Patient interface and cap for respiratory devices

Abstract

This application relates to a patient interface and headgear for a breathing apparatus. The patient interface includes a headgear, such as a nasal cannula. The interface has a flexible face mount and a more rigid gas flow manifold component. The flexible face mount has a nose fork and a base portion, while the more rigid gas flow manifold component has an inlet and an outlet. Gas is delivered into the manifold inlet and flows out through the outlet and into the base portion of the face mount. The outlet of the manifold component includes a groove that creates a gap between the base portion of the face mount and the manifold component in an area adjacent to the philtrum, thereby providing pressure relief on the nasal septum. The headgear has a strap. The portion of the headgear that contacts the face has a surface area for frictionally engaging with the skin. The material in these areas can be in the form of a sleeve, coating, or overmolded. The remaining portion of the strap has a different material property than the portion that contacts the face.

Description

[0001] This application is a divisional application of patent application 201480034448.3, filed on May 7, 2014, entitled "Patient Interface and Headgear for Breathing Device". Technical Field

[0002] The present invention specifically, but not exclusively, relates to delivering humidifying gas to a patient requiring respiratory assistance via a patient interface such as a nasal cannula and a headgear for supporting or holding the patient interface such as the nasal cannula on the user. Background Technology

[0003] In the design of respiratory support systems, it is important to provide a patient interface and headgear that are comfortable for the user, easy to wear, and maintain their operational position when the user moves during use.

[0004] Alternative patient interfaces and headgear systems are provided, allowing users to choose the style or type of device they will use. This choice can be made based on comfort, or whether the patient interface is better suited to be held on the user for improved respiratory therapy delivery, or both. For example, alternative holding configurations or settings can be provided by different headgear for different patient interfaces.

[0005] Nasal cannulas can be used to deliver high-flow therapy. High-flow therapy is used in some cases for pediatric patients. There is a market gap for high-flow nasal cannulas (especially for the 2-12 year age group) that can deliver high flow and high humidity while being comfortable enough for overnight wear and securely fastened to the face of young children.

[0006] Therefore, the object of the present invention is to provide a patient interface or headgear or both, which is designed to at least partially achieve some or all of the above considerations or at least provide the public with a useful option. Summary of the Invention

[0007] This invention generally relates to pediatric nasal intubation. More specifically, certain features, aspects, and advantages of this invention relate to such intubations designed for high-flow applications.

[0008] In some configurations, the low resistance to flow cannula allows for the delivery of high transnasal flow rates over a wide flow range (e.g., 10-50 L / min), particularly for children aged 2-12 years. Advantageously, pediatric cannula can be used at home and in hospitals.

[0009] In some such configurations, pediatric intubation allows this wide flow range to be used at low delivery pressures.

[0010] In some configurations, the paediatric cannula can be used in conjunction with one or more structures for securing the paediatric cannula to the patient. For example, in some such configurations, the paediatric cannula can be used in conjunction with one or more of a strap and an adhesive patch assembly. In such configurations, the strap and adhesive patch assembly can be used together or in an alternating fashion.

[0011] In a first aspect, the present invention can broadly be said to consist in a strap as part of a headgear for a patient interface, the strap comprising:

[0012] a strap having a pair of primary end portions, each of which is connected to or is to be connected to a component of the patient interface, and

[0013] intermediate each primary end portion is a pair of secondary end portions releasably connected to one another to establish a continuous strap between the primary end portions having a starting length, the continuous strap being for assisting in retaining the patient interface on the patient, and

[0014] wherein each secondary end portion is adapted to be releasably connected with a corresponding end portion of a further strap segment to provide a continuous strap between the primary end portions having an extended strap length relative to the starting length.

[0015] Preferably, each end portion of the further strap segment comprises a connector coupled to the strap segment and each secondary end portion of the strap comprises a connector coupled to the strap.

[0016] Preferably, the connector of each strap segment is configured to couple the connector of the corresponding secondary end portion of the strap.

[0017] Preferably, the connector of each secondary end portion of the strap is configured to couple the connector of the other secondary end portion of the strap and the connector of at least one end portion of the further strap segment.

[0018] Preferably, the connector of each of the end portions of the further strap segment or the connector of each secondary end portion of the strap or both has or comprises: a male or female part or both for being received by and connected to a complementary male or female part of the other corresponding connector; and a friction fit part for retaining the connection between the corresponding connectors.

[0019] Preferably, the connector comprises a male part for being received by a female part of the corresponding connector and a female part for receiving a male part of the corresponding connector.

[0020] Preferably, the connector is capable of receiving and retaining a corresponding terminal end of the associated strap or the associated further strap segment.

[0021] Preferably, the connector is configured to retain the corresponding terminal by friction fit engagement.

[0022] Preferably, the connector comprises a series of internal teeth positioned on the body of the connector for providing friction fit engagement with the corresponding terminal; and a pair of jaws of the connector body configured to close over the teeth so as to securely retain the terminal of the associated strap or of the associated further strap segment on the teeth.

[0023] Preferably, the strap has an elastic, textile material.

[0024] Preferably, the further strap segment has an elastic, textile material.

[0025] Preferably, the further strap segment comprises one or more further strap segments that are releasably connected to each other in end-to-end relationship so as to form a single continuous further strap segment for releasable connection to the secondary end of the strap.

[0026] The further strap segment can have one or more of the following lengths in any combination: about 2 cm, about 4 cm, or about 6 cm.

[0027] In a second aspect, the present invention can broadly be said to consist in a headgear for a patient interface, the headgear comprising

[0028] a strap forming a part of the headgear for assisting in retaining or stabilising the patient interface on a user,

[0029] wherein the strap, or a segment of the strap, to be positioned on or placed in contact with the face or a part of the face of the user, comprises a surface area for frictionally engaging the face of the user, the surface area having a relatively higher friction surface material compared to the remaining part of the strap forming the headgear or the part of the headgear.

[0030] Preferably, the strap or the corresponding segment of the strap comprises two symmetrical surface areas for frictionally engaging two symmetrical parts on either side of the face of the user.

[0031] Preferably, the remaining part of the strap is arranged to extend as a non-face-contacting strap or strap segment to be extended beyond the face or the part of the face of the user.

[0032] Preferably, each surface area comprising a relatively higher friction surface material for frictionally engaging the face of the user or the part of the face of the user assists in retaining or stabilising the patient interface on the face of the user.

[0033] Preferably, each surface area comprises a material applied to the strap or the corresponding segment of the strap.

[0034] In a first embodiment, the applied material is in the form of a sleeve positioned around the tie or a corresponding segment of the tie.

[0035] Preferably, the sleeve is configured to be detachably coupled around the tie or tie segment.

[0036] Preferably, the tie or corresponding segment of the tie extends through a passage in the sleeve.

[0037] Preferably, the tie or corresponding segment of the tie is adapted to spiral through the passage.

[0038] In an alternative embodiment, the applied material is in the form of a material coated on the tie or a corresponding segment of the tie.

[0039] In yet another alternative embodiment, the applied material is overmoulded on the tie or a corresponding segment of the tie.

[0040] Preferably, in any embodiment, the applied material is smooth and comfortable for skin contact.

[0041] Preferably, the applied material is a thermoplastic elastomer.

[0042] Preferably, each surface region is a surface having a wider surface area at an end located closer to the patient interface than a surface area at an opposite end further from the patient interface.

[0043] Preferably, the surface region tapers from a relatively wider surface area to a relatively smaller surface area.

[0044] Preferably, each segment of the tie or tie including the surface region further includes a component of the tie configured to releasably couple the patient interface.

[0045] Preferably, each portion of the user's face includes a cheek of the user.

[0046] In a third aspect, the present invention can broadly be said to consist in a headgear for a patient interface, the headgear comprising

[0047] a tie forming a portion of the headgear for assisting in retaining or stabilising the patient interface on the user,

[0048] a first connector at a first end of the tie for connecting the tie to the patient interface, and

[0049] a first cheek engaging member adapted to enclose the first connector and having a surface region adapted to be positioned between a cheek of the user and the connector to minimise direct contact of the connector with the user's skin in use.

[0050] Preferably, the headgear further comprises a second connector at a second, opposite end of the strap for connecting the strap to the patient interface; and a second cheek engaging member configured to enclose the second connector and having a surface area adapted to be positioned between the other cheek of the user to minimise direct contact of the connector with the user's skin in use.

[0051] Preferably, each cheek engaging member is configured to be detachably coupled about the corresponding connector.

[0052] Preferably, the surface area of each cheek engaging member comprises a material substantially softer than the material of the corresponding connector.

[0053] Preferably, the surface area of each cheek engaging member comprises a relatively higher friction surface material than the corresponding connector so as to assist in retaining or stabilising the patient interface on the user's face.

[0054] Preferably, the material is a thermoplastic elastomer.

[0055] Preferably, the surface area of each cheek engaging member is a wider surface area at an end of the corresponding cheek engaging member closer to the patient interface than at an opposite end of the cheek member further from the patient interface.

[0056] Preferably, the surface area of each cheek engaging member tapers from a relatively wider end to a relatively smaller end.

[0057] Preferably, each cheek engaging member is a sleeve configured to receiveably hold the corresponding connector therein.

[0058] Preferably, the sleeve is configured to be detachably coupled about the corresponding connector.

[0059] Preferably, the connector is adapted to extend through a passage in the sleeve.

[0060] Preferably, each connector is substantially encapsulated by the corresponding sleeve in an area adapted to be positioned adjacent the user's cheek in use.

[0061] Preferably, each sleeve is curved along at least a portion of the length of the sleeve so as to complement the contours of the corresponding cheek.

[0062] Preferably, each connector is curved along at least a portion of the length of the connector adapted to be positioned adjacent the corresponding cheek.

[0063] Preferably, the connector is pre-shaped in a curved profile.

[0064] Preferably, each sleeve is pre-shaped in a curved profile. Alternatively, each sleeve is curved when enclosing the corresponding connector.

[0065] Preferably, the connector comprises a clip for releasable connection with the patient interface.

[0066] Preferably, once in situ, each connector is frictionally or mechanically engaged with the corresponding cheek engaging member.

[0067] Preferably, each connector is configured to couple the respective formation on the respective side of the patient interface.

[0068] Preferably, each connector comprises a lateral protrusion at the end of the elongate body, the lateral protrusion being configured to engage the respective formation by a push-fit type arrangement.

[0069] Preferably, the elongate body is configured to be received and retained within a channel of the respective formation and the protrusion is configured to engage an abutment surface at an exit aperture of the channel.

