NASAL CANNULA ASSEMBLIES AND RELATED PARTS

FIELD OF THE INVENTION

[0001] The present disclosure relates to devices and systems for providing gases to patients for respiratory therapy. More specifically, the present disclosure relates to nasal cannula interfaces for providing gases to patients via the nasal passages.

BACKGROUND OF THE INVENTION

[0002] Medical professionals may wish to provide patients with respiratory assistance in the form of supplemental oxygen or airflow for many reasons in ICU (intensive care unit), other hospital, or home environments. Different types of interfaces for supplying gases to patients are available. For example, various nasal masks, full face masks, oral interfaces, nasal pillows, and nasal cannula interfaces exist. Nasal cannula interfaces typically include two nasal prongs that are placed in the patient's nostrils to deliver gases to the patient.

[0003] Nasal cannula assemblies generally consist of entry tubing, either symmetric or single sided that lies across the upper lip. Protruding from this tubing are open ended prongs which extend into the nares of the patient to deliver oxygen. Nasal cannula have the advantage of being more comfortable and acceptable than a face mask to most patients. A single flow entry nasal cannula has the advantage of being unobtrusive, and may be more relevant to delivering humidity than a dual flow entry style of nasal cannula, due to the advantage of flow rates and surface area for heat loss. A single flow entry however is provided at one side of the cannula, the left or the right side. If the tube is on the left side for example, the user has difficulty in use if the flow source is on the opposite or right side of the user requiring longer lengths of tubing and causing the tube to cross the body.

[0004] When providing humidified gases to a patient it is common to use a heated breathing circuit (tubing). This circuit is heavy and can drag and pull on the patient interface. It is common to use a short flexible tube between the heated circuit and patient interface to reduce any torque or twisting. In order to stop the weight pulling on the patient interface, circuit hangers are occasionally used. This is a large extendable metal arm to take the weight. It also has been known in the art to clip part of the tubing to the patient's clothes or bedclothes. Both of these solutions have been found to be quite unsuitable for mobile patients especially when sleeping and turning in bed.

[0005] With patient interfaces such as nasal cannula the stability of the nasal prongs on the face is very important, as movement of the prongs within the nares can cause severe irritation. Current methods employed to retain a single entry nasal cannula on the face use a simple elastic band of material around the back of the patients head. This is prone to rotating the nasal cannula relative to the patient's head especially when

turning ones head on a pillow. This rotation causes the prongs move within the nares, irritating this sensitive area.

[0006] In this specification where reference has been made to patent specifications, other external documents, or other sources of information, this is generally for the purpose of providing a context for discussing the features of the invention . Unless specifically stated otherwise, reference to such external documents is not to be construed as an admission that such documents, or such sources of information, in any jurisdiction, are prior art, or form part of the common general knowledge in the art.

[0007] It is an object of the present invention to provide an improved nasal cannula assembly or patient interface headgear, or to at least provide the public with a useful choice.

SUMMARY OF THE INVENTION

[0008] The nasal cannula interfaces described herein can advantageously be used to deliver gases to patients over a wide range of concentrations and flow rates. The nasal cannula interfaces described herein also include various features designed to improve patient comfort, safety, ease of use, and/or efficiency, reduce costs, and/or provide other benefits.

[0009] In some embodiments, a nasal cannula system includes a cannula and a manifold. The cannula includes a central body portion, first and second side portions that extend in opposite lateral directions from the central body portion and contact a cheek of a user when the system is in use, and first and second nasal prongs extending from the central body portion . The central body portion includes a patient facing side and at least one retention strap that cooperate to define a cavity. The first and second nasal prongs communicate with the cavity. The manifold receives a supply of gas from a gas source and includes a gas inlet and a gas outlet. The manifold is receivable within the cavity of the cannula such that the gas outlet is aligned with the first and second nasal prongs. The at least one retention strap defines first and second lateral edges, and the first and second nasal prongs are located between the first and second lateral edges.

[0010] In some embodiments, a nasal cannula system includes a cannula and a supply tube. The cannula includes a central body portion, first and second side portions that extend in opposite lateral directions from the central body portion and contact a cheek of a user when the system is in use, and first and second nasal prongs extending from the central body portion . The cannula defines a cavity having an inlet at a first end and a second end communicating with first and second gas paths. The first and second gas paths communicate with the first and second nasal prongs, respectively. The inlet is located at one of the first and second side portions, and the first and second gas paths extend in a lateral direction toward the first and second nasal prongs. The supply tube has a first end connectable to a supply of gas from a gas source and a second end coupled to the inlet of the cavity of the cannula.

[0011] In some embodiments, a nasal cannula system includes a cannula, a manifold, and a supply tube. The cannula includes a central body portion, first and second side portions that extend in opposite lateral directions from the central body portion, and first and second nasal prongs extending from the central body portion. The central body portion defines a cavity and a forward-facing inlet to the cavity. The first and second nasal prongs communicate with the cavity. The manifold receives a supply of gas from a gas source and includes a gas inlet and a gas outlet. The manifold is connectable with the cannula such that the gas outlet is aligned with the forward-facing inlet of the cannula and the gas inlet faces a lateral direction. The supply tube is connected to the gas inlet of the manifold and positioned forward of the forward-facing inlet of the cannula.

[0012] In some embodiments, a nasal cannula patient interface includes first and second nasal prongs, each including an inlet end and an outlet end, and at least one support portion configured to rest upon the nose of a patient at a point at or above the tip of the nose. In use, no portion of the patient interface contacts an upper lip of the patient to provide any substantial support to the patient interface.

[0013] In some embodiments, a nasal cannula system comprises a cannula having a central body portion, a first nasal prong and a second nasal prong extending from the central body portion . The cannula defines a cavity in communication with the first and second nasal prongs. An integrated head strap includes a first section and a second section, wherein the first and second sections extend in opposite lateral directions from the central body portion. The first section defines a rear portion of the head strap. An adjustable coupling arrangement permits coupling of the first and section sections in an adjustable manner such that a circumference of the head strap is adjustable. A supply tube has a first end connectable to a supply of gas from a gas source and a second end coupled to the cavity of the cannula.

[0014] In some embodiments, a nasal cannula system includes a cannula comprising a central body portion, a first nasal prong and a second nasal prong extending from the central body portion. The cannula defines a cavity in communication with the first and second nasal prongs. The cannula defines a lateral slot. A head gear strap extends through the lateral slot of the cannula. A supply tube has a first end connectable to a supply of gas from a gas source and a second end coupled to the cavity of the cannula.

[0015] In some embodiments, a nasal cannula system comprises a cannula comprising a central body portion, a first nasal prong and a second nasal prong extending from the central body portion. The cannula defines a cavity in communication with the

first and second nasal prongs. The cannula defines a first opening at a first location of the cavity and a second opening at a second location of the cavity spaced from the first location. A valve body is movable within the cavity. A supply tube has a first end connectable to either one of the first opening or the second opening of the cannula and a second end connectable to a supply of gas from a gas source. When the first end of the supply tube is connected to the first opening of the cannula, the valve body moves in response to a flow of gas in the cavity from the gas source to block the second opening such that the flow of gas is directed to the first and second nasal prongs and, when the first end of the supply tube is connected to the second opening of the cannula, the valve body moves in response to the flow of gas in the cavity from the gas source to block the first opening such that the flow of gas is directed to the first and second nasal prongs.

[0016] In some embodiments, a nasal cannula system comprises a cannula comprising a central body portion, a first nasal prong and a second nasal prong extending from the central body portion. The cannula defines a cavity in communication with the first and second nasal prongs. The cannula defines a first opening at a first location of the cavity and a second opening at a second location of the cavity spaced from the first location. The cannula comprises a first valve that selectively closes the first opening and a second valve that selectively closes the second opening. A supply tube has a first end connectable to either one of the first opening or the second opening of the cannula and a second end connectable to a supply of gas from a gas source. When the first end of the supply tube is connected to the first opening of the cannula, the second valve blocks the second opening such that a flow of gas from the gas source is directed to the first and second nasal prongs and, when the first end of the supply tube is connected to the second opening of the cannula, the first valve blocks the first opening such that the flow of gas is directed to the first and second nasal prongs.

[0017] In some embodiments, a nasal cannula system comprises a cannula comprising a central body portion, a first nasal prong and a second nasal prong extending from the central body portion. The cannula defines a cavity in communication with the first and second nasal prongs. The cannula defines a first opening at a first end of the cavity and a second opening at a second end of the cavity. A supply tube has a first end comprising a first insert and a second end comprising a second insert. Each of the first insert and the second insert is positionable within the cavity to seal the first opening and the second opening and deliver a flow of gas from the gas source to the first and second nasal prongs. When the first end of the supply tube is connected to the cannula, the second end is connectable to the gas source and, when the second end of the supply tube is connected to the cannula, the first end is connectable to the gas source.

[0018] In some embodiments, a nasal cannula system comprises a cannula comprising a central body portion, a first nasal prong and a second nasal prong extending from the central body portion. The cannula defines a cavity in communication with the first and second nasal prongs. A supply tube has a first end coupled to the cavity of the cannula and a second end connectable to a supply of gas from a gas source. The first end of the supply tube defines a connection axis relative to the cannula. The supply tube comprises a flexible portion at or adjacent the first end that can be bent at least about 90 degrees to either the left or right side without significant occlusion of an internal passage of the supply tube.

[0019] In some embodiments, a nasal cannula system comprises a cannula comprising a cavity and a first nasal prong and a second nasal prong in communication with the cavity. A supply tube receives a flow of gas from a gas source. The supply tube is connected to the cannula to supply the flow of gas to the cavity of the cannula. A clip removably receives the cannula. A retention arrangement secures the clip to the head of a patient. The cannula is positionable within the clip in a first orientation such that the supply tube extends in a first direction from the clip, and the cannula is positionable within the clip in a second orientation such that the supply tube extends in a second direction from the clip.

[0020] In some embodiments, a nasal cannula system comprises a cannula comprising a first nasal prong and a second nasal prong. The cannula defines a cavity in communication with the first and second nasal prongs. The cannula defines a first opening at a first location of the cavity and a second opening at a second location of the cavity spaced from the first location. A supply tube assembly comprises a clip that can be releasably coupled to the cannula in either of a first orientation and a second orientation . The supply tube assembly further comprises a supply tube connectable to a supply of gas from a gas source. The clip supports the supply tube and comprises a sealing portion. When the clip is connected to the cannula in the first orientation, the supply tube is connected to the first opening of the cannula and extends in a first direction from the cannula and the sealing portion at least substantially seals the second opening and, when the clip is connected to the cannula in the second orientation, the supply tube is connected to the second opening of the cannula and extends in a second direction from the cannula and the sealing portion at least substantially seals the first opening.

[0021] In some embodiments, a nasal cannula system comprises a cannula clip comprising a first nasal prong and a second nasal prong. The cannula defines a cavity in communication with the first and second nasal prongs. A supply tube assembly comprises a manifold having at least one manifold opening and a supply tube connectable to a supply of gas from a gas source. The cannula clip is capable of being releasably coupled to the manifold in either of a first orientation and a second orientation in which the manifold is received within the cavity of the cannula clip and the first and second prongs are aligned with the at least one manifold opening such that a flow of gas is provided to the first and second prongs. When the cannula clip is connected to the manifold in the first orientation, the supply tube extends in a first direction relative to the first and second prongs and, when the cannula clip is connected to the manifold in the second orientation, the supply tube extends in a second direction relative to the first and second prongs.

[0022] In some embodiments, a nasal cannula system comprises a cannula comprising a main body defining a cavity and a first nasal prong and a second nasal prong extending from the main body and in communication with the cavity. A supply tube is coupled to the cannula and is in communication with the cavity. The supply tube is connectable to a supply of gas from a gas source to deliver a flow of gas to the cavity and the first and second nasal prongs. The first and second nasal prongs are tiltable relative to the main body of the cannula between at least a first position in which the first and second nasal prongs are tilted in a first direction relative to the main body and a second position in which the first and second nasal prongs are tilted in a second direction relative to the main body. A first surface of the main body defines a patient-facing surface of the cannula in the first position and a second surface of the main body defines the patient-facing surface of the cannula in the second position to effectively switch the side from which the supply tube extends from the cannula between the first and second positions.

[0023] In some embodiments, a nasal cannula system comprises a cannula defining a cavity and comprising a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. A supply tube is coupled to the cannula and is in communication with the cavity. The supply tube is connectable to a supply of gas from a gas source to deliver a flow of gas to the cavity and the first and second nasal prongs. The first and second nasal prongs are directionally-oriented relative to the cannula and are movable between at least a first position in which the first and second nasal prongs are oriented such that openings of the prongs generally face in a first direction relative to the cannula and a second position in which the first and second nasal prongs are oriented such that the openings of the prongs generally face in a second direction relative to the cannula. A first surface of the cannula defines a patient-facing surface in the first position and a second surface of the cannula defines the patient-facing surface in the second position to effectively switch the side from which the supply tube extends from the cannula between the first and second positions.

[0024] In some embodiments, a nasal cannula system comprises a cannula defining a patient-facing surface and a cavity and comprising a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. A

manifold supports the cannula for rotation about at least one axis between at least a first position and a second position opposite the first position. A supply tube is coupled to the manifold and in communication with the cavity. The supply tube is connectable to a supply of gas from a gas source to deliver a flow of gas to the cavity and the first and second nasal prongs. When the cannula is in the first position, the supply tube is positioned on a first side of the first and second nasal prongs and, when the cannula is in the second position, the supply tube is positioned on a second side of the first and second nasal prongs to effectively switch the side from which the supply tube extends from the cannula between the first and second positions.

[0025] In some embodiments, a nasal cannula system comprises a cannula defining a cavity and comprising a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. A supply tube is coupled to the cannula and is in communication with the cavity. The supply tube is connectable to a supply of gas from a gas source to deliver a flow of gas to the cavity and the first and second nasal prongs. A pressure line is in communication with the cavity and is configured to be connectable to a control unit of the gas source or a display unit to provide a signal to the control unit or display unit indicative of a pressure within the cavity.

[0026] In some embodiments, a nasal cannula comprises a cannula body defining a cavity and comprising a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. The cannula defines a patient-facing surface having one or more comfort features selected from a plurality of through-holes, a plurality of raised bumps, a plurality of grooves and a gel pad.

[0027] In some embodiments, a nasal cannula comprises a cannula body defining a cavity and comprising a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. The cannula body comprises a central portion containing the first and second nasal prongs and first and second side portions extending from each side of the central portion. The cannula body defines a patient-facing surface. The central portion is spaced forwardly of adjacent portions of the first and second side portions such that, in use, the patient-facing surface of the central portion is spaced from the upper lip of the patient.

[0028] In some embodiments, a supply tube for a nasal cannula comprises a tube body having a first end a second end. The tube body comprises a malleable section that permits the section to be shaped by an external force and that substantially retains the shape after the external force is removed.

[0029] In some embodiments, a nasal cannula system comprises a cannula defining a cavity and comprising a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. A supply tube is coupled to the

cannula and is in communication with the cavity. The supply tube is connectable to a supply of gas from a gas source to deliver a flow of gas to the cavity and the first and second nasal prongs. A support arrangement supports the supply tube at a spaced location from the cannula. The support arrangement comprises a fastener having a first portion coupled to the supply tube and a second portion located at the spaced location.

[0030] In some embodiments, a nasal cannula system comprises a cannula defining a cavity and comprising a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. A supply tube is coupled to the cannula and is in communication with the cavity. The supply tube is connectable to a supply of gas from a gas source to deliver a flow of gas to the cavity and the first and second nasal prongs. A retention arrangement secures the cannula to the patient. A support arrangement supports the supply tube at a spaced location from the cannula, which is located on the retention arrangement.

[0031] In some embodiments, a nasal cannula system comprises a cannula defining a cavity and comprising a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. A supply tube is coupled to the cannula and is in communication with the cavity. The supply tube is connectable to a supply of gas from a gas source to deliver a flow of gas to the cavity and the first and second nasal prongs. A support arrangement supports the supply tube at a spaced location from the cannula. The support arrangement comprises a fastener that engages a piece of fabric at the spaced location.

[0032] In some embodiments, a nasal cannula system comprises a cannula defining a cavity and comprising a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. A supply tube is coupled to the cannula and is in communication with the cavity. The supply tube is connectable to a supply of gas from a gas source to deliver a flow of gas to the cavity and the first and second nasal prongs. A support arrangement supports the supply tube at a spaced location from the cannula. The support arrangement comprises at least one of an armband that engages the supply tube, an adhesive pad comprising a fastener for releasably fastening the supply tube to the adhesive pad, a generally U-shaped support that sits on the patient's shoulder and engages the supply tube, and a headgear strap comprising a strap extending over the top of the patient's head and engages the supply tube.

[0033] In some embodiments, a retention arrangement for a nasal cannula assembly comprises a headgear strap comprising a first ear loop and a second ear loop, each of which at least partially surround an ear of the patient. A connection portion connects the retention arrangement to the nasal cannula assembly. A strap portion extends around the back of the patient's head between the first and second ear loops. [0034] In some embodiments, a retention arrangement for a nasal cannula comprises a headgear strap comprising a strap portion. A first pad and a second pad, in use, contact first and second cheeks of the patient. A connection portion connects the retention arrangement to the nasal cannula. The strap portion extends around the patient's head and extends from the first and second pads at an angle relative to the nasal cannula.

[0035] In some embodiments, a retention arrangement for a nasal cannula comprises a frame comprising a connection portion that connects the retention arrangement to the nasal cannula. A first ear stem portion and a second ear stem portion extend rearwardly from opposite sides of the connection portion. The ear stem portions are configured to be positioned above the ears of the patient.

