Nose interface

Abstract

A respiratory interface device (1) and its components are disclosed. The respiratory interface device (1) includes a body (2), a frame (3), and an inlet conduit (4). The frame has a front wall (10a), side walls (10b), and side arms (12), and includes a support platform (11) extending rearward from the front wall (10a). An inlet opening (13) is formed in the support platform (11). The body (2) forms a chamber with the support platform (11) and includes at least one nostril outlet (5), a base opening (7), and at least one additional opening (6) through which the support platform (11) extends. The inlet conduit (4) includes a connector (18) that clamps the body (2) and support platform (11) together.

Description

Technical Field

[0001] The present invention relates to a respiratory interface device for providing a flow of breathing gas to a patient, components thereof, and a respiratory interface device kit.

Background Art

[0002] High-flow nasal therapy is applicable for improving the breathing efficiency of patients with mild to moderate respiratory distress.

[0003] In high-flow nasal therapy, a respiratory interface such as a nasal cannula can be used to deliver breathing gas to a patient. Typically, a nasal cannula comprises a cannula body having a pair of nasal prongs for delivering breathing gas into the patient's nostrils, and a side arm for connecting the cannula body to a head strap for securing the device to the patient. The breathing gas is supplied from an opening of the cannula body via a conduit connected to a gas supply tube.

[0004] Many commercially available respiratory interface devices include a simple silicone tube that is relatively soft and malleable. The cannula body, nasal prongs, and side arm may all be made of silicone. One problem with such devices is that the weight of the gas supply tube can pull on the interface device, causing it to deform or become detached from the patient. In some cases, a clip can be used to secure the gas supply tube to a headgear such as an elastic head strap to reduce the weight of the tube of the interface device itself. Another problem is that movement or manipulation of the headgear, such as when tightening a head strap, can cause movement in the cannula body and nasal protrusions. For example, the nasal-side prongs can be crushed, affecting the speed of the gas passing through the prongs and causing discomfort. Since any movement of the nasal-side prongs during use can cause irritation, the stability of such interface devices is an important consideration in their use.

[0005] In high-flow nasal therapy, most commonly, the flow of breathing gas is supplied horizontally to the breathing interface from one side of the interface device. In some configurations, it is possible to disconnect the gas supply from one side of the interface device and reconnect it on the other side, which in this example provides adaptability when the patient moves position during sleep or eating, or when a healthcare provider is involved, and allows movement between beds with gas supply units on different sides.

[0006] A variety of breathing devices have been proposed in the art.

[0007] For example, EP 1 481 702 discloses a nasal cannula assembly having a single horizontal side gas inlet. The assembly comprises a side attachment portion including at least one nasal prong and a removable gas flow manifold having a single horizontal side gas inlet that is in fluid communication with the gas transport means in use. The gas transport means may extend from either the right or left side of the nasal cannula assembly and is interchangeable therewith by removing the gas flow manifold from the face mount portion and reattaching it in the opposite orientation. A cord or strap is used to transfer the weight of the gas supply conduit to the patient's neck.

[0008] WO 2011 / 062510 discloses a series of breathing interface devices. Various aspects and embodiments will be described. In one aspect, the document discloses a nasal interface device comprising a flexible body having an inlet for connection to a conduit providing a flow of gas and at least one nostril outlet, and a more rigid frame attached to or integrally formed with the body, adapted to engage the conduit and secure the conduit to the body. The conduit may connect to the body from below the body and extend downwardly from the cannula. Alternatively, the conduit may be provided on one side of the nasal cannula and connected to a side arm lumen, or two conduits, one on each side of the cannula, may be provided and connected to respective side arm lumens.

[0009] WO 2015 / 193833 relates to a patient interface device and components. In one aspect, the patient interface device comprises a frame portion having a gas chamber and a nasal delivery element, and a manifold rotatably fixed to the frame portion, the manifold having a shaft structure and being configured to rotate relative to the frame portion. SUMMARY OF THE INVENTION PROBLEM TO BE SOLVED BY THE INVENTION

[0010] An object of the present invention is to provide an improved nasal interface device for providing a flow of breathing gas to a patient. MEANS FOR SOLVING THE PROBLEM

[0011] In a first aspect, the present invention provides a respiratory interface device comprising a body, a frame, and an inlet conduit: The frame includes a front portion having a front wall and two side walls, side arms, and a support platform extending rearward from the front wall, the support platform having an inlet opening formed therein; In use, the body comprises at least one nostril outlet for interfacing with the user's nostrils, a base opening, and at least one opening through which the support platform extends, the inlet conduit having a connector at a first end passing through the base opening of the body and the inlet opening of the support platform, the connector clamping the base wall of the body and the support platform together, and a chamber being defined between the support platform and the body, the chamber providing fluid communication between the inlet conduit and the one or more nostril outlets.

[0012] In a second aspect, the present invention provides a respiratory interface device comprising a body, a frame, and an inlet conduit: The frame comprises a front part having a front wall and two side walls, side arms, and a support platform extending rearward from the front wall, the support platform having an inlet opening through which a first end of the inlet conduit passes; The body comprises at least one nostril outlet for interfacing with the user's nostrils in use, a base opening, at least one opening through which the support platform extends, and a chamber defined between the support platform and the body, the chamber providing fluid communication between the inlet conduit and the one or more nostril outlets, and the side walls of the front part of the frame being separated from the platform.

[0013] In a third aspect, the invention provides a respiratory interface device comprising a body, a frame, and an inlet conduit: The frame comprises two side walls, side arms, and a platform extending between the two side walls, the platform having an inlet opening formed therein; The body comprises at least one nostril outlet for interfacing with the user's nostrils in use, a base opening, and a side opening through which the platform passes, the inlet conduit having a connector at a first end passing through the base opening of the body and the inlet opening of the support platform, the connector clamping the base wall of the body and the support platform together, and the chamber being defined between the support platform and the body, the chamber providing fluid communication between the inlet conduit and the one or more nostril outlets.

[0014] In a fourth aspect, the invention provides a frame for use in a respiratory interface device, the frame comprising a front part having a front wall and two side walls, side arms, and a support platform extending rearward from the front wall, the support platform having an inlet opening formed therein, and the side walls of the front part of the frame being separated from the platform.

[0015] In a fifth aspect, the present invention provides a conduit for use in a respiratory interface device, the conduit comprising a connector at a first end, the connector extending upwardly from the body of the conduit and configured to connect to and supply gas to a nasal cannula portion, and a second end of the conduit being configured to connect to a gas supply tube.

[0016] In a sixth aspect, the present invention provides a respiratory interface device kit, the kit comprising: a frame, a body, and an inlet conduit, which are provided as separate parts or fully assembled, and are described herein together with instructions for assembly and / or use.

[0017] A respiratory interface device according to the first and second aspects of the present invention A respiratory interface device according to the first aspect of the present invention comprises a body, a frame, and an inlet conduit. The frame comprises a front portion having a front wall and two side walls, both arms, and a support platform extending rearwardly from the front wall. The support platform has an inlet opening formed therein. The body comprises at least one nostril outlet for interfacing with the user's nostrils during use, a base opening, and at least one opening through which the support platform extends. The inlet conduit comprises a connector at a first end that passes through the base opening of the body and the inlet opening of the support platform. The connector clamps the base wall of the body and the support platform together. A chamber is defined between the support platform and the body, and this chamber provides fluid communication between the inlet conduit and the one or more nostril outlets.

[0018] The "front part" of the frame is the part of the frame that extends around the front and side surfaces of the support platform. The "side arm" is the part that extends to the side of the front part of the frame and enables the respiratory interface device to be held at a predetermined position on the patient's face. The side arm may extend from any position on the side wall of the front part of the frame. Thus, the side arm may be continuous from the "end" of the front part of the frame, or may extend from a position in front of the end on the side wall of the front part. In the context of the present application, the "end" of the front part of the frame is the part of the side wall of the front part that is closest to the patient's face during use. It is preferable that the side arm is continuous from the end of the front part of the frame.

