

[0189] It will certainly be appreciated that, although the foregoing is given by way of illustrative example of the invention, all such and other modifications and variations will be considered to fall within the broad scope and range of the invention as set forth herein by those skilled in the art.

Claims

1. A laryngeal mask airway (LMA) intubation guide for use in endotracheal intubation procedures and ventilation of a subject, the LMA intubation guide comprising: a. an elongated body defining a passageway extending between a proximal opening and a distal opening, the passageway configured for receiving a blade portion of an intubation device, the blade portion being a laryngoscope blade; b. a laryngeal mask at the distal opening, the laryngeal mask for covering a larynx of the subject; and c. a ventilation airway extending along the body, the ventilation airway being offset from the passageway, and the ventilation airway comprising: i) a ventilation port at a proximal end of the ventilation airway for connection to a ventilator; ii) an airway body portion extending along the body; and iii) a ventilation aperture at a distal end of the ventilation airway for allowing fluid communication between the ventilation airway and the passageway proximate the laryngeal mask, the ventilation aperture being internal to the passageway proximate the laryngeal mask, the ventilation aperture being configured to direct a flow of ventilation gas toward the larynx of the subject, wherein the LMA intubation guide is configured to be inserted into a mouth of the subject so that the proximal opening is positioned proximate the mouth of the subject and the laryngeal mask is positioned proximate the larynx of the subject, thereby allowing the blade portion of the intubation device to be inserted into the passageway of the LMA intubation guide to allow intubation of the subject using an endotracheal tube through the passageway while the subject is ventilated using the ventilation airway. The laryngeal mask includes a cuff for forming a seal around the larynx of the subject.

2. The LMA intubation guide of claim 1, wherein, The cuff is inflatable.

3. The LMA intubation guide of claim 2, wherein, The ventilation airway is laterally offset relative to a central plane of the LMA intubation guide, the central plane being aligned with a sagittal plane of the subject when the laryngeal mask covers the larynx of the subject.

4. The LMA intubation guide of claim 1, wherein, At least the airway body portion is integrally formed with the body.

5. The LMA intubation guide of claim 1, wherein, The ventilation airway includes an airway conduit portion extending distally from the proximal opening.

6. The LMA intubation guide of claim 1, wherein, The LMA intubation guide includes a closure for covering the proximal opening when the blade portion is not inserted through the passageway.

7. The LMA intubation guide of claim 1, wherein, The LMA intubation guide includes a seal covering the proximal opening, the seal being in a closed position to seal the proximal opening under normal circumstances and being movable to an open position when the blade portion of the intubation device is inserted through the passageway.

8. The LMA intubation guide of claim 1, wherein, The seal includes at least one resilient membrane configured to deform in response to the blade portion abutting the seal to define an opening for receiving the blade portion.

9. The LMA intubation guide of claim 8, wherein, The seal includes a resilient membrane supported around a perimeter of the proximal opening, the resilient membrane including an aperture that is substantially closed in the closed position and stretched to define the opening in the open position.

10. The LMA intubation guide of claim 9, wherein, The aperture is a slit.

11. The LMA intubation guide of claim 10, wherein, ​ 12. The LMA intubation guide of claim 10, wherein, The seal includes two or more elastic membranes supported around the perimeter of the proximal opening, respective apertures of each elastic membrane differing from apertures of other elastic membranes in at least one of: shape; position; and orientation.

13. The LMA intubation guide of claim 9, wherein, The seal includes two or more elastic membranes, each of the elastic membranes being supported around a respective portion of the perimeter of the proximal opening, and each of the elastic membranes including a respective unsupported edge, the unsupported edges at least partially overlapping in the closed position and separating in the open position to define the opening.

14. The LMA intubation guide of claim 8, wherein, The seal is biased towards the closed position, such that the seal returns to the closed position when the blade portion of the intubation device is removed from the passageway.

15. The LMA intubation guide of claim 14, wherein, The seal is configured to form a partial seal around at least one of the blade portion of the intubation device and the endotracheal tube in use.

16. The LMA intubation guide of claim 1, wherein, The LMA intubation guide includes a detachable cover for closing the proximal opening when the blade portion of the intubation device is not inserted into the passageway of the LMA intubation guide.

17. The LMA intubation guide of claim 16, wherein, The cover includes a seal for covering the proximal opening, the seal being in a closed position to seal the proximal opening in normal circumstances, and being movable to an open position when the blade portion of the intubation device is inserted through the passageway.

18. The LMA intubation guide of claim 1, wherein, The LMA intubation guide includes a flange around the proximal opening.

19. The LMA intubation guide of claim 18, wherein, The flange is configured to prevent over-insertion of the LMA intubation guide by abutting the subject's mouth, thereby ensuring that the proximal opening remains external to the mouth.

20. The LMA intubation guide of claim 1, wherein, The LMA intubation guide is configured to break along the passageway and the laryngeal mask.

21. The LMA intubation guide of claim 20, wherein, The body of the LMA intubation guide includes a break line extending longitudinally along one side of the passageway and the laryngeal mask, to thereby allow the LMA intubation guide to break along the break line.

22. The LMA intubation guide of claim 21, wherein, The break line is defined along a centre plane of the LMA intubation guide.

23. The LMA intubation guide of claim 1, wherein, The LMA intubation guide is formed of a flexible material.

24. The LMA intubation guide of claim 23, wherein, The LMA intubation guide is configured to expand upon receiving the blade portion.

25. The LMA intubation guide of claim 1, wherein, The LMA intubation guide is curved.

26. The LMA intubation guide of claim 1, wherein, The LMA intubation guide includes a gastric tube conduit for allowing a gastric tube to be advanced into the oesophagus of the subject via the gastric tube conduit.

27. The LMA intubation guide of claim 26, wherein, The gastric tube conduit extends along the body and includes a gastric tube conduit port at a proximal end of the gastric tube conduit and a gastric tube aperture at a distal end of the gastric tube conduit for allowing the gastric tube to be advanced into the oesophagus from the gastric tube aperture.

28. The LMA intubation guide of claim 27, wherein, The gastric tube aperture is external to the laryngeal mask and the passageway.

29. The LMA intubation guide of claim 28, wherein, The gastric tube aperture is configured to face the oesophagus of the subject in use.

30. The LMA intubation guide of claim 26, wherein, The gastric tube conduit is offset from the passageway.

31. The LMA intubation guide of claim 30, wherein, The ventilation airway and the gastric tube conduit are offset from the passageway on opposite sides of the passageway.

32. The LMA intubation guide of claim 26, wherein, The LMA intubation guide is configured to allow insertion of the gastric tube independently of ongoing intubation of the subject.

33. The LMA intubation guide of claim 1, wherein, The LMA intubation guide is configured in use to at least one of: a. hold the tongue of the subject; and b. depress the tongue.

34. The LMA intubation guide of claim 1, wherein, The LMA intubation guide is configured to allow ventilation of the subject independent of ongoing intubation of the subject. The LMA intubation guide is configured to allow ventilation of the subject independent of ongoing intubation of the subject.

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