Patent ID: 12239788

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The foregoing description of the invention includes preferred forms thereof. Modifications may be made thereto without departing from the scope of the invention.

It is desirable to provide for a patient interface in a manner that conforms to a user's changing facial geometry or which is configured in a manner to maintain a stable position upon the user or to at least help improve the maintenance of stability when external forces are applied to such a patient interface.

In achieving one or both of these outcomes, or yet other outcomes, the provision of alternative patient interfaces with improved stability and/or performance on the face of the user would be useful.

In one aspect, this invention relates to a patient interface, such as a nasal cannula, comprising a body to be positioned upon a user (preferably such as a user's face). The body including at least one (and preferably a pair of) nasal prong(s), the or each nasal prong including a lumen capable of being fluidly connected thereto for fluid communication with a supply of breathable gas. The, or each, nasal prong to be in a configuration either inserted into, or to direct a flow of gas toward, a nare or the nares of the user's nose. The body includes at least one element responsive to force(s) or movement(s), or both, experienced by at least a first region of the patient interface from being transferred to at least one other region of the patient interface.

In relation to such an invention, reference is made to the accompanying drawings which detail specific embodiments thereof. Details of the specific embodiments are provided in the various sections below.

Before the specific embodiment details, the following description relates to the invention as detailed above. For example, such an interface can include an element which facilitates the reduction in transfer of a force or movement, or both, as applied to at least a first region of the interface from being transferred to at least another region of the interface. It will be appreciated such an element may be the hinged portion as detailed below with reference to the figures and specific embodiment descriptions. It will also be appreciated that a first region may be any part, component, zone or area of a patient interface, which may be exposed to a force or movement (or both) imparted by a user directly, or whether imposed by a component of a breathing circuit or headgear or other componentry associated with a patient interface and breathing circuits providing for a supply of breathable gas, or other items that could be found in the user's vicinity e.g. pacifier, blanket, cushion, toys etc.

The element of this invention is designed to respond in a manner to localise the force or the movement, or both, experienced by the at least first region.

It may also be that the element is able to respond in a way so as to minimise or prevent transfer of the force or the movement, or both, from the at least first region to at least one other region of the patient interface. The outcome or result from this response is the ability for such an interface to be more stable when installed or positioned on a user.

In this context, it will be appreciated a patient interface may be particularly those such as nasal cannula.

Extension of this invention may also have applicability to yet other interfaces, such as to masks (whether full face, oral, nasal, nasal pillow or oro-nasal) or other derivatives or variants of these.

The element (or elements) incorporated into the interface preferably respond in a manner to maintain the at least one (and preferably the pair of) nasal prong(s) in the configuration of insertion in a nare or nares of the user's nose, or in the configuration of directing a flow of gas toward a nare or nares of the user's nose. For example, another desired outcome is that the response is such that the at least one (or preferably the pair of) nasal prong(s) maintain a stable position within or adjacent to the nares of a user's nose to which the prongs) is directed.

The element's response operates to go at least some way toward preventing or minimising transfer of force or movement from the at least first region of the interface to at least one other region of the interface. Accordingly, a more stable interface can be provisioned for use by a user. In providing for a more generally stable interface, an improvement in user comfort may he achieved. An improvement in the delivery of therapy to a user may also be achieved. Both such achievements may together result in a more user friendly interface or device.

Advantageously, this invention enables an interface having the capability or inclusion of elements which are responsive in a manner such that the interface maintains an operational position upon the user.

In addition, the force or movement, or both, experienced by at least a first region of the interface are either, or both, of i) an applied force(s) or a movement(s) between the nasal prong(s) and body of the patient interface, or ii) an applied force(s) or a movement(s) between the body of the patient interface and the nasal prong(s). The element responds to such forces or movements in a way so as to at least substantially ameliorate the transfer of forces or movements to other parts of the interface, or to at least do so in a manner so as to retain the interface on the user in an operational or comfortable configuration, or to at least mitigate the potential for the interface becoming uncomfortable or moving out of a therapeutic operational configuration for the user.

In certain embodiments, the element is a deformable member or a member that can be deformed in response to the force or movement (or both).

Predetermined or preferential modes of deformation by the element in response to the applied force or movement, or both, being experienced by at least a first region of the interface may be provided. For example, the element may be deformable in certain preferential geometries, such as about at least one axis or at least one plane, or both. It will he appreciated the deformation may be in a plurality of axes or planes or geometries, such deformation being in a preferential direction so as to provide for the response by the element to the applied force or movement (or both). It will also be appreciated such deformation may be one or a combination of at least a compression or a tension or a torsion or bending or other flexion of the element or a plurality of elements.

In respect of the element, the response may also be one or a combination of any one of a changing shape, or a changing of position, or a changing of configuration.

Various embodiments of such an element include, but are not specifically limited to one or more of the following, each of which may be used in combination with each other, or connected by members or other sections or components so as to provide for a plurality of elements which in combination provide for a desired response to ameliorate the transfer of a force or movement to the interface from at least a first region:hinges, pivots, articulated joints or articulately connected portions of the body or portions associated with the body, swivels, ball-and-socket type joints, pin-in-barrel type joints.materials which are relatively less flexible than other portions of the interface, materials which are relatively more flexible than other portions of the interface, materials of characteristics which change upon application of a force or movement, such as by increasing their resistance to the applied force or movement (or both), or by reducing their resistance to the applied force or movement (or both), or materials which are elastically deformable in response to the applied force or movement (or both), or materials which are preferentially deformable in particular or predetermined geometries and yet which may optionally be resistant to deformation in other particular or predetermined geometries,a pivot (or swivel) or region capable of pivoting (or swivelling),a hinge or a hinged region or region capable of being hinged relative to another component of the interface or another region of the interface,an articulation or articulated joint or region capable of being articulated.

The element can be configured to provide or to operate or to work in response to the force or movement or both to prevent or minimise or at least reduce the overall force of movement experienced by the at least first region of the interface from being transferred to at least one other region of the interface.

The element may be a structure or a mechanism or a material characteristic or any combinations of structure, mechanism and material characteristic, incorporated into the interface, or may be a region of the interface incorporating one or a plurality of such elements in, or upon the interface.

In certain forms, the element may have predetermined or preferential modes of deformation in response to the applied force or movement. For example, the element may be deformable about at least one axis or at least one plane, or about a preferential first geometry, or may be deformable by one or a combination of a compression or a tension or torsion or bending or other such flexion.

One or a plurality of elements can be utilised and incorporated into the interface, such elements may operate or work or provide for the response on their own or may do so in combination with each other. Certain combined response from a plurality of elements may have advantages in that some elements may provide for a response to ameliorate the transfer of a force or movement from one region of the interface to other regions, and yet other elements respond in a different manner. For example, different elements may have different modes of response or be connected to each other, operatively or not, or to other parts of the interface in desired manners. Such a combined response or use of elements can preferably allow for an overall improvement in the comfort or stability of the interface during use on a user.

An element as incorporated in an interface of this invention may desirably be provided as one or more of:an isolator or a region of isolation,an absorber or a region of absorption,a dampener or a region of dampening,or the any other structure or mechanism providing for a reactive response to a force(s) or movement(s) imparted to at least a first region of the patient interface from being transferred to at least a second or another region of the patient interface. In certain forms, the element can provide for a so called de-coupling of forces or movement (or both) which is applied to at least the first region of the interface from being transferred to at least one other region of the interface.

The response of an element may therefore be at least one (or a combination) of an isolation or an absorption or a dampening or a reduction or a de-coupling of the force(s) or movement(s) imparted to at least the first region from being transferred to at least one other region of the patient interface during use by a user.

Provision may be made so as to include an element which has a pre-form so as to be deformed or displaced in a preferential geometry or dimension as its response to the force or movement (or both).

For example, the element can facilitate a preferential bend or flexure or twist or torsion or a preferential or predetermined pivot or stretch or compression of a materials) or a component(s) forming the body of the interface.

The element may be a region of different material characteristic or structure, such a as spongy material or a material capable of withstanding tension, but not a compression, or a compression but not a tension, or allowing of a stretch or extension (or a compression) of a material or components of the element in certain geometries yet resistive to stretching or tension in other geometries.

Various configurations of elements, such as ball-and-socket joints may be provided which are provided between different regions of an interface, such as for example between an off-centre body portion of a nasal cannula interface (e.g. a left or a right body portion, or both) and a central portion or region (e.g. a bridge portion which may be in the septum area of a user), such an element facilitating a response which reducing the transfer of a force or movement to other parts of the interface, thereby helping to improve user interface comfort and continued maintenance of therapy delivery.

Yet other variations include sections of an interface in which the element is to be located, for example as a hinged portion or a pivot or swivel jointed portion or region so as to allow for the element to preferentially bend or accommodate an applied force or movement.

The force(s) or movement(s) can be any which are applied to or which the interface may experience. Typically, certain forces or movements may be resultant from a user of the interface changing their facial geometry to which the interface is retained or located or positioned, or such as by a user pulling or applying a force or movement on or to the interface or an associated headgear thereof, or a breathing circuit or other componentry of the interface applying a force or movement, such as by weighing down upon, a portion of the interface or a headgear associated thereof.

Changes in interface user facial geometry, such as during speech, eating, sleeping or other facial distortions and between relaxed and exaggerated conditions, can also contribute to forces or movements being applied or imparted to a region or regions of an interface.

The elements of this invention are beneficially configured to assist in reducing the likelihood of such forces or movements from impacting on comfort or delivery of therapy to a user of the interface.

In various examples, where the patient interface is a nasal cannula, the applied forces or movement between the nasal prong(s) and body of the patient interface, or between the body of the patient interface and the nasal prong may encourage the problem of prong flicking (where the nasal prongs of an interface move about with the nares of a user's nose or may even be removed entirely from the nares). Nasal prongs moving about in the nares may irritate a user, whilst removal or dislodgment of the prongs from the nares impacts on the preferred delivery of therapy to the user. Systems or methods to assist in avoiding prong flicking are advantageous.