[0019] In a preferred embodiment of the first aspect of the present invention, the side wall of the front part of the frame is separated from the support platform, and the body has a front opening through which the support platform extends. In an alternative embodiment, the side wall of the front part of the frame is separated from the support platform, and the body has a side opening through which the platform extends. In a further alternative embodiment, the side wall of the front part of the frame is joined to the support platform, and the body has a side opening through which the platform extends. The frame can have rounded or chamfered edges.

[0020] The respiratory interface device according to the second aspect of the present invention includes a main body, a frame, and an inlet conduit. The frame includes a front portion having a front wall and two side walls, side arms, and a support platform extending rearward from the front wall. The support platform has an inlet opening formed therein and receiving the first end of the inlet conduit. The main body includes at least one nostril outlet for interfacing with the user's nostrils during use, a base opening, at least one opening through which the support platform extends, and a chamber defined between the support platform and the main body, the chamber providing fluid communication between the inlet conduit and the one or more nostril outlets. The side walls of the front portion of the frame are separated from the platform. As described above, the "front portion" of the frame is the portion of the frame extending around the front and sides of the platform, and the "side arms" are the portions of the frame extending along the sides of the front portion of the frame and enabling the respiratory interface device to be held in a predetermined position on the patient's face. For the respiratory interface device according to the first aspect of the present invention, the side arms may extend from any position on the side walls of the front portion of the frame, and preferably, the side arms are continuous from the ends of the front portion of the frame. The frame can have rounded or chamfered edges.

[0021] In a preferred embodiment of the second aspect of the present invention, the main body includes a front opening through which the support platform extends. In an alternative embodiment, the main body includes a side opening through which the support platform extends.

[0022] Further examples of the first and second aspects of the present invention are described below. To avoid doubt, unless otherwise indicated, features described in connection with a particular embodiment of an aspect of the present invention can be combined with features described in connection with other particular embodiments of an aspect of the present invention.

[0023] Main body The respiratory interface device according to the first and second aspects of the present invention includes a main body, a frame, and an inlet conduit. As used herein, the term "main body" generally refers to a main body for a nasal cannula that includes an oral, upper, front, rear, and side walls, an inlet (opening) for receiving a conduit that provides a gas flow, and at least one nasal outlet provided on an upper wall for interfacing with a patient's nostrils during use.

[0024] The main body includes at least one opening through which a support platform extends. In some embodiments, the at least one opening through which the support platform extends is a pair of side wall openings in the side wall of the main body. In the context of this application, the term "extending through" includes an arrangement in which the support platform is entirely housed within the main body and is located between two side openings. In a preferred embodiment, the at least one opening through which the support platform extends is a front opening in the front wall of the main body. (In such a preferred embodiment, the side walls of the front portion of the frame are separated from the platform.)

[0025] The main body preferably includes a pair of nasal outlets (prongs) for interfacing with a patient's nostrils. The prongs are formed to comfortably fit within the patient's nostrils and may be curved, for example, in a shape that curves rearward and inward from the base of the prong with respect to the front and side portions of the main body.

[0026] The prongs may have a uniform cross-section and / or a uniform wall thickness along their length. In some embodiments, the region around the base of each prong is thinner than the rest of the main body. This may improve the flexibility of the prong and potentially attenuate the effect of forces acting on the prong.

[0027] The base opening of the main body corresponds to the inlet opening of the support platform such that the first end of the inlet conduit is received through both openings.

[0028] The body can comprise an annular outwardly projecting ring around the base opening. The ring is integrally formed with the body and can be distorted and / or compressed when the inlet conduit is attached to the frame, providing a better seal and thus reducing leakage at this interface between components. The ring also provides a degree of resistance to rotation so that in the assembled device, the inlet conduit can be attached to the frame in a rotatable manner (as described later), but will not rotate freely when not held in a fixed position on the frame. The annular outwardly projecting ring can comprise means for holding the inlet conduit in a fixed position on the respiratory interface device during use. For example, this can comprise one or more recesses for cooperating with corresponding projections on the inlet conduit, or one or more projections for cooperating with corresponding recesses on the inlet conduit.

[0029] The rear wall of the body may extend beyond its base, providing an increased area for contact with the patient's upper lip. This can reduce the pressure on the patient and potentially improve comfort.

[0030] The rear wall of the body is preferably formed to correspond to the shape of the patient's upper lip and may thus curve inwards from its outer edge.

[0031] The body is generally composed of a flexible material and is preferably transparent. For example, the body can be formed from silicone or a similar material. As will be understood by those skilled in the art, the desirable properties of the material for the body include softness and biocompatibility. Also, this substance needs to be compatible with highly concentrated (up to 100% O2) humidified gas. Elasticity and structural integrity are further desirable properties in a suitable material.

[0032] The transparency of the body material is preferred so that the level of any water collected in the chamber and any obstructions can be seen.

[0033] The material of the body is preferably suitable for surface printing and / or coating or the application of one or more surface finishes, for example, providing patient comfort and being suitable for labeling purposes. Suitable surface finishes can include, for example, any of satin finish, texture finish, gloss finish, and pattern finish. A satin finish may provide a softer feel to the body. A texture finish may be used to provide comfort or for labeling. A gloss finish improves visibility for labeling and provides improved transparency. Thus, such finishes may be useful in areas where condensation, etc. is likely to occur and improved visibility is considered useful. A pattern finish can provide decoration but can also be used to improve moisture wicking and comfort.

[0034] The body may be provided with different sizes, for example, different sizes of prongs. Thereby, a size suitable for an individual patient can be selected.

[0035] Frame The frame of the respiratory interface device according to the first and second aspects of the present invention includes a front portion, side arms, and a support platform. The front portion has a front wall and two side walls. The support platform extends rearward from the front wall of the front portion and has an inlet opening formed therein. The frame has a single inlet opening, that is, an inlet opening formed in the support platform of the frame. The frame can have rounded or chamfered edges.

[0036] In some embodiments of the first aspect of the present invention, the side walls of the front portion of the frame are joined to the support platform, and the support platform extends through an opening in the side wall of the body. In the second aspect of the present invention and in the preferred embodiments of the first aspect of the present invention, the side walls of the front portion of the frame are separated from the support platform, and the support platform extends through the front opening of the body or through the side opening of the body.

[0037] In particular, when the side walls of the front portion of the frame are separated from the support platform, the breathing interface device has improved flexibility, elasticity, and springiness, reducing the impact on the cannula body and nasal prong due to the force applied to one or both side arms. For example, the movement of the side arm does not necessarily result in an equal degree of movement of the corresponding side wall of the front portion of the frame, and any force applied to the side arm (such as may occur when the headgear is adjusted) causes movement of the side arm and does not necessarily result in an equal transmission of force along the side wall of the front portion of the frame and ultimately to the front wall of the breathing interface device, the support platform, and the body. The flexibility of the side arm can facilitate adjustment of the breathing interface device and improve its fit to the wearer.

[0038] The support platform has an inlet opening formed therein and can receive the connector of the inlet conduit through the inlet opening. The inlet opening is preferably circular and allows for a rotatable connection with the inlet conduit.

[0039] The support platform can include an annular wall extending upwardly around the inlet opening. Thus, the gas inlet point can be above the base of the platform, providing the advantage that any condensate generated within the chamber is collected below the gas inlet point. In this way, "gurgling", a characteristic generally associated with breathing interface devices, can be reduced. Gurgling can generate a significant amount of noise and can be bothersome to the patient. In addition to reducing gurgling, when the gas inlet point is above the base of the support platform, any accumulation of condensate is less likely to result in delivering a large amount of water to the patient (which otherwise could occur, for example, when the breathing interface device is moved).

[0040] The support platform extends rearward from the front wall of the front portion of the frame. Where the side walls of the front portion of the frame are separated from the support platform, the support platform can take any suitable shape. For example, the support platform may first extend directly rearward from the front wall of the front portion of the frame before widening along the contour of the side walls of the front portion of the frame. In this configuration, the support platform can comprise a first, narrower, "neck" portion and a second, wider, "shoulder" portion. Alternatively, the platform may extend directly rearward from the front wall of the front portion of the frame, or may extend rearward at an angle from the front wall of the front portion of the frame and increase in width rearward.

