Nasal cannula assemblies and related components

Abstract

A nasal cannula assembly for providing respiratory therapy to a patient is provided. A nasal cannula assembly may include a cannula, an optional removable manifold, a gas supply tube, and a securing mechanism. The fixation mechanism may include a headgear strap, a cheek pad, or an adhesive nasal strip. The nasal cannula assembly may also include a lanyard, a lanyard clip, and / or a lanyard connector to assist in supporting the weight of the primary gas delivery catheter.

Description

[0001] This divisional application is a divisional application of the patent application with Chinese invention patent application number 201810946451.2, invention title “Nasal cannula assembly and related components” and application date March 14, 2014, and the patent application with application number 201810946451.2 is a divisional application of the patent application with Chinese invention patent application number 201480015555.1 (international application number PCT / NZ2014 / 000040), invention title “Nasal cannula assembly and related components” and application date March 14, 2014. Technical Field

[0002] The present disclosure relates to devices and systems for providing gas to a patient for respiratory therapy. More specifically, the present disclosure relates to a nasal cannula interface for providing gas to a patient via the nasal passages. Background Art

[0003] In an ICU (intensive care unit), other hospital, or home environment, medical professionals may wish to provide respiratory assistance to patients in the form of supplemental oxygen or airflow for many reasons. Different types of interfaces are available for supplying gas to patients. For example, there are different nasal masks, full-face masks, oral interfaces, nasal pillows, and nasal cannula interfaces. The nasal cannula interface typically includes two nasal prongs that are placed in the patient's nostrils to deliver gas to the patient.

[0004] The nasal cannula assembly typically consists of a symmetrical or single-sided inlet tubing that passes over the upper lip. Protruding from this tubing is an open-ended prong that extends into the patient's nostril to deliver oxygen. Nasal cannulae have the advantage of being more comfortable and more acceptable to most patients than masks. Single-flow inlet nasal cannulae have the advantage of being unobtrusive and are more suitable for delivering humidified air than dual-flow inlet style nasal cannulas due to the advantages in flow rate and surface area for heat loss. However, the single-flow inlet is provided on one side of the cannula, i.e., the left or right side. For example, if the tube is located on the left, it may be difficult for the user to use if the flow source is located on the opposite side or right side of the user, thereby requiring a longer tubing and causing the tube to span the body.

[0005] When humidified gas is provided to a patient, a heated breathing circuit (tubing) is typically used. This circuit is heavy and can drag and pull on the patient interface. A short flexible tube is typically used between the heated circuit and the patient interface to reduce any torque or twisting. To prevent the weight from pulling on the patient interface, a circuit hanger is occasionally used. This is a large, expandable metal arm designed to bear the weight. It is also known in the art to clip a portion of the tubing to the patient's clothing or bedding. Both of these solutions have been found to be quite unsuitable for mobile patients, especially when asleep and turning over in bed.

[0006] For patient interfaces, such as nasal cannulas, the stability of the nasal prongs on the face is very important, as movement of these prongs within the nostrils can cause severe irritation. The current method used to hold single-portal nasal cannulas on the face is to use a simple elastic band around the back of the patient's head. This easily allows the nasal cannula to rotate relative to the patient's head, especially when a person turns their head on a pillow. This rotation causes the prongs to move within the nostrils, thereby irritating this sensitive area.

[0007] Where reference is made in this specification 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 expressly stated otherwise, reference to such external documents is not to be construed as an admission that these documents, or such sources of information, are prior art or form part of the common general knowledge in the art in any jurisdiction.

[0008] It is an object of the present invention to provide an improved nasal cannula assembly or patient interface headgear or at least to provide the public with a useful choice. Summary of the Invention

[0009] The nasal cannula interface described herein can be advantageously used to provide a wide range of concentrations and flow rates of gas to a patient. The nasal cannula interface described herein also includes different features designed to improve patient comfort, safety, ease of use, and / or efficiency, reduce costs, and / or provide other benefits.

[0010] In some embodiments, the nasal cannula system includes a cannula and a manifold. The cannula includes a central body portion, a first side portion and a second side portion extending from the central body portion in opposite lateral directions and contacting the cheeks of the user when the system is in use, and a first nasal prong and a second nasal prong extending from the central body portion. The central body portion includes a patient-facing side and at least one retaining strip for cooperatively defining a cavity. The first nasal prong and the second nasal prong are in communication 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 can be received within the cavity of the cannula so that the gas outlet is aligned with the first nasal prong and the second nasal prong. The at least one retaining strip defines a first lateral edge and a second lateral edge, and the first nasal prong and the second nasal prong are located between the first lateral edge and the second lateral edge.

