An intubation device for endotracheal intubation through a laryngeal mask airway and method of use thereof

Abstract

An intubation device, and method of use thereof, configured to be passed through a laryngeal mask airway (LMA) stabilised in a patient. The intubation device can replace the LMA and the LMA may be removed from the patient over the top of the intubation device. The intubation device may be loaded over a fibre optic intubation scope and comprise alignment members to ensure an end of the fibre optic scope remains cantered within an outlet end of the intubation device.

Description

AN INTUBATION DEVICE FOR ENDOTRACHEAL INTUBATION THROUGH A LARYNGEAL MASK AIRWAY AND METHOD OF USE THEREOFFIELD OF THE INVENTION

[0001] The invention relates to an intubation device, preferably for endotracheal intubation through a laryngeal mask airway, and method of use thereof. In particular, the invention relates, but is not limited, to endotracheal intubation of a patient that has a laryngeal mask airway inserted into their larynx with the device preferably, but not necessarily, used over a fibre optic intubation scope.BACKGROUND TO THE INVENTION

[0002] Reference to background art herein is not to be construed as an admission that such art constitutes common general knowledge.

[0003] Airway intubation, such as tracheal intubation or supraglottic intubation, often referred to as simply ‘intubation’, is the placement of tubing into a patient to maintain an open airway in patients that need their respiratory system supported. Airway intubation can also be used for the administration of inhalational anaesthetic agents into the lungs and to protect the airway in an unconscious patient. Such intubation is typically carried out with an endotracheal tube and / or a laryngeal mask airway (LMA), often referred to as simply a ‘laryngeal mask’.

[0004] Such laryngeal masks have been in use for decades and have, to some extent, superseded endotracheal tubes to maintain an airway while delivering anaesthesia to a patient as they are typically easier, faster and take less skill to deploy. Laryngeal masks have also recently been used by clinicians who are not skilled in the art of endotracheal intubation to place an airway in a patient in an emergency situation as they are easier to insert and require less skill and training than endotracheal intubation.

[0005] Laryngeal mask airways do not, however, secure an airway in the same manner as an endotracheal tube as soiling of the lungs with secretions or gastric regurgitant around the mask is possible and the pressure that is able to be applied through the mask to inflate the lungs for ventilation of the patient is limited. Endotracheal intubation with an endotracheal tube is therefore often considered the ‘gold standard’ for securing an airway.

[0006] Situations arise where a patient has a laryngeal mask airway placed in their larynx but subsequently require their airway to be secured by an endotracheal tube. Standard endotracheal tubes are too short to be reliably placed in the trachea through a laryngeal mask airway. Further when withdrawing the laryngeal mask over the endotracheal tube to remove it they require some form of stabilisation to prevent extubation. A known method of endotracheal intubation through a laryngeal mask airway is therefore to interrupt ventilation of the patient while the laryngeal mask is removed over the endotracheal tube. A solid pushing rod is used to maintain the position of the endotracheal tube while the laryngeal mask is removed over the endotracheal tube from the larynx of the patient, necessarily interrupting ventilation.

[0007] An intermediary tube may be employed to increase the length of the endotracheal tube to give it the required length to allow intubation through the laryngeal mask. However, there is a risk of dislocating the endotracheal tube from the trachea as the intermediary tube needs to be disconnected before the laryngeal mask airway is removed. The junction of the two tubes is further prone to disconnection when manipulating a fibre optic scope, airway tube, and laryngeal mask. The connection of the tubes is also necessarily situated within the lumen of the laryngeal mask tube making disconnection difficult.

[0008] The inflation lines of a standard endotracheal tube connecting a cuff at an inlet end of the endotracheal tube to a balloon and inflation valve are also too short and can become stuck between an outer wall of the endotracheal tube and an inner wall of the laryngeal mask airway when it is being withdrawn over the endotracheal tube. This can result in extubation and loss of the airway or rupture of the inflation balloon or inflation line. The short length of the inflationline prevents removal of the laryngeal mask unless the solid pushing rod or distal tube are removed to allow the pilot balloon and inflation valve to be delivered through the airway tube of the laryngeal mask.OBJECT OF THE INVENTION

[0009] It is an aim of this invention to provide an intubation device which overcomes alleviates one or more of the disadvantages or problems described above, or which at least provides a useful alternative and / or commercial choice.