[0041] In some embodiments of the first and second aspects of the present invention, the support platform extends through a side opening of the body, and the front wall of the front portion of the frame can have recesses on both of its sides to facilitate fitting of the body.

[0042] In some embodiments of the first and second aspects of the present invention, the support platform comprises one or more of a front wall, side walls, and a rear wall. Preferably, the support platform has no rear wall. In such a configuration, flexibility is maximized in the portion of the body that contacts the patient (i.e., the upper and rear portions of the body) during use.

[0043] According to preferred embodiments of the first and second aspects of the present invention, when the support platform extends through an opening in the front wall of the body, the support platform preferably comprises a front wall, more preferably a front wall and side walls. The front wall may be spaced (set back) from the front wall of the front portion of the frame to create a channel between the front wall of the support platform and the front wall of the front portion of the frame. In this configuration, the top or lip of the front wall of the body is received within the channel between the front wall of the support platform and the front wall of the front portion of the frame. Thus, the front wall of the body seals against the front surface of the front wall of the support platform. The front surface of the front wall of the support platform is a sealing surface. In a further preferred embodiment, the body is fitted into the front wall and side walls of the support platform. In this configuration, the front wall of the body seals against the front surface of the front wall of the support platform, and the side walls of the body seal against the outer surface of the side walls of the support platform. The front surface of the front wall of the platform and the outer surface of the side walls of the support platform are sealing surfaces. When the front wall is not provided, the front wall of the body seats on the inner surface of the front wall of the front portion of the frame. Where the side walls are not provided, the side walls of the body seat on the inner surface of the side walls of the front portion of the frame.

[0044] Here, according to embodiments of the first and second aspects of the present invention, the support platform extends through a side opening in the side wall of the body, the side walls of the front portion of the frame are separated from the support platform, and the support platform comprises side walls. In this arrangement, the body is fitted around the front wall of the front portion of the frame and the side walls of the support platform. The outer surface of the front wall of the frame and the outer surface of the side walls of the support platform are sealing surfaces. The front wall of the front portion of the frame is provided with recesses on either side thereof to facilitate fitting of the body, and in this arrangement the side walls of the support platform join the front wall of the front portion of the frame and the positions adjacent to the recesses of the front wall to form a continuous sealing surface between the outer wall of the front portion of the frame and the outer wall of the side walls of the support platform.

[0045] Here, according to an embodiment of the first aspect of the present invention, the side walls of the front portion of the frame are joined to a support platform, the support platform optionally includes side walls, the side walls are spaced inwardly from the side walls of the front portion of the frame, and channels are formed between each side wall of the support platform and the respective side walls of the front portion of the frame. In this arrangement, the body is fitted around the front wall of the front portion of the frame and the side walls of the support platform. The outer surfaces of the front wall of the front portion of the frame and the side walls of the support platform are sealing surfaces. As described above, the front wall of the front portion of the frame may be provided with recesses on any of its sides to facilitate the fitting of the body. In this arrangement, the side walls of the body are joined to the front wall of the front portion of the frame at a position adjacent to the recess of the front wall, resulting in a continuous sealing surface between the outer surface of the front wall of the frame and the outer surface of the side walls of the body.

[0046] Here, according to an embodiment of the first aspect of the present invention, the side walls of the front portion of the frame are joined to a support platform, the support platform does not include side walls, the body is fitted around the front wall of the front portion of the frame, and in one embodiment, it is seated on the inner surface of the side walls of the front portion of the frame. Further, the front wall of the front portion of the frame may be provided with recesses on both of its sides to facilitate the fitting of the body. In an alternative embodiment where the side walls are not included in the support platform, the body is fitted around the front wall of the front portion of the frame and also around the side walls of the front portion of the frame (fitted on the outer surface as well). In this embodiment, the outer surfaces of the front wall and the side walls of the front portion of the frame form a continuous sealing surface.

[0047] In an embodiment where the support platform extends through the side openings of the side walls of the body, the support platform preferably does not have a front wall.

[0048] If present, the rear wall of the support platform may be shaped to curve inwardly from its outer edge to correspond to the shape of the patient's upper lip. If the rear wall does not exist, the rear edge of the platform is shaped to correspond to the shape of the patient's upper lip and curves inwardly from its outer edge.

[0049] The side arm can be contoured to conform to the contour of the patient's face. In a plan view, the side arm may have a curved shape that curves convexly and then concavely. In a front view, the side arm can descend from the side wall of the front portion of the frame before curving upward. The side arm can have a greater height (vertical width) than the wall of the first portion of the frame, which can contribute to stability and comfort when worn on the patient's face. In some embodiments, the side arm may increase in height along its length. The side arm can be thinner (less depth) than the side wall of the first portion of the frame, particularly in embodiments where the side wall of the first portion of the frame is separated from the platform. This can provide greater flexibility in the side arm, while the thick side wall of the first portion of the frame can provide some rigidity to the frame.

[0050] The side arms can be provided with means for attaching to the headgear. For example, a pair of slots can be provided at the distal end of each side arm through which the ends of the head strap can be screwed. In contrast to existing devices having side arms made of silicone, the respiratory interface device of the present invention enables direct attachment of the head strap without the need for an additional bridge portion between the side arm and the headgear. For example, if a pair of parallel slots are provided in each side arm, adjustment of the head strap involves applying a force symmetric with respect to the head strap. In such an embodiment, substantially the same amount of force would be required to tighten or loosen the strap. In other embodiments, the details of the attachment means may be modified such that an asymmetric force acts for loosening or tightening the head strap (e.g., even if one or more walls of the slot are inclined or chamfered), and in such embodiments, either tightening or loosening of the strap may be made easier - for example, it is desirable to have an easier tightening to minimize the time required to secure the interface to the patient's face, but it is desirable to make loosening more difficult to ensure that unintentional loosening does not occur during use.

[0051] The respiratory interface device of the first and second aspects of the present invention can comprise means for holding the inlet conduit in a fixed position during use. Said means can take any suitable form. For example, each side wall of the front part of the frame can be provided with a recess for engaging a corresponding projection on the inlet conduit, or each side wall of the front part of the frame can be provided with a projection for engaging a corresponding recess on the inlet conduit. Thus, during use, the inlet conduit may be held in a fixed position on the side walls of the front part of the frame. Where the body covers the side walls of the front part of the frame, such a recess or projection can be provided on the side walls of the body. In other examples, holding means such as recesses or projections may be included on an annular outwardly raised ring around the base opening of the body for cooperating with a projection or recess at the first end of the inlet conduit.

[0052] The frame provides a rigid structure to the respiratory interface device while maintaining flexibility if necessary. The material of the frame should be able to maintain its shape and structure without breaking under normal use conditions. The frame can be made of, for example, a flexible plastic material. Suitable materials for the frame include polypropylene and polyethylene, which are both thermoplastic synthetic polymers, and more specifically, thermoplastic polyolefins. Polypropylene and polyethylene are preferred as the material of the frame, but other materials such as other flexible polymer materials may also be used as the material of the frame.

[0053] To improve patient comfort, a material with a soft feel may be applied to at least a part of the side arm. Suitable materials with a soft feel include, for example, thermoplastic elastomers or textile materials. The soft-touch material can be applied by any suitable means well known to those skilled in the art.

[0054] The integral structure of the frame of the present invention avoids the need for additional connections or connecting parts in the device and enhances the strength and robustness of the respiratory interface device.

[0055] Inlet conduit The inlet conduit according to the first and second aspects of the present invention has a connector at its first end for connecting to the support platform of the frame. The second end of the inlet conduit is adapted to connect to a gas supply pipe.

[0056] Preferably, the inlet conduit is elbow-shaped such that the connector extends upward from the main body of the inlet conduit at the first end of the inlet conduit.

[0057] The connector has a shape complementary to the shape of the inlet opening of the support platform and is preferably of substantially cylindrical shape. The connector may comprise means for permanently snap-fitting to the platform, for example, one or more protrusions adapted to snap-fit with the top of the annular wall of the platform.