[0036] In some embodiments, a nasal cannula system comprises a cannula having a central portion defining a cavity and comprising a first nasal prong and a second nasal prong extending from the central portion and in communication with the cavity. A first side portion and a second side portion extend in a lateral direction from opposing sides of the central portion . A supply tube is coupled to the cannula and is in communication with the cavity. The supply tube is connectable to a supply of gas from a gas source to deliver a flow of gas to the cavity and the first and second nasal prongs. A first adhesive pad and a second adhesive pad are configured to be adhesively secured to the face of the patient and connectable to a respective one of the first and second side portions of the cannula through an adjustable fastening arrangement.

[0037] In some embodiments, a nasal cannula system comprises a cannula defining a cavity and comprising a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. A modular retention arrangement secures the cannula to the patient. The cannula is configured to be used with any one of the retention arrangements selected from a set of adhesive pads that attach to the patient's face, a headgear strap and a halo-style headgear strap that has a strap portion extending over the top of the patient's head.

[0038] In some embodiments, a nasal cannula system comprises a cannula defining a cavity and comprising a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. A modular retention arrangement secures the cannula to the patient. The retention arrangement comprises a nose strip coupled to the cannula and attachable to the nose of a patient and a headgear strap comprising a clip configured to receive the cannula. The cannula can be secured to the patient using either the nose strip or the headgear strap.

[0039] In some embodiments, a retention arrangement for a nasal cannula comprises a headgear strap that is connectable to a nasal cannula and capable of being tensioned around the head of a patient. The headgear strap comprises a tension indicator that provides a first indication when the tension is at an incorrect value and a second indication when the tension is at a correct value.

[0040] In some embodiments, a retention arrangement for a nasal cannula comprises a headgear strap that is connectable to a nasal cannula. At least one strap extends around the head of a patient from one side to the other of the cannula. A tension adjuster tensions the headgear strap by varying an effective length of the at least one strap by winding up a portion of the at least one strap.

[0041] In some embodiments, a headgear strap for a nasal cannula comprises a first portion that is connectable to a nasal cannula and a second, elastic portion that is positioned at a back of a head of a patient in use. A pad extends at least partially along the second, elastic portion.

[0042] In some embodiments, a nasal cannula assembly comprises a cannula defining a cavity and comprising a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. A head strap is positioned around the head and above the ears of the patient in use. A first arm is coupled to a first side of the cannula and a second arm is coupled to a second side of the cannula. Upper end portions of each of the first and second arms are attached to the head strap.

[0043] In some embodiments, a nasal cannula system comprises a cannula defining an open cavity and comprises a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. A manifold is configured to be removably coupled to the cannula and a portion of the manifold received into the cavity of the cannula. The manifold includes first and second holes that align with the first and second nasal prongs when the manifold is coupled to the cannula, and the manifold also includes a side opening configured to be coupled to a tube. An inner surface of the cavity of the cannula includes a first attachment portion and an outer surface of the portion of the manifold includes a second attachment portion. The first and second attachment portions can be configured to engage one another to secure the manifold to the cannula.

[0044] In some embodiments of a nasal cannula system, the first and second attachment portions comprise cooperating portions of a hook and loop material fastener. The nasal cannula system can also include an arrangement in which the cavity and the portion of the manifold have corresponding symmetrical shapes so that the portion of the outer surface of the manifold can be positioned within the cavity in multiple orientations. In some embodiments, the cavity and the portion of the manifold are circular or oval shaped. In some embodiments, the first and second attachment portions are substantially planar.

[0045] In some embodiments, a nasal cannula assembly comprises a cannula defining a cavity and a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. The cannula includes a first outer surface and a second outer surface that are substantially planar and extending along the length of the cannula. The cannula also includes a first end and a second end. A retention arrangement is coupled to the cannula and configured to support the cannula on the face of a patient. A tube can be coupled to the cannula adjacent either the first end or the second end of the cannula and configured to be in communication with the cavity. The cannula has a first position in which the first outer surface contacts the face of the patient and the first and second nasal prongs extend into the nostrils of the patient. The cannula has a second position in which the second outer surface contacts the face of a patient and the first and second nasal prongs extend into the nostrils of the patient.

[0046] In some embodiments of a nasal cannula assembly, the cannula has a substantially triangular cross-sectional shape. The nasal cannula assembly can be arranged so that an angle between the first and second nasal prongs and the first outer surface is substantially the same as an angle between the first and second nasal prongs and the second outer surface. In some embodiments, the first and second nasal prongs extend outward from the cannula at a corner of the substantially triangular cross-sectional shape between the first and second outer surfaces.

[0047] In some embodiments, a nasal cannula assembly comprises a cannula body defining a cavity and comprises a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. The first and second nasal prongs can have a relaxed position in the absence of any substantial external force. An outer portion is configured to be movably coupled to the cannula body and configured to surround at least a portion of the cannula body. The outer portion defines at least one opening through which the first nasal prong extends and the outer portion includes at least one edge defining the at least one opening. The outer portion can move relative to the cannula body and the first and second nasal prongs, and the at least one edge is configured to engage the first and second prongs and deflect the first and second prongs from their relaxed positions.

[0048] In some embodiment of a nasal cannula assembly, the cannula body and the outer portion are substantially cylindrical and the outer portion extends around the circumference of the cannula body, and the outer portion can be rotated about the cannula body. Each of the first and second nasal prongs can include a flexible base portion configured to allow the angle at which the prong extends from the cannula body to change. The at least one opening can comprise a first opening and a second opening and the at least one edge can comprise a first edge and a second edge, the first opening defining the first edge and the second opening defining the second edge. The first nasal prong can extend through the first opening and the second nasal prong extends through the second opening. In some embodiments of a nasal cannula assembly, the outer portion includes a slot and the cannula body includes a protrusion that extends into the slot. The protrusion can be configured to move within the slot and the slot can have side walls configured to engage the protrusion and limit the amount of movement of the outer portion relative to the cannula body.

[0049] In some embodiments, a nasal cannula system comprises a cannula defining a cavity and comprises at least one nasal prong extending from the cannula and in communication with the cavity. A frame portion is configured to support the cannula and at least one head strap is coupled to the frame portion and positioned around the head of the patient in use. The cannula is slidably supported by the frame portion and can move relative to the frame portion, the cannula including an opening through which the frame portion extends. The cannula system can comprise a tube support member supported by the frame portion or the head strap and the tube support member can be configured to support and selectively release a tube.

[0050] In some embodiments of a nasal cannula system, the tube support member is configured to loosely support the tube so that the tube can slide within the support member. The tube support member can comprise a strap configured to wrap around a tube and a clip configured to couple the strap to the head strap or frame portion. The frame portion can have a circular or rounded cross-section and the cannula can move laterally relative to the frame portion and can rotate relative to the frame portion. In some embodiments of a nasal cannula system, the interface between the cannula and the frame portion is a friction fit that allows the cannula to retain its position relative to the frame portion when not being moved by a user. The frame portion can include a plurality of notches configured to interact with the cannula and provide discrete locations along the frame portion at which the cannula can be supported.

[0051] In some embodiments, a nasal cannula system comprises a cannula defining a cavity and comprises a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. The cannula includes an opening extending through a portion of the cannula and a head strap is positioned around the head of the patient in use. The opening on the cannula is configured to receive the head strap so that the head strap extends through the opening and supports the cannula and the cannula is configured to slide relative to the head strap and change positions along the head strap.

[0052] In some embodiments of a nasal cannula system, the cannula comprises a planar outer surface configured to contact the face of a patient when the first and second prongs are inserted into the nostrils of a patient. The head strap can be made of an elastic material and configured to hold the cannula against the face of a patient.

[0053] In some embodiments, a nasal cannula system comprises a cannula defining a cavity and comprising at least one nasal prong extending from the cannula and in communication with the cavity. The cannula includes a first slot and a second slot. A first frame portion is configured to be slidably received by the first slot of the cannula and a second frame portion is configured to be slidably received by the second slot. At least one head strap is coupled to the first and second frame portions and positioned around the head of the patient in use. The cannula is slidably supported by the first and second frame portions and can be selectively moved relative to the first and second frame portions.

[0054] In some embodiments of a nasal cannula system, the cannula includes a side opening configured to receive a supply tube, and the first and second frame portions are configured to allow a tube to pass between them. A nasal cannula system can also comprise a tube support member supported by the first and second frame portions and configured to slide relative to the first and second frame portions to position the supply tube relative to the first and second frame portions. The first and second frame portions can have circular cross-sections and the first and second slots can be configured to retain the first and second frame portions. In some embodiments of a nasal cannula system, the first frame portion is positioned above the second frame portion and the first and second slots are located on the outer side of the cannula facing away from the patient. The cannula can include a planar surface facing the face of the patient.

[0055] In some embodiments, a nasal cannula system comprises a cannula defining a cavity and comprising at least one nasal prong extending from the cannula and in communication with the cavity. The cannula includes a slot and a first frame portion is configured to be slidably received by the slot of the cannula. A second frame portion is fixedly coupled to the cannula. A first dial and a second dial are each coupled to both the first frame portion and the second frame portion. At least one head strap is coupled to the first and second frame portions and positioned around the head of the patient in use. The cannula is slidably supported by the first frame portion and the dials can be configured to rotate to move a section of the second frame portion and the cannula relative to the first frame portion. The first and second frame portions can be wires coated with a soft material. In some embodiments, the second frame portion is located above the first frame portion when the cannula system is worn by a patient.

[0056] In some embodiments, a retention arrangement for a nasal cannula comprises a band configured to extend around the head of a patient and a first arm pivotally coupled to the band at a first joint. A second arm is pivotally coupled to the first arm at a second joint and the second arm can be connectable to a nasal cannula at a third joint. The first, second and third joints are configured to allow three dimensional movement and are configured to retain the relative position of the band, first arm, second arm, and cannula unless moved by a user.

[0057] In some embodiments of a retention arrangement, the band includes a stabilizing portion that is wider than the band and configured to contact the head of a patient. The third joint can be coupled to the side of a cannula. In some embodiments, the first, second and third joints are ball joints.

[0058] In some embodiments, a nasal cannula system comprises a cannula defining a cavity and comprises at least one nasal prong extending from the cannula and in communication with the cavity. The cannula includes a slot and has a clip portion extending from the cannula. A frame is configured to support the cannula and be coupled to a head strap. The frame includes an opening configured to receive the clip portion of the cannula and the clip portion can be movable within the opening so that the cannula can assume different positions relative to the frame while being supported by the frame.

[0059] In some embodiments of a nasal cannula system, the cannula is positioned between the frame and the face of a patient when in use. The frame can include at least one pad member arranged to contact the face of a patient when in use. In some embodiments, the interface between the clip portion and the frame opening allows the cannula to be moved laterally and rotated relative to the frame. A cannula system can also include a head strap coupled to the frame and a tube support member supported by the head strap or frame.

[0060] In some embodiments, a nasal cannula system comprises a cannula defining a cavity and comprises at least one nasal prong extending from the cannula and in communication with the cavity. The cannula has a first end portion and a second end portion. A first corrugated tube section is coupled to the first end portion of the cannula and a second corrugated tube section is coupled to the second end portion of the cannula. The position of the cannula relative to a patient's face can be adjusted by expanding and compressing the first and second corrugated tube sections. In some embodiments, the cannula system also comprises a first non-corrugated tube coupled to the first corrugated tube section and a second non-corrugated tube coupled to the second corrugated tube section. The first and second corrugated tube sections can be backed by a head strap.

[0061] In some embodiments, a prong arrangement for a nasal cannula comprises a prong comprising a first prong portion comprising a first slot and a second prong portion comprising a first flange. The second prong portion is coupled to the first prong portion and the first flange extends longitudinally within the first slot. The first and second prong portions are configured to extend away from a cannula and define a passageway and the first flange is movable within the first slot so that the first prong portion and second prong portion can be moved toward and away from one another to adjust an outer dimension of the prong.

[0062] In some embodiments of a prong arrangement, the first and second prong portions each include a sealing member adjacent the cannula and the sealing members overlap each other and are configured to slide relative to one another. The prong can further comprise a size indicator configured to indicate the relative outer dimensions of the prong. In some embodiments, the prong includes a second slot and a second flange, the second flange extending longitudinally within the second slot. The first slot can comprises two side walls configured to limit the extent to which the first flange can move within the first slot.

[0063] In some embodiments, a prong arrangement for a nasal cannula comprises a prong comprising a first collapsible portion configured to be coupled to a cannula. The first collapsible portion includes a first passageway. A second collapsible portion is coupled to the first collapsible portion and has a second passageway. A third collapsible portion is coupled to the second collapsible portion and has a third passageway. The first, second and third collapsible portions are configured to collapse and expand telescopically relative to one another so that the height of the prong can be adjusted.

[0064] In some embodiments of a prong arrangement, the third collapsible portion includes a top edge that is configured to form a seal with a patient's nostril . The outer dimensions of the third collapsible portion can be larger than the outer dimensions of the second collapsible portion, and the outer dimensions of the second collapsible portion can be larger than the outer dimensions of the first collapsible portion. The first, second and third passageways can be coaxial .

[0065] In some embodiments, a prong arrangement for a nasal cannula comprises a cannula defining a cavity and the cannula includes a slot. A first prong extends from the cannula and is fixed relative to the cannula. A second prong extends from the cannula through the slot and is movable relative to the cannula. The second prong can be moved within the slot in order to adjust a distance between the first prong and the second prong.

[0066] In some embodiments of a prong arrangement, the second prong includes a pin and the slot includes multiple notches, and the notches are configured to receive the pin when the second prong is moved to discrete locations within the slot. The second prong can include a rib that extends from the base of the prong and the slot can include multiple grooves configured to receive the rib. In some embodiments, the second prong includes a tab having multiple notches that are configured to engage an edge of the slot so that the second prong can be held in multiple discrete positions relative to the slot.

[0067] In some embodiments, a prong for a nasal cannula comprises a film having a substantially cylindrical shape and a plurality of ribs coupled to the film around the circumference of the film. The film and ribs expand outward as gas flow increases through the prong, and the outer diameter of the prong increases to form a seal with a patient's nostril. In some embodiments, the ribs are substantially fixed and do not bend or move relative to one another.

[0068] In some embodiments, a nasal cannula system comprises a cannula defining a cavity and comprises at least one nasal prong extending from the cannula and in communication with the cavity. A support member is coupled to the cannula and configured to support the cannula. The support member is configured to extend upward from the cannula and around a patient's nose when in use. The support member contacts a portion above a tip of the patient's nose and the support member comprises a bendable material that can be shaped to correspond to the shape of the face of a patient.

[0069] In some embodiments, a nasal cannula system, also includes a head strap configured to wrap around the head of a patient and the head strap is removably coupled at one end to the support member and adjustably coupled to the support member at the other end. In some embodiments, the bendable material is a metal material and is located at the upper portion of the support member. The support member can include an attachment portion having multiple notches and the cannula can include an opening configured to receive the attachment portion. The notches can be configured to interact with the opening to couple the support member to the cannula and allow for adjustment of the support member relative to the cannula. In some embodiments, the cannula includes a first tube extending from one side of the cannula and a second tube extending from the other side of the cannula, and the support member is coupled to the first and second tubes of the cannula. The first tube can be supported by a first padded member and the second tube can be supported by a second padded member, and the first and second padded members can be configured to rest against a patient's face. In some embodiments, a nasal cannula system also includes a head strap coupled to the first and second padded members and configured to extend around the head of a patient. The first tube and the second tube can be removable from the cannula so that the cannula can be removed and rotated relative to the rest of the system.

[0070] In some embodiments, a tube arrangement for a nasal cannula system comprises a cannula tube comprising an outer wall and an opening. The tube includes a longitudinal axis and the outer wall comprises a thin material that has been folded or rolled and sealed at an edge.

[0071] In some embodiments of a tube arrangement, the outer wall is made of a fabric that provides insulation. Embodiments of a tube arrangement can also include a

spring extending within the outer wall. The cannula tube can also be coupled to a connector at its opening and the connector can include a valve. In some embodiments, the cannula tube further comprises an extruded tube extending within the outer wall. The outer wall can include a tab having one or more holes configured to be coupled to a head strap. In some embodiments, the outer wall is made of an insulating material, a spring extends within the outer wall, and a breathing tube extends within the spring.

[0072] In some embodiments of a tube arrangement, the outer wall is made of an insulating material, a breathing tube extends within the outer wall, a spring extends within the breathing tube, and at least a pressure line tube extends within the outer wall in addition to the breathing tube. Some embodiments can also include a breathing tube within the outer wall, the breathing tube having a cannula portion from which at least one prong extends, the cannula tube being flexible so that it can curve around the face of a patient. Each end of the cannula tube can include a tab with holes configured to receive a pin located on a head strap. Each end of the cannula tube can include a connector configured to receive an inspiratory tube connector, each connector including a valve. In some embodiments, the outer wall is made of a breathable material .

[0073] In some embodiments, a tube arrangement for a nasal cannula system comprises a tube comprising an outer wall and an opening . The tube includes a longitudinal axis and the outer wall comprises a thin material that has been folded or rolled, and the outer wall includes one or more cut portions that extend through the material. In some embodiments, the one or more cut portions comprise a tab that can be pulled away from the tube, and the tab is configured to engage a support device in order to hang the tube.