[0070] Preferably, the channel is elastically deformable for receiving the connector and for allowing the connector to be rotated axially by about 180° so as to enable easy removal of the connector from the channel.

[0071] Preferably, when the connector is rotated by about 180° within the channel, the lateral protrusion of the connector becomes disengaged from the abutment of the exit aperture of the channel.

[0072] In a fourth aspect, the application can broadly be said to consist in a nasal cannula comprising:

[0073] a face-mounting piece having a base portion and at least one elongate wing extending laterally from one side of the base,

[0074] at least one nasal prong extending laterally from the base portion and being engageable in at least one user nostril, and

[0075] wherein each wing comprises an outer surface adapted to contact a portion of a user's face in use, and an elongate ridge extending laterally along the wing from a side of the wing opposite the outer surface so as to assist in stabilising the face-mounting piece on a user's face in use.

[0076] Preferably, the face-mounting piece comprises a pair of wings extending laterally from either side of the base.

[0077] Preferably, the face-mounting piece comprises a pair of nasal prongs for engagement in each of a user's nostrils.

[0078] Preferably, the elongate ridge of each wing portion extends along an upper region of the wing portion.

[0079] Preferably, each wing portion includes a terminal end of the protrusion that extends, in use, substantially towards a corresponding cheek of the user.

[0080] Preferably, the terminal end of each wing portion is oriented at an obtuse angle relative to the longitudinal orientation of the base portion.

[0081] Preferably, the terminal end of each wing portion has substantially greater contact surface area compared to the contact surface area of the wing portion adjacent the base portion.

[0082] Preferably, the terminal end of each wing portion tapers outwardly.

[0083] Preferably, the distal end of each wing portion includes a configuration configured to releasably couple a complementary connector of a headgear associated with the nasal cannula.

[0084] Preferably, each connector includes a lateral protrusion at a terminal end of the elongate body configured to engage the corresponding configuration by a push-fit type arrangement.

[0085] Preferably, the configuration includes a channel having an entry aperture and an exit aperture and having an abutment surface at the exit aperture, and the connector includes an elongate body configured to be received and retained within the channel and wherein the protrusion is configured to engage the abutment surface at the exit aperture of the channel for retaining the connector therein.

[0086] Preferably, the channel is elastically deformable for receiving the connector and for allowing the connector to be axially rotated by about 180° to enable easy removal of the connector from the channel.

[0087] Preferably, the lateral protrusion of the connector becomes disengaged from the abutment of the exit aperture of the channel when the connector is rotated by about 180° within the channel.

[0088] Preferably, the nasal cannula further includes a bridge extending from the base portion to a lower region of the wing portions and forming a side inlet on either side of the bridge.

[0089] Preferably, the nasal cannula further includes a gas flow manifold piece having a gas inlet for receiving a gas flow from a gas source and a gas outlet for delivering the gas flow to at least one nasal prong of the face-mounting piece, the manifold piece being adapted to be received by the base portion through a side inlet of the face-mounting piece to fluidly connect the outlet of the manifold with the nasal prong of the face-mounting piece.

[0090] Preferably, the face-mounting piece further comprises a recess formed in the interior of the base portion, and the gas flow manifold piece comprises a corresponding lip at the outlet, which is adapted to releasably engage the recess so as to fluidly connect the outlet with the nasal prong of the face-mounting piece.

[0091] In a fifth aspect, the present application can broadly be said to consist in a nasal cannula assembly comprising:

[0092] a face-mounting piece having a base portion and at least one nasal prong extending from the base portion and being fitable in at least one user nostril, and

[0093] a gas flow manifold piece having a gas inlet for receiving a gas flow from a gas source, and a gas outlet for delivering the gas flow to the at least one nasal prong of the face-mounting piece, the manifold piece being adapted to be received by the base portion of the face-mounting piece so as to fluidly connect the outlet of the manifold with the at least one nasal prong of the face-mounting piece, and wherein the manifold piece further comprises a recess at the outlet for providing a gap between the base portion of the face-mounting piece and the manifold piece in a region of the base portion configured to be positioned adjacent a user septum in use, thereby to eliminate or at least mitigate pressure on the user septum from the manifold piece in use.

[0094] Preferably, the gas flow manifold piece is formed from a relatively hard material compared to the face-mounting piece.

[0095] Preferably, the gas flow manifold piece is formed from a substantially rigid plastic material such as polycarbonate.

[0096] Preferably, the face-mounting piece is formed from a substantially soft plastic material such as silicone.

[0097] Preferably, the recess at the outlet of the manifold piece is formed from a pair of opposing recesses on either side of the outlet periphery.

[0098] Preferably, the outlet periphery of the manifold is adapted to sealingly engage the interior of the base portion of the face-mounting piece.

[0099] Preferably, the outlet of the manifold piece comprises a lip extending around the outlet periphery and the interior of the base portion comprises a corresponding recess adapted to releasably receive the lip of the outlet of the manifold piece.

[0100] Preferably, the face-mounting piece comprises at least one substantially horizontal side access channel leading to the interior of the base portion for releasably receiving the outlet of the manifold piece therethrough.

[0101] Preferably, the face-mounting component comprises a pair of opposing side access channels to the interior of the base portion, each adapted to releasably receive the outlet of the manifold component therethrough.

[0102] Preferably, the face-mounting component comprises a pair of nose prongs.

[0103] Preferably, the base portion of the face-mounting component comprises a depression region between the nose prongs so as to extend the base portion away from the user's nasal septum and further relieve pressure on the nasal septum in use.

[0104] In a sixth aspect, the present invention can broadly be said to consist in a patient interface comprising a nasal cannula, according to any combination of the fourth aspect or the fifth aspect, and any combination of one or more preferred or alternative features and / or embodiments of those aspects.

[0105] In a seventh aspect, the present invention can broadly be said to consist in a headgear, according to any combination of the first aspect, the second aspect or the third aspect, and any combination of one or more preferred or alternative features and / or embodiments of those aspects.

[0106] Preferably, the headgear further comprises a head strap adapted to extend over the top of the user's head.

[0107] Preferably, the tie of the headgear is formed from an elastomeric material.

[0108] Preferably, the tie of the headgear is formed from a textile material.

[0109] In an eighth aspect, the present invention can broadly be said to consist in a respiratory assistance system comprising:

[0110] a patient interface according to the sixth aspect for delivering a flow of humidified gases to a patient, and

[0111] a headgear according to the seventh aspect for holding the patient interface on the face of a patient, having any combination of the preferred features thereunder.

[0112] Preferably, the respiratory assistance system further comprises a ventilator adapted to generate the flow of gases, and a humidifier coupled to an outlet of the ventilator for humidifying the flow of gases.

[0113] Preferably, the respiratory assistance system further comprises an inhalation conduit adapted to be coupled between the humidifier and the patient interface.

[0114] Preferably, the respiratory assistance system further comprises an extension tube adapted to be coupled between the inhalation conduit and the patient interface.

[0115] Preferably, the respiratory assistance system further comprises a retaining clip adapted to be coupled around the extension tube and to the headgear so as to tie the tube to the headgear and to reposition at least a portion of the pulling force on the extension tube from the patient interface to the headgear.

[0116] In a ninth aspect, the present invention can broadly be said to consist in a method of disconnecting a headgear comprising at least one connector at a terminal end of the headgear from a patient interface comprising a resiliently deformable formation for receiving and retaining the connector, the method comprising the steps of:

[0117] rotating the connector axially within the formation to change the orientation of the connector, and

[0118] pulling the connector away from the formation to disengage the connector from the patient interface.

[0119] Preferably, the step of rotating the connector comprises rotating the connector axially by about 180 degrees.

[0120] Preferably, the connector comprises an elongate body and a lateral protrusion extending from the body, and the corresponding formation of the patient interface comprises a channel having an entry aperture and an exit aperture and an abutment surface peripheral to the exit aperture, and wherein the step of rotating the connector axially comprises rotating the connector to disengage the protrusion from the abutment surface, and the step of pulling the connector comprises pulling the connector through the channel and out of the entry aperture.

[0121] Preferably, the headgear comprises a connector at either terminal end of the headgear, and the patient interface comprises a corresponding formation at either side of the interface.

[0122] In another aspect, there is a patient interface comprising a nasal cannula assembly and a headgear, the interface comprising:

[0123] a nasal cannula assembly, the nasal cannula assembly comprising:

[0124] a face mounting piece having a base portion and at least one nasal prong extending from the base portion and being fitable in at least one user nostril, and

[0125] a gas flow manifold part having a gas inlet for receiving a gas flow from a gas source, and a gas outlet for passing the gas flow to the at least one nasal prong of the face-mounting part, the manifold part being adapted to be received by the base portion of the face-mounting part so as to fluidly connect the outlet of the manifold with the at least one nasal prong of the face-mounting part, and wherein the manifold part further comprises a recess at the outlet for providing a gap between the base portion of the face-mounting part and the manifold part in a region of the base portion configured to be positioned adjacent to a user's septum in use, thereby to eliminate or at least mitigate pressure on the user's septum from the manifold part in use, and

[0126] a headgear for a patient interface, the headgear comprising:

[0127] a strap forming a part of the headgear for assisting in retaining or stabilising a patient interface on a user,

[0128] wherein the strap, or a section of the strap, to be positioned on or placed in contact with the face or a part of the user's face comprises a surface area for frictionally engaging with the user's face, the surface area having a relatively higher friction surface material compared to the remainder of the strap forming the headgear or a part of the headgear.

[0129] According to the above aspects, a nasal cannula as defined above can incorporate or include any one or more of the features as described herein.

[0130] According to the above aspects, a headgear for a patient interface as defined above can incorporate or include any one or more of the features as described herein.

[0131] The term "cheek" as used in the specification and claims means any area on a user's face at or adjacent to the zygomatic bone, and can include any area lateral and / or inferior to the zygomatic bone and / or can include any other area between the periphery of the user's respective eyes, ears, and nose.

[0132] The terms "upwardly", "across", and "rearwardly" are used in this specification in association with a manner of interfacing (unless the context dictates otherwise), when worn by an upright user, are through or relative to the interface approximately vertical, transverse horizontal, and anteroposterior horizontal.

[0133] The term "comprising", as used in the claims and specification, means "including at least the elements listed after this term". When interpreting each statement in this specification that includes the term "comprising", features other than those recited before the term are also included to the extent that the features do not exclude any of the described examples or any other of the described or recited features. Related terms such as "comprise" and "comprises" are to be interpreted in the same manner.

