WO2024207050A1

WO2024207050A1 - Airway interface apparatus and method

Info

Publication number: WO2024207050A1
Application number: PCT/AU2024/050246
Authority: WO
Inventors: Michael Mccarthy; Stuart PATERSON
Original assignee: Innovodent Solutions Pty Ltd
Priority date: 2023-04-04
Filing date: 2024-03-20
Publication date: 2024-10-10

Abstract

An interface apparatus for an airway device providing a fluid to a patient, and related method, enhance the ease and efficacy of ventilation procedures. The interface apparatus comprising: an inner frame member; an outer frame member; and an elastomeric member between the inner frame member and the outer frame member, the elastomeric member defining an internal seal surface adjacent the inner frame member and an external seal surface adjacent the outer frame member; wherein in use, the inner frame member is positioned within an oral cavity of the patient, the outer frame member is positioned outside the oral cavity of the patient, the internal seal surface engages an oral mucosa of the oral cavity, and the external seal surface engages the airway device.

Description

AIRWAY INTERFACE APPARATUS AND METHOD

FIELD OF THE INVENTION

[0001 ] This invention relates generally to an interface apparatus and method. More particularly, this invention relates to an interface apparatus for an airway device providing fluid, such as a breathable gas, to a patient.

BACKGROUND TO THE INVENTION

[0002] Oxygenation and ventilation of human patients is often necessary during emergency and non-emergency situations. During medical emergencies in patients experiencing either impaired ventilatory effort or respiratory failure, assisted ventilation may be required to force air or oxygen into the lungs of the patient. The use of airway ventilation devices, such as the self-inflating bag manual resuscitator, are often required by emergency medical personnel in order to provide positive pressure ventilation to a patient in respiratory distress. During both emergency and nonemergency situations, appropriate preoxygenation is also an important procedure. Administration of oxygen prior to induction of general anaesthesia is vital to adequately preoxygenate a patient in order to minimise the risk of hypoxia with prolonged apnoea.

[0003] The masks used in manual positive pressure ventilation (such as with a self-inflating bag manual resuscitator or other devices used during the delivery of oxygen) are often made of a flexible rubber or silicone designed to cover the mouth and/or nose of the patient. The selected material is often transparent so that the patient’s mouth and nose may be observed by the medical staff in attendance. Importantly, the flexibility of the mask is required to provide a proper seal against the patient's face so as to ensure sufficient positive pressure and ventilation can be achieved when the desired breathable gas, such as air, oxygen, or nitrous oxide, is administered. A tight seal between the mask and the patient’s face ensures minimal leakage and loss of pressure and/or breathable gas.

[0004] A significant percentage of men maintain the presence facial hair. The decision to grow and maintain a beard may be related to style and aesthetics, as well as cultural reasons. However, the presence of facial hair poses a significant risk when it comes to mask-face interface seal, as bearded patients are known to suffer from airflow leakage or pressure loss when undergoing manual or assisted positive pressure mask ventilation. The mask of the airway device may not be able to maintain contact with the bearded patient’s skin, which results in an impaired or improper maskface interface seal. A mask with an impaired seal will not provide adequate preoxygenation and/or ventilation, even when pressure or fresh gas flow is increased. Because of the inadequate airflow and/or pressure achieved, some bearded patients may be impossible to bag mask ventilate.

[0005] While it is possible to shave a patient prior to the application of a mask or ventilation device, the patient may not desire such an undertaking. Furthermore, emergency medical staff attending to patients, including outside of the hospital environment, may not be afforded the time or option of shaving a patient. Other methods to improve mask seal include the application of wound dressing such as Tegaderm to establish an improved interface surface for the mask. However, films such as Tegaderm may cling to the patient’s facial hair and cause discomfort, while still not guaranteeing an adequate sealing surface, for example due to the irregular contour caused by the patient’s facial hair. Gas flow may also be lost underneath the dressing in the presence of facial hair. Application of substances such as water based lubricant or ultrasound gel can assist with mask seal by providing a viscous barrier. However, the gel substance may be sticky and require additional cleaning after the ventilation process is complete.

[0006] Shielded Guedel airways are also known to minimise mask leakage by providing a rubber mask interface shield outside the patient’s oral cavity while delivering breathable gas directly into the patients airway. However, the shielded Guedel airway remains an invasive device and patients may not tolerate this form of airway particularly while conscious, as stimulation to the back of the tongue or throat may cause severe discomfort and/or trigger the patient’s pharyngeal reflex or gag reflex. The shielded Guedel airway may therefore be only suitable for an unconscious or anaesthetised patient. Still, any device inserted far into the oral or oropharynx cavity of the patient will also increase the risk of tissue damage or trauma. Shielded Guedel airways must also be removed prior to insertion of any other airway devices, such as a supraglottic airway or endotracheal tube. Patients with soft tissue deformities, or those that are edentulous, are also highly susceptible to mask leakage. Irregular contours surrounding the nose and/or mouth may cause similar issues affecting preoxygenation and/or manual or assisted mask positive pressure ventilation.