In one particular embodiment, at least one element or at least one of the elements, is located in the bridge region of a nasal cannula patient interface, such as substantially adjacent the septum region of a user.

In other embodiments, the interface can comprise of a plurality of elements utilised on their own or in combination with other elements to provide for the response.

In still further embodiments, the at least one element can be a hinged portion located or positioned as a bridge between a left body portion and a right body portion, each of the body portions together forming the body of an interface to be located upon a user's face, such a hinged portion providing for a preferential region of deformation in response to at least a first region of the body, or a portion of the body, experiencing a force or movement (or both) resulting from a change in the facial geometry of the user.

In all embodiments discussed here, there may be an additional but optional configuration of the interface to be generally conformed or conformable or be anatomically shaped for user's face or part of the body to which the interface is to be located. In this manner, a patient interface that is substantially conformed or conformable to the geometry of a user's face may allow for the element to respond to the force or movement (or both) to substantially maintain the interface in a preferred therapy delivery configuration for a user.

Provided below is yet further specific embodiments according to this invention and as illustrated with reference to the accompanying drawings.

An aspect of at least one of the embodiments disclosed herein includes the realization that with at least nasal interfaces, the stability of the nasal interface on the face is important, as movement of the nasal interface can cause severe irritation to the nares or cause the prongs to displace out of the patient's nares, which can lead to prevention or interruption of therapy.

The current methods of retaining nasal interfaces to a patient's face have disadvantages that can cause the prongs to displace out of the nares or irritate the sensitive area of the nares. These undesired consequences can occur from a variety of reasons, including but not limited to, incorrect application, incorrect sizing, patient position, facial movements and abnormal facial geometries.

In the case of tubing that is routed around the patient's ears, the tubing can fall off the ears and cause the prongs to dislodge from the nares. The tubing can also be displaced when the patient lies on the side of their head, causing the prongs to dislodge from the nares or rub against the sides of the nares. Furthermore, the use of a strap or an elastic band is disadvantageously prone to sliding of the nasal interface relative to the patient's head especially when the patient turns his/her head on a pillow, causing the prongs to dislodge from the nares or cause severe irritation. Other external forces can also cause the nasal prongs to dislodge from or irritate the nares, such as the supply tube getting caught on other objects or the patient pulling on the tubing.

Previously, adhesive medical tape has been used to retain the nasal interface in place. However, the fixation of the interface to the patient's face has been found to cause issues with the retention of the prongs in the patient's nares, especially for infants and neonates. When the patient's face is squeezed from lying on the side, current nasal interfaces tend to bend at the bridge of the nasal interface in a direction away from the face. The bending of the interface causes the prongs to displace out of the patient's nares, or become crushed against the sides of the patient's nose so as to cause at least a partial blockage of the gases being delivered to the patient.

It will be appreciated that in some embodiments the patient interfaces as described herein may be utilised in conjunction with a headgear system for locating or securing such a patient interface upon a user's face, yet such patient interfaces remain capable of being able to respond to forces or movements (or both) when used in such an arrangement.

In yet other embodiments, it will be appreciated that a headgear arrangement or configuration may operate to take some of the load the patient interface may experience due to forces or movements (or both) experienced by the interface, whilst the interface operates to take some of the load also.

Thus, in accordance with at least one of the embodiments disclosed herein, a nasal interface can be used that prevents or substantially reduces the likelihood of prongs displacing out of the patient's nares or irritating the nares as caused by facial movements or external forces.

A nasal interface can be configured to stabilize prongs on a patient's face when forces are exerted on the interface. The nasal interface can include an elongate body having an overall curvature that generally corresponds to a patient's facial profile, the body being configured to be coupled to a gases flow source and having at least one lumen extending at least partially through the body. The nasal interface can have prongs extending from the body and in fluid communication with the at least one lumen. The nasal interface can have one or more hinges, at least one hinge can he disposed between the pair of prongs, or between the nares when in use, that is predisposed to bend in a predefined direction.

The nasal interface can include one or more facial pads configured to rest on a patient's face. In some embodiments, the at least one hinge disposed between the pair of prongs can have a curvature that is generally inverted from the overall curvature of the elongate body. The at least one hinge disposed between the pair of prongs can be configured to bend inward towards the patient's face. The nasal interface can bend in more than one dimension.

The nasal interface can have a generally gullwing shape. In some embodiments, the nasal interface can have a wavy shape. In some embodiments, the nasal interface can have a curved space frame-like support structure.

The one or more hinges can include a notch. The one or more hinges can include a variable cross-sectional area. The one or more hinges can include a variable thickness. The one or more hinges can include two or more materials with different flexibilities. The one or more hinges can include an elastic hinge that is configured to be pre-stressed before application to a patient. The one or more hinges can include a barrel and pin. The one or more hinges can include a ball and socket.

In some embodiments, a nasal interface can include an elongate body having at least one lumen extending at least partially through the body, the body being configured to be coupled to a gases flow source. One or more prongs can extend from the body and be in fluid communication with the at least one lumen. The nasal interface can include one or more hinges that are predisposed to bend in predefined directions, wherein the one or more hinges are configured to stabilize a position of the one or more prongs on a patient's face when forces are exerted on the nasal interface.

The nasal interface can include one or more facial pads configured to rest on a patient's face. At least one of the one or more hinges can be located adjacent to or between the one or more prongs, or in addition, along one of the facial pads. At least one of the one or more hinges can be configured to bend inward towards the patient's face. At least one of the one or more hinges can be configured to bend downward. The nasal interface can bend in more than one dimension.

The nasal interface can have a generally gullwing shape. In some embodiments, the nasal interface can have a wavy shape.

The nasal interface can have a curved space frame-like support structure.

In some embodiments, the nasal interface can have two separate sides that are coupled by an over-strap bridge.

The one or more hinges can include a notch. The one or more hinges can include a variable cross-sectional area. The one or more hinges can include a variable thickness. The one or more hinges can include two or more materials with different flexibilities. The one or more hinges can include an elastic hinge that is configured to be pre-stressed before application to a patient. The one or more hinges can include a barrel and pin. The one or more hinges can include a ball and socket.

In some embodiments, a nasal interface can include an elongate body having at least one lumen extending at least partially through the body, the body configured to be coupled to a gases flow source. One or more prongs can be coupled to the body and be in fluid communication with the at least one lumen. The elongate body can have a shape that generally corresponds to an anatomical contour of a patient's or a group of patients' facial profile.

The group of patients can be one of premature babies, neonates, infant, pediatrics, teens or adults. In some embodiments, the tubular body can be initially malleable. The shape of the tubular body can he set through a hardening process.

It has been discovered that the behaviour of a nasal interface under loading can be controlled to improve its stability performance. In this disclosure, nasal interfaces that prevent or substantially reduce the likelihood of prongs displacing out of the patient's nares or irritating the patient's nares as a result of facial movements or external forces are described.

Human facial geometry varies greatly due to a large range of factors. These factors include but are not limited to gender, ethnicity, age and medical conditions. Incorrect sizing and geometry of nasal interfaces can adversely affect the stability and usability of the nasal interfaces. Other causes that can affect stability include, but are not limited to, incorrect application, patient position, patient crying and abnormal facial geometries.

Furthermore, when a patient speaks, eats, cries or has their facial features distorted or exaggerated in any way, it can affect the stability of an interface on the patient's face. More prolonged changes to facial features can arise from aspects such as patient position while sleeping for example. Long term changes in geometry can occur from patient growth and injury recovery.

When supporting items on a patients face, any external forces can affect device stability as well. In the case of a transverse nasal interface, external forces can arise from a range of sources such as patients pulling on the interface, breathing circuit weight being transmitted to the interface, head strap retention forces or any connected tubing getting caught on other equipment.

Nasal interfaces10traditionally have a manifold20with prongs30extending from the manifold10, as shown inFIG.1. A bridge40is connected between the prongs30and may allow for fluid communication between the prongs30. This design can be unstable on the patient's face, which can lead to dislodgement of the nasal prongs from the patient's nares and adverse effects on therapy to the patient. Oftentimes, the dislodgement of the prongs from the nares is a result of the interface's mechanical reaction to a particular force applied to it.

The behaviour of a nasal interface under loading, such as from a patient speaking or lying on the side of their face, can be affected by a variety or combination of different interface features, such as interface geometry and material properties. For example,FIG.2shows a traditional nasal interface10with forces50exerted to the sides of the interface. Forces50may be exerted on the interface, for instance, when the patient is lying on the side of their face or when the patient's face is squeezed. A traditional nasal interface10in a relaxed state is shown by dotted lines inFIG.2.FIG.2also shows the nasal interface in a squeezed state when forces50are exerted on the interface. With continued reference toFIG.2, when the forces50are exerted on the sides of the nasal interface, most traditional interfaces naturally tend to bend upward in the figure or away from the patient in the middle near the prongs30because of the geometric design and material properties of the interface. The bending of the interface displaces the position of the prongs30such that they flick out of the patient's nares or rub against the sides of the nares, irritating the sensitive skin of the nares.FIG.2illustrates the prongs30displaced from their normal relaxed positions by a distance of Y.

As described herein, nasal interface stability can be improved by utilizing one or more of anatomically formed shapes and geometrically dynamic forms in the interface design. These designs can at least partially mechanically react to facial movements or external forces to help maintain nasal prong stability.

With a traditional interface's straight design, additional retention such as adhesive tape is often required to secure the interface to a patient's facial geometry.FIG.3Ais a bottom view illustrating a traditional interface10on a patient's face60. As shown in this figure, retention forces F may be required to secure the interface10on the patient's face60. However, the retention forces F can change the shape of the interface10and the elastic properties of the nasal interface can produce restorative forces opposing the retention force. These restorative forces can cause the retention method to detach and cause the prongs to apply pressure on the inside of the nares, causing sores. The unnatural bent shape of the nasal interface can also cause the prongs to not fit properly and cause sores as well.