[0134] It is intended that the disclosure herein of ranges include all rational numbers within that range and therefore all sub-ranges of all ranges explicitly disclosed herein are expressly disclosed. These are only specific examples of what is generally disclosed and other such examples can be explicitly disclosed herein.

[0135] As used herein the terms "and / or" and "or" mean "and" or "or", or both.

[0136] As used herein the term "and / or" means "and", "or", or both.

[0137] The application can also be said broadly to consist in the parts, elements and features referred to or indicated in the specification of the application, individually or collectively, and any or all combinations of any two or more of said parts, elements or features, and where specific integers are mentioned herein which have known

[0138] The application consists in the foregoing and also envisages constructions of which the following gives examples. BRIEF DESCRIPTION OF DRAWINGS

[0139] Preferred embodiments of the application will now be described, by way of example only, and with reference to the accompanying drawings in which:

[0140] Figure 1 is a schematic view of an overall respiratory assistance system;

[0141] Figure 2A is a perspective view of a patient interface and a headgear of the first preferred form of the application in an assembled state;

[0142] Figure 2B is Figure 2Apatient interface and headgear of Figure 1 in an assembled state;

[0143] Figure 2C patient interface and headgear of Figure 1 in an assembled state; Figure 2A perspective view of a headgear of Figure 1 ;

[0144] Figure 3A patient interface and headgear of Figure 1 in an assembled state;

[0145] Figure 3B patient interface and headgear of Figure 1 in an assembled state; Figure 3A perspective view of a patient interface and headgear of Figure 1 in an assembled state;

[0146] Figure 4A patient interface and headgear of Figure 1 in an assembled state;

[0147] Figure 4B patient interface and headgear of Figure 1 in an assembled state; Figure 4A perspective view of a patient interface and headgear of Figure 1 in an assembled state;

[0148] Figure 5 perspective view of a facepiece of a patient interface of Figure 1 from an outer side of the facepiece;

[0149] Figure 6 perspective view of a gas flow manifold of a patient interface of Figure 1 ;

[0150] Figure 7 perspective view of a facepiece of Figure 1 from an inner side of the facepiece; Figure 5

[0151] perspective view of a facepiece of Figure 1 from an underside of the facepiece; Figure 8 Figure 5 perspective view of a connection between a patient interface and a headgear of the Figure 3 and 4 embodiments and showing a preferred form of sleeve associated with the headgear;

[0152] Figure 9 perspective view of a connection between a patient interface and a headgear of the Figure 3 and 4 embodiments and showing a preferred form of sleeve associated with the headgear;

[0153] Figure 10 Figure 5 perspective view of a connection between a patient interface and a headgear of the Figure 3 and 4 embodiments and showing a preferred form of sleeve associated with the headgear;

[0154] Figures 11A-11C perspective view of a retaining clip of a respiratory assistance system of the present invention;

[0155] Figures 12A-12C method for removing a connection of the first and second preferred forms of headgear from a patient interface;​​

[0156] Figures 13A-13B Correspondingly shown Figures 12A-12B A cross-sectional view;

[0157] Figures 14A-14C A preferred method is shown for removing the connector of the third preferred form of the headgear from the patient interface; and

[0158] Figures 15A-15B Correspondingly shown Figures 14A-14B A cross-sectional view. Detailed Implementation

[0159] The patient interface and headgear of the present invention provide an improvement in the delivery of respiratory care via a ventilator or gas supply.

[0160] Preferred patient interfaces and / or headgear will be described with reference to hospital-based respiratory care systems intended for use by adults and / or pediatric patients. It should be understood that the described patient interface and / or headgear embodiments can alternatively be used for delivering CPAP therapy.

[0161] It should also be understood that various aspects of the invention can be applied to any form of patient interface, including (but not limited to) indirect nasal masks (which cover the nose), direct nasal masks (including nozzles or pads that enter or engage the wearer's nostrils), masks (which cover the mouth), or full-face masks (which cover both the nose and mouth), and mouthpieces, but will be described with reference to nasal cannulas. Similarly, various aspects of the invention can be applied to any form of headgear, but these aspects will be described with reference to head straps.

[0162] Reference Figure 1This illustrates a ventilation and humidification system (respiratory system 10) that can be used with the present invention. In such a system 10, a patient 20 is supplied with a flow of humidified gas through a patient interface 100. The patient interface 100 is held in the operating position on the patient's face using an associated headgear 200. The interface 200 is connected to a humidified gas delivery path or inhalation conduit 30. The inhalation conduit 30 is connected at one end (directly or indirectly) to the patient interface 100 and at the opposite end to the outlet of a humidifier 40. In a preferred embodiment, the inhalation conduit is connected to the patient interface via an extension tube / conduit 300. The humidifier 40 receives and humidifies gas supplied from a gas supply source 50 (preferably including a blower 51). The humidifier 40 may include a humidification chamber 41 filled with water 42 and a heating device 43 for heating the water to humidify the gas path through the humidifier. The controller 52 may be provided to control and potentially modify one or more characteristics of the supplied gas, including (but not limited to) the gas pressure distribution, the gas flow rate distribution at the patient interface, the gas temperature, and / or the gas humidity. It should be understood that the control capability depends on the purpose and application of the respiratory system 10. For example, in a preferred application of in-hospital respiratory care, the flow rate of the supplied gas is monitored and controlled according to patient needs, but the pressure of the supplied gas does not necessarily need to be monitored and controlled. In alternative embodiments, such as the use of the present invention in CPAP, the pressure distribution of the supplied gas may be monitored and controlled.

[0163] Preferred embodiments of the invention will now be described with respect to the patient interface 100 and the headgear 200. Other aspects of the respiratory system 10 will not be described in detail for the sake of brevity; however, it should be understood that these aspects may take any desired form known in the art to achieve proper operation of the overall respiratory system 10 without departing from the scope of the invention.

[0164] Referring to Figures 2 through 11, preferred forms of a headgear 200 and a patient interface 100 are shown. These embodiments illustrate a patient interface 100 configured to deliver breathing gas from a gas supply and humidification source (not shown) to a patient, and a headgear 200 configured to support and hold the patient interface on the patient's face during use. In a preferred embodiment, the patient interface 100 is in the form of a nasal cannula 100 adapted to connect to an inspiratory conduit 300 and including at least one (but preferably two) nose forks 111 and 112 configured to fit within the patient's nostrils to deliver a flow of gas to the patient. The headgear 200 is in the form of a head strap 200, the length of which is preferably adjustable to customize the size of the strap for the patient.

[0165] The gas supply tube shown as article 300 is preferably a breathable tube. For example, it is advantageous that the gas supply tube is a robust and generally durable tube.

[0166] Nasal intubation

[0167] Referring to Figures 2 through 4, the nasal cannula 100 provides a patient interface suitable for delivering high-flow, high-humidity gas into the patient's nasal cavity / nostril. In some configurations, the cannula is adapted to deliver high gas flows over a wide flow rate range (e.g., preferably about 8 L / min, or higher, depending on other preferred therapeutic applications, possibly such as 10-50 L / min). In some configurations, the cannula is adapted to deliver relatively low-pressure gas.

[0168] The nasal cannula 100 includes a face mount 110 comprising at least one (but preferably a pair) tubular nose forks 111 and 112 integrally molded to or detachably attached to the face mount 110; and a gas flow manifold 120 detachably attached to or integrally molded to the catheter 300. As described further below, the gas flow manifold 120 is insertable into the face mount from either of two opposing horizontal directions (i.e., from the left or right). In this way, the position or orientation of the gas flow manifold 120 is reversible relative to the face mount 110. In other words, the user can choose to have the manifold 120 (and indeed the catheter 300 extending therefrom) extend from the left or right side of the cannula 100, depending on what is most convenient, for example, depending on which side the gas source or respirator is positioned on.

[0169] The facial mounting part 100 is formed of a soft, flexible material, such as silicone or other cannulation materials known in the art. The nose fork tips 111 and 112 are preferably flexible and may be formed of a sufficiently thin silicone layer to achieve this property.

[0170] The gas flow manifold component 120 is formed of a relatively rigid material such as polycarbonate, high-density polyethylene (HDPE), or any other suitable plastic material known in the art. The face mount component 110 provides a soft interface component to the patient for comfortable delivery of gas flow through nose forks 111 and 112, while the gas flow manifold component 120 fluidly connects the conduit 300 to the nose forks 111 and 112 of the face mount component 110.

[0171] Reference Figures 5-8 The nose forks 111 and 112 bend and extend into the patient's nostrils during use, providing a smooth flow path for gas. The inner surfaces of the forks 111 and 112 can be contoured to reduce noise. The bases of the forks 111 and 112 may include multiple curved surfaces to provide a smoother gas flow. This reduces noise levels during operation.

[0172] In some configurations, padding can be installed around the base of the fork head to reduce noise. The padding can be made of foam or moldable material that generally conforms to the patient's nasal anatomy. Alternatively, cushions or pillows can be provided.

[0173] The nose fork heads 111 and 112 are basically hollow and are basically tubular in shape.

[0174] The diameters of the nose forks 111 and 112 may be uniform along their length, but are preferably shaped to conform to the contours of the nostrils. Each fork 111 / 112 has an elongated opening 111a / 112a at its distal end opposite the base portion 118 of the face mount 110 to facilitate a high airflow into the cavity. In an alternative embodiment, the nose forks 111 and 112 may have a tapered shape with a wider end at the base portion 118 and a narrower end at the openings 111a and 112a.

[0175] These openings 111a and 112a can be cut out to guide gas flow upwards to the patient's nostrils. The facial mounting portion 110, and specifically the nasal forks 111 and 112, are preferably designed not to seal around the patient's nostrils to avoid excessive and potentially harmful pressure buildup during high-flow therapy. Therefore, the nasal forks 111 and 112 are sized to maintain sufficient clearance between the outer surfaces of the forks 111 and 112 and the patient's skin to avoid sealing the gas path between the cannula 100 and the patient.

[0176] The facial mounting part 110 is shaped to generally follow the contours of the patient's face around the upper lip region. In the area of ​​the face where the cannula is located, the facial mounting part 100 is molded or pre-formed to conform to the contours of the user's face and / or is flexible to adapt to, receive, and / or correspond to the contours of the user's face.