[0007] There is therefore a need for an improved interface apparatus for an airway device.

[0008] It is to be understood that, if any prior art information is referred to herein, such reference does not constitute an admission that the information forms part of the common general knowledge in the art, in Australia or any other country.

OBJECT OF THE INVENTION

[0009] It is a preferred object of the invention to provide apparatuses and/or systems and/or methods that address or ameliorate one or more of the aforementioned problems of the prior art and/or provide a useful commercial alternative.

SUMMARY OF THE INVENTION

[00010] The present invention relates to an interface apparatus for an airway device that according to some embodiments can enhance the ease and efficacy of ventilation procedures administered on a human patient. Embodiments of the interface apparatus can improve facemask oxygenation and ventilation of patients by providing an intra-oral seal within the oral cavity of the patient and an extra-oral seal against an airway mask. The interface apparatus according to the present invention provides a useful commercial alternative that according to some embodiments may provide one or more of the following advantages: suitability for bag mask ventilation and preoxygenation; ease of insertion and removal; comfort for the patient; increase visibility and accessibility of the oral cavity; and reduce oral trauma during airway instrumentation. [0001 1 ] In one form, although not necessarily the broadest form, the invention resides in an interface apparatus for an airway device providing a fluid to a patient, the interface apparatus comprising: an inner frame member; an outer frame member; and an elastomeric member between the inner frame member and the outer frame member, the elastomeric member defining an internal seal surface adjacent the inner frame member and an external seal surface adjacent the outer frame member; wherein in use, the inner frame member is positioned within an oral cavity of the patient, the outer frame member is positioned outside the oral cavity of the patient, the internal seal surface engages an oral mucosa of the oral cavity, and the external seal surface engages the airway device.

[00012] Preferably, an intermediate portion defined by the elastomeric member intermediate to the internal seal surface and the external seal surface is configured to engage and modulate an upper lip or a lower lip of the patient.

[00013] Preferably, the inner frame member or the outer frame member comprises a rim defined by at least a horizontal superior member, a left descending member and a right descending member, and wherein a distal end of the left descending member and a distal end of the right descending member defines a horizontal inferior member.

[00014] Preferably, the horizontal inferior member is more flexible than the horizontal superior member, or the horizontal inferior member comprises one or more connecting members removably connecting the distal end of the left descending member with the distal end of the right descending member.

[00015] Preferably, the interface apparatus further comprises a frangible portion with or without a securing connector, extending between two or more of; the inner frame member, the outer frame member, the internal seal surface, the intermediate portion, and the external seal surface.

[00016] Further preferably, the frangible portion is at an inferior location on the interface apparatus. [00017] Further preferably, the frangible portion connects the horizontal inferior member of the inner frame member and the horizontal inferior member of the outer frame member.

[00018] Preferably, the inner frame further comprises a left laterally extending member and a right laterally extending member, such that the left laterally extending member and the right laterally extending member are configured to engage a buccal mucosa or the oral mucosa when the interface apparatus is engaged with the oral cavity.

[00019] Preferably, the inner frame defines a saddle shape.

[00020] Preferably, the elastomeric member is made from one of: polyvinyl chloride, polyurethane, polyethylene, nitrile, elastomer, or synthetic rubber.

[00021 ] Preferably, the inner frame member or the outer frame member is made from one of: spring steel, glass fibre, or plastic polymer.

[00022] Preferably, the fluid is a breathable gas.

[00023] Preferably, the airway device comprises one of: an anaesthetic facemask, a bag mask ventilator, a CPAP (continuous positive airway pressure) mask, or a mechanical ventilator.

[00024] Preferably, the outer frame member defines an outer perimeter that is equal or greater than the size of a mask of the airway device.

[00025] In another aspect, the invention resides in a method for sealing an oral cavity of a patient and an airway device providing a fluid to the patient, the method comprising the steps of: compressing an inner frame member and/or an outer frame member of an interface apparatus; inserting the inner frame member of the interface apparatus into the oral cavity of the patient; relaxing the inner frame member and/or the outer frame member of the interface apparatus from compression to deploy the interface apparatus; engaging the oral cavity using an elastomeric member joining the inner frame member and the outer frame member; engaging an oral mucosa of the oral cavity using a portion of the elastomeric member adjacent the inner frame member to form an internal seal surface; and engaging the airway device using a portion of the elastomeric member adjacent the outer frame member to form an external seal surface.

BRIEF DESCRIPTION OF THE DRAWINGS

[00026] To assist in understanding the invention and to enable a person skilled in the art to put the invention into practical effect, preferred embodiments of the invention will be described by way of example only with reference to the accompanying drawings, in which:

[00027] Fig. 1 is a front perspective view of an interface apparatus according to a first embodiment of the present invention.

[00028] Fig. 2 is a front perspective view of an interface apparatus according to a second embodiment of the present invention.

[00029] Fig. 3 is a rear perspective view of the interface apparatus of Fig.

2.

[00030] Fig. 4 is a lower rear perspective view of the interface apparatus of Fig. 2.

[00031 ] Fig. 5 is a side view of a patient with an inner frame member overlaid for illustrative purposes.