The following describes components and properties of example nasal interfaces in greater detail. Sub-headings are used, such as “Anatomically Formed Interfaces” and “Dynamic Interfaces.” These sub-headings are not, and should not be construed as limiting. For example, aspects of one or more embodiments described under the Anatomically Formed Interfaces sub-heading can also apply to one or more embodiments described under the Dynamic Interfaces subheading, and vice versa.

Anatomically Formed Interfaces

Anatomically formed interfaces100are shaped to fit the facial profile of a given population, as illustrated inFIG.3B. These interfaces100incorporate shapes which are anatomically curved to fit the three-dimensional facial contours of a particular demographic; e.g., premature babies, neonates, infant, pediatrics and adult. The anatomically curved interface's100shape can significantly increase the stability of an interface on a patient's face60and can reduce the incidences of prong displacement out of the patient's nares.

Whilst not limiting, the illustrated embodiments may have particular applicability to neonates. For example, such interfaces may be especially suitable for use with neonates due to the increased facial distortion occurring in neonates, due to the small size of their head/face and any movements may be accentuated by their relatively small size.

The anatomically formed interface100conforms to a patient's facial profile while in a natural, relaxed shape. The interface does not need to be bent by retention forces to stabilize the interface on the patient's face60and thus no restorative forces are produced. Even when adhesive tape is used to fix the anatomically formed interface to the patient's face, no restorative forces are present because the tape does not bend the interface. The prongs remain in the patient's nose in a natural, unstressed position and the likelihood of dislodgement or injury to the patient's nares is reduced compared to traditional interfaces. Another advantage of the anatomically formed interface100is the reduced need for adhesive tapes to retain the interface on the patient's face60, reducing the likelihood of skin irritation or injury. The anatomically formed interface100has increased stability compared to a traditional interface and there is less need to tape the interface to the patient's face to maintain stability.

The anatomically formed interface100can be manufactured using plastic moulding methods to form a predetermined curved shape which has been identified to fit a given demographic of patient. For example an underdeveloped premature baby has a different facial profile to that of a fully developed term baby so for each of these demographics a common facial profile can be identified which compliments a high percentile of that population. A plurality of different sizes and shapes of interfaces can be produced to fit a wide variety of facial profiles.

In some embodiments, the anatomically formed interface can be modified by the patient or caregiver after manufacture. The anatomically formed interface can be flexible and formable into a custom shape to fit the patient's face. For example, the interface can be at least partially made of a malleable material such as medical putty or flexible plastic. The patient or caregiver can shape the malleable interface to generally correspond to the contours of the patients face and provide a stable fit with the patient's face.

In other examples, the anatomically formed interface can have a malleable frame extending through the interface that can be bent to generally match the contours of the patient's face and provide a structural shape to the interface. In order for the interface to maintain its shape after shaping, a post annealing process can be applied to the malleable frame in some embodiments.

Other types of formable interface materials can include one or more of silicone, rubber (synthetic or natural), thermoplastic and thermosetting polymers. The composite materials can be fabricated by co-moulding or overmoulding. These materials can be initially malleable so that they can be shaped to the patient's face shape, and then become rigid after a period of time or through an active hardening process, such as a UV treatment or heat treatment.

Dynamic Interface

A dynamic interface incorporates one or more hinges along the device that reacts to facial movements, both natural and forced, and external forces exerted on the interface. The hinges can minimise the effects of the facial movements and external forces on the fitment of the interface on the patient's face, particularly on the placement of the prongs in the patient's nares. As used herein, hinges refers generally to portions on the interface that are configured to bend in one or more directions. The hinges can be configured to bend in a predefined direction or directions, and in some embodiments the hinges can be restricted from bending in certain directions.

FIGS.4A-Billustrate an example of a relaxed facial shape of an infant andFIG.4Cillustrates a schematic of the geometric shape of a dynamic interface200on a relaxed face.FIG.4Ais a front view of an infant's face andFIG.4Bis a bottom view of the infant's face.FIG.4Cis a bottom view of a dynamic interface. The dynamic interface200can have one or more hinges210. Preferably, the dynamic interface has a center hinge212disposed between the prongs230. As can be noticed by comparingFIGS.4B and4C, the plurality of hinges210on the interface allows the interface200to conform to the general contours of the patient's face.

FIGS.5A-Billustrate a front view and a bottom view, respectively, of an example of a stressed or squeezed facial shape of an infant.FIG.5Cillustrates a bottom view schematic of the geometric shape of a dynamic interface300on a squeezed face. The squeezed face approximates, for example, the contortion of the face when patients lie on the side of their faces. As illustrated inFIG.5C, the hinges310help conform the interface300to the shape of the contorted face and maintain the position of the prongs330in the nares of the patient. The dynamic interface300is particularly helpful in the case of infants who tend to exhibit exaggerated cheek movement.

Each hinge310can be configured to react to an applied force in a predetermined fashion and different hinges can react differently depending on their position on the interface. For example, a hinge312located in the region between the prongs330may bend downward toward the lips and/or inward toward the face to form a concave shape when viewed from the front, while the hinges314adjacent the cheeks of the patient may bend outward to form a convex shape around the cheeks. The hinge312can resist movement outwards normal to the face and minimise the movement of the prongs330out of the nares due to forces applied laterally on the device. In some situations, the bending of hinge312can be limited by the patient's anatomy. For example, the inward bending of hinge312can be limited by the philtrum of the patient, which can beneficially limit the displacement of the prongs330. The forces applied to the interface may act on the other hinges (e.g., hinges314adjacent the cheeks) once the hinge312reaches its limit. Combinations of hinge types and hinge locations can allow the designer to control how an interface will react in a variety of situations. A hinge may be designed to allow for 1, 2 or 3 degrees of motion in any predefined direction depending on its desired function. Advantageously, an inherently stable interface can be developed that keeps the prongs in the patients nares under various loading conditions.

FIGS.6A-Billustrate an example of how a dynamic interface400can react to external forces460. As shown inFIG.6A, an extension450can be coupled to the dynamic interface400with a hinge416. The extension450can be a part of the dynamic interface400that connects to external devices, or the extension450can be a part of an external device that connects to the dynamic interface400. For example, the extension450can be a part of the dynamic interface400and connectable to a tube, or the extension450can be a part of a tube that connects to the interface400. The hinge416can be located at the connection point of the extension450and the interface400. With reference toFIG.6Bany external forces460, such as pushing or pulling on the tube, will be dampened by the reaction of the hinge416and reduce the forces being translated onto the dynamic interface400. The external forces460can be at least partially isolated from affecting the positioning of the prongs430in the patient's nares. Preferably, another hinge418is located on the extension450for increased dampening ability of the extension450. In some embodiments, further additional hinges can be disposed on the extension450for even more dampening ability.

The hinges and their positions on the interface can be customized to work effectively with the particular retention method of the interface. For example, with continued reference toFIGS.5A-C, if the interface is configured to be secured to the cheeks with tape or some similar retention method, there can be one or more hinges located between the cheek section and the prongs to account for facial movements. Similarly, with reference toFIGS.6A-B, if a head strap is connected to the extension450, at least one hinge can be located between the head strap and interface to account for external forces.

An example of a dynamic nasal interface500is illustrated inFIGS.7A-B. The gullwing shaped dynamic interface500can have an overall curvature that generally corresponds to a patient's facial profile. The dynamic interface500can include one or more nasal prongs502, a bridge504extending between the prongs502that is configured to be along a patient's upper lip beneath the nose in use, a pair of wings or facial pads506and integral tubing508, all spaced generally symmetrically about the sagittal plane. The dynamic interface500is formed as an integral or unitary component with the tubing508in fluid communication with the prongs502. The open end of each integrated tubing508is configured to receive a suitable breathing tube that is connected to a gases supply. The breathing tube may be adhered or otherwise coupled (or connected) to the interface tubing508. Preferably, the tubing508includes two separate sides that have independent flow paths. However in some embodiments, the two sides can be in fluid communication, such as through a tube that extends across the bridge to connect the two sides of tubing.

The facial pads506are anatomically shaped with a size, shape and curvature that reflects the facial geometry of the intended patient. The anatomical shape of the facial pads506gives the interface a positive engagement with a patient's face at a predetermined position where the contour of the facial pads506matches the patient's facial contour. The pre-shaped facial pads506compliment the nasal prongs502by improving the accuracy and speed with which the prongs502can be placed and retained within a patient's nares.

Pre-shaping or contouring the facial pads506to the patient's facial features reduces the pressure applied to the patient's face by any retention mechanism (adhesive tape, headgear or other means). This reduces the likelihood of pressure sores upon the user. The positive engagement promoted by the anatomical shape of the facial pads506increases the stability of the interface500and the prong502and therefore improves comfort and efficacy of the treatment being administered. In some embodiments, the facial pads506can be wider at the outer portions and taper to be narrower toward the middle. Further examples of nasal interfaces may be as described in International Patent Application Publication No. WO 2012/053910, which is hereby incorporated by reference, in its entirety.

With continued reference toFIGS.4A-B, the bridge504of the nasal interface500can have a bridge hinge510that is configured to bend inward toward the patient. As best illustrated in theFIG.7B, the bridge504has an inverted curvature compared to the rest of the nasal interface such that the interface has a gullwing-like shape. The bridge hinge510is curved toward the rear of the interface500such that the bridge504is convex shaped when viewed from the front. The curvature of the bridge504predisposes the hinge510to bend inward toward the patient, as opposed to outward as in the case of traditional nasal interfaces.

For example,FIG.7Cillustrates a nasal interface500, for example having a generally gullwing type shape, with forces550exerted to the sides of the interface. Forces550may be exerted to the interface, for instance, when the patient is lying on the side of their face or when the patient's face is squeezed. The nasal interface500in a relaxed state is shown by dotted lines inFIG.7C.FIG.7Calso shows the nasal interface in a stressed state when forces550are exerted on the interface. When the forces550are exerted on the sides of the nasal interface, the bridge504is inclined to bend inward at the bridge hinge510, as shown by the central arrow inFIG.7C. The inward bending of the bridge504displaces the prongs502inward closer to the patient, as opposed to outward away from the patient, where the prongs502may flick out of the nares, as is the case in traditional nasal interfaces. As discussed above, the bending of the bridge hinge510can he limited by the patient's anatomy. For example, the inward bending of the bridge hinge510can be limited by the philtrum of the patient, which can beneficially limit the displacement of the prongs502. The nasal interface design helps reduce the risk of the prongs502flicking out of the patient's nares or rubbing against the sides of the nares.

