Patient interfaces and headgear for respiratory devices

Abstract

The present application relates to a patient interface and headgear for a respiratory device. A patient interface with a headgear, such as a nasal cannula. The interface has a soft facial mounting part and a gas flow manifold part of a harder material, the soft facial mounting part having a nasal prong head and a base portion, and the gas flow manifold part of the harder material having 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 facial mounting part. The outlet of the manifold part includes a groove that provides a gap between the base portion of the facial mounting part and the manifold part at 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 facial area has a surface area for frictionally engaging with the skin. The material in these areas can be in the form of a sleeve or coating or overmolding. The remainder of the strap has different material properties than the portion that contacts the facial area.

Description

[0001] This application is a divisional application of invention patent application 201480034448.3, entitled “PATIENT INTERFACE AND HEAD CAP FOR RESPIRATORY DEVICE”, filed on May 7, 2014. Technical Field

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

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

[0004] Alternative patient interfaces and headgear systems are provided, which allow the user to select the style or type of device to be used. This selection can be made based on comfort, or the patient interface is better suited to be retained on the user for improved respiratory therapy delivery, or both. For example, alternative retention configurations or settings can be provided by different headgear for different patient interfaces.

[0005] Nasal cannulas can be used to deliver high flow therapy. In some cases, pediatric patients use high flow therapy. There is a gap in the market for a high flow nasal cannula (especially for the 2 to 12 year old age group) that can deliver high flow and high humidity and is comfortable enough to wear overnight and can be fastened on the face of a young child.

[0006] It is therefore an object of the present invention to provide a patient interface or headgear or both which is designed to achieve at least to some extent some or all of the above considerations or to at least provide the public with a useful choice. Summary of the invention

[0007] The present invention relates generally to pediatric nasal cannulas. More specifically, certain features, aspects and advantages of the present invention relate to such cannulas designed for high flow applications.

[0008] In some configurations, low resistance to the flow cannula can be used to deliver high nasal flows over a wide flow range (eg, 10-50 L / min), particularly for children aged 2-12 years. Advantageously, pediatric cannulas can be used both at home and in the hospital.

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

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

[0011] In a first aspect, the invention may be broadly considered to relate to a harness as part of headgear for a patient interface, the harness comprising:

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

[0013] intermediate each of the major ends is a pair of secondary ends releasably connected to one another to establish a continuous tie between the major ends of a starting length for helping to retain the patient interface on the patient, and

[0014] Each secondary end is adapted to be releasably connected to a corresponding end of another lace segment so as to provide a continuous lace between the primary ends having an extended lace length relative to the starting length.

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

[0016] Preferably, the connector of each tether segment is configured to couple with the connector of a corresponding secondary end of the tether.

[0017] Preferably, the connector of each secondary end of the tether is configured to couple the connectors of the other secondary ends of the tether and the connector of at least one end of a further tether segment.

[0018] Preferably, the connector at each end of the additional lace segment or the connector at each secondary end of the lace, or both, has or includes: a male part or a female part, or both, for being received by and connected to a complementary male part or female part of another corresponding connector; and a friction fit part for maintaining the connection between the corresponding connectors.

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

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

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

[0022] Preferably, the connector includes a series of internal teeth positioned on the body of the connector for providing a friction fit engagement with corresponding terminals; and a clamp of the connector body configured to close on the teeth so as to securely retain the terminal of the associated lace or associated additional lace segment on the teeth.

[0023] Preferably, the ties are of elastic, textile material.

[0024] Preferably, the further strap section comprises an elastic, textile material.

[0025] Preferably, the further tether segment comprises one or more further tether segments releasably connectable to one another in end-to-end relationship so as to form a single continuous further tether segment for releasably connecting to the secondary end of the tether.

[0026] The additional tie segments may have any combination of one or more of the following lengths: about 2 cm, about 4 cm, or about 6 cm.

[0027] In a second aspect, the invention may be broadly considered to relate to headgear for a patient interface, the headgear comprising

[0028] a strap forming a portion of the headgear for helping to hold or stabilize the patient interface on the user,

[0029] 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, includes a surface area for frictionally engaging with the user's face, the surface area having a relatively high friction surface material compared to the remainder of the strap forming the head cap or a part of the head cap.

[0030] Preferably, the strap, or corresponding section of the strap, comprises two symmetrical surface areas for frictionally engaging with two symmetrical portions on either side of a user's face.

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

[0032] Preferably, each surface area comprising a relatively high friction surface material for frictionally engaging a user's face or a portion of a user's face helps to hold or stabilize the patient interface on the user's face.

[0033] Preferably each surface region comprises material applied to the strap or a corresponding section of the strap.

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

[0035] Preferably, the sleeve is configured to be removably coupled about a tether or tether segment.

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

[0037] Preferably, the tether or a corresponding section of the tether is adapted to be threaded through the passage.

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

[0039] In yet another alternative embodiment, the applied material is over-molded onto the tether or corresponding section of the tether.

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

[0041] Preferably, the material applied 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 located further away from the patient interface.

[0043] Preferably, the surface area tapers from a relatively wide surface area to a relatively small surface area.

[0044] Preferably, the strap or each section of the strap comprising the surface area further comprises a portion of the strap configured to releasably couple to a patient interface.

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

[0046] In a third aspect, the present invention may be broadly considered to relate to headgear for a patient interface, the headgear comprising

[0047] a strap forming a portion of the headgear for helping to hold or stabilize the patient interface on the user,

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

[0049] A first cheek engaging member is adapted to enclose the first connector and has a surface area adapted to be positioned between a user's cheek and the connector to minimize direct contact of the connector with the user's skin in use.

[0050] Preferably, the head cap further includes a second connector located 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 user's other cheeks to minimize direct contact of the connector with the user's skin during use.

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

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

[0053] Preferably, a surface area of ​​each cheek engaging member comprises a relatively high friction surface material compared to the corresponding connector, so as to help retain or stabilise 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 surface having a wider surface area at the end of the corresponding cheek engaging member closer to the patient interface than the surface area at the 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 receivably retain a corresponding connector therein.

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

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

[0060] Preferably each connector is substantially enclosed by a corresponding sleeve in a region adapted to be positioned adjacent a user's cheek in use.

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

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

[0063] Preferably, the connecting element is preformed in a curved configuration.

[0064] Preferably, each sleeve is preformed with a curved profile. Alternatively, each sleeve is curved when enclosing the corresponding connector.

[0065] Preferably, the connector comprises a clip for releasably connecting to the patient interface.

[0066] Preferably, once in place, each connector frictionally or mechanically engages with a corresponding cheek engaging member.

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

[0068] Preferably, each connector includes a lateral projection at a distal end of the elongate body, the lateral projection being configured to engage a corresponding formation by a push-fit type arrangement.

[0069] Preferably, the elongate body is configured to be received and retained within a correspondingly configured channel and the projection is configured to engage the abutment surface at an exit opening of the channel.

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

[0071] Preferably, when the connecting element is rotated about 180° within the channel, the lateral projection of the connecting element becomes disengaged from the abutment of the exit opening of the channel.

[0072] In a fourth aspect, the invention may be broadly considered to relate to a nasal cannula comprising:

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

[0074] at least one nasal prong extending laterally from the base portion and adapted to fit within at least one nostril of a user, and

[0075] Each wing includes an outer surface adapted to contact a portion of a user's face during use, and an elongated ridge extending laterally along the wing from a side of the wing opposite the outer surface to help stabilize the facial mounting part on the user's face during use.

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

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

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

[0079] Preferably each wing comprises a raised terminal end which, in use, extends substantially towards a corresponding cheek of a user.

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

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

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

[0083] Preferably, the distal end of each wing includes a formation configured to releasably couple with a complementary connector of a head cap associated with the cannula.

[0084] Preferably, each connector includes a lateral projection at a distal end of the elongate body, the lateral projection being configured to engage a corresponding formation by a push-fit type arrangement.