[0177] The face mount 110 includes an elongated base portion 118 from which nose forks 111 and 112 extend, and two wings 113 and 114 extending laterally from either side of the base portion 118. These wings 113 and 114 are integrally formed with the base portion 118, but may alternatively be separate portions. The inner side 119 of the base portion 118 of the face mount 110 is formed with an elongated elliptical recess 119a configured to connect to a corresponding outlet of a manifold 120. An arched bridge 118a extends from the center of the base portion 118 to the inner wall 113a / 114a of the wings to form two horizontal side access channels 121a and 121b for insertion into the outlet 123 of the manifold 120 from either side 121a or 121b.

[0178] The gas flow manifold component 120 is generally tubular in shape, having a substantially annular inlet 122 at one end and curving back at the opposite end into an elongated elliptical outlet 123. The inlet 122 is preferably detachably attached to the conduit 300, preferably by threaded engagement, but alternatively by snap-fit ​​or any other type of connection known in the art. Alternatively, the inlet and conduit 300 are fixedly connected or integrally formed. The outlet 123 is shaped to correspond to the elongated recess 119a of the face mount component 110 and engages therein by a friction fit or snap-fit, such that considerable force, or at least intentional force applied by the user or caregiver, is required to detach the manifold 120 from the face mount component 110.

[0179] The desired outcome is to prevent accidental detachment of the manifold from the face-mounted components.

[0180] When the two parts 110 and 120 are engaged, an effective seal is also formed between the outlet 123 and the base portion 118. Specifically, an outer rim or lip 126 is formed around the outlet 123, which corresponds to and sealably fits into an inner groove around the periphery of the inner recess 119a, so that the outlet of the manifold 120 is held within the face mount part 110. When the parts 110 and 120 are joined, the upper surface of the lip 126 engages the inner surface 119b of the base portion 118 / the surface 119b of the recess 119a, so as to form an effective seal between the parts 110 and 120 for gas flow. The nose forks 111 and 112 are aligned with corresponding openings extending through the surface 119b of the base portion 118 to the recess 119a, so that the manifold outlet 123 is fluidly connected to the nose forks 111 and 112 during engagement. In defining the inlet channels 121a and 121b for the manifold 120, the bridge 118a also helps to retain the manifold 120 within the base 118 of the face mount 110. A corresponding recess 128 is formed on the outer surface of the outlet 123, which has opposing ridges 129a and 129b on either side, to form a push-fit engagement mechanism between the outlet 123 of the face mount 110 and the bridge 118a.

[0181] The outer surface and / or wings 111 and 112 of the face mounting portion may include one or more channels to facilitate or allow airflow between the lips and the cannula, thereby cooling the patient.

[0182] Multiple adhesive pads can be provided on each wing 111 and 112 to facilitate attachment of the cannula 110 to the patient—especially for younger children (e.g., under 5 years old).

[0183] Ridge on the wing

[0184] Each wing 113 / 114 extends laterally from the base portion 118 of the face mount 110 and includes an outer surface 113b / 114b configured to contact the patient's face in use, preferably at least the upper lip region of the patient's face and slightly extending beyond the corresponding cheek facing the user. The distal ends 113c and 114c of the wings 113 and 114 are configured to releasably connect the corresponding ends 201 and 202 of the head strap 200 together so that the face mount 110 is held on the patient's face.

[0185] In a preferred embodiment, each wing 113 / 114 includes an integral ridge 115 / 116 that extends laterally along the length of the wing 113 / 114 from the inner side of the face mount 110 opposite the outer surface 113b / 114b of the wing 113 / 114. In a preferred embodiment, each ridge 115 / 116 is substantially perpendicular to the outer contact surface 113b / 114b of the corresponding wing 113 / 114. Each ridge 115 / 116 preferably begins from the base portion 118 of the face mount 110 and extends along the upper region of the corresponding wing 113 / 114. The ridges 115 / 116 serve to stably abut the face mount 110 against the patient's face and minimize torsional stresses that could otherwise cause the nose forks 101 and 102 to flip out and leave the patient's nostrils. The dimensions of the ridge 115 / 116, including any combination of length, thickness and width (i.e., the extent to which the ridge extends away from the outer surface 113b / 114b), should be sufficient to improve the stabilization of the face mount part 110 on the patient's face.

[0186] The spine 115 / 116 can be overmolded or integrally formed with the corresponding wings 113 / 114 of the face mounting part 110.

[0187] protruding wings

[0188] In a preferred embodiment, the distal end or terminal 113c / 114c of each wing 113 / 114 is protruding or shaped with a contact surface area substantially larger than that of the wing 113 / 114 in the region adjacent to the nose fork. This distal portion 113c / 114c is preferably also angled relative to the overall longitudinal axis of the face mount 110 or the base 118. Specifically, the distal portion 113c / 114c extends at an obtuse angle from the base 118, or from the region adjacent to the corresponding wing 113 / 114 of the base, and faces the corresponding cheek of the patient. In this way, attaching the head strap 200 to the distal portions 113c and 114c of the wings 113 and 144 and wearing the interface 100 will form a generally V-shaped structure that generates a force vector acting on the wings 113 and 114 and the cannula 110 in the direction of the patient's cheek. This improves the retention of the nose forks 111 and 112 within the patient's nostrils and, when the distal ends 113c and 114c of the wings 113 and 114 are pulled by the corresponding ends 201 and 202 of the cap 200, causes the forks 111 and 112 to rotate into the nostrils. Each distal portion 113c / 114c can be smoothly angled or rounded, or it can be sharply or steeply angled relative to the remainder of the corresponding wing 113 / 114.

[0189] In a preferred embodiment, the distal portions 113c / 114c are tapered outwards to increase the contact surface area of ​​the corresponding wings 113 / 114 and also to angle the distal portions 113c / 114c toward the patient's cheek.

[0190] The increased surface area at the distal ends 113c and 114c provides increased effective area for forming a suitable connection mechanism for attaching the head strap 200. In a preferred embodiment, a plurality of clip holding features 101 and 102 are provided at each distal end 113c / 114c to releasably attach a plurality of clip components of the head strap 200 to the face mounting portion 110 of the cannula 100.

[0191] Recessed manifold

[0192] The nasal septum and / or columella of a patient are generally quite sensitive areas and can be a source of discomfort when subjected to excessive contact pressure over prolonged periods. This invention alleviates or reduces this pressure by providing a buffer zone for the cannula 100 adjacent to the patient's nasal septum / columella. In a preferred embodiment, the outlet 123 includes a pair of opposing recesses or grooves 124 / 125 at its periphery, which form a recess or depression 127 in the area adjacent to the nasal septum / columella during use. When coupled to the face mount portion 110, this depression 127 forms a gap between the base portion 118 and the outlet 123 of the manifold 120. During use, this gap buffers / softens the area of ​​the cannula 100 directly adjacent to the nasal septum / columella. This allows pressure from the stiffer manifold component 120 to disengage from the nasal septum / columella and allows the nasal septum / columella to rest only on the soft base of the face mount portion 110.

[0193] The base portion 118 is preferably also shaped with the hollow outer portion and / or recessed outer contour 118b between the forks 111 and 112 to relieve pressure at the nasal septum / columella. The hollow portion should be as large as possible without (significantly) reducing the flow delivered to the patient. The recessed portion 118b is preferably also complementary to the periphery of the outlet 123 to maintain an effective seal between the two parts of the cannula.

[0194] Headband

[0195] Now referring back to Figures 2 through 4, in a preferred embodiment, the headgear for holding the patient interface 100 against the patient's face includes a head strap 200 having a single continuous length and adapted to extend along the patient's cheek, above the ears, and around the back of the head in use.

[0196] The main ends 201 and 202 of the tether 200 are adapted to releasably connect the corresponding structures 101 and 102 together on either side of the nasal cannula 100 so as to hold the cannula 100 in place during use.

[0197] In a preferred embodiment, a clip component is provided at each end 201 / 202 that can be received and held within the corresponding configuration 101 / 102. This clip component can be attached to the strap at the corresponding main end according to one of the two preferred embodiments (described in further detail below). Furthermore, the length of the head strap 200 is adjustable to facilitate customizing the strap to fit the wearer's head. Three different head strap adjustment configurations are described below according to three preferred embodiments of the invention. In each of these embodiments, the strap 200 is preferably formed of a soft and stretchable / elastic material (such as an elastic, textile / fabric material that is comfortable for the wearer). Alternatively, the strap 200 may be formed of a substantially stiffer or less flexible material (such as a hard plastic material).

[0198] In any of the following embodiments, the headgear 200 may further include additional straps or connecting straps 200 to extend over other headgear components (such as...) during use. Figure 1 (As shown in the diagram). The head strap or headpiece can have the following benefits: during use, pulling the strap 200 upwards and above the patient's ears can improve fit and comfort.

[0199] First Embodiment

[0200] Overall, but also referring to Figures 2A-2C In a first preferred embodiment of the adjustable strap 200, the adjustment mechanism is provided in the form of one or more insertable / removable strap segments or strap extensions 220.

[0201] A fixed-length strap segment 220 can be releasably attached to the main strap 210 to extend its length. In this embodiment, the main strap 210 includes a pair of intermediate or secondary ends 203 / 204 that are releasably connected to each other and also releasably connected to corresponding ends 221 and 222 of the strap segment 220. When the secondary ends 203 and 204 are connected to each other, the main strap 210 has a continuous initial length / size for the wearer. To extend the length of the strap 200 beyond this initial length, the main strap 210 can be broken at the secondary ends 203 / 204 and one or more additional strap segments 220 can be attached therebetween.

[0202] For example, multiple lacing segments 220 of varying predetermined lengths 220A to 220C can be provided to offer multiple alternative adjustable lengths. For instance, one or more lacing segments 220 may be provided with lengths ranging from about 1 cm to about 10 cm, or from about 2 cm to about 6 cm. These lacing segments 220 have lengths of, for example, about 2 cm, about 4 cm, or about 6 cm. It should be understood that these examples are not intended to be limiting and that the length of each lacing segment can be of any size, depending on the user and / or application.

[0203] Furthermore, each end 221 / 222 of each lacing segment 220 is preferably connectable to the corresponding end 221 / 222 of another lacing segment 220 and / or the corresponding secondary end 203 / 204 of the main lacing 210, thereby enabling the user to combine one or more lacing segments 220 with the same or varying lengths to achieve the required / desired overall length of the customized extension.

[0204] These additional strap segments are preferably formed of a soft and stretchable / elastic material (such as an elastic, textile / fabric material that is comfortable for the wearer). For example, especially for comfort, tubular knitted head straps or multiple segments of head strap 210 can be used above the user's ears.