The displacement distance of the prongs502can typically be less than compared to traditional nasal interfaces.FIG.7Cillustrates the prongs502displaced from their normal relaxed positions by a displacement of Z, which is in the opposite direction and typically a smaller distance compared to the displacement of Y shown inFIG.2for a traditional nasal interface. The nasal cannula hinges in at least three locations, the bridge hinge510and outer hinges512,514on either sides of the prongs; whereas traditional nasal interfaces bend mainly at a single position at the bridge. The additional hinges of the nasal interface help stabilize the positions of the prongs502when the cannula is under stress and reduce the displacement distance, helping to keep the prongs in the nares of the patient and reduce the irritation of the nares by the prongs.

Another example of a dynamic nasal interface600is illustrated inFIGS.8A-C. The dynamic interface600, for example having a generally wavy type shape, includes one or more nasal prongs602, a bridge604extending between the prongs602, a pair of wings or facial pads606and tubing608coupled to the facial pads606, all spaced generally symmetrically about the sagittal plane. The dynamic interface600can be formed as an integral or unitary component with the tubing608in fluid communication with the prongs602. The open end of each integrated tubing608is configured to receive a suitable breathing tube that is connected to a gases supply. The breathing tube may be adhered or otherwise coupled (or connected) to the interface tubing608. Preferably, the tubing608includes two separate sides that have independent flow paths. However in some embodiments, the two sides can be in fluid communication, such as through a tube that extends across the bridge to connect the two sides of tubing.

The facial pads606are shaped to generally match the anatomical shape of the facial geometry of an intended patient. As illustrated inFIG.8B, the facial pads606can have a wavy shape that generally matches the shape of a patient's profile, as illustrated for example inFIG.4B. The facial pads606can have an outer concave portion612configured to lie over the protruding cheeks of the patient and an inner convex portion614configured to lie over the creases between the cheeks and upper lip. The bridge604can have a concave shape to accommodate the bump of the upper lip and philtrum. The tubing608can follow the contours of the nasal interface600.

The anatomical shape of the facial pads606gives the interface a positive engagement with a patient's face at a predetermined position where the contour of the facial pads606matches the patient's facial contour. The pre-shaped facial pads606compliment the nasal prongs602by improving the accuracy and speed with which the prongs602can be placed and retained within a patient's names.

FIG.8Cillustrates a front view of the nasal interface600. The facial pads606can be wider at the outer portions and taper to be narrower toward the middle. The bridge604can be integral with the facial pads606and in some embodiments connects the two facial pads606. In some embodiments, the bridge504can be curved downward and have a hinge610. The hinge610can he predisposed to bend downward such that when the nasal interface600experiences forces from facial movements or external forces, the bridge604can bend downward. The downward bending can help stabilize the prongs602and minimize movement of the prongs602in the sagittal plane (i.e., front/back) and coronal plane (i.e., up/down). The downward bending of the bridge604displaces the prongs602closer together, but does not displace the prongs602outward away from the nares, as is the case in traditional nasal interfaces. The nasal interface design helps reduce the risk of the prongs602flicking out of the patient's nares or rubbing against the sides of the nares.

FIGS.9A-Dillustrate another non-limiting example of a dynamic nasal interface700. The dynamic interface700includes one or more nasal prongs702, a curved space-frame support structure703with a bridge704extending between the prongs702, a pair of wings or facial pads706and tubing708coupled to the facial pads706, all spaced generally symmetrically about the sagittal plane. The dynamic interface700can be formed as an integral or unitary component with the tubing708in fluid communication with the prongs702. The open end of each integrated tubing708is configured to receive a suitable breathing tube that is connected to a gases supply. The breathing tube may be adhered or otherwise coupled to the interface tubing708. Preferably, the tubing708includes two separate sides that have independent flow paths. However in some embodiments, the two sides can be in fluid communication, such as through a tube that extends across the bridge to connect the two sides of tubing.

The facial pads706can be shaped to generally match the anatomical shape of the facial geometry of an intended patient. As illustrated inFIG.9B, the facial pads706can be disposed toward the outer portions of the dynamic interface700and curved to match the shape of a patient's cheeks. In some embodiments, the facial pads can extend further toward the middle of the dynamic interface and/or can be connected as a continuous pad extending across the entire dynamic interface. The facial pads706can have a concave portion712configured to lie over the protruding cheeks of the patient.

The anatomical shape of the facial pads706gives the interface a positive engagement with a patient's face at a predetermined position where the contour of the facial pads706matches the patient's facial contour. The pre-shaped facial pads706compliment the nasal prongs702by improving the accuracy and speed with which the prongs702can be placed and retained within a patient's nares.

With continued reference toFIGS.9A and9B, the nasal prongs702and tubing708can be at least partially supported by the support structure703. The support structure703can be coupled to the facial pads706and include a bridge704between the prongs702. The dynamic interface700with the space frame-like support structure703helps stabilize the interface from three-dimensional changes in the patient's facial geometry and helps maintain the prongs702in the nares of the patient. In some embodiments, the support structure703can be hollow and in fluid communication with the prongs702such that the prongs702are in fluid communication with each other. In other embodiments, the prongs702may be separate and not fluidly connected with each other, at least not through the support structure703. In these embodiments, the support structure703can be solid, hollow or filled with material such as for example foam or a malleable wire frame.

In some embodiments, the bridge704can be curved downward and have a hinge710. The hinge710can be predisposed to bend downward such that when the dynamic interface700experiences forces from facial movements or external forces, the bridge704can bend downward, as illustrated inFIGS.9C and9D.FIGS.9C and9Dillustrate squeezing of the dynamic interface700on a patient's face to simulate extreme facial deformations or external forces. The downward bending can help stabilize the prongs702and minimize movement of the prongs702in the sagittal plane (i.e., front/back) and coronal plane (i.e., up/down). The downward bending of the bridge704displaces the prongs702closer together, but does not displace the prongs702outward away from the nares, as is the case in traditional nasal interfaces. The dynamic interface700design may help reduce the risk of the prongs702flicking out of the patient's nares or rubbing against the sides of the nares.

With continued reference toFIGS.9C and9D, the support structure703can further include one or more inner hinges716and/or one or more outer hinges718, such that the support structure703has a zig-zag shape. The inner hinges716can be predisposed to bend upward such that when the dynamic interface700experiences forces, the inner hinges716can bend upward, as illustrated inFIGS.9C and9D. The outer hinges718can be predisposed to bend downward such that when the dynamic interface700experiences forces, the outer hinges718can bend downward, as illustrated inFIGS.9C and9D. When the dynamic interface700experiences facial movements or external forces, the hinges710,716,718can work in conjunction to deform and at least partially absorb the forces in order to stabilize the nasal prongs702and help prevent the prongs702from flicking out of the patient's nares or rubbing against the sides of the nares.

FIGS.10A-Fillustrate another non-limiting example of a dynamic nasal interface800that has hinges that bend in more than one dimension. The multi-dimensional dynamic interface800can include one or more nasal prongs802, a pair of wings or facial pads806and tubing808coupled to the facial pads806, all spaced generally symmetrically about the sagittal plane. The tubing808can be configured to receive a suitable breathing tube that is connected to a gases supply. The breathing tube may be adhered or otherwise coupled to the interface tubing808.

The facial pads806can be shaped to generally match the anatomical shape of the facial geometry of an intended patient. As illustrated inFIG.10A, the facial pads806can be disposed toward the outer portions of the dynamic interface800and curved to match the shape of a patient's cheeks. In some embodiments, the facial pads can extend further toward the middle of the dynamic interface and/or can be connected as a continuous pad extending across the entire dynamic interface. The facial pads706can have a concave portion configured to lie over the protruding cheeks of the patient.

The anatomical shape of the facial pads806gives the interface a positive engagement with a patient's face at a predetermined position where the contour of the facial pads806matches the patient's facial contour. The pre-shaped facial pads806compliment the nasal prongs802by improving the accuracy and speed with which the prongs802can be placed and retained within a patient's nares.

In some embodiments, the dynamic nasal interface800includes a structural member803that defines a shape and bending characteristic of the dynamic nasal interface800, as illustrated for example inFIG.10B. The structural member803can be overmoulded or otherwise attached to the dynamic nasal interface800, such as with adhesives, sonic welding, clamps, or the like. The structural member803illustrated inFIG.10Bincludes a bridge hinge810configured to be positioned between the prongs802and predisposed to bend downward. The illustrated structural member803also includes inner hinges812that are predisposed to bend upward, and outer hinges814that are predisposed to bend inward toward the patient. The bending hinges can occupy the grooves or cavities that naturally occur in the anatomy of most patients' faces, such as the crease between the cheeks and edges of the nose820, and the space in the philtrum822, as illustrated inFIG.10C. In some embodiments, the multi-directional dynamic interface800can be pre-stressed before being attached to the patient's face, as explained below, to help the hinges bend in a predetermined direction and stabilize the nasal prongs.

FIG.10Dillustrates a front view of a multi-directional dynamic interface800on a patient's face.FIG.10Eillustrates a front view of the multi-directional dynamic interface800as stresses are applied to the patient's face. When stresses such as squeezing forces are exerted on patient's face, the multi-directional dynamic interface800bends in a predefined manner. The bridge hinge810can bend downward and inward toward the space in the philtrum822, as illustrated inFIG.10E. The inner hinges812can bend upward. The outer hinges814bend inward toward the patient into the crease between the cheeks and nose820, as illustrated inFIG.10F. The bending of some of the hinges can be limited by the patient's anatomy. For example, the inward bending of bridge hinge810can be limited by the philtrum822of the patient, which may beneficially limit the displacement of the prongs802. The bending of the outer hinges814can be limited by the creases820, which may also beneficially limit the displacement of the prongs802. When the multi-directional dynamic interface800experiences facial movements or external forces, the hinges810,812,814can work in conjunction to deform in multiple dimensions to at least partially absorb the forces in order to stabilize the nasal prongs802and help prevent the prongs802from flicking out of the patient's nares or rubbing against the sides of the nares.

