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

JP2026520874APending Publication Date: 2026-06-25ビビアンバーノン

Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
ビビアンバーノン
Filing Date
2024-05-16
Publication Date
2026-06-25

AI Technical Summary

Technical Problem

Existing endotracheal intubation methods using laryngeal mask airways face challenges such as pulmonary contamination, limited ventilation pressure, and the risk of extubation due to short tube lengths and disconnections, especially when transitioning from a laryngeal mask to an endotracheal tube, which interrupts ventilation and poses risks of tube disconnection and inflation line entrapment.

Method used

An intubation device with a tubular body and inflatable cuff, designed to be maneuverable within the trachea, featuring a reinforced portion and alignment members to stabilize the tube, allowing for continuous ventilation and secure positioning without joints, and an extended inflation line to prevent disconnection during mask removal.

Benefits of technology

Enables controlled conversion from laryngeal mask airway to intratracheal airway with minimal ventilation interruption, suitable for various patient sizes, reducing the risk of extubation and maintaining stable airway access through the use of a continuous, long enough tube and centered fiber optic scope alignment.

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Abstract

An intubation device configured to pass through a stabilized laryngeal mask airway (LMA) within a patient, and a method of using the same. The intubation device may replace the LMA, which can be removed from the patient over the top of the intubation device. The intubation device may be mounted on an optical fiber intubator and may include an alignment member to ensure that the end of the optical fiber intubator remains centered within the exit end of the intubation device.
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Description

Technical Field

[0001] The present invention preferably relates to an intubation device for endotracheal intubation through a laryngeal mask airway and a method of using the same. In particular, the present invention relates to (but is not limited to) endotracheal intubation of a patient with a laryngeal mask airway inserted into the larynx, and the device is preferably used on a fiber optic intubation scope (but does not necessarily have to be).

Background Art

[0002] References to background art in this specification should not be construed as an admission that such technology constitutes common general knowledge. Airway intubation, such as endotracheal intubation or supraglottic intubation, is often simply referred to as "intubation" and involves placing a tube into a patient to keep the airway of a patient who requires respiratory support open. Airway intubation can also be used to administer inhaled anesthetics into the lungs and to protect the airway of an unconscious patient. Such intubation is typically performed using an endotracheal tube and / or a laryngeal mask airway (LMA) (often simply referred to as a "laryngeal mask").

[0003] Such laryngeal masks have been used for decades and have to some extent replaced endotracheal tubes for maintaining the airway while delivering anesthesia to a patient because they are typically easier, faster, and require less skill to deploy. More recently, laryngeal masks have also been used by clinicians inexperienced in endotracheal intubation techniques to place an airway in a patient in an emergency situation because they are easy to insert and require less skill and training than endotracheal intubation.

[0004] However, pulmonary contamination can occur due to secretions around the mask or gastric reflux, and the pressure that can be applied through the mask to inflate the lungs for patient ventilation is limited, so a laryngeal mask airway does not fix the airway in the same manner as an endotracheal tube. Therefore, endotracheal intubation using an endotracheal tube can often be considered the "gold standard" for securing the airway.

[0005] A patient has a laryngeal mask airway positioned in the larynx, but a situation arises where the airway needs to be secured by an endotracheal tube. Standard endotracheal tubes are too short to be securely positioned in the trachea through the laryngeal mask airway. Furthermore, when the laryngeal mask is withdrawn and removed over the endotracheal tube, some form of stabilization is necessary to prevent extubation. Therefore, known methods of endotracheal intubation through a laryngeal mask airway interrupt the patient's ventilation while the laryngeal mask is being removed over the endotracheal tube. A solid extrusion rod is used to maintain the position of the endotracheal tube while the laryngeal mask is being removed from the patient's larynx over the endotracheal tube, which inevitably interrupts ventilation.

[0006] An intermediate tube may be used to increase the length of the endotracheal tube to provide the necessary length to allow intubation through the laryngeal mask. However, there is a risk of the endotracheal tube coming out of the trachea because the intermediate tube must be disconnected before the laryngeal mask airway is removed. The junction of the two tubes is even more prone to disconnection when manipulating the fiber optic scope, airway tube, and laryngeal mask. The tube junction is also inevitably located within the lumen of the laryngeal mask tube, making disconnection difficult.

