Patient Interface

Abstract

Provide a patient interface such as a nasal cannula. The patient interface (4700) has a body portion that is positioned on the user's face during use and at least one side arm (4701) extending laterally from a bridge portion (4710) and positioned around the user's nasal septum region. The interface has a pair of nasal prongs (4705, 4707). The body portion has at least one fluid passageway for supplying gas to the nostrils of the user's nose connected to the nasal prongs. The bridge portion defines the spatial relationship of the outlets of a gas delivery system that supply gas to the outlets through each side arm. Each side arm may include one or more predetermined or pre-positioned localized compensation regions (or locations), which are positioned along the side arm or side arm element and accommodate compensation of the patient interface within or at one or more of the compensation regions.

Description

[Technical Field]

[0001] The present disclosure relates to patient interfaces for delivering gas to a user, and more particularly, but not exclusively, to patient interfaces for delivering a flow of gas to a user, or alternatively to patient interfaces for delivering gas to the user's nostrils or nasal passages, that compensate for or accommodate movements or forces applied to or imparted to the interface during use that destabilize the interface from a treatment delivery position on the user. [Background technology]

[0002] Patient interfaces for delivering gas to a user come in many forms, including full face masks, oronasal masks, nasal masks, and nasal cannulae. It is desirable to provide patient interfaces that are configured to conform to the varying facial geometry of a user or to maintain a stable position on the user when external forces are applied to such a patient interface, or at least to help improve the maintenance of stability.

[0003] There is a wide variety of patient interfaces available to users, each of which can have its own stability challenges.

[0004] Stability of the interface on the user is important for at least reasons of comfort and maintaining the desired delivery of treatment to the user. In achieving one or both of these results, or even other results, it would be useful to provide an alternative patient interface that provides improved stability and / or performance on the user's face.

[0005] Instability of the interface may lead to the interface or components of the interface becoming dislodged, which may affect the desired delivery or integrity of treatment to the user.

[0006] In various modes, instability of the interface on the user can be the result of loads, such as those caused by the user's speech and changes in the geometry of their face on which the interface is placed. Human facial geometry varies significantly due to a wide range of factors, which may include, but are not limited to, gender, age, or certain medical conditions. Incorrect sizing and geometry of the interface for a particular user may also adversely affect the stability and usability of a particular patient interface.

[0007] In terms of facial movement, when a user speaks, eats, cries, or otherwise distorts or significantly moves their facial features, such movement can affect the stability of the patient interface or components of the interface on the user, such as, for example, a nasal prong or a pair of such prongs on a nasal cannula that may unintentionally move out of a gas delivery position for delivering gas to the user's nostrils. Also, changes in facial features can occur over longer periods of time due to situations such as the user's position while sleeping. Long-term changes in geometry can also occur due to the user's growth and injury recovery.

[0008] In connection with the above, it will be appreciated that forces or movements may be transmitted to the interface and its components either by changes in the geometry of the user in which the patient interface is positioned or by further forces, such as by the user pulling on tubes or other components attached to the interface, etc. The application of such forces may cause problems for the user with respect to stability, comfort and operation of the patient interface.

[0009] Further aspects and advantages of the present invention will become apparent from the following description, which is given by way of example only. Summary of the Invention [Problem to be solved by the invention]

[0010] It is therefore an object of certain embodiments disclosed herein to provide a patient interface, or at least a portion of a patient interface, that when implemented in a patient interface at least partially addresses the aforementioned challenges or at least provides a useful option to the industry / public. [Means for solving the problem]

[0011] According to at least one embodiment disclosed herein, a. a body portion that is placed on a user's face in use, the body portion having a side arm, or preferably a pair of side arms, extending laterally from a generally central bridge portion that is placed in or around the user's nasal septum area in use; b. at least one, and preferably a pair of, nasal prongs extending from the bridge portion and for, in an operative position, being inserted into or directing the flow of gases into the nostril or nostrils of the user's nose; Including, c. the body portion has at least one fluid passageway connected to the nasal prongs for supplying gas to the nostrils of the user's nose; d. the cross-section of the passageway varies along the length of the body portion to provide a region of varying flexibility along the body portion; A patient interface, such as a nasal cannula, is provided.

[0012] In some embodiments, the or each said side arm includes one or more predetermined or pre-positioned points or localized compensation areas (or locations) disposed along the side arm to accommodate or facilitate compensation of the patient interface within or at one or more of the compensation areas (or locations), such that when a force applied to the patient interface is exerted on the side arm or sides of the interface, the compensation areas (or locations) of the side arm and / or side arm elements accommodate the force by flexing or bending or hinging or other displacement of the side arm and / or side arm elements.

[0013] In some embodiments, one or more of the compensation regions (or locations) is a region or location of bending or hinge region though or around at least two different (non-parallel) planes through the interface.

[0014] In some embodiments, the bridge portion includes a bridge portion element, and the bridge portion, the bridge portion element, or both the bridge portion and the bridge portion element are substantially decoupled from forces applied to or to the patient interface.

[0015] In some embodiments, the bridge element and the side arm element or elements are separate pieces that can be assembled to form a unitary structure.

[0016] In some embodiments, the bridge element is sufficiently sized to span the width of the user's nasal septum region, or is the distance or width between the gas outlets, or is defined by substantially the maximum distance spanning from one nasolabial fold to another nasolabial fold of the user, and the side arm elements are sized to extend at least partially apart along the length of the side arms.

[0017] In some embodiments, the bridge element includes one or a pair of cutouts or shaped portions for locating, positioning or accommodating at least one or a pair of outlets for a gas delivery system that supplies gas to the user's airway.

[0018] In some embodiments, the bridge element is or includes a textile material and is disposed on an exterior surface of the bridge, the bridge element increasing the rigidity of the bridge to maintain the distance between the prongs.

[0019] In some embodiments, the or each said side arm includes at least one substantially elastic or relatively more rigid side arm element, which side arm element at least partially defines the shape or curvature of the or each side arm and has one or more predetermined or pre-positioned points or local compensation areas (or locations) disposed along the or each side arm and / or the or each side arm element and adapted for patient interface compensation at the compensation area (or locations) or at one or more of the compensation areas (or locations), and the or each side arm is a patient interface stabilizer.

[0020] In some embodiments, the side arm element includes one or more notches to allow bending of the side arm element such that the side arm portion can bend in response to the application of force.

[0021] In some embodiments, the interface is overmolded onto the bridge element and the side arm element.

[0022] According to at least one embodiment disclosed herein, a. a body portion that is placed on a user's face during use, the body portion having left and right side arms and a bridge portion between the left and right side arms; b. at least one nasal prong extending from the bridge portion and for, in an operative position, being inserted into or directing the flow of gases into the nostril or nostrils of the user's nose; Including, c. the body portion has at least one fluid passageway connected to the nasal prongs for supplying gas to the nostrils of the user's nose; d. the cross-section of the passageway varies along the length of the body portion to provide a region of varying flexibility along the body portion; A patient interface is provided.

[0023] In some embodiments, the cross-sectional shape of the passageway varies along at least a portion of the length of the body portion, changing from a generally circular cross-section at or near the outer end for connection (either removably or permanently) with a respiratory tube or conduit, to an elongated cross-section having a major axis that is substantially vertically (parallel to the user's face) oriented.

[0024] In some embodiments, the elongated cross-section is located within or forms a bending region or hinge portion of the body portion, the elongated cross-section providing greater flexibility for bending the body portion in the direction of the minor axis of the elongated cross-section towards or away from the user's face.

[0025] In some embodiments, the at least one nasal prong comprises a pair of nasal prongs, the bridge region comprising a solid section between the prongs such that the bridge region is more rigid than the bend region, and the bridge region has a height or vertical dimension sufficient to provide torsional stability and prevent twisting of the bridge region during use.

[0026] In some embodiments, the bridge portion includes thicker wall sections than the wall sections of the bend region such that the bridge portion is stiffer than the bend region.

[0027] In some embodiments, the bridge portion comprises an even more rigid material to impart rigidity to the bridge region, and the bridge portion is formed from a different rigid material than the material forming the remainder of the patient interface.

[0028] In some embodiments, the side arm includes one or more side arm elements disposed on or within the side arm of the interface, the side arm elements being formed from a rigid material to provide rigidity to the side arm / portion, and the side arm elements further including one or more cuts or notches to allow the side arm to flex / hinge in response to forces applied or exerted on the side arm.

[0029] In some embodiments, the bridge portion transitions into the left and right side arms by flaring or curving outward away from the user's face side of the bridge portion, and the left and right side arms curve rearward from the front extent of the body portion away from the bridge portion, and the curvature of the user's face side of the bridge portion and / or the transition region between the bridge portion and the left and right side arms has a relatively large radius(s) so that pressure from the bridge and / or transition region on the user's face is distributed over the user's philtrum or upper lip area.

[0030] In some embodiments, when viewed from above, the body portion includes a U-shaped region between the at least one nasal prong and the adjacent left or right side arm, the inside of the U-shaped region facing the user's face in use, and when the left or right portion of the body portion is flexed towards or away from the user's face, each U-shaped region forms or is located within a bending region where the body portion preferentially bends, the bending region tending to bend in the valley of the U-shaped region.

[0031] In some embodiments, the interior angle of the U-shaped region is less than about 130 degrees, or 120 degrees, or 110 degrees, or 105 degrees.

[0032] In some embodiments, the patient interface is a single, integrally formed component formed from a single material in a single molding operation, wherein the patient interface is formed from a thermoplastic or silicone material having a Shore A hardness of about 5 to 60.

[0033] In some embodiments, the cross-section of the passageway at the base of the at least one nasal prong is asymmetrical, with one side of the cross-section being flatter than the other side of the cross-section, and the passageway extending along the at least one nasal prong changes shape from an asymmetrical cross-section at or near the base of the at least one nasal prong to a circular cross-section at or near the tip of the at least one nasal prong.

[0034] In some embodiments, the cross-sectional area of ​​the at least one nasal prong decreases from the base to the tip of the prong, with the flatter side of the at least one nasal prong being positioned toward the front side of the patient interface (facing away from the user's face).

[0035] In some embodiments, the at least one nasal prong has a base integrally formed with a bridge portion of the body portion of the patient interface, the base of the at least one nasal prong including a fillet between a wall of the prong and the bridge portion, the fillet extending around a circumference of the at least one nasal prong, and the radius of the fillet varying around the circumference of the at least one nasal prong.

[0036] In some embodiments, the patient interface includes at least one pad of a retention system for holding the interface in place when worn by a user in use, the pad attached to at least one of the left and right side arms of the main body portion, the pad being substantially symmetrical about a central generally vertical axis dividing the pad into left and right sides such that a pad of the same shape may be applied to both the left and right side arms of the main body portion, and optionally each pad of one pad attached to the left or right portion respectively by overmolding with an overmolding material, whether the pad or the pad is integrally molded with the pad and attached to the interface or is subsequently attached to the interface by overmolding the interface and the pad.

[0037] In some embodiments, the retention system includes a two-part detachable attachment (or connection) mechanism, which mechanism includes: a. Skin patches and user interface patches Including, b. the skin patch has a patient side and an interface side; c. the patient side of the skin patch is attachable to the skin of a user (e.g., by an adhesive, which is typically a dermatologically sensitive adhesive, such as a hydrocolloid); d. a first part of a two-part detachable attachment or connection system is provided on the interface side of the skin patch; e. the user interface patch has an interface side and a patient side; f. the patient side of the user interface patch is provided with a complementary second part of a two-part detachable attachment or connection system; g. The interface side of the user interface patch is attachable (or connectable) to a user interface and / or components associated with the user interface (eg, tubes or tubing).

[0038] In some embodiments, the body portion, or at least the left or right side arm, is co-molded or overmolded with the retention system so that the pad is retained on or within the side arm portion of the interface.

[0039] In some embodiments, each of the left and right side arms includes one or more predetermined or pre-positioned points or localized compensation areas (or locations) disposed along the or each side arm and adapted to accommodate compensation of the patient interface at the compensation area (or location) or at one or more of the compensation areas (or locations) and to accommodate forces due to flexing or bending or hinging or other displacement.

[0040] In some embodiments, one or more of the compensation regions (or locations) is a region or location of bending or hinge region though or around at least two different (non-parallel) planes through the interface.

[0041] In some embodiments, the bridge portion includes a bridge portion element, and the bridge portion, the bridge portion element, or both the bridge portion and the bridge portion element are substantially decoupled from forces applied to or to the patient interface.

[0042] According to at least one embodiment disclosed herein, a. one or preferably a pair of side arms extending laterally from a generally central bridge portion that is positioned in or around the user's nasal septum area in use; Including, b. A patient interface is provided in which the or each side arm is connected to a substantially resilient or relatively more rigid bridge element that defines a substantially predetermined spatial relationship of the outlet or outlets of the gas delivery system with the or each side arm.

[0043] According to at least one embodiment disclosed herein, a. one or preferably a pair of side arms extending laterally from a generally central bridge portion that is positioned in or around the user's nasal septum area in use; Including, b. the or each said side arm includes one or more predetermined or pre-positioned points or localized compensation areas (or locations), the one or more predetermined or pre-positioned points or localized compensation areas (or locations) being positioned along the side arm to accommodate or facilitate compensation of the patient interface within or at one or more of the compensation areas (or locations); c. A patient interface is provided in which the or each side arm is connected to a substantially resilient or relatively more rigid bridge element that defines a substantially predetermined spatial relationship of the outlet or outlets of the gas delivery system with the or each side arm.

[0044] According to at least one embodiment disclosed herein, a. comprising one or preferably a pair of side arms extending laterally from a generally central bridge portion that is positioned in or around the user's nasal septum area in use; b. the or each said side arm includes at least one substantially elastic or relatively more rigid side arm element, the side arm element at least partially defining the shape or curvature of the or each side arm and having one or more predetermined or pre-positioned points or localized compensation areas (or locations) disposed along the or each side arm and / or the or each side arm element and adapted for compensation of the patient interface at or in one or more of the compensation areas (or locations); c. the or each said side arm element is connected or interconnected via a connecting material to a substantially resilient or relatively more rigid bridge element, the bridge element defining a substantially predetermined spatial relationship of the outlet or outlets of the gas delivery system with the or each said side arm; A patient interface is provided.

[0045] According to one or more of the above aspects, one or more of the following further embodiments may be provided.

[0046] In some embodiments, the bridge portion or bridge portion element (or both) is substantially decoupled from forces that may be applied to or to the patient interface.

[0047] In some embodiments, a force applied to the patient interface may be exerted on one or more side arms of the interface, and a compensation region (or location) in the side arm or side arm element or both accommodates the force by flexing or bending or hinging or other displacement of the side arm or side arm element or both.

[0048] In some embodiments, the side arm or arms are patient interface stabilizers.

[0049] In some embodiments, the bridge element and the side arm element or elements are separate pieces that are assembled to form an integral component.

[0050] In some embodiments, the bridge element and one or more side arm elements are a single component, or at least the bridge element and at least one side arm element are a single component.

[0051] In some embodiments, the bridge element and one or more side arm elements are integrally formed as a single component, or at least the bridge element and at least one side arm element are integrally formed as a single component.

[0052] In some embodiments, the bridge element and the side arm element or elements are formed as a unitary component.

[0053] In some embodiments, the bridge element and at least one of the side arm element or elements are separate components, each of which may be substantially interconnected by the material of the patient interface, such as the side arm or arms, or may be provided in an interconnected relationship with one another.

[0054] In some embodiments, the bridge element is a discontinuous component of one or more of the side arm elements.

[0055] In some embodiments, the side arm includes one or more separate side arm elements, each of the one or more separate side arm elements being spaced apart through or along the length of the side arm.

[0056] In some embodiments, each of the one or more separate side arm elements is spaced apart in an array through or along the length of the or each said side arm.

[0057] In some embodiments, the bridge element and the side arm element or elements are separate components provided or interconnected in connection with each other via one or a pair of corresponding side arms, and optionally the corresponding side arms including the bridge, one or more corresponding side arm elements.

[0058] In some embodiments, each separate side arm element provides a relatively elastic portion, with side arm material sandwiched between or adjacent to each separate side arm element, and the side arm material provides a compensation region (or location).

[0059] In some embodiments, the patient interface includes a bridge element and at least one separate side arm element disposed within each one of the pair of side arms.

[0060] In some embodiments, the bridge portion is located intermediate the pair of side arms.

[0061] In some embodiments, the bridge element is positioned intermediate the side arm elements of the pair of side arms.

[0062] In some embodiments, the bridge element is sized (sufficiently) to span the width of the user's nasal septum region, or is the distance or width between the gas outlets, or is substantially defined by the maximum distance spanning from one nasolabial fold to another nasolabial fold of the user.

[0063] In some embodiments, the bridge element includes one or a pair of cutouts or shaped portions for locating, positioning or accommodating at least one or a pair of outlets for a gas delivery system that supplies gas to the user's airway.

[0064] In some embodiments, the bridge element includes one or a pair of cutouts or shaped portions for positioning, positioning, or accommodating a nasal prong or pair of nasal prongs as an outlet or outlets for a gas delivery system that supplies gas to a nostril or nostrils of a user.

[0065] In some embodiments, one or more of the compensation regions (or locations) facilitates flexure or bending or hinging or localized displacement and / or elastic deformation.

[0066] In some embodiments, one or more of the compensation regions (or locations) is a region or location of bending or hinge region though or around at least one surface through the interface.

[0067] In some embodiments, one or more of the compensation regions (or locations) is a region or location of bending though or around multiple parallel planes through the interface or a hinge region.

[0068] In some embodiments, one or more of the compensation regions (or locations) is a region or location of bending or hinge region though or around at least two different (non-parallel) planes through the interface.

[0069] In some embodiments, one or more of the compensation regions (or locations) is a region or location of bending though or about at least two different (orthogonal) planes through the interface or a hinge region.

[0070] In some embodiments, one or more compensation regions (or locations) may flex or bend (or hinge or may locally displace or elastically deform or move) more preferentially in one or more first directions or first set of directions and less preferentially in another direction or another set of directions.

[0071] In some embodiments, one or more compensation regions (or locations) are configured or adapted to substantially resist flexing or bending (or hinging or local displacement or elastic deformation) in a lower preferred direction or set of directions.

[0072] In some embodiments, the first direction or first set or directions is substantially in the transverse plane.

[0073] In some embodiments, the first direction or first set of directions may be substantially transverse in the ventral direction or the dorsal direction, or in both the ventral and dorsal directions.

[0074] In some embodiments, the first direction or first set of directions is in one or more of a substantially transverse plane, a substantially sagittal plane, and / or a substantially coronal plane.

[0075] In some embodiments, the first direction or first set of directions is a direction or directions that substantially facilitates moving or bending the side arm element relative to the bridge element.

[0076] In some embodiments, the side arm elements are formed substantially of a resilient material, or a. Between one compensation area (or location) located laterally outward from the bridge element and the outer end of the side arm element; b. Located between the outer compensation area (or location) of the side arm element and the outer end of the side arm element; c. provided between each of a series of compensation areas (or locations) of the side arm element; d. provided between two compensation areas (or locations) located laterally outward from the bridge element, and between a more outward compensation area (or location) of the side arm element and the outer end of the side arm element; configured or adapted to provide substantial resilience to flexing or bending (or hinging or localized displacement or elastic deformation) in a side arm element region selected from one or more of:

[0077] In some embodiments, each side arm element includes one compensation region (or location).

[0078] In some embodiments, each side arm element includes two compensation regions (or locations).

[0079] In some embodiments, each side arm element includes three compensation regions (or locations).

[0080] In some embodiments, each side arm element includes multiple compensation regions (or locations).

[0081] In some embodiments, at least one compensation region (or location) is located at the more inboard end of the side arm element in connection with the bridge element.

[0082] In some embodiments, at least one of the compensation regions (or locations) is located at a junction or connection between a side arm element and a bridge element.

[0083] In some embodiments, at least one of the compensation areas (or locations) is located within or in a zone of the bridge element substantially defined by the periphery or lateral outer edge of the user's nasal septum area.

[0084] In some embodiments, the or each side arm element is configured to flex or bend (or hinge or locally displace or may elastically deform or move) relative to the bridge element.

[0085] In some embodiments, the side arm element further comprises one or more small prongs.

[0086] In some embodiments, one or more small protrusions are provided that are engagable or of a shape or form that corresponds to the material of the side arm.

[0087] In some embodiments, the interaction or engagement of the small protrusions with the material of the side arm provides resistance to flexing or bending (or hinging or elastic deformation) of the side arm element.

[0088] In some embodiments, the material of the side arm is at least partially compressible (or may be substantially incompressible or partially compressible) such that the small protrusions can translate any force or movement applied to the side arm element as a compression of the material of the side arm (or can translate any force or movement applied to the side arm element as a stretch of the material when the material is tensioned by the small protrusions).

[0089] In some embodiments, the side arm material encapsulates or covers at least one side arm element.

[0090] In some embodiments, the side arm partially encloses or partially covers at least one side arm element.

[0091] In some embodiments, the side arm completely encloses or covers at least one side arm element.

[0092] In some embodiments, the material of the side arm fills one or more voids between the side arm element and the side arm.

[0093] In some embodiments, the side arm material surrounds the side arm element and positions the side arm element within, at, or adjacent to one or more predetermined or pre-positioned locations or localized compensation areas (or locations).

[0094] In some embodiments, when a pair of side arms are provided, each of the side arms extends laterally from the bridge portion, with one side arm of the pair being configured to extend substantially around the left side of the user's face and the other side arm of the pair being configured to extend substantially around the right side of the user's face.

[0095] In some embodiments, the or each side arm extends substantially around the user's face, optionally along at least a portion of the user's cheek.

[0096] In some embodiments, the or each side arm extends substantially laterally, away from or outward from the user's sagittal plane.

[0097] In some embodiments, the or each side arm element extends for at least a portion or a substantial portion of the length of each such side arm that includes said side arm element, or along or through each such side arm that includes said side arm element.

[0098] In some embodiments, the or each side arm element includes a plurality of side arm element limbs.

[0099] In some embodiments, the side arm element rim includes or comprises one or more small protrusions.

[0100] In some embodiments, the or each side arm or side arm element, or both, forms or is configured to provide at least a portion of a passageway for receiving a gas supply to be delivered to a user through the outlet or outlets, or for receiving a conduit for delivering gas to a user through the outlet or outlets.

[0101] In some embodiments, the side arm defines a passageway.

[0102] In some embodiments, the side arm element defines a passageway.

[0103] In some embodiments, the portion of the passageway formed at least in part by the side arm element is at least 50% of the wall perimeter (e.g., of a unit length portion) of the passageway so formed.

[0104] In some embodiments, the portion of the passageway at least partially formed by the side arm is the remainder of the wall perimeter or wall perimeter (e.g., a unit length portion) that would have been formed by the side arm element.

[0105] In some embodiments, the passageway is a void space or cavity or recess within or through the side arm or side arm element or both, into which gas may be directed or supplied for delivery to an outlet or outlets.

[0106] In some embodiments, the passageway is defined at least in part by the side arm and at least in part by the side arm element.

[0107] In some embodiments, the side arm includes a port for accessing a passageway extending to the gas outlet for delivering gas to the gas outlet.

[0108] In some embodiments, each side arm of the pair of side arms includes a port for accessing a passageway within each side arm that extends to a corresponding gas outlet.

[0109] In some embodiments, each side arm provides a separate passageway for separately delivering gas to a corresponding gas outlet.

[0110] In some embodiments, the side arm or arms are positioned over the user's face during use.

[0111] In some embodiments, the side arm or arms are placed on the user's face over the cheeks when in use.

[0112] In some embodiments, the interface is a nasal cannula that includes a pair of nasal prongs as outlets, and a pair of side arms that can be attached to a headgear or retention system to hold the nasal cannula in place when worn by a user in use.

[0113] In some embodiments, the support system includes a detachable connection system for detachably connecting a patient interface, such as at least a rear portion of each side arm, to the user's face (e.g., the detachable connection system may include a hook-and-loop or hook-and-hook type connector for such a detachable system).

[0114] In some embodiments, the detachable connection system includes at least one pad attached to the user's face, onto which the patient interface may be detachably engageable.

[0115] In some embodiments, the bridge elements are or include a polymeric material.

[0116] In some embodiments, the or each side arm element is or includes a polymeric material.

[0117] In some embodiments, the polymeric material is one or a combination of any one or more of a thermoplastic elastomer, a polypropylene-based elastomer, a liquid silicone rubber, or a breathable thermoplastic polyurethane, or a breathable polyamide; more preferably, the polymer may be a polyolefin, a thermoplastic elastomer, or a breathable thermoplastic elastomer, such as, but not limited to, a thermoplastic elastomer family including a styrene block copolymer, a copolyester elastomer, or a thermoplastic polyolefin elastomer, or a thermoplastic polyurethane elastomer; even more preferably, the polymer has a Shore A hardness of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90.

[0118] Nasal cannulae can be used as a patient interface in high-flow therapy systems. When worn, gas is delivered through nasal delivery elements (e.g., tubular prongs) of the nasal cannula, which are placed within the patient's nostrils. In some patients, particularly neonatal or infant patients, compressive forces exerted by another object (e.g., when resting the face on a pillow or bed frame) or facial contortions due to emotional expression (e.g., when crying or grimacing) can cause the forces acting on the nasal cannula to push the nasal delivery elements out of the nostrils. Although nasal cannulas may be configured to reduce the tendency of the nasal delivery elements to become dislodged from the nostrils due to many of these forces (see, e.g., commonly owned International Application No. PCT / NZ2014 / 000217, commonly owned U.S. Patent Application No. 61 / 891697, commonly owned U.S. Patent Application No. 61 / 919579, commonly owned U.S. Patent Application No. 62 / 052980, or commonly owned U.S. Patent Application No. 62 / 064106, the disclosures of each of which are incorporated herein by reference in their entireties), in some cases the nasal delivery elements may still splay apart when such forces are applied. A solution to the above problem is sought.

[0119] In some embodiments, the patient interface includes a first side arm adapted to be positioned on or adjacent a first portion of the user's face, a second side arm adapted to be positioned on or adjacent a second portion of the user's face, a bridge extending between and connecting the first and second side arms, and a support structure positioned across at least a portion of the bridge.

[0120] In some embodiments, the support structure extends across the entire bridge. In some configurations, the support structure is disposed across at least a portion of the user-facing portion of the bridge. In some configurations, the support structure is disposed across a portion of the non-user-facing portion of the bridge. In some configurations, the support structure is disposed across the entire non-user-facing portion of the bridge. In some configurations, the user-facing portion of the bridge is adapted to rest on or be adjacent to the user's philtrum. In some configurations, the support structure is configured to resist tension forces. In some configurations, the support structure is configured to resist compression forces. In some configurations, the support structure is configured to resist shear forces. In some configurations, the support structure alters the neutral axis of the bridge in use, reducing or resisting bending in the bridge section.

[0121] In some embodiments, the support structure is at least partially formed from a textile material. In some such configurations, the textile material is a woven, nonwoven, or knitted textile material.

[0122] In some embodiments, the support structure is a sheet. In some configurations, the support structure comprises a rigid material. In some configurations, the support structure comprises a semi-rigid material.

[0123] In some embodiments, the support structure is formed from a polymeric material. In some configurations, the support structure and the bridge are at least partially formed from the same polymeric material. In some configurations, the polymeric material comprises a malleable and flexible polymer. In some configurations, the polymeric material comprises a rigid polymer. In some configurations, the support structure is formed from a more rigid material than the material forming the bridge.

[0124] In some configurations, the first body is adapted to rest against a user's cheek.

[0125] In some embodiments, the first and second side arms are adapted to rest against the cheeks of a user.

[0126] In some embodiments, the first and / or second side arms include one or more nasal delivery elements or prongs adapted to rest within one or more of a user's nostrils. In some such configurations, the one or more nasal delivery elements are configured to allow ambient gases outside the patient interface to pass through the nares. In other words, the nasal delivery elements may be non-sealingly positioned within the nares. In some such configurations, the one or more nasal delivery elements are shaped or angled to extend inward toward the user's nasal septum. In some such configurations, the one or more nasal delivery elements are shaped or angled so that, in use, the tips of the one or more nasal delivery elements point toward the back of the user's head. In some such configurations, the first and / or second side arms include one or more gas delivery lumens in pneumatic communication with the one or more nasal delivery elements. In some such configurations, one or more gas delivery conduits may be in pneumatic communication with the one or more gas delivery lumens. In other configurations, the one or more nasal delivery elements may be configured to be sealingly positioned within the nares.

[0127] In some embodiments, the support structure extends along the first and / or second side arms. In some such configurations, the support structure extends along the user-facing portions of the first and / or second side arms. In some such configurations, the support structure extends only along the user-facing portions of the first and / or second side arms. In some such configurations, at least a portion of the support structure on the user-facing portions of the first and / or second side arms is adapted to connect with one or more fixation structures secured to the face to secure the patient interface to the face. In some configurations, the support structure extends along the non-user-facing portions of the first and / or second side arms.

[0128] In some embodiments, the patient interface is shaped to conform to the contours of a user's face. In some configurations, the first side arm and / or the second side arm include one or more hinge or pivot joints that allow movement of the first and / or second side arms relative to each other and / or relative to the bridge.

