WO2020201694A1

WO2020201694A1 - Oropharyngeal airway device

Info

Publication number: WO2020201694A1
Application number: PCT/GB2020/050646
Authority: WO
Inventors: Subrahmanyan RADHAKRISHNA
Original assignee: Sleep Merchants Ltd
Current assignee: Sleep Merchants Ltd
Priority date: 2019-04-04
Filing date: 2020-03-13
Publication date: 2020-10-08
Anticipated expiration: 2021-10-04
Also published as: GB202114827D0; GB2596759B; GB2596759A; GB201904732D0

Abstract

An oropharyngeal airway device and related methods. The device comprises: a conduit having a proximal end and a distal end, wherein on insertion into the mouth of a patient the proximal end locates in the mouth, with a front wall of the conduit facing the tongue to forwardly press against the tongue, and a rear wall of the conduit facing the palate. The conduit is convertible between a closed configuration and an open configuration. In use, conversion from the closed configuration to the open configuration opens the rear wall of the conduit, with the front wall of the conduit maintained in position against the tongue.

Description

OROPHARYNGEAL AIRWAY DEVICE

Technical Field

The present invention relates to oropharyngeal airway devices, and to related methods.

Background Art Oropharyngeal airway devices are used to maintain the airway of an unconscious patient, preventing the patient's tongue from obstructing the airway and providing a passage through with air can move to and from the patient's lungs. This is useful during anaesthesia, and to facilitate oxygenation of the patient in an emergency where the airway may be at risk.

In some clinical situations it may be desirable to place a tracheal tube in the airway to facilitate adequate ventilation of the patient’s lungs and also to prevent airway obstruction and aspiration of stomach contents. This may involve change of the oropharyngeal airway already positioned in the patient to an endotracheal tube. This can normally be achieved using a rigid laryngoscope but in certain patients the rigid scopes fail and cannot facilitate placement of the endotracheal tube. A thinner, flexible intubation scope like the fibre optic scope or a video scope is used in such situations to overcome the problem of a lost airway as it has greater manoeuvrability. In cases where tracheal intubation becomes desirable, but an oropharyngeal airway device is already in place removal of the oropharyngeal airway device before the tracheal intubation procedure is performed introduces a period where the airway may temporarily be lost, with a potential for reduced oxygen to the patient. Alternatively, leaving the oropharyngeal airway in place a fibre optic or video scope that has an endotracheal tube mounted on it can be guided into the trachea through the oropharyngeal airway easily and quickly. However, the oropharyngeal airway would then be in the path of the endotracheal tube and obstruct the progress of the tube in to the patient’s trachea. For the endotracheal tube to be advanced into the trachea over the flexible intubation scope there must be a means of sliding the oropharyngeal airway from the flexible scope to facilitate the above-described procedure.

Example embodiments of the present invention aim to address one or more problems associated with the background art.

Disclosure of Invention In one example there is provided an oropharyngeal airway device comprising: a conduit having a proximal end and a distal end, wherein on insertion into the mouth of a patient the proximal end locates in the mouth, with a front wall of the conduit facing the tongue to forwardly press against the tongue, and a rear wall of the conduit facing the palate; wherein the conduit is convertible between a closed configuration and an open configuration, characterised in that in use, conversion from the closed configuration to the open configuration opens the rear wall of the conduit, with the front wall of the conduit maintained in position against the tongue.

The oropharyngeal device can be used in a conventional manner when the conduit is in the closed configuration. However, if a need arises to perform an endotracheal intubation on a patient with the oropharyngeal airway device in place, the oropharyngeal airway device may be used to guide a fibre optic scope or other flexible intubation scope, on which an endotracheal tube has been mounted, into place in the trachea of the patient. The conduit of the oropharyngeal airway device can then be converted to the open configuration, which enables the oropharyngeal airway device to be removed from the mouth of the patient without disrupting the flexible scope thereby facilitating insertion of the endotracheal tube into the trachea, over the flexible scope which has already been placed in the trachea. During this procedure there is no opportunity for the tongue of the patient to occlude the airway of the patient. By keeping the front wall of the conduit intact in the open configuration, problems associated with movement of the tongue and occlusion of the airway are reduced.

In one example the front wall of the conduit is generally concave. In one example the rear wall or the conduit is generally convex.

In one example the conduit is curved.