[0074] In some embodiments of a tube arrangement, the tab includes a hole configured to receive a hook or hanger. The cut portions can comprise slots defining a portion of the material that can be pulled away from the tube while remaining connected at two sides, and the pulled away material can form a hook portion that can engage a hanger. In some embodiments, the cut portions can comprise two tabs that can be pulled away from the tube, the ends of the tabs being configured to be coupled together or to another structure. The tube can also comprise an inner tube and a spring within the inner tube.

[0075] In some embodiments, a cannula tube arrangement for a nasal cannula system comprises a tube comprising an outer wall and the outer wall comprises a thin film having a first edge and a second edge. The film is folded or rolled and the first and second edges are sealed together. A bead is located on the outer wall and configured to provide structural support to the tube.

[0076] In some embodiments of a cannula tube arrangement, the bead includes a cannula portion configured to receive a cannula with prongs, and the cannula portion includes two holes that extend through the film. The tube can include a first end and a second end, and the first end and second end can be coupled to connectors having valves. The first and second ends can each include a tab having a hole configured to be coupled to a head strap. In some embodiments, the first and second edges of the film are heat-sealed to form the tube. The bead can be printed or extruded onto the outer wall. The bead can have a pattern that is configured to create bend areas along the tube length. In some embodiments, the bead is on the inside of the tube. The bead can comprise thermal and structural elements printed on the film. In some embodiments, the first edge overlaps the second edge and the first and second edges can extend into the tube.

[0077] In some embodiments, a cannula tube arrangement for a nasal cannula system comprises a tube comprising an outer wall. The outer wall comprises a thin plastic film having a first edge and a second edge. A substantially planar side wall is coupled to the outer wall and a bead is located on the other wall and configured to provide structural support to the tube. The first edge is coupled to the side wall and the second edge is also coupled to the side wall so that a cavity exists between the outer wall and the side wall. In some embodiments, the first edge and second edge are heat-sealed to the side wall, and the side wall is made of a fabric material.

[0078] In some embodiments, a cannula tube arrangement comprises a spring having a length and a cross-section having at least one substantially planar side. A tube surrounds the spring and the tube defines a passageway through which gas can pass. At least one nasal prong is coupled to the tube and communicates with the passageway.

[0079] In some embodiments of a cannula tube arrangement, the spring has a V-shaped or triangular cross-section. The spring can comprise a thin folded sheet of metal having cut-out portions along the length of the spring. The spring can include a middle section and first and second ends, and the cross-section of the middle section can be smaller than the cross-section at the first and second ends. In some embodiments, the spring is a helical spring having a triangular cross-section. The spring can be a helical wire having bent ends that extend in the direction of a third side. The spring can also have a substantially triangular cross-section with curved sides. In some embodiments, the spring has a cross-section shaped like a half-circle.

[0080] In some embodiments, a cannula breathing tube arrangement comprises a tube made at least in part from a foam material. The tube has a length and a substantially planar side extending along the length of the tube and the tube defines a passageway. A spring extends through the passageway of the tube and along the length of the tube, and the spring is configured to impede kinking of the tube.

[0081] In some embodiments of a cannula breathing tube arrangement, the tube includes a cavity extending along the length of the tube and a shapeable rod extending through the cavity. In some embodiments, the foam material is a closed cell foam material. The tube can include a slot extending along the length of the tube, the slot being configured to receive a coupling member. In some embodiments, the coupling member is a mushroom head member configured to slide into the slot.

[0082] In some embodiments, a cannula tube arrangement comprises a tube having a length and a substantially planar side extending along the length of the tube. The tube defines a passageway and has an inner surface. The tube includes at least one rib located on the inner surface and extending along the length of the tube, and the at least one rib is configured to provide structural support and impede kinking of the tube.

[0083] In some embodiments of a cannula tube arrangement, the at least one rib comprises multiple ribs on the inner surface. The tube can comprise a rectangular cross-section and include a fabric material surrounding the tube. In some embodiments, the tube has a substantially triangular cross-section and in other embodiments, the tube has a substantially half-circle cross-section.

[0084] In some embodiments, a cannula tube arrangement comprises a cannula tube defining a passageway and having an end. A connector is coupled to the end of the cannula tube and a supply tube is configured to be coupled to the connector of the cannula tube. A wire configured to transfer heat extends out of the supply tube. The cannula tube is configured to receive the wire into the passageway, and the wire is configured to transfer heat into the cannula tube.

[0085] In some embodiments of a cannula tube arrangement, the wire is insulated and bendable so that it can conform to the shape of the cannula tube. The wire can be rigid enough to support the cannula tube.

[0086] In some embodiments, a cannula and tube arrangement comprises a cannula tube having a length and defining a passageway. A heating element extends along the length of the cannula tube and is configured to transfer heat to gas passing through the cannula tube. A cannula comprising at least one nasal prong and is coupled to the cannula tube.

[0087] In some embodiments of a cannula and tube arrangement, the heating element is a coiled wire that extends within the cannula tube. The cannula tube can include an end and an electrical connector coupled to the end of the cannula tube. In some embodiments, the electrical connector is also a tube connector configured to attach a second tube to the cannula tube. The heating element can be surrounded by a thin film. In some embodiments, the heating element comprises two wires coupled to a conductive polymer, and the two wires are configured so that a voltage can be applied through the polymer to generate heat. In some embodiments, the heating element is configured to provide structural support to the cannula tube. In some embodiments, the heating element is wrapped around the outer surface of the cannula tube.

[0088] In some embodiments of a cannula tube arrangement, the heating element comprises a film having a conductive strip, the film is wrapped around the cannula tube, and the conductive strip is configured to generate heat when a current is passed therethrough . In some embodiments, the heating element can be made from positive temperature coefficient material configured so that its resistance increases with temperature so that a constant voltage power supply can be used to power the heating element. In some embodiments, the cannula tube is made of a flexible and light material, the cannula tube is coupled to a connector, the connector is coupled to a tube that is less flexible and heavier than the cannula tube, and the heating element extends along substantially the entire length of the cannula tube and the tube. The connector can include an opening configured to receive a temperature sensor and the cannula tube can be configured to be removably attached to the cannula.

[0089] In some embodiments, a cannula tube arrangement comprises a cannula tube having a length and defining a first passageway. The cannula tube has an outer surface and a spiral tube is wrapped around the outer surface of the cannula tube. The spiral tube defines a second passageway and has an inner wall adjacent the cannula tube and an outer wall facing away from the cannula tube. A first opening extends through the cannula tube and through the inner wall of the spiral tube so that gas flowing inside the cannula tube can enter the spiral tube through the first opening.

[0090] In some embodiments of a cannula tube arrangement, the spiral tube includes a second opening extending through the outer wall of the spiral tube so that gas flowing in the spiral tube can escape into the surrounding environment. In some embodiments, the second opening is positioned at an opposite end of the cannula tube from the first opening.

[0091] In some embodiments, a cannula tube arrangement comprises a cannula tube having a length and defining a passageway. The cannula tube has an outer portion and the outer portion comprises a textile material and a heating element knitted or woven into the textile material. The heating element is configured to transfer heat to a gas passing through the passageway.

[0092] In some embodiments of a cannula tube arrangement, the heating element is a wire configured to generate heat when electrical current is passed therethrough . In some embodiments, the heating element is made of a semi-rigid material that provides structural support to the cannula tube.

[0093] In some embodiments, a manifold for a cannula assembly comprises a manifold body comprising a connector portion having an inlet opening and being configured to receive a tube. The manifold also includes a port configured to assist in measuring the pressure of the gas flow and an outlet portion configured to be in communication with the port and configured to be coupled to a pressure sensor.

[0094] In some embodiments of a manifold, the port is a static pressure port positioned on an inner wall of the manifold that is substantially parallel to the bulk flow direction of the gas within the manifold. In some embodiments, the port is a total pressure port that is directed towards the bulk flow direction and is configured to measure a combination of the static and dynamic pressure. In some embodiments, the port includes a shroud and is directed towards the bulk flow direction.

[0095] In some embodiments, a nasal cannula assembly comprises a cannula defining a cavity and comprising a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. The cannula also includes an opening. A valve is supported within the opening and configured to form a seal when nothing is inserted therethrough. The cannula and valve are configured so that a tube can extend through the valve, into the cavity, and through the second nasal prong.

[0096] In some embodiments of a nasal cannula assembly, the valve is a located substantially below the second prong. The valve in can be configured to form a seal around a tube extending therethrough. In some embodiments, the valve is a duck bill valve. Embodiments of a nasal cannula assembly can further comprise a removable cover coupled to the outer surface of the cannula and covering the opening. The cannula can also include two openings and two corresponding valves where each of the valves is configured to receive either a cannula tube or a nasogastric tube. In some embodiments, the cannula includes a first side and a second side, and one of the valves is located on each of the first and second sides. In some embodiments, the second prong is removable from the cannula.

[0097] In some embodiments, a nasal cannula assembly comprises a cannula defining a cavity and comprising a first nasal prong extending from the cannula and in communication with the cavity. The cannula includes a first groove and the first prong includes a second groove. The first groove is aligned with the second groove so that a portion of a tube can extend through the first and second grooves and is directed into a nostril of a patient.

[0098] In some embodiments of a nasal cannula assembly, the first and second grooves are configured to accommodate a nasogastric tube. The first prong can include an outer surface and the second groove can be located on the outer surface of the first prong and can extend longitudinally relative to the first prong. In some embodiments, the

cannula includes a second prong and a third groove, the second prong includes a fourth groove, and the third and fourth grooves are aligned so that a portion of a tube can extend through the third and fourth grooves and is directed into a nostril of a patient.

[0099] In some embodiments, a nasal cannula comprises a nasal prong having an outer wall and an end. The outer wall includes a cut portion defining a flap that can be pushed into the prong to form an opening in the outer wall of the prong. The opening is configured to receive a tube so that the tube can extend through the opening and out of the end of the prong.

[0100] In some embodiments of a nasal cannula, the outer wall defines a passageway, and the flap is configured to block the passageway when a tube is inserted through the opening. In some embodiments, the flap is configured to align with and form at least a substantial seal with the outer wall when a tube is not inserted through the opening. The prong can also include a slit that extends from the cut portion to the end of the prong, the slit being configured to allow a tube to selectively pass through the slit.

[0101] In some embodiments, a nasal cannula assembly comprises a cannula defining a cavity and comprising a first nasal prong extending from the cannula and in communication with the cavity. The cannula includes an opening and a valve supported within the opening. An inner member is supported within the cavity and movable relative to the cannula. The inner member includes a hole configured to receive a tube. The opening is positioned substantially below the first nasal prong and the inner member can be moved so that the hole is aligned with the valve so that a tube can extend through the valve and the hole and into the first prong.

[0102] In some embodiments of a nasal cannula assembly, the cannula includes a second opening having a second valve positioned substantially below a second nasal prong, and the inner member includes a second hole that can be aligned with the second valve and second prong. In some embodiments, the inner member is substantially cylindrical and is configured to be coupled to a supply tube. The valve can be configured to form a seal when nothing is extended therethrough.

[0103] In some embodiments, nasal cannula assembly comprises a cannula body having a first slot and a second slot. The assembly also includes a first sliding portion having a first prong coupled to a first tube and a second sliding portion having a second prong coupled to a second tube. A portion of the first sliding portion is configured to slide within the first slot and a portion of the second sliding portion is configured to slide within the second slot. The first and second prongs are movable relative to the cannula body so that each of the first and second prongs can be adjusted relative to the cannula body. In some embodiments, the first slot and the second slot extend substantially horizontally and are positioned side by side on the cannula body.

[0104] In some embodiments, a nasal cannula assembly comprises a cannula defining a cavity and comprising a first nasal prong extending from the cannula and in communication with the cavity. The assembly also includes a slider member that engages an outer surface of the cannula, and the slider member is configured to move relative to the cannula. The slider member is configured to selectively move along the outer surface of the cannula and over the first nasal prong.

[0105] In some embodiments of a nasal cannula assembly, the slider member includes a groove configured to receive a portion of a tube. In some embodiments, the first nasal prong is flexible and can fold under the slider member when the slider member is moved to cover the first nasal prong.

[0106] In some embodiments, a nasal cannula assembly comprises a cannula defining a cavity and comprising a single nasal prong extending from the cannula and in communication with the cavity. The assembly also includes a strap configured to support the prong and engage the face of a patient. The strap includes an adhesive material configured to selectively couple the strap to a patient's face. The strap includes an opening through which the prong extends and the strap is configured to extend from under the patient's nose upward along the sides of the patient's nose.

[0107] In some embodiments of a nasal cannula assembly, the strap includes at least one slot configured to receive a tube. In some embodiments, the strap includes holes positioned to align with a nostril of a patient when the strap is in use. The prong can include corrugations configured to allow the prong to bend and change shape. In some embodiments, the prong includes a tapered base portion that is configured to form a seal with a patient's nostril. In some embodiments, the cannula is coupled to a tube and the tube includes a support member configured to support the tube and be selectively coupled to the face of a patient. The support member can also include a support portion configured to receive and support a nasogastric or other tube. Embodiments of the cannula assembly can further comprise a cheek pad configured to adhere to a patient's cheek and be selectively coupled to the support member. In some embodiments, the prong includes a tapered base portion that is narrower toward the top and wider toward the bottom, and the prong includes a recess below the tapered portion and the recess is configured to retain the portion of the strap adjacent the opening.

[0108] In some embodiments, a nasal cannula assembly comprises a cannula defining a cavity and comprising a single nasal prong extending from the cannula and in communication with the cavity. The assembly also includes a frame having a bridge portion that extends away from the face of a patient and creates a space between the bridge portion and the patient's face. The bridge portion is configured to support the cannula, and the bridge portion including a slot and a portion of the cannula can move within the slot. A tube is coupled to the cannula and extends from a bottom portion of the cannula. The tube is configured to extend from under the cannula and bend upward so that it extends over the frame.

[0109] In some embodiments of a nasal cannula assembly, the cannula is supported by the frame and positioned substantially within the space between the bridge portion and the patient's face when the cannula assembly is in use. In some embodiments, the bridge portion of the frame includes cut out portions configured to receive a portion of the tube. In some embodiments, the cannula includes a grip portion that extends through the slot. The frame can include a pad configured to contact the face of a patient when in use. In some embodiments, the frame includes one or more openings configured to receive a head strap. In some embodiments, the bridge portion includes a tubing arm that at least partially defines a tubing recess through which the tube can extend.

[0110] In some embodiments, a nasal cannula assembly comprises a cannula frame having an upper extension portion, and the upper extension portion having a single prong and a prong opening in communication with the prong. The assembly also includes a retainer portion coupled to the extension portion and having a retainer opening aligned with the prong opening. The assembly also includes a manifold pivotally coupled to the retainer portion, and the manifold has a manifold opening aligned with the retainer opening and the prong opening. The manifold is configured to pivot relative to the cannula frame about the axis of the manifold opening, and gas can pass through the manifold and into the prong.

[0111] In some embodiments of a nasal cannula assembly, the cannula frame includes a lower extension portion and the retainer portion includes a lower portion that engages a bottom portion of the manifold. In some embodiments, the bottom portion of the manifold includes a pin and the lower portion of the retainer portion includes a hinge recess, and the pin is configured to be received within the hinge recess, and the manifold configured to pivot about the pin. In some embodiments, the manifold is configured to rotate about 180 degrees relative to the cannula frame so that tubing coupled to the manifold can exit in an opposite direction.

[0112] In some embodiments, a nasal cannula assembly comprises a cannula frame having an upper extension portion. The upper extension portion has a single prong and a prong opening in communication with the prong. The upper extension portion also has a bottom side. The assembly includes a tube rotatably coupled to the bottom side of the upper extension portion and in communication with the prong so that gas can pass from the tube through the prong opening and into the prong . The tube is configured to bend and rotate relative to the cannula frame.

[0113] In some embodiments, a nasal cannula assembly comprises a cannula defining a cavity and comprising a single nasal prong extending from the cannula and in communication with the cavity. The assembly comprises a cable configured to slidably support the cannula and a tube coupled to the cannula and configured to provide gas to the cavity. The position of the cannula can be adjusted by sliding the cannula along the cable.

[0114] In some embodiments of a nasal cannula assembly, the tube is tapered so that its cross-section is narrower closer to the cannula. Some embodiments further comprise an attachment portion coupled to the cable and configured to receive a portion of the tube. In some embodiments, the tube includes an attachment member that is configured to engage and be coupled to the attachment portion. In some embodiments, the cable can include indent portions configured to retain the cannula in a selected position.

[0115] In some embodiments, a nasal cannula assembly comprises a cannula frame having a bridge portion that extends away from the face of a patient and creates a space between the bridge portion and the patient's face. The bridge portion supports a single nasal prong. The assembly includes a first tube coupled to the prong and extending downward from the prong. The cannula frame defines a recess through which a second tube can extend between the bridge portion and a patient's face when in use.

[0116] In some embodiments of a nasal cannula assembly, the bridge portion includes a cut-out portion configured to receive a portion of the first tube, causing the tube to bend and extend away from the assembly to the side of a patient. In some embodiments, the cannula frame includes a contact portion that is configured to contact the face of a patient and comprises a soft material.

[0117] In some embodiments, a nasal cannula assembly comprises a cannula defining a cavity and comprising a single nasal prong extending from the cannula and in communication with the cavity. The cannula has a cannula opening in communication with the cavity and the opening has an axis. The assembly also includes a manifold pivotally coupled to the cannula and configured to pivot about the axis of the cannula opening. The assembly also includes a tube coupled to the manifold and configured to supply gas to the manifold. The manifold includes a manifold opening aligned with the cannula opening and in communication with the cavity.

