Nasal interface

Abstract

To disclose a respiratory interface device (1) and components thereof.SOLUTION: A respiratory interface device (1) comprises a body (2), a frame (3), and an inlet conduit (4). The frame has a front wall, side walls, and side arms (12), and a support platform extending rearward from the front wall. An inlet opening is defined in the support platform. The body (2) forms a chamber with the support platform and comprises at least one nasal outlet, a base opening, and at least one additional opening, through which the support platform extends. The inlet conduit (4) comprises a connector that clamps the body (2) and the support platform together.SELECTED DRAWING: Figure 1a

Description

[Technical Field]

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

[0002] High-flow nasal therapy is indicated for improving respiratory efficiency in patients with mild to moderate respiratory distress.

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

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

[0005] Most commonly in high-flow nasal therapy, the flow of respiratory gas is supplied to the respiratory interface horizontally 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, in this example providing flexibility when the patient changes position while sleeping or eating or drinking, or when a healthcare professional is present, and allowing for transfer between beds with gas supply units on different sides.

[0006] Various breathing apparatus have been proposed in the art.

[0007] For example, EP1481702 discloses a nasal cannula assembly having a single horizontal side gas inlet. The assembly includes a side mount portion containing at least one nasal prong and a removable gas flow manifold having a single horizontal side gas inlet that is in fluid communication with a gas transport means during use. The gas transport means may extend from either the right or left side of the nasal cannula assembly, and can be interchanged between the two by removing the gas flow manifold from the face mount portion and reattaching it in the opposite orientation. A string or strap is used to transfer the weight of the gas delivery conduit to the patient's neck.

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

[0009] WO2015 / 193833 relates to a patient interface device and components. In one embodiment, the patient interface device comprises a frame portion comprising a gas chamber and a nasal delivery element, and a manifold rotatably fixed to the frame portion, the manifold comprising an axle structure and configured to rotate relative to the frame portion. Summary of the Invention [Problem to be solved by the invention]

[0010] It is an object of the present invention to provide an improved nasal interface device for providing a flow of respiratory 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 comprising a front portion having a front wall and two side walls, side arms, and a support platform extending rearwardly from said front wall, said support platform having an entrance opening formed therein; In use, the body includes at least one nostril outlet for interfacing with a user's nostril, a base opening, and at least one opening through which the support platform extends, the inlet conduit includes 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 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.

[0012] In a second aspect, the present invention provides a respiratory interface device comprising a body, a frame, and an inlet conduit: the frame comprising a front portion having a front wall and two side walls, side arms, and a support platform extending rearwardly from the front wall, the support platform having an inlet opening formed therethrough through which a first end of the inlet conduit is formed; The body comprises at least one nostril outlet for interfacing with a user's nostril 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 a front sidewall of the frame is separated from the platform.

[0013] In a third aspect, the present invention provides a respiratory interface device comprising a body, a frame, and an inlet conduit: the frame comprising two side walls, a side arm, and a platform extending between the two side walls, the platform having an inlet opening formed therein; The body, in use, comprises at least one nostril outlet for interfacing with a user's nostril, a base opening, and a side opening through which the platform extends, the inlet conduit comprising a connector at a first end that extends 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 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 present invention provides 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 and a support platform extending rearwardly from the front wall, the support platform having an inlet opening formed therein, the side walls of the front portion of the frame being separate from the platform.

[0015] In a fifth aspect, the present invention provides a conduit for use in a respiratory interface apparatus, the conduit comprising a connector at a first end extending upwardly from the body of the conduit and configured to connect to and supply gases to a nasal cannula portion, and a second end of the conduit 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: It comprises a frame, a body, and an inlet conduit, which may be separate parts or fully assembled, and which are described herein together with instructions for assembly and / or use.

[0017] Respiratory interface devices according to the first and second aspects of the present invention A respiratory interface device according to a first aspect of the present invention comprises a body, a frame, and an inlet conduit, the frame having a front portion with a front wall and two side walls, arms, and a support platform extending rearward from the front wall, the support platform having an inlet opening formed therein, the body having at least one nostril outlet for interfacing with a user's nares in use, a base opening, and at least one opening through which the support platform extends, the inlet conduit having 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 clamping the base wall of the body and the support platform together, 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.

[0018] The "front" of the frame is the portion of the frame that extends around the front and sides of the support platform. The "side arms" are the portions that extend to the sides of the front of the frame and allow the respiratory interface device to be held in place on the patient's face. The side arms may extend from any position on the front sidewall of the frame. Thus, the side arms may be continuous with the front "end" of the frame, or may extend from a position on the front sidewall in front of said end. In the context of this application, the "end" of the front portion of the frame is the portion of the sidewall of the front portion that is closest to the patient's face in use. Preferably, the side arms are continuous with the front end of the frame.

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

[0020] A respiratory interface device according to a second aspect of the present invention comprises a body, a frame, and an inlet conduit, the frame comprising 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 through which a first end of the inlet conduit is received, the body comprising at least one nostril outlet for interfacing with a user's nares 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, the side walls of the front portion of the frame being separated from the platform. As noted above, the "front portion" of the frame refers to the portion of the frame that extends around the front and sides of the platform, and the "side arms" refer to the portions of the frame that extend around the sides of the front portion of the frame and enable the respiratory interface device to be held in place on a patient's face. In the respiratory interface device according to the first aspect of the present invention, the side arms may extend from any position on the front sidewall of the frame, and preferably the side arms are continuous with the front end of the frame. The frame may have rounded or chamfered edges.

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

[0022] Further examples of the first and second aspects of the invention are described below. For the avoidance of doubt, unless otherwise indicated, features described in relation to particular embodiments of an aspect of the invention may be combined with features described in relation to other particular embodiments of that aspect of the invention.

[0023] Main unit The respiratory interface device according to the first and second aspects of the present invention comprises a body, a frame and an inlet conduit. As used herein, the term "body" refers to a body for a nasal cannula, generally comprising oral, top, front, back and side walls, an inlet (opening) for receiving a conduit providing gas flow, and at least one nostril outlet provided in the top wall for interfacing with a patient's nares in use.

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

[0025] The body preferably includes a pair of nostril outlets (prongs) for interfacing with the patient's nostrils, the prongs being shaped to fit snugly within the patient's nostrils and may be curved, for example, so as to curve backward and inward from the base of the prongs relative to the front and sides of the body.