[0011] In some embodiments, the nasal cannula system includes a cannula and a supply tube. The cannula includes a central body portion, a first side portion and a second side portion extending in opposite lateral directions from the central body portion and contacting the cheeks of the user when the system is in use, and a first nasal prong and a second nasal prong extending from the central body portion. The cannula defines a cavity having an inlet at a first end and a second end, the first end and the second end being in communication with a first gas path and a second gas path. The first gas path and the second gas path are in communication with the first nasal prong and the second nasal prong, respectively. The inlet is located at one of the first side portion and the second side portion, and the first gas path and the second gas path extend in a lateral direction toward the first nasal prong and the second nasal prong. The supply tube has a first end connectable to a gas supply from a gas source and a second end coupled to the inlet of the cavity of the cannula.

[0012] In some embodiments, the nasal cannula system includes a cannula, a manifold, and a supply tube. The cannula includes a central body portion, a first side portion and a second side portion extending from the central body portion in opposite lateral directions, and a first nasal prong and a second nasal prong extending from the central body portion. The central body portion defines a cavity and a forward-facing inlet of the cavity. The first nasal prong and the second nasal prong are in communication 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 can be connected to the cannula so that the gas outlet is aligned with the forward-facing inlet of the cannula and the gas inlet faces in a lateral direction. The supply tube is connected to the gas inlet of the manifold and is positioned in front of the forward-facing inlet of the cannula.

[0013] In some embodiments, the nasal cannula patient interface comprises: first and second nasal prongs, each comprising an inlet end and an outlet end, and at least one support portion configured to rest on the patient's nose at a point or above the tip of the nose. In use, no portion of the patient interface contacts the patient's upper lip to provide any substantial support to the patient interface.

[0014] In some embodiments, the nasal cannula system includes 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 nasal prong and the second nasal prong. The integrated headband includes a first section and a second section, wherein the first section and the second section extend in opposite lateral directions from the central body portion. The first section defines a rear portion of the headband. An adjustable coupling arrangement allows the first section and the second section to be coupled in an adjustable manner so that the circumference of the headband is adjustable. The supply tube has a first end connectable to a gas supply from a gas source and a second end coupled to the cavity of the cannula.

[0015] In some embodiments, the nasal cannula system includes a cannula including 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 nasal prong and the second nasal prong. The cannula defines a transverse slot. The headgear strap extends through the transverse slot of the cannula. A supply tube has a first end connectable to a gas supply from a gas source and a second end coupled to the cavity of the cannula.

[0016] In some embodiments, the 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 communicating with the first nasal prong and the second nasal prong. The cannula defines a first opening at a first position of the cavity and a second opening at a second position of the cavity spaced apart from the first position. The valve body is movable within the cavity. The supply tube has a first end connectable to either the first opening or the second opening of the cannula and a second end connectable to a gas supply 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 the gas flow from the gas source in the cavity, thereby blocking the second opening so that the gas flow is directed to the first nasal prong and the second nasal prong, 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 gas flow from the gas source in the cavity, thereby blocking the first opening so that the gas flow is directed to the first nasal prong and the second nasal prong.

[0017] In some embodiments, the 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 nasal prong and the second nasal prong. The cannula defines a first opening at a first position of the cavity and a second opening at a second position of the cavity spaced apart from the first position. The cannula includes a first valve that selectively closes the first opening and a second valve that selectively closes the second opening. The supply tube has a first end that can be connected to either the first opening or the second opening of the cannula and a second end that can be connected to a gas supply 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 so that the gas flow from the gas source is directed to the first nasal prong and the second nasal prong, 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 so that the gas flow is directed to the first nasal prong and the second nasal prong.

[0018] In some embodiments, the 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 nasal prong and the second nasal prong. The cannula defines a first opening at a first end of the cavity and a second opening at a second end of the cavity. The 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 can be positioned within the cavity so as to seal the first opening and the second opening and deliver a gas flow from the gas source to the first nasal prong and the second nasal prong. When the first end of the supply tube is connected to the cannula, the second end can be connected to the gas source, and when the second end of the supply tube is connected to the cannula, the first end can be connected to the gas source.