[0129] In some embodiments, the first and / or second side arms include one or more regions of reduced thickness relative to adjacent regions of the first and / or second side arms. In some such configurations, the one or more regions of reduced thickness are located in portions of the first and / or second side arms that rest against one or more of the user's cheeks. In some such configurations, the one or more regions of reduced thickness are located on the outer edges of the first and / or second side arms. In some configurations, the one or more regions of reduced thickness are located only on the outer edges of the first and / or second side arms.

[0130] In some embodiments, the patient interface includes one or more mounting structures secured to the user-facing portions of the first and / or second side arms, the one or more mounting structures adapted to connect with one or more securing structures secured to the face to secure the patient interface to the face.

[0131] According to at least one aspect disclosed herein, there is provided a nasal cannula including first and second side arms adapted to be positioned against or adjacent to a user's cheeks, at least one nasal delivery element extending from the first and / or second side arms and adapted to be placed non-sealingly within one or more nostrils of the user, a bridge connecting the first and second side arms, and a reinforcing structure disposed over at least a portion of the bridge.

[0132] In other embodiments, the at least one nasal delivery element may be adapted to be sealingly placed within one or more nostrils of a user.

[0133] In some embodiments, the reinforcing structure is disposed over only a portion of the bridge. In some configurations, the reinforcing structure is disposed over at least a portion of the user-facing portion of the bridge. In some such configurations, the reinforcing structure is disposed over only a portion or all of the user-facing portion of the bridge. In some configurations, the reinforcing structure is configured to resist compressive forces. In some configurations, the reinforcing structure is configured to resist tension forces. In some configurations, the reinforcing structure is configured to resist shear forces. In some configurations, the reinforcing structure is configured to resist bending by displacing the neutral axis of the bridge in use.

[0134] In some embodiments, the reinforcing structure is at least partially formed from a textile material. In some such configurations, the textile material is a woven, nonwoven, or knitted textile material.

[0135] In some embodiments, the reinforcing structure is a sheet. In some configurations, the reinforcing structure comprises a rigid material. In some configurations, the reinforcing structure comprises a semi-rigid material.

[0136] In some embodiments, the reinforcement structure and the bridge are at least partially formed from the same polymeric material. In some configurations, the polymeric material comprises a malleable and flexible polymer. In some configurations, the polymeric material comprises a rigid polymer. In some configurations, the reinforcement structure comprises a material that is more rigid than the material forming the bridge.

[0137] In some embodiments, at least one nasal delivery element is shaped or angled to extend inward toward the user's nasal septum.

[0138] In some embodiments, at least one nasal delivery element is shaped or angled so that, in use, the tip points toward the back of the user's head.

[0139] In some embodiments, the first and / or second side arms include one or more gas delivery lumens in pneumatic communication with at least one nasal delivery element. In some such configurations, the nasal cannula further includes one or more gas delivery conduits in pneumatic communication with the one or more gas delivery lumens.

[0140] In some embodiments, the reinforcement structure extends along the first and / or second side arms. In some such configurations, the reinforcement structure extends along a user-facing portion of the first and / or second side arms. In some such configurations, the reinforcement structure extends only along a user-facing portion of the first and / or second side arms. In some such configurations, at least a portion of the reinforcement structure on the user-facing portion of the first and / or second side arms is adapted to connect with one or more securement structures secured to the face to secure the nasal cannula to the face. In some configurations, the reinforcement structure extends across a non-user-facing portion of the first and / or second side arms. In some configurations, the reinforcement structure is located on a non-user-facing portion of the bridge. In some configurations, the user-facing portion of the bridge is adapted to rest on or adjacent to the user's philtrum.

[0141] In some embodiments, the nasal cannula is shaped to conform to the contours of the user's face.

[0142] In some embodiments, the first and / or second side arms include one or more regions of reduced thickness relative to adjacent regions of the first and / or second side arms. In some such configurations, the regions of reduced thickness are located on the outer edges of the first and / or second side arms. In some such configurations, the regions of reduced thickness are located only on the outer edges of the first and / or second side arms.

[0143] In some embodiments, the nasal cannula further includes one or more mounting structures secured to the user-facing portions of the first and / or second side arms, the one or more mounting structures adapted to connect with one or more securing structures secured to the face to secure the nasal cannula to the face.

[0144] According to at least one aspect disclosed herein, a nasal cannula is disclosed, the nasal cannula including a first side arm adapted to rest on a first portion of a user's face, a second side arm adapted to rest on a second portion of the user's face, and at least one nasal delivery element extending from the first and / or second side arm adapted to be non-sealingly placed within one or more of the user's nostrils, wherein the first and / or second side arm include one or more regions of reduced thickness relative to adjacent regions of the first and / or second side arm.

[0145] In some embodiments, the first and second side arms are adapted to rest against the cheeks of a user.

[0146] In some embodiments, the one or more areas of reduced thickness are located on a portion of the first and / or second side arms that rests against one or more cheeks of the user.

[0147] In some embodiments, the one or more regions of reduced thickness are located on the outer edges of the first and / or second side arms, and in some such configurations, the one or more regions of reduced thickness are located only on the outer edges of the first and / or second side arms.

[0148] In some embodiments, the nasal cannula further includes a bridge connecting the first side arm and the second side arm.

[0149] In accordance with at least one aspect disclosed herein, a patient interface, such as a nasal cannula, includes: a. a pair of left and right side arms that are placed on the user's face in use; and b. at least one, and preferably a pair of, nasal prongs for insertion into one or more nostrils of the user's nose or for directing a flow of gas into the one or more nostrils of the user's nose. c. a bridge attached to a connection point with the left side arm and a connection point with the right side arm and extending from the connection point with the left side arm to the connection point with the right side arm, wherein one or each of the connection points includes a first movable joint, such as a hinged or pivot joint, that allows a first movement of the bridge relative to each side arm; Includes:

[0150] In some embodiments, the first movable joint allows relative rotation between the end of the bridge and each side arm about at least one axis.

[0151] In some embodiments, the first motion joint is one or a combination of an articulating joint, a pin and barrel joint, and a ball and socket joint.

[0152] In some embodiments, each side arm includes a face pad that is contoured to engage an area of ​​the user's face.

[0153] In some embodiments, at least one, and preferably a pair of, nasal prongs extend from one or each of the more medial ends of each of the left and / or right side arms, or from one or both regions of each side arm substantially adjacent the more medial ends, and the bridge is a bar extending across or adjacent said nasal prongs.

[0154] In some embodiments, the interface further includes a fixture attached to each side arm to facilitate connection of the bar, the fixture including a second movable joint, such as a hinged or pivot joint, that allows a second movement of the mount relative to each side arm to which it is attached, and the bar attached to the fixture via the first movable joint.

[0155] In some embodiments, the fittings are slidably attached to each side arm, allowing adjustment of their relative position along the side arm, thereby adjusting the distance between the prongs.

[0156] In some embodiments, when the patient interface is in situ on the user's face, displacement of the position of one or both of the left and / or right side arms is transmitted to the bar via the connection points or attachments and the first and / or second movable joints, respectively, in a manner that minimizes movement of the prong or prongs relative to the user's nostrils.

[0157] In some embodiments, the first movable joint and the second movable joint are aligned to allow movement of the attached components in substantially the same direction.

[0158] In some embodiments, the first and second movable joints are misaligned to allow movement in different orientations.

[0159] In some embodiments, the bar includes one or more additional moveable joints.

[0160] In some embodiments, the left and right side arms, including the nasal prongs, are relatively flexible or compliant with the bar and / or attachment.

[0161] In some embodiments, the connection point or fitting includes a finger extending outwardly from the connection point or fitting, on which the first movable joint for connecting to the bar is located.

[0162] In some embodiments, the bar is an over-center component of the patient interface, with connection points or attachments located symmetrically on each of the side arms.

[0163] In some embodiments, the second movable joint is one or a combination of an articulated joint, a pin and barrel joint, and a ball and socket joint.

[0164] In some embodiments, the bridge includes at least one and preferably a pair of nasal prongs.

[0165] In some embodiments, each first movable joint is disposed between an end of the bridge and an inner end of a respective side arm.

[0166] In some embodiments, the first movable joint allows relative rotation between the end of the bridge and each of the side arms about three substantially orthogonal axes.

[0167] In some embodiments, the first movable joint comprises a ball and socket joint.

[0168] In some embodiments, a pair of first movable joints are provided between each end of the bridge and the inner ends of the left and right side arms, respectively.

[0169] In some embodiments, when the patient interface is in situ on the user's face, displacement of the position of one or both of the left and / or right side arms is transmitted to the or each first movable joint in a manner that minimizes displacement of the bridge and the prong or prongs relative to the user's nostrils.

[0170] In accordance with at least one aspect disclosed herein, a patient interface, such as a nasal cannula, includes: a. a body portion that is placed on the user's face during use; b. at least one, and preferably a pair of, nasal prongs extending from the body portion and, in an operative position, for insertion into or directing the flow of gases into the nostril or nostrils of the user's nose; Including, c. the body has at least one hollow region having a fluid passageway connected to nasal prongs for supplying gas to the nostrils of the user's nose; d. substantially resisting transmission of displacement forces from one or more regions of the hollow region body portion to the nasal prongs during delivery of fluid through the fluid passageway, maintaining the operative position of the prongs.

[0171] In some embodiments, the body portion includes a generally rigid frame and at least one relatively soft hollow region extending from the rigid frame.

[0172] In some embodiments, at least one hollow region is expandable and expands in the direction of extension of the nasal prong or prongs.

[0173] In some embodiments, the hollow region is coupled to the nasal prongs and is inflatable upon delivery of gas to the nostrils of the user's nose, and the hollow region is positioned in at least an inflated state against the philtrum or upper lip region of the user to substantially maintain the nasal prongs in an operative position.

[0174] In some embodiments, in the expanded state, the hollow region is substantially deeper than the depth of the frame of the body portion adjacent the hollow region.

[0175] In some embodiments, either end of the body portion includes a user face-contacting surface that is contoured to engage the cheek region of a user's face in use.

[0176] In some embodiments, the body portion, or at least one end of the body portion, is shaped or curved to substantially complement the facial structure of a user in use.

[0177] In some embodiments, the body portion includes a pair of respective left and right body segments or side arms.

[0178] In some embodiments, the left and right body segments or side arms are substantially flexible.

[0179] In some embodiments, the nasal prongs extend from one or each of the more medial ends of each left and / or right body segment or side arm, or from one or both regions of each body segment or side arm substantially adjacent the more medial ends.

[0180] In some embodiments, the bridge portion connects to the more inner ends of each of the left and right side arms.

[0181] In some embodiments, the bridge portion is substantially stiffer than the left and right body segments.

[0182] In some embodiments, at least one, and preferably both, left and / or right body segments include hollow regions, each having a fluid passageway for delivering a quantity of gas to each nasal prong.

[0183] In some embodiments, the interface further comprises one or more internal struts, the one or more internal struts extending between opposing interior surfaces of the hollow region to maintain an open fluid passageway.

[0184] In some embodiments, the one or more internal struts comprise a plurality of struts spatially distributed within the hollow region.

[0185] In accordance with at least one aspect disclosed herein, a patient interface, such as a nasal cannula, includes: a. a body portion that is placed on the user's face during use; b. a bridge portion extending away from the body portion; c. at least one, and preferably a pair of, nasal prongs extending from the bridge portion and, in an operative position, for insertion into or directing the flow of gases into the nostril or nostrils of the user's nose; Including, d. The body portion is actively adjusted using potentials from the system or stored in the cannula.

[0186] In some embodiments, the body portion is placed on one cheek of the user's face during use, with the other cheek of the user's face free from the interface.

[0187] In accordance with at least one aspect disclosed herein, a patient interface, such as a nasal cannula, includes: a. a body portion that is placed on the user's face during use; b. at least one, and preferably a pair of, nasal prongs extending from the body portion and, in an operative position, for insertion into or directing the flow of gases into the nostril or nostrils of the user's nose; Including, c. the patient interface has a non-use configuration, wherein in the non-use configuration, the body portion is substantially flat or at least one end of the body portion is substantially flat and coplanar with the other end of the body portion, and at least one, and preferably a pair of, nasal prongs extend outwardly away from a central plane of the body portion; d. also having an in-use configuration, wherein the body portion, or at least one end of the body portion, is shaped or curved to substantially complement the facial structure of a user when in use, and wherein the nasal prongs extend in a direction substantially parallel to a central plane of the body portion.

[0188] In some embodiments, the body portion is a single, integrally formed component.

[0189] In some embodiments, the body portion and at least one and preferably a pair of nasal prongs are a single, integrally formed component.

[0190] In some embodiments, the end of the body portion is positioned over the user's face during use.

[0191] In some embodiments, the ends of the body portion are positioned on the cheeks of the user's face during use.

[0192] In some embodiments, the interface further comprises a bridge portion having a cavity that is concave when viewed away from the user.

[0193] In some embodiments, the or each cavity is filled or at least partially filled with a relatively soft and / or flexible material, or filled with a relatively stiffer or reinforcing material.

[0194] In some embodiments, the interface further comprises an arcuate transition between the bridge and the adjacent portion of the body.

[0195] In some embodiments, the arcuate transition is spaced outwardly from the prong.

[0196] In some embodiments, the center of each arcuate transition is located outward relative to the midline or longitudinal axis of the adjacent prong to reduce movement of the prongs during use.

[0197] In some embodiments, the body portion has a relatively thin thickness to reduce the resilience / spring force exerted on the user's philtrum.

[0198] In some embodiments, the flexing portion of the patient interface may have ridges, corrugations or notches to minimize or eliminate kinking of the patient interface.

[0199] In some embodiments, the prongs may be angled outwardly from one another at an angle of approximately 32° in the non-use configuration.

[0200] In some embodiments, the area of ​​the patient interface that will come into contact with the user's philtrum has a surface finish that enhances comfort.

[0201] In some embodiments, the interface further comprises a loop of material for releasably connecting the patient interface to the face of a user.

[0202] In some embodiments, the interface is a nasal cannula that includes a pair of nasal prongs as outlets, and the cannula can be fitted with a headgear or retention system to hold the nasal cannula in place when worn by a user in use.

[0203] In some embodiments, the support system includes a detachable connection system for detachably connecting the patient to the face of the user (e.g., the detachable connection system may include a hook-and-loop or hook-and-hook type connector for such a detachable system).

[0204] In some embodiments, one component of the detachable connection system is provided on the patient interface.

[0205] In some embodiments, a component of the detachable connection system provided on the patient interface is provided with the interface by overmolding or overmolding the interface to or around the component. By overmolding a portion of the interface onto a component of the detachable connection system, a more durable or robust attachment or engagement of the component to the interface may be achieved. The material used to form or mold into the interface may be allowed to simultaneously flow around or onto components of the detachable connection system, such as pads or patches that include loops (or alternatively hooks). This may allow for more integrated components that include such loops or hooks into the patient interface.

[0206] In some embodiments, the overmolding or overmolded connection of an interface to or around a part may extend around at least the periphery of the part, and optionally partially or entirely over the face of the part from which components of the detachable connection system may extend.

[0207] For example, in some embodiments, if the part provides a hook or loop or another type of two-part detachable connection system, the overmold may extend around the periphery of such part, or may extend partially or entirely over the surface from which the hook or loop or another type of two-part detachable connection system may extend.

[0208] Alternative embodiments are also provided in which the attachment of components to the patient interface may occur after the interface has first been molded or formed (or manufactured). For example, the molded or formed (or manufactured) interface may be used in a subsequent or additional overmolding process or step to connect or attach each of the components and the interface together via an overmolded connection. As noted above, the molding material may be allowed to flow around the periphery of such components, or may partially or entirely cover the face of the components.

[0209] In some embodiments, the detachable connection system includes at least one pad attached to the user's face, onto which the patient interface may be detachably engageable.

[0210] In some embodiments, the body portion or at least one end of the body portion comprises a resilient material.

[0211] In some embodiments, the body portion or at least one end of the body portion comprises a flexible material.

[0212] In some embodiments, the interface is or includes a polymeric material.

[0213] In some embodiments, the polymeric material is one or a combination of any one or more of a thermoplastic elastomer, a polypropylene-based elastomer, a liquid silicone rubber, or a breathable thermoplastic polyurethane, or a breathable polyamide; more preferably, the polymer may be, but is not limited to, a polyolefin, a thermoplastic elastomer, or a breathable thermoplastic elastomer, such as a styrene block copolymer, a copolyester elastomer, or a thermoplastic polyolefin elastomer, or a thermoplastic polyurethane elastomer family, and even more preferably, a polymer having a Shore A hardness of less than about 30, or from about 30 to about 90, or from about 30 to about 80, or from about 30 to about 70, or from about 30 to about 60, or from about 30 to about 50, or from about 30 to about 40, or from about 30, or from about 40, or from about 50, or from about 60, or from about 70, or from about 80, or from about 90.

[0214] According to at least one aspect disclosed herein, a patient interface, such as a nasal cannula, includes an elongated body that, in use, is positioned on a user's face, the body including at least one, and preferably a pair of, nasal prongs for insertion into or directing a flow of gases into a nostril or nostrils of the user's nose, and at least one, and preferably a pair of, face-contacting surfaces movably coupled to the body and responsive to force or movement, or both, applied to the face-contacting surfaces and at least partially reducing the transmission of such force and / or movement to the body and the nasal prongs.

[0215] In some embodiments, each face-contacting surface is movably coupled to an end portion of the body.

[0216] In some embodiments, each face-contacting surface is slidably coupled to the body.

[0217] In some embodiments, each face-contacting surface has a hollow guide associated with it for slidably receiving a portion of the body therein.

[0218] In some embodiments, the patient interface further includes a resilient member associated with each face-contacting surface.

[0219] In some embodiments, the elastic member is coupled between the face-contacting portion and the body.

[0220] In some embodiments, the elastic member urges the face-contacting surface toward the center of the body.

[0221] In some embodiments, the resilient member comprises a compression spring.

[0222] In some embodiments, the body includes a bridge portion from which the nasal prongs extend, hi some embodiments, the bridge portion curves inward and extends toward the user's nasal septum in situ.

[0223] In some embodiments, the body is substantially rigid.

[0224] In some embodiments, the body is substantially hollow and is fluidly coupled to the nasal prongs to allow gas flow within the body.

[0225] In some embodiments, at least one end, and preferably both ends, of the body are configured to fluidly couple to a gas flow path of a breathing circuit.

[0226] In some embodiments, each face-contacting surface is contoured to engage the cheeks of the user's face.

[0227] According to at least one aspect disclosed herein, a patient interface, such as a nasal cannula, includes a body that, in use, is placed on a user's face, the body including, in an operative position, at least one, and preferably a pair of, nasal prongs for insertion into or directing a flow of gases into a nostril or nostrils of the user's nose, and at least one, and preferably a pair of, active elements, each configured to be actuated in response to input energy to move at least one other region of the body to hold the nasal prong in the operative position.

[0228] In some embodiments, the input energy is non-mechanical energy.

[0229] In some embodiments, the at least one active element is configured to convert input energy into mechanical energy to move at least one other region of the body.

[0230] In some embodiments, each active element includes at least one, and preferably a pair of, expanding elements configured to expand in response to input energy and move at least one other area adjacent the nasal prongs to hold the nasal prong or prongs in an operative position.

[0231] In some embodiments, the expansion element is located on the user-engagement side of the body.

[0232] In some embodiments, the inflatable element is configured to be placed adjacent to the cheek of the user's face in situ.

[0233] In some embodiments, the patient interface further comprises one or more hinges, pivots or articulating joints, or any combination thereof, operable in response to actuation of one or more of the active elements.

[0234] In some embodiments, there are one or more hinges at the bridge of the body from which the nasal prongs extend.

[0235] In some embodiments, the expansion element is configured to expand in response to input energy and move a bridge portion of the body such that the nasal prongs extend toward and / or against the user's philtrum in situ.

[0236] In some embodiments, the body is flexible in at least one region and deforms in response to expansion of the expansion element, causing the bridge portion to move towards the philtrum in situ.

[0237] In some embodiments, the bridge portion includes one or more hinges.

[0238] In some embodiments, the at least one active element is an electromechanical element configured to receive electrical activation energy to move at least one other region of the body.

[0239] In some embodiments, the electromechanical element is coupled to an electrical circuit and is actuated in response to an electrical activation signal generated by a change in voltage, resistance, or current, or any combination, in the electrical circuit.

[0240] In some embodiments, movement or force or both experienced by one or more regions of the body generates an electrical activation signal.

[0241] In some embodiments, movement of one or more regions of the body engages electrical contacts in a circuit, generating an electrical activation signal.

[0242] In some embodiments, movement of one or more regions of the body causes a change in the electrical resistance of the circuit, generating an electrical activation signal.

[0243] In some embodiments, the electromechanical element comprises a conductive polymer or a bimetallic strip or any combination thereof.

[0244] In some embodiments, the electromechanical element includes a pair of electromagnets.

[0245] In some embodiments, the input energy is indicated by a change in humidity in one or more regions of the body, and the at least one active element is configured to activate in response to a threshold humidity or a change in humidity or both to move at least one other region of the body and hold the nasal prongs in an operative position.

[0246] In some embodiments, the active element is configured to absorb water and expand in response to a threshold humidity or a change in humidity or both, thereby displacing at least one other region of the body.

[0247] In some embodiments, the active element, or at least a portion of the active element, is positioned adjacent the base of a corresponding nasal prong and is configured to engage the philtrum in situ, such that expansion of the active element, or a portion of the active element, pivots the nasal prong toward the back of each nostril of the user and holds the nasal prong in the operative position.

[0248] In some embodiments, the at least one active element comprises a polymeric material configured to expand with increased humidity.

[0249] In some embodiments, the at least one active element forms at least a portion of the body.

[0250] In some embodiments, the body includes a left body portion or side arm and a separate right body portion or side arm, each of the left and right body portions or side arms having an active element and nasal prongs associated with each of the left and right body portions or side arms.

[0251] In some embodiments, the patient interface further includes a bridge portion that straddles the active elements of each of the left and right side arms and holds the elements in place against the user's philtrum.

[0252] In some embodiments, the patient interface further comprises at least one, and preferably a pair of, face-contacting pads configured to engage the user's face in use, with the or either end of the bridge portion being coupled to one or more face-contacting pads respectively.

[0253] In accordance with at least one embodiment disclosed herein, a patient interface, such as a nasal cannula, includes: a. a body portion that is placed on a user's face during use, the body portion having left and right side arms and a bridge portion between the left and right side arms; b. at least one, and preferably a pair of, nasal prongs extending from the bridge portion and for, in an operative position, being inserted into or directing the flow of gases into the nostril or nostrils of the user's nose; Including, c. the body portion has at least one fluid passageway connected to the nasal prongs for supplying gas to the nostrils of the user's nose; d. The cross section of the passageway varies along the length of the body portion to provide a region of varying flexibility along the body portion.

[0254] In some embodiments, the cross-sectional shape of the passageway varies along at least a portion of the length of the body portion.

[0255] In some embodiments, the cross-section changes from a generally circular cross-section at or near the outer end for connection (either removably or permanently) with a breathing tube or conduit to an elongated cross-section having a major axis that is positioned substantially vertically (parallel to the user's face).

[0256] In some embodiments, the elongated cross-section is located within or forms a bending region or hinge portion of the body portion, the elongated cross-section providing greater flexibility for bending the body portion in the direction of the minor axis of the elongated cross-section towards or away from the user's face.

[0257] In some embodiments, the elongated cross section is adjacent a bridge portion of the body portion between the prongs and the entrance to the passageway to which the breathing tube or conduit is attached.

[0258] In some embodiments, the body portion bends preferentially towards and away from the user's face at bending regions of the body portion.

[0259] In some embodiments, the cross-sectional area of ​​the passage is substantially constant along a portion of the length of the body portion.

[0260] In some embodiments, the bridge portion is relatively stiff compared to other portions of the patient interface.

[0261] In some embodiments, the bridge portion transitions into the left and right side arms by flaring or curving outward away from the user's face side of the bridge portion, and the left and right side arms curve rearward from the front extent of the body portion, away from the bridge portion.

[0262] In some embodiments, the curvature of the bridge portion on the user's face side and / or the transition regions between the bridge portion and the left and right side arms has a relatively large radius (or radii) so that pressure from the bridge and / or transition regions on the user's face is distributed over the user's philtrum or upper lip area.

[0263] In some embodiments, the body portions extend forward from each side of the bridge portion to a position forward of the bridge portion, and then extend rearward such that, at least in the in-use position, the distal ends of the left and right side arms are positioned rearward of the bridge portion.

[0264] In some embodiments, when viewed from above, the body portion includes a U-shaped region between each nasal prong and the left and right side arms, with the inside of the U-shaped region facing the user's face in use.

[0265] In some embodiments, each U-shaped region forms or is located within a bending region through which the body portion preferentially bends as the left or right portion of the body portion bends toward or away from the user's face.

[0266] In some embodiments, the bend region tends to bend at the valley of the U-shaped region.

[0267] In some embodiments, the interior angle of the U-shaped region is less than about 130 degrees, or 120 degrees, or 110 degrees, or 105 degrees.

[0268] In some embodiments, the bending region is located outward and forward from the nasal prongs relative to the facial side of the body portion.

[0269] In some embodiments, the patient interface is a single, integrally formed component formed from a single material.

[0270] In some embodiments, the patient interface is formed from a single molding operation.

[0271] In some embodiments, the patient interface is formed from a thermoplastic or silicone material having a Shore A hardness of about 5-60.

[0272] In some embodiments, the patient interface includes at least one pad of a retention system for holding the interface in place when worn by a user during use, the pad being attached to at least one of the left and right side arms of the body portion, the pad being substantially symmetrical about a central generally vertical axis dividing the pad into left and right sides so that the same shaped pad can be applied to both the left and right side arms of the body portion.

[0273] In some embodiments, the pad or pads include a hook portion for connecting to a complementary hook or loop portion of a corresponding pad on the user's face.

[0274] In some embodiments, the cross-section of the passageway at the base of the prong is an asymmetric cross-section, with one side of the cross-section being flatter than the other side of the cross-section.

[0275] In some embodiments, the passageway extending along the prong changes shape from an asymmetrical cross-section at the base of the prong to a circular cross-section at the tip of the prong.

[0276] In some embodiments, the cross-sectional area of ​​the prongs decreases from the base to the tip of the prongs.

[0277] In some embodiments, the flatter side of the prongs is positioned towards the front side of the patient interface (facing away from the user's face).

[0278] In some embodiments, the body portion includes more material per length (greater cross-sectional area) in the bridge portions than in other portions of the body portion.

[0279] In some embodiments, the bridge region includes solid sections between the prongs such that the bridge region is stiffer than the bending region.

[0280] In some embodiments, the bridge portion includes thicker wall sections than the wall sections of the bend region such that the bridge portion is stiffer than the bend region.

[0281] In some embodiments, the bridge portion also comprises a more rigid material to provide rigidity to the bridge region.

[0282] In some embodiments, the bridge region has a height or vertical dimension sufficient to provide torsional stability and prevent the bridge region from twisting during use.

[0283] In some embodiments, the passageway is located approximately vertically centered in the left and / or right portions of the body portion.

[0284] In some embodiments, the passageway is located approximately centrally on the pads of the retention system on each of the left and right side arms for holding the interface in place when worn by a user in use.

[0285] In some embodiments, the horizontal neutral bending axis of the body portion is disposed approximately vertically in the center of a fastening system for securing the interface to a user's face.

[0286] In some embodiments, the body portion includes varying geometries to achieve areas of greater flexibility and areas of lesser flexibility.

[0287] In some embodiments, the thickness of the body portion varies to provide regions with different flexibility.

[0288] In some embodiments, the body portion has a wall or section of thinner thickness surrounding the passageway in the bend region of the body portion than in other regions of the body portion.

[0289] In some embodiments, the cross-sectional area of ​​the body portion at the valley of the U-shaped region of the body portion is smaller than the cross-sectional area of ​​the adjacent region of the body portion.

[0290] In some embodiments, the body portion has a left passageway and a right passageway, the left passageway and the right passageway being separated by a dividing section in the bridge region.

[0291] In some embodiments, the dividing section is the central region of the bridge between the two nasal prongs.

[0292] In some embodiments, the central region of the bridge region is solid.

[0293] In some embodiments, each prong has a base integrally formed with the bridge portion of the body portion of the patient interface, the base of each prong including a fillet between a wall of the prong and the bridge portion, the fillet extending around the periphery of the prong, and the radius of the fillet varying around the periphery of the prong.

[0294] In some embodiments, the fillet radius varies around the circumference of the prong, varying the wall thickness of the prong at the base of the prong.

[0295] In some embodiments, the thickness of the prong base varies around the circumference of the prong.

[0296] In some embodiments, the radius of the fillet on the non-facial side of the body portion is smaller than the radius of the fillet on the inside of the prongs (between the two prongs) and the radius of the fillet on the outside of the prongs.

[0297] In some embodiments, the radius of the inner fillet of the prong is greater than the radius of the outer fillet of the prong.