[0007] The standard endotracheal tube inflation line, which connects the cuff at the inlet end of the endotracheal tube to the balloon and inflation valve, is also too short and can get stuck between the outer wall of the endotracheal tube and the inner wall of the laryngeal mask airway when the laryngeal mask airway is withdrawn over the endotracheal tube. This can result in extubation and loss of airway, or rupture of the inflation balloon or inflation line. The short length of the inflation line also hinders the removal of the laryngeal mask unless a solid extrusion rod or distal tube is removed to allow the pilot balloon and inflation valve to be delivered through the laryngeal mask airway tube.

[0008] The object of the present invention is to provide an intubation device that overcomes, mitigates, or at least provides a useful alternative and / or commercial option among the aforementioned drawbacks or problems.

[0009] Other preferred objects of the present invention will become apparent from the following description. [Overview of the Initiative]

[0010] In one embodiment, an intubation device is provided, which comprises a tubular body having an inlet end and an outlet end, the inlet end having a connector having an inner diameter greater than or equal to the inner diameter of the tubular body, and the outlet end having an inflatable cuff configured to be maneuverable and positionable within the patient's trachea on an optical fiber scope.

[0011] The outlet end may be configured to pass through the lumen of the airway tube and / or laryngeal mask located within the patient's larynx. The tubular body may be configured to pass through the lumen of the airway tube and / or laryngeal mask located within the patient's larynx.

[0012] The connector can be fitted onto the outer surface of the inlet end of the tubular body. The tubular body may include a reinforced portion. The tubular body may include 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 reinforced portion and / or unreinforced portion may be flexible. The reinforced portion may be elastic. The unreinforced portion may be cuttable. The reinforced portion may be at or facing the exit end of the tubular body. The unreinforced portion may be at or facing the inlet end of the tubular body. The reinforced and unreinforced portions may be joined distal to the patient's incisors, approximately 1–4 cm, preferably 2–3 cm. The unreinforced portion may be configured to be shorter to reduce dead space. The unreinforced portion may be shortened by cutting.

[0013] The intubation device may further comprise one or more alignment members for holding the optical fiber scope centered at the exit end of the tubular body. The one or more alignment members include a plurality of radially spaced internal projections at the exit end of the tubular body. The plurality of radially spaced internal projections at the exit end of the tubular body include projections molded within the exit end of the tubular body. The projections may be triangular, circular, fins, ribs, etc. The radially spaced internal projections may include three projections spaced about 120 degrees apart.

[0014] An inflatable cuff can be fluidly connected to an expansion tube. The expansion tube may have an integrated portion that is integral with the tubular body. The integrated portion may be located inside the tubular body. The expansion tube may have a free portion located outside the tubular body.

[0015] The inflation tube may include a cuff connector. The cuff connector may be detachably connected to an inflation valve and / or pilot balloon, which is fluid-connected to or connectable to the inflatable cuff. The cuff connector may include a hollow elongated body. The cuff connector may have at least one end that is detachably connectable to the inflation tube. The cuff connector may have one end fixed to the tube. The end fixed to the tube may be fluid-connected to an inflation valve and / or pilot balloon.

[0016] The tubular body may have sufficient length to be positioned and stabilized in the patient's trachea below the vocal cords while the laryngeal mask airway is removed from the patient on the intubation device. The tubular body may be at least 40 cm long. The tubular body may be configured to allow any excess length to be cut off once it is positioned and stabilized in the patient's trachea. The excess length may be the amount that extends beyond the patient's incisors once it is positioned and stabilized in the trachea. The transition between the reinforced and unreinforced portions of the tubular body may extend beyond the patient's incisors by about 1 cm to 4 cm, preferably 2 cm to 3 cm.

[0017] The tubular body may be continuous. The tubular body may not have a joint or connector between the inlet and outlet ends. The tubular body may include a tube of a single length. In another form, a method may be provided for intubating a patient having a laryngeal mask airway located in the larynx to keep the airway open and ventilate the lungs, the method comprising inserting an optical fiber scope through the tubular body of an intubation device; advancing the intubation device through the tube of the laryngeal mask airway so that the exit end of the intubation device passes through the lumen of the laryngeal mask airway; stabilizing the intubation device within the patient's airway; and removing the laryngeal mask airway.