In one example the conduit has uniform cross-section along its length. In one example the conduit has an oval cross-section. In one example the conduit is of tubular form, for example comprising a curved tube with an oval cross-section. In one example the conduit has a continuously curved cross-section. In one example the conduit has a generally circular, or a generally elliptical cross-section.

In one example, in the closed configuration the conduit is airtight between the proximal and distal ends. In one example, in the open configuration the conduit is self-supporting to maintain an opening along its length. When in the closed configuration, use of the oropharyngeal airway to maintain the airway of a patient, preventing the patient's tongue from obstructing the airway and providing a passage through with air can move to and from the patient's lungs can take place in the conventional manner.

In one example, in the closed configuration the distal end of the front wall and the distal end of the rear wall of the conduit are aligned.

In one example, in the closed configuration the proximal end of the front wall and the proximal end of the rear wall are aligned.

In one example, in the open configuration the distal end of the front wall and the distal end of the rear wall of the conduit are aligned. In one example, in the open configuration the proximal end of the front wall and the proximal end of the rear wall are aligned. Alignment of the front and rear walls at the distal end of the conduit is useful to reduce trauma to the patient's airway on insertion. Neither the front or rear wall projecting beyond the other means that there is no single protecting edge or wall portion that may catch on or produce high pressure on the patient's mucosa on insertion, and the aligned edges are more readily manipulatable during the insertion procedure so that engagement with the palate/pressing on the tongue can be balanced between the rear wall and front wall respectively.

In one example the oropharyngeal airway device further comprises a flange at the proximal end of the conduit. In one example the flange is convertible between a closed configuration and an open configuration on conversion of the conduit between the closed configuration and the open configuration thereof.

In one example the flange is separable into two parts, for example a front part and a rear part, on conversion of the flange between the closed configuration and the open configuration.

In one example the flange comprises interlocking mechanical features to hold the parts thereof together in the closed configuration.

In one example the conduit is separable into two parts, by removal of a removable panel on the rear wall, on conversion of the conduit between the closed configuration and the open configuration.

In one example the removable panel is connected to a rear part of the flange.

In one example the conduit comprises interlocking mechanical features on the rear wall and the panel to hold the conduit in the closed configuration.

In one example the panel comprises a minor part of the conduit, for example less than 50% of the conduit, considering the circumference of the cross-section. In one example the panel comprises less than 25% of the conduit, considering the circumference of the cross-section. By retaining a major part of the conduit in its original form when the panel is removed, effective pressure against the tongue can sufficient strength may be retained

In one example the panel comprises the rearmost portion of the conduit.

In one example the conduit and/or flange are formed of one material. In one example the conduit and/or flange are formed of plastic. In one example the conduit comprises a separation line on the rear wall thereof, and wherein converting the conduit between the closed configuration and the open configuration comprises opening, for example splitting, the conduit along the separation line.

In one example the separation line is formed at the rearmost portion of the conduit. In one example the separation line is formed along the length of the conduit, for example the whole length of the conduit from the proximal end to the distal end thereof.

In one example the separation line comprises one or more built-in lines of weakness and/or one or more built-in points of weakness. In one example the built-in line(s) and/or point(s) of weakness comprise thinner material than the portions of the conduit surrounding them. In one example the separation line comprises a continuous line of weakness.

In one example the separation line comprises a relatively weak portion of the conduit toward the distal end and a relatively strong portion of the conduit toward the proximal end. In one example the separation line is configured so that the conduit is of reducing strength along its length. In such examples weakness/strength may refer to relative resistance to separation at the separation line.

In one example the separation line comprises a line between butted edges, coupled to one another to form the rear wall of the conduit. In one example the separation line comprises a line between overlapped edges, coupled to one another to form the rear wall of the conduit. In one example the separation line comprises an adhered or welded connection between edges that are coupled to one another to firm the rear wall of the conduit.

In one example the separation line comprises a reinforced tear strip formed in the rear wall of the conduit, and wherein converting the conduit between the closed configuration and the open configuration comprises tearing the conduit with the tear strip.

In one example the tear strip is coupled to the distal end of the conduit such that pulling on the tear strip at the proximal end of the conduit initiates a tear at the distal end of the conduit. In one example the tear strip extends back to the proximal end of the conduit such that pulling on the tear strip at the proximal end of the conduit initiates a tear at the distal end of the conduit which then propagates toward the proximal end of the conduit. In one example the tear strip extends outside of the conduit material from the proximal end to the distal end of the conduit, and extends back from the distal end to the proximal end within the conduit material.