[0298] In some embodiments, the radius of the facial fillet of the body portion is between the inner and outer radii of the prongs.

[0299] In some embodiments, each prong has a base integrally formed with the bridge portion of the body portion of the patient interface, and the thickness of the prong base varies around the circumference of the prong.

[0300] In accordance with at least one embodiment disclosed herein, a patient interface, such as a nasal cannula, includes: a. a body portion that is placed on a user's face during use, the body portion having left and right side arms and a bridge portion between the left and right side arms; b. at least one, and preferably a pair of, nasal prongs extending from the bridge portion and for, in an operative position, being inserted into or directing the flow of gases into the nostril or nostrils of the user's nose; 1. A patient interface comprising: c. the body portion has at least one fluid passageway connected to the nasal prongs for supplying gas to the nostrils of the user's nose; d. at least one pad of a retention system for holding the interface in place on the user's face, the pad being attached to at least one of the left and right side arms of the body portion, the pad being substantially symmetrical about a central axis dividing the pad into left and right sides such that a pad of the same shape can be applied to both the left and right side arms of the body portion; a patient interface including:

[0301] In accordance with at least one embodiment disclosed herein, a patient interface, such as a nasal cannula, includes: a. a body portion that is placed on a user's face during use, the body portion having left and right side arms and a bridge portion between the left and right side arms; b. at least one, and preferably a pair of, nasal prongs extending from the bridge portion and for, in an operative position, being inserted into or directing the flow of gases into the nostril or nostrils of the user's nose; Including, c. the body portion has at least one fluid passageway connected to the nasal prongs for supplying gas to the nostrils of the user's nose; d. The passageway has an asymmetric cross-section at the base of the prong, one side of the asymmetric cross-section being flatter than the other side of the asymmetric cross-section.

[0302] In some embodiments, the passageway extending along the prong changes shape from an asymmetrical cross-section at the base of the prong to a circular cross-section at the tip of the prong.

[0303] In some embodiments, the cross-sectional area of ​​the prongs decreases from the base to the tip of the prongs.

[0304] In some embodiments, the flatter side of the prongs is positioned towards the front side of the patient interface (facing away from the user's face).

[0305] In accordance with at least one aspect disclosed herein, a patient interface, such as a nasal cannula, includes: a. a body portion that is placed on a user's face during use, the body portion having left and right side arms and a bridge portion between the left and right side arms; b. at least one, and preferably a pair of, nasal prongs extending from the bridge portion and for, in an operative position, being inserted into or directing the flow of gases into the nostril or nostrils of the user's nose; Including, c. the body portion has at least one fluid passageway connected to the nasal prongs for supplying gas to the nostrils of the user's nose; d. The patient interface is a single, integrally formed component made from a single material, and the bridge portion is relatively rigid compared to other portions of the patient interface, including the left and right side arms.

[0306] In some embodiments, the patient interface is formed from a thermoplastic or silicone material having a Shore A hardness of about 5-60.

[0307] In some embodiments, the body portion includes more material per length (greater cross-sectional area) in the bridge portions than in other portions of the body portion.

[0308] In some embodiments, the bridge region includes solid sections between the prongs.

[0309] In some embodiments, the bridge region has a height or vertical dimension sufficient to provide torsional stability and prevent the bridge region from twisting during use.

[0310] In some embodiments, the body portion includes varying geometries to achieve areas of greater flexibility and areas of lesser flexibility.

[0311] In some embodiments, the thickness of the body portion varies to provide regions with different flexibility.

[0312] In some embodiments, the body portion has a wall or section of thinner thickness surrounding the passageway in the bend region of the body portion than in other regions of the body portion.

[0313] In some embodiments, the cross-sectional area of ​​the body portion at the valley of the U-shaped region of the body portion is smaller than the cross-sectional area of ​​the adjacent region of the body portion.

[0314] In some embodiments, the body portion has a left passageway and a right passageway, the left passageway and the right passageway being separated by a dividing section in the bridge region.

[0315] In some embodiments, the dividing section is the central region of the bridge between the two nasal prongs.

[0316] In some embodiments, the central region of the bridge region is solid.

[0317] In accordance with at least one aspect disclosed herein, a patient interface, such as a nasal cannula, includes: a. a body portion that is placed on a user's face during use, the body portion having left and right side arms and a bridge portion between the left and right side arms; b. at least one, and preferably a pair of, nasal prongs extending from the bridge portion and for, in an operative position, being inserted into or directing the flow of gases into the nostril or nostrils of the user's nose; Including, c. The body portion has at least one fluid passageway connected to the nasal prongs for supplying gas to the nostrils of the user's nose, the passageway being located approximately vertically centered on the left and / or right side arms of the body portion.

[0318] In accordance with at least one aspect disclosed herein, a patient interface, such as a nasal cannula, includes: a. a body portion that is placed on a user's face during use, the body portion having left and right side arms and a bridge portion between the left and right side arms; b. at least one, and preferably a pair of, nasal prongs extending from the bridge portion and for, in an operative position, being inserted into or directing the flow of gases into the nostril or nostrils of the user's nose; 1. A patient interface comprising: c. the body portion has at least one fluid passageway connected to the nasal prongs for supplying gas to the nostrils of the user's nose; d. a pad of a retention system on each of the left and right side arms for holding the interface in place on the user's face, the pad having a passageway located approximately in the center of the pad; a patient interface including:

[0319] In accordance with at least one aspect disclosed herein, a patient interface, such as a nasal cannula, includes: a. a body portion that is placed on a user's face during use, the body portion having left and right side arms and a bridge portion between the left and right side arms; b. at least one, and preferably a pair of, nasal prongs extending from the bridge portion and for, in an operative position, being inserted into or directing the flow of gases into the nostril or nostrils of the user's nose; 1. A patient interface comprising: c. the body portion has at least one fluid passageway connected to the nasal prongs for supplying gas to the nostrils of the user's nose; a pad of a support system on each of the left and right side arms for holding the interface in place on the user's face, the pad having a horizontal neutral bending axis of the body portion disposed at approximately the vertical center of the pad; a patient interface including:

[0320] In accordance with at least one aspect disclosed herein, a patient interface, such as a nasal cannula, includes: a. a body portion that is placed on a user's face during use, the body portion having left and right side arms and a bridge portion between the left and right side arms; b. at least one, and preferably a pair of, nasal prongs extending from the bridge portion and for, in an operative position, being inserted into or directing the flow of gases into the nostril or nostrils of the user's nose; Including, c. the body portion has at least one fluid passageway connected to the nasal prongs for supplying gas to the nostrils of the user's nose; d. each prong has a base integrally formed with the bridge portion of the body portion of the patient interface, the base of each prong including a fillet between a wall of the prong and the bridge portion, the fillet extending around the periphery of the prong, the radius of the fillet varying around the periphery of the prong.

[0321] In some embodiments, the fillet radius varies around the circumference of the prong, varying the wall thickness of the prong at the base of the prong.

[0322] In some embodiments, the thickness of the prong base varies around the circumference of the prong.

[0323] In some embodiments, the radius of the fillet on the non-facial side of the body portion is smaller than the radius of the fillet on the inside of the prongs (between the two prongs) and the radius of the fillet on the outside of the prongs.

[0324] In some embodiments, the radius of the inner fillet of the prong is greater than the radius of the outer fillet of the prong.

[0325] In some embodiments, the radius of the facial fillet of the body portion is between the inner and outer radii of the prongs.

[0326] In accordance with at least one aspect disclosed herein, a patient interface, such as a nasal cannula, includes: a. a body portion that is placed on a user's face during use, the body portion having left and right side arms and a bridge portion between the left and right side arms; b. at least one, and preferably a pair of, nasal prongs extending from the bridge portion and for, in an operative position, being inserted into or directing the flow of gases into the nostril or nostrils of the user's nose; Including, c. the body portion has at least one fluid passageway connected to the nasal prongs for supplying gas to the nostrils of the user's nose; d. each prong has a base integrally formed with the bridge portion of the body portion of the patient interface, the thickness of the prong base varying around the circumference of the prong;

[0327] According to at least one aspect disclosed herein, the patient interface includes a single, integrally formed component formed from a single material with one or more bend or hinge regions.

[0328] In some embodiments, the patient interface includes a bridge portion and nasal prongs extending from the bridge portion, the bridge portion being more rigid than the bending or hinge region.

[0329] In some embodiments, the bend or hinge region may be formed by or include at least one bend or hinge element, for example a mechanical hinge.

[0330] The term "cheek" as used in this specification and claims means any area of ​​a user's face at or adjacent to the cheekbone, and may include any area beside and / or below the cheekbone, and / or any other area between around the corresponding user's eyes, ears and nose.

[0331] The term "compensation" as used herein and in the claims, particularly with respect to the various regions or locations thus identified, means a region or location that is capable of at least one or more of the following: shape change, or flexure, or bending, or twisting, shear or shear-type movement, or local displacement, or at least some other form of dynamic behavior or response resulting from the application of a force or applied movement to or resulting from a force or movement exerted on at least a portion of the patient interface.

[0332] As used herein, the term "comprising" means "consisting at least in part of." When interpreting each statement herein containing the term "comprising," there may be other features present than those preceding the term. Related terms such as "comprise" and "comprises" should be interpreted in the same manner.

[0333] The present invention may also be broadly considered to include the parts, elements, and features referred to or shown in the specification of this application, individually or collectively, and any combination of any two or more of said parts, elements, or features, in whole or in part. Where reference is made herein to a particular integer that has a known equivalent in the art to which the invention pertains, such known equivalent is deemed to be incorporated herein as if individually set forth.

[0334] The present invention encompasses the above and also contemplates the structures described below by way of example only.

[0335] These and other features, aspects and advantages of the present disclosure will be described with reference to the following drawings, which are illustrative but should not be taken as limiting the present disclosure. [Brief explanation of the drawings]

[0336] [Figure 1] 1 shows a typical setup of a humidification system for delivering a flow of humidified gas to a patient interface worn by a user. [Figure 2A] 2A-2C illustrate various angles of a patient interface, particularly one incorporating a bridge element into the interface. More specifically, FIG. 2A illustrates a front perspective view of the interface. [Figure 2B] 2A and 2B show various views of a patient interface, particularly one incorporating a bridge element into the interface. More specifically, FIG. 2B shows a rear perspective view of the interface. [Figure 2C]2A-2C illustrate various angles of a patient interface, particularly one incorporating a bridge element into the interface. More specifically, FIG. 2C illustrates a partial cross-sectional view of a side arm of the interface. [Figure 2D] 2A-2D illustrate various angles of a patient interface, particularly one incorporating a bridge element into the interface. More specifically, FIG. 2D illustrates a front perspective view of the bridge element. [Figure 2E] 2D, 2E, and 2F illustrate various angles of a patient interface, particularly one incorporating a bridge element into the interface. More specifically, FIG. 2E illustrates a rear perspective view of FIG. 2D. [Figure 2F-2G] Figure 2F shows a diagram illustrating the shape in plan view of the interface of Figure 2A before one or more compensation regions (or locations) are activated, and Figure 2G shows a diagram after one or more compensation regions (or locations) have been activated in response to an applied force. [Figure 3A] 3A-3C illustrate various angles of a patient interface, particularly one incorporating a bridge element into the interface. More specifically, FIG. 3A illustrates a front perspective view of the interface. [Figure 3B] 3A and 3B show various angles of a patient interface, particularly one incorporating a bridge element into the interface. More specifically, FIG. 3B shows a rear perspective view of FIG. 3A. [Figure 3C] 3A-3C show various views of a patient interface, particularly one incorporating a bridge element into the interface, and more particularly, FIG. 3C shows a partial cross-sectional view of a side arm of the interface. [Figure 3D-3E] Figure 3D shows a diagram illustrating in plan view the shape of the interface of Figure 3A before one or more compensation regions (or locations) are activated, and Figure 3E shows a diagram after one or more compensation regions (or locations) have been activated in response to an applied force. [Figure 4A] 4A-4C illustrate various angles of a patient interface, particularly one incorporating a bridge element into the interface. More specifically, FIG. 4A illustrates a front perspective view of the interface. [Figure 4B]4A and 4B show various angles of a patient interface, particularly one incorporating a bridge element into the interface. More specifically, FIG. 4B shows a rear perspective view of FIG. 4A. [Figure 4C] 4A-4C show various views of a patient interface, particularly one incorporating a bridge element into the interface, and more particularly, FIG. 4C shows a partial cross-sectional view of a side arm of the interface. [Figure 4D-4E] Figure 4D shows a diagram illustrating the shape in plan view of the interface of Figure 4A before one or more compensation regions (or locations) are activated, and Figure 4E shows a diagram after one or more compensation regions (or locations) have been activated in response to an applied force. [Figure 5A] 5A-5C illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element, and more particularly, FIG. 5A illustrates a front perspective view of the interface. [Figure 5B] 5A and 5B show various angles of a patient interface, particularly one incorporating a bridge element and a side arm element. More specifically, FIG. 5B shows a rear perspective view of FIG. 5A. [Figure 5C] 5A-5C illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element in the interface. More specifically, FIG. 5C illustrates a partial cross-sectional view of the side arm and side arm element of the interface. [Figure 5D] 5A-5D illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element in the interface. More specifically, FIG. 5D illustrates a front perspective view of a bridge element along with a side arm element. [Figure 5E] 5A-5D illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element. More specifically, FIG. 5E illustrates a rear perspective view of FIG. 5D. [Figure 5F-5G]Figure 5F shows a diagram illustrating the shape in plan view of the interface of Figure 5A before one or more compensation regions (or locations) are activated, and Figure 5G shows a diagram after one or more compensation regions (or locations) have been activated in response to an applied force. [Figure 6A] 6A-6C illustrate a patient interface from various angles, particularly where the interface incorporates a bridge element and a side arm element. More specifically, FIG. 6A illustrates a front perspective view of the interface. [Figure 6B] 6A and 6B show various angles of a patient interface, particularly one incorporating a bridge element and a side arm element. More specifically, FIG. 6B shows a rear perspective view of FIG. 6A. [Figure 6C] 6A-6C illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element in the interface. More specifically, FIG. 6C illustrates a partial cross-sectional view of the side arm and side arm element of the interface. [Figure 6D] 6A-6D show various views of a patient interface, particularly one incorporating a bridge element and a side arm element, and more particularly, FIG. 6D shows a rear perspective view of the bridge element along with the side arm element. [Figure 6E] 6A-6D illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element. More specifically, FIG. 6E illustrates a front perspective view of FIG. 6D. [Figures 6F-6G] Figure 6F shows a diagram illustrating the shape in plan view of the interface of Figure 6A before one or more compensation regions (or locations) are activated, and Figure 6G shows a diagram after one or more compensation regions (or locations) have been activated in response to an applied force. [Figure 7A] 7A-7C illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element, and more particularly, FIG. 7A illustrates a front perspective view of the interface. [Figure 7B]7A and 7B show various angles of the patient interface, particularly where the interface incorporates a bridge element and a side arm element. More specifically, FIG. 7B shows a rear perspective view of FIG. 7A. [Figure 7C] 7A-7C illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element in the interface. More specifically, FIG. 7C illustrates a partial cross-sectional view of the side arm and side arm element of the interface. [Figure 7D] 7A-7D show various views of a patient interface, particularly one incorporating a bridge element and a side arm element in the interface. More specifically, FIG. 7D shows a front perspective view of a bridge element along with a side arm element. [Figure 7E] 7A-7D illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element. More specifically, FIG. 7E illustrates a rear perspective view of FIG. 7D. [Figures 7F-7G] Figure 7F shows a diagram illustrating the shape in plan view of the interface of Figure 7A before one or more compensation regions (or locations) are activated, and Figure 7G shows a diagram after one or more compensation regions (or locations) have been activated in response to an applied force. [Figure 8A] 8A-8C illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element, and more particularly, FIG. 8A illustrates a front perspective view of the interface. [Figure 8B] 8A and 8B show various angles of a patient interface, particularly one incorporating a bridge element and a side arm element. More specifically, FIG. 8B shows a rear perspective view of FIG. 8A. [Figure 8C] 8A-8C illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element in the interface. More specifically, FIG. 8C illustrates a partial cross-sectional view of the side arm and side arm element of the interface. [Figure 8D]8A-8D show various views of a patient interface, particularly one incorporating a bridge element and a side arm element in the interface. More specifically, FIG. 8D shows a front perspective view of a bridge element along with a side arm element. [Figure 8E] 8A-8D illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element. More specifically, FIG. 8E illustrates a rear perspective view of FIG. 8D. [Figure 8F-8G] Figure 8F shows a diagram illustrating the shape in plan view of the interface of Figure 8A before one or more compensation regions (or locations) are activated, and Figure 8G shows a diagram after one or more compensation regions (or locations) have been activated in response to an applied force. [Figure 9A] 9A-9C illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element, and more particularly, FIG. 9A illustrates a front perspective view of the interface. [Figure 9B] 9A and 9B show various angles of a patient interface, particularly one incorporating a bridge element and a side arm element in the interface. More specifically, FIG. 9B shows a rear perspective view of FIG. 9A. [Figure 9C] 9A-9C illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element in the interface. More specifically, FIG. 9C illustrates a partial cross-sectional view of the side arm and side arm element of the interface. [Figure 9D] 9A-9D illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element in the interface. More specifically, FIG. 9D illustrates a front perspective view of a bridge element along with a side arm element. [Figure 9E] 9E shows a rear perspective view of FIG. 9D, particularly illustrating the patient interface incorporating bridge and side arm elements. [Figure 9F-9G]Figure 9F shows a diagram illustrating the shape in plan view of the interface of Figure 9A before one or more compensation regions (or locations) are activated, and Figure 9G shows a diagram after one or more compensation regions (or locations) have been activated in response to an applied force. [Figure 10A] 10A-10C illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element, and more particularly, FIG. 10A illustrates a front perspective view of the interface. [Figure 10B] 10A and 10B show various angles of a patient interface, particularly one incorporating a bridge element and a side arm element. More specifically, FIG. 10B shows a rear perspective view of FIG. 10A. [Figure 10C] 10A-10C illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element in the interface. More specifically, FIG. 10C illustrates a partial cross-sectional view of the side arm and side arm element of the interface. [Figure 10D] 10A-10D illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element in the interface. More specifically, FIG. 10D illustrates a front perspective view of a bridge element along with a side arm element. [Figure 10E] 10E shows a rear perspective view of FIG. 10D, particularly illustrating the patient interface incorporating bridge and side arm elements. [Figures 10F-10G] Figure 10F shows a diagram illustrating the shape in plan view of the interface of Figure 10A before one or more compensation regions (or locations) are activated, and Figure 10G shows a diagram after one or more compensation regions (or locations) have been activated in response to an applied force. [Figure 10H-10I] Figure 10H shows a diagram illustrating the configuration of the interface of Figure 10A as a front view before one or more compensation regions (or locations) are activated, and Figure 10I shows a diagram with one or more compensation regions (or locations) activated. [Figure 11A]11A-11C illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element, and more particularly, FIG. [Figure 11B] 11A and 11B show various angles of the patient interface, particularly where the interface incorporates a bridge element and a side arm element. More specifically, FIG. 11B shows a rear perspective view of FIG. [Figure 11C] 11A-11C illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element in the interface. More specifically, FIG. 11C illustrates a partial cross-sectional view of the side arm and side arm element of the interface. [Figure 11D] 11A-11D show various views of a patient interface, particularly one incorporating a bridge element and a side arm element, and more specifically, FIG. 11D shows a front perspective view of a bridge element along with a side arm element. [Figure 11E] 11A-11D illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element. More specifically, FIG. 11E illustrates a rear perspective view of FIG. 11D. [Figures 11F-11G] Figure 11F shows a first diagram illustrating the shape in plan view of the interface of Figure 11A before one or more compensation regions (or locations) are activated, and Figure 11G shows a diagram after one or more compensation regions (or locations) have been activated in response to an applied force. [Figures 11H-11I] Figure 11H shows a second diagram illustrating the shape in plan of the interface of Figure 11A before one or more compensation regions (or locations) are activated, and Figure 11I shows the diagram with one or more compensation regions (or locations) activated. [Figure 12A] 12A-12C illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element, and more particularly, FIG. 12A illustrates a front perspective view of the interface. [Figure 12B]12A and 12B show various angles of a patient interface, particularly one incorporating a bridge element and a side arm element. More specifically, FIG. 12B shows a rear perspective view of FIG. [Figure 12C] 12A-12C illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element in the interface. More specifically, FIG. 12C illustrates a partial cross-sectional view of the side arm and side arm element of the interface. [Figure 12D] 12A-12D show various views of a patient interface, particularly one incorporating a bridge element and a side arm element, and more particularly, FIG. 12D shows a front perspective view of a bridge element along with a side arm element. [Figure 12E] 12E shows a rear perspective view of FIG. 12D, particularly illustrating a patient interface incorporating a bridge element and a side arm element. [Fig. 12F-12G] Figure 12F shows a diagram illustrating the shape in plan view of the interface of Figure 9A before one or more compensation regions (or locations) are activated, and Figure 12G shows a diagram after one or more compensation regions (or locations) have been activated in response to an applied force. [Figure 13A] 13A-13C illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element, and more particularly, FIG. 13A illustrates a front perspective view of the interface. [Figure 13B] 13A and 13B show various angles of the patient interface, particularly where the interface incorporates a bridge element and a side arm element. More specifically, FIG. 13B shows a rear perspective view of FIG. [Figure 13C] 13A-13C illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element in the interface. More specifically, FIG. 13C illustrates a partial cross-sectional view of the side arm and side arm element of the interface. [Figure 13D]13A-13D show various views of a patient interface, particularly one incorporating a bridge element and a side arm element, and more particularly, FIG. 13D shows a front perspective view of a bridge element along with a side arm element. [Figure 13E] 13E shows a rear perspective view of FIG. 13D, particularly illustrating a patient interface incorporating a bridge element and a side arm element in the interface, from various angles. More specifically, FIG. [Figures 13F-13G] Figure 13F shows a diagram illustrating the shape in plan view of the interface of Figure 13A before one or more compensation regions (or locations) are activated, and Figure 13G shows a diagram after one or more compensation regions (or locations) have been activated in response to an applied force. [Figure 14A] 14A-14C illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element, and more particularly, FIG. 14A illustrates a front perspective view of the interface. [Figure 14B] 14A and 14B show various angles of a patient interface, particularly one incorporating a bridge element and a side arm element. More specifically, FIG. 14B shows a rear perspective view of FIG. 14A. [Figure 14C] 14A-14C illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element in the interface. More specifically, FIG. 14C illustrates a partial cross-sectional view of the side arm and side arm element of the interface. [Figure 14D] 14A-14D show various views of a patient interface, particularly one incorporating a bridge element and a side arm element, and more particularly, FIG. 14D shows a front perspective view of a bridge element along with a side arm element. [Figure 14E] 14E shows a rear perspective view of FIG. 14D, particularly illustrating a patient interface incorporating a bridge element and a side arm element. [Fig. 14F-14G]Figure 14F shows a diagram illustrating the shape in plan view of the interface of Figure 14A before one or more compensation regions (or locations) are activated, and Figure 14G shows a diagram after one or more compensation regions (or locations) have been activated in response to an applied force. [Figure 15A] 15A-15C illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element, and more particularly, FIG. 15A illustrates a front perspective view of the interface. [Figure 15B] 15A and 15B show various angles of a patient interface, particularly one incorporating a bridge element and a side arm element. More specifically, FIG. 15B shows a rear perspective view of FIG. 15A. [Figure 15C] 15A-15C illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element in the interface. More specifically, FIG. 15C illustrates a partial cross-sectional view of the side arm and side arm element of the interface. [Figure 15D] 15A-15D illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element in the interface. More specifically, FIG. 15D illustrates a front perspective view of a bridge element along with a side arm element. [Figure 15E] 15A-15D illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element. More specifically, FIG. 15E illustrates a rear perspective view of FIG. 15D. [Figures 15F-15G] Figure 15F shows a diagram illustrating the shape in plan view of the interface of Figure 15A before one or more compensation regions (or locations) are activated, and Figure 15G shows a diagram after one or more compensation regions (or locations) have been activated in response to an applied force. [Figure 16A] 16A-16C illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element, and more particularly, FIG. 16A illustrates a front perspective view of the interface. [Figure 16B]16A and 16B show various angles of a patient interface, particularly one incorporating a bridge element and a side arm element. [Figure 16C] 16A-16C illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element in the interface. More specifically, FIG. 16C illustrates a partial cross-sectional view of the side arm and side arm element of the interface. [Figure 16D] 16A-16D show various views of a patient interface, particularly one incorporating a bridge element and a side arm element, and more particularly, FIG. 16D shows a front perspective view of a bridge element along with a side arm element. [Figure 16E] 16A-16D illustrate various angles of a patient interface, particularly one incorporating a bridge element and a side arm element. More specifically, FIG. 16E illustrates a rear perspective view of FIG. 16D. [Figures 16F-16G] Figure 16F shows a diagram illustrating the shape in plan view of the interface of Figure 16A before one or more compensation regions (or locations) are activated, and Figure 16G shows a diagram after one or more compensation regions (or locations) have been activated in response to an applied force. [Figure 17A] 17A-17C illustrate various angles of a patient interface, particularly one incorporating a bridge element and a separate side arm element in the side arm of the interface. More specifically, FIG. 17A illustrates a front view of the interface. [Figure 17B] 17A and 17B show various angles of a patient interface, particularly one incorporating a bridge element and a separate side arm element in the side arm of the interface. More specifically, FIG. 17B shows a rear view of FIG. [Figure 17C] 17A-17C illustrate various angles of a patient interface, particularly one incorporating a bridge element and a separate side arm element into the side arm of the interface. More specifically, FIG. 17C illustrates a front perspective view of the bridge element and the separate side arm element in their relative spatial arrangement when incorporated into the interface. [Figure 17D] 17D is a rear perspective view of FIG. 17C, showing the patient interface from various angles, particularly where the side arms of the interface incorporate a bridge element and a separate side arm element. [Figure 17E] 17A and 17B illustrate various angles of a patient interface, particularly one incorporating a bridge element and a separate side arm element in the side arm of the interface. More specifically, FIG. 17E is a front perspective view of the interface of FIG. [Figures 17F-17G] Figure 17F shows a diagram illustrating the shape in plan view of the interface of Figure 17E before one or more compensation regions (or locations) are activated, and Figure 17G shows a diagram after one or more compensation regions (or locations) have been activated in response to an applied force. [Figure 18] FIG. 1 shows a front view of a patient interface. [Figure 19] FIG. 19 illustrates a rear view of the patient interface shown in FIG. 18. [Figure 20] FIG. 19 illustrates a side perspective view of the patient interface shown in FIG. 18. [Figure 21A] FIG. 19 shows an enlarged view of the rear elevation view shown in FIG. 18. [Figure 21B] FIG. 21B shows a schematic diagram illustrating the forces acting on the patient interface shown in FIG. 21A. [Figure 22A] 1 shows an enlarged view of a portion of the patient interface. [Figure 22B] FIG. 22B shows a schematic diagram illustrating the forces acting on the patient interface shown in FIG. 22A. [Figure 23] 1 shows a rear elevation view of the patient interface. [Figure 24] 1 shows a rear elevation view of the patient interface. [Figure 25A] 1 illustrates an embodiment of a patient interface from various angles. [Figure 25B] 1 illustrates an embodiment of a patient interface from various angles. [Figure 25C] 1 illustrates an embodiment of a patient interface from various angles. [Figure 26A] 10A-10C illustrate another embodiment of a patient interface from various angles. [Figure 26B] 10A-10C illustrate another embodiment of a patient interface from various angles. [Figure 26C] 10A-10C illustrate another embodiment of a patient interface from various angles. [Figure 27A] 10A-10C illustrate another embodiment of a patient interface from various angles. [Figure 27B] 10A-10C illustrate another embodiment of a patient interface from various angles. [Figure 27C] 10A-10C illustrate another embodiment of a patient interface from various angles. [Figure 28A] 10A-10C illustrate another embodiment of a patient interface from various angles. [Figure 28B] 10A-10C illustrate another embodiment of a patient interface from various angles. [Figure 29A] 10A-10C illustrate another embodiment of a patient interface from various angles. [Figure 29B] 10A-10C illustrate another embodiment of a patient interface from various angles. [Figure 29C] 10A-10C illustrate another embodiment of a patient interface from various angles. [Figure 30A] 10A-10C illustrate another embodiment of a patient interface in a non-use configuration from various angles; [Figure 30B] 10A-10C illustrate another embodiment of a patient interface in a non-use configuration from various angles; [Figure 30C] 10A-10C illustrate another embodiment of a patient interface in a non-use configuration from various angles; [Figure 30D] 10A-10C illustrate another embodiment of a patient interface in an in-use configuration from various angles; [Figure 30E] 10A-10C illustrate another embodiment of a patient interface in an in-use configuration from various angles; [Figure 30F] 10A-10C illustrate another embodiment of a patient interface in an in-use configuration from various angles; [Figure 31]A variation of the embodiment shown in Figures 30A-30F includes one part of a detachable connection system, such as a fastening system (one example is a loop of material), for detachably connecting the patient interface to the user's face. [Figure 32] 10 illustrates another embodiment of a patient interface. [Figure 33] 10 illustrates another embodiment of a patient interface. [Figure 34A] 10A-10C illustrate another embodiment of a patient interface from various angles. [Figure 34B] 10A-10C illustrate another embodiment of a patient interface from various angles. [Figure 34C] 10A-10C illustrate another embodiment of a patient interface from various angles. [Figure 35] 10 illustrates another embodiment of an interface. [Figure 36] FIG. 36 is a plan view of the interface of FIG. 35. [Figure 37] FIG. 36 is a plan view of the interface of FIG. 35. [Figure 38A] Indicates a pad. [Figure 38B] A recessed area is shown which may receive a pad. [Figure 39A] A portion of the interface of FIG. 35 is shown. [Figure 39B] A cross-sectional view taken along line AA in Figure 39A is shown. [Figure 40A] A portion of the interface of FIG. 35 is shown. [Figure 40B] A cross-sectional view taken along line BB in FIG. 40A is shown. [Figure 41A] A portion of the interface of FIG. 35 is shown. [Figure 41B] A cross-sectional view taken along line CC in FIG. 41A is shown. [Figure 42A] A portion of the interface of FIG. 35 is shown. [Figure 42B] A cross-sectional view taken along line DD in FIG. 42A is shown. [Figure 43A] A portion of the interface of FIG. 35 is shown. [Figure 43B] A cross-sectional view taken along line EE in Figure 43A is shown. [Figure 44] FIG. 36 is a front view of the interface of FIG. 35. [Figure 45] 36 illustrates a portion of the interface of FIG. 35 showing the base of the nasal prongs. [Figure 46] FIG. 20 shows a rear view of the portion of the patient interface shown in FIG. 19. [Figure 47] FIG. 20 illustrates a rear perspective view of the portion of the patient interface shown in FIG. 19. [Figure 48] FIG. 19 illustrates a rear elevation view of the portion of the patient interface shown in FIG. 18. DETAILED DESCRIPTION OF THE INVENTION

[0337] The present disclosure relates to a patient interface that, in use, is placed on the user's face and compensates for movement.