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

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

[0087] Preferably, when the connecting element is rotated about 180° within the channel, the lateral projection of the connecting element becomes disengaged from the abutment of the exit opening of the channel.

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

[0089] Preferably, the nasal cannula further includes a gas flow manifold part 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 nasal prong of the facial mounting part, the manifold part being adapted to be received by the base portion through the inlet on either side of the facial mounting part so as to fluidly connect the outlet of the manifold with the nasal prong of the facial mounting part.

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

[0091] In a fifth aspect, the invention may be broadly considered to relate to a nasal cannula assembly comprising:

[0092] a facial mounting part having a base portion and at least one nasal prong extending from the base portion and capable of fitting in at least one nostril of a user, and

[0093] A gas flow manifold part, the gas flow manifold part having a gas inlet for receiving a gas flow from a gas source, and a gas outlet for conveying the gas flow to the at least one nasal prong of the facial mounting part, the manifold part being adapted to be received by the base portion of the facial mounting part so as to fluidly connect the outlet of the manifold with the at least one nasal prong of the facial mounting part, and wherein the manifold part further includes a groove at the outlet, the groove being used to provide a gap between the base portion of the facial mounting part and the manifold part in an area 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 part on the nasal septum of the user during use.

[0094] Preferably, the gas flow manifold component is formed of a relatively stiff material compared to the face mount component.

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

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

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

[0098] Preferably, the outlet periphery of the manifold is adapted to sealably engage the interior of the base portion of the face mount component.

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

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

[0101] Preferably, the face mounting feature includes a pair of opposed side access passages leading to the interior of the base portion, each adapted to releasably receive an outlet of the manifold feature therethrough.

[0102] Preferably, the face mounting part includes a pair of nose prongs.

[0103] Preferably, the base portion of the face mounting part includes a recessed area between the nasal prongs so as to extend the base portion away from the user's nasal septum and further relieve pressure on the nasal septum during use.

[0104] In a sixth aspect, the invention may be broadly considered to relate to a patient interface including a nasal cannula according to any combination of the fourth or fifth aspects and any combination of one or more preferred or alternative features and / or embodiments of those aspects.

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

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

[0107] Preferably, the straps of the headgear are formed from an elastic material.

[0108] Preferably, the straps of the headgear are formed from a textile material.

[0109] In an eighth aspect, the present invention may be broadly considered to relate to a breathing assistance system comprising:

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

[0111] A headgear according to the seventh aspect for retaining a patient interface on a patient's face having any combination of preferred features thereunder.

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

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

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

[0115] Preferably, the breathing assistance system further comprises a retaining clip adapted to couple around the extension tube and to the head cap, thereby tying the tube to the head cap and relocating at least a portion of the tension on the extension tube from the patient interface to the head cap.

[0116] In a ninth aspect, the invention may be broadly considered to relate to 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] axially rotating the connector within the configuration to change the orientation of the connector, and

[0118] Pulling the connector away from the structure disengages the connector from the patient interface.

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

[0120] Preferably, the connector includes an elongated body and a lateral protrusion extending from the body, and the corresponding structure of the patient interface includes 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 includes rotating the connector to disengage the protrusion from the abutment surface, and the step of pulling the connector includes pulling the connector through the channel and out of the entry opening.

[0121] Preferably, the headgear includes connections at either end of the headgear and the patient interface includes corresponding formations 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 facial mounting part having a base portion and at least one nasal prong extending from the base portion and capable of fitting in at least one nostril of a user, 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 delivering 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 includes a groove at the outlet for providing a gap between the base portion of the face-mounting part and the manifold part in an area 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 part on the nasal septum of a user during use, and

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

[0127] a strap forming a portion of the headgear for helping to hold or stabilize the patient interface on the 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, includes a surface area for frictionally engaging with the user's face, the surface area having a relatively high friction surface material compared to the remainder of the strap forming the head cap or a part of the head cap.

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

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

[0131] The term "cheek" as used in this specification and claims means any area on the user's face at or adjacent to the cheekbone, and may include any area to the side and / or below the cheekbone and / or may include any other area between the user's respective eyes, ears, and the periphery of the nose.

[0132] The terms "upward," "across," and "rearward" are used in this specification in connection with an interface orientation (unless the context indicates otherwise) that is approximately vertical, horizontal, and front-to-back horizontal across or relative to the interface when worn by an upright user.

[0133] The term "comprising" as used in the specification and claims means "consisting at least in part of..." When interpreting each statement in the specification and claims including the term "comprising", features other than the one or those features beginning with the term may also be present. Related terms such as "comprise" and "comprises" are to be interpreted in the same manner.

[0134] It is intended herein that reference to a numerical range disclosed herein (e.g., 1 to 10) also incorporates reference to all rational numbers within that range (e.g., 1, 1.1, 2, 3, 3.9, 4, 5, 6, 6.5, 7, 8, 9, and 10) as well as any range of rational numbers within that range (e.g., 2 to 8, 1.5 to 5.5, and 3.1 to 4.7), and thus all subranges of all ranges explicitly disclosed herein are explicitly disclosed herein. These are only examples specifically contemplated, and all possible combinations of numerical values ​​between the lowest value and the highest value are considered to be expressly indicated in this application in a similar manner.

[0135] As used herein, the term and "and / or" means "and" or "or", or both.

[0136] As used herein, "(type)" following a noun refers to the plural and / or singular forms of that noun.

[0137] The present invention may also be broadly described as consisting of the parts, elements and features individually or collectively referred to or specified in the specification of the present application, as well as any or all combinations of any two or more of said parts, elements or features, and, when specific integers having known equivalents in the art to which the present invention relates are mentioned herein, such known equivalents are deemed to be incorporated herein as if individually listed.

[0138] The present invention lies in the foregoing, and also contemplates a variety of structures, only examples of which are given below. BRIEF DESCRIPTION OF THE DRAWINGS

[0139] Preferred embodiments of the invention are described, by way of example only, and with reference to the accompanying drawings, in which:

[0140] Figure 1 It is a schematic diagram of the overall respiratory assistance system;

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

[0142] Figure 2B yes Figure 2AA perspective view of a patient interface and a headgear in a disassembled state;

[0143] Figure 2C is available with a range of lacing extension options Figure 2A A perspective view of the head cap;

[0144] Figure 3A is a perspective view of a preferred form of patient interface and a second preferred form of headgear of the present invention in an assembled state;

[0145] Figure 3B yes Figure 3A A perspective view of a patient interface and a headgear in a disassembled state;

[0146] Figure 4A is a perspective view of a preferred form of patient interface and a third preferred form of headgear of the present invention in an assembled state;

[0147] Figure 4B yes Figure 4A A perspective view of a patient interface and a headgear in a disassembled state;

[0148] Figure 5 is a perspective view of a face mounting component of a preferred form of a patient interface of the present invention from the outside of the face mounting component;

[0149] Figure 6 is a perspective view of a gas flow manifold component of a preferred form of a patient interface of the present invention;

[0150] Figure 7 yes Figure 5 A perspective view of the face mounting part from the inside of the face mounting part;

[0151] Figure 8 yes Figure 5 A perspective view of the face mounting part from an underside of the face mounting part;

[0152] Fig. 9 is a close up perspective view of the connection between the patient interface and the headgear of the embodiment of FIGS. 3 and 4 and showing a preferred form of sleeve associated with the headgear;

[0153] Fig.10 yes Figure 5 A close up perspective view of the connection between the patient interface and the headgear of an embodiment and showing a sleeve of a preferred form of the headgear;

[0154] FIG. 11A to FIG. 11C A close up perspective view showing a retaining clip of a breathing assistance system of the present invention;

[0155] FIG. 12A to FIG. 12C showing a preferred form method for removing the connectors of the first and second preferred forms of headgear from the patient interface;

[0156] FIG. 13A to FIG. 13B Correspondingly, FIG. 12A to FIG. 12B A cross-sectional view of

[0157] FIG. 14A to FIG. 14C showing a preferred form method for removing the connector of the third preferred form headgear from the patient interface; and

[0158] FIG. 15A to FIG. 15B Correspondingly, FIG. 14A to FIG. 14B sectional view of . DETAILED DESCRIPTION

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

[0160] The preferred form of patient interface and / or headgear will be described with reference to an in-hospital respiratory care system to be used by adults and / or for use in pediatrics. It should be appreciated that the described patient interface and / or headgear embodiments may alternatively be used to deliver CPAP therapy.