[0118] In some embodiments of a nasal cannula assembly, the cannula includes frame portions extending outward from the cannula, the frame portions form one or more recesses between the cannula and the face of a patient when in use, and the one or more recesses are configured to receive a second tube. In some embodiments, the cannula includes a soft material on the side of the cannula facing a patient when in use. In some embodiments, the cannula includes a recess on each side of the prong so that a second tube can extend between the manifold and the cannula.

[0119] For purposes of summarizing the disclosure and the advantages achieved over the prior art, certain objects and advantages are described herein. Of course, it is to be understood that not necessarily all such objects or advantages need to be achieved in accordance with any particular embodiment. Thus, for example, those skilled in the art will recognize that the disclosure may be embodied or carried out in a manner that achieves or optimizes one advantage or group of advantages as taught or suggested herein without necessarily achieving other objects or advantages as may be taught or suggested herein. All of these embodiments are intended to be within the scope of the disclosure herein. These and other embodiments will become readily apparent to those skilled in the art from the following detailed description having reference to the attached figures, the disclosure not being limited to any particular disclosed embodiment(s).

[0120] In some embodiments, a nasal cannula assembly comprises:

a cannula part comprising a pair of tubular nasal prongs for insertion into the nares of a patient, and a manifold in fluid communication with the nasal prongs, the manifold comprising an aperture at left hand end of the manifold and an aperture at the right hand end of the manifold,

a connector adapted to receive an end of a gases flow conduit and be removably received in the aperture at left hand end of the manifold and the aperture at the right hand end of the manifold, and

a plug adapted to be removably received in the aperture at left hand end of the manifold and the aperture at the right hand end of the manifold,

in use the connector or the plug fitted to one of the apertures at the left and right sides of the manifold, and the plug fitted to the other one of the apertures at the left and right sides of the manifold to configure the conduit to extend from either the left side or right side of the nasal cannula assembly.

[0121] Preferably the plug and connector are separate parts.

[0122] Preferably the plug and connector are coupled or attached together by a lateral member to form a clip, optionally the lateral member is a connecting portion.

[0123] Preferably the clip is an integrally formed unitary member.

[0124] Preferably the clip and cannula part are complimentary adapted so that in use the lateral member is elastically deflected to fit the clip to the cannula part.

[0125] Preferably the clip is fitted to the cannula part by pushing the clip onto the cannula part in a direction perpendicular to a lateral direction of the cannula.

[0126] Preferably the cannula part comprises a rigid member for interfacing with the clip and the prongs are formed of a resilient material attached to the rigid member.

[0127] Preferably the rigid member and the lateral member are adapted so that the lateral member is flexed to spread the plug and connector apart when attaching the clip to the cannula part.

[0128] Preferably the clip is substantially 'C or 'U' shaped.

[0129] Preferably the plug and connector each extend into the aperture at the ends of the manifold.

[0130] Preferably the clip provides a positive force against the manifold to grip the manifold between the plug and the connector.

[0131] Preferably the cannula part comprises a recessed portion that is sized and shaped to receive the lateral member.

[0132] Preferably the cannula part comprising the manifold and nasal prongs is integrally formed.

[0133] Preferably the resilient material is over moulded to the rigid member.

[0134] Preferably the cannula part comprises side arms and the rigid member extends along the side arms.

[0135] Preferably the rigid part comprises through holes in the side arms for the resilient material to extend through by an over moulding process or assembly process.

[0136] Preferably the rigid member comprises a recessed portion that is sized and shaped to receive the lateral member.

[0137] Preferably the apertures at the ends of the manifold are formed in the rigid member.

[0138] Preferably the lateral member is length adjustable.

[0139] Preferably the clip comprises a first part and a second part, the first part comprises one of the plug and the connector and the second part comprises the other one of the plug and the connector, the first part comprises a first lateral member and the second part comprises a second lateral member, and

the first and second lateral members coupled together in a telescoping arrangement and comprising complementary features to set the lateral distance between the plug and the connector.

[0140] Preferably the complementary features comprise a projection on one of the first and second parts and a corresponding aperture in the other one of the first and second parts, the projection being received in the aperture to set the lateral distance between the plug and the connector.

[0141] Preferably one of the first and second parts comprises a plurality of corresponding apertures, the projection being received in the one of the plurality of apertures to set the lateral distance between the plug and the connector, the plurality of apertures providing for a range of cannula part sizes.

[0142] Preferably the clip is movably attached to the cannula part.

[0143] Preferably the clip is rotationally coupled to the cannula part.

[0144] Preferably the clip is rotationally coupled to the cannula part on a rotational axis on or parallel to the sagittal plane of the cannula to position the conduit to the left or right side of the nasal cannula assembly.

[0145] Preferably the manifold is formed of a relatively rigid material, and the cannula part comprises a resilient material moulded over the manifold, the nasal prongs integrally formed with the resilient material, and the cannula part comprises an axle extending from the manifold, and the clip rotationally mounted on the axle.

[0146] Preferably the axle is integrally formed with the manifold.

[0147] Preferably the clip comprises a keyway so that the clip can be removably mounted to the cannula part.

[0148] Preferably cannula part comprises a flange at the end of the axle to retain the clip on the axle in a direction along the rotational axis.

[0149] Preferably ends of the manifold are curved with a centre of curvature on the rotational axis, and the plug and the connector each have a complementary curvature so that the clip can rotate on the rotational axis to position the connector at either end of the manifold.

[0150] Preferably the over moulded resilient material covers ends of the manifold to provide a seal with the plug and connector.

[0151] In some embodiments a nasal cannula assembly comprises, for example such the assembly when the plug and connector are coupled or attached together by a lateral member to form a clip, the clip is fitted to the cannula part by pushing the clip laterally into the manifold via one of the aperture at the left hand end and the aperture at the right hand end so that the connector is received in one of the aperture at the left hand end and the aperture at the right hand end and the plug is received in the other one of the aperture at the left hand end and the aperture at the right hand end to configure the conduit to extend from either the left side or right side of the nasal cannula assembly.

[0152] Preferably the cannula part comprises a rigid member for interfacing with the clip and the prongs are formed of a resilient member attached to the rigid member, and the cannula part and the rigid member each comprise side arms extending laterally from the manifold.

[0153] In some embodiments, a nasal cannula assembly comprises:

a cannula part comprising a pair of tubular nasal prongs for insertion into the nares of a patient,

a connector adapted to receive an end of a gases flow conduit,

a manifold attached to or integrally formed with the connector, the connector providing an inlet to the manifold and the manifold having at least one outlet,

the cannula part movably attached to the manifold to be attached to the manifold in two orientations to configure the conduit to extend from either the left side or right side of the nasal cannula assembly.

[0154] Preferably the cannula part is rotatable relative to the manifold about a substantially vertical axis.

[0155] Preferably the manifold comprise an open top that is the manifold outlet, and the cannula part fits over the open top so that the prongs are in communication with the connector.

[0156] Preferably the manifold comprises a lip on a surface of the manifold to which the cannula part connects.

[0157] Preferably an axle extends from the manifold or the cannula part and the cannula part rotates relative to the manifold on the axle.

[0158] In some embodiments a nasal cannula assembly comprises:

a cannula part comprising a pair of tubular nasal prongs for insertion into the nares of a patient, and a left and a right lateral side arm for attaching headgear,

a first conduit for providing as flow of gas to one said nasal prong and a second conduit for providing a flow of gas to the other said nasal prong,

a first joint connecting the first conduit to one said nasal prong and a second joint connecting the second conduit to the other said nasal prong, the joints adapted to allow the first and second conduits to be routed to a left side or a right side of the nasal cannula assembly, and

a left clip on the left lateral side arm and a right clip on the right lateral side arm,

in use, the first conduit being held by the left clip or the right clip to configure the first conduit to extend from either the left side or right side of the nasal cannula assembly, and the second conduit being held by the left clip or the right clip to configure the second conduit to extend from either the left side or right side of the nasal cannula assembly.

[0159] Preferably the cannula part is an integrally formed part.

[0160] Preferably each joint is a flexible tube adapted to bend at least 90 degrees in any direction without substantial occlusion.

[0161] Preferably the flexible tubes comprise circu inferential ly extending ribs so that bending of the flexible conduit section does not cause the flexible conduit section to collapse.

[0162] Preferably each joint is a swivel joint.

[0163] Preferably each swivel joint rotates on an axis that is at an angle to an axis of the corresponding nasal prong so that rotation of the swivel joint allows both conduits to be routed to the left side or the right side without overlapping.

[0164] Preferably each swivel joint is a swivel elbow.

[0165] Preferably each said clip comprises two channels or receptacles each for receiving one of the tubes.

[0166] Preferably each flexible tube is integrally formed with a nasal prong.

[0167] Preferably each clip is integrally formed with a said side arm.

[0168] With respect to the embodiments above, reference to the manifold may be an open cavity formed by the cannula part, such as a cannula body, and in such embodiments the connector forms a component to be engaged with the open cavity, the connector forming a flow path for delivery of gases to the open cavity. Such embodiments may also be referred to below.

[0169] In some embodiments a nasal cannula system comprises:

a cannula body defining an open cavity and comprising at least one nasal prong extending from the cannula in communication with the cavity; and

a manifold comprising a manifold body capable of accepting a gases supply tube, the manifold body capable of being attached to the cannula in a first position and a second position, wherein the second position is different to the first position;

wherein the ends of the manifold body protrude into the open cavity of the cannula body, and the cannula body comprises a recess for retaining the manifold body.

[0170] Preferably wherein the manifold comprises a first side portion and a second side portion, where the first and second side portions extend from the manifold body and are adapted to be attached to headgear.

[0171] Preferably the recess of the cannula body retains the first and second side portions of the manifold.

[0172] Preferably one end of the manifold comprises a cap comprising a hinged area which divides the cap into inner and outer regions connected by a band, and wherein the hinged area permits relative motion between the inner and outer regions at the band.

[0173] In some embodiments a nasal cannula comprises:

a cannula body defining an open cavity and comprising at least one (and preferably a pair of) nasal prong(s) extending from the cannula in fluid communication with the open cavity; and

a manifold comprising a manifold body capable of engaging with the cannula for fluid connection with the open cavity, the manifold body orientable in either of a first operational position or a second operational position, wherein the first position and second positions are different to each other,

wherein the manifold body is adapted to accept a gases supply conduit at a first end of, or a gases inlet to, the manifold body, the first end adapted to engage with one end of the open cavity for delivery of gases into the open cavity, and a second end of the manifold body adapted to form a seal or connection with an other end of the open cavity, the manifold body forming an enclosure to the open cavity.

[0174] Preferably the cannula body comprises at least one recess or at least one surface relief or region of surface relief for retaining the manifold body in an engaged either of the first operational position or the second operational position.

[0175] Preferably the first end and the second end of the manifold body are connected to each other, the first end providing for a gases inlet to the open cavity and the second end providing for a plug or cap to substantially enclose the open cavity and provide for a fluid delivery pathway of supplied gases from the first end of the manifold body into the open cavity and to a terminal end of the at least one nasal prong.

[0176] Preferably the first and second ends of the manifold body are connected to each other by a connecting portion or connecting portions.

[0177] Preferably the connecting portion is one or more of at least one arm or at least one finger or at least one frame member.

[0178] Preferably the first and second ends of the manifold body are integrally formed. [0179] Preferably the connecting portion or the cannula body defining at least in part the open cavity, or both, comprise an alignment feature adapted to enable a predetermined geometric orientation of the manifold body relative to the cannula body for engagement therewith.

[0180] Preferably the alignment feature may be a region or regions of associated male and female parts or region or regions of associated surface relief.

[0181] Preferably the alignment feature is adapted to provide for an audible response to an engagement of the manifold with the cannula body when in an engaged operational first position or an engaged operational second position.

[0182] Preferably a connecting portion of the manifold body connecting the first and second ends to each other extends through an internal region of the open cavity, such that, in-situ, the first end of the manifold body is adapted to engage with one end of the open cavity for delivery gases into the open cavity, and the second end of the manifold body is adapted to form a seal or connection with the other end or any remaining portion of the open cavity requiring sealing to enable the delivery of gases to the open cavity.

[0183] Preferably the connecting portion extending through the internal region of the open cavity is shaped or configured to engage with, or be received by, an associated surface or region of the cannula body or an associated surface or region of the cannula body defining the open cavity.

[0184] Preferably a connecting portion of the manifold body connecting the first and second ends to each other extends about an external surface or exterior region of the cannula body defining at least in part the open cavity, such that, in-situ, the first end of the manifold body is adapted to engage with one end of the open cavity for delivery gases into the open cavity, and the second end of the manifold body is adapted to form a seal or connection with the other end or any remaining portion of the open cavity requiring sealing to enable the delivery of gases to the open cavity.

[0185] Preferably the connecting portion extending about the external surface or exterior region of the cannula body is shaped or configured to engage with, or be received by, an associated surface or region of the cannula body or an associated surface or region of the cannula body defining the open cavity.

[0186] Preferably a gas supply conduit is positioned or located substantially about a side or region of the cannula body from which the first end of the manifold body is positioned or projects from the cannula body.

[0187] Preferably the manifold can be oriented or is orientable with respect to the cannula body, such that a gas supply tube, in-use, is substantially positioned or located to one side of a user.

[0188] Preferably a first operational position allows for the first end of the manifold body to be located to either a left-end or a right-end of the cannula body defining the open cavity, and a second operational position allows for the first end of the manifold body to be located to either a respective right-end or a respective left-end of the cannula body defining the open cavity.

[0189] Preferably the first operational position or the second operational position enable for connection of a gases supply conduit to the first end of the manifold body from either a left or a right side.

[0190] Wherein the cannula body further comprises side arms or side portions extending away from the cannula body defining the open cavity, in-use, each of the side arms or side portions are adapted to extend at least in part along a portion of a user's face.

[0191] Preferably the nasal cannula as defined above comprises a first section formed from a first material and a second section formed from a second material, wherein the first section is relatively softer than the second section.

[0192] Optionally, the embodiments described above in relation to a first section being formed of a first material and a second section being formed of a second material are reiterated here.

[0193] Preferably a terminal end of the side arms adapted to accept connection thereto with a headgear.

[0194] Optionally the headgear to be associated with a nasal cannula described herein may be that as defined above in any of the other embodiments as described herein.

[0195] In some embodiments, a nasal cannula system comprises a nasal cannula assembly as defined in any one of the above embodiments and a headgear attached to the nasal cannula assembly for attaching the nasal cannula assembly to a patient's head.

[0196] In some embodiments there is a system for providing a flow of respiratory gases to a user or patient comprising a blower, a humidifier, the conduit and a nasal cannula system as defined in the embodiments described herein.

[0197] In some embodiments a headgear comprises:

a strap, each end of the strap adapted to be attached to a patient interface and extend around a patient's head to hold the patient interface in place on a patients face, wherein at least a portion of the strap is configured to bifurcate into more than one band to extend around the patients head.

[0198] Preferably the strap comprises a longitudinal frangible section extending along a portion of the strap to be torn by a user to separate the portion of the strap into more than one band.

[0199] Preferably the frangible section comprises a relatively thin section.

[0200] Preferably the frangible section is a perforated section.

[0201] Preferably the bands are separated by the frangible section.

[0202] Preferably the strap comprises a finger hole at the frangible section to assist with separating the bands by tearing the frangible section.

[0203] Preferably the strap comprises a hole at an end of the frangible section, the hole comprising a rounded portion defining an end of the frangible section to prevent tearing the strap beyond the frangible section.

[0204] Preferably the hole is a finger hole.

[0205] Preferably at least the portion of the strap is formed from fabric forming the bands, and the fabric is coated with a polymer with the bands arranged together, the coating providing the frangible section between the bands, the coating adapted to be torn to separate the bands.

[0206] Preferably the bands are formed by a longitudinal cut in the fabric along the portion of the strap, the polymer coating bridging the cut to hold the bands together in a non-bifurcating configuration.

[0207] Preferably the fabric is a foamed fabric.

[0208] Preferably the bands are separated by a removable section of the strap comprising a lift tab, the removable section joined to the bands by the frangible section.

[0209] Preferably the headgear comprises a clasp that is slidable along at least the portion of the strap configured to bifurcate.

[0210] Preferably to bifurcate the strap to separate the bands the clasp is slidable to an end of the bands, and the clasp is slidable to a midpoint of the bands to hold the bands together as a single strap.

[0211] Preferably to bifurcate the strap to separate the bands the clasp is slidable to an end of the bands, and the clasp is slidable to an opposite end of the bands to hold the bands together as a single strap.

[0212] Preferably each band comprises a feature that interfaces with a corresponding feature on the clasp to bind the bands together when in a non-bifurcated configuration.

[0213] Preferably the bands comprise interlocking teeth that are separated or mated by sliding the clasp along the bands.

[0214] Preferably the headgear comprises a web that extends between the bands, in a non-bifurcated configuration the web is bunched up or folded into a non-expanded configuration, and in a bifurcated configuration where the bands are spaced apart the web is expanded or unfolded to cover an area between the spaced apart bands.

[0215] Preferably the headgear comprises two clasps, in a non-bifurcated configuration both clasps are slid towards a central position of the strap to hold the bands together, and in a bifurcated configuration each clasp is slid to an end of the bands so that the bands may separate between ends of the bands.

[0216] Preferably each clasp and the straps are complementary adapted so that moving each clasp to an end of the bands forces the bands apart to separate the bands into a bifurcated configuration.