[0338] By compensating for motion, the patient interface may be provided with improved or increased stability on the user.

[0339] Improved stability may result in a more comfortable fit for the user and / or improved or more consistent delivery of therapy to the user when the interface is worn and in use. For example, minimizing or at least somewhat mitigating the transmission or transfer of force or motion to the gas outlet of the patient interface (i.e., the portion of the interface most closely associated with the delivery of gas to the user) may provide certain advantages in that therapy delivery is not impeded or at least not minimized, and user comfort is maintained.

[0340] Therefore, a patient interface that is operable to respond to forces or movements applied to the patient interface and to be an effective self-compensating device is desirable.

[0341] In patient interfaces such as nasal cannulas, nasal prongs are typically associated with the gas outlets of the interface. Prong flicking is a problem related to the movement of the patient interface, where the nasal prongs may move from their intended position and irritate the user's nares, or even become disturbed enough that they are no longer properly positioned within the nares. Such disturbance of the gas outlets or nasal prongs should be avoided whenever possible.

[0342] The patient interface of the present invention advantageously provides improved provision of respiratory care by a ventilator or gas supply, or in combination with a gas humidification system or other gas supply system for supplying gas to a patient or for delivering any other gas to a patient.

[0343] Various suitable forms of patient interfaces are described with reference to in-hospital respiratory care systems that may be used by adults and / or children and / or neonates. The described patient interface embodiments are used in the delivery of various respiratory therapies, such as, but not limited to, high-flow therapy, PAP therapy (e.g., CPAP or BIPAP), and ventilation therapy, and it will be understood that such patient interfaces may be occlusive or non-occlusive depending on the desired therapy.

[0344] Because relatively high gas delivery flow rates may be used in the embodiments or configurations described herein, the gas provided or delivered to a user or patient may be delivered to various portions of the user's or patient's airway. It will be understood that relatively high gas delivery flow rates may be used with either adults, children, or infants (e.g., neonatal or pediatric patients), with the flow rates selected or adjusted accordingly. Patient interface embodiments described herein include flow rate ranges suitable for use in adults and flow rate ranges suitable for neonatal or pediatric patients.

[0345] For example, according to the various embodiments and configurations described herein, the flow rate of gas supplied or provided through the system, such as to an interface or through a flow path, may include, but is not limited to, flows of at least about 2, 3, 4, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 L / min or more, and a useful range may be selected between any of these values ​​(e.g., about 40 to about 80, about 50 to about 80, about 60 to about 80, about 70 to about 100 L / min, about 70 to 80 L / min).

[0346] Such relatively high flow rates of gas may assist in providing the supplied gas to the user's airway or to various portions of the user's airway, for example, such flow rates may enable delivery of such gas to the upper or lower respiratory tract region, the upper respiratory tract region generally including the nasal cavity, pharynx, and larynx, and the lower respiratory tract region generally including the trachea, primary bronchi, and lungs.

[0347] As used in this disclosure, "high flow therapy" can refer to delivering gas to a patient at a flow rate of about 5 or 10 liters per minute (5 or 10 LPM) or greater for an adult. In some configurations, "high flow therapy" can refer to delivering gas to an adult patient at a flow rate of about 5 or 10 LPM to about 100 LPM, or about 15 LPM to about 95 LPM, or about 20 LPM to about 90 LPM, or about 25 LPM to about 85 LPM, or about 30 LPM to about 80 LPM, or about 35 LPM to about 75 LPM, or about 40 LPM to about 70 LPM, or about 45 LPM to about 65 LPM, or about 50 LPM to about 60 LPM. For example, according to the various embodiments and configurations described herein, the flow rate of gas supplied or provided through the system, such as to an interface or through a flow path, may include, but is not limited to, flows of at least about 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 L / min or more, and a useful range may be selected between any of these values ​​(e.g., about 40 to about 80, about 50 to about 80, about 60 to about 80, about 70 to about 1000 L / min, about 70 to 80 L / min).

[0348] For neonates and premature infants, "high flow therapy" can mean delivering gas at a flow rate of 0 LPM to 40 LPM, i.e., 0.1 LPM or greater, or about 5 LPM to 35 LPM, or about 10 LPM to about 30 LPM, or about 15 LPM to about 25 LPM. For example, according to the various embodiments and configurations described herein, the flow rate of gas delivered or provided through the system, such as to an interface or through a flow path, may include, but is not limited to, flows of at least about 0.1, 5, 10, 15, 20, 25, 30, 35, or 40 LPM or greater, and useful ranges may be selected between any of these values ​​(e.g., about 5 to about 15, about 20 to about 40, about 30 to about 40). Typically, gas delivery at a flow rate of 8 LPM to 10 LPM is suitable for neonates.

[0349] For pediatric patients, "high flow therapy" can mean delivering gas at a flow rate of about 2 or 5 LPM to about 100 LPM, or about 15 LPM to about 95 LPM, or about 20 LPM to about 90 LPM, or about 25 LPM to about 85 LPM, or about 30 LPM to about 80 LPM, or about 35 LPM to about 75 LPM, or about 40 LPM to about 70 LPM, or about 45 LPM to about 65 LPM, or about 50 LPM to about 60 LPM. For example, according to the various embodiments and configurations described herein, the flow rate of gas delivered or provided through the system, such as to the interface or through the flow path, may include, but is not limited to, flows of at least about 2, 3, 4, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 L / min or more, and useful ranges may be selected between any of these values ​​(e.g., about 40 to about 80, about 50 to about 80, about 60 to about 80, about 70 to about 1000 L / min, about 70 to 80 L / min). Typically, for pediatric patients, the flow rate is provided at 2 L / kg of body weight.

[0350] The delivered gas may include a percentage of oxygen. In some configurations, the percentage of oxygen in the delivered gas may be about 20% to about 100%, or about 30% to about 100%, or about 40% to about 100%, or about 50% to about 100%, or about 60% to about 100%, or about 70% to about 100%, or about 80% to about 100%, or about 90% to about 100%, or about 100%, or 100%.

[0351] High-flow therapy has been shown to be effective in meeting or exceeding a patient's normal maximal inspiratory demand in order to increase patient oxygenation and / or reduce the patient's work of breathing. Additionally, high-flow therapy can create a nasopharyngeal washout effect, such that the high incoming gas flow clears the anatomical dead space of the upper airway. This minimizes rebreathing of carbon dioxide, nitrogen, etc., while creating a reservoir of fresh gas available with every breath. It will also be understood that various aspects of the present invention will be described with reference to a nasal cannula, although they may be applied to any form of patient interface, including, but not limited to, indirect nasal masks (over the nose), direct nasal masks that include nozzles or pillows that enter or engage the wearer's nares, oral masks (over the mouth), or full-face masks (over the nose and mouth), and mouthpieces.

[0352] Similarly, it will be appreciated that various aspects of the present invention may be applied using any form of patient interface in conjunction with any suitable form of headgear or retention or fastening system for securing the patient interface on a user, suitable for holding the patient interface retained on the user for delivery of the desired therapy, such as, for example, a fastening system as described in International Application PCT / NZ2011 / 000218 (published as WO 2012 / 053910, the contents of which are incorporated herein by reference).

[0353] In one particularly preferred embodiment, the interface is a non-sealing nasal prong type nasal cannula of the delivery system. Such a nasal cannula may be used for the delivery of high-flow hypopressure therapy to a user.

[0354] High flow, low pressure therapy delivery may be provided, for example, but not limited to, from just over 9 L / min to 120 L / min, from about 20 L / min to about 50 L / min (e.g., for adult users), from about 5 L / min to about 30 L / min (e.g., for pediatric users), and from about over 0 L / min to about 8 L / min (e.g., for neonatal users).

[0355] A patient interface according to the present invention may be used in a respiratory care system, for example a humidified CPAP or in-hospital respiratory care system.

[0356] FIG. 1 illustrates a typical humidified breathing system. A patient 1 receives humidified and pressurized gases via a patient interface 100, shown in this example as a nasal cannula assembly. The nasal cannula assembly is connected to a humidified gas carrying path or inspiratory conduit 3, which is in turn connected to a humidifier 8 (including a humidification chamber 5), which is supplied with gases from a blower 15 or other suitable gas supply. Headgear 20 is provided to support and hold the patient interface against the patient's face. The inspiratory conduit 3 is connected to an outlet 4 of a humidification chamber 5, which contains a volume of water 6. The humidification chamber 5 is preferably formed from a plastic material and may have a highly thermally conductive base (e.g., an aluminum base). The highly thermally conductive base is in direct contact with a heater plate 7 of the humidifier 8. The humidifier 8 is provided with a control means or electronic controller 9. The control means or electronic controller 9 may include a microprocessor-based controller that executes the commands of computer software stored in corresponding memory. Gas flowing through the inspiratory conduit 3 is delivered to the patient via a patient interface 100.

[0357] The controller 9 receives input from sources such as a user input means or dial 10. Via the user input means or dial 10, a user of the device may, for example, set a predetermined required value (preset value) for the humidity or temperature of the gas delivered to the patient 1. In response to the input of the user-set humidity or temperature value via dial 10 and other possible inputs, such as internal sensors detecting gas flow or temperature, or parameters calculated by the controller, the controller 9 determines when (or to what level) to activate the heater plate 7 and heat the water 6 in the humidification chamber 5. As the volume of water 6 in the humidification chamber 5 is heated, water vapor begins to fill the volume of the chamber above the surface of the water and is delivered from the outlet 4 of the humidification chamber 5. A flow of gas (e.g., air) is supplied from a gas supply means or blower 15 and enters the chamber through an inlet 16. It should be noted that a correlation can be made between the humidity of the gas in the humidification chamber 5 and the temperature of the heater plate 7. Thus, the heater plate temperature can be used in an algorithm or look-up table to determine the humidity of the gas.

[0358] The blower 15 may be provided with a variable speed pump or fan 2 which draws air or other gas through a blower inlet 17. The speed of the variable speed pump or fan 2 may be controlled by a further control means or electronic control 18 (or alternatively the functions of this control 18 may be performed by another control 9) in response to input from the control 9 and of predefined required values ​​(preset values) set by the user for pressure or fan speed via dials 19.

[0359] A heating element 11 may be provided within the conduit or tubing 3 to help prevent condensation of the humidified gas within the conduit. Such condensation results from the temperature of the conduit walls being close to ambient temperature (the temperature of the surrounding atmosphere), which is typically lower than the temperature of the humidified gas within the conduit. The heater element effectively replaces the energy lost from the gas due to conduction and convection during its passage through the conduit. The conduit heater element therefore ensures that the delivered gas is at an optimum temperature and humidity.

[0360] FIG. 1 illustrates the use of a patient interface 200 in a respiratory treatment system 100. The respiratory treatment system 100 includes a flow generator 104. The flow generator 104 receives gas from a gas inlet 102 and directs the gas to a humidifier 106. The humidifier 106 heats and humidifies the gas. The heated and humidified gas is directed through a gas outlet 108. The gas travels from the gas outlet 108 to a gas conduit 110. The gas conduit 110 includes a heater 112 that reduces or prevents condensation of moisture along the walls of the gas conduit 110. The heater 112 may include resistive heating wire. The respiratory treatment system 100 includes a controller 114 that controls the operation of the flow generator 104. The controller 114 also controls the operation of the humidifier 106. The respiratory treatment system 100 includes an input / output module 116. The input / output module (I / O) 116 includes means for a user to interact with the flow generator 104 and / or humidifier 106, set parameters for the flow generator 104 and / or humidifier 106, and receive information regarding the operation of the respiratory treatment system 100 and its components. The I / O module 116 may include, for example, buttons, knobs, dials, switches, levers, a touchscreen, a speaker, a display, and / or other input or output elements. In some configurations, the humidifier 106 may be absent. In some configurations, the gas conduit 110 may not have a heater 112.

[0361] 2-17, a preferred embodiment of a patient interface 200 of the present invention will now be described.

[0362] 2-17, various alternative configurations and preferred forms of patient interfaces are shown.

[0363] In a first embodiment, a patient interface 200 is provided that includes at least one side arm 201 (and preferably a pair of side arms, each side arm being labeled item 201) extending laterally from a generally central bridge portion 202 that is positioned in or around the user's nasal septum area in use.

[0364] The or each side arm 201 is connected to a substantially resilient or relatively more rigid bridge element 203. The bridge element 203 defines a substantially predetermined spatial relationship between the outlet or outlets 204 of the gas delivery system and the or each side arm 201. In this manner, the spatial relationship of the outlets 204 (and, for example, nasal prongs 208 that may be provided in fluid communication with such outlets 204) may be maintained in a constant reference relationship with one another.

[0365] Providing the nasal prongs 208, or other form of gas delivery system fluidly connected to the gas outlet 204 in a regular spatial relationship, as may be suitable depending on the patient interface, is useful because the nasal prongs are maintained in a substantially constant position relative to the user, which may allow for minimizing prong flicking or other irritation caused by the prongs on the user's nose.

[0366] In a second embodiment, a patient interface 200 is provided that includes at least one side arm 201 (and preferably a pair of side arms, each side arm being labeled item 201) extending laterally from a generally central bridge portion 202 that is positioned in or around the user's nasal septum area in use.

[0367] The or each side arm 201 includes one or more predetermined or pre-positioned points or localized compensation areas (or locations) 205 disposed along the side arm 201. The various compensation area(s) (or locations) can accommodate or facilitate patient compensation and can act or function to accommodate or facilitate compensation of the patient interface within or at one or more of the compensation areas (or locations) when the interface is or has a force applied thereto.

[0368] The or each side arm 201 is connected to a substantially resilient or relatively more rigid bridge element 203. The bridge element 203 defines a substantially predetermined spatial relationship between the or each side arm 201 and an outlet or outlets 204 of the gas delivery system.

[0369] In a third embodiment, a patient interface 200 is provided that includes at least one side arm 201 (and preferably a pair of side arms, each side arm being labeled item 201) extending laterally from a generally central bridge portion 202 that is positioned in or around the user's nasal septum area in use.

[0370] The or each side arm 201 includes at least one substantially elastic or relatively more rigid side arm element 206. The or each side arm element 206 at least partially defines the shape or curvature of the or each side arm 201, and each side arm 201 and / or side arm element may include one or more predetermined or pre-positioned points or localized compensation areas (or locations) 205. Various one or more compensation areas (or locations) may be positioned along the or each side arm and / or the or each side arm element 206 to accommodate compensation of the patient interface within or at one or more of the compensation areas (or locations) 205.

[0371] The or each side arm element 206 is connected or interconnected via a connecting material to a substantially resilient or relatively more rigid bridge element 203. The bridge element 203 defines a substantially predetermined spatial relationship between the or each side arm 201 and the outlet or outlets 204 of the gas delivery system.

[0372] The connecting material may be a material that forms side arm 201 or part of side arm 201 and may include, for example, a thermoplastic elastomer.

[0373] With reference to the accompanying description, the areas or locations labeled 205 or 205s in the accompanying figures indicate compensation areas (or locations) of either the side arm 201 or the side arm element 206.

[0374] The following additional description is provided with reference to the above embodiments and with reference to the accompanying figures, it being understood that various iterations and alternative embodiments are provided by the description herein and that the figures are provided for illustrative purposes.

[0375] In various aspects of the present invention, it is particularly advantageous to provide a bridge portion 202 or bridge element 203, or a bridge portion via a bridge element, that can be substantially decoupled or isolated from forces that are applied to or may be exerted on the patient interface 200.

[0376] The force applied or exerted on the patient interface 200 may be applied to one or more side arms 201 of the interface, or to a side arm element 206, or to any other portion of the interface 200.

[0377] For example, such forces may be the result of a collision with a tube or conduit that is part of the breathing circuit or gas delivery system of the patient interface 200 (i.e., what is known as a "tube pull," or a tugging or jerking on a tube or conduit, whether intentionally or not, by the user or someone else, which in turn applies a force to the interface that would otherwise be held in a desired operating position on the user).

[0378] Forces may include, for example, movement or flexion or bending or twisting or torsion or compression or extension (such as tension) of the patient interface 200 (or parts of the interface), which may result from a user changing (either directly or indirectly) the shape of their face on which the patient interface is placed. A change in shape means that the patient interface 200 moves or is subjected to these forces (i.e., the patient interface is subjected to some form of dynamic behavior).

[0379] Thus, each side arm 201, or these side arms 201, which may additionally incorporate side arm elements 206, is provided with one or more predetermined or pre-positioned points or local compensation areas (or locations) 205 at various locations or positions along the side arm element 206.

[0380] The various compensation regions (or locations) can accommodate or facilitate compensation for the applied forces to at least somewhat decouple, absorb, or attenuate the forces, or at least minimize the transmission or movement of any such forces from disturbing the gas outlets from their desired treatment delivery locations. For example, if nasal prongs 208 may be fluidly connected to these outlets 204, it may be desirable to minimize or prevent movement of the prongs 208 within the user's nose.

[0381] The side arm(s) 201, or the or each side arm element 206, may respond (or be actuated in response) to forces applied to the patient interface. In particular, one or more of the compensation regions (or locations) 205 may respond (or be actuated) to accommodate such forces or at least a portion of such forces. Compensation by the regions (or locations) 205 may be by flexing or bending (or other response as described above) of the side arm 201 or side arm element 206 (or both).

[0382] Thus, the or each side arm 201 and / or the or each side arm element 206, which may be provided as part of the side arm 201, may facilitate a self-compensating system to mitigate forces or movements on the patient interface from being imparted to the bridge portion 202 or bridge element 203. For example, this may further affect the spatial stability of the gas outlet 204 and optionally any nasal prongs 208 within the user's nostrils.

[0383] Similarly, the side arm 201 or side arm element 206, which may be provided as part of the side arm 201, may facilitate a self-compensating system to mitigate forces or movements on the patient interface from being imparted to other portions or portions of the patient interface 200 itself. In this manner, forces or movements on one portion or region of the patient interface may be at least somewhat decoupled from being transmitted or transferred to the remainder of the patient interface 200. These forces or movements transmitted or transferred to other parts of the patient interface 200 may preferably be at a reduced force or lower level / amount of movement, or may be transmitted or moved such that other portions of the patient interface 200 may further decouple or absorb the forces or movements.

[0384] In view of the above, it will be appreciated that one or more side arms 201, optionally in combination with side arm element 206, can function as a patient interface stabilizer or patient interface stabilization system, or at least as part of such a stabilizer or stabilization system.

[0385] The bridge and side arms may be a single piece or may be assembled together from multiple pieces. The bridge portion 202 and side arms 201 may be provided as a single piece or integral component. Advantageously, the patient interface is an integral component, which is easier to manufacture due to the relatively simple finishing and assembly process. However, in some embodiments, the bridge portion 202 and side arms 201 may be assembled together from separate or multiple pieces.

[0386] Similarly, the bridge element 203 and the side arm element or elements 206 may be provided as a single or integral component, or may be assembled together from separate or multiple components. For example, the bridge element 203 and the side arm element or elements 206 may be integrally formed as a single component.

[0387] As shown in the various figures herein, the bridge portion 202 is typically located intermediate the pair of side arms 201. Accordingly, the bridge portion element 203 is typically located intermediate the side arm elements 206 of the pair of side arms 201.

[0388] 17A-17E, a patient interface 200 may be provided that includes a bridge portion element 203 and at least one of a plurality of side arm elements 206, each of which is a separate component. Each of these separate components may be substantially interconnected or may be provided in interconnected relationship with one another by a connecting material, such as the material of the side arm 201.

[0389] In view of the above, it will be appreciated that bridge element 203 may, in some embodiments, be provided as a component that is not continuous with or contiguous to one or more side arm elements 206.

[0390] In yet other embodiments, the side arm 201 may include one or more separate side arm elements 206 (see, for example, FIGS. 17A-17E). Each of these one or more separate side arm elements 206 may be spaced apart throughout or along the length of the side arm 201 in which it or they are located. Various other arrangements are possible depending on the complexity or sophistication of the side arm 201 and side arm elements 206 to provide multiple compensation regions (or locations) 205. For example, multiple side arm elements 206 may be spaced apart in an array throughout or along the length of one or each side arm 201 in which they are located.

[0391] Where separate bridge element 203 and separate side arm element or elements 206 are provided, they may be made to connect or interconnect with each other via one or a pair of corresponding side arms 201. Bridge element 203 may optionally be associated with side arm element 206 as a single component, although it will be appreciated that additional side arm elements 206 provided as separate components may be located at or alongside the side arm element. In this manner, several alternative compensation regions (or locations) 205 may be provided.

[0392] For example, although not shown, additional side arm elements may be positioned along the length of the side arm of interface 200 shown in Figures 17A-17E. In such an embodiment, depending on the location and configuration of such additional side arm elements 206, additional compensation regions (or locations) 205 are provided along the length of side arm 201.

[0393] Each side arm element 206, whether separate or as part of a continuous component that includes other side arm elements 206, can provide a relatively elastic portion of the side arm material sandwiched between or adjacent to each separate side arm element. In other words, the side arm 201 material sandwiched between the side arm elements may itself provide a compensation region (or location) 205 that facilitates compensation in response to forces.

[0394] As shown in the various figures herein, the bridge portion 202 is typically located intermediate the pair of side arms 201. Accordingly, the bridge portion element 203 is typically located intermediate the side arm elements 206 of the pair of side arms 201.

[0395] The bridge defines the spacing / spatial relationship of the prongs / gas outlets The bridge element 203 is advantageously sized (sufficiently) to span the width of the user's nasal septum region, or is configured to establish or define the distance or width between the gas outlets 204, or is defined by the maximum distance that spans substantially from one nasolabial fold to another nasolabial fold of the user.

[0396] The bridge element 203 may include one or a pair of cutouts or shaped portions 207 for locating, positioning or accommodating an outlet or a pair of outlets for a gas delivery system that supplies gas to the user's airway.

[0397] The bridge element 203 having cut or shaped portions 207 advantageously enables the gas outlets 204 to be maintained in a constant reference relationship to one another, more preferably so that the nasal prongs 208, when provided in fluid communication with the outlets 204, are maintained in a constant reference relationship to minimize problems with nasal prong movement or prong flicking within the user's nose.

[0398] Bridge element 203 may include one or a pair of notches or shaped portions 207 for positioning, locating, or accommodating a nasal prong or pair of nasal prongs, such as those labeled item 208, either connected to or as the outlet or outlets 204 for a gas delivery system that supplies gas to a user's nostril or nostrils.

[0399] It will be appreciated that different types and styles of patient-engaging gas delivery system outlets may be provided. In the figures, nasal prongs 208 are shown. Typically, these are non-sealing or nasal prongs. However, it will be appreciated that different forms of outlets may be provided that may be appropriate depending on the type or style of therapy being delivered and the type of patient interface. For example, sealing nasal prongs (e.g., those that may use "nasal pillows" or other nasal sealing systems for nasal prongs) may be used, or a nasal mask system or full face mask, such as may often be used for the delivery of positive airway pressure therapy, or a patient interface more commonly used for the delivery of high-flow therapy (but not of the sealing type), may be used.

[0400] It will be appreciated that the patient interface may be constructed of any suitable material, although medical grade materials are preferred. For example, the bridge and side arm elements may be or include a polymeric material.

[0401] A variety of polymeric materials may be used alone or in combination with others. Particularly suitable are medical grade polymers.

[0402] The polymer may be one or more of a thermoplastic elastomer, a polypropylene-based elastomer, a liquid silicone rubber, or a breathable thermoplastic polyurethane or a breathable polyamide, and more preferably the polymer is a thermoplastic elastomer such as a polyolefin, a thermoplastic elastomer, or a breathable thermoplastic elastomer, for example, a styrene block copolymer, a copolyester elastomer, a thermoplastic polyolefin elastomer, or a thermoplastic polyurethane elastomer, and even more preferably a polymer having a Shore A hardness of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90, but is not limited to these.

[0403] Bending direction Preferably, each one or more of the predetermined or pre-positioned points or localized regions (or locations) 205 facilitates flexing or bending or hinging and / or elastic deformation in response to an input of force or movement.

[0404] One or more compensation regions (or locations) 205 may provide though or around the following bending or hinge regions or locations.

[0405] At least one face through the interface

[0406] Multiple parallel planes through the interface

[0407] At least two different (non-parallel) planes passing through the interface

[0408] At least two different (orthogonal) planes through the interface.

[0409] For example, the embodiments of Figures 5, 6, 7, 8, and 9 generally show side arm element 206 having compensation region (or location) 205, with at least one or a series of hinge or bending or flexing regions or locations (i.e., compensation regions (or locations)), where the hinging or bending or flexing is (preferably primarily) in one plane through interface 200, and these planes are parallel to one another.

[0410] It will be appreciated that the compensation area (or location) 205 may be configured to provide different bending or hinge or flexure planes, e.g., offset planes, each orthogonal, parallel or not, to allow the compensation to function effectively in various planes, along with isolating or absorbing or attenuating forces at the interface so that they are not transmitted or transferred to the bridge portion or bridge portion elements.

[0411] FIG. 10, for example, illustrates an embodiment in which the compensation regions (or locations) allow hinging or bending or flexing in multiple planes, for example, as illustrated by the diagrams of FIGS. 10F-10I.

[0412] The compensation areas (or locations) may be molded or shaped cutouts or tapered (thinner or thicker) portions of the side arm 201 or side arm element 206 to provide various surfaces in which hinging or bending or bending may be preferentially promoted.

[0413] The compensation area (or location) may be preferentially located or positioned more towards the rear of the side arm 201 or side arm element 206, or may be located or positioned more towards the front of the side arm or side arm element (or may be more centrally located).

[0414] In certain embodiments, one or more of the compensation regions (or locations) 205 may flex or bend (or hinge or be locally displaceable or elastically deform or move or respond) to a force or motion input more preferentially in a first direction or set of directions and less preferentially in another direction or set of directions. For example, each one or more of the various compensation regions (or locations) 205 may be adapted or configured to be substantially more resistant to flexing or bending (or hinging or elastic deformation) in a less preferred direction or set of directions compared to flexing or bending (or any other hinging or elastic deformation response) in a more preferred direction.

[0415] In one particularly preferred mode, the first direction or first set or directions is substantially in a transverse plane (e.g., an XY plane of the user's body). More specifically, the first direction or first set of directions may be substantially in a transverse plane in a ventral direction or a dorsal direction, or may be in both a ventral direction and a dorsal direction.

[0416] In other preferred modes, the further preferred direction or set of directions (eg, the additional first direction or set of directions) may be one or more of a substantially transverse plane, a substantially sagittal plane, and a substantially coronal plane.

[0417] In yet another preferred mode, the first direction or first set of directions is one or more directions that substantially facilitate moving or bending the side arm 201 or side arm element 206 relative to the bridge portion 202 or bridge portion element 203.

[0418] For example, the compensation regions (or locations) 205 may allow bending, flexing, etc. in a forward or backward direction of the user's body. In this manner, each of the various regions (or locations) 205 is adapted or configured to allow bending, flexing, etc. in such directions more easily or with less resistance, but to be more resistant to bending, flexing, etc. in other directions.