[0161] It should also be understood that various aspects of the present invention can be applied to any form of patient interface, including (but not limited to) an indirect nasal mask (which covers the nose), a direct nasal mask (including a nozzle or pillow that enters or engages the wearer's nostrils), a mouth mask (which covers the mouth), or a full-face mask (which covers the nose and mouth), and a mouthpiece, but will be described with reference to a nasal cannula. Similarly, various aspects of the present invention can be applied to any form of headgear, but these aspects will be described with reference to a head strap.

[0162] Reference Figure 1, shows a ventilation and humidification system (respiratory system 10) as can be used with the present invention. In such a system 10, a patient 20 is supplied with a flow of humidified gas passing through a patient interface 100. The patient interface 100 is maintained in an operating position on the patient's face using an associated head cap 200. The interface 200 is connected to a humidified gas transport pathway or inspiratory duct 30. The inspiratory duct 30 is connected to the patient interface 100 at one end (directly or indirectly) and to the outlet of a humidifier 40 at the opposite end. In a preferred embodiment, the inspiratory duct is connected to the patient interface via an extension tube / duct 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 so as to humidify the gas path passing through the humidifier. A controller 52 may be provided to control and possibly change one or more characteristics of the supplied gas, including (but not limited to) the pressure profile of the gas, the flow rate profile of the gas at the patient interface, the temperature of the gas, and / or the humidity of the gas. It will be appreciated that the control capabilities depend 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 based on patient demand, but the pressure of the supplied gas is not necessarily monitored and controlled. In an alternative embodiment, such as use of the present invention in CPAP, the pressure profile of the supplied gas may be monitored and controlled.

[0163] The preferred embodiment of the present invention will now be described with respect to the patient interface 100 and the headgear 200. Other aspects of the breathing system 10 will not be described in detail to maintain 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 breathing system 10 without departing from the scope of the present invention.

[0164] Referring to Figures 2 to 11, preferred forms of headgear 200 and patient interface 100 are shown. These embodiments show a patient interface 100 configured to deliver respiratory gases from a gas supply and humidification source (not shown) to a patient, and a headgear 200 configured to support and maintain the patient interface on the patient's face during use. The patient interface 100 of the preferred embodiment is in the form of a nasal cannula 100, which is adapted to connect to an inspiratory conduit 300 and includes at least one (but preferably two) nasal prongs 111 and 112, which are configured to fit within the patient's nostrils so as to deliver the gas flow 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 item 300, is preferably a breathable tube. For example, it is advantageous that the gas supply tube is a strong and generally durable tube.

[0166] Nasal cannula

[0167] 2 to 4, the nasal cannula 100 provides a patient interface for the patient, which is suitable for delivering high airflow, high humidity gas flow to the patient's nasal cavity / nostril. In some configurations, the cannula is adapted to deliver high gas flow over a wide flow range (e.g., it may be preferably about 8 L / min, or may be higher, depending on other preferred therapeutic applications, 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-mounting part 110 including at least one (but preferably a pair) of tubular nasal prongs 111 and 112 that are integrally molded or removably attached to the face-mounting part 110, and a gas flow manifold part 120 that is removably attached or integrally molded to the conduit 300. As described in further detail below, the gas flow manifold part 120 is insertable into the face-mounting part from either of two relatively horizontal directions (i.e., from the left or from the right). In this way, the position or location of the gas flow manifold part 120 is reversible relative to the face-mounting part 110. In other words, the user can choose to have the manifold part 120 (and indeed the conduit 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 of the user the gas source or ventilator is located.

[0169] The face mount part 100 is formed of a soft, flexible material, such as silicone or other cannula materials known in the art. The nose prongs 111 and 112 are preferably flexible and can be formed of a sufficiently thin layer of silicone to achieve this property.

[0170] The gas flow manifold part 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 facial mounting part 110 provides a soft interface component to the patient for comfortably delivering gas flow through the nasal prongs 111 and 112, while the gas flow manifold part 120 fluidly couples the conduit 300 to the nasal prongs 111 and 112 of the facial mounting part 110.

[0171] Reference Figures 5 to 8 The nose prongs 111 and 112 are bent and extend into the patient's nostrils during use and provide a smooth flow path for gas to flow through. The inner surfaces of the prongs 111 and 112 can be contoured to reduce noise. The base of the prongs 111 and 112 can include multiple curved surfaces to provide a smoother gas flow. This can reduce the noise level during operation.

[0172] In some configurations, a cushion may be mounted around the base of the prongs to reduce noise. The cushion may be a foam or moldable material that generally conforms to the patient's nasal anatomy. Alternatively, a soft cushion or pillow may be provided.

[0173] The nose prongs 111 and 112 are substantially hollow and substantially tubular in shape.

[0174] The diameter of the nose prongs 111 and 112 may be uniform along their length, but are preferably shaped to match the contour of the nostrils. Each prong 111 / 112 has an elongated opening 111a / 112a at a distal end opposite the base portion 118 of the face mount part 110 to promote high gas flow into the cavity. In an alternative embodiment, the nose prongs 111 and 112 may have a tapered profile 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 may be hollowed out to direct the flow of gas upward to the patient's nostrils. The face mount portion 110, and specifically the nasal prongs 111 and 112, are preferably designed not to seal around the patient's nostrils to avoid excessive and potentially harmful buildup of pressure during high flow therapy. Therefore, the nasal prongs 111 and 112 are sized to maintain sufficient clearance between the outer surfaces of the prongs 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 so as to generally follow the contours of the patient's face around the upper lip area. In the area of ​​the face where the cannula is positioned, the facial mounting part 100 is molded or preformed so as to be able to conform to the contours of the user's face and / or is flexible so as to adapt, receive and / or correspond to the contours of the user's face.

[0177] The face mount part 110 includes an elongated base portion 118 from which the nose prongs 111 and 112 extend, and two wings 113 and 114 extending laterally from either side of the base portion 118. The two wings 113 and 114 are integrally formed with the base portion 118, but may alternatively be separate parts. The inner side 119 of the base portion 118 of the face mount part 110 is formed with an elongated oval recess 119a that is configured to couple with a corresponding outlet of the manifold 120. An arched bridge 118a extends from the center of the base portion 118 to the inner walls 113a / 114a of the wings so as to form two horizontal side access passages 121a and 121b for inserting the outlet 123 of the manifold 120 from either side 121a or 121b therethrough.

[0178] The gas flow manifold part 120 is generally tubular in shape, having a substantially annular inlet 122 at one end, and curving back into an elongated oval outlet 123 at the opposite end. The inlet 122 is preferably removably attached to the conduit 300, preferably by a threaded engagement, but alternatively by a snap fit or any other type of coupling known in the art. Alternatively, the inlet is fixedly coupled or integrally formed with the conduit 300. The outlet 123 is shaped to correspond to the elongated recess 119a of the face mount part 110 and fits therein by a friction fit or snap fit engagement, so that considerable force, or at least deliberate force applied by a user or caregiver, is required to separate the manifold 120 from the face mount part 110.