[0058] In some embodiments, three, four, or five or more protrusions can be provided. The protrusions may be equally spaced from each other. By providing a plurality of protrusions, the possibility of excessive stress being applied to a single protrusion can be avoided or minimized. The protrusion disposed closest to the second end of the inlet conduit may be thicker than the remaining protrusions or otherwise reinforced compared to the remaining protrusions. In this way, the protrusion that is most stressed by any moment applied from the gas supply pipe to the inlet conduit is adapted to absorb such stress. The protrusions may be arranged in any orientation with respect to the first and second ends of the conduit.

[0059] The inlet conduit can be made of the same material as the frame or of another material having sufficient flexibility, for example, to allow snap-fitting to the frame.

[0060] The inlet conduit may optionally comprise retaining means for cooperating with the frame or body to hold the inlet conduit in a fixed position during use. The retaining means may, for example, comprise protrusions on the inlet conduit for cooperating with corresponding recesses on the frame or body, or recesses on the inlet conduit for cooperating with corresponding protrusions on the frame or body. In some embodiments, the recesses may be provided on each side wall of the front portion of the frame or body, such that the inlet conduit is fixed in position on either side of the front portion of the frame or body and is rotatable between two fixed positions.

[0061] In a preferred embodiment, the inlet conduit is fixed to the support platform in a rotatable and non-removable manner. The permanent connection of the inlet conduit to the support platform contributes to the overall strength of the device, while the rotatable connection of the inlet conduit to the support platform allows the device to be operated in different orientations without the need for disassembly and reassembly. That is, a "swivel" connection can be provided between the support platform and the inlet conduit, such that in use, the inlet conduit can be rotated so that the main body of the inlet conduit moves between the left and right sides of the platform. This is advantageous, for example, when the patient changes position while sleeping or eating, when a healthcare worker is involved, or when for some reason the side from which the gas is supplied must be changed. Also, for example, when the patient is regularly moved to a prone position, as in the case of a patient with COVID-19, the rotatable connection allows the position of the gas supply tube to be easily changed, which is convenient.

[0062] The inlet conduit, and thus the gas supply tube, is connected to the rigid frame of the respiratory interface surface rather than to the body, so the weight of the gas supply tube does not cause significant distortion of the body. The weight of the gas supply tube does not lead to disconnection of the gas supply. This can occur in situations where there is a connection between the soft and deformable body and the inlet conduit.

[0063] Respiratory interface device according to a third aspect of the present invention According to a third aspect of the present invention, there is provided a respiratory interface device comprising a body, a frame, and an inlet conduit, the frame comprising two side walls, an arm, and a support platform extending between the two side walls and having an inlet opening formed therein, and the body comprising, in use, at least one nostril outlet for interfacing with the user's nostrils, a base opening, and a side opening through which the support platform extends; The inlet conduit comprises a connector at a first end extending through the base opening of the body and the inlet opening of the support platform, clamps the base wall of the body and the support platform together, the chamber is defined between the support platform and the body, and the chamber provides fluid communication between the inlet conduit and one or more nostril outlets.

[0064] To avoid ambiguity, unless otherwise indicated, the features of a particular embodiment of this aspect of the invention can be combined with the features of other particular embodiments of this aspect of the invention.

[0065] The support platform can comprise a rear wall. It does not have a front (frontal) wall. Also, the support platform may include side walls spaced inwardly from the side walls of the frame such that channels are formed between each side wall of the frame and the respective side wall of the support platform. Preferably, the support platform takes the form of a flat tray extending between the side walls of the frame, i.e., it does not have side walls (other than the side walls of the frame). In various examples of the first and second aspects of the invention, the trailing edge of the support platform, or the rear wall of the support platform, can be shaped to curve inwardly from its outer edge corresponding to the shape of the upper lip of the patient, the inlet opening can be circular in shape, and the support platform can comprise an annular wall extending upwardly around the inlet opening.

[0066] The side arms are as described in relation to the respiratory interface device of the first and second aspects of the invention.

[0067] The appropriate material for the frame is as described above in connection with the first and second aspects of the present invention. For the first and second aspects, the frame can have rounded or chamfered edges. The side walls of the frame of the respiratory interface device according to the third aspect of the present invention correspond to the side walls of the front part of the frame of the respiratory interface device of the first aspect of the present invention, and the side walls of the front part of the frame can be joined to the support platform and can have any of the features described in connection therewith.

[0068] The body is as described in connection with embodiments of the first and second aspects of the present invention where the body has side openings. When the support platform has side walls, the body is fitted around the said side walls, and the outer surface of the side walls of the support platform is a sealing surface. When the support platform has no side walls, the body is fitted around the side walls of the frame, and the outer surface of the side walls of the frame is a sealing surface.

[0069] The inlet conduit is as described in connection with the respiratory interface device of the first and second aspects of the present invention.

[0070] Manufacture and Use The respiratory interface device of the present invention is adapted to be used with, or may further comprise, a gas supply tube as commonly used with a respiratory interface device. The gas supply tube may be a lightweight flexible tube that is not heated. Preferably, the tube is transparent to enable detection of blockages and is reinforced to provide resistance to crushing and / or twisting. The gas supply tube may be provided with any suitable type of clip, known to those skilled in the art, for attachment to clothing or bedding, for example. Alternatively, or in addition to this, a cord or strap may be attached to the gas supply tube. The gas supply tube is connected to a gas source via a connector that can take any suitable form, as is well known to those skilled in the art. The respiratory interface device of the present invention is adapted to be used with, or may further comprise, a headgear such as a headstrap commonly used with a respiratory interface device.

[0071] The body, frame and inlet conduit of the device of the present invention may each be prepared by injection molding and then manually assembled. The elastic properties of the silicone allow the silicone to fit well to the frame which is the material of the body and the connector of the inlet conduit clamps the assembly together. Attachment of the body to the frame involves stretching the body around the base of the support platform and other relevant parts of the frame (e.g., in the first and second aspects of the present invention, the front wall and side walls of the support platform, the front wall of the frame and the side walls of the support platform, or the front wall and side walls of the frame, in the third aspect of the present invention, the side walls of the support platform or the side walls of the frame) to define a chamber between the platform and the body. Chamfered or rounded edges within the frame may facilitate the fitting of the silicone body thereto. Chamfered or rounded edges of the inlet opening of the support platform may facilitate the insertion of the inlet conduit into the frame.

[0072] The device of the present invention can be used for the treatment of hypoxia. The device is designed to meet or exceed the normal inspiratory requirements of the patient, cause minimal air dilution, and aim to deliver a higher rate of inspiratory oxygen for a longer time than a high-concentration non-breathing mask. Compared to a mask, the device also provides improved comfort and makes it easier for the patient to drink, eat, talk, and sleep. High-flow therapy provides versatility and continuity of care when the patient is weaned from the ventilator or when the patient's condition becomes more acute. This greater flexibility eliminates the need to switch between oxygen therapy delivery systems. The device is non-invasive and accurately provides a specified oxygen concentration (up to 100% O2) at a flow rate of 10 L to 50 L / min, 37°C, and 100% relative humidity.

[0073] Frame According to a fourth aspect of the present invention, a frame for use in a respiratory interface device comprises: A front portion having a front wall and two side walls; Side arms; A support platform extending rearward from the front wall of the front portion; The support platform has an inlet opening formed therein; and The side walls of the front portion of the frame are separated from the support platform.

[0074] A preferred embodiment of the frame according to this aspect of the present invention is as described above in connection with the second aspect of the present invention and also as described above in connection with the embodiments of the first aspect of the present invention, wherein the side walls of the front portion of the frame are separated from the support platform.

[0075] Conduit The inlet conduit described herein is novel and forms a fifth aspect of the present invention. Accordingly, the present invention further provides a conduit for use in a respiratory interface device, the conduit comprising a connector at a first end, the connector extending upwardly from the body of the conduit and configured to connect to a nasal cannula portion to provide a flow of gas thereto, and a second end of the conduit being configured to connect to a gas supply tube. Preferred features of the conduit are as described herein in relation to the first to third aspects of the present invention. Most preferably, the conduit is adapted to provide a rotatable, i.e. "swiveling", connection to a support platform so that the gas supply tube can be easily repositioned during use. For the sake of clarity, any feature described herein in relation to the inlet conduit may be combined with any other feature described herein in relation to the inlet conduit.