[0419] It will therefore be appreciated that one or more or a series of such compensation areas (or locations) 205 may be provided along the side arm 201 or side arm element 206 to provide a customized arrangement of areas or locations 205 of preferential bending or flexure or the like that can respond to forces or movements applied to the patient interface 200. In this manner, at least some absorption of forces or movements, or isolation or reduction of the transfer or transmission of such forces or movements to other parts of the interface, may be achieved. In particular, it is preferred that the transmission or transfer of forces or movements to the gas outlet 204 and, for example, the nasal prongs 208 be avoided or minimized.

[0420] According to this embodiment, the side arm 201 or the side arm element 206 (or both) may be formed of a substantially elastic material or may be configured to provide substantial resilience to flexing or bending (or hinging or elastic deformation) in a compensation region (or location) 205 of the side arm 201 or side arm element 206 selected from one or more of the following:

[0421] Between one compensation area (or location) 205 located laterally outward from the bridge portion 202 or bridge portion element 203 and the outer end 209 of the side arm 201 or side arm element 206,

[0422] Between the outer compensation area (or location) 205 of the side arm 201 or side arm element 206 and the outer end 209 of the side arm 201 or side arm element 206,

[0423] Between each of the series of compensation regions (or locations) 205 of the side arm 201 or side arm element 206,

[0424] It is provided between two compensation areas (or locations) 205 located laterally outward from the bridge portion 202 or bridge portion element 203, and between the more outer compensation area (or location) 205 of the side arm 201 or side arm element 206 and the outer end 209 of the side arm element 206.

[0425] In one embodiment, Figures 2A-2G show a patient interface 200 including a bridge element 203 connected to a pair of side arms 201 via connecting material on each side arm. Compensation areas (or locations) 205 are shown at the joints or connections between the bridge element 203 and the side arm 201 material. Additional compensation areas (or locations) 205s are shown on the side arms 201. The side arms 201 are shaped or shaped to provide such compensation areas (or locations) 205s. In particular, Figure 2F shows the shape of the patient interface before the interface and compensation areas (or locations) 205, 205s respond to a force applied or exerted on the interface, while Figure 2G shows the shape of the interface 200 when the compensation areas (or locations) are acting to compensate for the applied or exerted force.

[0426] In a further embodiment, Figures 3A-3C and 4A-4C respectively show a patient interface 200 similar to that of Figures 2A-2E. A gas supply conduit for delivering gas to the outlet 204 and nasal prongs 208 is shown housed or disposed by an item 213. Compensation areas (or locations) are shown as 205, 205s. The compensation areas (or locations) 205, 205s allow the patient interface to respond to applied forces and further minimize or isolate transmission or movement to the bridge portion and further to the gas outlet 204 and nasal prongs 208. It should be noted that Figures 3D and 4D show the shape of the patient interface before the interface functions to compensate for forces, while Figures 3E and 4E show the shape of the interface when the compensation areas (or locations) 205, 205s are operating in response to forces.

[0427] In one embodiment, one or each side arm 201 or one or each side arm element 206 may include one compensation region (or location) 205, 205s configured for such bending or flexing (or either hinging or local displacement or other response, such as elastic deformation or movement). See, for example, FIGS. 5A-5E, which illustrate one such embodiment in which the compensation region (or location) 205 is located near the bridge portion and is a portion of the side arm element 206 from which some material has been removed (e.g., it may be a slot, notch, slit, or cutout, or may be shaped or molded in this manner). The compensation region (or location) 205 is located more rearward of the side arm element to allow hinging or preferential bending or flexing of the side arm element in this region. It will be understood that there may optionally be a further compensation region (or location) 205, 205s at the outer end 209 of the or each side arm element 206, where the side arm 201 is attached or connected (i.e., interconnected) to the side arm element. In such regions (or locations) 205, 205s, differences in material properties may result in additional effective regions (or locations) 205, 205s for bending, flexing, etc. However, this may be an optional feature. Figures 5F and 5G show various nodes of suitable compensation regions (or locations) 205, 205s that may be provided by side arms or side arm elements. Figure 5F shows the shape of the interface 200 before application (or response by the compensation regions (or locations)), while Figure 5G shows the shape of the interface after the compensation regions (or locations) have been activated.

[0428] 6A-6E, the side arm element 206 is provided with at least two localized compensation areas (or locations) 205, 205s, and there may also be an optional compensation area (or location) 205 at the outer end of the side arm element 206 at the junction with the side arm 201 material, for example, where different material properties of the side arm and side arm element may interact or intersect to provide such additional compensation areas (or locations). Additionally, additional compensation areas (or locations) may be provided by the side arm 201 itself (e.g., as the side arm material deflects in response to forces such as changes in the shape of the user's face / cheek to which the side arm may be removably connected via a retention or fastening system). As shown, the side arm element 206 has a first compensation region (or location) 205 located at a more inboard end of the side arm element (near or adjacent to the bridge element), such first region (or location) 205 being a slot or notch or slit or cutout or molded cavity or void in the front side or face of the side arm element 206. A second compensation region (or location) 205 is then provided more laterally outward from the first region or location and is shown as a bevel or recess (or otherwise thinned portion or reduced material) formed in the top and bottom faces of the side arm element.

[0429] The diagrams of Figures 6F-6G illustrate at least one embodiment of how the interface of Figure 6A may respond to an applied force as region (or location) 205 bends, hinges, or flexes.

[0430] It will be appreciated that in each of the various embodiments shown, there may be a region 205, or optionally 205s, at the outer end 209 of the or each side arm element 206 where the side arm 201 is attached or connected to the side arm element 206. In such region (or location) 205, 205s, differences in material properties or other shaping or formation of the side arm 201 or side arm element 206 or their junctions may create an effective additional region (or location) 205 or 205s for bending, flexing, etc.

[0431] Figures 6F-6G, 7F-7G, 8F-8G, 9F-9G, 10F-10G (as top views of the node shown in Figure 10D), 10H-10I (as front views of the node shown in Figure 10D), 11F-11G, 11H-11I (as an example where an additional compensation area (or location) is provided on the outside or at the junction of the side arm 201 with the side arm element 206), 12F-12G, 13F-13G, 14F-14G, 15F-15G, and 16F-16G provide nodal diagrams showing the location and operation of the respective compensation areas (or locations) 205, 205s in these embodiments. Again, the shape of the interface 200 before the force is applied (or the compensation areas (or locations) are functional) is that of the first referenced figure above, and the second referenced figure is after the compensation areas (or locations) 205, 205s are activated or functional / responsive to the applied force.

[0432] In consideration of the various embodiments described above, it will be appreciated that one or more of the following may be defined in various modes, configurations or adaptations:

[0433] At least one point or local compensation area (or location) 205 may be located at a more inward end 210 of the side arm 201 or side arm element 206 in connection with the bridge portion 202 or bridge portion element 203 (e.g., the or each side arm element 206 may be configured to flex or bend (or hinge or locally displace or elastically deform or move) relative to the bridge portion element 203).

[0434] At least one of the points or localized areas (or locations) 205 may be located at a junction or connection between a side arm 201 or side arm element 206 and a bridge portion 202 or bridge portion element 203 .

[0435] At least one of the points or localized areas (or locations) 205 may be located within or in a zone of the bridge portion 202 or bridge portion element 203 substantially defined by the periphery or lateral outer edge of the user's nasal septum area.

[0436] The side arm element or side arm allows for space / gap for gas supply to one or more outlets. In yet another embodiment, side arm 201 or side arm element 206, either alone or in combination, may be shaped or configured or adapted to provide a passageway 213. Such passageway 213 may be formed by one or more lumens or void spaces or cavities or other recesses within side arm 201 and / or side arm element 206.

[0437] Such passages 213 may receive a gas supply (from a source) and route the gas to a user via one or more outlets 204, or alternatively may receive a gas supply conduit (not shown, but which may be received in or attached to such an article 213) and then deliver the gas to a user via one or more outlets 204.

[0438] Such passages 213 within or through the side arm 201 or side arm element 206, or both, allow for the formation of a conduit or lumen through which gas may be directed or supplied for delivery to the outlet or outlets 204.

[0439] The passageway 213 or conduit or lumen (or channel) thus formed by any one or more of the lumens or void spaces or cavities or other recesses in the side arm 201 and / or side arm element 206 may be defined at least in part by the side arm 201 and at least in part by the side arm element 206 (i.e., the side arm element 206 may itself form a portion of the wall of such article 213, and the side arm 201 itself may form another part or remainder of the article 213).

[0440] Each side arm 201 may include a port for accessing the passageway 213. Such a port may be located on the front surface of each side arm, at the more outer end of the side arm. The port is preferably located below the horizontal centerline of the patient interface and, more preferably, is oriented to receive a gas supply conduit or other gas connection from a direction below or below the side arm.

[0441] The portion of the passageway 213 formed at least in part by the side arm elements can be at least 10%, or at least 20%, or at least 30%, or at least 40%, or at least 50%, or at least 60%, or at least 70%, or at least 80%, or at least 90% of the wall perimeter or wall circumference (e.g., of a unit length portion) of the passageway so formed, or may be in the range of about 1-99%, or about 5-95%, or about 10-90%, or about 15-85%, or about 20-80%, or about 30-70%, or about 40-60%, or about 30-50%.

[0442] The walls of the passageway may be formed by a combination of side arm 201 and side arm element 206, so that side arm 201 may provide the remainder of the wall perimeter or wall perimeter that would otherwise be formed by the side arm element.

[0443] small protrusion When side arm elements 206 are used, one or more small protrusions 211 may be provided around or along such elements 206. These various small protrusions 211 are provided to be shaped or configured to engage with or correspond to the material of the side arm 201. See, for example, Figures 15A-15E, which illustrate such small protrusions 211.

[0444] The small protrusions 211 provide extensions of the side arm element 206 in various directions or planes, and in some embodiments may provide structural detail of the side arm element 206 with which the side arm 201 may engage, such as in an overmolded arrangement, or the material of the side arm 201 may otherwise be provided for engagement with the small protrusions 211. In this manner, such small protrusions 211 may be effectively embedded in the side arm 201. Such embedding may provide yet another additional region (or location) 205, or other stiffening or reinforcement of the side arm 201 or side arm element 206, or a combination thereof. For example, the interaction of the small protrusions 211 with the material of the side arm 201 may provide a particular resistance to flexing or bending (or hinging or elastic deformation) of the side arm element 206 of the side arm 201, or a combination thereof.

[0445] 15A-15E, the material of the side arm 201 can surround the small protrusions 211. The material of the side arm 201 can be at least partially compressible (or at least partially incompressible), or can have desired properties such that the small protrusions 211 can translate flexing or bending (or hinging or elastic deformation) of the side arm element 206 as compression of the material of the side arm 201 (or as stretching or extension of the side arm material in response to a force, such as tension).

[0446] In this way, the side arm material, or other portions of the side arm element (such as the walls of the notch or slit or slot or other incision in which it may be located), when compressed by the small protrusion, acts to resist hinging or bending deflection due to its material properties. Similarly, the side arm material may resist stretching or extension, for example, by the notch or slit or slot or other incision changing shape or increasing its angle in response to an applied force.

[0447] Various iterations of the patient interface 200 are shown in the accompanying figures. However, these figures should not be construed as limiting to any particular arrangement. When the patient interface 200 uses a side arm 201 in conjunction with a side arm element 206, for example, the material of the side arm 201 may in some configurations encapsulate or substantially cover (e.g., completely or entirely encapsulate or coat) the side arm element 206, while in other alternative configurations, it may only partially encapsulate or coat the side arm element 206.

[0448] The material of the side arm 201 may be used to fill any voids or gaps that may otherwise exist between the side arm 201 and the side arm element 206. In this manner, the side arm material can provide material that is inserted into voids or gaps or around other features of the side arm element 206, such as area (or location) 205. As noted above, the material of the side arm 201 may fully or partially encapsulate or cover the side arm element 206.

[0449] The material of the side arm 201 may be selected according to particularly suitable properties: the interaction of the region (or location) 205 or the small protrusion 211 (or both) with the material of the side arm 201 functions with one or more of the predetermined or pre-positioned points or localized regions (or locations) 205 to allow bending or flexing (or hinging or elastic deformation or movement or response) to an input of force or movement more preferentially in a first direction or set of directions, and less preferentially in another direction or set of directions, but may provide some resistance to such bending or flexing.

[0450] Side arms extend around each side of the face In certain embodiments, and for example, where the patient interface is provided with a pair of side arms 201, each of the side arms 201 is adapted to extend laterally from the bridge portion 202, such that one of the side arms 201 of the pair can extend substantially around the left side of the user's face and the other side arm can extend substantially around the right side of the user's face.

[0451] The or each side arm 201 can extend substantially laterally away from or outward from the user's sagittal plane. The or each side arm element 206 can extend a substantial length of, along, or across each such side arm 201 that includes such side arm element.

[0452] Thus, a pair of side arms 201 may be provided that allow the patient interface 200 to be positioned on the user's face, with each side arm 201 providing part of a retention or fastening system that may be coupled or associated with headgear. In this manner, the patient interface 200 may be held or fastened in a desired operating position on the user's face.

[0453] Each of the side arms 201 or side arm elements 206 may further respond to forces or movements applied to the patient interface by isolating, absorbing, attenuating, or at least somewhat mitigating the possibility of transmission or transfer of such forces or movements to other portions of the patient interface.

[0454] In preferred embodiments, forces or movements transmitted or imparted to the bridge portion 202 or bridge element 203 (or both) are minimized. This may allow for more stable placement or positioning of the gas outlet 204 and any such nasal prongs 208 associated with the bridge portion 202 or bridge element 203. This may further help reduce movement of such gas outlets or nasal prongs into the vicinity of the user's nose or its openings, and may help avoid prong flicking. Prong flicking is an undesirable consequence of movement of the gas outlet 204 or nasal prongs 208. Prong flicking may be irritating to the user and may interfere with the delivery of therapy.

[0455] As shown in certain figures, the or each side arm element 206 may be configured as multiple element limbs 212 (i.e., the side arm element 206 may be bifurcated or otherwise split or branched into a series of element limbs 212). One or more of these side arm element limbs 212 may themselves include one or more of the small protrusions 211 described above.

[0456] 2A-2E, one embodiment is provided in which bridge portion 202 includes bridge element 203, such bridge element 203 defining a pair of cutouts or shaped portions 207. Portions 207 provide a predetermined outlet 204 pathway or port to which nasal prongs 208 may fluidly connect for directing the flow of gases to the user's nares. As seen in FIG. 2C, there is a passageway 213 in or through side arm 201. Similarly, bridge element 203 is shaped or formed to allow the supply of gases through lumen or void space or cavity or recess 213 to be directed or supplied to one or more outlets 204 for delivery.

[0457] In the embodiment of Figures 2A-2E, the side arm 201 includes its own region (or location) 205s, which may be, for example, a general bowing of the side arm due to the side arm material in response to force.

[0458] 3A-3C and 4A-4C, an embodiment is provided in which bridge portion 202 includes bridge element 203, such bridge element 203 defining a pair of cutouts or shaped portions that define the spatial location of outlet 204, and from which a pair of nasal prongs 208 extend. Additionally, on each side arm 201, as part of a passageway 213, is a gas supply conduit locating portion 214 for locating or accommodating a gas supply conduit. The gas supply conduit may be secured in a predetermined location with the locating portion or within passageway 213 (e.g., may be glued in place). Bridge element 203 also includes such item 213 for receiving delivery of a gas supply and subsequently routing such gases to outlet 204 and nasal prongs 208.

[0459] In the embodiment of Figures 3A-3C, the gas supply conduit provides some resistance or at least some restriction to extension of the side arm 201 laterally outward of the side arm.

[0460] In the embodiment of Figures 4A-4C, the gas supply conduit provides a shorter length between fixed locations secured to one or each of the positioning portions 214, thereby providing greater resistance to extension of the side arms laterally outward from the bridge portion.

[0461] 5A-5E, an embodiment is provided in which the bridge portion 202 includes a bridge element 203 with a pair of left and right side arm elements 206. The bridge element 203 defines a pair of cutouts or shaped portions 207 that define the spatial location of the outlet 204, and from which a pair of nasal prongs extend. The side arm elements 206 include at least one region (or location) 205 about which a hinging feature is provided. The hinging feature allows the side arm elements 206 to bend, flex, or hinge, and absorbs or at least partially dampens the transmission or movement of forces or movements applied to the side arm elements 206 and prevents them from reaching the bridge portion 202 and bridge elements 203 that define the spatial location of the gas outlet 204 and prongs 208. As shown, region (or location) 205 can be a notch, slit, slot, or cutout in side arm element 206. Additionally, the joint or connection of materials between side arm 201 and side arm element 206 can provide an additional region (or location) 205 around which some bending or flexing can occur. The level of bending or flexing can depend, at least in part, on the materials of side arm 201 and side arm element 206 used and their relative properties. As shown in FIG. 5C, side arm 201 is shaped or formed to include, or form at least a portion of, a passageway 213 for positioning or accommodating a gas delivery conduit. Bridge element 203 is also shaped to facilitate such passageway 213 when combined with side arm 201. See, e.g., FIG. 5E.

[0462] 6A-6E, one embodiment is provided in which bridge portion 202 includes a bridge element 203 with a pair of left and right side arm elements 206. Bridge element 203 defines a pair of cutouts or shaped portions 207 that define the spatial location of outlet 204, from which a pair of nasal prongs extend. Side arm elements 206 include at least two regions (or locations) 205. A first region (or location) 205 is located at a more medial end 210 of side arm element 206, near the junction between bridge element 203 and side arm element 206. A second region or location (205) is located toward a more medial end 209 of side arm element 206. The first region (or location) allows for a preferred first direction or set of directions to be provided in which the side arm element can bend, flex or move outward from the user's face (i.e., in a lateral ventral direction), while the second region (or location) allows for a preferred first direction or set of directions to be provided in which the side arm element can bend, flex or move inward toward the user's face (i.e., in a lateral dorsal direction).

[0463] Additionally, a joint or connection of material between the side arm 201 and the side arm element 206 can provide an optional additional region (or location) 205. The level to which bending, flexing, etc. can occur may depend, at least in part, on the materials of the side arm 201 and the side arm element 206 used and their relative properties. As shown in FIG. 6C, the side arm 201 is shaped or formed to include, or form at least a portion of, a lumen or void space or cavity or other recess 213 for positioning or accommodating a gas delivery conduit. The bridge element 203 is also shaped to facilitate such an item 213 when combined with the side arm 201. See, e.g., FIG. 6D.

[0464] In the embodiment of Figures 6A-6E, the side arm 201 includes its own region (or location) 205s.

[0465] Similar to the embodiments described in connection with Figures 6A-6E, each of the embodiments of Figures 7-16 illustrate further arrangements using multiple regions or locations (205) and various preferential first directions to configure the patient interface 200 with a self-compensating ability to minimize the transmission or movement of forces or movements applied to or on the patient interface to the bridge portion 202 or bridge portion element 203, and also to the gas outlet 204 and, for example, nasal prongs that may be fluidly connected to the gas outlet 204.

[0466] The embodiment of Figures 7A-7E illustrates at least three regions (or locations) 205, and optional additional regions (or locations) 205 that may be promoted at the outer end of the side arm element 206, at the junction with the side arm 201. The first region (or location) 205 is located at the more inward end 210 of the side arm element 206, while the second and third regions (or locations) 205 are located more outwardly along the length of the side arm element 206. Note that the second and third (i.e., more outwardly located) regions (or locations) 205 are configured for preferential bending or flexing in a different, more inward direction than the first region (or location). This can enable various bending or flexing directions along the side arm element 206. As shown in Figure 7C, the side arm 201 is shaped or formed to include, or form at least a portion of, a lumen or void space or cavity or other recess 213 for positioning or accommodating a gas delivery conduit. Bridge element 203 is also shaped to facilitate such an item 213 when combined with side arm 201. See, for example, Figure 7E.

[0467] 7A-7E, the side arm 201 may include its own regions (or locations) 205s, as shown. Such side arm regions (or locations) 205s may be enabled by thinned or thickened portions or other shapes of the side arm material or side arm to allow hinging or bending or flexing in a preferential direction or plane.

[0468] The embodiment of Figures 8A-8E shows at least two regions (or locations) 205, and an optional additional region (or location) 205 that may be facilitated at the outer end of the side arm element 206 at the junction with the side arm 201. The first region (or location) 205 is located more inward (i.e., closer to the bridge element 203), and the second region (or location) 205. The different geometries of each region (or location) 205 allow for different types or levels of bending or flexing by each region (or location) 205. As shown in Figure 8C, the side arm 201 is shaped or formed to include, or form at least a portion of, a lumen, void space, cavity, or other recess 213 for positioning or accommodating a gas supply conduit. The bridge element 203 is also shaped to facilitate such an item 213 when combined with the side arm 201. See, for example, Figure 8E.

[0469] The embodiment of Figures 9A-9E illustrates at least two regions (or locations) 205, and an optional additional region (or location) 205 that may be promoted at the outer end of the side arm element 206, at the junction with the side arm 201. In this embodiment, a series of regions (or locations) 205 may be sequentially positioned or arranged along the length or body of the side arm element 206. A first region (or location) 205 is positioned more inward and closest to the bridge element 203. This first region (or location) 205 may allow a first preferred direction or set of directions that is different from the preferred direction or set of directions provided by a subsequently positioned region (or location) 205 that is more outwardly positioned than the first region (or location) 205. As shown in Figure 9C, the side arm 201 is shaped or formed to include, or form at least a portion of, a lumen or void space or cavity or other recess 213 for positioning or accommodating a gas delivery conduit. Bridge element 203 is also shaped to facilitate such an item 213 when combined with side arm 201. See, for example, Figure 9E.

[0470] The embodiment of Figures 10A-10E illustrates at least two regions (or locations) 205, and an optional additional region (or location) 205 that may be facilitated at the outer end of the side arm element 206, at the junction with the side arm 201. In this embodiment, a first region (or location) 205 may enable a first preferred direction or set of directions that is different from the preferred direction or set of directions provided by a subsequently disposed region (or location) 205 disposed more outwardly of the first region (or location) 205. For example, a region (or location) 205 disposed at a more inward position 210 of the side arm element 206 may provide complex or multiple bends or bending functions, for example, in multiple planes. As shown in Figure 10C, the side arm 201 is shaped or formed to include, or form at least a portion of, a lumen or void space or cavity or other recess 213 for positioning or accommodating a gas delivery conduit. Bridge element 203 is also shaped to facilitate such an item 213 when combined with side arm 201. See, for example, Figure 10E.

[0471] Each of Figures 11-16 illustrates additional arrangements of bridge portion 202, bridge portion element 203, and side arm element 206 for use with side arm 201. In each of these embodiments, side arm 201 is shaped or formed to include, or at least form a portion of, a lumen, void space, cavity, or other recess 213 for positioning or accommodating a gas delivery conduit. Bridge element 203 is also shaped to facilitate such item 213 when combined with side arm 201. Furthermore, each of these figures illustrates various and multiple arranged regions (or locations) 205 that provide a set or array of bending, flexing, hinging, etc., whether the same, different, or other combinations, that favor a first direction or set of directions over another direction or set of directions. Thus, patient interface 200 may be provided with any one or more of the configurations provided herein, or alternative combinations thereof.

[0472] As shown in the various figures, the material used for the side arm 201 may form part of the dynamic performance of the side arm element 206 or the side arm 201 itself. For example, the side arm 201 material may surround, encapsulate, or cover (partially or wholly) the side arm element 206. The side arm 201 material may then be inserted between or around the nub 211 or side arm element rim 212. In this manner, the side arm 201 material may provide resilience or resistance to flexing or bending or hinging, or may provide such resistance but still function to absorb forces or movements applied to the patient interface.

[0473] In use, the side arm or arms 201 are placed on the user's face, for example, on or around the cheeks of the face. An appropriate type of headgear (such as a head strap and back strap or other variation) can be connected to the side arms 201 to provide a retention system for maintaining or holding the patient interface 200 on the user. In a particularly preferred embodiment of the present invention, the patient interface 200 is a nasal cannula including a pair of side arms 201 and a pair of nasal prongs 208 in fluid communication with a gas outlet 204.

[0474] 18 , a patient interface 4200 is shown. In the configuration shown, the patient interface 4200 includes a nasal cannula. In some alternative configurations, the patient interface 4200 may include a sealing or non-sealing interface. For example, the patient interface 4200 may include a nasal mask, an oral mask, an oral-nasal mask, a full face mask, a nasal cannula, a non-sealing oral-nasal interface, a nasal pillow mask, an endotracheal tube, a combination of the above, or some other gas delivery system or device. Specific features, aspects, and advantages of the nasal cannula shown may be envisioned in other patient interfaces.

[0475] 18-23, the patient interface 4200 includes first and second nasal delivery elements 4202A, 4202B adapted to rest within the patient's nares. The illustrated nasal delivery elements 4202A, 4202B are substantially tubular and guide gases passing through the patient interface 4200 to the patient. The nasal delivery elements 4202A, 4202B are shaped and angled to extend generally inward toward the patient's nasal septum in use. The nasal delivery elements 4202A, 4202B terminate in tips that point toward the back of the patient's head in use. It should be understood that in some configurations, the nasal delivery elements 4202A, 4202B may have different shapes. For example, while the average cross-section of the nasal delivery elements 4202A, 4202B in the configuration shown is substantially circular, in some configurations the cross-section of the nasal delivery elements 4202A, 4202B may be substantially oval, substantially square, or substantially rectangular. In some configurations, the cross-section of the nasal delivery elements 4202A, 4202B may vary along the length of the nasal delivery elements 4202A, 4202B. In some configurations, the first and second nasal delivery elements 4202A, 4202B may have different characteristics. For example, the first nasal delivery element 4202A may be smaller or shorter than the second nasal delivery element 4202B. Some examples of nasal delivery elements with different characteristics are shown in commonly owned International Publication No. WO 2015 / 020540, the disclosure of which is incorporated herein by reference in its entirety. In some configurations, only one nasal delivery element may be used. In some configurations, more than two (eg, three or four) nasal delivery elements may be used.

[0476] The first and second nasal delivery elements 4202A, 4202B extend from first and second side arms (also referred to as first and second arms) 4206A, 4206B of the patient interface 4200. The first and second side arms 4206A, 4206B include internal gas delivery lumens 4210A, 4210B. The internal gas delivery lumens 4210A, 4210B receive gas from gas inlets 4208A, 4208B of the first and second side arms 4206A, 4206B and deliver the gas to the first and second nasal delivery elements 4202A, 4202B. The gas inlets 4208A, 4208B connect to a pair of gas delivery conduits 4218A, 4218B (see FIG. 1 ). In the configuration shown, the gas delivery conduits 4218A, 4218B are integrally formed with or permanently connected to the gas inlets 4208A, 4208B. The gas delivery conduits 4218A, 4218B are, in turn, integrally formed with or permanently connected to the gas conduit connector 222. The gas conduit connector 222 is configured to removably connect to a complementary connector 118 in pneumatic communication with the gas conduit 110 (described elsewhere in this disclosure with reference to FIG. 1). Other configurations are also contemplated. For example, in some configurations, the patient interface 4200 may be configured such that the first and second nasal delivery elements 4202A, 4202B receive gas from a single internal gas delivery lumen disposed in either the first or second side arms 4206A, 4206B, which in turn receives gas from a single gas delivery conduit. In some configurations, such gas delivery conduits 4218A, 4218B are not required, and one or more gas inlets 4208A, 4208B may be connected directly (or indirectly via a complementary connector 118 and / or gas conduit connector 222) to the gas conduit 110. In some such configurations, the first or second side arms 4206A, 4206B may be integrally formed or in the form of one continuous piece with the gas conduit 110. In some configurations, one or more of the gas delivery conduits 4218A, 4218B are removably coupled to one or more of the gas inlets 4208A, 4208B.In some configurations, one or more of the gas delivery conduits 4218A, 4218B are removably coupled to the gas conduit connector 222.

[0477] The first and second side arms 4206A, 4206B of the patient interface 4200 are adapted to rest on a patient's face. In the configuration shown, the first and second side arms 4206A, 4206B are adapted to rest on the patient's cheeks. Mounting structures 4216A, 4216B are provided on the patient-facing sides of the first and second side arms 4206A, 4206B to secure the first and second side arms 4206A, 4206B in place on the patient's face. The mounting structures 4216A, 4216B are adapted to maintain the patient interface 4200 in a desired alignment with the face (e.g., in this configuration, so that the nasal delivery elements 4202A, 4202B are comfortably and non-sealingly positioned within the nares). The mounting structures 4216A, 4216B are configured to be connectable to a securing structure attached to the face. In some configurations, the attachment structures 4216A, 4216B and the securing structures may be configured to complement one another. For example, the attachment structures 4216A, 4216B may include "loop" portions (e.g., constructed from textile or plastic) that are adhered or otherwise secured to the patient-facing sides of the first and second side arms 4206A, 4206B. The securing structures may also include "hook" pads that are adhered or otherwise secured to the face (e.g., for a "hook and loop" type connection). Some examples of hook and loop type connections are disclosed in commonly owned International Publication No. WO 2012 / 053910, the disclosure of which is incorporated herein by reference in its entirety. Other configurations are also contemplated. For example, in some configurations, the attachment structures 4216A, 4216B may directly connect to the face (e.g., through the use of adhesive pads or other structures). In some configurations, only one attachment structure may be used, or more than two (e.g., three or four) attachment structures may be used. In some configurations, the attachment structures 4216A, 4216B may include features other than "loop" portions. For example, the attachment structures 4216A, 4216B may include "hook" portions that connect with complementary "loop" portions on the anchoring structure.As another example, the mounting structures 4216A, 4216B may include snap fit features or other mechanical interlocking features that connect with features on the fixed structure. In some configurations, the patient interface 4200 may not include mounting structures. In some configurations, the patient interface 4200 may include headgear adapted to hold the patient interface 4200 in a desired orientation or alignment on the face. The headgear may include, for example, one or more straps configured to extend around the patient's head, buckles for adjusting the tightness of the straps by modifying the effective length of the straps, a cap, hood, hat, helmet, and / or one or more other features.