[0179] It is desirable to avoid accidental disengagement of the manifold from the face mounting 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 the inner groove around the periphery of the inner recess 119a to retain the outlet of the manifold 120 within the face mount part 110. When the parts 110 and 120 are coupled together, the upper surface of the lip 126 engages the inner surface 119b of the base portion 118 / surface 119b of the recess 119a to form an effective seal between the parts 110 and 120 for gas to flow therethrough. The nose prongs 111 and 112 are aligned with corresponding openings extending through the surface 119b of the base portion 118 to the recess 119a so that when coupled, the manifold outlet 123 is fluidly connected with the nose prongs 111 and 112. The bridge 118a also helps retain the manifold 120 within the base 118 of the face mount part 110 while defining entry passages 121a and 121b for the manifold 120. Corresponding dimples 128 are formed on the outer surface of the outlet 123 with opposing ridges 129a and 129b on either side to form a push-fit engagement mechanism between the outlet 123 of the face mount part 110 and the bridge 118a.

[0181] The outer surface of the face mount portion and / or wings 111 and 112 may include one or more channels to facilitate or allow air to flow between the lips and the cannula to cool the patient.

[0182] A plurality of adhesive pads may be provided on each wing 111 and 112 to facilitate coupling of the cannula 110 to a patient - particularly for younger children (eg, 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 part 110 and includes an outer surface 113b / 114b that is configured to contact the patient's face, preferably at least the upper lip area of ​​the patient's face and slightly beyond the corresponding cheek toward the user, during use. 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 to maintain the face mount portion 110 on the patient's face.

[0185] In a preferred embodiment, each wing 113 / 114 includes an integral ridge 115 / 116 extending laterally along the length of the wing 113 / 114 from the inner side of the facial mounting part 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 at the base portion 118 of the facial mounting part 110 and extends along the upper region of the corresponding wing 113 / 114. The ridges 115 / 116 serve to stabilize the facial mounting part 110 against the patient's face and minimize torsional stresses that would otherwise cause the nasal prongs 101 and 102 to flip out and away from the patient's nostrils. The dimensions of the ridges 115 / 116, including any combination of length, thickness, and width (ie, the extent to which the ridges extend away from the outer surface 113b / 114b) should be sufficient to improve stabilization of the face-mounting component 110 on the patient's face.

[0186] The ridges 115 / 116 may be overmolded or integrally formed with corresponding wings 113 / 114 of the face mount part 110 .

[0187] Raised wing

[0188] In a preferred embodiment, the distal end or terminal end 113c / 114c of each wing 113 / 114 is protruding or formed with a contact surface area that is substantially larger than the contact surface area of ​​the wing 113 / 114 in the area adjacent to the nasal prongs. This distal portion 113c / 114c is also preferably angled relative to the overall longitudinal axis of the face mounting part 110 or base 118. Specifically, the distal portion 113c / 114c extends away from the base 118, or away from the area of ​​the corresponding wing 113 / 114 adjacent to the base, at an obtuse angle in use and toward the corresponding cheek of the patient. In this way, connecting 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 has the effect of improving the retention of the nasal prongs 111 and 112 within the patient's nares and will cause the prongs 111 and 112 to pivot into the nostrils as the distal ends 113c and 114c of the wings 113 and 114 are pulled by the corresponding ends 201 and 202 of the headgear 200. Each distal portion 113c / 114c may be smoothly angled or rounded or it may be sharply or steeply angled relative to the remainder of the corresponding wing 113 / 114.

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

[0190] The increased surface area at the distal ends 113c and 114c provides increased real estate for forming a suitable connection mechanism for coupling the head strap 200. In a preferred embodiment, a plurality of clip retaining formations 101 and 102 are provided at each distal end 113c / 114c to releasably couple a plurality of clip components of the head strap 200 to the face mount 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 for an extended period of time. The present invention relieves or reduces this pressure by providing a cushioning area of ​​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 the outlet periphery that are used to form a recess or depression 127 in the area that is located adjacent to the nasal septum / columella in use. When coupled to the facial mounting portion 110, this depression 127 forms a gap between the base portion 118 and the outlet 123 of the manifold 120. In use, this gap cushions / softens the area of ​​the cannula 100 that is directly adjacent to the nasal septum / columella. This allows the pressure of the harder manifold part 120 to be disengaged from the nasal septum / columella and allows the nasal septum / columella to rest only on the soft base of the facial mounting portion 110.

[0193] The base portion 118 is preferably also formed with a hollow outer portion and / or a depressed outer profile 118b between the prongs 111 and 112 to relieve pressure at the nasal septum / columella. The hollowing should be as much as possible without (significantly) impairing the flow delivered to the patient. The depressed 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] Head strap

[0195] Now returning to reference Figures 2 to 4, in a preferred embodiment, the head cap for maintaining 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 cheeks, over the ears and around the back of the head during use.

[0196] The main ends 201 and 202 of the strap 200 are adapted to releasably connect corresponding formations 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 that can be received and retained in the corresponding structure 101 / 102 is provided at each end 201 / 202. The clip component can be connected to the strap at the corresponding main end according to one of the two preferred embodiments (described in further detail below). In addition, the length of the head strap 200 is adjustable to help customize the strap to the wearer's head. Three different head strap adjustment configurations are described below according to three preferred embodiments of the present invention. In each of these embodiments, the strap 200 is preferably formed of a soft and retractable / elastic material (such as an elastic, textile material / fabric that is comfortable for the wearer). Alternatively, the strap 200 can be formed of a substantially harder 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 Figure 1 ). An overhead strap or headpiece may have the benefit of pulling the strap 200 upward and over the patient's ears in use to improve fit and comfort.

[0199] First embodiment

[0200] In general, but also with reference to FIG. 2A to FIG. 2C In a first preferred embodiment of the adjustable lace 200, an adjustment mechanism is provided in the form of one or more insertable / removable lace segments or lace extensions 220.

[0201] A strap segment 220 having a fixed length can be releasably connected 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 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 starting length / size for the wearer. In order to extend the length of the strap 200 beyond this starting length, the main strap 210 can be disconnected at the secondary ends 203 / 204 and one or more additional strap segments 220 are connected therebetween.

[0202] For example, a plurality of lace segments 220 having varying predetermined lengths 220A to 220C may be provided to provide a plurality of alternative adjustment lengths. For example, one or more lace segments 220 having a length in the range of about 1 cm to about 10 cm, or in the range of about 2 cm to about 6 cm may be provided. These lace segments 220 have a length 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 lace segment may have any size, as this depends on the user and / or application.

[0203] In addition, each end 221 / 222 of each tie segment 220 is preferably connectable to a corresponding end 221 / 222 of another tie segment 220 and / or a corresponding secondary end 203 / 204 of the main tie 210, thereby enabling a user to combine one or more tie segments 220 of the same or varying lengths to customize the overall length of the extension as required / desired.

[0204] These additional strap segments are preferably formed of a soft and stretchable / elastic material (e.g., an elastic, textile material / fabric that is comfortable for the wearer). For example, a tubular knit type head strap or multiple segments of head strap 210 may be used over the user's ears, particularly for comfort.

[0205] It will be appreciated that particular comfort may be achieved by a head strap that is capable of providing proper positioning of the patient interface in a preferably 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, the further tether segments may be formed from a substantially rigid material, such as a hard plastics material.

[0207] A tether connector 230 is provided at each of the secondary end 203 / 204 of the primary tether 210 and the corresponding end 203 / 204 of the tether segment 220 .

[0208] Each connector 230 is provided with a lace connection mechanism at one end for connecting to a lace material and a connection mechanism at an opposite end for releasably connecting a corresponding end of a similar connector 230.

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

[0210] It should also be understood that the connector 230 can be positioned offset from the midpoint of the back of the user's head, or can be offset to one side of the user's head. This may be advantageous to avoid bumping into a portion of the user's head that may otherwise make the user uncomfortable in certain positions (such as sleeping).

[0211] In another embodiment, the strap segments may have different lengths to provide asymmetry or to help with operability with offset connector 230 positions. In addition, the two strap segments 210 may also be such that one of the straps is adjustable in length while the other is not. For example, one strap segment 210 may have a permanent length or be permanently connected to connector 230.