[0076] Kit The device of the present invention can be provided in a fully assembled state, but the frame, body, and inlet conduit can be provided as separate parts for assembly by the user. Accordingly, according to a sixth aspect of the present invention, a kit can comprise a frame, a body, and an inlet conduit as described herein, either as separate parts or as a fully assembled unit, together with instructions for assembly and / or use. The kit can include two or more bodies of different sizes.

Brief Description of the Drawings

[0077]

Figure 1a

Figure 1b

Figure 2a

Figure 2b

Figure 3a

Figure 3b

Figure 4a

Figure 4b

Figure 5

Figure 6

Figure 7

Figure 8

DETAILED DESCRIPTION OF THE INVENTION

[0078] The following detailed description illustrates devices according to the present invention and does not imply specific limitations on the devices.

[0079] Figures 1a and 1b show a front view (Figure 1a) and a rear view (Figure 1b) of a fully assembled breathing apparatus interface device according to the present invention. In the illustrated embodiment, the breathing apparatus interface device (1) includes a main body (2), a frame (3), and an inlet conduit (4). The main body (2) is fitted around the support platform of the frame (3) and is clamped to the support platform by an inlet conduit (4) that is rotatably connected to the support platform of the frame (3). Slots (17) are provided at the tip of each of the side arms (12) of the frame, enabling, for example, the attachment of a head strap.

[0080] Figures 2a and 2b show the main body according to the present invention. In the illustrated embodiment, the main body (2) comprises two nostril outlets (prongs, 5) for interfacing with a patient's nostrils during use. The main body has a front opening (6), a base opening (7), and an annular outwardly raised ring (7a) around the base opening (7) (as seen in Figure 2b).

[0081] The main body shown in Figures 2 and 2b seats inside the front wall of the front part of the frame, on the inner surface of the front wall of the front part of the frame, or in a channel between the said front wall and the front wall of the platform, as seen in Figure 1a, in the assembled device.

[0082] In the illustrated embodiment, the prong (5) curves rearwardly and inwardly towards the center away from the front of the main body (2), and the curve of the prong is a combination of a front and a side curve. The rear wall (8) of the main body (2) extends beyond its base, providing an increased contact area between the main body and the patient's upper lip. The rear wall (8) curves inwardly from its sides towards the center and thus takes a shape generally corresponding to the shape of the patient's upper lip. A discrete region (9) of the main body around the base of the prong (5) is thinner than the rest of the main body.

[0083] Figures 3a and 3b show the frame (3) according to the present invention.

[0084] In the illustrated embodiment, the frame (3) has a front portion (10) consisting of a front wall (10a) and side walls (10b), a support platform (11) extending rearward from the front wall (10a) of the front portion (10), and side arms (12) extending from each side end (10c) of the front portion (10). The support platform has an inlet opening (13) formed therein. In the illustrated embodiment, the side walls (10b) of the front portion (10) and the support platform (11) are separated (spaced apart) from each other. As can be seen from FIG. 3b, the support platform is continuous with the front wall of the front portion of the frame at its base. The front wall (14) of the support platform (11) is set back from the front wall (10a) of the front portion (10) of the frame (3), providing a channel between the front wall (14) and the front wall of the front portion (10). The side walls of the support platform (11) are spaced apart from the side walls of the front portion of the frame. Thus, the body may be fitted around the support platform (11) and clamped to the support platform by a connector of the inlet conduit. The rear edge (11a) of the support platform (11) curves inward from its sides to its center and thus generally conforms to the shape of the patient's upper lip. The inlet opening (13) provided at the base of the support platform for connection to an inlet conduit for supplying gas is generally circular. The support platform (11) further includes an annular wall (13a) extending upward around the inlet opening to facilitate fixation of the inlet conduit. The frame (3) further includes a recess (16) for locking a projection on the inlet conduit to a fixed position on the frame, with the projection on the inlet conduit engaging the recess. The side arms (12) extend from the ends (10c) of the side walls (10b) of the front portion (10) of the frame (3) and are provided with slots (17) for attachment to a headgear (as illustrated, for example, in FIG. 8).

[0085] Figures 4a and 4b show a frame (3) according to an embodiment of the present invention. In the illustrated embodiment, the support platform (11) is joined to the side wall (10b) of the front portion (10) of the frame (3). A channel (11b) is formed between the side wall of the support platform (11) and the side wall (10b) of the front portion of the frame (10). In the embodiment of Figure 4b, grooves, or recesses (3a), are formed on both sides of the front wall (10a) of the front portion (10) of the frame (3).

[0086] Figure 5 shows a body (2) having a side opening (6) located on the side surface of the body (2) (only one side opening is shown; there is an opening corresponding to the opposite side of the body).

[0087] Figure 6 illustrates an assembled device (1) in which the support platform extends through the side opening of the body (2). As can be seen from the figure, the body (2) is attached along the front wall of the frame (3). In the illustrated embodiment, the body (2) is seated in the groove (3a) of the front wall of the front portion of the frame.

[0088] Figure 7 shows an inlet conduit (4) according to the present invention. In the illustrated example, the inlet conduit (4) comprises a connector (18) at a first end, which is adapted to extend through the base opening of the body and the inlet opening of the support platform and clamps the base wall of the body and the support platform together. The connector (18) comprises a protrusion (19) for permanent snap connection to the top of the annular edge of the support platform. The inlet conduit (4) further comprises a protrusion (20) for engaging a recess in the frame or the body, whereby the inlet conduit can be locked in a fixed position in the frame or the body. The protrusion extends from an annular protrusion (21) on the inlet conduit. The second end of the inlet conduit (4) is adapted to connect to a gas supply pipe. In the illustrated example, threads (22) are provided at the second end of the inlet conduit to secure the gas supply pipe to the device of the present invention.

[0089] Figure 8 illustrates the device (1) according to the invention attached to the head strap (23) and the gas supply pipe (24). The clip (25) may be provided, for example, to enable the connection of the gas supply pipe (24) to, for example, clothing or bedding.

[0090] The respiratory interface device, frame, and kit of the present invention are further described with reference to the following.

[0091] A respiratory interface device comprising a body, a frame, and an inlet conduit, wherein: The frame includes a front portion having a front wall and two side walls, side arms, and a support platform extending rearward from the front wall, the support platform having an inlet opening formed therein; In use, the body comprises at least one nostril outlet for interfacing with the user's nostrils, a base opening in the base wall of the body, and at least one opening through which the support platform extends. The inlet conduit comprises a connector at a first end passing through the base opening of the body and the inlet opening of the support platform, clamping the base wall of the body and the support platform together, and a chamber is defined between the support platform and the body, the chamber providing fluid communication between the inlet conduit and the one or more nostril outlets.

[0092] The respiratory interface device according to paragraph

[91] , wherein the at least one opening through which the support platform passes is a front opening in the front wall of the body.

[0093] The respiratory interface device according to paragraph

[91] , wherein the at least one opening through which the support platform passes is a pair of side wall openings in the side wall of the body.

[0094] The respiratory interface device according to any one of paragraphs

[91] to

[93] , wherein the side walls of the front portion of the frame are separated from the support platform.

[0095] A respiratory interface device according to paragraph

[91] or paragraph

[93] , wherein a side wall of the front portion of the frame is joined to the support platform.

[0096] A respiratory interface device comprising a main body, a frame, and an inlet conduit, wherein: The frame includes a front portion having a front wall and two side walls, side arms, and a support platform extending rearward from the front wall, and the support platform has an inlet opening formed therein; The main body includes at least one nostril outlet for interfacing with a user's nostrils during use, at least one opening through which the support platform extends, and a chamber defined between the support platform and the main body, the chamber providing fluid communication between the inlet conduit and the one or more nostril outlets. The side wall of the front portion of the frame is separated from the support platform.

[0097] A respiratory interface device according to paragraph

[96] , wherein the at least one opening through which the support platform passes is a front opening in the front wall of the main body.

[0098] A respiratory interface device according to paragraph

[96] , wherein at least one opening through which the support platform penetrates is a pair of side wall openings in the side wall of the main body.