FIGS.11A-Cillustrate another non-limiting example of a dynamic nasal interface900. The dynamic nasal interface900can have an overall curvature that generally corresponds to a patient's facial profile and can include two separate sides, each with a nasal prong902, facial pad906and tubing908coupled to the facial pads906. The tubing908can be in fluid communication with the prongs902. An over-strap bridge904can extend between and connect the two sides of the over-strap dynamic interface900. The open end of the tubing908is configured to receive a suitable breathing tube that is connected to a gases supply. The breathing tube may be adhered or otherwise coupled to the interface tubing908.

The facial pads906can be shaped to generally match the anatomical shape of the facial geometry of an intended patient. As illustrated In the top view ofFIG.11B, the facial pads906can be disposed toward the outer portions of the dynamic interface906and can be curved to match the shape of a patient's cheeks. The facial pads906can have a concave portion configured to lie over the protruding cheeks of the patient.

The anatomical shape of the facial pads906gives the interface a positive engagement with a patient's face at a predetermined position where the contour of the facial pads906matches the patient's facial contour. The pre-shaped facial pads906compliment the nasal prongs902by improving the accuracy and speed with which the prongs902can be placed and retained within a patient's nares.

With continued reference toFIGS.11A and11B, an over-strap bridge904can extend between the two sides of the over-strap dynamic interface900. The over-strap bridge904can be coupled to the interface tubing908, as illustrated in the figures, or to the facial pads906and can be attached anywhere along each side of the dynamic interface900. In the illustrated example, the over-strap bridge904is connected generally toward the middle of the interface tubing908. In other embodiments, the over-strap bridge904can be connected toward the prongs902or toward the outer edges of the dynamic interface900. The connection912between the over-strap bridge904and the sides of the dynamic interface900can be a rigid connection. In some embodiments, the connection912can be adjustable or flexible, such as with a hinge.

The over-strap bridge904can be made of a resilient material that can be stretched or adjusted to conform to a patient's facial shape and size. For example, the over-strap bridge904can be adjusted to enable the prongs902to be spaced according to an individual patient's nasal anatomy, providing a wide range of patient sizes that can be accommodated by a particular over-strap dynamic interface900. The over-strap bridge904has a bridge hinge910that is predisposed to bend inward toward the patient such that when the dynamic interface900experiences forces from facial movements or external forces, the over-strap bridge904bends inward.

As illustrated in theFIG.11B, the bridge hinge910has an inverted curvature compared to the rest of the nasal interface. The bridge hinge910is curved toward the rear of the dynamic interface900such that the bridge hinge910is convex shaped when viewed from the front. The inward bending can help stabilize the prongs902and minimize movement of the prongs902in the sagittal plane (i.e., front/back) and coronal plane (i.e., up/down). The inward bending of the bridge hinge910can displace the prongs902closer together, but does not displace the prongs902outward away from the nares, as is the case in traditional nasal interfaces. The dynamic interface900design may help reduce the risk of the prongs902flicking out of the patient's nares or rubbing against the sides of the nares.

In some embodiments, the bridge904with bridge hinge910can be configured to be preloaded during fitting such that the over-strap dynamic interface900can absorb forces when the patient's face moves or when external forces are exerted on the dynamic interface900.

The dynamic interfaces described above can at least partially made of a resilient material that can return to its original shape after being deformed by the patient's facial movements or external forces. These materials are also preferably compliant so that they conform to the patients' facial geometries. The dynamic interface materials can include silicone, rubber (synthetic or natural), thermoplastic and thermosetting polymers. The composite materials can be fabricated by co-moulding or overmoulding.

Hinges

A variety of hinge types can be used in the dynamic interfaces. The hinges can bend in a predictable, limited number of directions to define the mechanical behaviour of the dynamic interface. The following paragraphs describe a number of hinge types and how they can he implemented. The described hinges are not an exhaustive list of the hinge types that can be used and the scope of the present invention should not be limited by the particular embodiments described. The hinge types include, but are not limited to: notches, cross-sectional area, variable thickness, composite, elastic hinge, barrel & pin, and ball & socket.

FIG.12Aillustrates a nasal interface1000with a hinge1010disposed at the bridge1004between the prongs1002. The hinge1010can be solid and can include one or more notches1012. In the embodiment illustrated inFIG.12B, the hinge1010includes three notches1012disposed on a side1014of the hinge1010facing away from the direction of the desired bend. The notches1012help the hinge1010bend in the illustrated direction of moment M because the notches1012help relieve tensile stress on the side1014as the notches1012open up. The hinge1010is predisposed to bending in direction M.

FIG.13Aillustrates another embodiment of a nasal interface1100having a bridge1104between the prongs1102. The bridge1104is hollow and allows gases to flow through such that the prongs1102are in fluid communication with each other through the bridge1104. A bridge1104can have a notch and act as a hinge1110. A number of non-limiting examples of notches are provided inFIGS.13B-D.FIG.13Billustrates a triangular notch1116,FIG.13Cillustrates a channel notch1118, andFIG.13Dillustrates a trapezoidal shaped notch1120. The notch designs can be altered to permit different amounts of bending at the hinge and a designer can choose the proper type of notch design to achieve the desired amount of bending.

A hinge can be designed into a structure through variations in its cross-sectional profile. Under an applied load a structure's cross-sectional area can predispose it to deflect in a certain direction. For example, the structure can be a bridge located between the prongs of the nasal interface. A loading force F is assumed in the transverse direction as illustrated for hinge1210inFIG.14A, simulating the exaggerated facial movements or external forces discussed above. The illustrated triangular cross-sectional profile promotes bending downwards towards the mouth in the example of the bridge. The downward bending reduces the effect of the load F on the prongs' position in the nares, as discussed above.

FIG.14Billustrates a triangular cross-sectional profile of hinge1210having a neutral axis1212of bending, which is located closer to the tensile region1214of the structure while in its bent state. Predisposing a structure to bond in a desired direction can be achieved through making the cross-sectional area at the tensile region1214(i.e., the region preferred to come into tension) greater than the cross-sectional area at the compression region1216(i.e., the region preferred to come under compression). Because materials tend to have a compressive elastic modulus greater than a tensile elastic modulus, when a loading force F is applied to the hinge1210, it takes less force to compress the compression regions1216and stretch the tensile region1214, as opposed to stretching the compression region1216and compressing the tensile region1214. Accordingly, the hinge1210can bend in a predictable downward direction.

FIGS.15A and15Billustrate an example of a design feature, such as cutouts, which allows for reduced compressive stress.FIG.15Aillustrates loading forces F on a nasal interface1300in the transverse direction. The nasal interface1300has one or more prongs1302and a hinge1310disposed between the prongs1302.FIG.15Bis a close-up cross-section of the hinge region. As shown in the figure, the hinge1310includes a tensile region1314and compression region1316. As discussed above, a structure can be predisposed to bend in a desired direction by making the cross-sectional area of the tensile region1314greater than the cross-sectional area at the compression region1316. In the example illustrated inFIG.15B, the compression region1316is comprised of flanges1318and a hollow channel1320between the flanges1318. The hollow channel1320gives the compression region1316a smaller cross-sectional area than the tensile region1314and the hinge1310can bend in a predictable downward direction.

FIGS.16A and16Billustrate an example of a hinge1410that has a variable thickness. Similar to as shown inFIG.15A, loading forces F may be exerted on the nasal interface1400in the transverse direction. With reference toFIG.16A, the nasal interface1400has one or more prongs1402and a hinge1410disposed between the prongs1402. The hinge1410can be thinner in a particular direction compared to other directions such that the hinge1410is predisposed to bending in the direction of thinnest material. For example, in the illustrated embodiment, the hinge1410is thinner in the direction of prong extension, i.e., the up/down direction in the view ofFIG.16A.FIG.16Bis a close-up cross-section of the hinge region showing an elliptical cross-section. The hinge1410will bend in a predictable downward direction because the hinge is thinnest in the up/down direction.

FIGS.17A and17Billustrate a hinge1510that includes two materials with different properties, such as a rigid and flexible material overlaid together, that function to bend in a predetermined direction.FIG.17Aillustrates an embodiment having a flexible portion1514and a rigid portion1516in an unbent state. When forces are exerted onto the flexible portion1514, bending is predisposed in the direction opposing the rigid portion1516, as illustrated inFIG.17B. The rigid portion1516prevents the flexible portion1514from bending toward the rigid portion1516, and the flexible portion1514can only bend in one or more predisposed direction. The two material types can be secured using overmoulding techniques or the like to bond the materials at a central location1518of the hinge150. In some embodiments, the two material types can be removably secured in one or more locations of the hinge. The outer portions of the flexible material1514are preferably allowed unconstrained movement.

An elastic hinge can be utilised to aid securement of an interlace onto a patient's face. An elastic hinge can store elastic energy by pre-stressing the nasal interface before application to a patient. Once the nasal interface is on the patient, the stored elastic energy in the elastic hinges acts upon the patient's face to aid securement. An elastic hinge can have a relaxed state where substantially no elastic energy is stored in the hinge, and a pre-stressed state where some external forces have bent the hinge allowing it to store some elastic energy.

For example, a patient's face can be in a relaxed state, such as shown inFIG.4A, or in a stressed state, such as shown inFIG.5A. The nasal interface can be formed such that the relaxed state of the interface generally corresponds to the stressed profile of the patient's face.FIG.18Aillustrates an example of an elastic hinge nasal interface1600in a relaxed state. As illustrated inFIG.18B, the nasal interface1600in a relaxed state can generally correspond to the stressed profile of a patient's face and in this configuration the nasal interface1600may exert no forces on the patient's stressed face.