[00032] Fig. 6 is an in-use front view of an interface apparatus according to a third embodiment of the present invention.

[00033] Fig. 7 is a diagrammatic front view of an inner frame member. DETAILED DESCRIPTION OF THE INVENTION

[00034] The present invention relates to an interface apparatus for an airway device providing fluid, such as a breathable gas, to a patient. Elements of the invention are illustrated in concise outline form in the drawings, showing only those specific details that are necessary to understanding the embodiments of the present invention, but so as not to clutter the disclosure with excessive detail that will be obvious to those of ordinary skill in the art in light of the present description.

[00035] According to one aspect, the present invention is defined as an interface apparatus for an airway device that enhances the ease and efficacy of ventilation procedures for a human patient. According to some embodiments, the interface apparatus improves facemask oxygenation and ventilation of patients by providing an internal intra-oral seal within the oral cavity of the patient and an external extra-oral seal against an airway mask. The combined effect of the internal intra-oral seal and the external extra-oral seal can provide a satisfactory near air-tight seal and ensure proper ventilation and/or preoxygenation of the patient, minimising or eliminating any mask leak.

[00036] Further advantages of some embodiments of the present invention include suitability for bag mask ventilation and preoxygenation of bearded patients, edentulous patients, or patients with facial soft tissue deformities. The present invention provides a useful interface apparatus for an airway device that is easy to insert and remove, comfortable for the patient, and allows visibility and accessibility of the oral cavity for other airway instrumentation. The present invention is minimally invasive and reduces the risk of mucosal injury and any trauma to the patient’s oral cavity and soft tissue.

[00037] Those skilled in the art will appreciate that not all of the above advantages are necessarily included in all embodiments of the present invention.

[00038] Fig. 1 is a front perspective view of an interface apparatus according to a first embodiment of the present invention. An interface apparatus 100 is for an airway device (not shown) providing a fluid to a patient (not shown). The interface apparatus 100 preferably comprises an inner frame member 105, an outer frame member 1 10, and an elastomeric member 1 15 between, and connecting, the inner frame member 105 and the outer frame member 1 10. The elastomeric member 1 15 defines an internal seal surface 120 adjacent the inner frame member 105 and an external seal surface 125 adjacent the outer frame member 1 10. In use, the inner frame member 105 is positioned within an oral cavity of the patient and the outer frame member 110 is positioned outside the oral cavity of the patient. The internal seal surface 120 thereby engages an oral mucosa of the oral cavity and the external seal surface 125 engages the airway device used for ventilation of the patient. The elastomeric member 1 15 can be made of a film or material that is flexible and impermeable to air and water. Further, the elastomeric member 1 15 can be made from various materials, including: polyvinyl chloride, polyurethane, polyethylene, nitrile, elastomer, or synthetic rubber. The person skilled in the art will understand that the selected material should be non-toxic and/or medical grade as required by existing standards, and minimise choking hazard, infection risk, and cross-contamination risk.

[00039] An intermediate portion 130 defined by the elastomeric member

1 15 intermediate to the internal seal surface 120 and the external seal surface 125 is configured to engage and modulate a lip of the patient’s oral cavity. The intermediate portion 130 may engage the upper lip and/or lower lip of the patient so as to retract the lip and provide better access and view of the oral cavity and airway. Retraction of at least the upper lip, for example, is shown to improve airway grade according to Cormack-Lehane Grading. Improving view and access will significantly reduce injury during procedures and greatly improves patient safety. The intermediate portion 130 of the elastomeric member 1 15 also protects the patient’s top and bottom lip from trauma during instrumentation, including but not limited to laryngoscopy and supraglottic airway insertion.

[00040] The inner frame member 105 or the outer frame member 1 10 comprises a rim 105 A, 1 10 A defined by at least a horizontal superior member 105 B, 1 10 B with a left descending member 105 C, 1 10 C and a right descending member 105 D, 1 10 D. A distal end 105 E, 1 10 E of the left descending member 105 C, 1 10 C and a distal end 105 F, 110 F of the right descending member 105 D, 110 D defines a horizontal inferior member 105 G, 1 10 G. The horizontal inferior member 105 G, 1 10 G may optionally be made of a material that is more flexible than the horizontal superior member 105 B, 1 10 B. In one embodiment, as shown in Fig. 1 , the horizontal inferior member 105 G, 110 G is defined by the edge of the internal seal surface 120 or the edge of the external seal surface 125 between the distal end 105 E, 1 10 E of the left descending member 105 C, 1 10 C and the distal end 105 F, 1 10 F of the right descending member 105 D, 1 10 D. In a preferred embodiment, the horizontal inferior member 105 G of the inner frame member 105 is defined by the edge of the internal seal surface 120 as previously stated, while the horizontal inferior member 110 G of the outer frame member 1 10 is contiguous with, and made from the same material as, the left descending member 1 10 C and the right descending member 1 10 D. Optionally, the horizontal inferior member 1 10 G of the outer frame may be more flexible than the rest of the rim 110 A by being thinner in cross section and/or thickness at one or more portions.