[0010] Other preferred objects of the present invention will become apparent from the following description.SUMMARY OF INVENTION

[0011] In one form, although it need not be the only or indeed the broadest form, there is provided an intubation device comprising a tubular body having an inlet end and an outlet end, wherein the inlet end has connector with an internal diameter not less than an internal diameter of the tubular body and the outlet end having an inflatable cuff configured to be manoeuvrable and locatable in the trachea of a patient over a fibre optic scope

[0012] The outlet end may be configured to pass through airway tubing and / or a lumen of a laryngeal mask located in the larynx of the patient. The tubular body may be configured to pass through airway tubing and / or a lumen of a laryngeal mask located in the larynx of the patient.

[0013] The connector may be fitted to an external surface of the inlet end of the tubular body.

[0014] The tubular body may comprise a reinforced portion. The tubular body may comprise an unreinforced portion. The reinforced portion may be reinforced with wire. The reinforced portion may be reinforced with filament. The unreinforced portion may be polyvinyl chloride (PVC). The reinforce portion and / or unreinforced portion may be flexible. The reinforced portion may be resilient. The unreinforced portion may be cuttable. The reinforced portion maybe at or towards the outlet end of the tubular body. The unreinforced portion may be at or towards the inlet end of the tubular body, the reinforced portion and unreinforced portion may join approximately 1 to 4cm, preferably 2 to 3cm, distal to the incisor teeth of the patient. The unreinforced portion may be configured to be shortened to reduce dead space. The unreinforced portion may be shortened by being cut.

[0015] The intubation device may further comprise one or more alignment members to keep the fibre optic scope centred in the outlet end of the tubular body. The one or more alignment members comprise a plurality of radially spaced internal projections at the outlet end of the tubular body. The plurality of radially spaced internal projections at the outlet end of the tubular body comprise projections moulded into the outlet end of the tubular body. The projections may be triangle shaped, rounded, fins, ribs, or the like. The radially spaced internal projections may comprise three projections approximately 120 degrees apart.

[0016] The inflatable cuff may be fluidly connected to an inflation tube. The inflation tube may have an integrated portion that is integral with the tubular body. The integrated portion may be located internally to the tubular body. The inflation tube may have a free portion located externally to the tubular body.

[0017] The inflation tube may comprise a cuff connector. The cuff connector may allow removable connection of an inflation valve and / or pilot balloon fluidly connected or connectable to the inflatable cuff. The cuff connector may comprises a hollow elongate body. The cuff connector may have at least one end that is removably connectable the inflation tube. The cuff connector may have one end affixed to tubing. The end affixed to tubing may be fluidly connected to the inflation valve and / or pilot balloon.

[0018] The tubular body may have sufficient length to be positioned and stabilised in the trachea of the patient below the vocal cords while a laryngeal mask airway is removed from the patient over the intubation device. The tubular body may be at least 40cm long. The tubular body may be configured to allow any excess length once positioned and stabilised in the trachea of thepatient to be cut. The excess length may be an amount extending beyond incisors of the patient once positioned and stabilised in the trachea. A transition between a reinforced portion and an unreinforced portion of the tubular body may occur approximately 1 cm to 4cm, preferably 2cm to 3cm, beyond the incisors of the patient.

[0019] The tubular body may be continuous. The tubular body may have no joins or connectors between the inlet end and outlet end. The tubular body may comprise a single length of tubing.

[0020] According to another form, there may be provided a method of intubating a patient having a laryngeal mask airway located in their larynx to keep their airway open and ventilate their lungs, the method comprising: inserting a fibre optic scope through a tubular body of an intubation device; advancing the intubation device through tubing of the laryngeal mask airway such that an outlet end of the intubation device passes through a lumen of the laryngeal mask airway; stabilising the intubation device in the airway of the patient; and removing the laryngeal mask airway.

[0021] The method may further comprise disconnecting an inflation balloon and / or valve from the intubation device to allow passage through the lumen of the laryngeal mask airway. The method may further comprise cutting excess tubing of the intubation device distal of the incisor teeth of the patent once stabilised in the trachea of the patent. The intubation device may be the intubation device as hereinbefore described.