In one example there is provided a tracheal intubation method performed using an oropharyngeal airway device as described herein, the method comprising: inserting the oropharyngeal airway device into the mouth of a patient a patient such that the proximal end locates in the mouth with a front wall of the conduit facing the tongue to forwardly press against the tongue, and the rear wall of the conduit facing the palate, the oropharyngeal airway device being in the closed configuration; guiding a flexible intubation scope through the conduit of the oropharyngeal airway device and to the trachea of the patient; converting the oropharyngeal airway device to the open configuration while maintaining the front wall of the conduit in position against the tongue of the patient; and with the flexible intubation scope maintained in the trachea of the patient, removing the oropharyngeal device from the flexible intubation scope via the open rear wall of the conduit.

In this way the oropharyngeal device can readily be removed from the mouth of a patient without disrupting the flexible intubation scope, with there being no opportunity for the tongue of the patient to occlude the airway of the patient during the procedure. The term flexible intubation scope includes fibre optic scopes, video scopes, CMOS scopes and combination devices including the same, and related flexible devices that facilitate visualisation of the trachea as part of the introduction of the device.

According to the present invention there is provided an apparatus and method as set forth in the appended claims. Other features of the invention will be apparent from the dependent claims, and the description which follows.

Brief Description of Drawings

For a better understanding of the invention, and to show how embodiments of the same may be carried into effect, reference will now be made, by way of example only, to the accompanying diagrammatic drawings in which:

Figure 1 shows a perspective view of an oropharyngeal airway device according to an example embodiment, in a closed configuration;

Figures 2A shows a perspective view of a major part of the oropharyngeal airway device of Figure 1 , after conversion of the oropharyngeal airway to an open configuration;

Figure 2B shows a perspective view of a minor part of the oropharyngeal airway device of Figure 1 , after conversion of the oropharyngeal airway device to an open configuration;

Figure 3 shows a cross-sectional perspective view of the oropharyngeal airway device of Figure 1 ; and

Figure 4 shows steps in a tracheal intubation method performed using an oropharyngeal airway device according to an example embodiment.

Modes for Carrying Out the Invention Referring now to Figure 1 , there is shown an oropharyngeal airway device 1 according to an example embodiment. In Figure 1 the oropharyngeal airway device 1 is shown in a perspective view with front, proximal end and a first side visible. Figure 1 shows a conduit 10 of the oropharyngeal airway device 1 in a closed configuration.

The oropharyngeal airway device 1 comprises: a conduit 10 having a proximal end 1 1 and a distal end 12. On insertion into the mouth of a patient the proximal end 1 1 locates in the mouth. In use, a front wall 13 of the conduit 10 faces the tongue of the patient, to forwardly press against the tongue of the patient. A rear wall 14 of the conduit 10 faces the palate of the patient. The conduit 10 shown in Figure 1 is in a closed configuration, such that the conduit 10 provides a continuous airtight tube between openings at the proximal end 1 1 and distal end 12 thereof.

In the closed configuration the oropharyngeal device 1 can be used in a conventional manner, preventing occlusion of the airway of an unconscious patient by pressing the tongue forward and allowing air to pass along the conduit 10 between the openings at the proximal end 1 1 and the distal end 12. A flange 21 is provided at the proximal end 1 1 of the conduit 10 to prevent the oropharyngeal airway device from being inhaled or ingested, and reinforces the proximal end 1 1 of the conduit 10.

If a need arises to perform an endotracheal intubation on a patient with the oropharyngeal airway device 1 in place, the oropharyngeal airway device 1 may be used to guide a fibre optic scope or other similar flexible intubation scope into place in the trachea of the patient. The conduit of the oropharyngeal airway device can be converted to the open configuration, for example with a self-supporting opening provided along its length.

Figure 2A shows the major part of the oropharyngeal airway device 1 of Figure 1 after conversion to an open configuration is shown, and Figure 2B the corresponding minor part. In Figures 2A and 2B the with front, proximal end and second sides are visible. In the open configuration the rear wall 14 of the conduit 10 is opened along the length of the conduit 10. The opening in the rear wall 14 of the conduit 10 provided in the open configuration enables the oropharyngeal airway device 1 to be removed from the mouth of the patient without disrupting the fibre optic or other flexible scope from the trachea of the patient, even though the flexible intubation scope was passed through the conduit 10 to reach the trachea of the patient while the oropharyngeal airway device was in the closed configuration. During this procedure there is no opportunity for the tongue of the patient to occlude the airway of the patient as the front wall 13 of the conduit 10 is maintained in position against the tongue of the patient.