[00041 ] According to some embodiments, a frangible portion 135 extends between two or more of; the inner frame member 105, the outer frame member 1 10, the internal seal surface 120, the intermediate portion 130, and the external seal surface 125. The frangible portion 135 is at an inferior location on the interface apparatus 100. The frangible portion 135 may be a perforated line that allows the interface apparatus 100 to be torn and separated at the inferior location. Optionally, the frangible portion 135 may be made of small holes, slots, reinforced edgings, a thinner material, or otherwise weakened portion compared to the adjacent bodies of the frangible portion 135. Further optionally, the frangible portion 135 may be one or more straight lines or a curved path extending between two or more of; the inner frame member 105, the outer frame member 1 10, the internal seal surface 120, the intermediate portion 135, and the external seal surface 125. The frangible portion 135 connects the horizontal inferior member 105 G of the inner frame member 105 and the horizontal inferior member 1 10 G of the outer frame member 1 10 such that the interface apparatus 100 can be completely separated at the inferior location.

[00042] By tearing the interface apparatus 100 along the frangible portion

135 and separating the interface apparatus 100 at the inferior location, removal of the interface apparatus 100 is possible without unnecessarily manipulating the oral cavity of the patient. Once the frangible portion 135 has been separated, the rim 105 A, 110 A may be collapsed inwards to reduce tension on the patient’s oral mucosa and lips. The frangible portion 135 separating the contiguous body of the interface apparatus 100 into a flexible ‘C’ shape with an opening at the inferior aspect also makes removal of the interface apparatus 100 possible when other airway devices, such as endotracheal tubes, laryngoscopes and supraglottic airway devices, are positioned within the oral cavity of the patient. The opening of the ‘C’ shape formed by tearing of the frangible portion 135 will allow any instruments located within the patient’s oral cavity to pass through the interface apparatus 100. Optionally, a left tab 110 H located at the distal end 1 10 E of the left descending member 1 10 C and a right tab 1 10 I located at the distal end 110 F of the right descending member 1 10 D can be included to assist with tearing of the frangible portion 135, providing additional purchase when in use.

[00043] Fig. 2 is a front perspective view of an interface apparatus 200 according to a second embodiment of the present invention. Similar to the first embodiment, the interface apparatus 200 according to the second embodiment also comprises an inner frame member 205, an outer frame member 210, and an elastomeric member 215 between the inner frame member 205 and the outer frame member 210. The elastomeric member 215 defines an internal seal surface adjacent the inner frame member 205 and an external seal surface 225 adjacent the outer frame member 210. In use, the inner frame member 205 is likewise positioned within an oral cavity of the patient and the outer frame member 210 is positioned outside the oral cavity of the patient.

[00044] Fig. 2 illustrates, in particular, one or more connecting members removably connecting the distal end 210 E of the left descending member 210 C of the outer frame member 210 with the distal end 210 F of the right descending member 210 D of the outer frame member 210. The one or more connecting members are a left tab 210 H and a right tab 210 I configured to removably mate and fasten to one another. Optionally, the one or more connecting members may interface via a connector 210 J, further optionally in the form of an interference fitting button. The left tab 210 H may comprise a protrusion that interference fits within a cavity or aperture formed on the right tab 210 I. The person skilled in the art will understand that different fastening methods may be implemented so long as the left distal end 210 E can be releasably secured or attached to the right distal end 210 F.

[00045] The connector 210 J positioned at an inferior aspect allows the outer frame member 210 to remain secure while in use and become disconnected at an inferior position, when desired. Optionally, the connector 210 J may be located at another position on the outer frame member 210, for example along the left descending member 210 C, the right descending member 210 D, or the horizontal superior member 210 B. The connector 210 J is secured while the interface apparatus 200 is in use and engaged with the oral cavity of the patient. This ensures that a frangible portion 235 allowing the interface apparatus 200 to be torn and separated at the inferior location remains intact, and that outwardly spring tension provided by the outer frame member 210 is maintained. Once the connector 210 J is disconnected, the left tab 210 H and the right tab 210 I may be pulled apart and away from each other such that the frangible portion 235 separates from the outer frame member 210 through to the inner frame member 205. Flat surfaces provided on the left tab 210 H and the right tab 210 I assist with tearing of the frangible portion 235, providing additional purchase when in use.

[00046] Fig. 3 is a rear perspective view of the interface apparatus 200 of

Fig. 2. The rear perspective view of the interface apparatus 200 shows that, according to the second embodiment of the present invention, the inner frame member 205 may comprise a horizontal inferior member 205 G that is formed only by the edge of the elastomeric member 215 located between the distal end 205 E of the left descending member 205 C of the inner frame member 205 and the distal end 205 F of the right descending member 205 D of the inner frame member 205.

[00047] The horizontal inferior member 205 G as illustrated by Fig. 3 is defined by a break in the solid rim of the inner frame member 205, the break being located at an inferior aspect of the frame member 205. This configuration allows the inner frame member 205 improved flexibility and also allows the interface apparatus 200 to be easily separated along the frangible portion 235. To further assist with separation of the frangible portion 235, a notch 240 may be included on the elastomeric member 215 adjacent the outer frame member 210, where the frangible portion 235 begins.