[0212] In a preferred embodiment, the lace connection mechanism may include a series of internal teeth positioned within the connector body for establishing a friction fit engagement with the opposite ends of the lace. An articulated clamp of the body is provided and closed on the teeth so that the end of the lace is firmly held on the teeth. The releasable coupling mechanism on the other end includes a pair of male and female members (such as corresponding protrusions and openings) that are adapted to be connected to corresponding male and female members of a similar connector 230. The support on the protrusion can connect the recess in the female member to provide a snap-fit ​​engagement between these members. It should be understood that in alternative embodiments, any other suitable connector configuration can be used to releasably connect the secondary ends of the lace to each other, as well as to releasably connect to the ends of other lace segments.

[0213] Also refer to Fig. 9 , cannula connectors 240 are provided at the primary ends 201 and 202 of the primary tether 210. These connectors 240 have similar tether connection mechanisms to the tether connectors 230 of the secondary ends 203 and 204, but include a clip member, such as a push-fit clip 241, at the end of the connector 240 opposite the tether end. The clip 241 is configured to releasably couple a corresponding structure 101 / 102 on one side of the cannula 110. The clip member 241 is preferably a bendable part, such as a plastic part, which forms a hinged portion relative to the tether. For example, the clip 241 is preferably preformed to have a curved shape along its length, such as a curved shape having an angle between flat and 20 degrees. This bend allows the clip 241 to fit the contour of the patient's face in the area of ​​the clip 241.

[0214] Reference Fig. 12A -C and Fig.13A-B, the method of 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 clamp member 241 having an elongated connector body 242 and a lateral projection 243 at the terminal end of the body 242. The lateral projection 243 includes an inwardly facing engagement surface 243a. The face 244 of the connector 240 opposite the face 245 from which the projection 243 extends is preferably substantially smooth or flat. The corresponding configuration 101 / 102 of the cannula 110 includes a channel 101a / 102a having an entry opening 101b / 102b and an exit opening 101c / 102c at either end of the channel 101a / 102a. The peripheral wall of the exit opening 101c / 102c defines an abutment 101ci / 102ci configured to engage with a surface 243a of the projection 243 of the clamp member 241. The periphery 101bi / 102bi of the entry opening 101b / 102b defines an abutment for engaging a flange 246 at the opposite end of the body 242 to the projection 243. This serves to limit the extent of insertion of the connector 240 into the respective channel 101a / 102a. The flange 246 may be provided by a terminal end and / or sleeve 270 of the lace connection mechanism.

[0215] like Fig. 12A and Fig.13A As shown in , to couple the connector 240 with the cannula 110, the user inserts the elongated body 242 through the entry opening 101b / 102b of the corresponding channel 101a / 102a, with the protruding end 243 advanced until the protrusion 243 protrudes through the exit opening 101c / 102c and engages the corresponding abutment 101ci / 102ci and when the flange 246 engages the surface 101bi / 102bi. In order to achieve the engagement of the lateral protrusion 243 with the corresponding abutment 101ci / 102ci, the user must orient the connector 240 so that the protrusion 243 is aligned with the abutment 101ci / 102ci.

[0216] In a preferred embodiment, the abutment 101ci / 102ci is located at the upper peripheral wall of the exit opening 101c / 102c, but in alternative embodiments, the abutment 101ci / 102ci may be located at any other portion of the peripheral wall of the opening 101c / 102c. For a preferred embodiment, in order to engage the surface 243a of the projection 243 with the abutment 101ci / 102ci, the user may align the projection 243 with the upper peripheral wall of the exit opening 101c / 102c. This may be done before or after inserting the elongated body 242 through the channel 101a / 102a. In other words, the user may insert the connector 240 having the protrusion 243 in a direction facing the adjacent piece 102ci / 102ci so that the surface 243a is immediately engaged with the adjacent piece 102ci / 102ci when the protrusion 243 exits the channel 101a / 102a through the opening 101c / 102c. Alternatively, the user may insert the connector 240 having the protrusion 243 in a direction that is not aligned with the adjacent piece 101ci / 102ci (e.g., away from the adjacent piece 101ci / 102ci or 180 degrees different from the direction of the adjacent piece 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 is aligned with and engaged with the adjacent piece 101ci / 102ci.

[0217] The engagement between the projection 243 and the abutment 101ci / 102ci resists pulling forces on the connector 240 that could cause the connector to accidentally disconnect from the cannula 110. Thus, both the connector 240 and the corresponding structure 101 / 102 are configured to provide a certain level of resistance against the forces used to pull the connector 240 back through the channel 101a / 102a. This resistance can prevent accidental removal and also make intentional disconnection of the connector 240 substantially difficult or cumbersome.

[0218] Now refer to Fig. 12B , Fig. 12C and Fig. 13B To avoid requiring additional pulling force, a preferred form of method for removing the connector 240 from the cannula 110 includes rotating the connector 240 about its longitudinal axis within the channel 101a / 102a to disengage the protrusion 243 from the adjacent member 101ci / 102ci ( Fig. 12B and Fig. 13B ), and then pull the connector 240 out of the channel 101a / 102a by entering the opening 101b / 102b ( Fig. 12C). In a preferred embodiment, the projection 243 is axially rotated about 180 degrees away from the adjacent member 101ci / 102ci so that the projection is aligned with the base or opening of the channel 101a / 102a, and so that the flat surface 244 is aligned with the adjacent member 101ci / 102ci and with the upper guide wall of the channel 101a / 102a. In an alternative embodiment, the connector 240 can be axially rotated another angle that is sufficient to disengage the projection 243 from the adjacent member 101ci / 102ci so as to reduce the resistance to the removal of the connector 240 from the channel 101a / 102a.

[0219] In a preferred embodiment, the formations 101 and 102 are resiliently flexible and preferably integral with the resiliently flexible cannula 110 relative to the substantially more rigid connector 240. Thus, during insertion or removal, when the connector 240 is axially rotated about its longitudinal axis, the channels 101a / 102a of the formations 101 / 102 are resiliently deformed to enable the rotation.

[0220] Second embodiment

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

[0222] In this embodiment, the cannula connectors 240 at the main ends 201 and 202 have the same configuration as the cannula connectors 240 described for the first embodiment. The same methods of inserting and / or removing the connectors 240 into and / or from the cannula 110 as described above for the first head cap embodiment apply 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 comprising 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 operated on either side by the wearer to adjust the effective length of the strap 210 in use. The side adjustment buckles 251 and 252 are positioned at or adjacent the cheeks of the wearer, between the ends 201 and 202 of the head strap 200 and the patient interface 100, in use.

[0225] Also refer to Fig.10 , in this embodiment, the side buckles 251 and 252 are integrally formed with the cannula connector 260. The connector 260 includes an elongated clip member, such as a push-fit clip 261, which is configured to releasably couple the corresponding structure 101 / 102 on the cannula 110 side at one end; and a tether buckle 251 / 252 at the opposite end. The clip 261 is elongated so as to extend from the upper lip area of ​​the patient to the patient's cheek or at least substantially toward the patient's cheek in use. The clip member 261 is preferably a bendable part, such as a plastic part, which forms an articulated portion relative to the tether. For example, the clip 261 is preferably preformed to have a curved shape along its length, such as a curved shape having an angle between flat and 20 degrees. When the patient interface 100 and the head strap 200 are properly worn by the patient, the curvature allows the clip 261 to fit the contour of the patient's face or cheek.

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

[0227] The same method of inserting the connector 260 into the cannula 110 and / or removing the connector 260 from the cannula 110 as described above for the first head cap embodiment is applicable to Fig.14A -C and Fig.15A - This connection 260 / embodiment shown in B.