[0019] In some embodiments, the 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 nasal prong and the second nasal prong. A supply tube has a first end that can be coupled to the cavity of the cannula and a second end that can be connected to a gas supply from a gas source. The first end of the supply tube defines a connection axis relative to the cannula. The supply tube includes a flexible portion at or adjacent to the first end that can be bent at least about 90 degrees to the left or right without significantly obstructing an internal passage of the supply tube.

[0020] In some embodiments, a nasal cannula system includes 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 so as to supply the flow of gas to the cavity of the cannula. A clip removably receives the cannula. A retaining arrangement secures the clip to the patient's head. The cannula can be positioned within the clip in a first orientation such that the supply tube extends from the clip in a first direction, and the cannula can be positioned within the clip in a second orientation such that the supply tube extends from the clip in a second direction.

[0021] In some embodiments, the nasal cannula system includes a cannula comprising a first nasal prong and a second nasal prong. The cannula defines a cavity in communication with the first nasal prong and the second nasal prong. The cannula defines a first opening at a first position of the cavity and a second opening at a second position of the cavity spaced apart from the first position. The supply tube assembly includes a clamp that can be releasably coupled to the cannula in either a first orientation or a second orientation. The supply tube assembly further includes a supply tube that can be connected to a gas supply from a gas source. The clamp supports the supply tube and includes a sealing portion. When the clamp is connected to the cannula in the first orientation, the supply tube is connected to the first opening of the cannula and extends from the cannula in a first direction, and the sealing portion at least substantially seals the second opening, and, when the clamp is connected to the cannula in the second orientation, the supply tube is connected to the second opening of the cannula and extends from the cannula in a second direction, and the sealing portion at least substantially seals the first opening.

[0022] In some embodiments, the nasal cannula system includes a cannula clamp comprising a first nasal prong and a second nasal prong. The cannula defines a cavity in communication with the first nasal prong and the second nasal prong. The supply tube assembly includes a manifold having at least one manifold opening and a supply tube connectable to a gas supply from a gas source. The cannula clamp can be releasably coupled to the manifold in either a first orientation and a second orientation, wherein the manifold is received in the cavity of the cannula clamp and the first and second prongs are aligned with the at least one manifold opening so that a gas flow is provided to the first and second prongs. When the cannula clamp 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 clamp is connected to the manifold in the second orientation, the supply tube extends in a second direction relative to the first and second prongs.

[0023] In some embodiments, a nasal cannula system includes a cannula comprising a body defining a cavity, and first and second nasal prongs extending from the body and communicating with the cavity. A supply tube is coupled to the cannula and communicates with the cavity. The supply tube can be connected to a gas supply from a gas source so as to deliver a flow of gas to the cavity and the first and second nasal prongs. The first and second nasal prongs can be tilted relative to the body of the cannula between at least a first position (wherein the first and second nasal prongs are tilted in a first direction relative to the body) and a second position (wherein the first and second nasal prongs are tilted in a second direction relative to the body). The first surface of the body defines a patient-facing surface of the cannula in the first position, and the second surface of the body defines a patient-facing surface of the cannula in the second position, thereby effectively switching the supply tube between the first and second positions from the side of the cannula from which it extends.

[0024] In some embodiments, a nasal cannula system includes a cannula defining a cavity and including first and second nasal prongs extending from the cannula and communicating with the cavity. A supply tube is coupled to the cannula and communicates with the cavity. The supply tube can be connected to a gas supply from a gas source to deliver a gas flow to the cavity and the first and second nasal prongs. The first and second nasal prongs are oriented relative to the cannula and are movable between at least a first position (wherein the first and second nasal prongs are oriented such that the openings of the prongs face generally in a first direction relative to the cannula) and a second position (wherein the first and second nasal prongs are oriented such that the openings of the prongs face generally in a second direction relative to the cannula). The first surface of the cannula defines a patient-facing surface in the first position, and the second surface of the cannula defines the patient-facing surface in the second position, thereby effectively switching the supply tube between the first and second positions from the side of the cannula from which it extends.

[0025] In some embodiments, the nasal cannula system includes a cannula that defines a patient-facing surface and includes first and second nasal prongs extending from the cannula and communicating 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 communicates with the cavity. The supply tube can be connected to a gas supply from a gas source to deliver a gas flow 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, thereby effectively switching the supply tube between the first and second positions from the side from which the cannula extends.