[0022] Further features and advantages of the present invention will become apparent from the following detailed description.BRIEF DESCRIPTION OF THE DRAWINGS

[0023] By way of example only, preferred embodiments of the invention will be described more fully hereinafter with reference to the accompanying figures, wherein:

[0024] Figure 1 illustrates an intubation device;

[0025] Figure 2 illustrates the standard 15mm ISO connector inserted into the distal end of an endotracheal tube (prior art);

[0026] Figure 3 illustrates a cross sectional view of tubing of the intubation device of figure 2 (prior art);

[0027] Figure 4 illustrates a longitudinal cross sectional view of an end of an intubation device;

[0028] Figure 5 illustrates a transverse cross sectional view of a tubing portion of an intubation device;

[0029] Figure 6 illustrates a laryngeal mask airway inserted into a patient’s larynx (prior art);

[0030] Figure 7 illustrates a distal end of an intubation device being loaded over a fibre optic scope being inserted through the lumen of the laryngeal mask airway tube;

[0031] Figure 8 illustrates a fibre optic scope positioned in the trachea of a patient and an intubation device being advanced over the stabilised scope through the larynx and into the trachea;

[0032] Figure 9 illustrates an intubation device placed in the trachea of a patient with the cuff inflated and the laryngeal mask being withdrawn from the larynx and mouth over the intubation device;

[0033] Figure 10 illustrates a side view of a connector; and

[0034] Figure 11 illustrates a cross sectional view of the connector of figure10.DETAILED DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 illustrates an intubation device 10 comprising a tubular body 100 having an inlet end 120 and an outlet end 140. The tubular body 100 is hollow and configured to allow passage of gases, such as air, oxygen, and / or inhalational anaesthetic agents therethrough. The tubular body 100 has areinforced portion 104 and an unreinforced portion 102. The reinforced portion 104 may be reinforced with wire or other suitable resilient material, as is known in the art. The unreinforced portion 102 may be clear PVC or other suitable unreinforced tubing material known in the art. The reinforced portion 104 is located adjacent the outlet end 140 of the tubular body 100 and the unreinforced portion is located adjacent the inlet end 120 of the tubular body.

[0036] The reinforced portion 104 of the tubular body 100 preferably extends at least a substantial portion of the tubular body 100 configured to be inserted into a patient. Typically, the reinforced portion 104 of the tubular body 100 will extends between approximately a quarter of the length of the tubular body 100 to approximately half of the length of the tubular body. A standard endotracheal tube is typically approximately 26 to 28 cm long and the junction 106 of the reinforced portion 104 and unreinforced portion 102 is typically less than this length. In the illustrated form the reinforced portion 104 may be approximately 18 to 20 cm long as indicated by the dimension indicia 108 printed thereon (noting that the reinforcement does not extend fully to the outlet end 140 of the tubular body 100).

[0037] The intubation device 10 has an inflatable cuff 160 fluidly connected by inflation tube 162 to inflation valve 180 and pilot balloon 182. The inflation tube 162 has an integrated portion 164 that is integral with, or located internally to, the tubular body 100, preferably the reinforced portion 104 of the tubular body 100. The inflation tube 162 also has a free portion 180 located externally to the tubular body 100. In a standard endotracheal tube the inflation tubing is typically around 26 to 28 cm long. The inflation tubing 162 is preferably longer than this length, even more preferably around 30 to 40 cm long. In the illustrated form, the inflation tubing 162 is approximately 34 cm long.

[0038] At the inlet end 120 of the tubular body 100 is a connector 122 that attaches to an outer surface of the tubular body 100. The connector 122 may facilitate connection of the intubation device 10 to standard medical equipment, such as a gas supply, as is known in the art.

[0039] Figures 2 and 3 illustrate how a standard 15mm ISO connector 22 typically fits into the lumen of the end of a standard endotracheal tube 20. This may be done to allow connection to a gas supply or to allow connection of endotracheal tube to an intermediary tube. However, doing so reduces the internal diameter 24 of the endotracheal tube 20 which limits the diameter of a fibre optic scope that could be introduced through the endotracheal tube 20 to achieve an endotracheal position before the endotracheal tube is advanced over the scope through the larynx into the trachea. This internal diameter 24 reduction is particularly problematic with paediatric endotracheal tubes that necessarily already have smaller internal diameters.

[0040] Figure 4 illustrates the outlet end 140 of the tubular body 100 of the intubation device 10. When using standard endotracheal tubes for endotracheal intubation over a fibre optic scope, the angle between the bevel 142 of the tube and the fibre optic intubation scope (not shown) causes the endotracheal tube to often become impinged or caught on the laryngeal structures preventing passage of the tube over the scope into the trachea. This then requires further manipulation and increases the complications of intubation including potential hypoxia.