[00048] Fig. 3 also illustrates a left laterally extending member 205 K and a right laterally extending member 205 L on the inner frame member 205. The left laterally extending member 205 K and the right laterally extending member 205 L are configured to engage a buccal mucosa and/or the oral mucosa when the interface apparatus 200 is engaged with the oral cavity of the patient. This ensures a secure seal and engagement against at least the buccal mucosa, allowing the inner frame member 205 to be firmly positioned and held in place by the musculature of the lips.

[00049] Fig. 4 is a lower rear perspective view of the interface apparatus

200 of Fig. 2. The inner frame member 205 of the interface apparatus 200 is a saddle shape and curves posteriorly to the patient when viewed from a side elevation. Fig. 5 is a side view of a patient with an inner frame member 205 overlaid for illustrative purposes, exemplifying the saddle shape of the inner frame member 205 curving posteriorly to the patient. The extending members 205 J, 205 K protrude rearwardly and also outwardly to assist with preventing the interface apparatus 200 from dislodging. Optionally, the extending members 205 J, 205 K protrude laterally and/or posteriorly. These configurations, including the outwardly protruding configuration, are useful for engaging the buccal mucosa of the patient and extending members 205 J, 205 K extend towards the patient’s vestibule, securing the inner frame member 205 from dislodgement even when performing a jaw thrust manoeuvre, wherein the jaw is moved anteriorly such that the lower central incisors are anterior to the upper central incisors. The person skilled in the art will understand that the jaw thrust manoeuvre is common in airway rescue techniques and necessary for preventing obstruction of the patient’s upper airway. Optionally, the extending members 205 K, 205 L may further comprise tabs, wings, or other suitable protrusions or features for engaging the patient’s buccal mucosa. The extending members 205 K, 205 L also improve the lateral volume of the cheeks, allowing improved fitment of an airway mask. The interface apparatus 200 maintains the ability for the patient to freely open and close their mouth while the interface apparatus 200 is in place.

[00050] The lower rear perspective view of Fig. 4 illustrates the left tab

210 H and the right tab 210 I of the one or more connecting members securing together the distal end 210 E of the left descending member 210 C of the outer frame member 210 with the distal end 210 F of the right descending member 210 D of the outer frame member 210. In a preferred embodiment, the left tab 210 H and the right tab 210 I are configured to overlap each other, with the connector 210 J providing an interference fit in the form of a button. The person skilled in the art will understand that the protruding connector 210 J may a connector in the broadest sense, and any suitable connecting and/or mating feature may be used to releasably secure the left tab 210 H to the right tab 210 I. Once the connector 210 J is separated, the frangible portion 235 may be split to facilitate with removal of the interface apparatus 200.

[00051 ] The curved cross section of the interface apparatus 200 is also shown in Fig. 4, wherein in use the elastomeric member 215 curves inward from the inner frame member 205 and outward to meet the outer frame member 210. The elastomeric member 215 adjacent the inner frame member 205 forms an internal seal surface 220. In particular, the inner surface of the elastomeric member 215 adjacent the inner frame member 205 forms the internal seal surface 220 configured to seal against the inside of the patient’s oral cavity. The elastomeric member 215 adjacent the outer frame member 210 forms an external seal surface 225. In particular, the outer surface of the elastomeric member 215 adjacent the outer frame member 210 forms the external seal surface 225 configured to seal against the airway mask. An intermediate portion 230 defined by the elastomeric member 215 intermediate to the internal seal surface 220 and the external seal surface 225 is configured to engage a lip, such as the upper lip and/or the lower lip, of the patient’s oral cavity. In particular, the intermediate portion 230 defined by the inside surface of the elastomeric member 215 intermediate to the internal seal surface 220 and the external seal surface 225 is configured to engage the lip of the patient’s oral cavity. An aperture 245 defined by the outside surface of the intermediate portion 230 allows flow of breathable gas, or a mixture of gases or other substance as required, into the oral cavity of the patient and facilitates visibility and/or application of additional instrumentation as required.

[00052] Fig. 6 is an in-use front view of an interface apparatus 300 according to a third embodiment of the present invention. In one embodiment, the interface apparatus 300 may comprise an outer frame member 310 with a horizontal inferior member 310 G defined by an edge of the elastomeric member 315 between the distal end 310 E of the left descending member 310 C and the distal end 310 F of the right descending member 310 D. Optionally, the horizontal superior member 310 B of the outer frame member 310 may comprise one or more curves, bends, or angles to accommodate the patient’s nose and/or other facial features. Further optionally, the horizontal superior member 310 B comprises a curve towards the patient’s mouth such that clearance is provided for the patient’s nose. An external seal surface 325 defined by the elastomeric member 315 adjacent the outer frame member 1 10 provides a sealing surface for an airway mask.