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

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

[0028] The body may include an annular, outwardly raised ring around the base opening. The ring is integrally formed with the body and may distort and / or compress when the inlet conduit is attached to the frame, providing a better seal and thus reducing leakage at this interface between the components. The ring also provides a degree of resistance to rotation, so that in the assembled device, the inlet conduit may be rotatably attached to the frame (as described below) but will not rotate freely when not held in a fixed position on the frame. The annular, outwardly raised ring may include means for holding the inlet conduit in a fixed position on the respiratory interface device during use. For example, this may include one or more recesses for cooperating with corresponding protrusions on the inlet conduit, or may include one or more protrusions 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, which may reduce pressure on the patient and improve comfort.

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

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

[0032] The transparency of the body material preferably allows the level of any water collected within the chamber, as well as any blockages, to be visible.

[0033] The body material is preferably suitable for surface printing and / or coating or the application of one or more surface finishes, for example, to provide patient comfort and for labeling purposes. Suitable surface finishes can include, for example, satin, textured, glossy, and patterned finishes. A satin finish may provide a softer feel to the body. A textured finish may be used to provide comfort or to accommodate labeling. A glossy finish improves visibility for labeling and provides improved transparency. Such finishes may therefore be useful in areas prone to condensation and where improved visibility would be beneficial. A patterned finish can provide decoration but can also be used to improve moisture wicking and comfort.

[0034] The body may be provided in different sizes, for example with different sized prongs, allowing selection of an appropriate size for an individual patient.

[0035] frame The frame of the respiratory interface device according to the first and second aspects of the present invention comprises a front section, side arms, and a support platform. The front section has a front wall and two side walls. The support platform extends rearward from the front wall of the front section and has an inlet opening formed therein. The frame has a single inlet opening, i.e., 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 invention, the front sidewall of the frame is joined to the support platform, and the support platform extends through an opening in the sidewall of the body. In preferred embodiments of the second aspect of the invention and the first aspect of the invention, the front sidewall of the frame is separate from the support platform, and the support platform extends through a front opening in the body or through a side opening in the body.

[0037] In particular, when the front sidewall of the frame is separated from the support platform, the respiratory interface device has improved flexibility, resilience, and springiness, reducing impact on the cannula body and nasal prongs from forces applied to one or both side arms. For example, movement of a side arm does not necessarily result in an equal degree of movement of the corresponding front sidewall of the frame, and any force applied to a side arm (such as may occur when headgear is adjusted) results in movement of said side arm, which is not necessarily transmitted equally along the front sidewall of the frame and ultimately to the front wall, support platform, and body of the respiratory interface device. The flexibility of the side arms can facilitate adjustment of the respiratory interface device and improve fit to the wearer.

[0038] The support platform has an inlet opening formed therein through which a connector of the inlet conduit can be received, the inlet opening preferably being circular to allow for a rotatable connection with the inlet conduit.

[0039] The support platform may include an annular wall extending upwardly around the inlet opening. Thus, the gas entry point may be above the base of the platform, providing the advantage that any condensation generated within the chamber will collect below the gas entry point. In this manner, "gargling," a characteristic commonly associated with respiratory interface devices, may be reduced. Gargling can generate a significant amount of noise and can be annoying to the patient. In addition to reducing gargling, when the gas entry point is above the base of the support platform, any buildup of condensation is less likely to result in the delivery of large amounts of water to the patient (which may otherwise occur, for example, when the respiratory interface device is moved).

[0040] The support platform extends rearward from the front wall of the frame. Where the front sidewall of the frame is 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 frame before widening to follow the contours of the front sidewall of the frame. In this configuration, the support platform may include a first, narrower "neck" portion and a second, wider "shoulder" portion. Alternatively, the platform may extend rearward directly from the front wall of the frame, or may extend rearward at an angle from the front wall of the frame, increasing in width rearward.

[0041] In some embodiments of the first and second aspects of the invention, the support platform extends through a side opening in the body, and the front wall of the front part of the frame may be provided with recesses on either side thereof to facilitate fitting of the body thereto.

[0042] In some embodiments of the first and second aspects of the present invention, the support platform includes one or more of a front wall, a side wall, and a rear wall. Preferably, the support platform does not have a rear wall. Such a configuration maximizes flexibility in the portions of the body that contact the patient (i.e., the top and rear 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 includes a front wall, more preferably a front wall and a side wall. 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 apex or lip of the front wall of the body is received in 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 the 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 surfaces of the side walls of the support platform. The front surface of the front wall of the platform and the outer surfaces of the side walls of the support platform are the sealing surfaces. If a front wall is not provided, the front wall of the body rests against the inner surface of the front wall of the front portion of the frame. Where no side walls are provided, the side walls of the body rest against the inside surface of the front side wall of the frame.

[0044] 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, and the front side wall of the frame is separated from the support platform, the support platform having a side wall. In this arrangement, the body fits around the front wall of the frame and the side wall of the support platform. The outer surfaces of the front wall of the frame and the side wall of the support platform are sealing surfaces. The front wall of the frame has a recess on either side to facilitate fitting of the body, and in this arrangement, the side wall of the support platform joins with the front wall of the frame at a position adjacent the recess in the front wall, forming a continuous sealing surface between the outer wall of the front part of the frame and the outer wall of the side wall of the support platform.

[0045] According to an embodiment of the first aspect of the present invention, the sidewalls of the front portion of the frame are joined to the support platform, which optionally includes sidewalls spaced inward from the front sidewalls of the frame to form channels between each sidewall of the support platform and a respective sidewall of the front portion of the frame. In this arrangement, the body is fitted around the front wall of the frame and the sidewalls of the support platform. The outer surfaces of the front wall of the frame and the sidewalls of the support platform are sealing surfaces. As mentioned above, the front wall of the frame may have a recess on either side thereof to facilitate fitting of the body, and in this arrangement, the sidewalls of the body are joined to the front wall of the frame at positions adjacent to the recesses in the front wall, creating a continuous sealing surface between the outer surface of the front wall of the frame and the outer surfaces of the sidewalls of the body.