[0018] The method may further include disconnecting the inflatable balloon and / or valve from the intubation device to allow passage through the lumen of the laryngeal mask airway. The method may further include cutting the excess tubing of the intubation device distal to the patient's incisors once it has stabilized in the patient's trachea. The intubation device may be one of the intubation devices described above.

[0019] Further features and advantages of the present invention will become apparent from the following detailed description.

[0020] As merely an example, preferred embodiments of the present invention will be described more fully below with reference to the accompanying drawings.

Brief Description of the Drawings

[0021] [Figure 1] It is a diagram showing an intubation device. [Figure 2] It is a diagram showing a standard 15 mm ISO connector inserted at the distal end of an endotracheal tube (prior art). [Figure 3] It is a cross-sectional view of the tube of the intubation device in FIG. 2 (prior art). [Figure 4] It is a longitudinal cross-sectional view of the end of the intubation device. [Figure 5] It is a transverse cross-sectional view of the tube portion of the intubation device. [Figure 6] It is a diagram showing a laryngeal mask airway inserted into a patient's larynx (prior art). [Figure 7] It is a diagram showing the distal end of an intubation device loaded on an optical fiber scope inserted through the lumen of a laryngeal mask airway tube. [Figure 8] It is a diagram showing an optical fiber scope positioned in a patient's trachea and an intubation device advancing on the scope stabilized in the trachea through the larynx. <00​​​​​​​​​​​​​​Figure 1 shows 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 gases such as air, oxygen, and / or inhaled anesthetics to pass through. The tubular body 100 has a reinforced portion 104 and an unreinforced portion 102. The reinforced portion 104 may be reinforced with wire or other suitable elastic material, as is known in the art. The unreinforced portion 102 may be transparent PVC or other suitable unreinforced tubular material known in the art. The reinforced portion 104 is located adjacent to the outlet end 140 of the tubular body 100, and the unreinforced portion is located adjacent to the inlet end 120 of the tubular body.

[0023] The reinforcing portion 104 of the tubular body 100 preferably extends to at least a substantial portion of the tubular body 100 configured to be inserted into a patient. Typically, the reinforcing portion 104 of the tubular body 100 will extend to about one-quarter to about half the length of the tubular body 100. A standard endotracheal tube is typically about 26–28 cm long, and the junction 106 between the reinforcing portion 104 and the unreinforcing portion 102 is typically shorter than this length. In the illustrated configuration, the reinforcing portion 104 may be about 18–20 cm long, as indicated by the dimension markings 108 printed thereon (note that the reinforcement does not extend completely to the exit end 140 of the tubular body 100).

[0024] The intubation device 10 has an inflatable cuff 160 which is fluidly connected to an inflation valve 180 and a pilot balloon 182 by an inflation tube 162. The inflation tube 162 has an integrated portion 164 which is integrated with or located inside the tubular body 100, preferably a reinforcing portion 104 of the tubular body 100. The inflation tube 162 also has a free portion 180 which is located outside the tubular body 100. In a standard endotracheal tube, the inflation tube is typically about 26–28 cm in length. The inflation tube 162 is preferably longer than this length, and more preferably about 30–40 cm in length. In the illustrated configuration, the inflation tube 162 is about 34 cm in length.

[0025] The inlet end 120 of the tubular body 100 has a connector 122 that attaches to the outer surface of the tubular body 100. The connector 122 can facilitate connection of the intubation device 10 to standard medical devices such as a gas supply source, as is known in the art.

[0026] Figures 2 and 3 show how a standard 15 mm 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 source or to allow connection to an intermediate tube of the endotracheal tube. However, doing so reduces the inner diameter 24 of the endotracheal tube 20, which limits the diameter of the fiber optic scope that can be introduced through the endotracheal tube 20 to ensure an intratracheal position before the endotracheal tube advances along the scope through the larynx into the trachea. This reduction in inner diameter 24 is particularly problematic with pediatric endotracheal tubes, which inevitably already have a smaller inner diameter.

[0027] Figure 4 shows the outlet end 140 of the tubular body 100 of the intubation device 10. When using a standard endotracheal tube for endotracheal intubation on an optical fiber scope, the angle between the bevel 142 of the tube and the optical fiber intubation scope (not shown) often causes the endotracheal tube to collide with or become trapped in the laryngeal structure, preventing the tube from passing through the scope into the trachea. This then requires further manipulation and increases the risk of intubation complications, including potential hypoxia.