[00053] The elastomeric member 125, 225, 325 can be made from various materials, including: polyvinyl chloride, polyurethane, polyethylene, nitrile, elastomer, or synthetic rubber, and the inner frame member 105, 205, 305 and/or the outer frame member 1 10, 210, 310 can be made from, for example: spring steel, glass fibre, or plastic polymer. The materials selected for the inner frame member 105, 205, 305 and/or the outer frame member 110, 210, 310 are suited for medical applications and will provide enough tension for the inner frame member 105, 205, 305 and/or the outer frame member 1 10, 210, 310 to maintain sufficient rigidity during use while not causing the patient discomfort. The material selected for the elastomeric member 125, 225, 325 is generally flexible and resilient enough for application within the oral cavity of the patient and providing a suitable internal seal surface 120, 220, 320 and external seal surface 125, 225, 325 that is impermeable to gas and liquid. The person skilled in the art will understand that the aforementioned materials do not constitute an exhaustive list, and alternative materials, thicknesses, and combinations may be used to achieve a desired tension for the inner frame member 105, 205, 305 and/or the outer frame member 110, 210, 310, as well as a flexible elastomeric member 125, 225, 325 that provides suitable sealing against oral mucosa and the airway mask. The selected materials generally allow sufficient flexibility for the internal seal surface 120, 220, 320 to be maintained while providing freedom of movement for the patient’s jaw and lips.

[00054] The interface apparatus 100, 200, 300 according to the present invention is thereby generally suitable for use with an airway device comprising, for example: an anaesthetic facemask, a bag mask ventilator, a mechanical ventilator, or any other suitable device as required. The person skilled in the art will understand that additional forms of airway devices and respiratory devices providing a breathable gas, such as continuous positive airway pressure devices and nebulisers, are also suitable for use with, and will obtain benefit from, the interface apparatus 100, 200, 300. The interface apparatus 100, 200, 300 thereby assists in providing a suitable seal for an airway mask delivering breathable gas, including air, oxygen, nitrous oxide, a mixture of gases, or other aerosolised medicaments, as required. The outer frame 1 10, 210, 310 of the interface apparatus 100, 200, 300 is suitably sized to define an outer perimeter that is equal or greater than the size or width of a mask of the airway device, or any other suitable device as required, so as to ensure adequate sealing surface area.

[00055] The present invention also resides in a method for sealing an oral cavity (and/or perioral region) of a patient and an airway device providing a fluid to the patient, the method comprising the steps of: compressing an inner frame member 105, 205, 305 and/or an outer frame member 1 10, 210, 310 of an interface apparatus 100, 200, 300; inserting the inner frame member 105, 205, 305 of the interface apparatus 100, 200, 300 into the oral cavity of the patient; relaxing the inner frame member 105, 205, 305 and/or the outer frame member 1 10, 210, 310 of the interface apparatus 100, 200, 300 from compression to deploy the interface apparatus 100, 200, 300; engaging the oral cavity using an elastomeric member 1 15, 215, 315 joining the inner frame member 105, 205, 305 and the outer frame member 110, 210, 310; engaging an oral mucosa of the oral cavity using a portion of the elastomeric member 1 15, 215, 315 adjacent the inner frame member 105, 205, 305 to form an internal seal surface 120, 220, 320; and engaging the airway device using a portion of the elastomeric member 1 15, 215, 315 adjacent the outer frame member 1 10, 210, 310 to form an external seal surface 125, 225, 325.

[00056] The step of compressing an inner frame member 105, 205, 305 and/or an outer frame member 1 10, 210, 310 of an interface apparatus 100, 200, 300 further involves the step of administering a one-handed pinch grip to pull lateral aspects of the interface apparatus 100, 200, 300 towards each other, forming a compressed shape. The lateral aspects of the interface apparatus 100, 200, 300 may comprise one or more of left descending members 105 E, 205 E, 305 E, 1 10 E, 210 E, 310 E and right descending members 105 D, 205 D, 305 D, 1 10 D, 210 D, 310 D.

[00057] Fig. 7 is a diagrammatic front view of an inner frame member 105,

205, 305 in relation to an aperture 745 defined by the opening of a patient’s oral cavity and/or the intermediate portion of the elastomeric member (not shown). One or more features described herein with relation to the inner frame member 105, 205, 305 according to this fourth embodiment may also be applied to other embodiments of the present invention. The method according to the present invention may include compressing the inner frame member 105, 205, 305 to pull lateral aspects of the interface apparatus 100, 200, 300 towards each other. In particular, the lateral aspects of the interface apparatus may comprise the left laterally extending member 105 K, 205 K, 305K and right laterally extending member 105 L, 205 L, 305 L. As exemplified in Fig. 7, the left laterally extending member 105 K, 205 K, 305K and right laterally extending member 105 L, 205 L, 305 L may further comprise tabs, wings, or other suitable protrusions for engaging the patient’s buccal mucosa, also improving the lateral volume of the cheeks, allowing improved fitment of an airway mask. The tabs, wings, or other suitable protrusions may optionally be provided by a thickened portion of the inner frame member 105, 205, 305 or an additional flattened member to improve rigidity and increase volume.