When fitting an elastic hinge nasal interface1600on a patient's face, a user can pre-stress the nasal interface by, for example, stretching the nasal interlace as illustrated inFIG.18C. When the pre-stressed nasal interface is placed on a patient's relaxed state face, the curves in the nasal interlace serve as elastic hinges1610, as shown by cross-hatching onFIG.18D. When the patient's face is stressed, the elastic hinge nasal interface1600is predisposed to bend back to its relaxed state shown inFIG.18B. The elastic hinge nasal interface1600can follow the patient's facial profile as the face goes from a relaxed profile to a stressed profile, which can stabilize the nasal prongs and help prevent the prongs from flicking out of the patient's nares or rubbing against the sides of the nares.

The nasal interface can be attached to the patient's face through a plurality of different types of retention methods, such as for example adhesives and straps. Preferably, the retention method of the nasal interface on the patient's face has a strength that can at least withstand the pre-stress energy stored in the elastic hinges.

The elastic hinge nasal interface can be made of a resilient material that can store energy when stretched from its relaxed state. Some non-limiting examples of materials include rubber, plastics, composites and steel.

Another hinge design that can be used with the dynamic interfaces includes a pin and barrel design.FIG.19Aillustrates a dynamic interface1700with a pin and barrel hinge design disposed at the bridge1704between the nasal prongs1702. When a patient's facial profile chances, for example due to external forces or facial movement, the angle of the pin and barrel hinge can adjust to accommodate the facial movement or external forces. The adjustment by the pin and barrel hinge helps stabilize the prongs in the patient's nares.

FIG.19Billustrates an example of a pin and barrel hinge1710. A first side of the hinge can have a pin1712attached or integrally formed on first side. A second side can have a barrel1714(e.g., through hole) attached or integrally formed on the second side. The pin1712can be inserted into the barrel1714and retained by a functional coupler. The pin1712can rotate relative to the barrel1714to form the hinge1710.

FIGS.19C and19Dillustrate a pin and barrel hinge1710with directional movement. The pin and barrel hinge1710includes a stop1716that prevents the hinge from bending in a certain direction, so that the hinge1710is predisposed to bend in a desired direction, for example downward away from the patient's nares. The directional hinge designs can be strategically disposed in particular portions of a nasal interface to control the way the interface bends when a force is applied to the interface. Although the directional hinge design is illustrated herein in combination with a pin and barrel design, the directional hinge design can also be used with other types of hinges, such as those described herein.

FIG.20illustrates an example of a nasal interface1800having a ball and socket hinge1810between the nasal prongs1802. A first side of the hinge1810can have a ball1812attached or integrally formed on first side. A second side can have a barrel1814(e.g., cavity) attached or integrally formed on the second side. The ball1812can move and rotate inside the barrel1814to provide three degrees of movement about the centre of the hinge. When a patient's facial profile changes, for example due to external forces or facial movement, the three degrees of movement of the ball and socket hinge1810can adjust to accommodate the facial movement or external forces, and help to stabilize the prongs1802in the patient's nares.

With reference to the embodiment shown inFIGS.21A to21C, a patient interface2100, such as a nasal cannula, has a pair of respective left2101and right2103body portions, each body portion to be located, in-use, upon a face of a user, each of the body portions being separate from each other. At least one, and preferably both, of the body portions include a nasal prong2105,2107to be inserted into, or to direct a flow of gas into, a nare or the nares of the user's nose. A bar2109extends from a connection point2109awith the left body portion to a connection point2109bwith the right body portion. The bar comprises a substantially elastically deformable region2111.

A displacement of one or both of the left and/or right body portions2101,2103when in-situ is transmitted to the bar2109via the connection point, the substantially elastically deformable region2111being deformable as a reactive response to the displacement.

The substantially elastically deformable region2111of the bar2109is a substantially flexible section that is deformable to substantially absorb the displacement. The substantially elastically deformable region2111of the bar reduces transmission of a displacement by one of the body portions to the other of the body portions.

The connection point2109a,2109bof the bar2109to a body portion is via an anchor, in the form of a barbed projection2121. The barbed projection2121is received by a region2123of the body portion located substantially distal to the respective prong such that the barbed projection and the prong are in fluid communication.

The elastically deformable region2111is substantially aligned with the or both prongs2105,2107in at least one plane. Each connection point2109a,2109bof the bar2109is in fluid communication with the prong of the respective body portion and is configured to couple a gas flow path of a breathing circuit. The interface also has a facial pad2115,2117associated with each body portion. Each facial pad2115,2117is contoured to engage a region of the user's face.

With reference to the embodiments shown inFIGS.22to23C, a patient interface2400/2500, such as a nasal cannula, has a pair of respective left2401/2501and right2403/2503body portions, to be located, in-use, upon a face of a user. A bridge2409/2509portion extends between each of the left and right body portions. A nasal prong2405/2505,2407/2507extends from one, or each, of the inner-more ends of the respective left and/or right body portions, or extends from a region of one or both of the respective body portions substantially adjacent to the inner-more ends. The nasal prongs2405/2505,2407/2507are to be inserted into, or to direct a flow of gas into, a nare or the nares of the user's nose.

The bridge portion2409/2509allows movement of the respective body portions2401/2501,2403/2503with the inner-more ends of the body portions being brought toward each another, yet resists movement of the respective body portions with the inner-more ends being moved away from each other. A displacement of the position of one or both of the left and/or right body portions, when the patient interface is in-situ upon a user's face, is transmitted to the bridge portion2409/2509in a manner so as to minimise movement of the prong or prongs in relation to the user's nare(s).

With reference to the embodiment shown inFIG.22, the bridge portion2409extends and connects inner-more ends of the respective body portions2401,2403. The bridge portion2409is a material that, in a direction extending between the respective inner-more ends of the body portions, is able to undergo a compression and resists or withstands a tension applied thereto. The direction extending between the respective inner-more ends of the body portions is a longitudinal direction extending along the respective body portions. The bridge portion preferably comprises a textile material, which may be a woven, knitted, or non-woven textile material.

With reference to the embodiments shown inFIGS.23A to23C, the bridge portion2509is axially expandable/stretchable, but resilient to resist movement of the respective body portions with the inner-more ends being moved away from each other. A length of the bridge portion between a connection point2509a,2509bon the left body portion and a connection point on the right body portion is larger than a distance between the nasal prongs2505,2507. The bridge portion2509preferably comprises a flexible polymeric material.

With reference to the embodiments shown inFIGS.24A to24C, the patient interface2800, such as a nasal cannula, has a pair of respective left2901and right2903body portions, to be located, in-use, upon a face of a user. A bridge portion2809extends between each of the left and right body portions. A nasal prong2805,2807extends from one, or each, of the inner-more ends of the respective left and/or right body portions, or extends from a region of one or both of the respective body portions substantially adjacent to the inner-more ends. The nasal prong2805,2807is inserted into, or to direct a flow of gas into, a nare or the nares of the user's nose. One, and preferably both, of the respective body portions include a user facial contacts surface2909,2911oriented relative to the respective nasal prong such that, when in situ, a torsional force applied to the left and/or right body portions substantially retains the nasal prong(s) in, or in a position to direct a flow of gas into, the nare(s) of the user's nose.

Rotation of the body portion, and preferably rotation of both body portions, towards a user's face maximises a contact surface area between the facial contacting surface(s) and the face of the user and locates the nasal prong(s) into, or in the position for directing the flow of gases into, the nare(s) of the user's nose.

The bridge section2809/2909is of a relatively smaller diameter than the left and right body portions. Each body portion comprises a channel fluidly connected to the respective nasal prong at one end and open for fluidly coupling a gas flow path of a breathing circuit at an opposing end.

With reference to the embodiment shown inFIGS.24A to24C, at least one, and preferably each, of the left and right body portions includes an axially twisted facial2909,2911contacting surface moveable between a relaxed position and a torsioned position in which a surface area for locating adjacent the user's face is increased.

The facial contacting surface2909,2911is axially twisted along a length of the body portion from an inner end of the body portion to an outer end of the body portion. The facial contacting surface2909,2911extends helically along the length of the body portion. The facial contacting surface, in the relaxed position, faces away from a direction of extension of the nasal prong(s) at the distal end, and in the torsioned position, faces in the direction of extension of the nasal prong(s) and is substantially planar along a substantial length of the body portion.

With reference to the embodiment shown inFIGS.25A to25C, the nasal prong(s)2905,2907are angled relative to the respective left and right body portions to exert torsion on the body portion upon insertion of the nasal prong(s) into the nares) of the user's nose. The facial contacting surface of the respective left and/or right body portion is contoured to engage the user's facial cheek.

With reference to the embodiment shown inFIG.26, a patient interface3000, such as a nasal cannula, has a pair of respective left and right body portions3001,3003, to be located, in-use upon a face of a user. A bridge portion extends between each of the left and right body portions. A nasal prong extends from one, or each, of the inner-more ends3005,3007of the respective left and/or right body portions, or extends from a region of one or both of the respective body portions substantially adjacent to the inner-more ends. The nasal prongs are inserted into, or to direct a flow of gas into, a nare or the nares of the user's nose. The interface has a series of discrete and separate facial contacting surface(s)3009,3011movable relative to each other to respond to force(s) or movement(s), or both, experienced by facial contacting surface(s) and at least partially alleviate the transfer of such force(s) and/or movement(s) to the nasal prong(s).

With reference to the embodiment shown inFIGS.27A to27C and28, a patient interface3200/3300, such as a nasal cannula, has a pair of respective left3201/3301and right3203/3303body portions, each body portion to be located, in-use, upon a face of a user. The patient interface3200/3300also has a bridge portion3209/3309extending between the left and right body portions. A nasal prong3205/3305,3207/3307extends from one, or each, of the inner-more ends of the respective left and/or right body portions, or extends from a region of one or both of the respective body portions substantially adjacent to the inner-more ends. The nasal prong3205/3305,3207/3307is inserted into, or to directs a flow of gas into, a nare or the nares of the user's nose. The cannula includes at least one hinged region, described in detail blow. The at least one hinged region is pivotable relative to another region of the cannula about at least a pair of substantially orthogonal axes, or along a pair of substantially orthogonal planes, or both, to respond to force(s) or movement(s), or both, experienced by the other region and at least partially alleviate the transfer of such force(s) and/or movement(s) to the nasal prong(s). The at least one hinged region may be pivotable about three substantially orthogonal axes, or along three substantially orthogonal planes, or both.