The flange is separable into two parts, the first part of the flange 21’ retained on the major part of the oropharyngeal airway device, which comprises the front part, and the second part of the flange 21 retained on the minor part of the oropharyngeal airway device, which comprises the rear part. The first and second parts of the flange 21 ,2T are provided with interlocking mechanical features 22,22’ to hold the parts thereof together when the oropharyngeal airway device 1 is in the closed configuration.

As will be appreciated, conversion of the oropharyngeal airway device to the open configuration in this example involves separating the conduitI O into two parts, by removal of a removable panel 23 which comprises the rearmost part of the conduit 10. The removable panel 23 is connected to the rear part of the flange 21 , which together form the minor part of the oropharyngeal airway device, whereas the major part is formed by the remainder of the conduit 10 and the front part of the flange 21’. To keep the panel 23 in place while the conduit 10 is in the closed configuration the removable mechanical features 22,22’ on the flange 21 , 2T cooperate with interlocking mechanical features 24 on the edges of the rear wall and the panel. The interlocking mechanical features on the edges of the real wall and the panel allow sliding of the removable panel out of the rear wall 14 of the conduit 10 when converting from the closed configuration to the open configuration, as a way of splitting the conduit. Such mechanical features 24 are provided as tongue and groove connections in the example embodiment shown.

In other embodiments, not shown in the Figures, alternative ways of converting the conduit from the closed configuration to the open configuration are contemplated.

A separation line may be provided on the rear wall of the conduit, rather than a removable panel. Converting the conduit between the closed configuration and the open configuration in such embodiments comprises opening the conduit along the separation line such that the rear of the conduit assumes, and suitably retains, and opening along its length from the proximal end to the distal end thereof. The opening process in such embodiments may comprise tearing of the material along the built-in line of weakness. In certain example embodiments the separation line is formed as a built-in line of weakness formed by scoring the rear wall of the conduit, such as by mechanical or laser scoring techniques.

In certain embodiments a separation line may be provided between edges of a pre-formed split in the conduit, the edges being coupled to one another to form the rear wall of the conduit when in the closed configuration. Converting the conduit to the open configuration comprises uncoupling the edges. Tearing or uncoupling portions of the rear wall is advantageous in that it maintains the oropharyngeal airway device as a single component, thus reducing the risk that any minor parts are lost or become a hazard to the patient once separated from the major part of the oropharyngeal airway device. In some embodiments the separation line comprises a reinforced tear strip formed in the rear wall of the conduit, to aid conversion of the conduit between the closed configuration and the open configuration.

It will be appreciated that the separation of the flange may also be achieved using separation line features as described for the conduit. Providing a flange as separable parts with a distinct mechanical interconnection from the features involved in conversion of the conduit is also envisaged, with the parts of the flange being readily manipulated to aid the process of opening the conduit along a separation line and/or removal of a removable panel.

Figure 4 shows steps in a tracheal intubation method performed using an oropharyngeal airway device according to an example embodiment. At step S101 the method comprises inserting the oropharyngeal airway device into the mouth of a patient a patient such that the proximal end locates in the mouth with a front wall of the conduit facing the tongue to forwardly press against the tongue, and the rear wall of the conduit facing the palate. At step S101 the oropharyngeal airway device is in the closed configuration.

Next, at step S102 the method comprises guiding a flexible intubation scope such as a fibre optic scope through the conduit of the oropharyngeal airway device and into the trachea of the patient. The flexible intubation scope is pre-loaded with an endotracheal tube over it. The trachea can be visualised using the flexible intubation scope, and once the flexible intubation scope is in place the method comprises at step S103 converting the oropharyngeal airway device to the open configuration while maintaining the front wall of the conduit in position against the tongue of the patient. This may involve separating the conduit into two pieces, or breaking/separating edges of the conduit along a separation line.

At step S104 the method comprises removing the oropharyngeal airway device. This involves separating the oropharyngeal airway device from the flexible intubation scope via the open rear wall of the conduit and removing the oropharyngeal airway device from the mouth of the patient without disrupting the flexible intubation scope from its position within the trachea of the patient.