[0205] It should be understood that exceptional comfort can be achieved by a head strap that provides a suitable positioning of the patient interface in a preferred, relatively stable position on the user's face, while also providing a relatively loose fit or low-tension fit around the user's head.

[0206] Alternatively, these additional tether segments can be formed of essentially rigid materials, such as hard plastic materials.

[0207] The lacing connector 230 is provided at each of the secondary ends 203 / 204 of the main lacing 210 and the corresponding ends 203 / 204 of the lacing segment 220.

[0208] Each connector 230 is provided with a lacing connection mechanism at one end for attaching to a lacing material, and a connection mechanism at the opposite end for releasably attaching to the corresponding end of a similar connector 230.

[0209] In an alternative, connector 230 may be a variety of adjustable buckles suitable for adjusting the length or tension of head strap segments 210, which hold the patient interface in place around the user's head.

[0210] It should also be understood that connector 230 can be positioned offset from the midpoint behind the user's head, or offset to one side of the user's head. This can be advantageous to avoid impacting a portion of the user's head, which could otherwise cause discomfort in certain positions (such as while sleeping).

[0211] In another embodiment, these tether segments may have different lengths so that they can be provided asymmetrically or to aid in operability in the offset position of the connector 230. Furthermore, the two tether segments 210 may be such that one of the tethers is adjustable in length while the other is not. For example, one tether segment 210 may have a permanent length or be permanently attached to the connector 230.

[0212] In a preferred embodiment, the tie-connecting mechanism may include a series of internal teeth positioned within the connector body for establishing a frictional engagement with the opposite ends of the tie. A hinged clamp on the body is provided and closes on the teeth to securely hold the ends of the tie on them. A releasable connection mechanism at the other end includes a pair of convex and concave members (e.g., corresponding protrusions and openings) adapted to connect to corresponding convex and concave members of a similar connector 230. Supports on the protrusions may engage recesses in the concave members to provide a snap-fit ​​engagement between these members. It should be understood that in alternative embodiments, any other suitable connector configuration may be used to releasably connect secondary ends of the tie to each other, and releasably connect to the ends of additional tie segments.

[0213] Also refer to Figure 9 Cannula connectors 240 are provided at the main ends 201 and 202 of the main tether 210. These connectors 240 have a similar tether connection mechanism to the secondary ends 203 and 204 of the tether connectors 230, but include clamping members, such as push-fit clamps 241, at the ends of the connectors 240 opposite the ends of the tether. The clamps 241 are configured to releasably engage corresponding configurations 101 / 102 on one side of the cannula 110. The clamping member 241 is preferably a flexible part, such as a plastic part, which forms a hinged portion relative to the tether. For example, the clamps 241 are preferably pre-formed to have a curved shape along their length, such as a curved shape having an angle between flat and 20 degrees. This curvature allows the clamps 241 to conform to the contours of the patient's face in the area of ​​the clamps 241.

[0214] Reference Figure 12A -C and Figure 13A-B, A method for engaging and disengaging each connector 240 of the head strap 200 to and from the patient interface 110 will now be described. Each connector 240 includes a clamping member 241 having an elongated connector body 242 and a lateral protrusion 243 at the end of the body 242. The lateral protrusion 243 includes an inwardly facing engagement surface 243a. The face 244 of the connector 240 opposite to the face 245 from which the protrusion 243 extends is preferably substantially smooth or flat. The corresponding configuration 101 / 102 of the cannula 110 includes channels 101a / 102a having an entry opening 101b / 102b and an exit opening 101c / 102c at either end of the channels 101a / 102a. The outer walls of the exit openings 101c / 102c define abutment members 101ci / 102ci, which are configured to engage with the surface 243a of the protrusion 243 of the clamping member 241. The outer walls 101bi / 102bi of the entry openings 101b / 102b define abutment members for engaging flanges 246 at opposite ends of the body 242 onto the protrusions 243. This limits the insertion depth of the connector 240 into the corresponding channels 101a / 102a. The flanges 246 may be provided by the terminals of the tethered connection mechanism and / or the sleeve 270.

[0215] like Figure 12A and Figure 13A As shown, to connect the connector 240 to the cannula 110, the user inserts the elongated body 242 through the entry openings 101b / 102b of the corresponding channels 101a / 102a, with the protruding end 243 extended forward until the protrusion 243 protrudes through the exit openings 101c / 102c and engages with the corresponding adjacent pieces 101ci / 102ci and when the flange 246 engages the surfaces 101bi / 102bi. To achieve engagement of the lateral protrusion 243 with the corresponding adjacent pieces 101ci / 102ci, the user must orient the connector 240 so that the protrusion 243 is aligned with the adjacent pieces 101ci / 102ci.

[0216] In a preferred embodiment, the abutment members 101ci / 102ci are located at the upper peripheral wall of the exit opening 101c / 102c; however, in an alternative embodiment, the abutment members 101ci / 102ci may be positioned at any other portion of the peripheral wall of the opening 101c / 102c. For a preferred embodiment, to engage the surface 243a of the protrusion 243 with the abutment members 101ci / 102ci, the user can align the protrusion 243 with the upper peripheral wall of the exit opening 101c / 102c. This can be done before or after the insertion of the elongated body 242 through the channel 101a / 102a. In other words, the user can insert the connector 240 with the protrusion 243 in the direction facing the adjacent member 102ci / 102ci, so that the surface 243a immediately engages with the adjacent member 102ci / 102ci when the protrusion 243 exits the channel 101a / 102a through the opening 101c / 102c. Alternatively, the user can insert the connector 240 with the protrusion 243 in a direction that is not aligned with the direction of the adjacent member 101ci / 102ci (e.g., away from the adjacent member 101ci / 102ci or 180 degrees away from the direction of the adjacent member 101ci / 102ci), and then axially rotate the connector 240 after the protrusion 243 exits the channel 101a / 102a through the opening 101c / 102c so that the surface 243a aligns with and engages with the adjacent member 101ci / 102ci.

[0217] The engagement between the protrusion 243 and the adjacent members 101ci / 102ci resists pulling forces on the connector 240 that could cause the connector to accidentally detach from the cannula 110. Thus, both the connector 240 and the corresponding configurations 101 / 102 are configured to provide a certain level of resistance against forces used to pull the connector 240 backward through the channel 101a / 102a. This resistance prevents accidental removal and also makes intentional disconnection of the connector 240 substantially difficult or troublesome.

[0218] Now refer to Figure 12B , Figure 12C and Figure 13B To avoid requiring additional pulling force, a preferred method for removing the connector 240 from the cannula 110 includes rotating the connector 240 about its longitudinal axis within the channels 101a / 102a to disengage the protrusion 243 from the adjacent members 101ci / 102ci. Figure 12B and Figure 13B ), and then pull the connector 240 out of the channel 101a / 102a by entering the opening 101b / 102b. Figure 12CIn a preferred embodiment, the protrusion 243 is axially rotated approximately 180 degrees away from the adjacent members 101ci / 102ci to align the protrusion with the base or opening of the channel 101a / 102a, and to align the plane 244 with the adjacent members 101ci / 102ci and with the upper guide wall of the channel 101a / 102a. In an alternative embodiment, the connector 240 may be axially rotated at another angle sufficient to disengage the protrusion 243 from the adjacent members 101ci / 102ci, thereby reducing resistance to the removal of the connector 240 from the channel 101a / 102a.

[0219] In a preferred embodiment, constructions 101 and 102 are elastically flexible, and preferably, the connector 240, which is substantially more rigid, is integrated with the elastically flexible cannula 110. Thus, during insertion or removal, when the connector 240 rotates axially about its longitudinal axis, the channels 101a / 102a of constructions 101 / 102 elastically deform to allow rotation.

[0220] Second Embodiment

[0221] exist Figure 3A and Figure 3B In the second preferred embodiment shown, a single strap is provided with an adjustment mechanism including an adjustment buckle 250. The strap, as is well known in the art, is looped around the adjustment buckle 250 and is operated by the wearer to adjust the effective length by pulling on an appropriate portion of the strap 210. The adjustment buckle 250 is positioned in a central area of ​​the strap 200, adjacent to the back of the patient's head during use.

[0222] In this embodiment, the cannula connectors 240 at the main ends 201 and 202 have the same configuration as those described for the first embodiment. The same method described above for the first headgear embodiment—inserting the connector 240 into the cannula 110 and / or removing the connector 240 from the cannula 110—is applicable to this embodiment.

[0223] Third Embodiment

[0224] Reference Figure 4A and Figure 4B In a third preferred form of adjustment mechanism, a single strap is provided with an adjustment mechanism including two adjustment buckles 251 and 252 at the main ends 201 and 202 of the strap. The strap is looped around each adjustment buckle as is well known in the art and is adjusted by the wearer on either side to change the effective length of the strap 210 in use. The side adjustment buckles 251 and 252 are positioned in use at or near the wearer's cheek, between the ends 201 and 202 of the head strap 200 and the patient interface 100.

[0225] Also refer to Figure 10 In this embodiment, side buckles 251 and 252 are integrally formed with the cannula connector 260. The connector 260 includes elongated clamping members, such as a push-fit clamp 261, configured to releasably engage corresponding configurations 101 / 102 on the side of the cannula 110 at one end; and tether buckles 251 / 252 at opposite ends. The clamp 261 is elongated to extend from the patient's upper lip region to the patient's cheek or at least substantially toward the patient's cheek during use. The clamping member 261 is preferably a flexible part, such as a plastic part, forming a hinged portion relative to the tether. For example, the clamp 261 is preferably pre-formed to have a curved shape along its length, such as a curved shape having an angle between flat and 20 degrees. This curvature allows the clamp 261 to conform to the contours of the patient's face or cheek when the patient interface 100 and head tether 200 are properly worn by the patient.

[0226] Reference Figure 14A -C and Figure 15A -B, As in the first and second embodiments, the connector 260 includes a clamping member 261 having an elongated connector body 262 and a lateral protrusion 263 at the end of the body 262. The lateral protrusion 263 includes an inwardly facing engagement surface 263a. The face 264 of the connector 260 opposite to the face 265 from which the protrusion 263 extends is preferably substantially smooth or flat. The corresponding configuration 101 / 102 of the cannula 110 includes channels 101a / 102a having an entry opening 101b / 102b and an exit opening 101c / 102c at either end of the channels 101a / 102a. The peripheral wall of the exit opening 101c / 102c defines an abutment 101ci / 102ci, which is configured to engage with the surface 263a of the protrusion 243 of the clamping member 241. The periphery 101bi / 102bi of the openings 101b / 102b defines an abutment for engaging the flange 266 at the opposite ends of the body 262 to the protrusion 263. This limits the insertion depth of the connector 260 into the corresponding channel 101a / 102a. The flange 266 may be provided by the end of a tethered connection mechanism and / or a sleeve 270.