[0099] A frame for use in a respiratory interface device, the frame comprising: A front portion having a front wall and two side walls; Side arms; A support platform extending rearward from the front wall of the front portion, the support platform having an inlet opening formed therein, and the side walls of the front portion of the frame being separated from the platform.

[0100] A frame for use with a respiratory interface device as described in any of paragraphs

[91] ,

[92] ,

[94] , and

[96] -

[97] , or as described in paragraph

[99] , wherein the support platform comprises a front wall, the front wall is spaced from the front wall of the frame, and a channel is formed between the front wall and the front wall.

[0101] A frame for use in a respiratory interface device as described in any of paragraphs

[91] -

[98] and

[0100] , or as described in paragraph

[99] or paragraph

[0100] , wherein the support platform comprises side walls.

[0102] A frame for use in a respiratory interface device as described in any of paragraphs

[91] -

[98] and

[0100] -

[0101] , or as described in any of paragraphs

[99] -

[0101] , wherein the support platform comprises a rear wall.

[0103] A frame for use in a respiratory interface device as described in any of paragraphs

[91] -

[98] and

[0100] -

[0102] , or as described in any of paragraphs

[99] -

[0102] , wherein the trailing edge of the support platform, or the rear wall of the support platform, is shaped to correspond to the shape of the patient's upper lip and curves inwardly from its outer edge.

[0104] A frame for use in a respiratory interface device as described in any of paragraphs

[91] -

[98] and

[0100] -

[0103] , or as described in any of paragraphs

[99] -

[0103] , wherein the inlet opening in the support platform is circular.

[0105] A respiratory interface device as described in paragraph

[0104] or a frame used in a respiratory interface device, wherein the support platform comprises an annular wall extending upwardly around the inlet opening.

[0106] A respiratory interface device as described in any of paragraphs

[91] to

[98] and

[0100] to

[0105] , or a frame used in a respiratory interface device as described in any of paragraphs

[99] to

[0105] , wherein the side arms are contoured to correspond to the contour of a patient's face.

[0107] A respiratory interface device as described in any of paragraphs

[91] to

[98] and

[0100] to

[0106] , or a frame used in a respiratory interface device as described in any of paragraphs

[99] to

[0106] , wherein each side arm comprises means for attachment to a headgear.

[0108] A respiratory interface device as described in paragraph

[0107] or a frame used in a respiratory interface device, wherein a pair of slots are provided at the distal ends of each side arm for securing an end of a head strap to the side arm.

[0109] A frame for use in a respiratory interface device as described in any of paragraphs

[91] to

[98] and

[0100] to

[0108] , or a respiratory interface device as described in any of paragraphs

[99] to

[0108] , wherein means are provided for holding an inlet conduit at a fixed position on the front of the frame or at a fixed position on the body.

[0110] A respiratory interface device as described in paragraph

[0109] or a frame used in a respiratory interface device, wherein the inlet conduit comprises a projection and each side wall of the front portion of the frame or the body comprises a corresponding recess.

[0111] A breathing apparatus interface device as described in paragraph

[0109] or a frame used in a breathing apparatus interface device, wherein the inlet conduit has a recess, and each side wall of the front part of the frame or the main body has a corresponding protrusion.

[0112] A breathing apparatus interface device as described in any of paragraphs

[91] to

[98] and

[0100] to

[0110] , or a frame used in a breathing apparatus interface device as described in any of paragraphs

[99] to

[0110] , wherein the frame is made of a flexible plastic material.

[0113] A breathing apparatus interface device as described in paragraph

[0112] or a frame used in a breathing apparatus interface device, wherein the frame is made of a thermoplastic synthetic polymer.

[0114] A breathing apparatus interface device as described in paragraph

[0113] or a frame used in a breathing apparatus interface device, wherein the frame is made of polypropylene or polyethylene.

[0115] A breathing apparatus interface device as described in any of paragraphs

[91] to

[98] ,

[0100] to

[0101] , and

[0103] to

[0114] , or a frame used in a breathing apparatus interface device as described in any of paragraphs

[99] to

[0101] and

[0103] to

[0114] , wherein the support platform lacks a rear wall.

[0116] A breathing apparatus interface device as described in any of paragraphs

[91] to

[98] and

[0100] to

[0115] , or a frame used in a breathing apparatus interface device as described in any of paragraphs

[99] to

[0115] , wherein the frame has chamfered or rounded edges.

[0117] The frame used in the respiratory interface device described in any of paragraphs

[91] to

[98] and

[0100] to

[0116] , or the respiratory interface device described in any of paragraphs

[99] to

[0116] , wherein the base opening of the support platform has a chamfered or rounded edge.

[0118] A respiratory interface device described in any of paragraphs

[91] ,

[92] ,

[94] ,

[96] ,

[97] and

[0100] to

[0117] , wherein the main body includes a front surface, a rear surface, a base, side surfaces, and an upper surface wall, the front wall has a front opening, the base wall has a base opening, the upper surface wall has one or more nostril outlets (nasal protrusions) for interfacing with the patient's nostrils, and the base opening is arranged to correspond to the inlet opening of the support platform.

[0119] A respiratory interface device described in any of paragraphs

[91] ,

[93] to

[96] ,

[98] and

[0101] to

[0117] , wherein the main body includes a front surface, a rear surface, a base, side walls, and an upper surface wall, each side wall has an opening inside, the base wall has a base opening, the upper surface wall has one or more nostril outlets (nasal protrusions) for interfacing with the patient's nostrils, and the base opening is arranged to correspond to the inlet opening of the support platform.

[0120] A respiratory interface device described in any of paragraphs

[91] to

[98] and

[0100] to

[0119] , wherein an annular outwardly raised ring is provided around the base opening.

[0121] A respiratory interface device described in any of paragraphs

[91] to

[98] and

[0100] to

[0120] , wherein the main body includes a pair of nasal prongs.

[0122] A respiratory interface device according to any one of paragraphs

[91] to

[98] and

[0100] to

[0121] , wherein each nasal prong is curved in shape and curves rearward and inwardly from the base of each nasal prong with respect to the front and side surfaces of the main body.

[0123] A respiratory interface device according to any one of paragraphs

[91] to

[98] and

[0100] to

[0122] , wherein each nasal prong has a uniform cross-section and / or a uniform wall thickness along its length.

[0124] A respiratory interface device according to any one of paragraphs

[91] to

[98] and

[0100] to

[0123] , wherein the region around the base of each prong is thinner than the rest of the main body.

[0125] A respiratory interface device according to any one of paragraphs

[91] to

[98] and

[0100] to

[0124] , wherein the rear wall of the main body extends beyond the base and provides an increased area for contact with the patient's upper lip.

[0126] A respiratory interface device according to any one of paragraphs

[0118] to

[0125] , wherein the rear wall of the main body is shaped to correspond to the shape of the patient's upper lip and curves inwardly from its outer edge.

[0127] A respiratory interface device according to any one of paragraphs [9,1] to

[98] and paragraphs

[0100] to

[0126] , wherein the main body is composed of a flexible material.

[0128] A respiratory interface device according to any one of paragraphs

[91] to

[98] and

[0100] to

[0127] , wherein the main body is made of silicone.

[0129] The respiratory interface device according to any one of paragraphs

[91] to

[98] and

[0100] to

[0128] , wherein the inlet conduit has a connector at a first end, the connector being for connecting to the support platform of the frame and having a shape complementary to the shape of the inlet opening.

[0130] The respiratory interface device according to paragraph

[0129] , wherein the inlet conduit has an elbow shape and the connector extends upward from the conduit at a first end of the inlet conduit.

[0131] The respiratory interface device according to paragraph

[0129] or paragraph

[0130] , wherein the connector comprises means for permanently snap - fitting to the support platform.

[0132] The respiratory interface device according to paragraph

[0131] , wherein the connector comprises one or more protrusions adapted to snap - fit with the support platform.

[0133] The respiratory interface device according to paragraph

[0132] , wherein the protrusion located closest to the second end of the connector is thicker or reinforced compared to the remaining protrusions.

[0134] The respiratory interface device according to any one of paragraphs

[91] to

[98] and

[0100] to

[0133] , wherein the inlet conduit is fixed to the support platform in a rotatable and non - removable manner.