[0217] Preferably each clasp comprises two spaced apart flanges and three pins extending between the spaced apart flanges, the bands extending between the flanges, one said pin positioned between the bands and the other two pins positioned on outer edges of the bands, and the bands comprises a cross over portion near ends of the bands.

[0218] Preferably one or each band may comprise a central tab or stop to limit the amount of travel of the clasps along the bands.

[0219] Preferably the portion of the strap configured to bifurcate extends around the back of the patient's head from behind the patient's ears in use.

[0220] Preferably ends of the bands are pivotally coupled together.

[0221] Preferably the bands in a non-bifurcated configuration are arranged edge-to-edge.

[0222] Preferably the bands in a non-bifurcated configuration are arranged side-by-side.

[0223] Preferably the bands in the non-bifurcated configuration are held together by one or more of tearable stitching, a clasp or clasps, buttons, clips, hook and loop fasteners or magnets.

[0224] In some embodiments, there is a headgear for securing a patient interface to a user's face, the headgear comprising :

a strap, each end of the strap adapted to be attached to a patient interface and extend around a patient's head to hold the patient interface in place on a patients face, wherein the strap comprises a non-stretchable section and a stretchable section, the non-stretchable section adapted to be attached the patient interface and support a gases supply conduit coupled to the patient interface.

[0225] Preferably each end of the strap is a non-stretchable section adapted to be attached to the patient interface and the stretchable section is an intermediate section that extends between the non-stretchable sections around the back of the patient's head.

[0226] Preferably the non-stretchable section is adapted to be attached to one side of the patient interface and the stretchable section is adapted to be attached to an opposite side of the patient interface.

[0227] Preferably the non-stretchable section comprises a feature for securing the conduit.

[0228] In some embodiments there is a headgear for securing a patient interface to a user's face comprising :

a strap comprising a first stretchable section adapted to be attached to one side of a patient interface and a second stretchable section adapted to be attached to an opposite side of a patient interface, and a non-stretchable intermediate section extending between each end of the stretchable sections.

[0229] Preferably the intermediate portion is an annular portion, ends of the stretchable sections attached to the annular portion.

[0230] Preferably the headgear comprises a first non-stretchable sleeve and a second non-stretchable sleeve each extending from the non-stretchable intermediate section, and the first stretchable section extends along an inside of the first non-stretchable sleeve and the second stretchable section extends along an inside of the second non-stretchable sleeve.

[0231] Preferably the first and second non-stretchable sleeves extend from the intermediate portion to forward of the patient's ears in use.

[0232] Preferably the first and second stretchable sections are not attached to the first and second non-stretchable sleeve along the length of the sleeve from the intermediate portion.

[0233] Preferably one or both sleeves is/are adapted to support a gas conduit for providing a gas flow to the patient interface.

[0234] Preferably the head gear comprises a lanyard connected to a said sleeve adapted to secure the gas conduit.

[0235] Preferably the lanyard is stretchable.

[0236] Preferably the non-stretchable intermediate section is bifurcated to comprise two separate bands.

[0237] Preferably the non-stretchable section is configured to bifurcate into more than one band to extend around the patients head.

[0238] Preferably the headgear comprises a bifurcated section comprising two bands and one said band is the non-stretchable intermediate section.

[0239] Preferably the headgear comprises a first non-stretchable Ύ connector connecting between the first stretchable section and one end of the two bands and a second non-stretchable V connector connecting between the second stretchable section and an opposite end of the two bands.

[0240] Preferably one of the two bands is a stretchable band.

[0241] Preferably an upper one of the two bands is the stretchable band and a lower one of the two bands is the non-stretchable band.

[0242] Preferably the non-stretchable band is length adjustable.

[0243] Preferably at least one of the bands is adjustable in length.

[0244] Preferably an upper one of the two bands is adjustable in length.

[0245] In some embodiments there is a headgear for a patient interface comprising :

a stretch region, a non-stretch region, wherein said stretch region located sufficiently away from a tube loading region.

[0246] In some embodiments, there is a headgear, interface and tube assembly comprising, at least one stretch region, at least one non-stretch region, said stretch region located sufficiently away from a tube loading region, said stretch-region located at the back a user's head in use, wherein the tube is configured to be attached to either side of the interface.

[0247] In some embodiments, there is a headgear, interface and tube assembly comprising, at least one stretch region, at least one non-stretch region, said stretch region located sufficiently away from a tube loading region, where the tube loading region is a region that the tube is tethered to the headgear or interface.

[0248] In some embodiments there is a nasal cannula for administering a source of gases, such as breathable gases, to a user (e.g. a patient), the nasal cannula comprising :

at least a first section formed from a first material; and

at least a second section formed from a second material;

wherein the first section is relatively softer than the second section.

[0249] Preferably the second material is the same as the first material (for example, may be the same material but may be a different grade of such a material having different characteristics, such as a different Shore hardness or other rating).

[0250] Preferably the second material is different from the first material (for example, may be a different material having different characteristics, such a different Shore hardness or other ratings).

[0251] Preferably the sections are integrally formed with each other.

[0252] Preferably the sections are assembled to each other through the use of one or more mechanical fasteners or one or more chemical fastening systems (e.g. such as adhesive or plastic welding or ultrasonic welding of first and second sections, or portions thereof, together).

[0253] Preferably the first section provides for a user-friendly or comfort contacting component part of a nasal cannula.

[0254] Preferably the second section provides for a structural or support or shape-defining, component part, of a nasal cannula. Alternatively, the second section, in-use, is non-contacting of a user.

[0255] Preferably the configuration or shape of the first section is at least in part defined by parts or portions of the second section.

[0256] Preferably the first section forms a patient contacting surface, and the second section forms a frame upon which the first section is attached.

[0257] Preferably the first section encapsulates at least a part of the second section.

[0258] Preferably the second section is at least in part over-moulded by the first section.

[0259] Preferably the first section is at least an arm or a pair of arms extending outwards from a central body portion that comprises at least one (or preferably a pair of) nasal prong(s).

[0260] Preferably headgear is connectable to one or each arm, the headgear extending substantially about a rear part of a user's head.

[0261] Preferably the first section is adapted to receive a manifold connection for delivery of a source of gases to the nasal cannula or a body of the nasal cannula in fluid communication with a delivery system for delivery of gases to the user, such as via at least one nasal prong (or preferably a pair of nasal prongs) to, in-use, the nare or nares of the user.

[0262] Preferably the second section is adapted to receive a manifold connection for delivery of a source of gases to the nasal cannula or a body of the nasal cannula in fluid communication with a delivery system for delivery of gases to the user, such as via at least one nasal prong (or preferably a pair of nasal prongs) to, in-use, the nare or nares of the user.

[0263] Preferably a manifold is a component of a relatively rigid material, relative to the first material, the manifold connectable with an associated region of the nasal cannula or a body of the nasal cannula.

[0264] Preferably the first section comprises one or more surface relief portions, the surface relief portion(s) of the first section engageable with an associated one or more commensurately or complimentarily shaped or configured surface relief portions of the second section.

[0265] Preferably the first section comprises at least one raised region receivable by an associated aperture or detent region of the second section.

[0266] Preferably the first section comprises raised tabs or mushroom-shaped heads, and the second section comprises associated apertures receivable of the raised tabs or mushroom-shaped heads.

[0267] Preferably the first section comprises a cannula body portion defining at least in part an open cavity receivable of a supply of gases directed thereto via a manifold, the open cavity in fluid communication with one or a pair of nasal prongs.

[0268] Preferably the first section and second section are commensurately or complimentarily shaped or configured to communally receive a manifold connection for delivery of a source of gases to be delivered to a user.

[0269] Preferably the first section is at least in part a nasal cannula body defining an open cavity.

[0270] In an alternative, or additionally, the second section at least in part surrounds a nasal cannula body defining an open cavity.

[0271] Preferably the second section supports the first section in a predetermined configuration.

[0272] Preferably the second section extends substantially about the length of a nasal cannula defined by a first section. Alternatively, the second section extends to a longer length than the nasal cannula defined by a first section. In a further alternative, the second section extends to a shorter length than the nasal cannula defined by a first section.

[0273] Preferably a nasal cannula includes a pair of side arms extending outwardly from a cannula body defining at least in part an open cavity receivable of a source of gases, such as via a manifold connection.

[0274] Preferably located substantially toward each end of the side arms is a connection system for connecting a headgear, the headgear in-use, to be worn by a user.

[0275] Preferably the connection system is a part of the second section.

[0276] Preferably the first section provides for a gasket-type seal for a manifold connection or a manifold receivable by at least a part of the first section, such as that defining an open cavity of a cannula body.

[0277] Preferably the second section provides for a structure to which a manifold connection may be made, and the first section provides for a sealing, such as a fluid-type seal, of a manifold in making such a manifold connection.

[0278] Preferably a nasal cannula comprises a body defining an open cavity engageable by a manifold, a rear portion of said body being, in-use, substantially adjacent to a user's septum region, the rear portion being substantially compliant or deformable in response to a pressure applied by a user to said rear portion.

[0279] Preferably the rear portion is a substantially thinned wall section of the body. Wherein the rear portion is defined by a hollow section of the body, with the open cavity being a separate distinct region of the body.

[0280] In an alternative, the rear portion defines at least a part of a wall of the open cavity.

[0281] Preferably the rear portion is substantially elasticised.

[0282] Preferably the rear portion is elastically deformable.

[0283] Preferably, the body comprises a hollowed enclosure substantially adjacent to the user's septum region,

[0284] Preferably, the body comprises a pillow section substantially adjacent to the user's septum region.

[0285] Preferably, the pillow section is a hollow region, the hollow region bounded by walls of the body, and separate to an open chamber (such as a plenum chamber), and having a relatively thin wall or elasticised section in the region substantially adjacent to, in use, the user's septum. Alternatively, the pillow section is formed by a rear wall of such an open cavity (or plenum chamber), the rear wall being a relatively thin wall or elasticised section in the region substantially adjacent to, in use, the user's septum.

[0286] Preferably, the pillow section is formed of a material capable of deforming under application of a pressure by a user during use.

[0287] As noted above, in some configurations or embodiments, the nasal cannula interface may comprise a first section and a second section. The first section may comprise a relatively soft material. The second section may comprise a relatively hard material. Preferably, the first section in use contacts the patient's face, and the second section in use does not contact the patient's face.

[0288] The sections may be assembled together by any method of manufacture. In some configurations, the sections could be overmoulded, for example, one on top of the other. In some configurations, the sections could be glued together using an adhesive. In some configurations, the sections could be assembled together using ultrasonic welding. In some configurations, the sections could be assembled together using one or more mechanical or other fasteners or fastening systems.

[0289] Preferably a nasal cannula as defined above may be utilised in combination with each of the other details described in this specification to provide for a nasal cannula interface.

[0290] In some embodiments a patient interface, such as a nasal cannula, comprises a gases delivery mechanism (such as one or a pair of nasal prongs to engage with the nare or nares of a user's nose), and a body from which the gases delivery mechanism is associated, and extending from the body is a pair of side arms, the body and side arms being connected in a manner such that application of a tension to the side arms directs the gases delivery mechanism to move away from a position otherwise imposing upon a user's nasal spine.

[0291] In some embodiments a nasal cannula, comprising a cannula body from which a nasal prong or a pair of nasal prongs extend to engage with the nare(s) of a user, and from which a pair of side arms extends outwardly and to which a headgear system is connectable, the cannula body being substantially conformable to a user's face yet providing sufficient rigidity so that, in-use, a force or a tension applied to outer-more portions of the side arms directs or encourages the nasal prong or nasal prongs to impose less upon a user's nasal spine region.

[0292] Preferably a continuous section of material extends along each side arm and connects, or is mechanically coupled, in a region of the nasal prong or nasal prongs.

[0293] Preferably the continuous section of material is a material capable of translating an applied force or tension from the side arms to the region of the nasal prong or nasal prongs.

[0294] Preferably each of the side arms define a pre-form or shape such that, before application of a force or a tension from a headgear, the side arms curve outwardly away from the face of the user, extending more outwardly so as the side arms extend further away from a gas delivery mechanism of the interface or from a nasal prong or a pair of nasal prongs.

[0295] Preferably each of the side arms is substantially in contact with a user's face as the arms extend outwardly away from the gas delivery mechanism or nasal prong or pair of nasal prongs, with each of the side arms becoming less in contact or more distant (or both) from a user's face the further the arms extend from the gas delivery mechanism or nasal prong or pair of nasal prongs.

[0296] Preferably, the side arms define a pre-form or shape such that, in-use, application of a force or a tension to the side arms via the headgear encourages (or directs) the side arms to more into a position of greater facial contact with the user's face or cheeks and the body is encouraged (or directed) to move into a position less engaged with, or imposing upon, or further away from, the user's nasal spine region.

[0297] Preferably the side arms are configured to, in-use, encourage the translation or location or re-locating or distribution or re-distribution of a force or a tension being applied by a headgear to a nasal cannula, to a user's cheeks and away from the user's nasal spine region or away from the force or tension being applied to the user's nasal spine region .

[0298] Preferably each of the side arms are pre-formed or shaped such that, in-use, application of a force or a tension to the side arms, requires the side arms, or at least portions of the side arms, to move closer to a user's face, a hinging or flexing point (or point of flexure) of the side arm upon a user's face being established upon a cheek region, and the nasal prong or nasal prongs or another gases delivery mechanism being encouraged away from imposing upon a user's nasal spine region.

[0299] Preferably the hinging or flexing point (or point of flexure) being established in-use, is a region at or about any one or more of the user's left or right (or both) : lower outer maxilla, upper outer maxilla, zygomatic arch, maxilla recess (or below the zygomatic arch).

[0300] In some embodiments a connector for connecting a breathing tube to a device (such as a humidifier or ventilator or other source of gases), or for connecting to at least another breathing tube, the connector comprising :

an inner body and an outer body,

each of the inner body and outer body having a first end and a second end, the first end of the inner and outer bodies for receiving a terminal end of a first breathing tube, and the second end of the inner and outer bodies for connecting to a further

component, such as for example: a further breathable tube, or a device (e.g. such as a humidifier, or a ventilator or a source of gases),

wherein the first end of the inner body receives and fluidly connects with the terminal end of the first breathing tube, the inner body providing a lumen for fluid connection between the first end and the second end of said inner body,

and wherein the inner body is rotatable relative to the outer body.

[0301] Preferably the inner body is adapted to swivel relative to the outer body.

[0302] Preferably the outer body may comprise one or more surface relief features. More preferably, such surface relief features are provided, in use, as finger grips for a user.

[0303] Preferably the second ends of the inner body and/or the outer body are adapted to provide a connection system for connecting with another breathing tube or with a device (e.g. such as a humidifier, or a ventilator or a source of gases).

[0304] Preferably the terminal end of the first breathing tube connected to the first end of the inner body may be, in use, longitudinally rotatable with respect to the outer body.

[0305] Preferably the inner body is sleeved with respect to the outer body.

[0306] Preferably the connector as defined above may be provided as a connector for use with a gas supply tube for a nasal cannula or other patient interface as described in this specification .

[0307] Preferably the second end of the outer body is adapted to connect to the further component, the outer body being non-swivelable relative to a connection being made with the further component, for example at a machine end of a breathing circuit.

[0308] The various references to tube or conduit in this specification may optionally, but not necessarily, relate to application of such tubes or conduit to those typically understood to as being "breathing tubes", such as those referred to in ISO 5367 : 2000(E) (Fourth edition, 2000-06-01). It will be appreciated the tubes or conduits of this invention may relate to, or find particular application to, such breathing tubes for use in delivery of gases to a user or a patient.

[0309] As used herein the term "and/or" means "and" or "or", or both.

[0310] As used herein "(s)" following a noun means the plural and/or singular forms of the noun .

[0311] The sagittal plane of a nasal cannula or other patient interface is defined as the sagittal plane of a user that extends through the cannula or patient interface when the cannula or patient interface is positioned on a user's face in use. For example, the sagittal plane of a nasal cannula comprising a nasal prong for each nostril is positioned centrally between the nasal prongs.

[0312] The lateral direction with respect to a nasal cannula is the direction extending between left and right hand ends of the cannula. The lateral direction is perpendicular to a direction extending between the front and back of the cannula. The sagittal plane of a cannula is perpendicular to the lateral direction.

[0313] The invention involves the foregoing and also envisages constructions of which the following gives examples only.

BRIEF DESCRIPTION OF THE DRAWINGS

[0314] These and other features, aspects and advantages of the present disclosure will be described with reference to the following drawings, which are illustrative but should not be limiting of the present disclosure.