[0227] The method of inserting the connector 260 into the cannula 110 and / or removing the connector 260 from the cannula 110, which is the same as the method described above for the first headgear embodiment, is applicable as follows: Figure 14A -C and Figure 15A -B shows this connector 260 / embodiment.

[0228] It should be understood that for any of the above head strap embodiments, any other suitable connector configuration can be used to releasably connect the main end of the strap to the nasal cannula.

[0229] cheek support

[0230] Now refer to Figures 2 to 4. Figure 9 and Figure 10 In a preferred embodiment, each segment of the headband 200 on either side and adjacent to the corresponding main ends 201 / 202 includes or has a cheek support 270 applied thereto. This cheek support includes at least a surface area 271 for frictionally engaging with the user's face, thereby stabilizing the headband 200 on the face at the cheek (e.g., cheekbone or below, or area thereof) during attachment to the patient interface 100 and during subsequent use. The surface area 270 preferably has a relatively higher frictional surface material compared to the remainder of the headband 200.

[0231] The high-friction surface material 271 is adapted to extend and cover a portion of the patient's face during use, preferably at or at least substantially toward the patient's cheek, to help keep or stabilize the patient interface 100 on the patient's face. The high-friction surface material, which can be positioned on the user's cheek, further helps to keep the remainder of the head strap 200 separate from the user's eyes or eye sockets and preferably extends below the user's eyes or eye sockets to prevent visual obstruction and / or discomfort caused by the head strap 200 bridging on or near the eyes or eye sockets.

[0232] It should be understood that the high-friction surface material 271 can be adapted to extend and cover a portion of the patient's face during use, for example, extending backward and upward across the left and right cheeks from or near the left and right outer upper lips.

[0233] In a preferred embodiment, the friction surface material is provided in the form of an elongated sleeve 270, which is configured to receive the corresponding main ends 201 / 202 of the tether 200. The sleeve 270 is configured to be detachably connected (or alternatively permanently connected) around the tether 200, a section of the tether 200, and / or the insertion connector 240 / 260 at the main ends of the tether.

[0234] Refer to Figures 2 and 3. Figure 9According to the first two preferred embodiments described above, the sleeve 270 is connected around the strap 210 at the main ends 201 / 202 and also around a portion of the connector 240. The strap 210 extends through a channel 272 in the sleeve 270. The strap 210 is adapted to spiral through this channel and preferably remain free when in the sleeve configuration to allow for stretching or elasticization or extension. The connector 240 is substantially encapsulated by the sleeve 270 or masked by a surface area to minimize direct contact with the user's skin, thereby improving the stability and comfort of the cap 200. A clip 241 extends from the end 273 of the sleeve 270. In another embodiment, the sleeve 270 may be overmolded onto the connector 240 and / or the strap 210.

[0235] Refer to Figure 4 and Figure 10 According to a third preferred embodiment, the sleeve 270 is engaged at the main ends 201 / 202 around the connector 260 extending from the strap 210. In this embodiment, the connector 260 is substantially enclosed by the sleeve 270 or masked by a surface area to minimize direct contact with the user's skin, thereby improving the stability and comfort of the cap 200. In other words, the connector 260 extends sufficiently through the channel 272 of the sleeve 270. Buckles 251 / 252 extend from the ends 274 of the sleeve 270 and clips 261 extend from the opposite ends 273.

[0236] The sleeve 270 can be pre-formed to have a curved shape along its length, such as a curved shape with an angle between flat and 20 degrees. This curvature allows the sleeve to conform to the contours of the patient's face or cheek in the sleeve area during use. Alternatively, the sleeve 270 can take the shape of a curved sleeve when engaged with the main ends 201 / 202 of the head strap 200 or the connector 260.

[0237] Sleeve 270 provides a surface area with a relatively high-friction surface material for frictional engagement with the user's face or facial skin. This surface area will be positioned for frictional engagement with the user's facial cheek skin. This surface area is at least localized to the frenulum or the segment of the frenulum to be positioned on the user's cheek. The surface area with the relatively high-friction surface material preferably has a smooth and comfortable material on the patient's skin. Therefore, sleeve 270 or at least surface area 271 is formed of a material that is relatively softer than connectors 240 and 260.

[0238] In a preferred embodiment, the surface region 271 or sleeve 270 is formed of a soft thermoplastic elastomer (TPE), but may alternatively be formed of another plastic material (such as silicone) or any other biocompatible material.

[0239] Surface region 271 may be a surface with a wider surface area closer to the patient interface compared to a surface area further away from the patient interface. In a preferred embodiment, sleeve 270 gradually decreases in size from a relatively wide surface area 273 to a relatively small surface area 274 in a direction extending away from the connection point between connector 240 / 260 and patient interface 100. The width of sleeve at end 273 is preferably the same as or similar to the width of the tapered distal ends 113c / 114c of the corresponding wings 113 / 114 of face mount part 110. This provides a smooth transition between patient interface 100 and headgear 200, improving aesthetics and achieving a visually appealing effect.

[0240] In addition to nasal cannulas, headgear for other forms of interfaces may also include, on or near either side of the headgear's strap, a plurality of cheek supports 270 as described or similar, attached to the mask for frictional engagement with the user's face to stabilize the mask on the cheek and, specifically (e.g.), guide a plurality of nasal masks, including nozzles or cushions, into or engage the wearer's nostrils. Such headgear may further include a single head strap adapted to extend in use along the patient's cheek, above the ears, and around the back of the head, with the ends including a plurality of clips of any suitable form, attached to or permanently attached to the mask on either side 9.

[0241] Hold clip

[0242] Reference Figures 11A-11C In a preferred embodiment, a retaining clip 280 is provided, comprising a tubular body 281 for receiving and accommodating a portion therein of the catheter 300. A hook 282 protrudes from the body 281 to engage other components of the tether or cap 200. In this manner, the catheter 300 can be attached or secured to the head tether 210 or cap 200 during use. If the catheter 300 is pulled, the force will be applied to the head tether 210 and not directly to the cannula 100. This repositioning of the force reduces the likelihood of the forks 111 and 112 of the cannula 100 protruding from the patient's nostrils.

[0243] One or more tethering points for attaching clip 280 may be available on cap 200, wherein preferably at least two symmetrical tethering points are located on either side of cap to improve usability.

[0244] It should also be understood that the retaining clip may be detachable from the gas supply tube shown as article 300 or may be a permanent fitting on the gas supply tube.

[0245] The retaining clip 280 can be attached to or retained on a portion of the patient interface, such as a portion of the interface that provides a relatively rigid area (e.g., to facilitate support for the gas supply tube article 300).

[0246] The retaining clip can also be positioned or attached to a specific location on the gas supply tube article 300, for example, a predetermined position can be provided to hold the retaining clip in place.

[0247] The conduit 300 can be a heated or unheated conduit. The conduit can be an extension of any desired length.

[0248] Other preferred features

[0249] 1. The intubation can have overall low resistance to flow. In some configurations, the intubation can include multiple tapered forks. These tapered forks can close the nostrils for improved PEEP. Tapered nasal forks will allow for smaller size options because a single design can be used for patients of different sizes and can be fitted into the user's nostril in an upright position. For example, for patients with larger nostrils, the nasal fork can be inserted deeper into the nostril. In some configurations, the nasal fork can direct expiratory flow away from the patient to reduce heat.

[0250] 2. The protruding V-shape helps to tilt these fork tips into the nose when the wings are pulled open. In other words, the stretching of the V-shaped cheek pad and frenulum pulls the nasal fork tips toward the patient and into the nostrils. The angle shown on the cheek pad can create a structure that improves this aspect.

[0251] 3. A double-fastening method can be used so that the cannula can generally be held in place by a tether, or multiple adhesive pads (swing pads), or a combination of both. The head tether can be adjustable from the back of the head, unlike most interface components where adjustability is desired at the front to facilitate adjustment without reaching the back of the patient's head. These adhesive pads can be positioned on the wings of the cannula. It is conceivable that younger children (e.g., under 5 years old) will use both adhesive pads and a tether, while older children will use only a tether.

[0252] 4. Large pads can be fitted onto the cheeks to reduce or eliminate pressure marks. These pads help stabilize the cannula on the face. Stabilization can reduce the likelihood or severity of deflection (e.g., cannula twisting). In some configurations, the cannula may include a covering molded part or structural member to stiffen the base of the cannula while reducing the likelihood or severity of deflection. In some configurations, the cannula may include a stabilizing ridge. In some such configurations, the stabilizing ridge may be positioned on top of the cannula. In some such configurations, the stabilizing ridge on top of the cannula can reduce or eliminate the possibility of the fork tip tipping out of the nose. These pads may have a soft surface on the underside (i.e., the side adjacent to the face).

[0253] 5. These pads can be installed around the base of the fork head to reduce noise. The pad can be installed at the base of the fork head. In some configurations, the pad can be made of foam material. In some configurations, the pad can be made of a moldable material that generally conforms to the patient's nasal anatomy. In some configurations, multiple pads or pillows can be provided.

[0254] 6. The surface around the fork head base can have a noise-reducing profile. In some configurations, the fork head base may include multiple curved surfaces to provide a smoother airflow. The configuration shown (illustrated by way of several figures drawn to scale) can provide a reduced noise level due to the smoother airflow.

[0255] 7. The user-facing surface of the cannula may include multiple grooves. These grooves behind the cannula can facilitate or allow airflow between the lips and the cannula to cool the patient.

[0256] Further preferred combinations of features are now defined based on the following numbered paragraphs:

[0257] 1A. A tie, as part of a headgear for a patient interface, the tie comprising:

[0258] The tether has a pair of main ends, each of which is connected to a patient interface or to a component to be connected to the patient interface.

[0259] In the middle of each primary end are a pair of secondary ends releasably connected to each other to establish a continuous tether between the primary ends having an initial length. This continuous tether helps to hold the patient interface to the patient.

[0260] Each secondary end is adapted to be releasably connected to the corresponding end of another tether segment to provide a continuous tether between primary ends having an extended tether length relative to the initial length.