[0228] It will be appreciated that for any of the above head strap embodiments, any other suitable connector configuration may 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, Fig. 9 and Fig.10 In a preferred embodiment, each segment on either side of the head strap 200 and adjacent the corresponding major end 201 / 202 includes or has applied thereto a cheek support 270 including at least a surface area 271 for frictionally engaging with the user's face so as to stabilize the headgear 200 on the face at the cheek (e.g., at or below the cheekbone or region thereof) during coupling of the headgear to the patient interface 100 and thereafter in use. The surface area 270 preferably has a relatively higher friction surface material than the remainder of the strap 200.

[0231] The high friction surface material 271 is adapted to extend over a portion of the side of the patient's face in use, preferably at or at least substantially towards the patient's cheek, so as to help maintain or stabilize the patient interface 100 on the patient's face. The high friction surface material positionable on the user's cheek further helps to keep the remainder of the head strap 200 separated from the user's eyes or eye sockets and preferably extends to below the user's eyes or eye sockets to prevent visual obstruction and / or discomfort caused by the head strap 200 bridging over or near the eyes or eye sockets.

[0232] It will be appreciated that the high friction surface material 271 may be adapted to extend over a portion of the side of the patient's face during use, for example, extending backwards and upwards from at or near or above the left and right outer upper lips across the left and right cheeks.

[0233] In a preferred form, the friction surface material is provided in the form of an elongated sleeve 270 configured to receive the corresponding major end 201 / 202 of the lace 200. The sleeve 270 is configured to be removably coupled (or alternatively permanently coupled) around the lace 200, a section of the lace 200, and / or the cannula connector 240 / 260 at the major end of the lace.

[0234] Refer to Figures 2, 3 and Fig. 9According to the first two preferred embodiments described above, the sleeve 270 is connected around the strap 210 at the main end 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 be spiraled through this channel and, when in the sleeve configuration, preferably remains free to stretch or elasticize or extend. 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 head cap 200. The clip 241 extends from the end 273 of the sleeve 270. In another embodiment, the sleeve 270 can be overmolded on the connector 240 and / or the strap 210.

[0235] Refer to Figure 4 and Fig.10 According to a third preferred embodiment, a sleeve 270 is coupled at the major end 201 / 202 around a connector 260 extending from the strap 210. In this embodiment, the connector 260 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 headgear 200. In other words, the connector 260 extends fully through the channel 272 of the sleeve 270. The buckle 251 / 252 extends from an end 274 of the sleeve 270 and the clip 261 extends from an opposite end 273.

[0236] The sleeve 270 may be preformed to have a curved shape along its length, such as one having an angle between flat and 20 degrees. The curve allows the sleeve to fit the contour of the patient's face or cheek in the sleeve area in use. Alternatively, the sleeve 270 may take the shape of a curved sleeve when engaged with the main end 201 / 202 or connector 260 of the head strap 200.

[0237] Sleeve 270 provides a surface area with a relatively high friction surface material for frictionally engaging with the user's face or facial skin. This surface area will be positioned for frictional engagement with the user's facial cheek skin. The surface area is at least localized to the strap or the segment of the strap that will be positioned on the user's cheek. The surface area provided 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 relatively softer material than connectors 240 and 260.

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

[0239] The surface area 271 can be a surface having a wider surface area closer to the patient interface than a surface area further away from the patient interface. In a preferred embodiment, the sleeve 270 tapers from a relatively wider surface area 273 to a relatively smaller surface area 274 in a direction extending away from the connection point between the connector 240 / 260 and the patient interface 100. The width of the sleeve at the end 273 is preferably the same or similar to the width of the tapered distal end 113c / 114c of the corresponding wing 113 / 114 of the facial mounting part 110. This provides a smooth transition between the patient interface 100 and the headgear 200 for improved aesthetics and a visually appealing effect.

[0240] In addition to nasal cannulas, headgear for other forms of interfaces may also include multiple cheek supports 270 as described or similar at or adjacent to either side of the headgear strap of the interface, connected to the mask for frictionally engaging with the user's face to stabilize the mask on the face at the cheeks, and specifically (for example) guide multiple nasal masks including nozzles or pillows that enter or engage the wearer's nostrils. Such headgear may in turn include a single head strap adapted to extend along the patient's cheeks, over the ears and around the back of the head in use, with the ends including multiple clips in any suitable form that are connected to the mask on either side 9 or are permanently attached to the mask.

[0241] Retaining clip

[0242] Reference FIG. 11A to FIG. 11C In a preferred embodiment, a retaining clip 280 is provided that includes a tubular body 281 for receiving and accommodating a portion of the catheter 300 therein. A hook 282 protrudes from the body 281 to connect to a strap or other component of the headgear 200. In this way, the catheter 300 can be connected or tied to the head strap 210 or headgear 200 during use. If the catheter 300 is pulled, then the force will be applied to the head strap 210 and will not be applied directly to the cannula 100. This relocation of force will reduce the possibility of the prongs 111 and 112 of the cannula 100 protruding out of the patient's nostrils.

[0243] One or more tie points for connecting the clip 280 may be available on the head cap 200, with at least two symmetrical tie points preferably being on either side of the head cap to improve usability.

[0244] It should also be appreciated that the retaining clip may be removable from the gas supply tube shown as item 300 or may be a permanent fit on the gas supply tube.

[0245] The retaining clip 280 may be connected or retained to a portion of the patient interface, such as, for example, a portion of the interface that provides a relatively stiffer area (eg, to facilitate support of the gas supply tube article 300).

[0246] The retaining clips may also be positioned or attached at specific locations on the gas supply tube article 300, for example, predetermined positions may be provided to hold the retaining clips in place.

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

[0248] Other preferred features

[0249] 1. The cannula can have an overall low resistance to flow. In some configurations, the cannula can include multiple tapered prongs. These tapered prongs can close off the nostrils for improved PEEP. The tapered nasal prongs will allow for smaller size options because a single design can be used for patients of different sizes and can fit within the user's nostrils with a vertical position. For example, for a patient with larger nostrils, the nasal prongs can be inserted deeper in the nostrils. In some configurations, the nasal prongs can direct the exhaled air flow away from the patient to reduce heat.

[0250] 2. The raised V-shape can help tilt the prongs into the nose when the wings are pulled apart. In other words, the V-shaped cheek pads and the stretching of the straps can pull the nose prongs toward the patient and into the nostrils. The angles shown in the cheek pads can create a structure that will improve this aspect.

[0251] 3. A dual fastening method may be used so that the cannula may be generally held in place by a tie, or multiple adhesive pads (swing pads), or a combination of the two. The head tie may be adjustable from the back of the head, as opposed to most interface assemblies where adjustability is desired to be in the front to facilitate adjustment without reaching the back of the patient's head. These adhesive pads may be positioned on the wings of the cannula. It is envisioned that younger children (e.g., less than 5 years old) will use the adhesive pads as well as the tie, while older children will use only the tie.

[0252] 4. Large pads can fit on the cheeks to reduce or eliminate indentations on the cheeks. These pads can help stabilize the cannula on the face. Stabilization can reduce the likelihood or severity of roll-out (e.g., twisting of the cannula). In some configurations, the cannula can include an overmolding or structural member that hardens the base of the cannula while reducing the likelihood or severity of roll-out. In some configurations, the cannula can include a stable ridge. In some such configurations, the stable ridge can be positioned on the top of the cannula. In some such configurations, the stable ridge on the top of the cannula can reduce or eliminate the likelihood of the prongs tipping over and out of the nose. These pads can have a soft surface on the underside (i.e., the side adjacent to the face).

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

[0254] 6. The surface around the base of the fork can be contoured to reduce noise. In some configurations, the base of the fork can include multiple curved surfaces for providing smoother airflow. The illustrated configuration (which is shown by multiple figures drawn to scale) can provide reduced noise levels due to smoother airflow.

[0255] 7. The user-facing surface of the cannula may include a plurality of channels. These channels behind the cannula may facilitate or allow air to flow between the lip and the cannula to cool the patient.