[0135] A respiratory interface device kit comprises: The frame, the body, and the inlet conduit as described in paragraphs

[91] to

[0133] , either as separate components or as a fully assembled unit, and also comprises instructions for assembly and / or use.

[0136] The respiratory interface device kit described in paragraph

[0135] , comprising two or more bodies of different sizes.

[0137] A respiratory interface device comprising a body, a frame, and an inlet conduit, wherein: The body comprises a front face, a rear face, a base, and an upper wall, the front wall has a front opening, the bottom wall has a base opening, and the upper wall has one or more nostril outlets for interfacing with the patient's nostrils; The frame comprises a front part having a front wall and two side walls, side arms, and a support platform extending rearward from the front wall, the support platform having an inlet opening formed therein; Each side wall of the front part of the frame is separated from the support platform; The base opening of the body is arranged to correspond to the inlet opening of the support platform; The inlet conduit has a connector at its first end; The support platform extends through the front opening of the front wall of the body, the inlet conduit extends through the base opening of the base of the body and the inlet opening of the support platform, and clamps the body and the support platform together.

[0138] An inlet conduit for use in a respiratory interface device, the inlet conduit comprising a connector at its first end, the connector extending upward from the body of the inlet conduit and configured to connect to a nasal cannula portion to supply gas thereto, and the second end of the inlet conduit being configured to connect to a gas supply pipe.

[0139] The inlet conduit described in paragraph

[0138] , wherein the connector has a generally cylindrical shape for rotatably connecting to the nasal cannula portion.

[0140] The inlet conduit described in paragraph

[0138] or paragraph

[0139] , wherein the connector comprises means for permanently connecting to the nasal cannula portion.

[0141] A respiratory interface device comprising a body, a frame, and an inlet conduit, wherein: The frame comprises two side walls, side arms, and a support platform extending between the two side walls, and the support platform has an inlet opening formed therein; The body comprises at least one nostril outlet for interfacing with the user's nostrils during use, a base opening, and a side opening where the support platform extends, and the base opening corresponds to the inlet opening of the support platform; and The inlet conduit comprises a connector at a first end extending through the base opening of the body and the inlet opening of the support platform, clamps the base wall of the body and the support platform together, and a chamber is defined between the support platform and the body, and the chamber provides fluid communication between the inlet conduit and one or more nostril outlets.

[0142] The respiratory interface device according to paragraph

[0141] , wherein the support platform comprises side walls spaced inwardly from the side walls of the frame.

[0143] The respiratory interface device according to paragraph

[0141] or paragraph

[0142] , wherein the support platform comprises a rear wall.

[0144] The respiratory interface device according to paragraph

[0141] , wherein the support platform lacks walls other than the side walls of the frame.

[0145] The respiratory interface device according to any one of paragraphs

[0141] to

[0144] , wherein the rear end of the support platform, or the rear wall of the support platform, is shaped to correspond to the shape of the patient's upper lip and curves inwardly from its outer edge.

[0146] The respiratory interface device according to any one of paragraphs

[0141] to

[0145] , wherein the inlet opening of the support platform is circular.

[0147] The respiratory interface device according to any one of paragraphs

[0141] to

[0146] , wherein the support platform includes an annular wall extending upward around the inlet opening.

[0148] The respiratory interface device according to any one of paragraphs

[0141] to

[0147] , wherein the side arm is contoured to correspond to the contour of the patient's face.

[0149] The respiratory interface device according to any one of paragraphs

[0141] to

[0148] , wherein each side arm includes means for attachment to a headgear.

[0150] The respiratory interface device according to any one of paragraphs

[0141] to

[0149] , wherein a pair of slots configured to fix an end of a head strap to the side arm are provided at a distal end of each side arm.

[0151] The respiratory interface device according to any one of paragraphs

[0141] to

[0150] , wherein means for holding an inlet conduit are provided at a fixed position in the front part of the frame or a fixed position of the main body.

[0152] The respiratory interface device according to paragraph

[0151] , wherein the inlet conduit includes a protrusion, and each side wall of the frame or the main body includes a corresponding recess.

[0153] The respiratory interface device according to paragraph

[0151] , wherein the inlet conduit includes a recess, and each side wall of the frame or the main body includes a corresponding protrusion.

[0154] The respiratory interface device according to any one of paragraphs

[0141] to

[0153] , wherein the frame is made of a flexible plastic material.

[0155] The respiratory interface device according to paragraph

[0154] , wherein the frame is made of a thermoplastic synthetic polymer.

[0156] The respiratory interface device according to paragraph

[0155] , wherein the frame is made of polypropylene or polyethylene.

[0157] The respiratory interface device according to any one of paragraphs

[0141] to

[0156] , wherein the frame has chamfered or rounded edges.

[0158] The respiratory interface device according to any one of paragraphs

[0141] to

[0157] , wherein the base opening of the support platform has a chamfered or rounded edge.

[0159] The respiratory interface device according to any one of paragraphs

[0141] to

[0158] , wherein the main body includes a front surface, a back surface, a base, side walls, and an upper surface wall. Each side wall has an opening inside, the base wall has a base opening, the upper surface wall has one or more nostril outlets (nose protrusions) for interfacing with the patient's nostrils, and the base opening is arranged to correspond to the inlet opening of the support platform.

[0160] The respiratory interface device according to any one of paragraphs

[0141] to

[0159] , wherein an annular outwardly raised ring is provided around the base opening.

[0161] The respiratory interface device according to any one of paragraphs

[0141] to

[0160] , wherein the main body includes a pair of nasal prongs.

[0162] The respiratory interface device according to any one of paragraphs

[0141] to

[0161] , wherein each nasal prong is curved in shape and curves rearward and inwardly from its base with respect to the front and side surfaces of the main body.

[0163] A respiratory interface device according to any one of paragraphs

[0141] to

[0162] , wherein each nasal prong has a uniform cross-section and / or a uniform wall thickness along its length.

[0164] A respiratory interface device according to any one of paragraphs

[0141] to

[0163] , wherein the area around the base of the main body or each prong is thinner than the rest of the main body.

[0165] A respiratory interface device according to any one of paragraphs

[0141] to

[0164] , wherein the rear wall of the main body extends beyond its base to provide an increased area for contact with the patient's upper lip.

[0166] A respiratory interface device according to any one of paragraphs

[0141] to

[0165] , wherein the rear wall of the main body is formed to correspond to the shape of the patient's upper lip and curves inwards from its outer edge.

[0167] A respiratory interface device according to any one of paragraphs

[0141] to

[0166] , wherein the main body is made of a flexible material.

[0168] A respiratory interface device according to any one of paragraphs

[0141] to

[0167] , characterized in that the main body is made of silicone.

[0169] A respiratory interface device according to any one of paragraphs

[0141] to

[0168] , wherein the inlet conduit has a connector at a first end and is connected to the support platform of the frame and has a shape complementary to the shape of the inlet opening.

[0170] A respiratory interface device according to any one of paragraphs

[0141] to

[0169] , wherein the inlet conduit has an elbow shape and the connector extends upward from the inlet conduit at the first end of the inlet conduit.

[0171] A respiratory interface device according to any one of paragraphs

[0169] to

[0170] , wherein the connector comprises means for permanently snap-fitting to the support platform.

[0172] A respiratory interface device according to paragraph

[0171] , wherein the connector comprises one or more protrusions adapted to snap-fit with the support platform.

[0173] A respiratory interface device according to paragraph

[0172] , wherein the protrusion located closest to the second end of the connector is thicker or reinforced compared to the remaining protrusions.

[0174] A respiratory interface device according to any one of paragraphs

[0141] to

[0173] , wherein the inlet conduit is fixed to the support platform in a rotatable and non-removable manner.

[0175] A respiratory interface device kit comprises: A frame, a body, and an inlet conduit according to any one of paragraphs

[0141] to

[0173] , wherein the frame, the body, and the inlet conduit are separate components or fully assembled, and Instructions for assembly and / or use.

[0176] A respiratory interface device kit according to paragraph

[0175] , comprising two or more bodies of different sizes.