[0315] Figure 1A illustrates an example embodiment of a nasal cannula assembly coupled to a patient;

[0316] Figure IB illustrates a partial front perspective view of the nasal cannula assembly of Figure 1A;

[0317] Figure 1C illustrates an exploded view of the nasal cannula assembly of Figures 1A and IB;

[0318] Figure 2A illustrates a front perspective view of an example embodiment of a nasal cannula assembly including a cannula and manifold;

[0319] Figure 2B illustrates a partial rear perspective view of the nasal cannula assembly of Figure 2A;

[0320] Figure 3A illustrates a front perspective view of an example embodiment of a nasal cannula assembly including a cannula and manifold;

[0321] Figure 3B illustrates a partial rear perspective view of the nasal cannula assembly of Figure 3A;

[0322] Figure 4 illustrates a partial front perspective view of an alternative configuration of the nasal cannula assembly of Figures 3A and 3B;

[0323] Figure 5A illustrates a front perspective view of an example embodiment of a nasal cannula assembly including a cannula without a manifold;

[0324] Figure 5B illustrates a partial rear perspective view of the nasal cannula assembly of Figure 5A;

[0325] Figure 6A illustrates a front perspective view of an example embodiment of a nasal cannula assembly including cheek pads;

[0326] Figure 6B illustrates a partial rear perspective view of the nasal cannula assembly of Figure 6A;

[0327] Figure 7A illustrates a front perspective view of an example embodiment of a nasal cannula assembly including a cannula with an integrated head strap;

[0328] Figure 7B illustrates a partial rear perspective view of the nasal cannula assembly of Figure 7A;

[0329] Figure 7C illustrates an example embodiment of a lanyard connector for a nasal cannula assembly;

[0330] Figure 8A illustrates a front perspective view of an example embodiment of a nasal cannula assembly including a cannula and manifold;

[0331] Figure 8B illustrates a partial rear perspective view of the nasal cannula assembly of Figure 8A;

[0332] Figure 8C illustrates an exploded view of the nasal cannula assembly of Figures 8A and 8B;

[0333] Figure 9A illustrates a front perspective view of an example embodiment of a nasal cannula assembly including a cannula and manifold;

[0334] Figure 9B illustrates a partial rear perspective view of the nasal cannula assembly of Figure 9A;

[0335] Figure 9C illustrates a variation of the nasal cannula assembly of Figures 9A and 9B;

[0336] Figure 10A illustrates a side perspective view of an example embodiment of a nasal cannula assembly including a cannula and a nose strip attached to a patient's face;

[0337] Figure 10B illustrates a partial rear perspective view of the nasal cannula assembly of Figure 10A;

[0338] Figure 11 illustrates an alternative configuration of the nasal cannula assembly of Figures 10A and 10B;

[0339] Figure 12A illustrates a partial front perspective view of an example embodiment of a nasal cannula assembly including two cannulas;

[0340] Figure 12B illustrates top, front, and side views of one of the cannulas of Figure 12A;

[0341] Figure 12C illustrates a front perspective view of the nasal cannula assembly of Figure 12A coupled to a patient;

[0342] Figure 13A illustrates a front perspective view of an example embodiment of a nasal cannula assembly including a cannula and retainer;

[0343] Figure 13B illustrates a partial side perspective view of the nasal cannula assembly of Figure 13A;

[0344] Figure 13C illustrates a partial front perspective view of the nasal cannula assembly of Figures 13A and 13B coupled to a patient;

[0345] Figure 14A illustrates a front perspective view of a nasal cannula assembly including a manifold and a cannula having nasal flaps;

[0346] Figure 14B illustrates an exploded view of the nasal cannula assembly of Figure 14A; and

[0347] Figure 14C illustrates the nasal cannula assembly of Figures 14A and 14B coupled to a patient.

[0348] Figures 15A-G illustrate an example embodiment of a nasal cannula assembly with a shuttle valve.

[0349] Figures 16A-F illustrate example embodiments of a nasal cannula assembly with a manifold having a one way valve formed from an exhalation style valve with a loosely hinged flap.

[0350] Figures 16G-L illustrate embodiments of a nasal cannula assembly with a manifold having a one way valve formed from a slit valve of various types.

[0351] Figures 17A and 17B illustrate an example embodiment of a nasal cannula assembly with a tube threaded through the manifold to allow for selective side switching of the tube exit side.

[0352] Figures 18A and 18B illustrate an example embodiment of a nasal cannula assembly with each tubing exit hole sealed by a thin membrane that is pierced by a sharpened end of the supply tube.

[0353] Figures 19A and 19B illustrate an example embodiment of a manifold with a flexible tube exiting the front tubing exit hole of the manifold.

[0354] Figures 20A-C illustrate an example embodiment of a manifold that snaps into an assembly securing device or clip.

[0355] Figures 21A-F illustrate example embodiments of a nasal cannula assembly with a removable tubing assembly and manifold.

[0356] Figures 21G and 21H illustrate an example embodiment of a nasal cannula assembly with a manifold receiving structure, separate nasal prong insert and a manifold. [0357] Figures 22A-D illustrate an example embodiment of a nasal cannula assembly with a manifold insert and a manifold receiving structure.

[0358] Figures 23A-C illustrate an example embodiment of a nasal cannula assembly with a manifold insert which can be clipped over a tubing assembly.

[0359] Figures 24A-C illustrate an example embodiment of a nasal cannula assembly having prongs formed with a ripple shape around the base to allow for flexibility of the prongs.

[0360] Figures 24D-F illustrate an example embodiment of the prongs formed with a corrugated geometry to allow for flexibility of the prongs.

[0361] Figure 25A illustrates an example embodiment of a nasal cannula assembly that includes individually rotatable prongs.

[0362] Figures 25B-C illustrate an example embodiment of a nasal cannula assembly that includes a pair of prongs mounted on a vertical shaft and rotatable as a unit.

[0363] Figures 26A-F illustrate an example embodiment of a nasal cannula assembly configured to allow insertion of a removable prong insert in at least two orientations.

[0364] Figures 27A-D illustrate example embodiments of a nasal cannula assembly that includes a manifold that is rotatable about an axis extending in a generally fore-aft direction.

[0365] Figures 28A and 28B illustrate example embodiments of a nasal cannula assembly that includes a manifold and supply tube that can be coupled to the cannula in at least two orientations.

[0366] Figure 29A illustrates an example embodiment of a respiratory assistance system with a nasal cannula assembly having pressure measurement capability.

[0367] Figures 29B-L illustrate example embodiments of nasal cannula assemblies having pressure measurement capability.

[0368] Figures 30A-I illustrate example embodiments of nasal cannula assemblies having features to address, reduce or minimize patient discomfort, especially at or near the upper lip area.

[0369] Figures 31A-F illustrate example embodiments of adjustable or formable supply tubes for nasal cannula assemblies.

[0370] Figures 32A-N illustrate example embodiments of nasal cannula assemblies having arrangements and features to manage the positioning of the supply tube.

[0371] Figures 33A-S illustrate example embodiments of arrangements for providing support to the supply tube.

[0372] Figures 34A-K illustrate example embodiments of headgear arrangements for securing the cannula to the face of a patient.

[0373] Figures 35A-G illustrate example embodiments of retention arrangements for nasal cannula assemblies.

[0374] Figures 36A-K illustrate example embodiments of retention arrangements, such as headgear straps, including an indicator of tightness, such as strap tension.

[0375] Figure 37A illustrates an example embodiment of a headgear strap having a strap pad.

[0376] Figures 37B-E illustrate example embodiments of an adjustable headgear strap arrangement for a nasal cannula assembly.

[0377] Figures 38A-G illustrate example embodiments of an adjustable cannula and prong arrangement for a nasal cannula assembly.

[0378] Figures 39A-I illustrate example embodiments of a cannula and prong arrangement with adjustable alignment for a nasal cannula assembly.

[0379] Figures 40A-J illustrate example embodiments of adjustable prong arrangements for a nasal cannula assembly.

[0380] Figures 41A-D illustrate example embodiments of support arrangements for a nasal cannula assembly.

[0381] Figures 42A-0 illustrate example embodiments of insulation and tubing arrangements for a nasal cannula assembly.

[0382] Figures 43A-0 illustrate example embodiments of tubing arrangements for a nasal cannula assembly.

[0383] Figures 44A-G illustrate example embodiments of tubing arrangements for a nasal cannula assembly.

[0384] Figures 45A-Q illustrate example embodiments of temperature regulation arrangements for a nasal cannula assembly.

[0385] Figures 46A-E illustrate example embodiments of pressure measurement port arrangements for a nasal cannula assembly.

[0386] Figures 47A-0 illustrate example embodiments of nasal cannula arrangements configured to accommodate a nasogastric (IMG) or nasojejunal (NJ) tube.

[0387] Figures 48A-S illustrate example embodiments of single prong arrangements for a nasal cannula assembly.

[0388] Figure 49 illustrates a respiratory humidifier system that may be used with a nasal cannula assembly according to one or more embodiments of the present invention.

[0389] Figures 50A and 50B illustrate a nasal cannula assembly comprising a cannula part and a separate plug and conduit connector.

[0390] Figure 51 illustrates a nasal cannula assembly comprising cannula part and a clip comprising a plug and conduit connector for connecting a gas conduit to the cannula part.

[0391] Figures 52A and 52B illustrate a nasal cannula assembly comprising cannula part and a clip comprising a plug and conduit connector for connecting a gas conduit to the cannula part. The cannula part comprises a rigid member for interfacing with the clip.

[0392] Figures 53A and 53B illustrate a clip comprising a conduit connector and a plug, for connecting a gas conduit to a cannula part. A lateral distance between the plug and connector is adjustable. Figure 53B is an exploded view.

[0393] Figure 54A to 54C illustrate a nasal cannula assembly comprising a cannula part and a clip comprising a plug and conduit connector for connecting a gas conduit to the cannula part. The clip is rotationally mounted to the cannula part.

[0394] Figures 55A and 55B illustrate a nasal cannula assembly comprising a cannula part and a conduit connector comprising a manifold. The cannula part is rotationally mounted to the manifold.

[0395] Figures 56A to 56C illustrate a nasal cannula assembly comprising a cannula part and a clip comprising a plug and conduit connector for connecting a gas conduit to the cannula part. The clip is inserted laterally into a manifold of the cannula part.

[0396] Figure 57A illustrates a cannula assembly comprising a pair of gas supply conduits, each conduit connected to a nasal prong via a flexible tube section, and a clip at each side of the cannula assembly for configuring the conduits to extend from the left or right side of the cannula.

[0397] Figures 57B and 57C illustrate a nasal cannula assembly comprising a pair of gas supply conduits, each conduit connected to a nasal prong via a swivel elbow.

[0398] Figure 58A illustrates a bifurcate-able strap for a headgear comprising a frangible section to bifurcate a portion of the strap into two separate bands.

[0399] Figure 58B illustrates a bifurcate-able strap in use in a non-bifurcated configuration.

[0400] Figure 58C illustrates a bifurcate-able strap in use in a bifurcated configuration. [0401] Figure 58D illustrates how a bifurcate-able strap comprising a frangible section is separated to form a bifurcated a portion comprising two separate bands.

[0402] Figure 58E illustrates a bifurcate-able strap in a non-bifurcated configuration.

[0403] Figure 58F illustrates a cross section of the strap of Figure 58E.

[0404] Figure 58G illustrates a cross section of the strap of Figure 58A.

[0405] Figure 59 illustrates a bifurcate-able strap for a headgear comprising a lift out portion defined by a frangible section, for bifurcating a portion of the strap into two separate bands.

[0406] Figures 60A and 60B illustrate a bifurcate-able strap for a headgear comprising a clasp slidable along a bifurcate-able section of the strap to configure the bifurcate-able section into a bifurcated or a non-bifurcated configuration.

[0407] Figures 61A to 61C illustrate a bifurcate-able strap for a headgear comprising two clasps slidable along a bifurcate-able section of the strap to configure the bifurcate-able section into a bifurcated or a non-bifurcated configuration.

[0408] Figure 62 illustrates a bifurcate-able strap wherein ends of separate bands of the strap are pivotally coupled.

[0409] Figure 63 illustrates a headgear strap comprising a stretchable and a non-stretchable portion. The non-stretchable portion is bifurcated into two separate bands.

[0410] Figure 64 illustrates a headgear strap comprising a bifurcated portion wherein at least one band of the bifurcated portion is stretchable and ends of the bifurcated bands are joined by a non-stretchable Y connector.

[0411] Figure 65 illustrates a head gear strap comprising a stretchable portion and a non-stretchable portion. The non-stretchable portion supports a gases supply conduit.

[0412] Figure 66 illustrates a head gear strap comprising a first non-stretchable section attached to one side of a patient interface and a second non-stretchable section attached to an opposite side of the patient interface, and a stretchable intermediate section extending between the first and second non-stretchable sections.

[0413] Figure 67 illustrates a head gear strap comprising a first stretchable section attached to one side of a patient interface and a second non-stretchable section attached to an opposite side of the patient interface, and a non-stretchable annular intermediate section extending between the first and second non-stretchable sections.

[0414] Figure 68 illustrates a head gear strap comprising a bifurcated portion wherein at least one band of the bifurcated portion is adjustable in length.

[0415] Figure 69 is a perspective view of a sectioned nasal cannula system that is arranged and configured in accordance with certain features, aspects, and advantages of the present disclosure.

[0416] Figure 70 is an exploded view of a sectioned nasal cannula in which the sections are configured to be mechanically fastened to one another.

[0417] Figure 71 is a magnified view of the mechanical fastening means of Figure 70 in use.

[0418] Figure 72 is similar to the exploded view shown in Figure 70, but includes a clip-on gases flow supply tube.

[0419] Figure 73 is a perspective view of a sectioned nasal cannula system similar to that of Figure 72, except the cannula system has been assembled from the exploded components.

[0420] Figure 74 is a perspective view of an exploded cannula system with a clip-on supply tube attachment.

[0421] Figure 75 is a perspective view of an exploded alternative cannula system (relative to Figure 74) with a clip-on supply tube attachment.

[0422] Figure 76 is a perspective view of the cannula system of Figure 75, except that the cannula system has been assembled from the exploded components.

[0423] Figure 77 is a perspective view of an exploded alternative cannula system (relative to Figures 74 and 75) with a clip-on supply tube attachment.

[0424] Figure 78 is a perspective view of a clip-on supply tube attachment with a hinged end cap.

[0425] Figure 79 is a close view of the hinged end cap of Figure 78.

[0426] Figure 80 is a top-down view of the clip-on supply tube of Figure 78, where the hinged end cap has moved towards the gases supply tubing.

[0427] Figure 81 is a top-down view of the clip-on supply tube of Figure 78, where the hinged end cap has moved away from the gases supply tubing.

[0428] Figure 82 is a perspective view of an assembled cannula system with the clip-on supply tube attachment of Figure 78.

[0429] Figure 83 is one embodiment of a nasal cannula system, including a pair of nasal prongs, a cannula body, a pair of side arms extending from the cannula body, a headgear in connection with the side arms, a gas supply tube for providing a source of gases to be in fluid communication with a pair of nasal prongs, and a connector associated with the gas supply tube.

[0430] Figure 84 is another embodiment of a nasal cannula system, including a pair of nasal prongs, a cannula body, a pair of side arms extending from the cannula body, a headgear in connection with the side arms, a gas supply tube for providing a source of gases to be in fluid communication with a pair of nasal prongs, and a connector associated with the gas supply tube.

[0431] Figure 85 is a cross-sectional view through the embodiment shown in Figure 84, the cross-section illustrating one example of how a first section of first material may be provided in combination with a second section of second material, in combination with one example of a pivoting or swivel type manifold.

DETAILED DESCRIPTION

[0432] Although certain embodiments and examples are described below, those of skill in the art will appreciate that the disclosure extends beyond the specifically disclosed embodiments and/or uses and obvious modifications and equivalents thereof. Thus, it is intended that the scope of the disclosure herein disclosed should not be limited by any particular embodiments described below. Various features described herein can be used individually or in various combinations and sub-combinations in existing and/or improved respiratory interfaces.

[0433] Whether used in a hospital environment or in a home environment, a system for providing a flow of gases to a patient or user may comprise four main pieces of apparatus. Firstly a blower for providing a flow of pressurised gas to the patient. Secondly an active humidifier that controls the temperature of a heater plate heating a body of water to achieve a desired temperature and humidity of the flow of gas. Thirdly a transport conduit from the humidifier to the patient is also required, which may be heated to reduce condensation, or "rain out". Fourthly a patient interface for delivering the pressurized humidified flow of gases to a patient, for example a nasal cannula designed to fit into the nasal cavity of a patient or user. In some situations a flow of pressurized gases may be provided to a patient without humidification, in which case a humidifier is not a necessary apparatus.

[0434] Referring to Figure 49 a humidifying circuit as might be used with a patient interface comprising the present invention is shown . A patient 100001 is receiving humidified and pressurised gases through a nasal cannula assembly 10020 connected to a humidified gases transportation pathway or inspiratory conduit 100003 that in turn is connected to a humidifier 100008 (including humidification chamber 100005) that is supplied with gases from a blower 10015 or other appropriate gases supply means. The inspiratory conduit 100003 is connected to the outlet 100004 of a humidification chamber 100005 which contains a volume of water 100006. Humidification chamber 100005 is preferably formed from a plastics material and may have a highly heat conductive base

(for example an aluminium base) which is in direct contact with a heater plate 100007 of humidifier 100008. The humidifier 100008 is provided with control means or electronic controller 100009 which may comprise a microprocessor based controller executing computer software commands stored in associated memory. Gases flowing through the inspiratory conduit 100003 are passed to the patient by way of the nasal cannula assembly 100020.

[0435] Controller 100009 receives input from sources such as user input means or dial 10010 through which a user of the device may, for example, set a predetermined required value (preset value) of humidity or temperature of the gases supplied to patient 100001. In response to the user set humidity or temperature value input via dial 10010 and other possible inputs such as internal sensors that sense gases flow or temperature, or by parameters calculated in the controller, controller 100009 determines when (or to what level) to energise heater plate 100007 to heat the water 100006 within humidification chamber 10005. As the volume of water 100006 within humidification chamber 100005 is heated, water vapour begins to fill the volume of the chamber above the water's surface and is passed out of the humidification chamber 100005 outlet 100004 with the flow of gases (for example air) provided from a gases supply means or blower 10015 which enters the chamber through inlet 10016. It should be noted that it is possible to obtain the relationship between the humidity of the gases in humidification chamber 100005 and the temperature of the heater plate 100007. Accordingly, it is possible to utilise the heater plate temperature in an algorithm or a look-up table to determine the humidity of the gases.