[0046] According to an embodiment of the first aspect of the present invention, the front sidewall of the frame is joined to a support platform, which does not include a sidewall, and the body is fitted around the front wall of the frame, and in one embodiment, sits on the inner surface of the front sidewall of the frame. The front wall of the frame may also have recesses on both sides to facilitate fitting of the body. In an alternative embodiment where the sidewall is not included in the support platform, the body is fitted around the front wall of the frame and also fits around (on the outer surfaces of) the front sidewall of the frame. In this embodiment, the outer surfaces of the front wall and sidewall of the frame form a continuous sealing surface.

[0047] In embodiments in which the support platform extends through a side opening in the side wall of the body, the support platform preferably does not include a front wall.

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

[0049] The side arms can be contoured to accommodate the contours of the patient's face. In plan view, the side arms can have a curved shape that is convexly curved and then concavely curved. In front view, the side arms can descend from the side walls of the front of the frame before curving upward. The side arms can have a greater height (vertical width) than the walls 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 arms can increase in height along their length. The side arms can be thinner (less deep) than the side walls of the first portion of the frame, particularly in embodiments where the side walls of the first portion of the frame are separated from the platform. This can provide greater flexibility in the side arms, while the thick side walls of the first portion of the frame can provide some rigidity to the frame.

[0050] The side arms can be provided with means for attachment to 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 straps can be threaded. In contrast to existing devices with side arms constructed from silicone, the respiratory interface device of the present invention allows for direct attachment of the head strap without the need for an additional bridge between the side arm and the headgear. For example, if a pair of parallel slots are provided in each side arm, adjusting the head strap involves applying symmetrical forces 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 can be modified to provide asymmetrical forces for loosening or tightening the head strap (e.g., one or more walls of the slots may be sloped or chamfered), making it easier to either tighten or loosen the strap—for example, it may be desirable to have an easier tightening to minimize the time required to secure the interface to the patient's face, but a more difficult loosening 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 may include means for holding the inlet conduit in a fixed position during use. The means may take any suitable form. For example, each front side wall of the frame may include a recess for engaging a corresponding protrusion on the inlet conduit, or each front side wall of the frame may include a protrusion for engaging a corresponding recess on the inlet conduit. Thus, during use, the inlet conduit may be held in a fixed position on the front side wall of the frame. Such recesses or protrusions may be provided on the side walls of the body where the body covers the front side walls of the frame. In another example, retention means such as a recess or protrusion may be included on an annular, outwardly raised ring around the base opening of the body to cooperate with a protrusion or recess on the first end of the inlet conduit.

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

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

[0054] The unitary construction of the frame of the present invention avoids the need for additional connections or connecting parts in the device, increasing the strength and robustness of the respiratory interface device.

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

[0056] Preferably, the inlet conduit is elbow shaped so that the connector extends upwardly 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 in the support platform, and is preferably generally cylindrical. The connector may include means for permanently snapping onto the platform, for example, it may include one or more protrusions adapted to snap onto the top of the annular wall of the platform.

[0058] In some embodiments, three, four, five, or more protrusions may be provided. The protrusions may be equally spaced from one another. Providing multiple protrusions can avoid or minimize the possibility of excessive stress on a single protrusion. The protrusion located closest to the second end of the inlet conduit may be thicker or otherwise reinforced relative to the remaining protrusions. In this manner, the protrusion most stressed by any moment applied to the inlet conduit from the gas supply pipe is adapted to absorb such stress. The protrusions may be positioned in any orientation relative to the first and second ends of the conduit.

[0059] The inlet conduit may be made from the same material as the frame or from a different material that is flexible enough to allow it to be snap-fit ​​into the frame, for example.

[0060] The inlet conduit may optionally be provided with retaining means cooperating with the frame or body to hold the inlet conduit in a fixed position during use. The retaining means may, for example, comprise a protrusion on the inlet conduit for cooperating with a corresponding recess on the frame or body, or a recess on the inlet conduit for cooperating with a corresponding protrusion on the frame or body. In some embodiments, a recess may be provided in each side wall of the front of the frame or body, such that the inlet conduit is fixed in position on either side of the front 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. A permanent connection of the inlet conduit to the support platform contributes to the overall strength of the device, while a rotatable connection of the inlet conduit to the support platform allows the device to be operated in different orientations without requiring disassembly and reassembly. That is, a "swivel" connection can be provided between the support platform and the inlet conduit, whereby, during use, the inlet conduit can be rotated so that its main body can be moved between the left and right sides of the platform. This is advantageous, for example, when a patient changes position while sleeping or eating, when a medical professional is present, or when the gas delivery side must be changed for some reason. The rotatable connection is also advantageous when a patient is regularly moved to a prone position, as is the case with patients with COVID-19, as it allows the gas delivery tube to be easily repositioned.

[0062] Because the inlet conduit, and therefore the gas supply conduit, connects to the rigid frame of the respiratory interface surface rather than to the body, the weight of the gas supply conduit does not cause significant distortion of the body. The weight of the gas supply conduit does not lead to a disconnection of the gas supply, which can occur in situations where there is a connection between a soft, 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 apparatus 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, the support platform having an inlet opening formed therein, the body comprising, in use, at least one nostril outlet for interfacing with a user's nostril, a base opening, and a side opening through which the support platform extends; The inlet conduit includes a connector at a first end that extends 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, 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.

[0064] For the avoidance of doubt, unless otherwise indicated, features of particular embodiments of this aspect of the invention may be combined with features of other particular embodiments of this aspect of the invention.

[0065] The support platform may include a rear wall or no anterior (front) wall. Alternatively, the support platform may include side walls spaced inwardly from the side walls of the frame such that a channel is 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., has no side walls (other than the side walls of the frame). In various embodiments of the first and second aspects of the present invention, the rear edge of the support platform, or the rear wall of the support platform, may be shaped to curve inward from its outer edge to correspond to the shape of the patient's upper lip, the entrance opening may be circular, and the support platform may include an annular wall extending upwardly around the entrance opening.

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

[0067] Suitable materials for the frame are as described above in relation to the first and second aspects of the invention, for which the frame may have rounded or chamfered edges. The side walls of the frame of the respiratory interface device according to the third aspect of the invention correspond to the side walls of the front part of the frame of the respiratory interface device of the first aspect of the invention, said side walls of the front part of the frame being joined to the support platform and may comprise any of the features described in relation thereto.