[00058] When compressing the inner frame member 105, 205, 305, the method includes the step of deflecting and/or contracting of the horizontal inferior member 105 G, 205 G, 305 G as the left descending member 105 C, 205 C, 305 C and the right descending member 105 D, 205 D, 305 D are pulled together. Optionally, the horizontal inferior member 105 G, 205 G, 305 G is defined by the taught edge of the internal seal surface 120, 220, 320. Further optionally, the edge of the internal seal surface 120, 220, 230 may be made from a thicker section of the elastomeric member 1 15, 215, 315.

[00059] Optionally, insertion of the interface apparatus 100, 200, 300 comprises the step of manually retracting one or both sides of the patient’s cheek to assist with insertion. This is achievable with a free hand of a single operator as the pinch grip compressing the interface apparatus 100, 200, 300 is able to be done using one hand. Once the inner frame member 105, 205, 305 has been positioned within the patient’s oral cavity, the laterally extending members 105 K, 205 K, 305K, 105 L, 205 L, 305 L may be relaxed and positioned towards the patient’s buccal or labial vestibules, securing the inner frame member 105, 205, 205 from dislodgement even when performing a jaw thrust manoeuvre, as previously discussed.

[00060] Proper insertion of the inner frame member 105, 205, 305 will engage the internal seal surface 120, 220, 320 against the patient’s buccal mucosa, forming the intra-oral seal. The outer frame member 1 10, 210, 310 can then be manipulated and positioned to cover the external area of the patient’s oral cavity as desired. The airway mask can then be placed over the external seal surface 125, 225, 325 defined by the elastomeric member 1 15, 215, 315 adjacent the outer frame member 1 10, 210, 310.

[00061 ] Optionally, the method further comprises the step of removing the airway mask, exposing the aperture 745 to the oral cavity of the patient such that any airway adjunct may be used, including but not limited to instrumentation including an oropharyngeal airway. Further optionally, exposure of the aperture 745 may also provide treating medical staff with visibility of the oral cavity and the oropharynx, allowing access as needed. Further optionally, the method includes the step of replacing the airway mask after access to the aperture 745 is no longer required, allowing the patient to quickly return to ventilation or preoxygenation, if desirable.

[00062] The method involves the step of removing the interface apparatus

100, 200, 300 once the airway mask is no longer required. Optionally, the interface apparatus 100, 200, 300 may be compressed as previously discussed to retract the laterally extending members 105 K, 205 K, 305K, 105 L, 205 L, 305 L, allowing easy removal of the interface apparatus 100, 200, 300 without causing discomfort to the patient. This provides an atraumatic removal process with minimal risk of tissue damage. Further optionally, the method involves the step of separating the interface apparatus 100, 200, 300 by tearing the frangible portion 135, 235, 335 extending between extending between two or more of; the inner frame member 105, 205, 305, the outer frame member 1 10, 210, 310, the internal seal surface 120, 220, 320, the intermediate portion 135, 235, 335, and the external seal surface 125, 225, 325. According to some embodiments, the frangible portion 135, 235, 335 connects the horizontal inferior member 105 G, 205 G, 305 G of the inner frame member 105, 205, 305 and the horizontal inferior member 110 G, 210 G, 310 G of the outer frame member 110, 210, 310 such that the interface apparatus 100, 200, 300 can be completely separated at the inferior location.

[00063] Separation of the interface apparatus 100, 200, 300 allows the contiguous body to be broken into a flexible ‘C’ shape with an opening at the inferior aspect also makes removal of the interface apparatus 100, 200, 300 possible when other airway devices, such as endotracheal tubes, laryngoscopes and supraglottic airway devices, are positioned within the oral cavity of the patient. Optionally, the step of removing the interface apparatus 100, 200, 300 involves passing any instruments located within the patient’s oral cavity via the opening of the ‘C’ shape formed by tearing of the frangible portion 135, 235, 335.

[00064] Optionally, the step of tearing the frangible portion 135, 235 involves the use of the left tab 110 H, 210 H and the right tab 1 10 I, 210 I as provided by the first and second embodiments, which provide additional purchase to the medical staff removing the interface apparatus 100, 200. Further optionally, the step of tearing the frangible portion 235 involves firstly disconnecting the connector 210 J removably fastening the left tab 210 H and the right tab 210 I, as provided by the second embodiment. Disconnection of the connector 210 J then allows the frangible portion 235 to be separated. [00065] The skilled addressee will understand that alternate forms of the interface apparatus 100, 200, 300 may be provided to suit different preferences, circumstances, and patients. The interface apparatus 100, 200, 300 may also be sized according to the patient and/or the airway device used. Optionally, the interface apparatus 100, 200, 300 is enclosed in a sterile or clean package for removal prior to use. Further optionally, the sterile package is colour coded to identify different sizes and/or features appropriate for different applications.