The bridge3209also comprises a bridge hinge3219adjacent the nasal prong or between the pair of nasal prongs. The bridge hinge3219is predisposed to have an acute curvature. The bridge hinge3219is predisposed to bend inwardly toward the user, and downwardly away from the nare(s) in situ.

The bridge3209further comprises a second hinge on one side of the bridge hinge, or a pair of opposed second hinges3216,3220on either side of the bridge hinge3219and adjacent the nasal prong or nasal prongs. The second hinge or each hinge of the pair of second hinges3216,3220is predisposed to have an acute curvature. The second hinge, or each hinge of the pair of second hinges3216,3220is predisposed to bend upwardly towards the nare(s) of the user and outwardly away from the user in situ.

The bridge3209comprises a third hinge adjacent the left or the right body portion, or a pair of third hinges3214,3221disposed adjacent the respective left and right body portions. The third hinge or each of the pair of third hinges3214,3221is predisposed to have an acute curvature. The third hinge or each of the pair of third hinges3214,3221is predisposed to bend downward away from the nare(s) and outward away from the user in situ.

With reference to the embodiment shown inFIGS.27A to27C, one end of the bridge portion extends substantially orthogonally from the third hinge, or either end3222,3223of the bridge portion extends substantially orthogonally from either one of the pair of third hinges and inwardly towards the facial cheek(s) of the user in situ. Each body portion has a facial pad3224,3225contoured to engage a region of the user's face. Either end of the bridge portion extends along at least a portion of the facial pad.

The bridge portion3209is substantially hollow at least at either end of the bridge portion to transport a flow of gases there through. Either end of the bridge portion is configured to couple a gas flow path of a breathing circuit. The bridge portion3209comprises an annular cross section along at least a substantial portion of the length of the bridge portion.

The nasal prong(s)3205,3207extend(s) from, and is/are fluidly coupled to, a respective end of the bridge portion.

With reference to the embodiment shown inFIG.28, the bridge further comprises a fourth hinge adjacent the third hinge, or a pair of fourth hinges3326,3327adjacent the respective pair of third hinges. The fourth hinge or each hinge of the pair of fourth hinges is predisposed to have an acute curvature. The fourth hinge, or each hinge of the pair of fourth hinges is predisposed to bend downwardly away from the nare(s) of the user and inwardly toward the facial cheek(s) of the user in situ. Each body portion comprises a facial pad3324,3325contoured to engage upon a region of the user's face.

Although certain embodiments, features, and examples have been described herein, it will be understood by those skilled in the art that many aspects of the methods and devices illustrated and described in the present disclosure may be differently combined and/or modified to form still further embodiments. For example, any one component of the nasal interfaces illustrated and described above can be used alone or with other components without departing from the spirit of the present invention. Additionally, it will be recognized that the methods described herein may be practiced in different sequences, and/or with additional devices as desired. Such alternative embodiments and/or uses of the methods and devices described above and obvious modifications and equivalents thereof are intended to be included within the scope of the present invention. Thus, it is intended that the scope of the present invention should not be limited by the particular embodiments described above, but should be determined only by a fair reading of the claims that follow.