[0068] The body is as described in relation to the embodiments of the first and second aspects of the invention, wherein the body has a side opening. If the support platform has side walls, the body fits around said side walls, and the outer surfaces of the side walls of the support platform are the sealing surfaces. If the support platform does not have side walls, the body fits around the side walls of the frame, and the outer surfaces of the side walls of the frame are the sealing surfaces.

[0069] The inlet conduit is as described in relation to the respiratory interface devices of the first and second aspects of the invention.

[0070] Manufacture and use The respiratory interface device of the present invention may be adapted for use with, or may further comprise, a gas delivery tube, such as those commonly used with respiratory interface devices. The gas delivery tube may be an unheated, lightweight, flexible tube. Preferably, the tube is transparent to allow for detection of occlusions and reinforced to provide resistance to crushing and / or kinking. The gas delivery tube may be provided with any suitable type of clip, as known to those skilled in the art, for attachment to clothing or bedding, for example. Alternatively, or in addition, a string or strap may be attached to the gas delivery tube. The gas delivery tube is connected to a gas source via a connector, which may take any suitable form, as known to those skilled in the art. The respiratory interface device of the present invention may be adapted for use with, or may further comprise, headgear, such as a head strap, commonly used with respiratory interface devices.

[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 silicone provide a good fit for the frame, where silicone is the body material, and the connector of the inlet conduit clamps the assembly together. Attaching the body to the frame involves stretching the body around the base of the support platform and other relevant portions of the frame (e.g., in the first and second embodiments of the present invention, the front and side walls of the support platform, the front and side walls of the frame, or the front and side walls of the frame; in the third embodiment of the present invention, the side walls of the support platform or the side walls of the frame), thereby defining a chamber between the platform and the body. Chamfered or rounded edges in the frame may facilitate fitting the silicone body thereto. Chamfered or rounded edges at the inlet opening of the support platform may facilitate insertion of the inlet conduit into the frame.

[0072] The device of the present invention can be used to treat hypoxia. It is designed to meet or exceed a patient's normal inspiratory demand, creating minimal air dilution and delivering a higher percentage of inspired oxygen for a longer period than high-concentration non-respiratory masks. Compared to masks, the device also provides improved comfort, allowing patients to drink, eat, talk, and sleep more easily. High-flow therapy provides versatility and continuity of care when a patient is weaned from a ventilator or when their condition becomes more acute. This greater flexibility eliminates the need for switching between oxygen therapy delivery systems. The device is noninvasive and accurately delivers a prescribed oxygen concentration (up to 100% O2) at flow rates of 10-50 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: anterior part with a front wall and two side walls; Sidearm; a support platform extending rearwardly from the front wall of said forward portion; the support platform having an entrance opening formed therein; and The front sidewall of the frame is separated from the support platform.

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

[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 extending upwardly from the body of the conduit and configured to connect to and provide a flow of gases to a nasal cannula portion, and a second end of the conduit configured to connect to a gas supply tube. Preferred features of the conduit are as described herein in connection with the first through third aspects of the present invention. Most preferably, the conduit is adapted to provide a rotatable, or "swivel," connection to the support platform so that the gas supply tube can be easily repositioned during use. For clarity, any feature described herein in connection with the inlet conduit may be combined with any other feature described herein in connection with the inlet conduit.

[0076] kit The device of the present invention can be provided fully assembled, although the frame, body, and inlet conduit can be provided as separate parts for assembly by the user. Thus, according to a sixth aspect of the present invention, a kit can comprise a frame, body, and inlet conduit as described herein, either as separate parts or fully assembled, and instructions for assembly and / or use. The kit can include two or more bodies of different sizes. [Brief explanation of the drawings]

[0077] [Figure 1a] FIG. 1 is a front view of a respiratory interface device according to an embodiment of the first and second aspects of the present invention. [Figure 1b] FIG. 1 is a rear view of a respiratory interface device according to an embodiment of the first and second aspects of the present invention. [Figure 2a] 1 shows a body with a front opening according to an embodiment of the respiratory interface device of the first and second aspects of the present invention; [Figure 2b] FIG. 2b is a view of the main body of FIG. 2a from another direction. [Figure 3a] FIG. 10 is a top view of a frame according to the fourth embodiment of the present invention and the first and second embodiments of the respiratory interface device of the present invention, in which the front side wall of the frame is separated from the platform and the side arms are continuous with the ends of the front side wall of the frame. [Figure 3b] FIG. 3b is a bottom view of the frame of FIG. 3a. [Figure 4a] 1 shows a frame according to an embodiment of the respiratory interface device of the first aspect of the present invention, where the front platform and side wall of the frame are joined and the side arms are continuous with the ends of the front side wall of the frame. [Figure 4b] 1 shows a frame according to an embodiment of the respiratory interface device of the first aspect of the present invention, where the front platform and side wall of the frame are joined and the side arms are continuous with the ends of the front side wall of the frame. [Figure 5] 1 shows a body with a side opening according to an embodiment of the respiratory interface device of the first, second and third aspects of the present invention. [Figure 6] 6 shows an assembled respiratory interface device comprising the body of FIG. 5 and the frame of FIG. 4b. [Figure 7] 10A and 10B are top views of an inlet conduit according to an embodiment of the fifth aspect of the invention and according to embodiments of the respiratory interface device of the first, second and third aspects of the invention; [Figure 8] 1 shows a device according to an embodiment of the respiratory interface device of the first and second aspects of the present invention fully assembled, together with a head strap and gas delivery tube. DETAILED DESCRIPTION OF THE INVENTION

[0078] The following detailed description is illustrative of an apparatus according to the present invention and is not intended to suggest any particular limitations on the apparatus.

[0079] 1a and 1b show a front view (FIG. 1a) and a rear view (FIG. 1b) of a fully assembled respiratory interface device according to the present invention. In the illustrated embodiment, the respiratory interface device (1) includes a body (2), a frame (3), and an inlet conduit (4). The body (2) fits around and is clamped to the support platform of the frame (3) by the inlet conduit (4), which is rotatably connected to the support platform of the frame (3). A slot (17) is provided at the end of each of the frame's side arms (12) to allow for the attachment of, for example, a head strap.