[00066] The interface apparatus 100, 200, 300 therefore addresses at least some of the aforementioned problems, providing an interface apparatus 100, 200, 300 that delivers efficient sealing of an airway mask when ventilating or delivering a breathable gas to a patient. The interface apparatus 100, 200, 300 allows easy insertion and removal from the patient’s oral cavity, allowing simple and atraumatic removal even when adjunct airways are in place within the oral cavity of the patient. Disadvantages of invasive devices causing discomfort from stimulation to the back of the tongue as are minimised or eliminated, and the apparatus 100, 200, 300 can be suitably used for awake and anaesthetised patients. The apparatus 100, 200, 300 provides significantly improved airway mask sealing and mitigates gas leaks for bearded patients and patients with facial deformities, without relying on sticky film and/or gel.

[00067] The skilled addressee will understand that the interface apparatus

100, 200, 300 can therefore be a valuable tool for bag mask ventilation and anaesthetic preoxygenation, as well as other applications including, but not limited to, continuous positive airway pressure devices and nebulisers for delivering an aerosolised medicament. The interface apparatus 100, 200, 300 is therefore useful in multiple situations and environments involving airway masks, from off-site paramedicine and retrieval, to in-hospital emergency and intensive care, as well as during elective procedures involving anaesthesia.

[00068] In this patent specification, adjectives such as first and second, left and right, top and bottom, up and down, upper and lower, rear, front and side, etc., are used solely to define one element or method step from another element or method step without necessarily requiring a specific relative position or sequence that is described by the adjectives. Words such as “comprises” or “includes” are not used to define an exclusive set of elements or method steps. Rather, such words merely define a minimum set of elements or method steps included in a particular embodiment of the present invention.

[00069] 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. 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. Accordingly, this patent specification 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 scope of the above described invention, which is determined by the following claims.

Claims

1 . An interface apparatus for an airway device providing a fluid to a patient, the interface apparatus comprising: an inner frame member; an outer frame member; and an elastomeric member between the inner frame member and the outer frame member, the elastomeric member defining an internal seal surface adjacent the inner frame member and an external seal surface adjacent the outer frame member; wherein in use, the inner frame member is positioned within an oral cavity of the patient, the outer frame member is positioned outside the oral cavity of the patient, the internal seal surface engages an oral mucosa of the oral cavity, and the external seal surface engages the airway device.

2. The interface apparatus of claim 1 , wherein an intermediate portion defined by the elastomeric member intermediate to the internal seal surface and the external seal surface is configured to engage and modulate an upper lip or a lower lip of the patient.

3. The interface apparatus of any preceding claim, wherein the inner frame member or the outer frame member comprises a rim defined by at least a horizontal superior member, a left descending member and a right descending member, and wherein a distal end of the left descending member and a distal end of the right descending member defines a horizontal inferior member.

4. The interface apparatus of claim 3, wherein the horizontal inferior member is more flexible than the horizontal superior member, or the horizontal inferior member comprises one or more connecting members removably connecting the distal end of the left descending member with the distal end of the right descending member.

5. The interface apparatus of claim 2, further comprising a frangible portion with or without a securing connector, extending between two or more of: the inner frame member, the outer frame member, the internal seal surface, the intermediate portion, and the external seal surface.

6. The interface apparatus of claim 5, wherein the frangible portion is at an inferior location on the interface apparatus.

7. The interface apparatus of claim 5 or 6, wherein the frangible portion connects the horizontal inferior member of the inner frame member and the horizontal inferior member of the outer frame member.

8. The interface apparatus of any preceding claim, wherein the inner frame further comprises a left laterally extending member and a right laterally extending member, such that the left laterally extending member and the right laterally extending member are configured to engage a buccal mucosa or the oral mucosa when the interface apparatus is engaged with the oral cavity.

9. The interface apparatus of any preceding claim, wherein the inner frame defines a saddle shape.

10. The interface apparatus of any preceding claim, wherein the elastomeric member is made from one of: polyvinyl chloride, polyurethane, polyethylene, nitrile, elastomer, or synthetic rubber.

1 1 . The interface apparatus of any preceding claim, wherein the inner frame member or the outer frame member is made from one of: spring steel, glass fibre, or plastic polymer.

12. The interface apparatus of any preceding claim, wherein the fluid is a breathable gas.

13. The interface apparatus of any preceding claim, wherein the airway device comprises one of: an anaesthetic facemask, a bag mask ventilator, a CPAP (continuous positive airway pressure) mask, or a mechanical ventilator.

14. The interface apparatus of any preceding claim, wherein the outer frame member defines an outer perimeter that is equal or greater than the size or width of a mask of the airway device.

15. A method for sealing an oral cavity of a patient and an airway device providing a fluid to the patient, the method comprising the steps of: compressing an inner frame member and/or an outer frame member of an interface apparatus; inserting the inner frame member of the interface apparatus into the oral cavity of the patient; relaxing the inner frame member and/or the outer frame member of the interface apparatus from compression to deploy the interface apparatus; engaging the oral cavity using an elastomeric member joining the inner frame member and the outer frame member; engaging an oral mucosa of the oral cavity using a portion of the elastomeric member adjacent the inner frame member to form an internal seal surface; and engaging the airway device using a portion of the elastomeric member adjacent the outer frame member to form an external seal surface.