[0478] The bridge 4204 connects the first side arm 4206A and the second side arm 4206B. The bridge 4204 is an extension of the first and / or second side arms 4206A, 4206B that does not include an internal gas lumen and functions to help maintain the nasal delivery elements 4202A, 4202B in a desired orientation relative to one another. Other configurations are also contemplated. For example, in some configurations, the bridge 4204 may be composed of a second material or a different material than the remainder of the interface, e.g., the first and second arms. In some such configurations, only one of the side arms 4206A, 4206B includes an internal gas lumen and / or gas inlet. In some configurations, the bridge 4204 extends between a first connection point on the first side arm 4206A and a second connection point on the second side arm 4206B. In some such configurations, the first and / or second connection points may include one or more movable joints. In some such configurations, the one or more joints may include one or more hinge regions. A hinged joint may be part of the hinge region. In some such configurations, the one or more joints may include one or more pivot joints. The one or more joints may allow movement of the bridge 4204 relative to the first and / or second side arms 4206A, 4206B.

[0479] 19, the first and second side arms 4206A, 4206B decrease in width as they extend toward the nasal delivery elements 4202A, 4202B and / or the bridge 4204. When the mounting structures 4216A, 4216B are used in conjunction with a fixation structure, the mounting structures 4216A, 4216B are located on wider portions of the first and second side arms 4206A, 4206B proximal to the outer edges of the first and second side arms 4206A, 4206B to improve stability of the patient interface 4200 on the face. Additionally, as seen in FIG. 23, the patient interface 4200 is generally shaped or configured to substantially conform to the contours of the face. The patient interface 4200 is also configured so that when a force F1 acts on the first and second side arms 4206A, 4206B, forcing the outer edges of the side arms 4206A, 4206B inward toward the bridge 4204 (which may be caused, for example, by the face being pressed against a pillow or by a facial expression during an emotional state), the side arms 4206A, 4206B and / or an interior portion of the bridge 4204 act as a hinge region, causing a force F2 to act on the nasal delivery elements 4202A, 4202B, moving them toward the patient. This movement of the nasal delivery elements 4202A, 4202B toward the patient can help retain the nasal delivery elements 4202A, 4202B within the patient's nares.

[0480] 18, the outer edges of the first and second side arms 4206A, 4206B include detachment structures 4212A, 4212B. The detachment structures 4212A, 4212B are located on the outer portions of the side arms 4206A, 4206B and spaced apart from the gas inlets 4208A, 4208B. In the configuration shown, the detachment structures 4212A, 4212B are tabs that include an inner region that has a reduced thickness relative to the adjacent portions of the side arms 4206A, 4206B. Outward of the inner region of the tab and toward the outer edges of the side arms 4206A, 4206B, the tabs further include outer regions that have a normal thickness or an increased thickness relative to the same adjacent portions of the side arms 4206A, 4206B. The tabs are configured such that the outer regions may be grasped and pulled by a patient or another person (e.g., a medical professional such as, but not limited to, a nurse or doctor). When pulled, the outer region may rotate about the inner region and may exert sufficient force on the patient interface 4200 to detach the attachment structures 4216A, 4216B from the securing structures on the face. The detachment structures 4212A, 4212B may therefore be used to more easily remove the patient interface 4200 from the face. Other configurations are also contemplated. For example, in some configurations, only one detachment structure may be located on one body of the patient interface 4200. In some configurations, the patient interface 4200 may include more than two (e.g., three or four) detachment structures. In some configurations, the detachment structures 4212A, 4212B may be located on other portions of the side arms 4206A, 4206B or on other portions of the patient interface 4200. In some configurations, the detachment structures 4212A, 4212B may include structures other than tabs. For example, the engagement and disengagement structures 4212A, 4212B may include extensions of the first and / or second side arms 4206A, 4206B that can be pulled or otherwise manipulated to separate the patient interface 4200 from the face.

[0481] 21A and 21B, a close-up view of the patient interface 4200 is shown. Figure 24B specifically shows a schematic diagram of the bridge 4204 and nasal delivery elements 4202A, 4202B, and illustrates the bridge 4204 as a beam, showing a neutral axis N of the bridge 4204, a compression side C, and an extension side (e.g., the side facing towards the patient) T. As described elsewhere in this disclosure with reference to Figure 23, as forces act on the first and second side arms 4206A, 4206B, urging the side arms inward towards the bridge 4204, the shape of the patient interface 4200 moves the nasal delivery elements 4202A, 4202B towards the patient such that the nasal delivery elements 4202A, 4202B are retained within the patient's nares. However, a portion of the force F that acts to push the nasal delivery elements 4202A, 4202B may also act to push the nasal delivery elements 4202A, 4202B apart, causing them to move out of alignment with one another. In some cases, the nasal delivery elements 4202A, 4202B are spread apart, rotating through a displacement angle D1 in substantially opposite directions. As shown in FIG. 21B , the force F applies tension to the patient-facing side of the bridge 4204, effectively stretching and curving the patient-facing side of the bridge 4204 and spreading the nasal delivery elements 4202A, 4202B (see the dotted outline in FIG. 21B , which shows the nasal delivery elements 4202A, 4202B in their unspread position). The opposite side of the bridge 4204 similarly becomes compressed and generally does not retain its curve or shape due to the force F. As the nasal delivery elements 4202A and 4202B spread apart from each other, in some cases the nasal delivery elements 4202A, 4202B may distort against the inside of the nostril and may "pop out" or shift and be positioned outside the nostril, which may be inconvenient for the patient or another person providing service to the patient.

[0482] 22A and 22B show a modified patient interface 4200. The modified patient interface 4200 includes a support structure 4220 disposed on a patient-facing side of a bridge 4204. In the configuration shown, the support structure 4220 is configured to reinforce the bridge 4204 and resist the tendency of the nasal delivery elements 4202A, 4202B to spread apart when a force F is applied to the bridge 4204 (e.g., the support structure 4220 acts as a reinforcement structure 4204). In effect, as shown in the schematic diagram of FIG. 22B, the presence of the support structure 4220 on the patient-facing side of the bridge 4204 moves the neutral axis N from being approximately centered or central to the bridge 4204 to being closer to the extension side T of the bridge 4204. The tensile strength of the bridge 4204 may be improved. Thus, for the same force F, the nasal delivery elements 4202A, 4202B may be displaced by a smaller displacement angle D2, reducing the tendency to distort against the inside of the nostril or to shift out of position outside the nostril.

[0483] In some configurations, the support structure 4220 is made at least in part from a textile material. For example, the support structure 4220 may be made from a woven, nonwoven, or knitted textile material. In the configuration shown, the support structure 4220 is made from a polymer (e.g., polypropylene) sheet. Making the support structure 4220 from a textile material gives the support structure 4220 sufficient strength to move the neutral axis and resist spreading of the nasal delivery elements 4202A, 4202B. Additionally, the use of a textile material on the patient-facing side of the bridge 4204 may maintain or improve comfort of the patient interface 4200 on the face and may help reduce or prevent sores that may occur as a result of prolonged use of the patient interface 4200 on the face. However, in other configurations, other forms of support structure may be used for the support structure 4220, including, but not limited to, sheets, films, plates, panels, slabs, and other masses of various shapes and sizes, and other materials including, but not limited to, polymers, plastics, metals, ceramics, fabrics, waxes, and other materials of various qualities. In the configuration shown, the support structure 4220 is of a generally constant thickness throughout the length and width of the support structure 4220, although in some configurations the support structure 4220 may have a non-uniform thickness along the length and / or width of the support structure 4220 (e.g., in some cases the support structure 4220 may have a "bumpy" or "wavy" patient-facing surface).

[0484] In some configurations, the support structure 4220 is adhered to the patient-facing side of the bridge 4204. In some configurations, the support structure 4220 and / or the bridge 4204 are configured to rest against the user's philtrum. In some configurations, the support structure 4220 may be attached to the patient-facing side of the bridge 4204 by other joining structures or means. For example, in some configurations, the support structure 4220 may be overmolded to the patient-facing side of the bridge 4204, adhered (e.g., by using one or more adhesives or glues) to the patient-facing side of the bridge 4204, melt bonded to the patient-facing side of the bridge 4204, welded using ultrasonic or radio frequency welding, sown, fastened, screwed, and / or bolted. In some configurations, the support structure 4220 may be chemically bonded to the bridge 4204. In some such configurations, the support structure 4220 may be made from the same material (e.g., the same plastic, e.g., polypropylene) as the bridge 4204 (and possibly the same material as the rest of the patient interface 4200). For example, if the support structure 4220 and bridge 4204 are both made from polypropylene (in this example, the support structure 4220 is a polypropylene textile and the bridge 4204 is another polypropylene mass), chemical bonding may be easier to facilitate and may allow for a more seamless and aesthetically acceptable join between the support structure 4220 and the bridge 4204.

[0485] It should be understood that the support structure 4220 need not necessarily be located only on the patient-facing side of the bridge 4204. In some configurations, and as seen in FIG. 24 , the support structure 4220 may extend across at least a portion of the first and / or second side arms 4206A, 4206B. The support structure 4220 may be in the form of a strip having substantially the same width as the bridge 4204 across the length of the support structure 4220. In other configurations, the support structure 4220 may decrease in width across the length of the support structure 4220. In yet other configurations, the support structure 4220 may increase in width across the length of the support structure 4220. In some such configurations, the width of the support structure 4220 increases to approximate or match the width of the first and / or second side arms 4206A, 4206B (in the configuration shown, the first and / or second side arms 4206A, 4206B increase in width as they extend outward from the bridge 4204 and / or nasal delivery elements 4202A, 4202B). In some configurations, and as seen in FIG. 23 , the support structure 4220 may extend the entire length of the patient interface 4200, including the bridge 4204 and the first and second side arms 4206A, 4206B. In some configurations, the support structure 4220 may be discontinuous across the length of the support structure 4220 (e.g., the support structure 4220 may be in the form of three discontinuous segments).

[0486] In some configurations, the support structure 4220 may be configured to be used as one or more of the mounting structures 4216A, 4216B if the support structure 4220 extends into the patient-facing sections of the side arms 4206A, 4206B that normally carry one or more of the mounting structures 4216A, 4216B. In some such configurations, one or more of the mounting structures 4216A, 4216B are not required, and the support structure 4220 may be configured to perform the function of one or more of the mounting structures 4216A, 4216B. For example, the support structure 4220 may include a "loop" section that may connect with a complementary "hook" section of a securing structure that is secured to the face. As another example, the support structure 4220 may be attached directly to the face.

[0487] It should be understood that the support structure 4220 does not necessarily have to be located on the patient-facing side of the patient interface 4200 (including, but not limited to, the first side arm 4206A, the second side arm 4206B and / or the bridge 4204). In some configurations, the support structure 4220 may be located on other sides of the patient interface 4200 (including, but not limited to, the side of the bridge 4204, the first side arm 4206A and / or the second side arm 4206B facing away from the face and / or opposite one or more patient-facing sides), provided that the material and / or structure and / or configuration of the support structure 4220 resists spreading of the prongs upon application of force and shifts the neutral axis in an appropriate manner to urge the first and / or second side arms inward toward the bridge 4204 and / or first and / or second nasal delivery elements 4202A, 4202B. In some configurations, the support structure 4220 rests on a non-user-facing side of the bridge 4204. In some configurations, the support structure 4220 rests on a non-user-facing side of the first and / or second side arms 4206A, 4206B. In the configuration shown, the support structure 4220 is configured to resist tension. The support structure 4220 provides resistance to bending of the bridge 4204 by shifting the neutral axis. In some configurations, the support structure 4220 can resist compression to shift the neutral axis. In a further alternative configuration, the support structure 4220 is configured to resist shear forces.

[0488] The patient interface of the present disclosure advantageously provides improved provision of respiratory care by a ventilator or gas supply, or in combination with a gas humidification system or other gas supply system for supplying gas to a patient or for delivering any other gas to a patient.

[0489] 25A-26C, a patient interface 2201 / 2301, such as a nasal cannula, includes a pair of left and right side arms 2201 / 2301 and 2303 / 2303 (also referred to as body portions) that, in use, are positioned on a user's face, and at least one and preferably a pair of nasal prongs 2205 / 2305, 2207 / 2307 for insertion into or directing the flow of gases to a nostril or nostrils of the user's nose. The patient interface 2201 / 2301 also includes a bridge 2209 / 2309 attached to and extending from a point of connection with the left side arm or body portion to a point of connection with the right side arm or body portion. The bridge 2209 / 2309 includes a substantially inelastic component.

[0490] One or each of the connection points includes a first movable joint 2211 / 2311, 2213 / 2313, such as a hinged or pivot joint, that allows a first movement of the bridge relative to the respective side arm or body portion. The first movable joint allows relative rotation about at least one axis between the end of the bridge 2209 / 2309 and the respective side arm or body portion. The first movable joint may be one or a combination of an articulating joint, a pin-and-barrel joint, or a ball-and-socket joint. The interface also includes a face pad 2215 / 2315, 2217 / 2317 associated with each side arm. Each face pad is contoured to engage an area of ​​the user's face.

[0491] Referring to the embodiment shown in FIGS. 25A-25C, the bridge 2209 includes at least one, and preferably a pair of, nasal prongs 2205, 2207. Each first movable joint is provided between an end of the bridge 2209 and an inner end of each of the side arms. The first movable joints allow relative rotation between the end of the bridge and each of the side arms about three substantially orthogonal axes. The first movable joints include ball-and-socket joints 2211, 2213. A pair of first movable joints is provided between each end of the bridge 2209 and the inner ends of the left and right side arms 2201, 2203, respectively. When the patient interface is in situ on the user's face, displacement of the position of one or both of the left and / or right body portions 2201, 2203 is transmitted to the or each first movable joint in a manner that minimizes displacement of the bridge and the prong or prongs relative to the user's nostrils.

[0492] Referring to Figures 26A-26C, at least one and preferably a pair of nasal prongs 2305, 2307 extend from one or each of the more medial ends of each of the left side arm 2301 and / or right side arm 2303, or from one or both regions of each side arm substantially adjacent the more medial end, and a bridge 2309 is a bar extending across or adjacent said nasal prongs.

[0493] In this embodiment, the patient interface further includes a fixture 2319, 2321 attached to each side arm to facilitate connection points for the bar 2309. The fixtures include a second movable joint, such as a hinged or pivot joint 2311, 2313, to allow a second movement of the mount relative to each side arm to which it is attached. The bar is attached to the fixtures via a first movable joint.

[0494] The attachments 2319, 2321 are slidably attached to each side arm to allow adjustment of the relative position along the side arm, thereby adjusting the distance between the prongs. When the patient interface is in situ on the user's face, displacement of the position of one or both of the left side arm 2301 and / or right side arm 2303 is transmitted to the bar via the connection points or attachments and the first and / or second moveable joints, respectively, in a manner that minimizes movement of the prong or prongs relative to the user's nostrils.

[0495] The first and second movable joints are aligned to allow movement of the attached components in substantially the same direction. In alternative embodiments, the first and second movable joints may be misaligned to allow movement in different directions. In another alternative embodiment, the bar may have one or more additional movable joints.

[0496] The side arms, including the nasal prongs, are relatively flexible or compliant relative to the relatively inflexible or non-compliant bar and / or attachment. The connection points or attachments include fingers extending outwardly therefrom, on which first movable joints are located for connecting to the bar. The bar is an over-center component of the patient interface, and the connection points or attachments are symmetrically located on each of the side arms. The second movable joint is one or a combination of an articulating joint, a pin-and-barrel joint, and a ball-and-socket joint.

[0497] 27A-28B, a patient interface, such as a nasal cannula, has a body portion 2601 that is positioned on a user's face during use. The patient interface has at least one and preferably a pair of nasal prongs 2605 / 2705, 2607 / 2707 extending from the body portion and, in the operative position, for insertion into a nostril or nostrils of the user's nose or for directing the flow of gases into the nostril or nostrils of the user's nose. The body 2601 has at least one hollow region 2619 / 2719, 2721 connected to the nasal prongs and having a fluid passageway for delivering gases to the nostrils of the user's nose. During delivery of fluid through the fluid passageway, the hollow region 2619 / 2719, 2721 substantially resists transmission of displacement forces from one or more regions of the body portion to the nasal prongs 2605 / 2705, 2607 / 2707, maintaining the operative position of the prongs.

[0498] 27A-27C, the body portion 2601 includes a generally rigid frame 2601a and at least one relatively soft hollow region 2619 extending from the rigid frame. The at least one hollow region 2619 is inflatable and expands in the direction of extension of the nasal prongs. The hollow region 2619 is coupled to the nasal prongs and is inflatable upon delivery of gas to the nostrils of the user's nose. The hollow region 2619, at least in its inflated state, is positioned in the philtrum or upper lip region of the user to substantially maintain the nasal prongs in an operative position.

[0499] In the inflated state, the hollow region 2619 is substantially deeper than the depth of the frame of the body portion adjacent the hollow region. Either end of the body portion 2601 includes a user face-contacting surface 2615, 2617 that is contoured to engage the cheek region of a user's face in use. The body portion 2601, or at least either end of the body portion, is shaped or curved to substantially complement the facial structure of a user in use.

[0500] Referring to the embodiment shown in Figures 28A-28B, the body portion includes a pair of left and right side arms 2701 and 2703. The left and right side arms 2701 and 2703 are substantially flexible. Nasal prongs 2705, 2707 extend from one or each of the more medial ends of the left and / or right side arms, respectively, or from one or both regions of each side arm substantially adjacent the more medial end. A bridge portion 2709 connects the more medial ends of the left and side arms, respectively. The bridge portion 2707 is substantially rigid relative to the left and right side arms.

[0501] At least one, and preferably both, left body segment 2701 and / or right body segment 2703 include hollow regions 2719, 2721, each of which has a fluid passageway for delivering a volume of gas to each nasal prong.

[0502] The patient interface 2700 includes one or more internal struts extending between opposing interior surfaces of the hollow region for maintaining an open fluid pathway. The one or more internal struts include a plurality of struts spatially distributed within the hollow region.

[0503] 29A-29C, a patient interface 3100, such as a nasal cannula, has a body portion 3103 that is placed on a user's face during use, a bridge portion 3102 extending away from the body portion, and at least one, and preferably a pair of, nasal prongs 3105, 3107 extending from the bridge portion and, in an operative position, for insertion into or directing gas flow into a nostril or nostrils of the user's nose. The body portion actively regulates using potentials from the system or stored in the cannula. During use, the body portion is placed on one cheek of the user's face, with the other cheek of the user's face free from the interface.

[0504] 34A-34C, a patient interface 3400, such as a nasal cannula, has an elongated body 3402 that, in use, is placed on a user's face. The body 3402 has at least one, and preferably a pair of nasal prongs 3405, 3407 for insertion into or directing the flow of gases into the nostril or nostrils of the user's nose, and at least one, and preferably a pair of face-contacting surfaces 3415, 3417 movably coupled to the body 3402 and responsive to force or movement, or both, applied to the face-contacting surface and at least partially reducing the transmission of such force and / or movement to the body and nasal prongs.

[0505] Each face-contacting surface 3415, 3417 is contoured to engage the cheek of the user's face. Each face-contacting surface 3415, 3417 is movably coupled to an end portion of the body, preferably slidably coupled to the body. Each face-contacting surface 3415, 3417 has an associated hollow guide 3409, 3411 for slidably receiving a portion of the body 3402 therein.

[0506] The patient interface 3400 further includes a resilient member (not shown) associated with each face-contacting surface 3415, 3417. The resilient member is coupled between the face-contacting surface 3415, 3417 and the body and urges the face-contacting surfaces 3415, 3417 toward the center of the body 3402. In the preferred embodiment shown, the resilient member includes a compression spring.

[0507] The body 3402 includes a bridge portion 3409 from which extend the nasal prongs 3405, 3407. The bridge portion 3409 curves inward and extends toward the user's nasal septum in situ. The body (preferably the entire body) 3402 is generally rigid and substantially hollow, and is fluidly coupled to the nasal prongs to allow gas flow therethrough. At least one end, and preferably both ends, of the body are configured to fluidly couple to the gas flow path of the breathing circuit.

[0508] 32 and 33, a patient interface 3500 / 3600, such as a nasal cannula, has a body 3501 / 3601 that, in use, is placed on a user's face. The body 3501 / 3601 includes at least one and preferably a pair of nasal prongs 3605, 3607 for insertion into or directing the flow of gases into a nostril or nostrils of the user's nose in an operative position. The patient interface 3500 / 3600 also includes at least one active element 3501 and preferably a pair of active elements 3601, 3603, each of which is configured to operate in response to input energy to move at least one other region of the body to hold the nasal prongs in the operative position.

[0509] The input energy is non-mechanical energy. At least one active element 3501 / 3601, 3603 is configured to convert the input energy into mechanical energy and move at least one other region of the body. Each active element 3501 / 3601, 3603 includes at least one, and preferably a pair of, expansion elements configured to expand in response to the input energy and move at least one other region adjacent the nasal prongs to hold the nasal prong or prongs in an operative position.

[0510] The inflatable element is disposed on the user-engaging side of the body and is configured to be placed adjacent to the cheek of the user's face in situ.

[0511] The patient interface also has one or more hinges, pivots, or articulating joints, or any combination thereof, operable in response to actuation of one or more of the active elements. The patient interface has one or more hinges at a bridge portion of the body from which the nasal prongs extend.

[0512] Referring to the embodiment shown in FIG. 32, the inflatable element forms a body 3501 and is configured to expand in response to input energy to move a bridge portion 3509 of the body 3501 that extends toward and / or against the philtrum of the user where the nasal prongs are naturally positioned.

[0513] At least one active element 3501 is an electromechanical element configured to receive electrical activation energy to move at least one other region of the body, the electromechanical element being coupled to an electrical circuit and actuated in response to an electrical activation signal generated by a change in voltage, resistance, or current, or any combination, in the electrical circuit.

[0514] The movement or force or both experienced by one or more regions of the body generates an electrical activation signal. The movement of one or more regions of the body engages electrical contacts in a circuit, generating an electrical activation signal. The movement of one or more regions of the body causes a change in electrical resistance in the circuit, generating an electrical activation signal.

[0515] The electromechanical element may be or include a conductive polymer or a bimetallic strip or any combination thereof, or may be or include a pair of electromagnets.

[0516] The patient interface further includes at least one, and preferably a pair of, face contact pads 3515, 3517 configured to engage the user's face in use, with the or either end of the bridge portion being coupled to one or more face contact pads, respectively.

[0517] Referring to the embodiment shown in FIG. 33, the input energy is indicated by a change in humidity in one or more regions of the body, and at least one active element 3601, 3603 is configured to activate in response to a threshold humidity or a change in humidity or both to move at least one other region of the body and hold the nasal prongs in an operative position.

[0518] The body 3501 is flexible in at least one region and deforms in response to expansion of the inflatable element, causing the bridge portion 3609 to move toward the philtrum in its natural position. The bridge portion 3609 includes one or more hinges 3621, 3623. The bridge portion 3609 is preferably a rigid component to prevent or at least substantially inhibit upward movement of the inflatable element, urging the inflatable element to move downward onto the user's philtrum.

[0519] The active elements 3601, 3603 are configured to absorb water and expand in response to a threshold humidity or a change in humidity, or both, thereby displacing at least one other region of the body. The active elements 3601, 3603, or at least a portion of the active elements 3601, 3603, are positioned adjacent the base of the corresponding nasal prong and are configured to engage the philtrum in situ, such that expansion of the active element or a portion of the active element pivots the nasal prong toward the back of the user's respective nostril and holds the nasal prong in an operative position. At least one active element 3601, 3603 is or includes a polymeric material configured to expand with increased humidity. At least one active element forms at least a portion of the body.

[0520] The body includes a left side arm and a separate right side arm, each of the left and right side arms having an active element and a nasal prong associated with the active element. The patient interface further includes a bridge portion 3609 that straddles the active element of each of the left and right side arms and holds the element against the user's philtrum in place.

[0521] The patient interface further comprises at least one, and preferably a pair of, face-contacting pads 3615, 3617 configured to engage the user's face in use, with the or either end of the bridge portion being coupled to one or more face-contacting pads, respectively. The patient interface further comprises another face-contacting pad 3625 configured to engage the user's face, and in particular the philtrum, in use.

[0522] 30A-30F, a patient interface 3700, such as a nasal cannula, has a body portion having a left side arm 3701 and a right side arm 3703 that, in use, rests on a user's face. The patient interface 3700 has at least one, and preferably a pair of, nasal prongs 3705, 3707 extending from the left and right side arms for insertion into or directing the flow of gases into a nostril or nostrils of the user's nose when in the operative position. When in the operative position, the left and right side arms rest in a substantially curved configuration over the cheeks of the user's face, as will be described in more detail below.

[0523] The patient interface 3700 has the non-use configuration shown in Figures 30A-30C. In this configuration, the body portion is substantially flat, or at least one end of the body portion is substantially flat and substantially coplanar with the other end of the body portion. As shown in Figure 30C, in this configuration, the face-contacting surfaces 3715, 3717 at each end are substantially flat surfaces that are substantially coplanar with each other. At least one, and preferably a pair of, nasal prongs extend outwardly away from the central plane of the body portion.

[0524] In alternative embodiments, either or both ends 3701, 3703 of the body portion are substantially coplanar; that is, they may be offset relative to one another. Additionally or alternatively, while in the non-use configuration, either or both ends 3701, 3703 of the body portion, the face-contacting surfaces 3715, 3717, may have a slight curve or other shape. Either or both ends 3701, 3703 of the body portion are preloaded / prestressed to bias them back into the coplanar arrangement.

[0525] The patient interface 3700 has a bridge portion 3710 that has a concave cavity when viewed away from the user. The cavity may be filled or at least partially filled with a soft and / or flexible material. Alternatively, the cavity may be filled or at least partially filled with a relatively harder material. An advantage of filling the cavity with a suitable material is that the cavity does not attract and / or retain dirt. As described above, either or both ends 3701, 3703 of the body portion are preloaded. This preload urges the bridge portion toward and into contact with the user's philtrum as the face-contacting portion stretches, bends, and is placed on the user's face.

[0526] The cavity, whether hollow, partially filled, or filled, reduces the resilient / spring force exerted on the user's philtrum compared to a bridge without a cavity. One or more other sections of the patient interface may have cavities that may be unfilled, filled, or at least partially filled with a soft and / or flexible material or a relatively harder material. In preferred embodiments, the bridge has been shown and described as being relatively flexible and / or resilient. In alternative embodiments, the bridge may include a relatively rigid bridge portion to define at least the initial orientation and / or spatial position of the nasal prongs. The relatively rigid portion may be a filled or partially filled cavity as described above, or may be a co-molded or overmolded portion of the patient interface.

[0527] When viewed from above, the left and right side arms initially extend outward, flaring from the bridge before transitioning into a substantially flat section. The transitions 3719, 3721 between the bridge and the left and right side arms are smooth, arcuate transitions. The transitions 3719, 3721 have relatively large radii so that pressure from the bridge and transitions 3719, 3721 on the user's face is evenly distributed across the philtrum. The transitions 3719, 3721 are spaced outward from the prongs. In particular, the center of each transition curve 3720 is positioned outward relative to the midline or longitudinal axis A of the adjacent prong, reducing prong movement during use. The patient interface has a relatively thin thickness between the surface 3721 and the surface 3725 to reduce elastic / spring forces experienced by the user's philtrum.

[0528] Opposite the face-contacting surfaces 3715, 3717, the outer surfaces 3727, 3729 of the left and right side arms are slightly arcuate and convex when viewed away from the user. However, when in the non-use configuration, the overall shape of the left and right side arms is substantially flat. The outer surfaces 3727, 3729 are relatively thin and have relatively little material so that the patient interface is flexible. The face-contacting surfaces 3715, 3717 are spaced a relatively small distance from adjacent portions of the left and right side arms. The profile of the flexing portion of the patient interface may be designed to minimize kinking in either the use or non-use configuration. For example, the flexing portion of the patient interface may have ridges, corrugations, or notches to minimize or eliminate kinking of the patient interface.