[0080] Figures 2a and 2b show a body according to the present invention. In the embodiment shown, the body (2) comprises two nostril outlets (prongs, 5) for interfacing with the patient's nares in use. The 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 body illustrated in Figures 2 and 2b sits inside the front wall of the front part of the frame in the assembled device, on the inner surface of the front wall of the front part of the frame, or in a channel between said front wall and the front wall of the platform, as seen in Figure 1a.

[0082] In the illustrated embodiment, the prongs (5) curve rearward away from the front of the body (2) and inward toward the center, with the prong curve being a combination of the front and side curves. The rear wall (8) of the body (2) extends beyond its base to provide an increased contact area between the body and the patient's upper lip. The rear wall (8) curves inward from its sides toward the center, thus assuming a shape that generally corresponds to the shape of the patient's upper lip. A discrete region (9) of the body around the base of the prongs (5) is thinner than the remainder of the body.

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

[0084] In the illustrated embodiment, the frame (3) has a front section (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 section (10), and side arms (12) extending from each side end (10c) of the front section (10). The support platform has an inlet opening (13) formed therein. In the illustrated embodiment, the side walls (10b) of the front section (10) and the support platform (11) are separated (spaced apart) from each other. As can be seen in FIG. 3b, the support platform is continuous at its base with the front wall of the frame's front section. The front wall (14) of the support platform (11) is set back from the front wall (10a) of the frame's front section (10) to provide a channel between the front wall (14) and the front wall of the frame (10). The side walls of the support platform (11) are spaced apart from the front side walls of the frame. The body may then be fitted around the support platform (11) and clamped to it by the inlet conduit connector. The rear edge (11a) of the support platform (11) curves inward from its side to its center, thus generally conforming to the shape of the patient's upper lip. The inlet opening (13) 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) into which a protrusion on the inlet conduit engages to lock the inlet conduit in a fixed position on the frame. The side arm (12) extends from the end (10c) of the side wall (10b) of the front (10) of the frame (3) and includes a slot (17) for attachment to headgear (e.g., as illustrated in FIG. 8).

[0085] Figures 4a and 4b show a frame (3) according to an embodiment of the present invention. In the illustrated embodiment, a 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 front side wall (10b) 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] FIG. 5 illustrates the body (2) with side openings (6) located on the sides of the body (2) (only one opening is shown; there is a corresponding opening on the other side of the body).

[0087] Figure 6 illustrates the assembled device (1) with the support platform extending through a side opening in the body (2). As can be seen, the body (2) is mounted along the front wall of the frame (3). In the illustrated embodiment, the body (2) sits in a groove (3a) in the front wall of the front of the frame.

[0088] FIG. 7 illustrates an inlet conduit (4) according to the present invention. In the illustrated embodiment, the inlet conduit (4) includes a connector (18) at a first end adapted to extend 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. The connector (18) includes a protrusion (19) for permanently snap-fit ​​connection to the top of the annular rim of the support platform. The inlet conduit (4) further includes a projection (20) for engaging a recess in the frame or body, thereby locking the inlet conduit in a fixed position on the frame or body. The projection extends from an annular projection (21) on the inlet conduit. The second end of the inlet conduit (4) is adapted to connect to a gas supply tube. In the illustrated embodiment, a screw thread (22) is provided on the second end of the inlet conduit for securing the gas supply tube to the device of the present invention.

[0089] Figure 8 illustrates a device (1) according to the invention attached to a head strap (23) and a gas supply tube (24). A clip (25) may be provided, for example, to allow the gas supply tube (24) to be connected to, for example, clothing or bedding.

[0090] The respiratory interface devices, frames, and kits 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, comprising: the frame comprising a front portion having a front wall and two side walls, side arms, and a support platform extending rearwardly from said front wall, said support platform having an entrance opening formed therein; In use, the body comprises at least one nostril outlet for interfacing with a user's nostril, a base opening in the base wall of the body and at least one opening through which the support platform extends, an 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 and clamps 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 walls of the body.

[0094] A respiratory interface device according to any of paragraphs

[91] to

[93] , wherein the front sidewall of the frame is separated from the support platform.

[0095] In the respiratory interface device described in paragraph

[91] or paragraph

[93] , the front sidewall of the frame is joined to the support platform.

[0096] A respiratory interface device comprising a body, a frame, and an inlet conduit, comprising: the frame comprising a front portion having a front wall and two side walls, side arms, and a support platform extending rearwardly from said front wall, said support platform having an entrance opening formed therein; the body comprising at least one nostril outlet for interfacing with a user's nostril in use, 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; The front sidewall of the frame is separated from the support platform.

[0097] The 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 body.

[0098] The respiratory interface device according to paragraph

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

[0099] 1. A frame for use in a respiratory interface device, the frame comprising: a front part having a front wall and two side walls; A sidearm and a support platform extending rearward from a front wall of the front portion, the support platform having an entrance opening formed therein, the front side wall of the frame being separated from the platform.

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

[91] ,

[92] ,

[94] and

[96] -

[97] , or a respiratory interface device as set forth in paragraph

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

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

[91] to

[98] and

[0100] , or in a respiratory interface device as set forth in paragraph

[99] or paragraph

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

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

[91] to

[98] and

[0100] to

[0101] , or in a respiratory interface device as described in any of paragraphs

[99] to

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

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

[91] -

[98] and

[0100] -

[0102] , or a respiratory interface device as described in any of paragraphs

[99] -

[0102] , wherein the rear 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 inward from its outer edge.

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

[91] to

[98] and

[0100] to

[0103] , or in a respiratory interface device as described in any of paragraphs

[99] to

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

[0105] A respiratory interface device or a frame for use in a respiratory interface device as described in paragraph

[0104] , wherein the support platform has an annular wall extending upwardly around the inlet opening.

[0106] A frame for use in a respiratory interface device as set forth in any of paragraphs

[91] to

[98] and

[0100] to

[0105] , or in a respiratory interface device as set forth in any of paragraphs

[99] to

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

[0107] A frame for use in a respiratory interface device as set forth in any of paragraphs

[91] to

[98] and

[0100] to

[0106] , or in a respiratory interface device as set forth in any of paragraphs

[99] to

[0106] , wherein each side arm is provided with means for attachment to headgear.