[0041] To avoid or at least reduce this occurring, the outlet end 140 of the tubular body 100 has a plurality of alignment members 144 configured to keep the fibre optic scope centred within the tubing 100. The alignment members are preferably in the form of internal projections spaced radially. Figure 5 is a cross-sectional view across line ‘A’ in figure 4 showing three alignment members 144 spaced approximately 120 degrees apart around the longitudinal axis of the tubular body 100. The illustrated alignment members 144 are triangle shaped projections moulded into the outlet end 140 of the tubular body 100 but it should be appreciated that other shaped projections could be employed such as, for example, rounded projections or fins, or the like. The alignment members 144 preferably start on the internal wall of the intubation device 10 proximally and increase in height distally so not to impede the passage of the scope through the lumen of the tube.

[0042] In use, the intubation device 10 may be used to intubate a patient who already has a laryngeal mask airway (LMA) in place. Figure 6 illustrates a standard (prior art) laryngeal mask 30 inserted into the larynx of a patient 50 connectable to an airway / ventilation source (not shown) by connector 22. Figure 7 illustrates the laryngeal mask 30 with the airway connector 22 removed and an intubation device 10 loaded over a fibre optic intubation scope 40 that has been inserted into the lumen of the tubing 32 of the laryngeal mask 30.

[0043] Figure 8 illustrates the laryngeal mask 30 where the fibre optic scope 40 has been positioned in the trachea of the patient and is stabilised. The intubation device 10 has been placed over the scope 40 through the larynx and is now placed in the trachea. The connector 122 is mated with a connector with a port for the scope 40 and a connection to a gas / ventilation source (not shown). The inflation tubing 162 passes through the lumen of the laryngeal mask 30 which connects to the inflation balloon 182 and valve 180 which are proximal and exterior to the lumen of the laryngeal mask 30.

[0044] Figure 9 illustrates the laryngeal mask 30 where the intubation device 10 is now positioned in the trachea of the patient 50 with the cuff 160 in an inflated state. The laryngeal mask 30 has been partially removed over the tubular body 100 of the intubation device 10. Notably, the inflation device tubing 162 has sufficient length to allow the pilot balloon 182 and valve 180 to be delivered through the airway tubing of the laryngeal mask 30 distal to the inlet end 120 of the tubular body 100 of the intubation device 10.

[0045] Figures 10 and 11 illustrate an optional cuff connector 60 which has a hollow elongate body 600 with a fixed tubing end 610 and a removable tubing end 620. The fixed tubing end 610 may be permanently mounted, moulded, or affixed to its respective tubing. As seen better in the cross-sectional view of figure 11 , the removable tubing end 620 has a tapered opening 622 and a friction fit in the form of gripping ridges 624. The cuff connector 60 allows the pilot balloon and inflation valve to be removed from the inflation device tubing 162. This is particularly advantageous for small patients who use a size 0 or 1laryngeal mask 30 as the lumen of these masks is so small that even the pilot balloon and inflation valve can get caught and / or stuck.

[0046] To allow effective usage, the tubular body 100 is generally shorter than typical intubation scopes. The working length of the standard intubation scope is around 60 cm (A) and the length of the airway tube of the largest intubating laryngeal mask is around 18 cm (B). The length in the larynx from the distal lumen of the laryngeal mask to the vocal cords is approximately 3-6 cm (C). The intubation device 10 should be placed with the outlet end 140 at a depth of at least 5 cm (D) from the vocal cords of the patient 50 into the trachea. The connector 122 to the gas supply with the port to insert the fibre optic scope 40 adds around 2cm (E) to the proximal end of the endotracheal tube. With the intubation device 10 loaded onto the fibre optic scope 40 there should be at least around 7 cm (F) distal to the outlet end of the intubation device.

[0047] Taking these dimensions into account, in a large male the required length of the tubular body 100 will be at least 18cm (B) + 6cm (C) + 5cm (D) = 29cm. In contrast, the length of a large standard endotracheal tube is 28cm. The length of the intubation device 10 may be a maximum of 60 (A) - 7 (F) - 2(E) = 51cm.

[0048] For removal of the laryngeal mask airway over the intubation device in a large male the intubation device will be around 26cm (G) into the patient measured from the incisor teeth. To remove the scope 40 over the intubation device requires 2 cm (H) of tubing above the incisor teeth for the tube to be grasped to stabilize the intubation device 10 when removing the laryngeal mask. The length of the intubation device 10 therefore needs to be at least 26cm (G) + 2cm (H) +18cm (B)=46cm (I).