ADDITIONAL EMBODIMENTS

Item 1: A patient interface, such as a nasal cannula, comprising:a pair of respective left and right body portions, each body portion to be located, in-use, upon a face of a user, each of the body portions being separate from each other,at least one, and preferably both, of the body portions including a nasal prong to be inserted into, or to direct a flow of gas into, a nare or the nares of the user's nose, anda bar extending from a connection point with the left body portion to a connection point with the right body portion, the bar comprising a substantially elastically deformable region,wherein a displacement of one or both of the left and/or right body portions when in-use is transmittable to the bar via the connection point, the substantially elastically deformable region being deformable as a reactive response to the displacement.Item 2. The patient interface as defined in item 1, wherein the substantially elastically deformable region of the bar comprises a substantially flexible section.Item 3. The patient interface as defined in item 1 or 2, wherein the substantially elastically deformable region of the bar is deformable to substantially absorb the displacement.Item 4. The patient interface as defined in any one of items 1-3, wherein the substantially elastically deformable region of the bar reduces transmission of a displacement by one of the body portions to the other of the body portions.Item 5. The patient interface as defined in any one of items 1-4, wherein the connection point of the bar to a body portion is via an anchor.Item 6. The patient interface as defined in item 5, wherein the anchor is a barbed projection to be received by a region of the body portion located substantially distal to the respective prong.Item 7. The patient interface as defined in item 6, wherein the barbed projection and the prong are in fluid communication.Item 8. The patient interface as defined in any one of items 1-7, wherein the elastically deformable region is substantially aligned with the or both prongs in at least one plane.Item 9. The patient interface as defined in any one items 1-8, wherein each connection point of the bar is in fluid communication with the prong of the respective body portion and is configured to couple a gas flow path of a breathing circuit.Item 10. The patient interface as defined in any one items 1-9, further comprising a facial pad associated with each body portion, the facial pad being contoured to engage a region of the users face.Item 1a: A patient interface, such as a nasal cannula, comprising: a pair respective left and right body portions, to be located, in-use, upon a face of a user, anda bridge portion extending between each of the left and right body portions,a nasal prong extending from one, or each, of the inner-more ends of the respective left and/or right body portions, or extending from a region of one or both of the respective body portions substantially adjacent to the inner-more ends, the nasal prong to be inserted into, or to direct a flow of gas into, a nare or the nares of the user's nose,the bridge portion allowing movement of the respective body portions with the inner-more ends of the body portions being brought toward each another, yet resisting movement of the respective body portions with the inner-more ends being moved away from each other.Item 2a. The patient interface as defined in item 1a, wherein a displacement of the position of one or both of the left and/or right body portions, when the patient interface is in-situ upon a user's face, is transmitted to the bridge in a manner so as to minimise movement of the prong or prongs in relation to the user's nare(s).Item 3a. The patient interface as defined in item 1a or 2a, wherein the bridge portion extends and connects inner-more ends of the respective body portions.Item 4a. The patient interface as defined in any one of items 1a-3a, wherein the bridge portion is a material that, in a direction extending between the respective inner-more ends of the body portions, is able to undergo a compression and resists or withstands a tension applied thereto.Item 5a. The patient interface as defined in item 4a, wherein the direction extending between the respective inner-more ends of the body portions is a longitudinal direction extending along the respective body portions.Item 6a. The patient interface as defined any one of items 1a-5a, wherein the bridge portion comprises a textile material.Item 7a. The patient interface as defined in either item 1a or 2a, wherein the bridge portion is axially expandable/stretchable but resilient to resist movement of the respective body portions with the inner-more ends being moved away from each other.Item 8a. The patient interface as defined in item 7a, wherein a length of the bridge portion between a connection point on the left body portion and a connection point on the right body portion is larger than a distance between the nasal prongs.Item 9a. The patient interface as defined in item 7a or 8a, wherein the bridge portion comprises a flexible polymeric material.Item 1b. A patient interface, such as a nasal cannula, comprising:a pair of respective left and right body portions, to be located, in-use, upon a face of a user,a bridge portion extending between each of the left and right body portions, anda nasal prong extending from one, or each, of the inner-more ends of the respective left and/or right body portions, or extending from a region of one or both of the respective body portions substantially adjacent to the inner-more ends, the nasal prong to be inserted into, or to direct a flow of gas into, a nare or the nares of the user's nose,wherein one, and preferably both, of the respective body portions include a user facial contacting surface oriented relative to the respective nasal prong such that, when in situ, a torsional force applied to the left and/or right body portions substantially retains the nasal prong(s) in, or in a position to direct a flow of gas into, the nare(s) of the user's nose.Item 2b. The patient interface as defined in item 1b, wherein rotation of the body portion, and preferably rotation of both body portions, towards a user's face maximises a contact surface area between the facial contacting surface(s) and the face of the user and locates the nasal prong(s) into, or in the position for directing the flow of gases into, the nare(s) of the user's nose.Item 3b. The patient interface as defined in item 1b or 2b, wherein the bridge section is of a relatively smaller diameter than the left and right body portions.Item 4b. The patient interface as defined in any one items 1b-3b, wherein each body portion comprises a channel fluidly connected to the respective nasal prong at one end and open for fluidly coupling a gas flow path of a breathing circuit at an opposing end.Item 5b. The patient interface as defined in any one of items 1b-4b, wherein at least one, and preferably each, of the left and right body portions includes an axially twisted facial contacting surface moveable between a relaxed position and a torsioned position in which a surface area for locating adjacent the user's face is increased.Item 6b. The patient interface as defined in item 5b, wherein the facial contacting surface is axially twisted along a length of the body portion from an inner end of the body portion to an outer end of the body portion.Item 7b. The patient interface as defined in item 5b, wherein the facial contacting surface extends helically along the length of the body portion.Item 8b. The patient interface as defined in either of item 5b or 6b, wherein the facial contacting surface, in the relaxed position, faces away from a direction of extension of the nasal prong(s) at the distal end, and in the torsioned position, faces in the direction of extension of the nasal prong(s) and is substantially planar along a substantial length of the body portion.Item 9b. The patient interface as defined in any one of items 1b-4b, wherein nasal prong or the nasal prongs are angled relative to the respective left and right body portions to exert torsion on the body portion upon insertion of the nasal prong(s)into the nare(s) of the user's nose.Item 10b. The patient interface as defined in item 9b, wherein the facial contacting surface of the respective left and/or right body portion is contoured to engage the user's facial cheek.Item 1c. A patient interface, such as a nasal cannula, comprising:a pair of respective left and right body portions, to be located, in-use, upon a face of a user, anda bridge portion extending between each of the left and right body portions,a nasal prong extending from one, or each, of the inner-more ends of the respective left and/or right body portions, or extending from a region of one or both of the respective body portions substantially adjacent to the inner-more ends, the nasal prong to be inserted into, or to direct a flow of gas into, a nare or the nares of the user's nose, anda series of discrete and separate facial contacting surface(s) movable relative to each other to respond to force(s) or movement(s), or both, experienced by facial contacting surface(s) and at least partially alleviate the transfer of such force(s) and/or movement(s) to the nasal prong(s).Item 1d. A patient interface, such as a nasal cannula, comprising:a pair of respective left and right body portions, each body portion to be located, in-use, upon a face of a user, anda bridge portion extending between the left and right body portions, anda nasal prong extending from one, or each, of the inner-more ends of the respective left and/or right body portions, or extending from a region of one or both of the respective body portions substantially adjacent to the inner-more ends, the nasal prong to be inserted into, or to direct a flow of gas into, a nare or the nares of the user's nose,wherein the cannula includes at least one hinged region pivotable relative to another region of the cannula about at least a pair of substantially orthogonal axes, or along a pair of substantially orthogonal planes, or both, to respond to force(s) or movement(s), or both, experienced by the other region and at least partially alleviate the transfer of such force(s) and/or movement(s) to the nasal prong(s).Item 2d. The interface as defined in item 1d, wherein at least one hinged region is pivotable about three substantially orthogonal axes, or along three substantially orthogonal planes, or both.Item 3d. The interface as defined in either item 1d or 2d, wherein the bridge comprises a bridge hinge adjacent the nasal prong or between the pair of nasal prongs.Item 4d. The interface as defined in item 3d, wherein the bridge hinge is predisposed to have an acute curvature.Item 5d. The interface as defined in item 3d or 4d, wherein the bridge hinge is predisposed to bend inward toward the user, and downward away from the nare(s) in situ.Item 6d. The interface as defined in any one of items 3d-5d, wherein the bridge further comprises a second hinge on one side of the bridge hinge, or a pair of opposed second hinges on either side of the bridge hinge and adjacent the nasal prong or nasal prongs.Item 7d. The interface as defined in item 6d, wherein the second hinge or each hinge of the pair of second hinges is predisposed to have an acute curvature.Item 8d. The interface as defined in item 6d or 7d, wherein the second hinge, or each hinge of the pair of second hinges is predisposed to bend upwardly towards the nare(s) of the user and outwardly away from the user in situ.Item 9d. The interface as defined in any one of items 6d-8d, wherein the bridge comprises a third hinge adjacent the left or the right body portion, or a pair of third hinges disposed adjacent the respective left and right body portions.Item 10d. The interface as defined in item 9d, wherein the third hinge or each of the pair of third hinges is predisposed to have an acute curvature.Item 11d. The interface as defined in item 9d or 10d, wherein the third hinge or each of the pair of third hinges is predisposed to bend downward away from the nare(s) and outward away from the user in situ.Item 12d. The interface as defined in any one of items 9d-11d, wherein one end of the bridge portion extends substantially orthogonally from the third hinge, or either end of the bridge portion extends substantially orthogonally from either one of the pair of third hinges and inwardly towards the facial cheek(s) of the user in situ.Item 13d. The interface as defined in item 12d, wherein each body portion comprises a facial pad contoured to engage a region of the user's face.Item 14d. The interface as defined in item 13d, wherein either end of the bridge portion extends along at least a portion of the facial pad.Item 15d. The interface as defined in any one of items 12d-14d, wherein the bridge portion is substantially hollow at least at either end of the bridge portion to transport a flow of gases there through.Item 16d. The interface as defined in item 15d, wherein either end of the bridge portion is configured to couple a gas flow path of a breathing circuit.Item 17d. The interface as defined in item 15d or 16d, wherein the nasal prong, or each nasal prong, extends from, and is fluidly coupled to, a respective end of the bridge portion.Item 18d. The interface as defined in any one of items 1d-17d, wherein the bridge portion comprises an annular cross section along at least a substantial portion of the length of the bridge portion.Item 19d. The interface as defined in any one of items 9d-18d, wherein the bridge further comprises a fourth hinge adjacent the third hinge, or a pair of fourth hinges adjacent the respective pair of third hinges.Item 20d. The interface as defined in item 19d, wherein the fourth hinge or each hinge of the pair of fourth hinges is predisposed to have an acute curvature.Item 21d. The interface as defined in item 19d or 20d, wherein the fourth hinge, or each hinge of the pair of fourth hinges is predisposed to bend downwardly away from the nares) of the user and inwardly toward the facial cheek(s) of the user in situ.Item 22d. The interface as defined in any one of items 19d-21d, wherein each body portion comprises a facial pad contoured to engage upon a region of the user's face.Item 1f. A nasal interface configured to stabilize prongs on a patient'san elongate body having an overall curvature that generally corresponds to a patient's facial profile, the body configured to be coupled to a gases flow source and comprising at least one lumen extending at least partially through the body;a pair of prongs extending from the body and in fluid communication with the at least one lumen; andone or more hinges, at least one hinge disposed between the pair of prongs that is predisposed to bend in a predefined direction.Item 2f. The nasal interface as defined in item 1f, further comprising one or more facial pads configured to rest on a patient's face.Item 3f. The nasal interface as defined in item 1f or 2f, wherein the at least one hinge disposed between the pair of prongs has a curvature that is generally inverted from the overall curvature of the elongate body.Item 4f. The nasal interface as defined in item 3f, wherein the at least one hinge disposed between the pair of prongs is configured to bend inward towards the patient's face.Item 5f. The nasal interface as defined in any one of items 1f-4f, wherein the nasal interface has a generally gullwing shape.Item 6f. The nasal interface as defined in any one of items 1f-4f, wherein the nasal interface has a wavy shape.Item 7f. The nasal interface as defined in any one of items 1f-4f, wherein the nasal interface has a curved space frame-like support structure.Item 8f. The nasal interface as defined in any one of items 1f-7f, wherein the nasal interface bends in more than one dimension.Item 9f. The nasal interface as defined in any one of items 1f-8f, wherein the one or more hinges comprises a notch.Item 10f. The nasal interface as defined in any one of items 1f-9f, wherein the one or more hinges comprises a variable cross-sectional area.Item 11f. The nasal interface as defined in any one of items 1f-10f, wherein the one or more hinges comprises a variable thickness.Item 12f. The nasal interface as defined in any one or more of items 1f-11f, wherein the one or more hinges comprises two or more materials with different flexibilities.Item 13f. The nasal interface as defined in any one or more of items 1f-12f, wherein the one or more hinges comprises an elastic hinge that is configured to be pre-stressed before application to a patient.Item 14f. The nasal interface as defined in any one of items 1f-13f, wherein the one or more hinges comprises a barrel and pin.Item 15f. The nasal interface as defined in any one of items 1f-13f, wherein the one or more hinges comprises a ball and socket.Item 16f. A nasal interface comprising:an elongate body comprising at least one lumen extending at least partially through the body, the body configured to be coupled to a gases flow source;one or more prongs extending from the body and in fluid communication with the at least one lumen; andone or more hinges that are predisposed to bend in predefined directions;wherein the one or more hinges are configured to stabilize a position of the one or more prongs on a patient's face when forces are exerted on the nasal interface.Item 17f. The nasal interface as defined in item 16f, further comprising one or more facial pads configured to rest on a patient's face.Item 18f. The nasal interface as defined in item 16f or 17f, wherein at least one of the one or more hinges is located adjacent to or between the one or more prongs.Item 19f. The nasal interface as defined in any one of items 16f-18f, wherein at least one of the one or more hinges is configured to bend Inward towards the patient's face.Item 20f. The nasal interface as defined in any one of items 16f-18f, wherein at least one of the one or more hinges is configured to bend downward.Item 21f. The nasal interface as defined in any one of items 16f-20f, wherein the nasal interface has a generally gullwing shape.Item 22f. The nasal interface as defined in any one of items 16f-20f, wherein the nasal interface has a wavy shape.Item 23f. The nasal interface as defined in any one of items 16f-20f, wherein the nasal interface has a curved space frame-like support structure.Item 24f. The nasal interface as defined in any one of items 16f-23f, wherein the nasal interface bends in more than one dimension.Item 25f. The nasal interface as defined in any one of claims 16f-24f, wherein the nasal interface comprises two separate sides that are coupled by an over-strap bridge.Item 26f. The nasal interface as defined in any one of items 16f-25f, wherein the one or more hinges comprises a notch.Item 27f. The nasal interface as defined in any one of items 16f-26f, wherein the one or more hinges comprises a variable cross-sectional area.Item 28f. The nasal interface as defined in any one of items 16f-27f, wherein the one or more hinges comprises a variable thickness.Item 29f. The nasal interface as defined in any one of items 16f-28f, wherein the one or more hinges comprises two or more materials with different flexibilities.Item 30f. The nasal interface as defined in any one of items 16f-29f, wherein the one or more hinges comprises an elastic: hinge that is configured to be pre-stressed before application to a patient.Item 31f. The nasal interface as defined in any one of items 16f-30f, wherein the one or more hinges comprises a barrel and pin.Item 32f. The nasal interface as defined in any one of items 16f-30f, wherein the one or more hinges comprises a ball and socket.Item 33f. A nasal interface comprising:an elongate body comprising at least one lumen extending at least partially through the body, the body configured to be coupled to a gases flow source; andone or more prongs coupled to the body and in fluid communication with the at least one lumen;wherein the elongate body has a shape that generally corresponds to an anatomical contour of a patient's or a group of patients' facial profile.Item 34f. The nasal interface as defined in item 33f, wherein the group of patients is one of premature babies, neonates, infant, pediatrics or adults.Item 35f. The nasal interface as defined in item 33f or 34f, wherein the tubular body is initially malleable.Item 36f. The nasal interface as defined in any one of items 33f-35f, wherein the shape of the tubular body is set through a hardening process.Item 37f. The nasal interface as defined in any one of items 1f-36f, wherein at least one of the one or more hinges is predisposed to bend in a pre-defined direction.