[0028] To avoid or at least reduce this occurrence, the exit end 140 of the tubular body 100 has a plurality of alignment members 144 configured to keep the optical fiber scope centered within the tube 100. The alignment members are preferably in the form of internal projections spaced radially apart. Figure 5 is a cross-sectional view across line "A" in Figure 4, showing three alignment members 144 spaced about 120 degrees apart around the longitudinal axis of the tubular body 100. The illustrated alignment members 144 are triangular projections formed within the exit end 140 of the tubular body 100, but it should be understood that other shapes of projections, such as rounded projections or fins, may also be used. The alignment members 144 preferably begin proximal on the inner wall of the intubation device 10 and increase in height distally so as not to obstruct the passage of the scope through the lumen of the tube.

[0029] When in use, the intubation device 10 can be used to intubate a patient who already has a laryngeal mask airway (LMA) in place. Figure 6 shows a standard (prior art) laryngeal mask 30 inserted into the larynx of a patient 50, which can be connected to an airway / ventilation source (not shown) by a connector 22. Figure 7 shows the laryngeal mask 30 with the airway connector 22 removed and the intubation device 10 loaded onto an optical fiber intubator 40 inserted into the lumen of the tube 32 of the laryngeal mask 30.

[0030] Figure 8 shows a laryngeal mask 30 with an optical fiber scope 40 positioned and stabilized within the patient's trachea. An intubation device 10 is positioned on the scope 40 through the larynx, here within the trachea. A connector 122 is mated with a connector having a port for the scope 40 and a connection to a gas / ventilation source (not shown). An inflation tube 162 passes through the lumen of the laryngeal mask 30 and connects to an inflation balloon 182 and valve 180 located proximal and external to the lumen of the laryngeal mask 30.

[0031] Figure 9 shows the intubation device 10, with a laryngeal mask 30 positioned in the trachea of ​​patient 50, with the cuff 160 inflated. The laryngeal mask 30 is partially detached from the tubular body 100 of the intubation device 10. In particular, the inflation device tube 162 is long enough to allow the pilot balloon 182 and valve 180 to be delivered through the airway tube of the laryngeal mask 30 distal to the inlet end 120 of the tubular body 100 of the intubation device 10.

[0032] Figures 10 and 11 show an optional cuff connector 60 having a hollow elongated body 600 with a fixed tube end 610 and a removable tube end 620. The fixed tube end 610 can be permanently mounted, molded, or attached to its respective tube. As is better seen in the cross-sectional view of Figure 11, the removable tube end 620 has a tapered opening 622 and a friction fitting in the form of a gripping ridge 624. The cuff connector 60 allows the pilot balloon and inflation valve to be removed from the inflation device tube 162. This is particularly advantageous for small patients using laryngeal masks 30 of size 0 or 1, as the lumen of these masks is so small that even the pilot balloon and inflation valve could be trapped and / or stuck.

[0033] To enable effective use, the tubular body 100 is generally shorter than a typical intubator scope. The working length of a standard intubator scope is approximately 60 cm (A), and the length of the airway tube of the largest intubation laryngeal mask is approximately 18 cm (B). The length of 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 positioned so that its outlet end 140 enters the trachea at a depth of at least 5 cm (D) from the patient's vocal cords 50. The connector 122 to the gas supply unit, which has a port for inserting the fiber optic scope 40, adds approximately 2 cm (E) to the proximal end of the endotracheal tube. With the intubation device 10 loaded on the fiber optic scope 40, it should be at least approximately 7 cm (F) distal to the outlet end of the intubation device.

[0034] Considering these dimensions, for a large male, the required length of the tubular body 100 is at least 18 cm (B) + 6 cm (C) + 5 cm (D) = 29 cm. In contrast, the length of a large standard endotracheal tube is 28 cm. The length of the intubation device 10 can be up to 60 cm (A) - 7 cm (F) - 2 cm (E) = 51 cm.

[0035] In large males, to remove the laryngeal mask airway over the intubation device, the intubation device should be approximately 26 cm (G) in the patient, measured from the incisors. To remove the scope 40 over the intubation device, 2 cm (H) of tube is needed above the incisors to grasp the tube in order to stabilize the intubation device 10 when removing the laryngeal mask. Therefore, the length of the intubation device 10 must be at least 26 cm (G) + 2 cm (H) + 18 cm (B) = 46 cm (I).