[0529] The left and right side arms are positioned on the user's face during use. Preferably, the left and right side arms of the body portion are positioned on the cheeks of the user's face during use. The patient interface has the in-use configuration shown in FIGS. 30D-30F. In this configuration, the body portion, or at least the left and right side arms, are shaped or curved to substantially complement the user's facial structure during use, with the nasal prongs extending in a direction substantially parallel to the central plane of the body portion, or at least at an angle less than that in the in-use configuration. In particular, when viewed from the user's position, the face-contacting surfaces 3715, 3717 are arcuate, concave surfaces. When viewed from the position shown in FIG. 30F, the left and right side arms are substantially arcuate. In this configuration, the transitions between the bridge and the left and right side arms are also smooth, arcuate transitions.

[0530] The body portion is a single, integrally formed component. As shown in Figures 30A-30F, the body portion and at least one and preferably a pair of nasal prongs are a single, integrally formed component. That is, the patient interface 3700 is a single, integrally formed component.

[0531] The prongs may be angled outward from one another at an angle greater than 0° and less than 180° in the non-use configuration. For example, the angle between the prongs may be greater than 0° and less than or equal to about 60°, between about 5° and about 55°, between about 10° and about 50°, between about 15° and about 45°, between about 20° and about 40°, about 5°, about 10°, about 30°, about 32°, about 45°, about 60°, about 80°, about 90°, about 100°, about 120°, about 140°, about 160°, or about 170°. When the interface is extended and / or applied to the user's face, the interface 3700 orients the prongs into a substantially parallel configuration.

[0532] The interface is a nasal cannula including a pair of nasal prongs as an outlet for the cannula, and the cannula can be fitted with a headgear or retention system for holding the nasal cannula in place when worn by a user in use. The retention system (or fastening system) may include a detachable connection system for detachably connecting or fastening the patient interface to the user's face (e.g., the detachable connection system may include a hook-and-loop or hook-and-hook connector for such a system). Such a detachable connection or fastening system may include at least one pad (comprising a material such as hydrocolloid) attached to the user's face, onto which the patient interface may be detachably engageable.

[0533] It will also be appreciated that various aspects of the present disclosure may be applied using any form of patient interface in conjunction with any suitable form of headgear or retention or fastening system for securing the patient interface on a user, such as the fastening system described in International Application PCT / NZ2011 / 000218 (published as WO 2012 / 053910, the contents of which are incorporated herein by reference), suitable for holding the patient interface on a user for delivery of a desired therapy. Thus, one or a pair of side arms may be provided that allow the patient interface to be positioned on the user's face, each or both of the side arms providing part of a retention or fastening system that may be coupled or associated with the headgear. In this manner, the patient interface may be held or fastened in a desired operating position on the user's face.

[0534] The body portion or at least one end of the body portion comprises a resilient and / or flexible material.

[0535] The patient interface 3700 may be or include a polymeric material, such as, but not limited to, one or a combination of one or more of a thermoplastic elastomer, a polypropylene-based elastomer, a liquid silicone rubber, or a breathable thermoplastic polyurethane, or a breathable polyamide, more preferably, the polymer is from the thermoplastic elastomer family, such as a polyolefin, a thermoplastic elastomer, or a breathable thermoplastic elastomer, for example, a styrene block copolymer, a copolyester elastomer, or a thermoplastic polyolefin elastomer, or a thermoplastic polyurethane elastomer, even more preferably, a polymer having a Shore A hardness of less than about 30, or about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90. In embodiments where the cavity is filled with a material, the material preferably has a Shore A hardness of from about 0 to about 30, or from about 10 to about 20, or about 10, or about 15, or about 20, or about 30.

[0536] Areas of the patient interface that will come into contact with the user's philtrum may have a surface finish that enhances comfort, such as a shallow pattern, a sandblasted surface finish, a bead blasted surface finish, a roughened or patterned surface finish, dots, channels or grooves, or other surface relief features.

[0537] The body portion may be shaped or configured or adapted to provide passageways 3711, 3713. Such passageways 3711, 3713 may be formed by one or more lumens or void spaces or cavities or other recesses within the body portion.

[0538] Such passageways 3711, 3713 allow for the provision of a pathway for receiving a gas supply (from a source) and delivering the gas to a user via the prongs 3705, 3707, or alternatively, for receiving a gas supply conduit (not shown, but which may be received in or attached to such articles 3711, 3713) and then delivering the gas through the prongs to a user. Such passageways 3711, 3713 within or through the side arm 201 and / or side arm element 206 allow for the formation of a conduit or lumen through which gas may be guided or supplied for delivery to the prongs 3705, 3707.

[0539] FIG. 31 shows an alternative embodiment 3800 that is a modification of the embodiment shown in FIGS. 30A-30F and includes a loop of material 3816 for detachably connecting the patient interface to the user's face. The loop of material 3816 is preferably part of a hook-and-loop connector of a detachable connection system for detachably connecting the patient interface to the user's face. In the embodiment shown, the loop of material 3816 is divided into sections with spaces between the sections to prevent the loop material from bunching or gathering when the patient interface is placed on the user's face. Alternatively, the loop of material 3816 may be a single piece of material extending from the end of one or each side arm toward the center of the patient interface. In this embodiment, the loop of material is flexible so that it does not bunch or gather when the patient interface is in use. In another alternative embodiment, the loop of material may be adjacent or adjacent sections with full or partial cuts between the sections to allow the sections to move relative to each other and prevent bunching or gathering when the patient interface is in use.

[0540] 30A-30F and 31, and in particular the embodiment shown in FIGS. 30F and 31, each of the prongs 3705 / 3805, 3707 / 3807 extends at an angle θ relative to a central plane P of the patient interface. This angle is defined by the angle between a central axis passing through each prong and the central plane. As noted above, the prongs may angle outwardly from each other in the non-use configuration. This is shown in FIG. 31. In the in-use configuration, the shape of the patient interface, as well as the properties of the material from which the patient interface is formed, allow the prongs to extend at an angle that is at least less than the angle in the non-use configuration.

[0541] 35-45, a patient interface 4700, such as a nasal cannula, has a body portion having a left side arm 4701 and a right side arm 4703 that, in use, is placed on a user's face. The patient interface 4700 has at least one, and preferably a pair of, nasal prongs 4705, 4707 for insertion into or for directing the flow of gases into a nostril or nostrils of the user's nose. In use, the left and right side arms are placed on the user's face, over the cheeks.

[0542] The patient interface 4700 has a bridge portion 4710. Nasal prongs 4705, 4707 extend from the bridge portion. In some embodiments, the bridge portion may be relatively rigid so as to define at least the initial orientation and / or spatial position of the nasal prongs. By "relatively rigid," it is meant that the bridge portion is more rigid than the rest of the body portion such that, in use, the rest of the body portion bends or otherwise deforms before the bridge portion bends or deforms. The bridge portion may be more rigid because it is either wider and / or thicker in height. Alternatively, the bridge may be more rigid by including bridge portion elements.

[0543] When viewed from above, the bridge portion transitions into the left and right side arms by flaring or curving outward away from the bridge portion's face. The left and right side arms 4701, 4703 curve rearward from the front extent of the interface's main body, away from the bridge portion. The curve of the bridge portion's face side 4720 and / or the transition regions 4719, 4721 between the bridge and the left and right side arms is smooth. The face side of the bridge portion and / or the transition regions 4719, 4721 have relatively large radii so that pressure from the bridge and transition regions 4719, 4721 on the user's face is evenly distributed over the philtrum or upper lip area between the user's upper lip and nose. The transition regions 4719, 4721 are spaced outward from the prongs.

[0544] In some embodiments, as described above, the body portions extend forward from each side of the bridge portion 4710 to a location forward of the bridge portion, and then extend rearward so that an end of the body portion is disposed rearward of the bridge portion. This arrangement, when viewed from above as shown in FIG. 36 , provides a general "U" shape between each nasal prong 4705, 4707 and the left or right side arm 4701, 4703 of the body portion. The U-shaped regions 4723, 4725, respectively, provide a hinging or bending region where the body portion tends to bend as the left or right side of the body portion flexes inward to conform to the user's face. In some embodiments, the U-shaped region tends to bend at the base or bottom of the valley 4730 of the U-shaped region. However, the bending region may bend in a region extending a distance along the body portion in some embodiments. The bending region may bend at discrete points in the body portion, as well as over an area or region of the body portion.

[0545] The bend or hinge regions 4723, 4725 decouple flexing of the left and right portions of the interface from the bridge portion and therefore from the nasal prongs, thereby at least partially decoupling facial movements that may be transmitted to the left and right sides of the interface from the prongs so that, in use, the position of the prongs within the user's nostrils is not disturbed by the user's facial movements.

[0546] The U-shape of the body portion in the bending region positions the bending region outward and forward from the nasal prongs relative to the facial side of the body portion. This positioning further promotes flexibility of the bending portion by positioning the general surfaces 4750 of the left and right sides of the body portion farther away from the nasal prongs than an interface without the U-shaped region, for example, as shown by the dashed line on the left-hand side of FIG. 37 . A user's facial movements are generally on the general surfaces 4750 of the left and right portions, and positioning this surface further away from the nasal prongs (as indicated by arrows 4751 in FIG. 37 ) further separates facial movements from the prongs, helping to reduce the effect of facial movements on the position of the prongs within the user's nostrils. The flexibility of the bending region may determine how large the distance should be between the general surfaces of the left and right sides of the body portion and each nasal prong.

[0547] In some embodiments, the bend or hinge region may be formed by or include at least one bend or hinge element, such as a mechanical hinge, e.g., the mechanical hinge may be molded into the hinge region or may be a region of the body portion.

[0548] The body portion of the interface of Figures 35-45 is a single, integrally formed component. As shown, the left and right side arms, the bend portion, the bridge portion, and at least one and preferably a pair of nasal prongs are a single, integrally formed component. That is, the patient interface 4700 is a single, integrally formed component. In some embodiments, the patient interface is formed from a single molding operation.

[0549] The patient interface 4700 is formed from a polymeric material. The polymeric material may be one or a combination of one or more of a thermoplastic elastomer, a polypropylene-based elastomer, a liquid silicone rubber, a breathable thermoplastic polyurethane, or a breathable polyamide. More preferably, the polymer may be, but is not limited to, a polyolefin, a thermoplastic elastomer, or a breathable thermoplastic elastomer, such as a thermoplastic elastomer family including, for example, a styrene block copolymer, a copolyester elastomer, a thermoplastic polyolefin elastomer, or a thermoplastic polyurethane elastomer. In a preferred embodiment, the patient interface has a body portion made from a thermoplastic or silicone material having a Shore A hardness of about 5-60. In some embodiments, the body portion has a Shore A hardness of about 10-50, or about 10-40, or about 20-40, or about 10-30. In some embodiments, the body portion is made from Thermolast® K.

[0550] The interfaces of FIGS. 35-45 may include a retention system, as described in the previous embodiments, for holding the interface in place when worn by a user during use. As described above, the retention system (or fastening system) may include a detachable connection system, such as a hook-and-loop or hook-and-hook connector, for detachably connecting or fastening the patient interface to the user's face. Such a detachable connection or fastening system may include at least one pad (comprising a material such as a hydrocolloid) attached to the user's face, onto which the patient interface may be detachably engageable. For example, a pad may be attached to each of the left and right hand sides of the body portion of the interface. The pad may include one half of a hook-and-loop or hook-and-hook connection. A corresponding pad including a second half of a hook-and-loop or hook-and-hook connection may also be attached to the user's face.

[0551] In some embodiments, the pad attached to the body portion is substantially symmetrical about a central upright (e.g., vertical or near-vertical) axis that divides the pad into left and right sides, as shown, for example, in FIG. 32A. Thus, the same shaped pad may be applied to both the left and right hand sides 4701, 4703 of the body portion. In some embodiments, the pad may be symmetrical about a horizontal axis. In some embodiments, the pad may be symmetrical about both the vertical and horizontal axes.

[0552] A symmetrical retaining pad simplifies the manufacturing process by allowing the same loop pad to be applied to both sides of the interface, increasing production speed and reducing operator error. This also means that only one type of pad needs to be stocked for both the left and right sides of the interface. The pads do not have to be symmetrical along a horizontal line. The pads may be attached to recessed areas on each of the left and right side arms of the main body portion of the interface. Recessed areas 4760 are shown in FIG. 38B. The recesses into which the pads are placed may also be symmetrical, so that the left and right hand sides of the recess have the same or similar shape to match the shape of the pads.

[0553] In various embodiments or configurations described herein, a two-part connection system is used to allow attachment, detachment, and reattachment of the interface to the user's face, which can allow for proper repositioning of the interface, for example, for improved comfort or for delivery of therapy (or both).

[0554] Furthermore, in various embodiments of the configurations described herein, a portion of the detachable connection system is provided on the patient interface. This portion of the detachable connection system that is provided on the patient interface may itself be provided with the interface in various ways, one of which may be by overmolding or overmolding connection of the interface to or around this portion. Overmolding a portion of the interface onto a portion of the detachable connection system may provide a more durable or robust attachment or engagement of this portion to the interface. The material used to form or mold into the interface may also be flowed around or over a portion of the detachable connection system, such as a pad or patch that includes loops (or alternatively hooks). This may allow for more integrated parts in the patient interface that include such loops or hooks. Optionally, for example, the overmolding or overmolding connection may extend around at least the periphery of the part (to connect / attach this part to the interface), and such overmolded material may optionally extend partially or entirely over the face of the part from which components of the detachable connection system may extend. For example, if the part provides a hook or loop or another type of two-part detachable connection system, the overmold may extend around the periphery of such part, or may extend partially or entirely over the surface along which the hook or loop or another type of two-part detachable connection system may extend.

[0555] The part that may be overmolded to the interface may be either the loop or hook part of the two-part connection system.

[0556] 38A and 38B illustrate where a hook or loop pad section or component may be located within the recessed section 4760. It is contemplated that a loop component may be specifically provided in such a section 4760, while a hook component may be provided on the other component of the two-component connection system (e.g., a pad or patch that may be provided on the user's face).

[0557] Overmolding such components is advantageous because it may allow the loop or hook pad components to be positioned and maintained more accurately than adhesive bonding, which is often performed by hand. Overmolding can provide a stronger bond between the loop or hook pad component section and the patient interface. The molded arrangement of the loop or hook pad component and the patient interface may be more robust, making the loop or hook pad component section less likely to peel, rip, or tear away from the section of the interface to which it is attached. More specifically, because it is the patient interface itself that is overmolded onto this component, including the hook or loop or other component of a two-part connection system, this component allows for a more integrated arrangement of the interface and the component of the detachable connection system, thus allowing for a more robust and permanent or durable connection of the interface with the component.

[0558] Alternatively, an arrangement may be provided in which attachment of components to the patient interface may occur after the interface has first been molded or formed (or manufactured). For example, a molded or formed (or manufactured) interface may be used in a subsequent or additional overmolding process or step to connect or attach each of the components and the interface together via an overmolded connection. As described below, the molding material may be allowed to flow around the periphery of such components, or may partially or entirely cover the face of the components.

[0559] The overmolding material of the loop or hook pad component section may be controlled to ensure that the polymer or plastic in the overmolding flows to cover a portion of the loop or hook pad component, but not the entire loop or hook pad component, while still maintaining sufficient exposure of the loop or hook of the component to allow connection to the opposing component of the two-component connection system, for example, the hook component of a pad or patch provided on the user's face.

[0560] In some alternative embodiments, the overmolding material may be controlled to extend or flow into some of the loop or hook components to integrally bond the components to the interface to which it is attached.

[0561] Overmolding may be performed as part of the interface (e.g., nasal cannula) molding process itself, or may be performed as a later step, or may be performed after the interface body (e.g., nasal cannula body) is formed.

[0562] In other embodiments or configurations, the loop or hook components are overmolded as part of the interface manufacturing process, thus using the same material as the rest of the interface body (e.g., nasal cannula body) to ensure a secure bond (i.e., no loss of material compatibility between the interface and the overmolded material).

[0563] It will be appreciated that the pads shown in FIG. 38A may be "components" as described above that may be attached to the patient interface by an overmolding process or by an overmolding material to connect or attach the pads or "components" to the interface. FIG. 38B shows a recessed area 4760 that may preferably receive a "component" or pad. It will be appreciated that a "component" that is one component of the two-component detachable connection system described herein may be provided on other portions of the interface; for example, as shown in other figures, a two-component connection system may use pads or components on other areas of the interface. Overmolding such components or pads onto the interface provides another way in which they may be attached or connected to the interface, for example, providing a more secure or robust connection or attachment. Such overmolding may avoid the use of adhesives or glues that may otherwise be required to attach or connect such pads or components to the interface.

[0564] In a particularly preferred embodiment, the nasal cannula is formed or molded and thereby simultaneously overmolded onto a part such as a pad containing loops (forming one part of a two-part detachable connection system). Such a part with loops can be held in place and allows the plastic or polymer used to form the cannula to flow onto / around the loop containing part, thus forming an integral loop pad with the cannula itself.

[0565] It will therefore be appreciated that in one embodiment the patient interface may be formed by a molding process or the like, and during this process a component (e.g., loop or hook) comprising one of the two-part connection systems may be incorporated into the so-formed interface (i.e., the component is formed as an integral part of the interface during the formation of the interface itself). In alternative embodiments, the patient interface may be formed by a molding process or the like, and after this process a component (e.g., loop or hook) comprising the two-part connection system may be incorporated and a portion of the interface may be formed by an overmolded connection (i.e., the interface and component are attached or connected to one another by an overmolded material).

[0566] As mentioned above, the body portion includes bend regions 4723, 4725 between the left and right side arms 4701, 4703 of the body portion and the bridge portion 4710. Preferably, pad regions 4760 of the body portion for receiving pads of the support system are located outside of the bend regions 4723, 4725. In other words, the support system does not straddle or cover the bend regions, and the fastening system is separated or decoupled from the bridge portion by the bend regions.

[0567] The body portion may be shaped or configured or adapted to provide passageways 4711, 4713. Such passageways 4711, 4713 may be formed by one or more lumens or void spaces or cavities or other recesses within the body portion.

[0568] Such passageways 4711, 4713 allow for the provision of a pathway for receiving a gas supply (from a source) and delivering the gas to a user via the prongs 4705, 4707, or alternatively, for receiving a gas supply conduit (not shown, but which may be received in or attached to such articles 4711, 4713) and then delivering the gas through the prongs to a user. Such passageways 4711, 4713 in or through the side arms 4701, 4703 allow for the formation of a conduit or lumen through which gas may be guided or supplied for delivery to the prongs 4705, 4707.

[0569] In some embodiments, the cross-section of the passages 4711, 4713 varies along the length of the passages 4711, 4713 to provide or impart different structural features or properties to the body portions of the interface, such that the body portions have regions of different flexibility. Unless the context indicates otherwise, the term "cross-section" is intended to mean a transverse cross-section of the passage across the passage rather than along the length of the passage. The passage may pass through a cross sectional transition point along the length of the passage.

[0570] The variation in cross section along the length of the passageway is shown in Figures 38A-41 B. As shown in Figure 39B, the cross section of the passageway at or near where the breathing tube or conduit joins the passageway is substantially circular to accommodate a circular tube or conduit.

[0571] As one moves along the passageway from the breathing tube or conduit towards the nasal prongs, the cross section of the passageway changes from circular to oval or elongated with the major axis oriented perpendicular or upright relative to the direction towards the user's face (approximately parallel to the user's face in use), as shown in FIG. 40B.

[0572] The elongated cross-section provides a low-profile interface. This means that for a given cross-sectional area of ​​the passageway, the passageway is thinner, allowing the interface to move a smaller distance away from the user's face. The elongated cross-section also provides greater flexibility for bending laterally, e.g., toward the user's face along the short axis of the elongated cross-section. In other words, a thinner or elongated cross-section is easier to bend around an axis generally parallel to the user's face compared to a circular cross-section of the same or similar area. For example, as shown in FIG. 38B , the cross-sections of the bending regions 4723, 4724 described above are preferably elongated, with their long axes oriented generally parallel to the user's face and their short axes oriented generally perpendicular to the user's face. The elongated cross-section and U-shape of the body portion combine to create a bending region that preferentially bends laterally toward and away from the user's face compared to other regions of the body portion. The bending region reduces the likelihood that facial movement will cause the prongs to pop out of the user's nostrils (e.g., forward). The described bending regions are created without any kind of mechanical hinge structure, but rather the elongated or elliptical shape of the air passages allows the body portion to warp or bend more easily in thinner regions.

[0573] 35-45, it will be appreciated that the patient interface may include one or more of the side arm or bridge elements described above. These elements are or include a relatively more rigid material than the remainder of the patient interface and have the appropriate features and functionality described above in connection with the previous embodiments. The side arm and / or bridge elements add stability and structure to the patient interface while still maintaining the flexibility provided by other features of the patient interface.

[0574] The bending region allows for greater flexibility of movement at the user's cheek. This bending region is wider than would be the case if the passageway were circular. The long axis of the elongated cross section helps the body portion to bend primarily in a substantially horizontal or lateral direction (i.e., the left or right portion bending inward toward the bridge of the body portion) and not twist or bow in other directions (i.e., bending across the user's face).

[0575] The cross-section of the passageway transitions at the base of the nasal prongs to an asymmetrical shape in which one side of the cross-section is flatter than the opposite side of the cross-section, as shown in FIG. 41B. The asymmetrical shape may be generally described as having a "D" shape. The advantages of the "D" shape are described below.

[0576] In some embodiments, one or both prongs may include a "D" shaped or asymmetrical shaped passageway along a portion of the length of the passageway, or may include a "D" shaped / asymmetrical shaped passageway along the entire length of the prong. In the embodiment shown in Figures 39A-43B, as you progress along the prong, the cross section of the passageway transitions from D-shaped to circular, such that the passageway is generally circular at the exit or tip of the prong, as shown in Figure 43B. Figure 42B shows a cross section approximately midway through the prong. The cross-sectional area may decrease slightly from the base of the prong to the tip of the prong.

[0577] The different cross-sectional areas of the passages from the tube or conduit end to the base of the prongs are preferably substantially constant to maintain similar resistance to flow along the passages. Thus, flow resistance due to the change in shape from round to flat is substantially avoided. As noted above, the passages may narrow slightly along the prongs toward the prong tips.

[0578] 41B, in some embodiments, the nasal prongs include at least a base region or end of the prongs with an asymmetric cross section. The asymmetric shape includes one side 4771 that is flatter than the other side 4772 of the cross section. The asymmetric shape can be generally described as having a "D" shape.

[0579] The flatter side of the prongs is positioned toward the front or non-face side of the patient interface (facing away from the user's face). Asymmetric shapes are particularly beneficial from a manufacturing standpoint. This shape allows for refinement of the part line and allows for the part line to be moved away from sensitive areas of the nose. The part line is formed where the mold tools are pulled apart to allow for the formation of the molded components. The part line can often be a rough / sharp line. Therefore, it is desirable to move the part line away from the face and have flat-sided prongs to make manufacturing easier, as this makes the tool design simpler. In flat-sided or asymmetric shapes, the flat side of the tool remains stationary, and the curved side of the tool moves toward and away from the flat part. Typically, more rounded prongs require a more complex arrangement with two movable tools that move toward and away from each other. Additionally, this shape avoids or reduces the need for shape edges at the parting line, aiding in user comfort during use.

[0580] No sharp edges are formed at the prong parting line. This allows for greater patient comfort as no sharp edges come into contact with the patient. The more rounded side of the prong is positioned closer to the user's face, maintaining comfort at the base of the nostrils. The rounded rear shape also maintains structural stability at the base of the prong, and the flatter side of the "D" is more likely to deflect in response to applied force compared to the rounded side. Furthermore, this asymmetrical shape does not significantly change the airflow resistance of the passageway along the prong. In some embodiments, the radius of the fillet between the prong and bridge may be increased to provide additional rigidity at the base of the prong. Further discussion of this arrangement is provided below.

[0581] In some embodiments, the bridge portion 4710 between the two bent portions 4723, 4725 from which the prongs extend may be reinforced to prevent outward movement relative to each of the prongs. Reinforcement may be achieved without the use of reinforcement members embedded in the body portion by including more material in the bridge region (e.g., thicker wall sections).

[0582] In some embodiments, the height or vertical dimension of the bridge region 4710 is greater than other patient interfaces. The height of the bridge region is best seen in the front view of FIG. 44. The increased vertical dimension improves torsional stability, helping to prevent twisting of the body portion and prongs from popping out of the nares upon flexion, and may also help distribute the load or contact area across the user's philtrum. To maintain patient comfort, the height of the bridge region should be lower than the philtrum. The required bridge region height may depend on how much flexibility is available in the bending regions of the body portion to direct movement of the left and right side arms away from the bridge and prevent or reduce the occurrence of prong popping out of the user's nares.

[0583] As mentioned above, the bridge region and the area of ​​the body portion between the bend regions 4723, 4725 and the bridge region 4710 have a relatively large radius of curvature. This arrangement prevents sharp edges from contacting the patient. In some embodiments, the prongs are angled slightly inward, as shown in FIG. 44.

[0584] In some embodiments, the passages 4711, 4713 are located approximately vertically in the center of the cheek pads. This location may provide more predictable behavior in terms of how the body portion deforms, and may encourage the prongs to move in a substantially horizontal direction rather than a substantially vertical direction when force is applied to the breathing tube or conduit, thereby preventing the prongs from popping in and out of the user's nostrils.

[0585] By locating the passageway approximately vertically centered on the body portion, the horizontal neutral bending axis 4780 of the body portion is also approximately vertically centered, which may place the neutral axis approximately in the center of the fastening system for securing the interface to the user's face, thereby reducing forces acting to pull or pull the interface away from the user's face compared to if the neutral axis were closer to the top or bottom edge of the body portion.

[0586] Additionally, having a tube or conduit running through the center of the interface, with the passageway located in the center of the body portion, helps maintain the correct positioning of the prongs within the user's nostrils. For example, an upward force on a tube located closer to the base of the body portion may cause the center of the body portion to move outward, causing the prongs to rotate outward from the user's nose, which is less desirable.

[0587] As described above, the interface 4700 includes features to provide the necessary flexibility in the body portion in areas required for improved fit with the user's face. For example, as described, the body portion may include passages with varying cross-sections and / or regions of varying shape to provide flexible areas, e.g., to decouple movement of the user's face (e.g., cheeks) from the nasal prongs. Flexibility of the body portion may be enhanced by varying the material, geometry, or thickness of sections containing hinge points, as well as varying the shape of tubular portions such as passages along the body portion and prongs as described above.

[0588] As mentioned above, in a preferred embodiment, the patient interface 4700 is a single, integrally formed component made from a thermoplastic or silicone material. A single, integral component is easier to manufacture than an interface that includes many parts and / or different materials, for example, some materials overmolded with other materials. Different geometric shapes of the body portions are selected to achieve regions of greater flexibility and regions of lesser flexibility in a single, integral component formed from a single material.

[0589] As discussed above, in a preferred embodiment, bend region 4723 and bend region 4725 are more flexible than the bridge portion and the left and right side arms of the body portion. At least a portion of the passageway extends into the bend region and is shaped to aid flexibility. The passageway extends into bridge region 4710 and along the prongs. However, the bridge region preferably includes a solid section having more material than the adjacent bend regions 4723, 4725 to provide greater stiffness in the bridge region. The prongs should not be so flexible that they collapse or compress too easily in the nose. Therefore, the purpose of the varying geometry of the body portion is to have any warping and bending or flexing occur in the bend region rather than the bridge region.

[0590] The thickness of the material of the body portion may vary to help maintain various flexible and less flexible regions. The body portion may have thinner walls or sections surrounding the passageways in the bend region than in other regions of the body portion. In some embodiments, the cross-sectional area of ​​the material of the body portion at the valley 4730 of the U-shaped regions 4723, 4725 is smaller than adjacent regions of the body portion. In a preferred embodiment, the body portion provides left and right passageways, with the left and right passageways 4711, 4713 separated by a dividing section in the bridge region. The dividing section is a central region of the bridge between the two nasal prongs. The central region of the bridge region may be solid to provide relative rigidity to the bridge region. In some embodiments, the bridge portion includes thicker wall sections than the wall sections in the bend region, making the bridge portion more rigid than the bend region. The thicker walls in the bridge portion provide more material in the bridge portion than in the hinge or bend region, providing greater rigidity to the bridge portion. In some embodiments, the bridge portion further comprises a more rigid material to provide rigidity to the bridge region, for example, a more rigid or stiff material may be molded into the bridge portion, for example, by a two-shot overmolding or multiple molding process.

[0591] In some embodiments, the left and right side arms or regions of the body portion are flexible to allow for easy bending on the user's face. The left and right regions are preferably more flexible than the bridge region. In some embodiments, the left and right regions are more flexible than the nasal prongs. In some embodiments, the bending region is more flexible in at least one plane than the prongs, the bridge region, and the left and right side arms.

[0592] Each prong has a base 4715, 4717 integrally formed with the bridge portion 4710 of the body portion of the patient interface. In some embodiments, the base of each prong includes a fillet between the wall of the prong and the bridge portion. The fillet extends around the periphery of the prong. The fillet causes the outer surface of the prong to curve into the outer surface of the bridge portion.