In certain embodiments of the method, d the step S104 of removing the oropharyngeal airway device may take place while the flexible intubation scope is in place in the trachea and after an endotracheal tube is positioned over the flexible intubation scope.

As will be appreciated, the form and dimensions of the oropharyngeal airway device, when in the closed configuration may suitably correspond to those of conventional devices. The principles of conversion, and methods of use may be applicable to human patients and equally to animals in a veterinary context, with suitable changes to accommodate the relevant nonhuman anatomy. Attention is directed to all papers and documents which are filed concurrently with or before this specification in connection with this application and which are open to public inspection with this specification, and the contents of all such papers and documents are incorporated herein by reference. All the features disclosed in this specification (including any accompanying claims, abstract and drawings), and/or all the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive.

Each feature disclosed in this specification (including any accompanying claims, abstract and drawings) may be replaced by alternative features serving the same, equivalent or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example only of a generic series of equivalent or similar features.

The invention is not restricted to the details of the foregoing embodiment(s). The invention extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

Claims

1. An oropharyngeal airway device comprising: a conduit having a proximal end and a distal end, wherein on insertion into the mouth of a patient the proximal end locates in the mouth, with a front wall of the conduit facing the tongue to forwardly press against the tongue, and a rear wall of the conduit facing the palate; wherein the conduit is convertible between a closed configuration and an open configuration, characterised in that in use, conversion from the closed configuration to the open configuration opens the rear wall of the conduit, with the front wall of the conduit maintained in position against the tongue.

2. The oropharyngeal airway device of claim 1 , wherein the front wall of the conduit is generally concave.

3. The oropharyngeal airway device of claim 1 or 2, wherein the conduit is curved.

4. The oropharyngeal airway device of any preceding claim, wherein the conduit has uniform cross-section along its length.

5. The oropharyngeal airway device of any preceding claim, wherein with the conduit in the closed configuration the distal end of the front wall and the distal end of the rear wall are aligned, and/or the proximal end of the front wall and the proximal end of the rear wall are aligned.

6. The oropharyngeal airway device of any preceding claim, wherein with the conduit in the open configuration the distal end of the front wall and the distal end of the rear wall are aligned, and/or the proximal end of the front wall and the proximal end of the rear wall are aligned.

7. The oropharyngeal airway device of any preceding claim further comprising a flange at the proximal end of the conduit, the flange being convertible between a closed configuration and an open configuration on conversion of the conduit between the closed configuration and the open configuration thereof.

8. The oropharyngeal airway device of claim 7, wherein the flange is separable into two parts (front part and rear part) on conversion of the flange between the closed configuration and the open configuration.

9. The oropharyngeal airway device of claim 8, wherein the flange comprises interlocking mechanical features to hold the parts thereof together in the closed configuration.

10. The oropharyngeal airway device of any preceding claim, wherein the conduit is separable into two parts, by removal of a removable panel on the rear wall, on conversion of the conduit between the closed configuration and the open configuration.

11. The oropharyngeal airway device of claim 10 as dependent on claim 8 or 9, wherein the removable panel is connected to a rear part of the flange.

12. The oropharyngeal airway device of claim 10 or 11 , wherein the conduit comprises interlocking mechanical features on the rear wall and the panel to hold the conduit in the closed configuration.

13. The oropharyngeal airway device of any preceding claim, wherein the conduit comprises a separation line on the rear wall thereof, and wherein converting the conduit between the closed configuration and the open configuration comprises splitting the conduit along the separation line.

14. The oropharyngeal airway device of any preceding claim, wherein the separation line comprises a tear line formed in the rear wall of the conduit, and wherein converting the conduit between the closed configuration and the open configuration comprises tearing the conduit along the tear line.

15. A tracheal intubation method performed using the oropharyngeal airway device of any preceding claim, the method comprising: inserting the oropharyngeal airway device into the mouth of a patient a patient such that the proximal end locates in the mouth with a front wall of the conduit facing the tongue to forwardly press against the tongue, and the rear wall of the conduit facing the palate, the oropharyngeal airway device being in the closed configuration; guiding a flexible intubation scope through the conduit of the oropharyngeal airway device to the trachea of the patient; converting the oropharyngeal airway device to the open configuration while maintaining the front wall of the conduit in position against the tongue of the patient; and with the flexible intubation scope maintained in the trachea of the patient, removing the oropharyngeal airway device from the flexible intubation scope via the open rear wall of the conduit.