Claims

**Claim 1** A respiratory interface device comprising a body, a frame, and an inlet conduit, wherein: The frame comprises a front portion having a front wall and two side walls, side arms, and a support platform extending rearward from the front wall, the support platform having an inlet opening formed therein; The body comprises at least one nostril outlet for interfacing with a user's nostrils during use, a base opening in the base wall of the body, and at least one opening through which the support platform extends; The inlet conduit comprises a connector at a first end that penetrates the base opening of the body and the inlet opening of the support platform, clamping the base wall of the body and the support platform together, a chamber being defined between the support platform and the body, the chamber providing fluid communication between the inlet conduit and one or more nostril outlets. A respiratory interface device. **Claim 2** The respiratory interface device according to claim 1, wherein the at least one opening through which the support platform extends is a front opening in the front wall of the body. **Claim 3** The respiratory interface device according to claim 1, wherein the at least one opening through which the support platform extends is a pair of side wall openings in the side walls of the body. **Claim 4** The respiratory interface device according to any one of claims 1 to 3, wherein the side walls of the front portion of the frame are separated from the support platform. **Claim 5** The respiratory interface device according to claim 1 or claim 3, wherein the side walls of the front portion of the frame are joined to the support platform. **Claim 6** The respiratory interface device according to any one of claims 1, 2, and 4, wherein the support platform comprises a front wall, the front wall being spaced apart from the front wall of the frame, a channel being formed between the front wall and the front wall. **Claim 7** The respiratory interface device according to any one of claims 1 to 6, wherein the support platform comprises side walls. **Claim 8** The respiratory interface device according to any one of claims 1-7, wherein the support platform comprises a rear wall. **Claim 9** The trailing edge of the support platform or the rear wall of the support platform is shaped to correspond to the shape of the patient's upper lip and curves inwardly from the outer edge of the trailing edge or the rear wall, the respiratory interface device according to any one of claims 1 to 8.

10. The inlet opening of the support platform is circular, the respiratory interface device according to any one of claims 1-9.

11. The support platform comprises an annular wall extending upwardly around the inlet opening, the respiratory interface device according to any one of claims 1 to 10.

12. The side arms are contoured to correspond to the contour of the patient's face, the respiratory interface device according to any one of claims 1-11.

13. Each side arm includes means for attachment to a headgear, the respiratory interface device according to any one of claims 1 to 12.

14. At the distal end of each side arm, a pair of slots are provided for securing an end of a head strap to the side arm, the respiratory interface device according to any one of claims 1 to 13.

15. The front portion of the frame is provided with means for holding an inlet conduit at a fixed position, the respiratory interface device according to any one of claims 1 to 14.

16. The inlet conduit comprises a projection and each side wall of the front portion of the frame comprises a corresponding recess, the respiratory interface device according to any one of claims 1 to 15.

17. The inlet conduit comprises a recess and each side wall of the front portion of the frame comprises a corresponding projection, the respiratory interface device according to any one of claims 1 to 15.

18. The frame is made of a flexible plastic material, the respiratory interface device according to any one of claims 1 to 17.

19. The frame is made of a thermoplastic synthetic polymer, the respiratory interface device according to claim 18.

20. The frame is made of polypropylene or polyethylene, the respiratory interface device according to claim 19.

21. The support platform lacks a rear wall, the respiratory interface device according to any one of claims 1 to 7 and 9 to 20.

22. The frame includes a chamfered edge or a rounded edge, and the respiratory interface device according to any one of claims 1 to 21.

23. The base opening of the support platform includes a chamfered edge or a rounded edge, and the respiratory interface device according to any one of claims 1 to 22.

24. The main body includes a front surface, a back surface, a base, side walls, and an upper wall surface. The front wall has a front opening, the base wall has a base opening, the upper wall surface has one or more nostril outlets (nasal protrusions) for interfacing with the patient's nostrils, and the base opening is arranged to correspond to the inlet opening of the support platform. The respiratory interface device according to any one of claims 1, 2, 4, and 6 to 23.

25. The main body includes a front surface, a back surface, a base, side walls, and an upper wall surface. Each side wall has an opening inside it, the base wall has a base opening, the upper wall surface has one or more nostril outlets (nasal protrusions) for interfacing with the patient's nostrils, and the base opening is arranged to correspond to the inlet opening of the support platform. The respiratory interface device according to any one of claims 1, 3, and 7 to 23.

26. The main body includes an annular outwardly raised ring around the base opening, and the respiratory interface device according to any one of claims 1 to 25.

27. The main body includes a pair of nasal prongs, and the respiratory interface device according to any one of claims 1 to 26.

28. Each nasal prong is curved in shape and curves rearward and inward from its base with respect to the front and side surfaces of the main body. The respiratory interface device according to any one of claims 1 to 27.

29. Each nasal prong has a uniform cross-section and / or a uniform wall thickness along its length, and the respiratory interface device according to any one of claims 1 to 28.

30. The area around the base of the main body or each prong is thinner than the rest of the main body, and the respiratory interface device according to any one of claims 1 to 29.

31. The rear wall of the main body extends beyond the base, providing an increased area for contact with the patient's upper lip. The respiratory interface device according to any one of claims 1 to 30 for use.

32. The respiratory interface device according to any one of claims 22 to 31, wherein the rear wall of the main body is shaped to correspond to the shape of the upper lip of the patient and curves inward from the outer edge of the rear wall.

33. The respiratory interface device according to any one of claims 1 to 32, wherein the main body is made of a flexible material.

34. The respiratory interface device according to any one of claims 1 to 33, wherein the main body is made of silicone.

35. The respiratory interface device according to any one of claims 1 to 34, wherein the inlet conduit has a connector at a first end, is connected to the support platform of the frame, and has a shape complementary to the shape of the inlet opening.

36. The respiratory interface device according to claim 35, wherein the inlet conduit has an elbow shape such that the connector extends upward from the inlet conduit at the first end of the inlet conduit.

37. The respiratory interface device according to claim 35 or claim 36, wherein the connector comprises means for permanently snap-fitting to the support platform.

38. The respiratory interface device according to claim 37, wherein the connector comprises one or more protrusions adapted to snap-fit with the support platform.

39. The respiratory interface device according to claim 38, wherein the protrusion located closest to the second end of the connector is thicker or reinforced compared to the remaining protrusions.

40. The respiratory interface device according to any one of claims 1 to 39, wherein the inlet conduit is fixed to the support platform in a rotatable and non-removable manner.

41. A respiratory interface device kit comprising: the respiratory interface device according to any one of claims 1 to 40, wherein the main body, the frame and the inlet conduit are separate components, or the respiratory interface device is fully assembled; and instructions for assembly and / or use.

42. The respiratory interface device kit according to claim 41, wherein the main body, the frame and the inlet conduit are separate components and comprise two or more main bodies of different sizes.

43. A respiratory interface device comprising a body, a frame, and an inlet conduit, wherein: The body comprises a front face, a rear face, a base, and an upper wall, the front wall has a front opening, the bottom wall has a base opening, and the upper wall has one or more nostril outlets for interfacing with a patient's nostrils; The frame comprises a front portion having a front wall and two side walls, a side arm, and a support platform extending rearwardly from the front wall, the support platform having an inlet opening formed therein; Each side wall of the front portion of the frame is separated from the support platform; The base opening of the body is arranged to correspond to the inlet opening of the support platform; The inlet conduit has a connector at a first end; The support platform extends through the front opening of the front wall of the body, the inlet conduit extends through the base opening of the base wall of the body and the inlet opening of the support platform, and a respiratory interface device that clamps the body and the support platform together.

44. A respiratory interface device comprising a body, a frame, and an inlet conduit, wherein: The frame comprises two side walls, a side arm, and a support platform extending between the two side walls, the support platform having an inlet opening formed therein; The body comprises at least one nostril outlet for interfacing with a user's nostrils during use, a base opening, and a side opening while the support platform extends, the base opening corresponding to the inlet opening of the support platform; The inlet conduit comprises a connector at a first end extending through the base opening of the body and the inlet opening of the support platform, clamps the base wall of the body and the support platform together, a chamber is defined between the support platform and the body, and the chamber provides fluid communication between the inlet conduit and the one or more nostril outlets.

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