[0256] Further preferred combinations of features are now also defined according to the following numbered paragraphs:

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

[0258] a strap having a pair of main ends, each of which is connected to the patient interface or to a component to be connected to the patient interface, and

[0259] intermediate each of the major ends is a pair of secondary ends releasably connected to one another to establish a continuous tie between the major ends of a starting length for helping to retain the patient interface on the patient, and

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

[0261] 2A. The tether of claim 1A wherein each end of an additional tether segment includes a connector coupled to the tether segment and each secondary end of the tether includes a connector coupled to the tether.

[0262] 3A. The tether of claim 2A, wherein the connector of each tether segment is configured to couple to the connector of a corresponding secondary end of the tether.

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

[0264] 5A. A lace as described in any one of claims 2A to 4A, wherein the connector at each end of the additional lace segment or the connector at each secondary end of the lace, or both, has or includes: a male part or a female part, or both, for being received by and connected to a complementary male part or female part of another corresponding connector; and a friction fit part for maintaining the connection between the corresponding connectors.

[0265] 6A. A tie as described in claim 5A, wherein the connecting member includes a protruding male part for being received by a recessed female part of a corresponding connecting member and a recessed female part for receiving the protruding male part of the corresponding connecting member.

[0266] 7A. A tie as described in any one of claims 5A or claim 6A, wherein the connector is capable of receiving and retaining a corresponding terminal end of an associated tie or an associated additional tie segment.

[0267] 8A. A tie as described in claim 7A, wherein the connector is configured to retain the corresponding terminal ends through a friction fit engagement.

[0268] 9A. A lace as described in claim 8A, wherein the connector includes a series of internal teeth positioned on the body of the connector for establishing a friction fit engagement with corresponding terminals; and a clamp of the body of the connector configured to close on the teeth so as to securely retain the terminal of the associated lace or associated additional lace segment on the teeth.

[0269] 10A. A tie as described in any of the above claims, wherein the tie is of an elastic, textile material.

[0270] 11A. A tie as described in any of the above claims, wherein the additional tie segments are of elastic, textile material.

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

[0272] 13A. The tie of any of the above claims, wherein the additional tie segments have 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] a strap forming a portion of the headgear for helping to hold or stabilize the patient interface on the user,

[0275] 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, includes a surface area for frictionally engaging with the user's face, the surface area having a relatively high friction surface material compared to the remainder of the strap forming the head cap or a part of the head cap.

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

[0277] 3B. A head cap as claimed in any one of claims 1B or claim 2B, wherein the remainder of the strap is arranged to extend as a non-face contacting strap or strap segment that will extend beyond the user's face or a portion of the user's face.

[0278] 4B. A head cap as described in any one of claims 1B or claim 3B, wherein each surface area for frictionally engaging with a user's face or a portion of a user's face includes a relatively high friction surface material that helps to maintain or stabilize the patient interface on the user's face.

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

[0280] 6B. A headgear as described in claim 5B, wherein the applied material is in the form of a sleeve positioned around the strap or a corresponding section of the strap.

[0281] 7B. A headgear as described in claim 6B, wherein the sleeve is configured to be removably coupled around a strap or strap segment.

[0282] 8B. A headgear as described in claim 7B, wherein the strap or a corresponding section of the strap extends through a channel in the sleeve.

[0283] 9B. A headgear as described in claim 8B, wherein the strap or a corresponding section of the strap is adapted to be spirally passed through the channel.

[0284] 10B. A headgear as described in claim 5B, wherein the applied material is in the form of a material coated on the straps or corresponding sections of the straps.

[0285] 11B. A headgear as described in claim 5B, wherein the applied material is overmolded onto the strap or corresponding section of the strap.

[0286] 12B. The headgear of any one of Claims 4B to 11B, wherein the applied material is smooth and comfortable for skin contact.

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

[0288] 14B. A headgear as described in any of claims 1B to claim 13B, wherein 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 located farther away from the patient interface.

[0289] 15B. A headgear as described in claim 14B, wherein each surface area tapers from a relatively wider surface area to a relatively smaller surface area.

[0290] 16B. The headgear of any one of claims 1B to 15B, wherein the strap or each segment of the strap that includes the surface area further includes a portion of the strap that is configured to releasably couple to a patient interface.

[0291] 17B. A headgear as described in any one of claims 1B to claim 16B, wherein each portion of the user's face includes the user's cheeks.

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

[0293] a strap forming a portion of the headgear for helping to hold or stabilize the patient interface on the user,

[0294] a first connector at a first end of the strap for connecting the strap to a patient interface, and

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

[0296] 2C. A head cap as described in claim 1C, further comprising 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, the second cheek engaging member being 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 of the connector with the user's skin during use.

[0297] 3C. A head cap as described in any one of claims 1C or claim 2C, wherein each cheek engaging member is configured to be removably connected around a corresponding connecting member.

[0298] 4C. A head cap as described in any one of claims 1C to claim 3C, wherein a surface area of ​​each cheek engaging member comprises a material that is substantially softer than the material of the corresponding connecting member.

[0299] 5C. A head cap as described in any one of claims 1C to claim 4C, wherein a surface area of ​​each cheek engagement member includes a relatively high friction surface material compared to the corresponding connecting member to help maintain or stabilize the patient interface on the user's face.

[0300] 6C. A headgear as described in any one of claim 4C or claim 5C, wherein the material is a thermoplastic elastomer.

[0301] 7C. In a head cap as described in any one of claims 1C to claim 6C, a surface area of ​​each cheek engaging member is a surface having a wider surface area at the end of the corresponding cheek engaging member closer to the patient interface than the surface area of ​​the relative end of the cheek member farther from the patient interface.

[0302] 8C. A head cap as described in claim 8C, wherein the surface area of ​​each cheek engaging member tapers from a relatively wider end to a relatively smaller end.

[0303] 9C. A head cap as described in any one of claims 1C to claim 8C, wherein each cheek engaging member is a sleeve configured to receivably retain a corresponding connecting member therein.

[0304] 10C. The headgear of claim 9C, wherein the sleeve is configured to be removably coupled around a corresponding connector.

[0305] 11C. The headgear of either claim 9C or claim 10C, wherein the connector is adapted to extend through a passage in the sleeve.

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

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

[0308] 14C. The headgear of 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 a corresponding cheek.

[0309] 15C. A head cap as described in claim 14C, wherein the connector is pre-formed in a curved shape.

[0310] 16C. The head cap of any one of claims 13C to 15C, wherein each sleeve is preformed in a curved configuration.

[0311] 17C. The headgear of any one of claims 13C to 15C, wherein each sleeve is curved when enclosing a corresponding connector.

[0312] 18C. A headgear as described in any one of claims 1C to claim 17C, wherein the connector includes a clip for releasably connecting to the patient interface.

[0313] 19C. A head cap as described in any one of claims 1C to claim 18C, wherein once in place, each connector is frictionally or mechanically engaged with a corresponding cheek engaging 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 nasal prong extending laterally from the base portion and adapted to fit within at least one nostril of a user, and

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

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

[0319] 3D. A nasal cannula as described in any one of claims 1D or claim 2D, wherein the facial mounting part includes a pair of nasal prongs for fitting in each nostril of the user.

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

[0321] 5D. A nasal cannula as claimed in any one of claims 1D to claim 4D, wherein each wing includes a protruding terminal end which, in use, extends substantially in the direction of a corresponding cheek of a user.

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

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

[0324] 8D. The nasal cannula of claim 7D, wherein the terminal end of each wing tapers outwardly.

[0325] 9D. The nasal cannula of any one of claims 1D to 8D, wherein the distal end of each wing includes a structure configured to releasably couple to a complementary connector of a head cap associated with the nasal cannula.

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

[0327] 11D. The nasal cannula as described in claim 10D further includes a gas flow manifold part, which has 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 nasal prong of the facial mounting part, and the manifold part is adapted to be received by the base portion through the inlet on either side of the facial mounting part so as to fluidly connect the outlet of the manifold with the nasal prong of the facial mounting part.