[0049] The junction of the inflation line 162 to the inflation balloon 182 and valve 190 should be 2cm distal to the outlet end 140 of the intubation device 10 and should be 46cm (I) + 2cm = 48cm from the inlet end 120 of the intubation device 10 so not to get caught between the outer surface of the intubation device tube 100 and the lumen of the laryngeal mask 30 when it is removed.

[0050] Notwithstanding the above dimensions, it should be appreciated that there is a wide variation between adult and child anatomical dimensions and the diameters of the intubation device 10 and the fibre optic scopes 40 all vary which should be considered in manufacturing appropriate intubation devices 10 for different aged and sized patients.

[0051] In typical use, a laryngeal mask airway 30 has typically already been placed in the patient’s larynx to keep the airway open and ventilate the lungs. The inlet end 120 of the intubation device 10 with the connector 122 having an internal diameter not less than an internal diameter of the tubular body, typically by being attached to the outer wall of the tubing 100, is then mated to a connector that has a port through which the fibre optic scope 40 may be inserted and an arm connecting the gas supply and ventilation mechanism. The fibre optic scope 40 is then inserted though this connector and through the lumen of the intubation device 10 until at least around 7cms of the distal end of the fibre optic scope 40 is proximal to the outlet end 140 of the intubation device 10. The laryngeal mask 30 located in the patient 50 is then disconnected from the gas supply and the intubation device 10 that has been loaded over the fibre optic scope 40 is then inserted through the lumen of the laryngeal mask 30. The complex is connected to the gas / ventilation source allowing ventilation and oxygenation of the patient 50 as soon as the outlet end 140 of the intubation device 10 is in the lumen of the laryngeal mask 30.

[0052] The intubation device 10 loaded over a fibre optic scope 40 is then advanced through the airway tube 32 of the laryngeal mask 30 until the anatomy of the larynx is visualized through the fibre optic scope 40. The distal 5cms of the scope 40 is passed through the vocal cords and into the trachea of the patient 50. The fibre optic scope 40 is then stabilised while the intubation device 10 may be ‘railroaded’ to advance it into the trachea. When the clinician is satisfied with the position of the intubation device 10 in the trachea the cuff 160 is inflated to secure the airway.

[0053] The cuff of the laryngeal mask 30 may then be deflated, and the intubation device 10 is then stabilised while the laryngeal mask 30 is withdrawnfrom the larynx over the intubation device 10. The position of the tube 100 in the trachea can still be visualised through the fibre optic scope 40. Once the tubing 100 of the intubation device 10 can be seen at the level of the patients’ teeth with the laryngeal mask 30 exiting the mouth it is grasped and stabilised.

[0054] The inflation line 162 is in between the lumen of the laryngeal mask 30 and the outer surface of the endotracheal tube with the balloon 182 and inflation valve 180 being proximal to the inlet end of the laryngeal mask 30. The scope 40 is then withdrawn from the intubation device 10 and the connector 122 disconnected from the inlet end 120 of the device to allow the balloon 182 and inflation valve 180 attached by the inflation tubing 162 to be fed through the lumen of the laryngeal mask 30 around 2cm distal to the inlet end 120 of the intubation device 10 as it is completely removed over the intubation device 10.

[0055] The excess length of the intubation device 10 distal to the patient’s incisor teeth (usually 3-6cms of tubing distal to the incisor teeth is adequate) may then be cut off and removed which reduces anatomical dead space and improves ventilation. A standard 15mm ISO connector may be inserted into the lumen of the new (cut) outlet end of the intubation device 10 allowing connection to the gas source and ventilation mechanism.

[0056] Advantageously, the intubation device 10 has allows a patient to be converted from a laryngeal mask airway (LMA) to an endotracheal airway in a controlled manner with minimal interruption. The intubation device 10 is configured to be passed through even the smallest LMAs allowing use in smaller patients such as children. The alignment members ensure the end of fibre optic scopes are cantered in the intubation device an less likely to be caught or injure the patient.