[0036] The connection point of the inflation line 162 to the inflation balloon 182 and valve 190 should be 2 cm distal to the exit end 140 of the intubation device 10 and 46 cm(I) + 2 cm = 48 cm from the inlet end 120 of the intubation device 10. Therefore, when the laryngeal mask 30 is removed, the connection point will not be trapped between the outer surface of the intubation device tube 100 and the lumen of the laryngeal mask 30.

[0037] Despite the dimensions described above, it should be understood that there is a wide range of variation between the anatomical dimensions of adults and children, and that the diameters of the intubation device 10 and the fiber optic scope 40 will also vary. This should be taken into consideration when manufacturing an appropriate intubation device 10 for patients of different ages and sizes.

[0038] In typical use, the laryngeal mask airway 30 is typically already positioned in the patient's larynx to keep the airway open and ventilate the lungs. The inlet end 120 of the intubation device 10, which has a connector 122 having an inner diameter greater than or equal to the inner diameter of the tubular body, is typically fitted into a connector having a port into which an optical fiber scope 40 can be inserted, and an arm connecting a gas supply source and a ventilation mechanism, by attaching the connector 122 to the outer wall of the tube 100. The optical fiber scope 40 is then inserted through this connector and through the lumen of the intubation device 10 until at least about 7 cm of the distal end of the optical fiber scope 40 is proximal to the outlet end 140 of the intubation device 10. The laryngeal mask 30, located within the patient 50, is then disconnected from the gas supply source, and the intubation device 10, loaded on the optical fiber scope 40, is then inserted through the lumen of the laryngeal mask 30. As soon as the outlet end 140 of the intubation device 10 enters the lumen of the laryngeal mask 30, this complex is connected to a gas / ventilation source that enables ventilation and oxygen supply to the patient 50.

[0039] Next, the intubation device 10, loaded onto the fiber optic scope 40, is advanced through the airway tube 32 of the laryngeal mask 30 until the anatomical structure of the larynx is visualized through the fiber optic scope 40. The distal 5 cm of the scope 40 passes through the vocal cords and enters the trachea of ​​the patient 50. The fiber optic scope 40 is then stabilized while the intubation device 10 can be "forcibly" advanced into the trachea. Once the clinician is satisfied with the position of the intubation device 10 in the trachea, the cuff 160 is inflated to secure the airway.

[0040] The cuff of the laryngeal mask 30 can then be deflated, and the intubation device 10 is then stabilized while the laryngeal mask 30 is being withdrawn from the larynx on the intubation device 10. The position of the tube 100 in the trachea can still be visualized through the fiber optic scope 40. Once the tube 100 on the intubation device 10 is visible at the level of the patient's teeth with the laryngeal mask 30 protruding from the mouth, the tube 100 is grasped and stabilized.

[0041] The inflation line 162 is located between the lumen of the laryngeal mask 30 and the outer surface of the endotracheal tube, and the balloon 182 and inflation valve 180 are located proximal to the inlet end of the laryngeal mask 30. Next, the scope 40 is withdrawn from the intubation device 10, and the connector 122 is disconnected from the inlet end 120 of the device, allowing the balloon 182 and the inflation valve 180, attached by the inflation tube 162, to be supplied through the lumen of the laryngeal mask 30, which is approximately 2 cm distal to the inlet end 120 of the intubation device 10, and is then completely removed from the intubation device 10.

[0042] The excess length of the intubation device 10 distal to the patient's incisors (usually a 3-6 cm tube distal to the incisors is appropriate) can then be cut and removed, thereby reducing anatomical dead space and improving ventilation. A standard 15 mm ISO connector can be inserted into the lumen of the new (cut) outlet end of the intubation device 10 to allow connection to a gas source and ventilation mechanism.

[0043] Advantageously, the intubation device 10 allows the patient to be converted from a laryngeal mask airway (LMA) to an intratracheal airway in a controlled manner with minimal interruption. The intubation device 10 is configured to pass through even the smallest LMAs, enabling use in smaller patients such as children. Alignment members ensure that the end of the fiber optic scope is centered within the intubation device, reducing the likelihood of the end of the fiber optic scope becoming trapped or injuring the patient.