[0436] The blower 10015 may be provided with a variable speed pump or fan 100002 which draws air or other gases through the blower inlet 10017. The speed of variable speed pump or fan 100002 may be controlled by a further control means or electronic controller 10018 (or alternatively the function of this controller 10018 could be carried out by the other controller 100009) in response to inputs from controller 100009 and a user set predetermined required value (preset value) of pressure or fan speed via dial 10019.

[0437] A heating element 10011 may be provided within the conduit or tubing 100003 to help prevent condensation of the humidified gases within the conduit. Such condensation is due to the temperature of the walls of the conduit being close to the ambient temperature, (being the temperature of the surrounding atmosphere) which is usually lower than the temperature of the humidified gases within the conduit. The heater element effectively replaces the energy lost from the gases through conduction and convection during transit through the conduit. Thus the conduit heater element ensures the gases delivered are at an optimal temperature and humidity.

[0438] With reference to Figures 1A-1C, an example embodiment of a nasal cannula assembly or system includes a manifold 12 and cannula 14. The cannula 14 includes nasal prongs 20a, b, side straps 22, and a tubular aperture 24 defined or encircled by a retention strap 26 and configured to receive the manifold 12. In some embodiments, the manifold is generally tubular and includes a circular inlet 16 and an elongated oval outlet 18. In use, the manifold 12 is coupled to the cannula 14 by inserting the manifold 12 into the aperture 24 so that the manifold outlet 18 is aligned and in fluid communication with the nasal prongs 20a, b. The manifold inlet 16 is configured to be coupled, removably or permanently, to a gas supply tube 50. In use, the gas supply tube 50 is coupled to and in fluid communication with a main delivery conduit 90, which is configured to be connected to and supply gases from a gas source, for example, a ventilator, gas tank, wall outlet, and/or humidifier that heats and/or humidifies gases before they are delivered to a patient. The gas supply tube 50 can be coupled to the main delivery conduit 90 by a connector 52.

[0439] The nasal cannula system can further include a securement mechanism to secure the cannula 14 to a user's head in a proper operational position. In the illustrated embodiment, the securement mechanism includes a headgear strap 40. The strap 40 can be coupled to the side straps 22 of the cannula 14. The nasal cannula system can also include a lanyard 46 that in use is placed around the patient's neck. The lanyard 46 can be coupled to the supply tube 50 and/or the connector 52 via a lanyard connector 54, which can also allow for adjustment of a length of the lanyard. The lanyard 46 advantageously helps support the weight of the main delivery conduit 90 to reduce patient discomfort and the potential for dislodgement of the cannula 14. Further details regarding example nasal cannula assemblies or systems can be found in U.S. Publication 2010/0192957, the entirety of which is incorporated by reference herein. Various components and features of such nasal cannula assemblies can be selected and modified to achieve various benefits as described herein.

[0440] With reference to Figures 2A and 2B, an embodiment of a nasal cannula assembly or system includes a cannula 114, manifold 112, headgear strap 140, gas supply tube 150, and lanyard 146. The cannula 114 can be formed of a thermoplastic, silicone-like material and includes nasal prongs 120a, b, side straps 122, and two spaced manifold retention portions or straps 126a, b defining/encircling an aperture configured to receive the manifold 112. In some embodiments, the nasal prongs 120a, b, side straps 122, and manifold retention straps 126a, b are integrally formed. The cannula 114 is configured such that the manifold 112 can be inserted into the aperture of the manifold retention straps 126a, b from either side, so that the manifold inlet 116 can be positioned to either side of the cannula 114. The side straps 122 can include flex slots 128 to provide ventilation and allow the cannula 114 to bend or stretch more easily, for example, when adjusting the headgear strap 140 and when adjusting the cannula 114 against the users face to help achieve a more effective and/or comfortable fit. The flex slots 128 can be generally vertical as shown or diagonally slanted. As shown in Figure 2B, a patient facing and contacting side 130 of the cannula 114 can have a contoured surface to better and more comfortably fit the patient's face, reduce the overall profile of the cannula system, and help align the supply tube 150. For example, transition portions 132 positioned between a central body portion 134 of the cannula 114 and the side straps 122 can curve toward the patient's face to rest against the nasolabial folds. The side straps 122 can taper in thickness toward outer edges of the straps 122 to create a thin profile and help further reduce the cannula system profile.

[0441] The headgear strap 140 can be coupled to the side straps 122 via clips or buckles 142. The clips 142 can include an aperture 144 so that an inner edge 145 of the clip 142 on the side nearest the center of the cannula 114 can engage a corresponding undercut on the side strap 122. As shown in Figure 2B, the clips 142 do not substantially contact the patient's skin, thereby maintaining a smooth and more comfortable patient contacting surface. A side of the clip 142 farthest from the center of the cannula 114 can include a buckle mechanism configured to receive ends of the headgear strap 140 and allow for adjustment of the circumference of the headgear strap 140 to fit the patient's head. In some embodiments, the strap 140 can be flexible (e.g., elastic) to allow the strap 140 to accommodate a wide range of patient head sizes with minimal adjustment required.

[0442] In use, the manifold 112 is coupled to the cannula 114 by inserting the manifold 112 into the aperture 124 and stretching the flexible cannula 114 around the manifold 112. As described above, the manifold 112 can be inserted into the aperture 124 of the manifold retention straps 126a, b from either side, so that the manifold inlet 116 and, thus, the supply tube 150 can be positioned to either side of the cannula 114. In some embodiments, the manifold 112 is made of a relatively hard plastic material that can withstand relatively high loading conditions to protect the manifold 112 from being crushed. In addition, the retention straps 126a, b can be spaced apart from one another to provide support to the manifold 112 at spaced apart locations, which can inhibit or resist undesirable movement (e.g., rotation or twisting) of the manifold 112, such as that caused by forces acting on the supply tube 150, for example. In some configurations, the outer lateral edges of the retention straps 126a, b are spaced outwardly of the nasal prongs 120a, b such that the nasal prongs 120a, b are located between the lateral edges of the retention straps 126a, b. In some configurations, the inner edges of the retention straps 126a, b can be substantially aligned with or spaced outwardly from the nasal prongs 120a, b. Although a pair of retention straps 126a, b is illustrated, other suitable retention arrangements or structures are possible, such as a single retention strap, for example. In the illustrated embodiment, the manifold inlet 116 has an inner diameter slightly larger than an outer diameter of the supply tube 150 so that the tube 150 can be coupled to the manifold 112 by inserting an end of the tube 150 into the manifold inlet 116. The supply tube 150 can have a reduced diameter compared to other supply tubes to allow for this coupling. An end of the tube 150 opposite the manifold can include a connector 152 configured to couple the supply tube 150 to the main delivery conduit coupled to the gas source. In the illustrated embodiment, the connector 152 is a 22 mm taper connector.

[0443] The cannula system can include a lanyard connector 154, which in the illustrated embodiment is located on the supply tube 150 proximal (nearer to the patient) the connector 152. The lanyard connector 154 can include mechanisms 155 for receiving ends of the lanyard 146 on either side. For example, each side of the lanyard connector 154 can include three or more offset slots or posts through which an end of the lanyard 146 is threaded. The slots or posts can be internal to the lanyard connector 154 or exposed. This configuration advantageously allows one or both ends of the lanyard to be adjusted as needed or desired, and allows the weight of the connector 152 (and the main delivery circuit 90) to be hung or oriented in a vertical orientation or direction. In some embodiments, the lanyard 146 is non-elastic. The lanyard 146 is secured to the lanyard connector 154 via friction between the lanyard 146 and slots or posts. The lanyard 146 can be ribbed to help secure the lanyard 146 to the lanyard connector 154. However, the lanyard 146 and lanyard connector 154 can be designed so that the friction force is overcome and the lanyard 146 releases from the lanyard connector 154 if the connector 154 is pulled too far away from the patient and/or pulled with sufficient force to avoid the lanyard 146 choking or otherwise causing discomfort to the patient. The lanyard connector 154 can include a grip 156 to allow the patient or others to better grasp the lanyard connector 154 for adjustments and/or for easy removal of the connector 152 from the main delivery conduit 90.

[0444] With reference to Figures 3A and 3B, a nasal cannula assembly or system includes a cannula 214, manifold 212, headgear strap 240, gas supply tube 250, and lanyard 246. The cannula 214 includes nasal prongs 220a, b, side straps 222, and a manifold retention strap 226 defining or encircling an aperture configured to receive the manifold 212. The cannula 214 is configured such that the manifold 212 can be inserted into the aperture of the manifold retention strap 226 from either side, so that the manifold inlet 216 can be positioned to either side of the cannula 214. In the illustrated embodiment, the manifold retention strap 226 is wide compared to the retention strap 26 shown in Figures 1A and IB and straps 126a, b shown in Figure 2. The retention strap 226 can include a window 227 that allows part of the manifold 212 to be visible, for example, indicating that the manifold 212 is correctly inserted into manifold retention strap 226. The window 227 can display, for example, branding, size, and/or other information printed, stamped, adhered or otherwise presented on the visible portion of the manifold 212.

[0445] The cannula 214 is generally soft and flexible for patient comfort. Outer portions 223 of the side straps 222 can be made to have increased strength, for example, by making the outer portions 223 thicker or otherwise reinforcing them, such as via strengthening ribs, which can be positioned at upper and/or lower edges of the side straps 222, for example. The added strength allows the headgear strap 240 to be coupled directly to the outer portions 223 of the side straps 222 without the need for additional clips, buckles, or other attachment mechanisms and allows the cannula 214 and side straps 222 to hold their moulded shape, preventing or inhibiting deformation during tension. The outer portions 223 of the side straps 222 can include two or more slits or apertures through which ends 243 of the strap 240 can be threaded and pulled through a desired length to obtain a headgear strap 240 circumference appropriate to fit the patient. The ends 243 of the headgear strap 240 can be folded back and removably secured to portions of the headgear strap 240 proximate the outer portions 223 of the side straps 222 via a hook and loop type closure. For example, a segment of fabric including hooks can be attached (e.g., sewn, adhered, etc.) to the ends 223 of the headgear strap 240, and a segment of fabric including loops can be attached (e.g., sewn, adhered, etc.) to the portions of the headgear strap 240 proximate the outer portions 223 of the side straps 222. An opposite side of the ends 243 of the strap 240 visible when worn can include branding or other information printed, stamped, adhered, or otherwise attached thereto.

[0446] As shown in Figure 3B, a rear or patient-facing side of the side straps 222 can include recessed areas 221 to accommodate the portions of the headgear strap 240 looped through the side straps 222 so that the strap 240 does not significantly press against the patient's face. A section of the headgear strap 240 configured to be placed against the back of the patient's head in use can include a padded section 241 for patient comfort. The padded section can be inserted between two halves of the headgear strap 240 or placed on top of or around the headgear strap 240.

[0447] In use, the manifold 212 is coupled to the cannula 214 by inserting the manifold into the aperture defined by the manifold retention strap 226. The manifold 212 can be inserted into the aperture of the manifold retention strap 226 from either side, so that the manifold inlet 216 can be positioned to either side of the cannula 214. In the illustrated embodiment, the manifold 212 includes a cylindrical inlet 216. The inlet 216 has an inner diameter slightly larger than an outer diameter of the supply tube 250 so that the tube 250 can be coupled to the manifold 212 by inserting an end of the tube 250 into the manifold inlet 216. An end of the tube 250 opposite the manifold 212 can include a connector 252 configured to couple the supply tube 250 to the main delivery conduit coupled to and in fluid communication with the gas source.

[0448] The cannula system can further include a lanyard connector 254 located on the supply tube 250 proximal to the connector 252. In some embodiments, the lanyard connector 254 is color coded to indicate size or other information. One side of the lanyard connector 254 can include a mechanism 255 for adjustably receiving one end of the lanyard 246. For example, one side of the lanyard connector 254 can include two slits or apertures through which the end of the lanyard 246 can be threaded. This mechanism 255 allows the lanyard 246 to be easily placed around the patient's neck and coupled to the lanyard connector 254 without having to put the lanyard 246 over the patient's head. The lanyard connector 254 can also include a grip 256 to allow the patient or others to better grasp the lanyard connector 254 for adjustments and/or easy removal the connector 252 from the main delivery conduit 90.

[0449] One side of the lanyard connector 254 can include a breakaway clip 257. An end of the lanyard 246 can include molding configured to be inserted into the breakaway clip 257 to secure the lanyard 246 to the lanyard connector 254. The breakaway clip 257 is designed so that if the lanyard 246 applies too great a force to the patient's neck due to, for example, the main delivery conduit, connector 252, supply tube 250, and/or lanyard connector 254 being pulled away from the patient with a force exceeding a certain threshold, the breakaway clip 257 releases the lanyard 246 or detaches from the lanyard connector 254 to avoid patient injury or discomfort. This configuration advantageously allows the weight of the connector 252 (and the main delivery circuit 90) to be hung or oriented in a vertical orientation or direction. In some embodiments, the lanyard 246 is made of an inelastic material to improve the function of the breakaway clip 257 and so that the weight of the main delivery conduit coupled to the connector 252 does not stretch the lanyard 246 and apply additional force to the patient's neck. In some embodiments, the breakaway clip 257 allows the lanyard 246 to be easily looped around the patient's neck then inserted into the breakaway clip 257.

[0450] Figure 4 illustrates a cannula system having a cannula 314 and headgear strap 340 similar in some ways to the cannula 214 and headgear strap 240 illustrated in Figures 3A and 3B. However, the cannula system of Figure 4 lacks a manifold retention strap and includes a reversible manifold 312. The manifold 312 can pivot or rotate or be decoupled from the cannula 314 and turned 180° so that the inlet 316 can be located to either side of the cannula 214.

[0451] An embodiment of a nasal cannula assembly or system as illustrated in Figures 5A and 5B includes a cannula 414, headgear strap 440, and gas supply tube 450. The cannula 414 includes nasal prongs 420a, b, side straps 422, and an inlet 416. In the illustrated embodiment, an end of the gas supply tube 450 couples directly to the inlet 416 of the cannula 414. The supply tube 450 can have a reduced diameter so that the end of

the supply tube 450 can be received within the inlet 416. The supply tube 450 can be secured to the cannula 414 by stretching the cannula inlet 416 over the end of the supply tube 450, using an adhesive (e.g., glue), mechanical interference features, and/or other means. The cannula 414 further includes two gas paths 417a, b extending from and in fluid communication with the inlet 416, so that a first gas path 417a extends to and is in fluid communication with a first nasal prong 420a, and a second gas path 417b extends to and is in fluid communication with a second nasal prong 420b. The geometry of the gas paths 417a, b can be designed to balance gas flow between the two gas paths 417a, b and nasal prongs 420a, b so that the patient receives balanced flow in both nostrils. The flow path has reduced, minimal or no significantly abrupt transitions or sharp corners, which advantageously reduces or minimizes resistance to flow.

[0452] Ends of the side straps 422 can include apertures or slots 421 designed to receive ends of the headgear strap 440. The headgear strap 440 can be formed of a highly elastic material capable of a large degree of stretch to allow the strap 440 to accommodate and fit various patient head sizes, particularly where, as in the illustrated embodiment, the side straps 422 do not include clips or buckles to allow for adjustment of the circumference of the headgear strap 440. For example, the headgear strap 440 can be made of a material having a relatively flat force extension curve so that the strap 440 maintains the same or substantially the same tension over a range of degree of stretch. The ends of the headgear strap 440 can include a rigid material overmolded thereon to help secure the ends of the strap 440 within the apertures 421. The strap 440 can also or alternatively be secured to the cannula 414 with an adhesive (e.g., glue), ultrasonic welding, and/or other means.

[0453] The cannula system can include a tube clip 442 coupled (permanently or removably, immovably or movably) to the headgear strap 440. The tube clip 442 can be located on the side of the cannula 414 nearest the inlet 416 and can receive the supply tube 450 to help hold the tube 450 away from the mouth and face of the patient in use. An end of the supply tube 450 opposite the end coupled to the cannula inlet 416 can include a connector 452 configured to couple the supply tube 450 to the main delivery conduit. The cannula system can include a lanyard clip 454 positioned on the supply tube 450 proximal to the connector 452. The lanyard clip 454 can releasably clip to a lanyard worn around the patient's neck in use. Alternatively, the lanyard clip 454 can be directly attached to, for example, the patient's clothing or hospital gown, bed sheets, or another location nearby to help support the weight of the main delivery conduit. The nasal cannula system illustrated in Figures 5A and 5B does not include a manifold or clips or buckles for attaching the headgear strap 440 to the cannula 414. This configuration minimizes the parts of the nasal cannula system, which can advantageously help provide easier manufacturing and/or reduce the cost.

[0454] Another embodiment of a nasal cannula assembly or system includes a cannula 514, manifold 512, gas supply tube 550, and lanyard 546 as shown in Figures 6A and 6B. The cannula 514 includes nasal prongs 520a, b, a manifold retention strap 526, and cheek pads 522. The cheek pads 522 are designed to be positioned on the patient's cheeks and/or upper cheeks in use. The cannula 514 includes thin flex areas 532 located at transition regions between a central body portion 534 of the cannula 514 and the cheek pads 522. The thin flex areas 532 have a reduced cross-sectional thickness to allow the cheek pads 522 to move and be adjusted relative to the central body portion 534 more easily to improve the fit, positioning, and comfort of the cannula 514 on the patient's face. A rear or patient contacting side of the central body portion 534 can include soft and/or thin wall cushion details 535. The cushion details 535 can include, for example, a ribbed, rippled, folded or other surface designed to space the central body portion 534 of the cannula 514 away from the patient's face slightly. This advantageously allows for airflow between the central body portion 534 and the patient's face and provides a collapsible region to help absorb forces pressing the cannula 514 into the patient's face.