[0108] A respiratory interface device or a frame for use in a respiratory interface device as described in paragraph

[0107] , wherein the distal end of each side arm is provided with a pair of slots adapted to secure the ends of a head strap to the side arm.

[0109] A frame for use with 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] , comprising means for holding an inlet conduit in a fixed position on the front of the frame or on the body.

[0110] A respiratory interface device or a frame for use in a respiratory interface device as described in paragraph

[0109] , wherein the inlet conduit has a protrusion and each side wall of the front of the frame or body has a corresponding recess.

[0111] A respiratory interface device or a frame for use in a respiratory interface device as described in paragraph

[0109] , wherein the inlet conduit has a recess and each side wall of the front of the frame or body has a corresponding protrusion.

[0112] A frame for use in a respiratory interface device described in any of paragraphs

[91] to

[98] and

[0100] to

[0110] , or in a respiratory interface device described in any of paragraphs

[99] to

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

[0113] A respiratory interface device or a frame for use in a respiratory interface device as described in paragraph

[0112] , wherein the frame is made of a thermoplastic synthetic polymer.

[0114] A respiratory interface device or a frame for use in a respiratory interface device as described in paragraph

[0113] , wherein the frame is made of polypropylene or polyethylene.

[0115] A frame for use in a respiratory interface device as described in any of paragraphs

[91] to

[98] ,

[0100] to

[0101] and

[0103] to

[0114] , or in a respiratory 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 frame for use in a respiratory interface device as set forth in any of paragraphs

[91] to

[98] and

[0100] to

[0115] , or in a respiratory interface device as set forth in any of paragraphs

[99] to

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

[0117] A frame for use in a respiratory interface device as set forth in any of paragraphs

[91] to

[98] and

[0100] to

[0116] , or in a respiratory interface device as set forth 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 according to any one of paragraphs

[91] ,

[92] ,

[94] ,

[96] ,

[97] and

[0100] to

[0117] , wherein the body has a front, a rear, a base, a side, and a top wall, the front wall having a front opening, the base wall having a base opening, the top wall having one or more nostril outlets (nasal prongs) for interfacing with the patient's nares, and the base openings are arranged to correspond to the inlet openings of the support platform.

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

[91] ,

[93] to

[96] ,

[98] and

[0101] to

[0117] , wherein the main body has a front surface, a rear surface, a base, side walls, and a top wall, each side wall having an opening therein, the base wall having a base opening, and the top wall having one or more nostril outlets (nasal prongs) for interfacing with the patient's nares, the base openings being positioned to correspond to the inlet openings of the support platform.

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

[91] to

[98] and

[0100] to

[0119] , comprising an annular, outwardly raised ring around the base opening.

[0121] A respiratory interface device according to any one of paragraphs

[91] to

[98] and

[0100] to

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

[0122] A respiratory interface device as described in any of paragraphs

[91] to

[98] and

[0100] to

[0121] , wherein each nasal prong is curved in shape and curves backward and inward from the base of each nasal prong relative to the front and sides of the body.

[0123] A respiratory interface device as described in any of paragraphs

[91] to

[98] and

[0100] to

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

[0124] A respiratory interface device as described in any of paragraphs

[91] to

[98] and

[0100] to

[0123] , wherein the area around the base of each prong is thinner than the remainder of the body.

[0125] A respiratory interface device as described in any of paragraphs

[91] to

[98] and

[0100] to

[0124] , wherein the rear wall of the body extends beyond the base to provide 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 body is shaped to correspond to the shape of the patient's upper lip and curves inward from its outer edge.

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

[91] to

[98] and paragraphs

[0100] to

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

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

[91] to

[98] and

[0100] to

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

[0129] A respiratory interface device as described in any 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] A respiratory interface device as described in paragraph

[0129] , wherein the inlet conduit is elbow-shaped and the connector extends upward from the inlet conduit at a first end of the conduit.

[0131] A respiratory interface device as described in paragraph

[0129] or paragraph

[0130] , wherein the connector comprises means for permanently snapping onto the support platform.

[0132] A respiratory interface device as described in paragraph

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

[0133] A respiratory interface device as described in paragraph

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

[0134] A respiratory interface device as described in any 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] The Respiratory Interface Device Kit includes: It comprises the frame, body, and inlet conduit described in paragraphs

[91] to

[0133] , either as separate parts or fully assembled, and also includes instructions for assembly and / or use.

[0136] A respiratory interface device kit as 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, comprising: the body comprising a front, a rear, a base, and a top wall, the front wall having a front opening, the bottom wall having a base opening, and the top wall having one or more nostril outlets for interfacing with the patient's nares; the frame comprising a front portion having a front wall and two side walls, side arms, and a support platform extending rearwardly from the front wall, the support platform having an entrance opening formed therein; Each side wall of the front of the frame is separated from the support platform; the base opening of the body is positioned to correspond to the inlet opening of the support platform; the inlet conduit having a connector at a first end; The support platform extends through a front opening in the front wall of the body, and the inlet conduit extends through a base opening in the base of the body and through an inlet opening in the support platform to clamp the body and support platform together.

[0138] An inlet conduit for use in a respiratory interface device, the inlet conduit having a connector at a first end thereof extending upwardly from a body of the inlet conduit and configured to connect to and supply gases to a nasal cannula portion, the second end of the inlet conduit being configured to connect to a gas supply tube.

[0139] An inlet conduit as described in paragraph

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

[0140] An inlet conduit as described in paragraph

[0138] or paragraph

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

[0141] A respiratory interface device comprising a body, a frame, and an inlet conduit, comprising: the frame comprising 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 including at least one nostril outlet for interfacing with a user's nostril in use, a base opening, and a side opening through which the support platform extends, the base opening corresponding to the inlet opening of the support platform; and The inlet conduit includes a connector at a first end that extends 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, 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.

[0142] A respiratory interface device as described in paragraph

[0141] , wherein the support platform has a side wall spaced inward from the side wall of the frame.

[0143] A respiratory interface device as described in paragraph

[0141] or paragraph

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

[0144] A respiratory interface device as described in paragraph

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

[0145] A 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 inward from its outer edge.

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

[0141] to

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

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

[0141] to

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

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

[0141] to

[0147] , wherein the side arms are contoured to correspond to the contours of the patient's face.

[0149] A respiratory interface device as described in any of paragraphs

[0141] to

[0148] , wherein each side arm is provided with means for attachment to headgear.