[0593] In some embodiments, the fillet radius at the base of each prong varies around the circumference of the prong to improve prong stability and reduce warping or bending of the prong at its base. A larger fillet radius may provide a smoother transition from the outer surface of the bridge portion to the outer surface of the prong, reducing the likelihood that the prong will bend or break at its base.

[0594] In some embodiments, the fillet radius at the base of each prong varies around the circumference of the prong, varying the prong wall thickness at the base 4715, 4717 of the prongs 4705, 4707. A larger fillet radius can result in thicker material at the base of the prong, and therefore a stiffer base. Varying the fillet radius around the prong base to vary the thickness of the base may be used to vary the stiffness of the prong base around the circumference of the prong.

[0595] The thickness of the prong base may be varied in other ways, for example, by varying the passageway geometry to vary the prong wall thickness at the base of the prong with a constant fillet radius on the outside of the body portion between the prong and the bridge portion. However, this arrangement for varying the prong wall thickness may be less preferred because increasing the wall thickness in this way may reduce the cross-sectional area of ​​the passageway, thereby increasing flow resistance.

[0596] Fillet radii may vary according to the size constraints of a particular patient interface. For example, referring to FIG. 45, in some embodiments, it may be desirable to have fillets with a small radius between the prongs and the bridge on the non-facial side of the body portion, and fillets with larger radii on the inside of the prongs (between the two prongs) and on the outside of the prongs. The radius of the fillets on the inside of the prongs may be larger than the radius of the fillets on the outside of the prongs. The fillets on the facial side of the body portion may have a radius between the inside and outside radii of the prongs. Example dimensions are shown in FIG. 45, but other arrangements may also be useful.

[0597] In an alternative embodiment, the patient interface includes features of the embodiments described in connection with Figures 35-45 along with side arm elements and / or bridge elements.

[0598] In particular, one such embodiment includes a body portion that is positioned on a user's face during use, the body portion having left and right side arms and a bridge portion between the left and right side arms. A patient interface extends from the bridge portion and has at least one nasal prong for insertion into or directing a flow of gas into a nostril or nostrils of the user's nose in an operative position. The body portion has at least one fluid passageway connected to the nasal prongs for supplying gas to the nostrils of the user's nose. The cross-section of the passageway varies along the length of the body portion, providing a region of varying flexibility along the body portion. In this embodiment, each of the left and right side arms may include one or more predetermined or pre-positioned points or localized compensation regions (or locations). One or more predetermined or pre-positioned locations or localized compensation areas (or locations) are disposed along the or each side arm and are configured to accommodate compensation of the patient interface at or at one or more of the compensation areas (or locations) to accommodate forces due to flexure, bending, hinging, or other displacement. One or more of the compensation areas (or locations) may be bending areas or locations or hinge areas though or about at least two different (non-parallel) planes through the interface. In this embodiment, the side arm may include one or more side arm elements disposed at or within the side arm of the interface, the side arm elements being formed from a rigid material to impart rigidity to the side arm / portion. The side arm elements may further include one or more cuts or notches to allow the side arm to bend / hinge in response to forces applied to or exerted on the side arm. In addition to or instead of one or more side arm elements, the bridge portion may include a bridge portion element, wherein the bridge portion, the bridge portion element, or both the bridge portion and the bridge portion element are substantially isolated from forces applied to or to the patient interface.

[0599] In addition to or instead of the above-described embodiments, attention is further drawn to the first and second side arms 4206A, 4206B. Referring to FIGS. 46 and 47, the second side arm 4206B is shown. It should be understood that in the configuration shown, the patient interface 4200 is substantially symmetrical. In other configurations, the patient interface 4200 may be asymmetrical. As can be seen in FIGS. 46 and 47, the second side arm 4206B includes regions 4214B1, 4214B2, 4214B3, 4214B4 having reduced thickness located on the outer edge of the second side arm 4206B (other than one region 4214B1 located on the outer edge of an inward-facing portion of a flange defining a section of the patient-facing portion of the body 4206B, which is adapted to retain a second mounting structure 4216B). The regions of reduced thickness 4214B1, 4214B2, 4214B3, 4214B4 may be, for example, notches or cutouts along the second side arm 4206B. The regions of reduced thickness 4214B1, 4214B2, 4214B3, 4214B4 are configured to increase the flexibility of the portion of the second side arm 4206B that is configured to rest on the patient's cheek. Using the regions of reduced thickness 4214B1, 4214B2, 4214B3, 4214B4 to increase the flexibility of the patient interface 4200 in this region may improve the patient interface 4200's conformance to facial contours, particularly when force F1 is applied to the side arms 4206A, 4206B (see FIG. 48). Other configurations are also contemplated. For example, in some configurations, the region of reduced thickness may be located on the second side arm 4206B or elsewhere on the bridge 4204 to improve compliance of the patient interface 4200. It should be understood that a similar region of reduced thickness may be located on the first side arm 4206A as disclosed. However, in some configurations, only one body may include a region of reduced thickness.In the configuration shown, four regions of reduced thickness 4214B1, 4214B2, 4214B3, 4214B4 are used on the second side arm 4206B, although it should be understood that fewer or more regions (e.g., one, two, three, five, or six regions) may be used. In some configurations, the second side arm 4206B may not include any regions of reduced thickness. In some configurations (not shown), the first and / or second side arms 4206A, 4206B may include one or more hinge points associated with each respective body to allow each body to pivot or move relative to the bridge 4204 or each other body. In some configurations, at least a portion of one of the side arms may pivot relative to the bridge 4204 and / or each other body.

[0600] Certain embodiments of the interfaces described herein may be suitable for and for providing flow therapy to infants, newborns, or children. Due to the high facial movement of infants, newborns, or children, certain embodiments of the interfaces described herein are particularly useful for use with infants, newborns, or children. However, it will be understood that certain embodiments of the interfaces described herein may also be used to treat adults with high-flow therapy.

[0601] Unless the context clearly requires otherwise, throughout the specification and claims, the words "comprise," "comprising," and the like are to be construed in an inclusive sense, i.e., in the sense of "including, but not limited to," as opposed to an exclusive or exhaustive sense.

[0602] Although the present disclosure has been described in terms of specific embodiments, other embodiments apparent to those skilled in the art are also within the scope of the present disclosure. Accordingly, various changes and modifications may be made without departing from the spirit and scope of the present invention. For example, various components may be rearranged as desired. Moreover, not all features, aspects, and advantages are essential to the practice of the present disclosure. Accordingly, the scope of the present disclosure is defined solely by the following claims.

[0603] Various embodiments have been described by way of example, and in some embodiments, any one or more features of one or more of the described embodiments may be combined with one or more features of other embodiments.

[0604] As used herein, words of degree, such as "approximately," "about," "generally," and "substantially," when used herein, refer to a value, amount, or characteristic that is close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms "approximately parallel" and "substantially parallel" refer to a value, amount, or characteristic that may deviate by 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, 0.1 degrees, or less from exact parallelism.

[0605] In this specification and claims, terms such as top, bottom, above, below, vertically, and horizontally are relative to a user with the patient interface positioned on their face when the user is in an upright position, unless the context indicates otherwise. The terms inner or inward and outer or outward, and similar such terms, are relative to a central vertical plane of the patient interface when positioned on the user's face (i.e., the user's sagittal plane), unless the context indicates otherwise. The terms forward, backward, and rearward are relative to a user with the patient interface positioned on their face, unless the context indicates otherwise.

[0606] References herein to patents, other external documents, or other sources of information are generally for the purpose of providing a context for discussing features of the present invention. Unless otherwise specified, the reference to such external documents should not be construed as an admission that such documents or such sources are prior art or form part of the common general knowledge in the art in any jurisdiction.

[0607] The foregoing description of the invention includes preferred forms thereof. Modifications may be made thereto without departing from the scope of the invention.

[0608] Additional Features Item A1. a. a first body adapted to rest on a first portion of a user's face; b. a second body adapted to rest on a second portion of the user's face (hereinafter, the first body and the second body refer to a pair of side arms); c. a bridge connecting the first body and the second body; d. a support structure disposed across at least a portion of the bridge; a patient interface including:

[0609] Item A2. The patient interface of item A1, wherein the support structure is disposed over at least a portion of the user-facing portion of the bridge.

[0610] Item A3. The patient interface of any one of items A1-A2, wherein the support structure is formed at least in part from a textile material.

[0611] Item A4. The patient interface of item A3, wherein the textile material is a woven, nonwoven, or knitted textile material.

[0612] Item A5. The patient interface of any one of items A1-A2, wherein the support structure is formed at least in part from a molded polymer.

[0613] Item A6. The patient interface of item A5, wherein the support structure is formed from a molded polymer sheet.

[0614] Item A7. The patient interface of any one of items A1-A6, wherein the support structure and the bridge are formed at least in part from the same polymer.

[0615] Item A8. The patient interface of any one of items A1-A7, wherein the first body is adapted to rest against a user's cheek.

[0616] Item A9. The patient interface of any one of items A1-A8, wherein the first and second bodies are adapted to rest against opposite cheeks of a user.

[0617] Item A10. The patient interface of any one of items A1-A9, wherein the first and / or second body includes one or more nasal delivery elements adapted to be placed within one or more nostrils of the user.

[0618] Item A11. The patient interface of item A10, wherein the one or more nasal delivery elements are configured to allow ambient gases external to the patient interface to pass through the nares.

[0619] Item A12. The patient interface of any one of items A10-A11, wherein the one or more nasal delivery elements are shaped or angled to extend inward toward the user's nasal septum.

[0620] Item A13. A patient interface described in any one of items A10 to A12, wherein the one or more nasal delivery elements are shaped or angled so that, in use, the tips of the one or more nasal delivery elements point toward the back of the user's head.

[0621] Item A14. The patient interface of any one of items A10-A13, wherein the first and / or second body includes one or more gas delivery lumens in pneumatic communication with the one or more nasal delivery elements.

[0622] Item A15. The patient interface of item A14, further comprising one or more gas delivery conduits in pneumatic communication with the one or more gas delivery lumens.

[0623] Item A16. The patient interface of any one of items A1-A15, wherein the support structure extends along the first and / or second body.

[0624] Item A17. The patient interface of item A16, wherein the support structure extends along a user-facing portion of the first and / or second body.

[0625] Item A18. The patient interface of item A17, wherein at least a portion of the support structure on the user-facing portion of the first and / or second body is adapted to connect with one or more fixation structures secured to the face to secure the patient interface to the face.

[0626] Item A19. The patient interface of any one of items A1-A18, wherein the patient interface is shaped to conform to the contours of a user's face.

[0627] Item A20. The patient interface of any one of items A1-A19, wherein the first and / or second body includes one or more regions having a reduced thickness relative to adjacent regions of the first and / or second body.

[0628] Item A21. The patient interface of item A20, wherein the one or more regions of reduced thickness are disposed on portions of the first and / or second body that rest against one or more cheeks of the user.

[0629] Item A22. A patient interface according to any one of items A20 to A21, wherein the one or more regions of reduced thickness are disposed on the outer edge of the first and / or second body.

[0630] Item A23. The patient interface of any one of items A1-A22, further comprising one or more mounting structures secured to a user-facing portion of the first and / or second body, the one or more mounting structures adapted to connect with one or more securing structures secured to the face to secure the patient interface to the face.

[0631] Item A24. a. first and second bodies adapted to rest against the cheeks of a user; b. at least one nasal delivery element extending from the first and / or second body adapted to be non-sealingly placed within one or more nostrils of a user; and c. a bridge connecting the first body and the second body; d. a reinforcing structure disposed across at least a portion of the bridge; Including, nasal cannula.

[0632] Item A25. The nasal cannula of item A24, wherein the reinforcing structure is disposed over at least a portion of the user-facing portion of the bridge.

[0633] Item A26. The nasal cannula of any one of items A24-A25, wherein the reinforcing structure is formed at least in part from a molded polymer.

[0634] Item A27. The nasal cannula of item A26, wherein the reinforcing structure is formed from a molded polymer sheet.

[0635] Item A28. The nasal cannula of any one of items A24-A25, wherein the reinforcing structure is formed at least in part from a textile material.

[0636] Item A29. The nasal cannula according to item A28, wherein the textile material is a woven, nonwoven, or knitted textile material.

[0637] Item A30. The nasal cannula of any one of items A24 to A29, wherein the reinforcing structure and the bridge are at least partially formed from the same polymer.

[0638] Item A31. The nasal cannula of any one of items A24 to A30, wherein at least one nasal delivery element is shaped or angled to extend inward toward the user's nasal septum.

[0639] Item A32. The nasal cannula of any one of items A24 to A31, wherein at least one nasal delivery element is shaped or angled so that, in use, the tip points toward the back of the user's head.

[0640] Item A33. The nasal cannula of any one of items A24 to A32, wherein the first and / or second body includes one or more gas delivery lumens in pneumatic communication with at least one nasal delivery element.

[0641] Item A34. The nasal cannula of item A33, further comprising one or more gas delivery conduits in pneumatic communication with the one or more gas delivery lumens.

[0642] Item A35. The nasal cannula of any one of items A24 to A34, wherein the reinforcing structure extends along the first and / or second body.

[0643] Item A36. The nasal cannula of item A35, wherein the reinforcing structure extends along a user-facing portion of the first and / or second body.

[0644] Item A37. The nasal cannula of item A36, wherein at least a portion of the reinforcing structure on the user-facing portion of the first and / or second body is adapted to connect with one or more fastening structures secured to the face to secure the nasal cannula to the face.

[0645] Item A38. The nasal cannula according to any one of items A24 to A37, wherein the nasal cannula is shaped to conform to the contours of the user's face.

[0646] Item A39. The nasal cannula of any one of items A24 to A38, wherein the first and / or second body includes one or more regions having a reduced thickness relative to adjacent regions of the first and / or second body.

[0647] Item A40. The nasal cannula of item A39, wherein the one or more regions of reduced thickness are disposed on an outer edge of the first and / or second body.

[0648] Item A41. The nasal cannula of any one of items A24 to A40, further comprising one or more mounting structures secured to a user-facing portion of the first and / or second body, the one or more mounting structures adapted to connect with one or more securing structures secured to the face and secure the nasal cannula to the face.

[0649] Item A42. a. a first body adapted to rest on a first portion of a user's face; b. a second body adapted to rest on a second portion of the user's face; c. at least one nasal delivery element extending from the first and / or second body adapted to be non-sealingly placed within one or more nostrils of a user; and Including, d. the first and / or second body includes one or more regions having a reduced thickness relative to adjacent regions of the first and / or second body; Nasal cannula.

[0650] Item A43. The nasal cannula of item A42, wherein the first and second bodies are adapted to rest on opposite cheeks of a user.

[0651] Item A44. A nasal cannula described in any one of items A42 to A43, wherein one or more areas of reduced thickness are located in portions of the first and / or second body that rest on one or more cheeks of the user.

[0652] Item A45. A nasal cannula according to any one of items A42 to A44, wherein the one or more regions of reduced thickness are disposed on the outer edge of the first and / or second body.

[0653] Item A46. The nasal cannula according to any one of Items A42 to A45, further comprising a bridge connecting the first body and the second body.

[0654] Item B1. a. one or preferably a pair of side arms extending laterally from a generally central bridge portion that is positioned in or around the user's nasal septum area in use; Including, b. A patient interface wherein the or each said side arm is connected to a substantially resilient or relatively more rigid bridge element, the bridge element defining a substantially predetermined spatial relationship of the outlet or outlets of the gas delivery system with the or each said side arm.

[0655] Item B2. a. one or preferably a pair of side arms extending laterally from a generally central bridge portion that is positioned in or around the user's nasal septum area in use; Including, b. the or each said side arm includes one or more predetermined or pre-positioned points or localized compensation areas (or locations), the one or more predetermined or pre-positioned points or localized compensation areas (or locations) being positioned along the side arm to accommodate or facilitate compensation of the patient interface within or at one or more of the compensation areas (or locations); c. A patient interface wherein the or each side arm is connected to a substantially resilient or relatively more rigid bridge element, the bridge element defining a substantially predetermined spatial relationship of the outlet or outlets of the gas delivery system with the or each side arm.

[0656] Item B3. a. one or preferably a pair of side arms extending laterally from a generally central bridge portion that is positioned in or around the user's nasal septum area in use; Including, b. the or each said side arm includes at least one substantially elastic or relatively more rigid side arm element, the side arm element at least partially defining the shape or curvature of the or each side arm and having one or more predetermined or pre-positioned points or localized compensation areas (or locations) disposed along the or each side arm and / or the or each side arm element and adapted for compensation of a patient interface within or at one or more of the compensation areas (or locations); c. the or each said side arm element is connected or interconnected via a connecting material to a substantially resilient or relatively more rigid bridge element, the bridge element defining a substantially predetermined spatial relationship of the outlet or outlets of the gas delivery system with the or each said side arm; Patient interface.

[0657] Item B4. The interface of any one of items B1-B3, wherein the bridge portion or bridge portion element (or both) is substantially decoupled from forces that may be applied to or to the patient interface.

[0658] Item B5. The interface of any one of items B1-B4, wherein a force applied to the patient interface may be exerted on one side arm or multiple side arms of the interface, and a compensation region (or location) of the side arm or side arm element or both accommodates the force by flexing or bending or hinging or other displacement of the side arm or side arm element or both.

[0659] Item B6. The interface of any one of items B1-B5, wherein the side arm or arms are patient interface stabilizers.

[0660] Item B7. The interface of any one of items B1-B6, wherein the bridge section element and the side arm element or elements are separate pieces that are assembled to form an integral component.

[0661] Item B8. The interface of any one of items B1 to B7, wherein the bridge portion element and one or more side arm elements are a single component, or at least the bridge portion and at least one side arm element are a single component.

[0662] Item B9. The interface of any one of Items B1 to B8, wherein the bridge element and one or more side arm elements are integrally formed as a single component, or at least the bridge element and at least one side arm element are integrally formed as a single component.

[0663] Item B10. The interface according to any one of items B1 to B9, wherein the bridge element and the side arm element or elements are formed as an integral component.

[0664] Item B11. The interface of any one of items B1-B6, wherein the bridge element and at least one of the side arm element or elements are separate components, each of which may be substantially interconnected by material of the patient interface, such as the side arm or arms, or may be provided in an interconnected relationship with one another.

[0665] Item B12. The interface of any one of items B1 to B6, wherein the bridge element is a discontinuous component of the one or more side arm elements.

[0666] Item B13. The interface of any one of items B1-B6, wherein the side arm includes one or more separate side arm elements, each of the one or more separate side arm elements being spaced apart through or along the length of the side arm.

[0667] Item B14. The interface of item BB13, wherein each of the one or more separate side arm elements is spaced apart in an array through or along the length of the or each side arm.

[0668] Item B15. The interface of any one of items B1-B6, wherein the bridge portion element and the side arm element or elements are separate components provided or interconnected in connection with each other via one or a pair of corresponding side arms, and optionally the corresponding side arms including the bridge portion, one or more corresponding side arm elements.

[0669] Item B16. The interface of any one of items B13-B15, wherein each separate side arm element provides a relatively elastic portion, and the side arm material is sandwiched between or adjacent to each separate side arm element, and the side arm material provides a compensation area (or location).

[0670] Item B17. The interface of any one of items B1-B6, wherein the patient interface includes a bridge element and at least one separate side arm element disposed within each one of the pair of side arms.

[0671] Item B18. The interface according to any one of Items B1 to B17, wherein the bridge portion is disposed midway between the pair of side arms.

[0672] Item B19. The interface according to any one of items B1 to B18, wherein the bri...

Claims

1. a body portion that is positioned on a user's face in use, said body portion having a side arm, or preferably a pair of side arms, extending laterally from a generally central bridge portion that is positioned in or around the user's nasal septum area in use; b. at least one, and preferably a pair of, nasal prongs extending from said bridge portion and for, in an operative position, being inserted into or directing the flow of gases into a nostril or nostrils of the user's nose; Including, c) the body portion has at least one fluid passageway connected to the nasal prongs for delivering gas to the nostrils of the user's nose; d. the cross-section of the passageway varies along the length of the body portion to provide a region of varying flexibility along the body portion; Patient interfaces such as nasal cannulas.

2. 10. A patient interface according to claim 1, wherein the or each side arm includes one or more predetermined or pre-positioned points or localized compensation areas (or locations) disposed along the side arm to accommodate or facilitate compensation of the patient interface within or at one or more of the compensation areas (or locations), and wherein when a force applied to the patient interface is exerted on a side arm or sides of the interface, the compensation areas (or locations) of the side arm and / or side arm elements accommodate the force by flexing or bending or hinging or other displacement of the side arm and / or side arm elements.

3. 3. A patient interface according to claim 1 or 2, wherein one or more of the compensation areas (or locations) is a hinge area or location of bending in or around at least two different (non-parallel) planes through the interface.

4. 4. A patient interface according to any one of claims 1 to 3, wherein the bridge portion comprises a bridge element, and wherein the bridge portion, the bridge element, or both the bridge portion and the bridge element are substantially decoupled from forces applied to or exerted on the patient interface.

5. 5. A patient interface according to claim 4, wherein the bridge element and the side arm element or elements are separate pieces that can be assembled to form a unitary structure.

6. 6. A patient interface according to claim 4 or 5, wherein the bridge element is of sufficient dimension to span the width of the user's nasal septum region, or is the distance or width between gas outlets, or is defined by substantially the maximum distance spanning from one nasolabial fold to another nasolabial fold of the user, and the side arm elements are dimensioned to extend at least partially apart along the length of the side arms.

7. 7. A patient interface according to any one of claims 4 to 6, wherein the bridge element includes one or a pair of cutouts or shaped portions for locating, positioning or accommodating at least one or a pair of outlets for a gas delivery system for supplying gas to the user's airway.

8. 8. A patient interface according to any one of claims 4 to 7, wherein the bridge element is or includes a textile material and is disposed on an outer surface of the bridge portion, the bridge element increasing the rigidity of the bridge portion to maintain the distance between the prongs.

9. 9. A patient interface according to any one of claims 1 to 8, wherein the or each side arm comprises at least one substantially elastic or relatively more rigid side arm element, said side arm element at least partially defining the shape or curvature of the or each side arm and having one or more predetermined or pre-arranged points or localized compensation areas (or locations) disposed along the or each side arm and / or said or each side arm element for accommodating compensation of the patient interface at or in one or more of the compensation areas (or locations), and wherein the or each side arm is a patient interface stabilizer.

10. 9. A patient interface according to any one of claims 1 to 8, wherein the side arm element includes one or more notches to permit bending of the side arm element such that the side arm portion can bend in response to the application of a force.

11. A patient interface according to any preceding claim, wherein the interface is overmolded onto the bridge element and the side arm elements.

12. a. a body portion that is placed on a user's face during use, the body portion having left and right side arms and a bridge portion between the left and right side arms; b. at least one nasal prong extending from the bridge portion and adapted, in an operative position, to be inserted into or direct the flow of gases into a nostril or nostrils of the user's nose; Including, c) the body portion has at least one fluid passageway connected to the nasal prongs for delivering gas to the nostrils of the user's nose; d. the cross-section of the passageway varies along the length of the body portion to provide a region of varying flexibility along the body portion; Patient interface.

13. 13. A patient interface as described in claim 12, wherein the cross-sectional shape of the passageway varies along at least a portion of the length of the body portion, changing from a generally circular cross-section at or near an outer end for connection (either removably or permanently) with a respiratory tube or conduit, to an elongated cross-section having a major axis that is substantially vertically (parallel to the user's face).

14. 14. A patient interface according to claim 13, wherein the elongated cross-section is located within or forms a bending region or hinge of the body portion, the elongated cross-section providing greater flexibility for bending the body portion in the direction of a minor axis of the elongated cross-section, towards or away from a user's face.

15. 15. A patented interface according to any one of claims 12 to 14, wherein the at least one nasal prong comprises a pair of nasal prongs, the bridge region including a solid section between the prongs such that the bridge region is stiffer than the bend region, the bridge region having a height or vertical dimension sufficient to provide torsional stability and prevent twisting of the bridge region in use.

16. 16. A patient interface according to any one of claims 12 to 15, wherein the bridge portion includes a wall section that is thicker than a wall section of the bending region such that the bridge portion is stiffer than the wall section of the bending region.

17. 17. A patient interface according to any one of claims 12 to 16, wherein the bridge portion comprises an even more rigid material to impart rigidity to the bridge region, the bridge portion being formed from a different rigid material to the material forming the remainder of the patient interface.

18. 18. A patient interface according to any one of claims 12 to 17, wherein the side arm includes one or more side arm elements provided at or within the side arm of the interface, the side arm elements being formed from a rigid material to impart rigidity to the side arm / portion, and the side arm elements further including one or more cuts or notches to allow the side arm to flex / hinge in response to forces applied or exerted on the side arm.

19. 19. A patient interface according to any one of claims 12 to 18, wherein the bridge portion transitions into the left and right side arms by flaring or curving outwardly away from a side of the bridge portion that is closer to the user's face, and wherein the left and right side arms curve rearward from a forward extent of the body portion away from the bridge portion, and wherein the curvature of the side of the bridge portion that is closer to the user's face and / or in the transition region between the bridge portion and the left and right side arms has a relatively large radius(s) so that pressure from the bridge and / or transition region on the user's face is distributed over the user's philtrum or upper lip region.

20. 20. A patient interface according to any one of claims 12 to 19, wherein when viewed from above, the body portion includes a U-shaped region between the at least one nasal prong and the adjacent left or right side arm, an inner side of the U-shaped region facing a user's face in use, and wherein as the left or right portion of the body portion flexes towards or away from the user's face, each U-shaped region forms or is located within a bending region about which the body portion preferentially bends, the bending region tending to bend in a valley of the U-shaped region.

21. 21. A patient interface according to claim 20, wherein an interior angle of the U-shaped region is less than about 130 degrees, or 120 degrees, or 110 degrees, or 105 degrees.

22. 22. A patient interface according to any one of claims 12 to 21, wherein the patient interface is a single, integrally formed component formed in a single molding operation from a single material, the patient interface being formed from a thermoplastic or silicone material having a Shore A hardness of about 5 to 60.

23. 23. A patient interface according to any one of claims 12 to 22, wherein a cross-section of the passageway at the base of at least one nasal prong is asymmetrical, one side of the cross-section being flatter than the other side of the cross-section, and wherein the passageway extending along at least one nasal prong changes in shape from the asymmetrical cross-section at or near the base of at least one nasal prong to a circular cross-section at or near the tip of at least one nasal prong.

24. 24. The interface of claim 23, wherein the cross-sectional area of ​​at least one nasal prong decreases from the base to the tip of the prong, the flatter side of at least one nasal prong being disposed toward a front side (facing away from a user's face) of the patient interface.

25. 25. A patient interface according to any one of claims 12 to 24, wherein at least one nasal prong has a base integrally formed with the bridge portion of the body portion of the patient interface, the base of at least one nasal prong including a fillet between a wall of the prong and the bridge portion, the fillet extending around a circumference of the at least one nasal prong, the radius of the fillet varying around the circumference of the at least one nasal prong.

26. 26. A patented interface according to any one of claims 1 to 25, comprising at least one pad of a retention system for holding the interface in place when worn by a user in use, the pad being attached to at least one of the left and right side arms of the body portion, the pad being substantially symmetrical about a central substantially vertical axis dividing the pad into left and right sides such that pads of the same shape may be applied to both the left and right side arms of the body portion, and optionally each pad of said one pad being attached to the left or right portion respectively by overmolding with an overmolding material, whether attached to the pad or the interface by being integrally molded therewith, or subsequently attached to the interface by overmolding the interface and the pad.

27. The retention system includes a two-part detachable attachment (or connection) mechanism, the mechanism comprising: a. includes a skin patch and a user interface patch; b. the skin patch has a patient side and an interface side; c. the patient side of the skin patch is attachable to the skin of a user (e.g., by an adhesive, which is typically a dermatologically sensitive adhesive such as a hydrocolloid); d. a first part of a two-part detachable attachment or connection system is provided on the interface side of the skin patch; e. the user interface patch has an interface side and a patient side; f. the patient side of the user interface patch is provided with a second part of the two-part detachable attachment or connection system; g. The interface side of the user interface patch is attachable (or connectable) to the user interface and / or a component associated with the user interface (e.g., a tube or tubing); 27. A patient interface according to claim 26.

28. 28. A patient interface according to claim 26 or 27, wherein the body portion, or at least the left or right side arm, is co-molded or overmolded with the support system such that the pad is retained on or within the side arm portion of the interface.

29. 29. A patient interface according to any one of claims 12 to 28, wherein each of the left and right side arms includes one or more predetermined or pre-positioned points or localized compensation areas (or locations) disposed along the or each side arm and adapted to accommodate compensation of the patient interface within or at one or more of the compensation areas (or locations) and configured to accommodate forces due to flexing or bending or hinging or other displacement.

30. 30. A patient interface according to claim 29, wherein one or more of the compensation areas (or locations) is a hinge area or location of bending in or about at least two different (non-parallel) planes through the interface.

31. 31. A patient interface according to claim 29 or 30, wherein the bridge portion comprises a bridge element, and wherein the bridge portion, the bridge element, or both the bridge portion and the bridge element are substantially decoupled from forces applied to or exerted on the patient interface.

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