[0057] Features of certain aspects of the invention may be as follows:1 . An intubation device including: an airway ventilation device having tubing located between an inlet end and an outlet end, the outlet end being configured to be locatable in the trachea of a patient, the patient having a laryngeal mask airway already placed in the patients larynx, the intubation device being, preferably, loaded over a fibre optic scope before the scope and intubationdevice are then advanced through the airway tubing of the laryngeal mask airway, once the inlet end of the intubation device is located in the trachea the laryngeal mask airway may be completely removed over the intubation device.2. The intubation device of 1 having at the inlet end a removable 15mm connector designed to be fitted onto the external surface of the intubation device tubing as to not reduce the internal diameter of the tubing. Being removable allows the laryngeal mask airway to be removed over the intubation device. Not reducing the internal diameter of the intubation device allows it to be used over a fibre optic scope in smaller internal diameter endotracheal tubes for use in paediatric patients,3. The intubation device of 1 where the length of airway tubing (by way of example, calculated for the largest intubation device) from the inlet to the outlet end is increased from 28cm which is the standard large endotracheal tube size to 46cm(l) for the intubation device to allow for sufficient length for the tubing to be well positioned in the trachea below the vocal cords and still have still have sufficient length to be cut to an appropriate length, unlike the devices where the airway tubes are connected to form a long tube resulting in the length of the proximal tube in the airway to be too short to allow sufficient length distal to the incisor teeth when the intermediate tube is removed.4. The intubation device of 1 and 3 where the intubation device is of sufficient length(l) to allow the intubation device to be stabilized with the inlet end positioned in the trachea, while the laryngeal mask airway is removed from the patient over the intubation device.5. The intubation device of 1 and 3 where the tubing of the airway device is continuous without a join between 2 tubes which is liable to become disconnected when manipulating the fibre optic scope through the connected tubing and when removing the laryngeal mask over the connected tubing. Further the connection between the tubes reduces the internal diameter of the tubing at the join preventing the use of fibre optic intubation scopes in the smaller internal diameter airway tubes.6. The intubation device of 1 and 3 where the patient is able to be connected to a gas source and ventilated while introducing the device into the trachea through the laryngeal mask airway and while removing the laryngeal mask airway over the intubation device unlike similar devices with an endotracheal tube and a solid pushing rod or an endotracheal tube connected to a proximal tube, the proximal tube needing to be removed before the laryngeal mask can be completely removed.7. The intubation device of 1 and 3 where the device may have clear PVC tubing or a combination of reinforced tubing and clear PVC tubing. The length of the reinforced tubing should be calculated that after the inlet end is placed in the trachea the reinforced tubing continues for 3cm distal to the patients’ teeth so as to prevent tube obstruction if the patient bites on the tube but allow the tube to be cut to a suitable length through the clear PVC tubing distal to the reinforced tubing and a 15mm connector introduced into the lumen of the tube to reduce the dead space and resistance to ventilation. The plain clear PVC tubing is similarly cut to length after the laryngeal mask has been removed over it.8. The intubation device of 1 where the inflation tubing is of sufficient length that it connects to the pilot balloon and inflation valve 2cm distal to the inlet end of the intubation device to allow the balloon and valve to trail above the inlet end of the intubation device when removing the laryngeal mask. This allows the whole tube to remain in place being stabilized at the teeth unlike the devices with a solid pushing rod or 2 tubes joined together where either the sold pushing rod or the distal tube of the 2 tubes joined must be disconnected from the proximal tube and removed from the lumen of the laryngeal mask airway as the inflation line is not of sufficient length and the pilot balloon and inflation valve would prevent removal of the laryngeal mask airway. This disconnection while the laryngeal mask is removed over the tubing has the potential for the tube to migrate from its position in the trachea with the potential of accidental extubation.9. The intubation device of 1 where the distal end of the intubation device in has a minimum of three moulded projections 120 degrees apart, projecting into the lumen of the intubation device to centre the fibre optic scope in the inlet lumen of the intubation device to reduce the incidence of impingement on laryngeal structures preventing the intubation device being advanced over the fibre optic scope into the trachea.10. The intubation of 1 to 9 where all the features describe combine to give this intubation device the characteristics, and when combined with a method of use to make it safer and easier to use than existing devices and allows smaller internal diameter tubing than existing devices to be used for endotracheal intubation over a fibre optic scope.

[0058] In this specification, adjectives such as first and second, left and right, top and bottom, and the like may be used solely to distinguish one element or action from another element or action without necessarily requiring or implying any actual such relationship or order. Where the context permits, reference to an integer or a component or step (or the like) is not to be interpreted as being limited to only one of that integer, component, or step, but rather could be one or more of that integer, component, or step etc.