[0455] Rear surfaces of the cheek pads 522 include attachment pads 560 integrally formed with the cheek pads 522 or sewn, adhered, or otherwise attached thereto. The attachment pads 560 can include a releasable and reattachable adhesive to attach the cheek pads 522 to the patient's face. Alternatively, the attachment pads 560 can include one portion of a hook and loop fastener, for example, a fabric segment including the hooks. Patches containing the other portion of the fastener, for example the loops, can be attached to the patient's face at desired locations on the cheeks and/or upper cheeks to allow the attachment pads 560 to be releasably attached to the patient's face.

[0456] The manifold 512 includes an inlet 516 designed to receive the gas supply tube 550 and an outlet designed to be aligned and in fluid communication with the nasal prongs 520a, b in use. The manifold 512 is coupled to the cannula 514 by sliding the manifold 512 into an aperture defined by the manifold retention strap 526 so that the outlet aligns with the nasal prongs 520a, b and stretching the cannula 514 around edges of the manifold 512. The manifold 512 can be inserted into the aperture of the manifold retention strap 526 from either side, so that the manifold inlet 516 can be positioned to either side of the cannula 514. The retention strap 526 can include a window 527 that allows part of the manifold 512 to be visible, for example, indicating that the manifold 512 is correctly inserted into manifold retention strap 526. The window 527 can display, for example, branding, size, and/or other information printed, stamped, adhered or otherwise presented on the visible portion of the manifold 512.

[0457] In the illustrated embodiment, the supply tube 550 is a small diameter spiral tube. Other types of gas supply conduits are also possible. An end of the supply tube 550 opposite the end coupled to the manifold 512 can include a connector 552 configured to be connected to the main delivery conduit. The cannula system can include a lanyard retention connector 554 located on the connector 552 or on the supply tube 550 proximal to the connector 552. One end of the lanyard 546 can be integrally formed with or coupled to one side of the lanyard retention connector 554. An opposite side of the lanyard retention connector 554 can include a slot designed to receive a free end 547 of the lanyard 546. The free end 547 of the lanyard 546 can include a series of protrusions or notches 548. The protrusions 548 can be pulled through the slot of the lanyard retention connector 554 to adjust the circumference of the lanyard 546 but resist sliding through the slot when not being adjusted to help secure the lanyard 546 at the desired circumference. The lanyard 546 can be made of a stamped fabric, for example, white non-woven laminated polyethylene, which can advantageously help reduce the cost of the cannula system.

[0458] An example embodiment of a cannula system as shown in Figures 7A-7B includes a cannula 614, gas supply tube 650, and lanyard 646. The cannula 614 includes nasal prongs 620a, b, a retention strap 626, and an integrated headgear strap 640. In some embodiments, the headgear strap 640 can include a break on one side so that the headgear strap 640 includes a first section 640a and a second section 640b. The free end of one section (first section 640a in the illustrated embodiment) can include a slot 642 configured to receive the free end of the other section (second section 640b in the illustrated embodiment). A segment of the strap 640 near the free end of the second section 640b can include teeth 643 configured to engage sides of the slot 642 to help inhibit the second section 640b from being pulled out of the slot 642. A rear portion 641 of the headgear strap 640, which is part of the first section 640a in the illustrated embodiment, can separate into a double strap configuration to aid stability of headgear strap 640 on the patient's head and/or help distribute forces on the patient's head and improve patient comfort.

[0459] In the illustrated embodiment, an end of the gas supply tube 650 is coupled directly to the cannula 614. The supply tube 650 can have a reduced diameter so that the end of the supply tube 650 can be received within an aperture defined by the retention strap 626. The supply tube 650 can be secured to the cannula 614 by stretching the manifold retention strap 626 over the end of the supply tube 650, using an adhesive (e.g., glue), mechanical interference feature, and/or other means. The cannula system can include a tube clip 642 coupled (permanently or removably, immovably or movably) to the supply tube 650. The tube clip 642 can include a hook configured to be placed on the headgear strap 640 to help hold the tube 650 away from the mouth and face of the patient in use.

[0460] An end of the supply tube 650 opposite the end coupled to the cannula 614 can include a connector 652 configured to be connected to the main delivery conduit. The cannula system can further include a lanyard retention connector 654. The connector 652 can include a lower portion and an upper portion 653 including grip features. In some embodiments, the connector 652 includes a reduced diameter section between the upper and lower portions to receive the lanyard retention connector 654. Alternatively, the upper and lower portions can be separate pieces. In use, the lanyard retention connector 654 is pressed over a portion of the connector 652 and held in place between the upper and lower portions or in the reduced diameter section.

[0461] In the illustrated embodiment, the lanyard 646 is integrally formed with one side of the lanyard retention connector 654. Alternatively, the lanyard 646 can be coupled to the lanyard retention connector 654. An opposite side of the lanyard retention connector 654 can include a slot designed to receive a free end 647 of the lanyard 646. The free end 647 of the lanyard 646 can include a series of notches 648 along the sides. In use, the lanyard 646 is wrapped around the patient's neck and the free end 647 of the lanyard is threaded through the slot of the lanyard retention connector 654 to achieve the desired circumference of the lanyard 646. The notches 648 allow the free end 647 of the lanyard 646 to be pulled through the slot of the lanyard retention connector 654 to adjust the circumference of the lanyard 646 but resist sliding through the slot when not being adjusted to help secure the lanyard 646 at the desired circumference. The lanyard 646 can be made of a stamped fabric, for example, white non-woven laminated polyethylene, which can advantageously help reduce the cost of the cannula system.

[0462] In an alternative embodiment, shown in Figure 7C, the cannula system can include a connector 752, a lanyard connector 754 positioned on the supply tube 650 proximal to the connector 752, and a separate lanyard 746. The lanyard connector 754 includes two slots to receive the ends of the lanyard 746. Both ends of the lanyard 746 can include a series of notches 748 similar to the notches 648 described herein to allow for adjustment of one or both ends of the lanyard 746. This configuration advantageously allows the weight of the connector 752 (and the main delivery circuit 90) to be hung or oriented in a vertical orientation or direction.

[0463] In some embodiments, for example as shown in Figures 8A-8C, a cannula system includes a cannula 814, manifold 812, headgear strap 840, gas supply tube 850, and lanyard 846. The cannula 814 includes nasal prongs 820a, b, and an inlet 824. As shown in Figure 8C, a flange 825 encircles a perimeter of the inlet 824. The manifold 812 includes an inlet 816 configured to receive the supply tube 850 and an outlet 818. The outlet 818 of the manifold 812 includes a recess 819 configured to receive the flange 825 of the cannula 814. In some embodiments, the manifold 812 and cannula 814 can be

designed to have a reduced size to advantageously reduce the profile of the cannula system on the patient's face, which can improve patient comfort and reduce the chance of obstructing the face or mouth in some circumstances.

[0464] In use, the manifold 812 is coupled to the cannula 814 by inserting one side of the manifold 812 into the cannula 814 inlet 824 so that the flange 825 of the cannula 814 sits in the recess 819 of the manifold 812 and stretching the cannula 814 around the manifold 812 outlet 818 so that the flange 824 sits in the recess 819 around the entire perimeters of the cannula 814 outlet 824 and manifold 812 outlet 818. The flange 824 and corresponding recess 819 advantageously help secure the connection between the cannula 814 and manifold 812 and can also help prevent air leaks at the connection. The manifold 812 can further include a tab 880 designed to fit into a corresponding recess or aperture 882 on the cannula 814 to help further secure the manifold 812 to the cannula 814 and indicate that the manifold 812 is correctly inserted into the cannula 814. As shown in Figure 8C, the manifold 812 is reversible, i .e., the manifold 812 can be coupled to the cannula 814 so that the manifold inlet 816 extends to either side of the cannula 814. The manifold 812 can include a grip 815 to advantageously assist a user in grasping the manifold 812 to couple and/or remove the manifold 812 to and/or from the cannula 814.

[0465] In the illustrated embodiment, the headgear strap 840 is coupled directly to the cannula 814, and the cannula system does not include clips, buckles, or other mechanisms that allow for adjustment of the circumference of the strap 840. Sides of the cannula 814 can include apertures or slots 821 designed to receive ends of the headgear strap 840. The ends of the strap 840 can be secured to the cannula 814 with an adhesive (e.g., glue), ultrasonic welding, and/or other means. The headgear strap 840 can be formed of a highly elastic material capable of a large degree of stretch to allow the strap 840 to accommodate and fit various patient head sizes. For example, the headgear strap 840 can be made of a material having a relatively flat force extension curve so that the strap 840 maintains the same or substantially the same tension over a range of degree of stretch. A pitch of threads of the headgear strap 840 material can be changed to adjust the tightness of the strap 840.

[0466] The gas supply tube 850 can be coupled to the manifold 812 inlet 816 at one end and a connector 852 configured to couple the supply tube 850 to the main delivery conduit at an opposite end. The gas supply tube 850 can have a reduced diameter so that the end of the tube 850 can be inserted into the manifold inlet 816. In some embodiments, the connector 852 can include grip details 856 to help the user grasp the connector 852 more easily to adjust various components of the cannula system. In some embodiments, the gas supply tube 850 can include a pressure line 870. The pressure line 870 can be configured to convey pressure feedback from the end of the supply tube 850 coupled to the manifold 812 to a pressure sensor and/or controller. The pressure line 870 can be integral with or coupled to the supply tube 850. In some embodiments, the pressure line 870 lies within the main flow path of the supply tube 850. In other embodiments, the pressure line 870 lies adjacent the main flow path of the supply tube 850. For example, in some embodiments, the supply tube 850 can be a spiral bubble tube, and the pressure line 870 can lie in the hollow spiral of the spiral bubble supply tube 850.

CLAIMS

1. A nasal cannula for administering a breathable gas to a patient (or user), the nasal cannula comprising :

a first section formed from a first material; and

a second section formed from a second material;

wherein the first section is relatively softer than the second section.

2. The nasal cannula as claimed in claim 1, where the second material that is the same as the first material.

3. The nasal cannula as claimed in claim 1, where the second material that is different from the first material.

4. The nasal cannula as claimed in any one of claims 1-3, where the sections are assembled through the use of one or more mechanical fasteners.

5. The cannula as claimed in any one of claims 1-4, wherein the sections are assembled to each other through the use of one or more fastening systems.

6. The cannula as claimed in any one of claims 1-5, wherein the first section provides for a user-friendly or comfort contacting component part of a nasal cannula.

7. The cannula as claimed in any one of claims 1-6, wherein the second section provides for a structural or support or shape-defining, component part, of a nasal cannula.

8. The cannula as claimed in any one of claims 1-7, wherein the configuration or shape of the first section is at least in part defined by parts or portions of the second section.

9. The cannula as claimed in any one of claims 1-8, wherein the first section forms a patient contacting surface, and the second section forms a frame upon which the first section is attached.

10. The cannula as claimed in any one of claims 1-9, wherein the first section encapsulates at least a part of the second section.

11. The cannula as claimed in any one of claims 1-10, wherein the second section is at least in part over-moulded by the first section.

12. The cannula as claimed in any one of claims 1-11, wherein the first section is at least an arm or a pair of arms extending outwards from a central body portion that comprises at least one (or preferably a pair of) nasal prong(s).

13. The cannula as claimed in any one of claims 1-12, wherein the first section is adapted to receive a manifold connection for delivery of a source of gases to the nasal cannula or a body of the nasal cannula in fluid communication with a delivery system for delivery of gases to the user, such as via at least one nasal prong (or preferably a pair of nasal prongs) to, in-use, the nare or nares of the user.

14. The cannula as claimed in any one of claims 1-13, wherein the second section is adapted to receive a manifold connection for delivery of a source of gases to the nasal cannula or a body of the nasal cannula in fluid communication with a delivery system for delivery of gases to the user, such as via at least one nasal prong (or preferably a pair of nasal prongs) to, in-use, the nare or nares of the user.

15. The cannula as claimed in any one of claims 1-14, wherein a manifold is a component of a relatively rigid material, relative to the first material, the manifold connectable with an associated region of the nasal cannula or a body of the nasal cannula.

16. The cannula as claimed in any one of claims 1-15, wherein the first section comprises one or more surface relief portions, the surface relief portion(s) of the first section engageable with an associated one or more commensurately or complimentarily shaped or configured surface relief portions of the second section.

17. The cannula as claimed in any one of claims 1-16, wherein the first section comprises at least one raised region receivable by an associated aperture or detent region of the second section.

18. The cannula as claimed in any one of claims 1-17, wherein the first section comprises a cannula body portion defining at least in part an open cavity receivable of a supply of gases directed thereto via a manifold, the open cavity in fluid communication with one or a pair of nasal prongs.

19. The cannula as claimed in any one of claims 1-18, wherein the first section and second section are commensurately or complimentarily shaped or configured to communally receive a manifold connection for delivery of a source of gases to be delivered to a user.

20. The cannula as claimed in any one of claims 1-19, wherein the first section is at least in part a nasal cannula body defining an open cavity.

21. The cannula as claimed in any one of claims 1-20, wherein the second section at least in part surrounds a nasal cannula body defining an open cavity.

22. The cannula as claimed in any one of claims 1-21, wherein the second section supports the first section in a predetermined configuration.

23. The cannula as claimed in any one of claims 1-22, wherein the second section extends: substantially about the length of a nasal cannula defined by a first section, or substantially to a longer length than the nasal cannula defined by a first section, or wherein the second section extends to a shorter length than the nasal cannula defined by a first section.

24. The cannula as claimed in any one of claims 1-23, wherein a nasal cannula includes a pair of side arms extending outwardly from a cannula body defining at least in part an open cavity receivable of a source of gases, such as via a manifold connection.

25. The cannula as claimed in any one of claims 1-24, wherein located substantially toward each end of the side arms is a connection system for connecting a headgear, the headgear in-use, to be worn by a user.

26. The cannula as claimed in any one of claims 1-25, wherein the connection system is a part of the second section.

27. The cannula as claimed in any one of claims 1-26, wherein the first section provides for a gasket-type seal for a manifold connection or a manifold receivable by at least a part of the first section, such as that defining an open cavity of a cannula body.

28. The cannula as claimed in any one of claims 1-27, wherein the second section provides for a structure to which a manifold connection may be made, and the first section provides for a sealing, such as a fluid-type seal, of a manifold in making such a manifold connection.

29. The cannula as claimed in any one of claims 1-28, wherein a nasal cannula comprises a body defining an open cavity engageable by a manifold, a rear portion of said body being, in-use, substantially adjacent to a user's septum region, the rear portion being substantially compliant or deformable in response to a pressure applied by a user to said rear portion.

30. The cannula as claimed in claim 29, wherein the rear portion is a substantially thinned wall section of the body.

31. The cannula as claimed in claim 29 or 30, wherein the rear portion is defined by a hollow section of the body, with the open cavity being a separate distinct region of the body.

32. The cannula as claimed in any one of claims 29-31, wherein the rear portion defines at least a part of a wall of the open cavity.

33. The cannula as claimed in any one of claims 29-32, wherein the rear portion is substantially elasticised.

34. The cannula as claimed in any one of claims 29-33, wherein the rear portion is elastically deformable.

35. The cannula as claimed in any one of claims 29-34, wherein the body comprises a hollowed enclosure substantially adjacent to the user's septum region,

36. The cannula as claimed in any one of claims 29-35, wherein the body comprises a pillow section substantially adjacent to the user's septum region.

37. The cannula as claimed in claim 36, wherein the pillow section is a hollow region, the hollow region bounded by walls of the body, and separate to an open chamber, and having a relatively thin wall or elasticised section in the region substantially adjacent to, in use, the user's septum.

38. The cannula as claimed in claim 36 or 37, wherein the pillow section is formed by a rear wall of such an open cavity, the rear wall being a relatively thin wall or elasticised section in the region substantially adjacent to, in use, the user's septum.

39. The cannula as claimed in any one of claims 36-38, wherein the pillow section is formed of a material capable of deforming under application of a pressure by a user during use.

40. A headgear comprising :

a strap, each end of the strap adapted to be attached to a patient interface and extend around a patient's head to hold the patient interface in place on a patients face, wherein

at least a portion of the strap is configured to bifurcate into more than one band to extend around the patients head.

41. The headgear as claimed in claim 40, wherein the strap comprises a longitudinal frangible section extending along a portion of the strap to be torn by a user to separate the portion of the strap into more than one band.

42. The headgear as claimed in claim 41, wherein the frangible section comprises a relatively thin section.

43. The headgear as claimed in claim 42, wherein the frangible section is a perforated section.

44. The headgear as claimed in any one of claims 41-43, wherein the bands are separated by the frangible section.

45. The headgear as claimed in any one of claims 41-44, wherein the strap comprises a hole at an end of the frangible section, the hole comprising a rounded portion defining an end of the frangible section to prevent tearing the strap beyond the frangible section.

46. The headgear as claimed in any one of claims 41-45, wherein at least the portion of the strap is formed from fabric forming the bands, and the fabric is coated with a polymer with the bands arranged together, the coating providing the frangible section between the bands, the coating adapted to be torn to separate the bands.

47. The headgear as claimed in claim 46, wherein the bands are formed by a longitudinal cut in the fabric along the portion of the strap, the polymer coating bridging the cut to hold the bands together in a non-bifurcating configuration.