[0328] 12D. A nasal cannula as described in claim 11D, wherein the facial mounting part further includes a recess formed in the interior of the base portion, and the gas flow manifold part includes a corresponding lip at the outlet, which is adapted to releasably engage the recess to fluidly connect the outlet with the nasal prong head of the facial mounting part.

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

[0330] a facial mounting part having a base portion and at least one nasal prong extending from the base portion and capable of fitting in at least one nostril of a user, and

[0331] A gas flow manifold part, the gas flow manifold part having a gas inlet for receiving a gas flow from a gas source, and a gas outlet for conveying the gas flow to the at least one nasal prong of the facial mounting part, the manifold part being adapted to be received by the base portion of the facial mounting part so as to fluidly connect the outlet of the manifold with the at least one nasal prong of the facial mounting part, and wherein the manifold part further includes a groove at the outlet, the groove being used to provide a gap between the base portion of the facial mounting part and the manifold part in an area 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 part 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 relatively stiff material compared to the face mount component.

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

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

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

[0336] 6E. The nasal cannula of claim 5E, wherein the outlet periphery of the manifold is adapted to sealably engage the interior of the base portion of the face mount 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 adapted to releasably receive the lip of 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 the outlet of the manifold component therethrough.

[0339] 9E. The nasal cannula of claim 8E, wherein the facial mounting component includes a pair of opposing side access passages leading to the interior of the base portion, each adapted to releasably receive an outlet of the manifold component therethrough.

[0340] 10E. The nasal cannula of any one of claims 1E to 9E, wherein the face mounting part comprises a pair of nasal prongs.

[0341] 11E. The nasal cannula of claim 10E, wherein the base portion of the face mounting part includes a recessed area between the nasal prongs so as to extend the base portion 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 head cap 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 of claim 2F, further comprising a headband adapted to extend over the top of the user's head.

[0345] 4F. A head cap as described in any one of claim 1F or claim 2F, wherein the straps of the head cap are formed of an elastic material.

[0346] 5F. A head cap as described in any one of claims 2F to claim 4F, wherein the straps of the head cap are formed of a textile material.

[0347] 6F. A breathing assistance system comprising:

[0348] A patient interface for delivering a flow of humidified gas to a patient as claimed in claim 1F, and

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

[0350] 7F. A breathing assistance system as described in claim 6F, further comprising a ventilator adapted to generate a gas flow, and a humidifier connected to the outlet of the ventilator for humidifying the gas flow.

[0351] 8F. A breathing assistance system as described in claim 7F, further comprising an inspiratory conduit adapted to be connected between the humidifier and the patient interface.

[0352] 9F. A breathing assistance system as described in claim 8F, further comprising an extension tube adapted to be connected between the inspiratory conduit and the patient interface.

[0353] 10F. A breathing assistance system as described in claim 9F, further comprising a retaining clamp adapted to be coupled around the extension tube and to the head cap, thereby connecting the tube to the head cap and repositioning at least a portion of the tension on the extension tube from the patient interface to the head cap.

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

[0355] axially rotating the connector within the configuration to change the orientation of the connector, and

[0356] Pulling the connector away from the structure disengages the connector from the patient interface.

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

[0358] 3G. A method as described in any one of claims 1G or claim 2G, wherein the connector includes a slender body and a lateral protrusion extending from the body, and the corresponding structure of the patient interface includes 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 includes rotating the connector to disengage the protrusion from the abutment surface, and the step of pulling the connector includes pulling the connector through the channel and out of the entry opening.

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

[0360] The above description of the invention includes 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 nasal cannula, comprising: a face mounting member having a base portion and at least one elongated wing extending laterally from a side of the base portion; a pair of nasal prongs extending laterally from the base portion and adapted to fit in each nostril of a user, wherein the pair of nasal prongs are non-sealing prongs sized to maintain a sufficient gap between an outer surface of each nasal prong and the skin of the user to avoid sealing a gas path between the nasal cannula and the user, such that in use no seal is formed between the nasal prongs and the nostrils of the user; Each wing includes: a terminal end extending in a direction toward a corresponding cheek of the user during use and formed with a contact surface area larger than the contact surface area of ​​the wing in an area adjacent to the nose prong; an outer surface adapted to contact a portion of the user's face during use; and an elongated ridge extending laterally along the wing from a side of the wing opposite to the outer surface so as to help stabilize the facial mounting part on the user's face during use, the elongated ridge of each wing extending from a base portion of the facial mounting part and extending along an upper area of ​​the wing.

2. The nasal cannula of claim 1, wherein: The face mounting feature includes a pair of wings extending laterally from either side of the base portion.

3. The nasal cannula according to claim 1 or 2, wherein: The terminal end of each wing is at an obtuse angle relative to the longitudinal orientation of the base portion.

4. The nasal cannula of claim 3, wherein: The terminal end of each wing increases in size longitudinally toward the end of the terminal end of each wing.

5. The nasal cannula of claim 1, wherein: The distal end of each wing includes a structure configured to releasably couple with a complementary connector of a headgear for retaining the nasal cannula on the user's face.

6. The nasal cannula of claim 5, wherein: Each connector includes a lateral projection at a distal end of the elongated body configured to engage a corresponding said formation by a push-fit type arrangement.

7. The nasal cannula of claim 6, wherein: The structure includes a channel having an entry opening and an exit opening, and an adjacent surface at the exit opening, the connector includes a slender body, the slender body is configured to be received and retained in the channel, and the lateral protrusion is configured to engage the adjacent surface at the channel exit opening to retain the connector in the channel.

8. The nasal cannula of claim 7, wherein: The channel is resiliently deformable for receiving the connector and for allowing the connector to be axially rotated approximately 180° to enable easy removal of the connector from the channel.

9. The nasal cannula of claim 8, wherein: When the connector is rotated approximately 180° within the channel, the lateral projections of the connector become disengaged from the abutment surface at the exit opening of the channel.

10. The nasal cannula of claim 1, wherein: The nasal cannula also includes a bridge extending from the base portion to the lower region of the wing and forming side inlets on either side of the bridge.

11. The nasal cannula of claim 1, wherein: The nasal cannula also includes a gas flow manifold part, which has a gas inlet for receiving a gas flow from a gas source and a gas outlet for conveying the gas flow to a nasal prong of the facial mounting part, and the gas flow manifold part is adapted to be received by the base part through at least one substantially horizontal side inlet of the facial mounting part so as to fluidly connect the outlet of the manifold with the nasal prong of the facial mounting part.

12. The nasal cannula of claim 11, wherein: The face mounting part also includes a recess formed in the interior of the base portion, and the gas flow manifold part includes a corresponding lip at the gas outlet, which is adapted to releasably engage the recess to fluidly connect the gas outlet with the nose prong of the face mounting part.

13. The nasal cannula of claim 11, wherein: The face mount component is formed of a softer, flexible material relative to the gas flow manifold component.

14. A breathing assistance system comprising: A nasal cannula according to any preceding claim, for delivering a humidified gas flow to a user; and Head cap used to hold the nasal cannula on the patient's face.

15. A breathing assistance system according to claim 14, further comprising a gas supply adapted to generate a gas flow and a humidifier coupled to an outlet of the gas supply for humidifying the gas flow.

16. A breathing assistance system according to claim 15, further comprising an inspiratory conduit adapted to be coupled between the humidifier and the nasal cannula.

17. The breathing assistance system of claim 15, further comprising an extension tube adapted to be coupled between the inspiratory conduit and the nasal cannula.

18. A breathing assistance system according to claim 17, further comprising a retaining clip adapted to couple around the extension tube and to the head cap, thereby fastening the extension tube to the head cap and relocating at least a portion of the tension on the extension tube from the nasal cannula to the head cap.

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