[0261] 2A. The lacing as claimed in claim 1A, wherein each end of the additional lacing segment includes a connector attached to the lacing segment and each secondary end of the lacing includes a connector attached to the lacing.

[0262] 3A. The lacing as claimed in claim 2A, wherein the connector of each lacing segment is configured to connect to the connector of the corresponding secondary end of the lacing.

[0263] 4A. The tether as claimed in claim 1A or claim 2A, wherein the connector at each secondary end of the tether is configured to connect the connectors at other secondary ends of the tether to the connectors at at least one end of another tether segment.

[0264] 5A. The lacing as claimed in any one of claims 2A to 4A, wherein the connector of each of the ends of the other lacing segments or the connector of each secondary end of the lacing, or both, has or includes: a convex part or a concave part or both, for being received and connected thereto by a complementary convex part or concave part of another corresponding connector; and a friction-fitting part for maintaining the connection between the corresponding connectors.

[0265] 6A. The strap of claim 5A, wherein the connector includes a protruding protruding part for receiving by a recessed part of the corresponding connector and a recessed part for receiving the protruding protruding part of the corresponding connector.

[0266] 7A. The tether as claimed in claim 5A or claim 6A, wherein the connector is capable of receiving and retaining the corresponding end of the associated tether or associated additional tether segment.

[0267] 8A. The strap of claim 7A, wherein the connector is configured to retain the corresponding end by friction engagement.

[0268] 9A. The tether as claimed in claim 8A, wherein the connector includes a series of internal teeth positioned on the body of the connector for establishing a frictional engagement with a corresponding end; and a clamp of the body of the connector configured to close on the teeth to securely hold the end of the associated tether or associated additional tether segment on the teeth.

[0269] 10A. The tie as claimed in any of the preceding claims, wherein the tie is made of an elastic, textile material.

[0270] 11A. The tie as claimed in any of the preceding claims, wherein a further tie segment is made of an elastic, textile material.

[0271] 12A. The frenulum as claimed in any of the preceding claims, wherein the additional frenulum segment comprises one or more additional frenulum segments releasably connected to each other in an end-to-end relationship to form a single continuous additional frenulum segment for releasable attachment to a secondary end of the frenulum.

[0272] 13A. The ligature as claimed in any of the preceding claims, wherein the additional ligature segment has any combination of one or more of the following lengths: about 2 cm, about 4 cm, or about 6 cm.

[0273] 1B. A headgear for a patient interface, the headgear comprising:

[0274] The ties, which form part of the headgear, help to hold or stabilize the patient interface on the user.

[0275] The strap, or a section thereof, which is to be positioned on or in contact with the face or a portion of the user's face, includes a surface area for frictionally engaging with the user's face, the surface area having a relatively high frictional surface material compared to the remainder of the strap forming the cap or a portion of the cap.

[0276] 2B. The headgear as claimed in claim 1B, wherein the strap or corresponding segment of the strap includes two symmetrical surface regions for frictionally engaging with two symmetrical portions on either side of the user's face.

[0277] 3B. The headgear as claimed in any one of claims 1B or 2B, wherein the remaining portion of the strap is arranged as a non-facial contact strap or strap segment extending beyond the user's face or the portion of the user's face.

[0278] 4B. The headgear as claimed in any one of claim 1B or claim 3B, wherein each surface region for frictionally engaging with the user's face or a portion of the user's face comprises a relatively high-friction surface material that helps to hold or stabilize the patient interface on the user's face.

[0279] 5B. The headgear as claimed in any one of claims 1B to 4B, wherein each surface region comprises material applied to the strap or a corresponding segment of the strap.

[0280] 6B. The cap as claimed in claim 5B, wherein the material used is in the form of a sleeve positioned around the strap or a corresponding segment of the strap.

[0281] 7B. The cap as claimed in claim 6B, wherein the sleeve is configured to be detachably connected around the strap or strap segment.

[0282] 8B. The cap as claimed in claim 7B, wherein the strap or a corresponding segment of the strap extends through a channel in the sleeve.

[0283] 9B. The cap as claimed in claim 8B, wherein the strap or a corresponding segment of the strap is adapted to spiral through the channel.

[0284] 10B. The headgear as claimed in claim 5B, wherein the material used is in the form of a material coated on the straps or the corresponding segments of the straps.

[0285] 11B. The headgear as claimed in claim 5B, wherein the material used is overmolded onto the straps or the corresponding segments of the straps.

[0286] 12B. The headgear as claimed in any one of claims 4B to 11B, wherein the material used is smooth and comfortable to the touch.

[0287] 13B. The headgear as claimed in any one of claims 4B to 12B, wherein the material used is a thermoplastic elastomer.

[0288] 14B. The headgear as claimed in any one of claims 1B to 13B, wherein each surface region is a surface having a wider surface area at the end located closer to the patient interface than the surface area at the opposite end located further away from the patient interface.

[0289] 15B. The headgear as claimed in claim 14B, wherein each surface region gradually decreases in size from a relatively wide surface area to a relatively small surface area.

[0290] 16B. The headgear as claimed in any one of claims 1B to 15B, wherein the strap or each segment of the strap including the surface area further includes a component of the strap configured to releasably engage a patient interface.

[0291] 17B. The headgear as claimed in any one of claims 1B to 16B, wherein each portion of the user's face includes the user's cheek.

[0292] 1C. A headgear for a patient interface, the headgear comprising:

[0293] The ties, which form part of the headgear, help to hold or stabilize the patient interface on the user.

[0294] A first connector, located at a first end of the tether, is used to connect the tether to the patient interface.

[0295] A first cheek engagement member is adapted to enclose a first connector and has a surface area adapted to be positioned between the user's cheek and the connector to minimize direct contact between the connector and the user's skin during use.

[0296] 2C. The headgear as claimed in claim 1C, further comprising a second connector at a second opposite end of the strap for connecting the strap to a patient interface; and a second cheek engagement member configured to enclose the second connector and having a surface area adapted to be positioned between the user's other cheeks to minimize direct contact between the connector and the user's skin during use.

[0297] 3C. The headgear as claimed in claim 1C or claim 2C, wherein each cheek joint member is configured to be detachably connected around the corresponding connector.

[0298] 4C. The headgear as claimed in any one of claims 1C to 3C, wherein the surface area of ​​each cheek joint member comprises a material that is substantially softer than the material of the corresponding connector.

[0299] 5C. The headgear as claimed in any one of claims 1C to 4C, wherein the surface area of ​​each cheek engagement member includes a surface material with relatively high friction compared to the corresponding connector, in order to help hold or stabilize the patient interface on the user's face.

[0300] 6C. The headgear as claimed in any one of claims 4C or 5C, wherein the material is a thermoplastic elastomer.

[0301] 7C. The headgear as claimed in any one of claims 1C to 6C, wherein the surface area of ​​each cheek joint member is a surface having a wider surface area at the end of the corresponding cheek joint member that is closer to the patient interface than the surface area of ​​the opposite end of the cheek member that is further away from the patient interface.

[0302] 8C. The headgear as claimed in claim 8C, wherein the surface area of ​​each cheek joint member gradually decreases from a relatively wide end to a relatively small end.

[0303] 9C. The headgear as claimed in any one of claims 1C to 8C, wherein each cheek engagement member is a sleeve configured to receptively retain the corresponding connector therein.

[0304] 10C. The cap as claimed in claim 9C, wherein the sleeve is configured to be detachably connected around the corresponding connector.

[0305] 11C. The cap as claimed in any one of claims 9C or 10C, wherein the connector is adapted to extend through a channel in the sleeve.

[0306] 12C. The headgear as claimed in any one of claims 9C to 11C, wherein each connector is substantially encapsulated by a corresponding sleeve in an area adapted to be positioned adjacent to the user's cheek in use.

[0307] 13C. The headgear as claimed in any one of claims 9C to 12C, wherein each sleeve is bent along at least a portion of the length of the sleeve to complement the contour of the corresponding cheek.

[0308] 14C. The headgear as claimed in any one of claims 9C to 13C, wherein each connector is bent along at least a portion of the length of the connector adapted to be positioned adjacent to the corresponding cheek.

[0309] 15C. The headgear as claimed in claim 14C, wherein the connector is pre-formed in a curved shape.

[0310] 16C. The headgear as claimed in any one of claims 13C to 15C, wherein each sleeve is pre-formed in a curved shape.

[0311] 17C. The headgear as claimed in any one of claims 13C to 15C, wherein each sleeve is bent when enclosing the corresponding connector.

[0312] 18C. The headgear as claimed in any one of claims 1C to 17C, wherein the connector includes a clip for releasable connection to a patient interface.

[0313] 19C. The headgear as claimed in any one of claims 1C to 18C, wherein once in place, each connector is frictionally or mechanically engaged with the corresponding cheek engagement member.

[0314] 1D. A nasal cannula, comprising:

[0315] A face mounting part having a base portion and at least one elongated wing extending laterally from one side of the base.

[0316] At least one nose fork head, which extends laterally from the base portion and is capable of engaging in at least one user's nostril, and

[0317] Each wing includes an outer surface adapted to contact a portion of the user's face during use, and a slender ridge extending laterally along the wing from one side opposite the outer surface to help stabilize the face mount part on the user's face during use.

[0318] 2D. The nasal cannula of claim 1D, wherein the facial mounting component includes a pair of wings extending laterally from either side of the base.

[0319] 3D. The nasal cannula as claimed in claim 1D or claim 2D, wherein the facial mounting component includes a pair of nose forks for mating in each user's nostril.

[0320] 4D. The nasal cannula as claimed in any one of claims 1D to 3D, wherein the elongated ridge of each wing extends along the upper region of the wing.

[0321] 5D. The nasal cannula as claimed in any one of claims 1D to 4D, wherein each wing includes a projecting terminal that extends substantially toward the corresponding cheek of the user during use.

[0322] 6D. The nasal cannula of claim 5D, wherein the terminal of each wing is at an obtuse angle relative to the longitudinal orientation of the base portion.

[0323] 7D. The nasal cannula of claim 6D or any one of claim 7D, wherein the terminal of each wing has a substantially larger contact surface area than the contact surface area of ​​the wing adjacent to the base portion.

[0324] 8D. The nasal cannula as claimed in claim 7D, wherein the terminal of each wing tapers outward.

[0325] 9D. The nasal cannula as claimed in any one of claims 1D to 8D, wherein the distal end of each wing includes a configuration for releasably engaging a complementary connector to a cap associated with the nasal cannula.