[0059] The above description of various embodiments of the present invention is provided for purposes of description to one of ordinary skill in the related art. It is not intended to be exhaustive or to limit the invention to a single disclosed embodiment. As mentioned above, numerous alternatives and variations to the present invention will be apparent to those skilled in the art of the above teaching. Accordingly, while some alternative embodiments have been discussed specifically, other embodiments will be apparent or relatively easily developed by those of ordinary skill in the art. The invention is intended to embrace all alternatives, modifications, and variations of the present invention that have been discussed herein, and other embodiments that fall within the spirit and scope of the above-described invention.

[0060] As used herein, an element or operation recited in the singular and proceeded with the word “a” or “an” should be understood as not excludingplural elements or operations, unless such exclusion is explicitly recited. Furthermore, references to “one embodiment” of the present disclosure are not intended to be interpreted as excluding the existence of additional embodiments that also incorporate the recited features.

[0061] In this specification, the terms ‘comprises’, ‘comprising’, ‘includes’, ‘including’, or similar terms are intended to mean a non-exclusive inclusion, such that a method, system or apparatus that comprises a list of elements does not include those elements solely but may well include other elements not listed.

Claims

The claims defining the invention are as follows:1 . An intubation device comprising: a tubular body having an inlet end and an outlet end, wherein the inlet end has connector with an internal diameter not less than an internal diameter of the tubular body and the outlet end having an inflatable cuff configured to be manoeuvrable and locatable in the trachea of a patient over a fibre optic scope.

2. The intubation device of claim 1 , wherein outlet end and tubular body are configured to pass through airway tubing and lumen of a laryngeal mask located in the larynx of the patient.

3. The intubation device of claim 1 or 2, wherein the connector is fitted to an external surface of the inlet end of the tubular body.

4. The intubation device of any one of claims 1 to 3, wherein the tubular body comprises a reinforced portion and a unreinforced portion.

5. The intubation device of claim 4, wherein the reinforced portion is at or towards the outlet end of the tubular body and the unreinforced portion is at or towards the inlet end of the tubular body.

6. The intubation device of any one of claims 1 to 5, further comprising one or more alignment members to keep the fibre optic scope centred in the outlet end of the tubular body.

7. The intubation device of claim 6, wherein the one or more alignment members comprise a plurality of radially spaced internal projections at the outlet end of the tubular body.

8. The intubation device of claim 7, wherein the plurality of radially spaced internal projections at the outlet end of the tubular body comprise triangle shaped projections moulded into the outlet end of the tubular body.

9. The intubation device of any one of claims 1 to 8, wherein the inflatable cuff is fluidly connected to an inflation tube that has an integrated portion that is integral with, or located internally to, the tubular body and a free portion located externally to the tubular body.

10. The intubation device of claim 9, wherein the inflation tube comprises a cuff connector to allow removable connection of an inflation valve and pilot balloon fluidly connectable to the inflatable cuff.11 . The intubation device of claim 10, wherein the cuff connector comprises a hollow elongate body having at least one end that is removably connectable the inflation tube.

12. The intubation device of any one of claims 1 to 11 , wherein the tubular body has sufficient length to be positioned and stabilised in the trachea of the patient below the vocal cords while a laryngeal mask airway is removed from the patient over the intubation device.

13. The intubation device of claim 12, wherein the tubular body is configured to allow any excess length extending beyond incisors of the patient once positioned and stabilised in the trachea of the patient to be cut off.

14. The intubation device of any one of claims 1 to 13, wherein the tubular body is continuous without joins or connectors.

15. A method of intubating a patient having a laryngeal mask airway located in their larynx to keep their airway open and ventilate their lungs, the method comprising:inserting a fibre optic scope through a tubular body of an intubation device; advancing the intubation device through tubing of the laryngeal mask airway such that an outlet end of the intubation device passes through a lumen of the laryngeal mask airway; stabilising the intubation device in the airway of the patient; and removing the laryngeal mask airway.

16. The method of claim 15, further comprising disconnecting an inflation balloon and / or valve from the intubation device to allow passage through the lumen of the laryngeal mask airway.

17. The method of claim 15 or 16, further comprising cutting excess tubing of the intubation device distal of the incisor teeth of the patent once stabilised in the trachea of the patent.

18. The method of any one of claims 15 to 17, wherein the intubation device is the intubation device as claimed in any one of claims 1 to 14.

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