[0150] A respiratory interface device as described in any of paragraphs

[0141] to

[0149] , wherein the distal end of each side arm is provided with a pair of slots configured to secure an end of a head strap to the side arm.

[0151] A respiratory interface device as described in any of paragraphs

[0141] to

[0150] , comprising means for holding an inlet conduit in a fixed position at the front of the frame or in a fixed position on the body.

[0152] A respiratory interface device as described in paragraph

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

[0153] A respiratory interface device as described in paragraph

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

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

[0141] to

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

[0155] A respiratory interface device as described in paragraph

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

[0156] A respiratory interface device as described in paragraph

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

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

[0141] to

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

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

[0141] to

[0158] , wherein the main body comprises a front surface, a back surface, a base, side walls, and a top surface wall, each side wall having an opening therein, the base wall having a base opening, and the top surface wall having one or more nostril outlets (nasal prongs) for interfacing with the patient's nares, the base openings being positioned to correspond to the inlet openings of the support platform.

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

[0141] to

[0159] , comprising an annular, outwardly raised ring around the base opening.

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

[0141] to

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

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

[0141] to

[0161] , wherein each nasal prong is curved in shape and curves backward and inward from its base relative to the front and sides of the body.

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

[0141] to

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

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

[0141] to

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

[0165] A respiratory interface device as described in any of paragraphs

[0141] to

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

[0166] In the respiratory interface device described in any one of paragraphs

[0141] to

[0165] , the rear wall of the body is formed to correspond to the shape of the patient's upper lip and curves inward 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 as described in any of paragraphs

[0141] to

[0168] , 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.

[0170] A respiratory interface device as described in any of paragraphs

[0141] to

[0169] , wherein the inlet conduit is elbow-shaped and the connector extends upwardly 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 snapping onto the support platform.

[0172] A respiratory interface device as described in paragraph

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

[0173] A respiratory interface device as described in 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] The Respiratory Interface Device Kit includes: A frame, a body, and an inlet conduit as set forth in 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 as described in paragraph

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

Claims

1. A respiratory interface device comprising a body, a frame, and an inlet conduit, comprising: the frame includes a front portion having a front wall and two side walls, side arms, and a support platform extending rearwardly from the front wall, the support platform having an entrance opening formed therein; the body comprising at least one nostril outlet for interfacing with a user's nostril in use, a base opening in a base wall of the body, and at least one opening through which the support platform extends; a respiratory interface device, wherein the inlet conduit comprises a connector at a first end that passes through a base opening of the body and an 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.

2. The respiratory interface device of claim 1 , wherein the at least one opening through which the support platform extends is a front opening in a front wall of the body.

3. The respiratory interface device of claim 1 , wherein the at least one opening through which the support platform extends is a pair of sidewall openings in a sidewall of the body.

4. A respiratory interface device according to any preceding claim, wherein the front sidewall of the frame is separated from the support platform.

5. 4. A respiratory interface device according to claim 1 or claim 3, wherein the front sidewall of the frame is joined to the support platform.

6. A respiratory interface device comprising a body, a frame, and an inlet conduit, comprising: the frame includes a front portion having a front wall and two side walls, side arms, and a support platform extending rearwardly from the front wall, the support platform having an entrance opening formed therein; the body comprising at least one nostril outlet for interfacing with a user's nostril in use, a base opening, at least one opening through which a 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; A respiratory interface device wherein a front sidewall of the frame is separated from the support platform.

7. The respiratory interface device of claim 6 , wherein the at least one opening through which the support platform extends is a front opening in a front wall of the body.

8. The respiratory interface device of claim 6 , wherein the at least one opening through which the support platform extends is a pair of side wall openings in a side wall of the body.

9. 1. A frame for use in a respiratory interface device, said frame comprising: a front portion having a front wall and two side walls; a support platform extending rearwardly from a front wall of the front portion, the support platform having an entrance opening formed therein, the front side wall of the frame being separated from the support platform;

10. 8. A respiratory interface device according to any one of claims 1, 2, 4 and 6-7, or a frame for use in a respiratory interface device according to claim 9, wherein the support platform comprises a front wall, the front wall being spaced apart from the front wall of the frame, such that a channel is formed between the front wall and the front wall.

11. A frame for use in a respiratory interface device according to any one of claims 1 to 8 or a respiratory interface device according to claim 9 or claim 10, wherein the support platform comprises a side wall.

12. A frame for use in a respiratory interface device according to any one of claims 1-8 and 10-11 or a respiratory interface device according to any one of claims 9-11, wherein the support platform comprises a rear wall.

13. A respiratory interface device as claimed in any one of claims 1 to 8 and 10 to 12, or a frame for use in a respiratory interface device as claimed in any one of claims 9 to 12, wherein the rear 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 inward from the outer edge of the rear edge or rear wall.

14. A respiratory interface device according to any one of claims 1-8 and 10-13, or a frame for use with a respiratory interface device according to any one of claims 9-13, wherein the inlet opening in the support platform is circular.

15. 15. A respiratory interface device or a frame for use with said respiratory interface device according to claim 14, wherein the support platform comprises an annular wall extending upwardly around the inlet opening.

16. A frame for use in a respiratory interface device as claimed in any one of claims 1-8 and 10-15 or a respiratory interface device as claimed in any one of claims 9-15, wherein the side arms are contoured to correspond to the contours of a patient's face.

17. A respiratory interface device according to any one of claims 1 to 8 and 10 to 16, or a frame for use in a respiratory interface device according to any one of claims 9 to 16, wherein each side arm includes means for attachment to headgear.

18. 18. A respiratory interface device or a frame for use with said respiratory interface device according to claim 17, wherein the distal end of each side arm is provided with a pair of slots adapted to secure the ends of a head strap to said side arm.

19. A respiratory interface apparatus as claimed in any one of claims 1 to 8 and any one of claims 10 to 18, or a frame for use in a respiratory interface apparatus as claimed in any one of claims 9 to 18, comprising means for holding an inlet conduit in a fixed position in front of the frame.

20. 20. A respiratory interface device or a frame for use with said respiratory interface device according to claim 19, wherein the inlet conduit comprises a protrusion and each side wall of the front of the frame comprises a corresponding recess.