[0326] 10D. The nasal cannula as claimed in any one of claims 1D to 9D, further comprising a bridge extending from the base portion to the lower region of the wing and forming a side inlet on either side of the bridge.

[0327] 11D. The nasal cannula of claim 10D, further comprising a gas flow manifold component having a gas inlet for receiving a gas flow from a gas source and a gas outlet for conveying the gas flow to at least one nose fork of the face mount component, the manifold component being adapted to be received by a base portion through an inlet on either side of the face mount component to fluidly connect the outlet of the manifold to the nose fork of the face mount component.

[0328] 12D. The nasal cannula of claim 11D, wherein the face mounting component further includes a recess formed in the interior of the base portion, and the gas flow manifold component includes a corresponding lip at the outlet, the lip being adapted to releasably engage the recess to fluidly connect the outlet to the nose fork of the face mounting component.

[0329] 1E. A nasal cannula assembly, comprising:

[0330] A facial mounting component having a base portion and at least one nose fork extending from the base portion and capable of engaging in at least one user's nostril, and

[0331] A gas flow manifold component having a gas inlet for receiving an airflow from a gas source and a gas outlet for conveying the gas flow to at least one nose fork of a face mount component, the manifold component being adapted to be received by a base portion of the face mount component to fluidly connect the outlet of the manifold to the at least one nose fork of the face mount component, and wherein the manifold component further includes a groove at the outlet for creating a gap between the base portion of the face mount component and the manifold component in a region of the base portion configured to be positioned adjacent to the philtrum of a user during use, thereby eliminating or at least alleviating pressure from the manifold component on the nasal septum of the user during use.

[0332] 2E. The nasal cannula of claim 1E, wherein the gas flow manifold component is formed of a material that is relatively harder than the facial mounting component.

[0333] 3E. The nasal cannula as claimed in any one of claims 1E or 2E, wherein the gas flow manifold component is formed of a substantially rigid plastic material such as polycarbonate.

[0334] 4E. The nasal cannula as claimed in any one of claims 1E to 3E, wherein the facial mounting part is formed of a substantially soft plastic material such as silicone.

[0335] 5E. The nasal cannula as claimed in any one of claims 1E to 4E, wherein the groove at the outlet of the manifold component is formed by a pair of opposing recesses on either side of the outlet periphery.

[0336] 6E. The nasal cannula of claim 5E, wherein the periphery of the manifold outlet is adapted to sealably engage the interior of the base portion of the facial mounting component.

[0337] 7E. The nasal cannula of claim 6E, wherein the outlet of the manifold component includes a lip extending around the periphery of the outlet and the interior of the base portion includes a corresponding recess of the lip adapted to releasably receive the outlet of the manifold component.

[0338] 8E. The nasal cannula of any one of claims 1E to 7E, wherein the facial mounting component includes at least one substantially horizontal side access channel leading to the interior of the base portion for releasably receiving an outlet of the manifold component passing through it.

[0339] 9E. The nasal cannula of claim 8E, wherein the facial mounting component includes a pair of opposing side entry channels leading into the interior of the base portion, each adapted to releasably receive an outlet of the manifold component passing through it.

[0340] 10E. The nasal cannula as claimed in any one of claims 1E to 9E, wherein the facial mounting component comprises a pair of nose forks.

[0341] 11E. The nasal cannula of claim 10E, wherein the base portion of the facial mounting component includes a recessed area between the nasal forks to allow the base portion to extend away from the user's nasal septum and further relieve pressure on the nasal septum during use.

[0342] 1F. A patient interface comprising a nasal cannula as described in any one of claims 1D to 12D, or any one of claims 1E to 11E, or any combination thereof.

[0343] 2F. A headgear as described in any one of claims 1A to 13A, or claims 1B to 17B, or claims 1C to 19C, or any combination thereof.

[0344] 3F. The headgear as claimed in claim 2F, further comprising a headband adapted to extend over the user's head.

[0345] 4F. The headgear as claimed in any one of claims 1F or 2F, wherein the headgear straps are formed of an elastic material.

[0346] 5F. The headgear as claimed in any one of claims 2F to 4F, wherein the headgear's straps are made of textile material.

[0347] 6F. A respiratory support system, comprising:

[0348] The patient interface for delivering a humidifying gas stream to the patient as described in claim 1F, and

[0349] A headgear for holding the patient interface on the patient's face, as claimed in any one of claims 2F to 5F.

[0350] 7F. The respiratory support system of claim 6F, further comprising a respirator adapted to generate a gas flow and a humidifier connected to the outlet of the respirator for humidifying the gas flow.

[0351] 8F. The respiratory support system of claim 7F, further comprising an inspiratory conduit adapted to connect between the humidifier and the patient interface.

[0352] 9F. The respiratory support system of claim 8F, further comprising an extension tube adapted to connect between the inspiratory duct and the patient interface.

[0353] 10F. The respiratory support system of claim 9F, further comprising a retaining clip adapted to connect and attach to the headgear around the extension tube, thereby connecting the tube to the headgear and repositioning at least a portion of the tension on the extension tube from the patient interface to the headgear.

[0354] 1G. A method for disconnecting a headgear, including at least one connector at the end of a headgear, from a patient interface including an elastically deformable structure for receiving and retaining the connector, the method comprising the steps of:

[0355] Within this structure, the connector is rotated axially to change its orientation, and

[0356] Pull the connector away from the structure to detach it from the patient interface.

[0357] 2G. The method of claim 1G, wherein the step of rotating the connector includes axially rotating the connector by about 180 degrees.

[0358] 3G. The method of any one of claim 1G or claim 2G, wherein the connector comprises an elongated body and a lateral protrusion extending from the body, and a corresponding configuration of the patient interface comprises a channel having an entry opening and an exit opening and having an abutment surface at the periphery of the exit opening, and wherein the step of axially rotating the connector comprises rotating the connector to disengage the protrusion from the abutment surface, and the step of pulling the connector comprises pulling the connector through the channel and pulling it out of the entry opening.

[0359] 4G. The method of any one of claims 1G to 3G, wherein the headgear includes a connector at either end of the headgear, and the patient interface includes a corresponding construction on either side of the interface.

[0360] The above description of the invention includes the preferred forms of the invention. Modifications may be made to the invention without departing from the scope of the invention as defined by the appended claims.

Claims

1. A respiratory assistance system comprising a patient interface and a headgear, the patient interface comprising: a facepiece having at least one nasal prong extending laterally from a base portion of the facepiece and configured to fit in at least one nare of a patient; the facepiece including at least one elongate wing extending laterally from a side of the base portion, a distal end of the wing extending at an obtuse angle away from the base portion or from a region of the wing adjacent the base portion and towards a corresponding cheek of the patient in use; the headgear being configured to hold the patient interface on the patient's face, the headgear including a tie, the tie having a clip configured to releasably connect to the distal end of the wing; wherein the clip includes an elongate body and a lateral projection at a terminal end of the elongate body; wherein a face of the clip opposite a face from which the lateral projection extends is flat; wherein the distal end of the wing includes a formation for releasable coupling to the clip, the formation including an entry aperture, a channel and an exit aperture for receiving the lateral projection, the formation further including an abutment surface at a periphery of the exit aperture; wherein the elongate body of the clip is configured to be received and held within the channel; wherein the lateral projection is configured to engage the formation by a push-fit type arrangement; wherein the lateral projection is configured to engage the abutment surface at the exit aperture of the channel to hold the clip within the channel; wherein the lateral projection is configured to disengage the abutment surface by rotation of the elongate body about a longitudinal axis; wherein the facepiece is formed from a soft, flexible material, the clip being substantially stiffer than the facepiece.

2. The respiratory assistance system of claim 1, wherein, the lateral projection includes an engagement surface configured to engage the abutment surface, the flat face of the clip being configured not to engage the abutment surface.

3. The respiratory assistance system of claim 1, wherein, the distal end of the wing is protruding, outwardly tapered or shaped with a greater contact surface area than a contact surface area of the wing in a region adjacent the nasal prong.

4. The respiratory assistance system of claim 1, wherein, the headgear further includes a sleeve configured to releasably hold the clip.

5. The respiratory assistance system of claim 4, wherein, the sleeve is adapted to enclose a portion of the clip, the sleeve including a surface area between the patient's cheek and the clip to minimise contact of the clip with the patient's skin in use.

6. The respiratory assistance system of claim 5, wherein, the surface area of each sleeve includes a material that is softer than a material of the clip.

7. The respiratory assistance system of claim 1, wherein, the soft, flexible material forming the facepiece is silicone.

8. The respiratory assistance system of claim 4, wherein, when the headgear is connected to the facepiece, the clip is enclosed within the channel and the sleeve passage to minimise contact between the clip and the patient's face in use.

9. The respiratory assistance system of claim 8, wherein, the sleeve includes a terminal end for insertion of a portion of the clip therethrough, the terminal end of the sleeve being configured to be adjacent the facepiece in use.

10. The respiratory assistance system of claim 9, wherein, a portion of the clip is inserted into the sleeve passage, the elongate body and lateral projection of the clip extending through the terminal end of the sleeve.

11. The respiratory assistance system of claim 9, wherein, a width of the terminal end of the sleeve is the same or similar to a width of the distal end of the wing in use.

12. The respiratory assistance system of claim 1, wherein, the tie further includes an adjustment buckle configured to be positioned behind the patient's head in use.

13. The respiratory assistance system of claim 1, wherein, the at least one nasal prong is a non-sealing prong and is configured such that no seal is formed between the at least one nasal prong and the user's nare in use.

14. The respiratory assistance system of claim 13, wherein, The at least one nasal prong is sized to maintain a sufficient gap between an outer surface of the at least one nasal prong and the patient's skin to avoid sealing the gas path between the patient interface and the patient.

15. The respiratory assistance system of claim 1, wherein, The at least one nasal prong is curved so that the at least one nasal prong extends into the patient's nostril in use.

16. The respiratory assistance system of claim 1, further comprising an extension tube extending from the left or right side of the patient interface, the extension tube configured to be coupled to an inspiratory conduit of the respiratory assistance system.

17. The respiratory assistance system of claim 1, further comprising a retention clip adapted to be coupled around the extension tube configured to be coupled to the inspiratory conduit of the respiratory assistance system and to the headgear so as to tether the extension tube to the headgear and to reposition at least a portion of the pulling force on the extension tube from the patient interface to the headgear.

18. The respiratory assistance system of claim 1, wherein, The clip is shaped to have an angle between flat and 20 degrees along the length of the clip.

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