[0044] The features of a particular embodiment of the present invention may be as follows: 1. An intubation device comprising an airway ventilation device having a tube positioned between an inlet end and an outlet end, wherein the outlet end is configured to be positioned within the patient's trachea, and the patient has a laryngeal mask airway already positioned within the patient's larynx, and the intubation device is preferably loaded onto a fiber optic scope before the intubation device advances through the airway tube of the laryngeal mask airway, and once the inlet end of the intubation device is positioned within the trachea, the laryngeal mask airway can be completely removed on the intubation device.

[0045] 2. The intubation device according to 1, having a removable 15 mm connector at its inlet end, designed to fit onto the outer surface of the intubation device tube so as not to reduce the inner diameter of the tube. Removability allows the laryngeal mask airway to be removed from the intubation device. Not reducing the inner diameter of the intubation device allows the intubation device to be used on an optical fiber scope with smaller inner diameter endotracheal tubes for use in pediatric patients.

[0046] 3. Unlike devices in which an airway tube is connected to form a long tube, and as a result the length of the proximal tube in the airway is too short to provide sufficient length distal to the incisors when the intermediate tube is removed, the intubation device according to 1, wherein the length of the airway tube from inlet to outlet end (calculated, for example, for the largest intubation device) is increased to 28 cm to 46 cm(I), which is a standard large endotracheal tube size, for the intubation device, allowing the tube to be long enough to be well positioned in the trachea below the vocal cords, and still having enough length to be cut to an appropriate length.

[0047] 4. The intubation device according to 1 and 3, wherein the intubation device is of sufficient length (I) to allow the intubation device to be stabilized at its inlet end positioned within the trachea while the laryngeal mask airway is removed from the patient on the intubation device.

[0048] 5. The intubation device according to 1 and 3, wherein the tubing of the airway device is continuous without a joint between the two tubes that is prone to disconnection when operating an optical fiber scope through the connected tube and when removing a laryngeal mask on the connected tube. Furthermore, the joint between the tubes reduces the inner diameter of the tube at the joint, preventing the use of an optical fiber intubation scope in airway tubes with smaller inner diameters.

[0049] 6. Unlike similar devices in which an endotracheal tube and a solid extrusion rod or an endotracheal tube are connected to a proximal tube, and the proximal tube must be removed before the laryngeal mask can be completely removed, the intubation device described in 1 and 3 is introduced into the trachea through the laryngeal mask airway, and the patient can be connected to a gas source and ventilated while the laryngeal mask airway is removed on the intubation device.

[0050] 7. The intubation device according to 1 and 3, wherein the device may have a clear PVC tube, or a combination of a reinforcing tube and a clear PVC tube. The length of the reinforcing tube should be calculated so that, after the inlet end is placed in the trachea, the reinforcing tube extends 3 cm distal to the patient's teeth, thereby preventing tube occlusion if the patient bites the tube, but the tube can be cut to an appropriate length through the clear PVC tube distal to the reinforcing tube, and a 15 mm connector can be introduced into the lumen of the tube to reduce dead space and airflow resistance. The plain clear PVC tube is similarly cut to length after the laryngeal mask has been removed over it.

[0051] 8. The intubation device according to 1, wherein the inflation tube is long enough to connect to a pilot balloon and inflation valve located 2 cm distal to the intubation end of the intubation device, allowing the balloon and valve to follow over the intubation end of the intubation device when the laryngeal mask is removed. This allows the entire tube to remain stably in place on the teeth, unlike devices having a solid extrusion rod or two joined tubes, where the inflation line is not long enough and the pilot balloon and inflation valve must be disconnected from the proximal tube and removed from the lumen of the laryngeal mask airway, thus preventing the removal of the laryngeal mask airway. This disconnection while the laryngeal mask is removed on the tube has the potential to move from its position in the trachea with the possibility of accidental extubation.

[0052] 9. The intubation device according to 1, wherein the distal end of the intubation device has at least three molded projections spaced 120 degrees apart that protrude into the lumen of the intubation device, in order to centrally position the fiber optic scope within the inlet lumen of the intubation device and reduce the occurrence of collisions with laryngeal structures that would prevent the intubation device from advancing beyond the fiber optic scope into the trachea.