21. 20. A respiratory interface device or a frame for use with the respiratory interface device according to claim 19, wherein the inlet conduit comprises a recess and each side wall of the front of the frame comprises a corresponding protrusion.

22. A respiratory interface device according to any one of claims 1 to 8, 10 to 20, or a frame for use in a respiratory interface device according to any one of claims 9 to 20, wherein the frame is made from a flexible plastic material.

23. 23. A respiratory interface device or a frame for use with said respiratory interface device according to claim 22, wherein the frame is made from a thermoplastic synthetic polymer.

24. 24. A respiratory interface device or a frame for use with said respiratory interface device according to claim 23, wherein the frame is made from polypropylene or polyethylene.

25. A respiratory interface device according to any one of claims 1 to 8, 10 to 11 and 13 to 24, or a frame for use with a respiratory interface device according to any one of claims 9 to 11 and 13 to 24, wherein the support platform is devoid of a rear wall.

26. A respiratory interface device according to any one of claims 1 to 8, 10 to 25 or a frame for use in a respiratory interface device according to any one of claims 9 to 25, wherein the frame includes chamfered or rounded edges.

27. A respiratory interface device according to any one of claims 1 to 8, 10 to 26 or a frame for use with a respiratory interface device according to any one of claims 9 to 26, wherein the base opening of the support platform includes a chamfered or rounded edge.

28. 28. The respiratory interface device of any one of claims 1, 2, 4, 6, 7, and 10-27, wherein the body comprises a front wall, a rear wall, a base, side walls, and a top wall, the front wall having a front opening, the base wall having a base opening, and the top wall having one or more nostril outlets (nasal prongs) for interfacing with a patient's nares, the base openings being positioned to correspond to the inlet openings of the support platform.

29. 28. The respiratory interface device of any one of claims 1, 3-6, 8 and 11-27, wherein the body comprises a front, a back, a base, side walls and a top wall, each side wall having an opening therein, the base wall having a base opening, and the top wall having one or more nostril outlets (nasal prongs) for interfacing with a patient's nares, the base openings being positioned to correspond with the inlet openings of the support platform.

30. A respiratory interface device according to any preceding claim, wherein the body comprises an annular outwardly raised ring around the base opening.

31. A respiratory interface device according to any one of claims 1-8 and 10-30, wherein the body comprises a pair of nasal prongs.

32. 32. A respiratory interface device according to any one of claims 1 to 8 and 10 to 31, wherein each nasal prong is curved in shape, curving backwards and inwards from its base relative to the front and sides of the body.

33. A respiratory interface device according to any one of claims 1 to 8 and 10 to 32, wherein each nasal prong has a uniform cross-section and / or a uniform wall thickness along its length.

34. A respiratory interface device according to any one of claims 1-8 and 10-33, wherein the area around the base of the body or each prong is thinner than the remainder of the body.

35. A respiratory interface device according to any one of claims 1 to 8 and any one of claims 10 to 34, wherein the rear wall of the body extends beyond the base to provide an increased area for contact with the patient's upper lip.

36. A respiratory interface device according to any one of claims 28 to 35, wherein the rear wall of the body is shaped to correspond to the shape of the patient's upper lip and curves inwardly from an outer edge of the rear wall.

37. A respiratory interface device according to any one of claims 1-8 and 10-36, wherein the body is made from a flexible material.

38. A respiratory interface device according to any one of claims 1-8 and 10-37, wherein the body is made of silicone.

39. 9. A respiratory interface device according to any preceding claim, wherein the inlet conduit has a connector at a first end connected to the support platform of the frame and has a shape complementary to the shape of the inlet opening.

40. 40. A respiratory interface device according to claim 39, wherein the inlet conduit is elbow shaped such that the connector extends upwardly from the inlet conduit at the first end of the inlet conduit.

41. 41. A respiratory interface device according to claim 39 or claim 40, wherein the connector comprises means for permanently snapping onto the support platform.

42. 42. A respiratory interface device according to claim 41, wherein the connector comprises one or more protrusions adapted to snap-fit ​​with the support platform.

43. 43. A respiratory interface device according to claim 42, wherein the protrusion located closest to the second end of the connector is thicker or reinforced compared to the remaining protrusions.

44. A respiratory interface device according to any one of claims 1 to 8 and any one of claims 10 to 43, wherein the inlet conduit is fixed to the support platform in a rotatable and non-removable manner.

45. A frame, body, and inlet conduit as claimed in claims 1-43, either as separate parts or fully assembled; and instructions for assembly and / or use.

46. 46. ​​The respiratory interface device kit of claim 45, comprising two or more bodies of different sizes.

47. A respiratory interface device comprising a body, a frame, and an inlet conduit, comprising: the body comprising a front wall, a rear wall, a base, and a top wall, the front wall having a front opening, the bottom wall having a base opening, and the top wall having one or more nostril outlets for interfacing with the patient's nares; the frame includes a front portion having a front wall and two side walls, side arms, and a support platform extending rearwardly from the front wall, the support platform having an entrance opening formed therein; each sidewall of the front of the frame is separated from the support platform; the base opening of the body is positioned to correspond to the inlet opening of the support platform; the inlet conduit having a connector at a first end; The support platform extends through a front opening in a front wall of the body, and the inlet conduit extends through a base opening in a base wall of the body and through an inlet opening in the support platform to clamp the body and the support platform together.

48. 1. A conduit for use in a respiratory interface device, the conduit comprising a connector at a first end thereof extending upwardly from a body of the conduit and configured to connect to a nasal cannula portion to supply gas, the connector configured to connect to a gas supply tube at a second end of the conduit.

49. 49. The conduit of claim 48, wherein the connector has a generally cylindrical shape for rotatable connection with the nasal cannula portion.

50. 49. A conduit according to claim 47 or claim 48, wherein the connector comprises means for permanently connecting with a nasal cannula portion.

51. A respiratory interface device comprising a body, a frame, and an inlet conduit, comprising: the frame comprising 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 comprising at least one nostril outlet for interfacing with a user's nostril in use, a base opening, and a side opening between which the support platform extends, the base opening corresponding to the inlet opening of the support platform; a respiratory interface device, wherein the inlet conduit comprises a connector at a first end that extends through a base opening of the body and an 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 the one or more nostril outlets.

Images