[0053] 10. The intubation device described in 1-9, wherein all features are combined to characterize this intubation device, and when combined with the method of use, makes its use safer and easier than existing devices, and allows for tubes with smaller inner diameters than existing devices used for endotracheal intubation on an optical fiber scope.

[0054] In this specification, adjectives such as first and second, left and right, upper and lower may be used solely to distinguish one element or action from another, and do not necessarily require or imply an actual relationship or order. Where the context allows, references to integers, components, or steps (or similar) should not be interpreted as being limited to only one of those integers, components, or steps, but rather to one or more of them.

[0055] The above description of various embodiments of the present invention is provided for the purpose of explaining to those skilled in the art. It is not intended to be exhaustive or to limit the invention to a single disclosed embodiment. As stated above, numerous alternative and modified forms of the invention will be apparent to those skilled in the art in the above teachings. Thus, although several alternative embodiments have been specifically discussed, other embodiments will be apparent or relatively easily developed to those skilled in the art. The present invention is intended to encompass all alternative, modified, and modified forms of the invention discussed herein, as well as other embodiments that fall within the spirit and scope of the invention as described above.

[0056] Where used herein, an element or action described in the singular form and followed by the phrase “one (a or an)” should be understood not to exclude multiple elements or actions unless such exclusion is expressly stated. Furthermore, references to “one embodiment” in this disclosure are not intended to be construed as excluding the existence of additional embodiments that also incorporate the described features.

[0057] In this specification, the terms “comprises,” “comprising,” “includes,” “including,” or similar terms are intended to mean non-exclusive inclusion, and as a result, a method, system, or apparatus comprising a list of elements may include, in abundance, other elements not listed, rather than including those elements alone.

Claims

1. An intubation device, It comprises a tubular body having an inlet end and an outlet end, An intubation device having an inlet end with a connector having an inner diameter greater than or equal to the inner diameter of the tubular body, and an outlet end with an inflatable cuff configured to be maneuverable and positionable within the patient's trachea on an optical fiber scope.

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

3. The tube insertion device according to claim 1 or 2, wherein the connector is fitted to the outer surface of the inlet end of the tubular body.

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

5. The intubation device according to claim 4, wherein the reinforcing portion is located at or facing the outlet end of the tubular body, and the unreinforcing portion is located at or facing the inlet end of the tubular body.

6. The intubation device according to any one of claims 1 to 5, further comprising one or more alignment members for holding the optical fiber scope in the center of the outlet end of the tubular body.

7. The tube insertion device according to claim 6, wherein one or more of the alignment members include a plurality of internal protrusions arranged at radial intervals at the outlet end of the tubular body.

8. The intubation device according to claim 7, wherein the plurality of radially spaced internal protrusions at the outlet end of the tubular body include a triangular protrusion formed within the outlet end of the tubular body.

9. The intubation device according to any one of claims 1 to 8, wherein the inflatable cuff is fluidly connected to an expansion tube having an integrated portion that is integral with the tubular body or located inside the tubular body and a free portion located outside the tubular body.

10. The intubation device according to claim 9, wherein the expansion tube includes a cuff connector that detachably connects an expansion valve and a pilot balloon to the inflatable cuff, with fluid connectivity.

11. The intubation device according to claim 10, wherein the cuff connector includes a hollow elongated body having at least one end that can be detachably connected to the expansion tube.

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

13. The intubation device according to claim 12, wherein the tubular body is configured to allow any excess length extending beyond the patient's incisors to be cut off once it has been positioned and stabilized within the patient's trachea.

14. The intubation device according to any one of claims 1 to 13, wherein the tubular body is continuous without a joint or connector.

15. A method of intubation for a patient having a laryngeal mask airway located in the larynx in order to keep the airway open and ventilate the lungs, Inserting the fiber optic scope through the tubular body of the intubation device, The intubation device is advanced through the tube of the laryngeal mask airway so that the outlet end of the intubation device passes through the lumen of the laryngeal mask airway, To stabilize the intubation device within the airway of the patient, Removing the aforementioned laryngeal mask airway, Methods that include...

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

17. The method according to claim 15 or 16, further comprising cutting off any excess tubing of the intubation device distal to the patient's incisors once it has been stabilized in the patient's trachea.

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