[0026] In some embodiments, the nasal cannula system includes a cannula defining a cavity and including first and second nasal prongs extending from the cannula and communicating with the cavity. A supply tube is coupled to the cannula and communicates with the cavity. The supply tube can be connected to a gas supply from a gas source so as to deliver a gas flow 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 or a display unit of the gas source, thereby providing a signal indicating the pressure within the cavity to the control unit or the display unit.

[0027] In some embodiments, a nasal cannula system includes a cannula body defining a cavity and including first and second nasal prongs extending from the cannula and communicating 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 bumps, a plurality of grooves, and a gel pad.

[0028] In some embodiments, the nasal cannula system includes a cannula body defining a cavity and including first and second nasal prongs extending from the cannula and communicating with the cavity. The cannula body includes 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 from adjacent portions of the first and second side portions such that, during use, the patient-facing surface of the central portion is spaced apart from the patient's upper lip.

[0029] In some embodiments, a supply tube for a nasal cannula includes a tube body having a first end and a second end. The tube body includes an expandable segment that allows the segment to be shaped by an external force and substantially retain the shape after the external force is removed.

[0030] In some embodiments, the nasal cannula system includes a cannula defining a cavity and including first and second nasal prongs extending from the cannula and communicating with the cavity. A supply tube is coupled to the cannula and communicates with the cavity. The supply tube can be connected to a gas supply from a gas source so as to deliver a gas flow to the cavity and the first and second nasal prongs. A support arrangement supports the supply tube at a spaced position away from the cannula. The support arrangement includes a fastener having a first portion coupled to the supply tube and a second portion located at the spaced position.

[0031] In some embodiments, the nasal cannula system includes a cannula defining a cavity and including first and second nasal prongs extending from the cannula and communicating with the cavity. A supply tube is coupled to the cannula and communicates with the cavity. The supply tube can be connected to a gas supply from a gas source to deliver a gas flow to the cavity and the first and second nasal prongs. A retaining arrangement secures the cannula to the patient. A support arrangement supports the supply tube at a spaced position away from the cannula, the spaced position being located on the retaining arrangement.

[0032] In some embodiments, the nasal cannula system includes a cannula defining a cavity and including first and second nasal prongs extending from the cannula and communicating with the cavity. A supply tube is coupled to the cannula and communicates with the cavity. The supply tube can be connected to a gas supply 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 position away from the cannula. The support arrangement includes a fastener that engages a piece of fabric at the spaced position.

[0033] In some embodiments, the nasal cannula system includes a cannula defining a cavity and including first and second nasal prongs extending from the cannula and communicating with the cavity. A supply tube is coupled to the cannula and is in communication with the cavity. The supply tube can be connected to a gas supply from a gas source so as to deliver a gas flow to the cavity and the first and second nasal prongs. A support arrangement supports the supply tube at a spaced position away from the cannula. The support arrangement includes at least one of an armband engaging the supply tube, an adhesive pad including a fastener for releasably securing the supply tube to the adhesive pad, a generally U-shaped support member located on the patient's shoulder and engaging the supply tube, and a headgear strap including a strip extending over the top of the patient's head and engaging the supply tube.

[0034] In some embodiments, a retention arrangement for a nasal cannula assembly includes a headgear strap comprising a first ear loop and a second ear loop, each ear loop at least partially surrounding an ear of the patient. A connecting 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 ear loop and the second ear loop.

[0035] In some embodiments, a retention arrangement for a nasal cannula includes a headgear strap comprising a strap portion. First and second pads contact a patient's first and second cheeks during use. A connecting 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.

[0036] In some embodiments, a retention arrangement for a nasal cannula includes a frame including a connecting portion that connects the retention arrangement to the nasal cannula. A first ear stem portion and a second ear stem portion extend rearward from opposite sides of the connecting portion. The ear stem portions are configured to be positioned over a patient's ear.

[0037] In some embodiments, the nasal cannula system includes a cannula having a central portion defining a cavity and including first and second nasal prongs extending from the central portion and communicating with the cavity. First and second side portions extend in a lateral direction from opposite sides of the central portion. A supply tube is coupled to the cannula and communicates with the cavity. The supply tube can be connected to a gas supply from a gas source so as to deliver a gas flow to the cavity and the first and second nasal prongs. First and second adhesive pads are configured to be adhesively secured to the patient's face and can be connected to the first and second side portions of the cannula by an adjustable fastening arrangement.

[0038] In some embodiments, the nasal cannula system includes a cannula defining a cavity and including first and second nasal prongs extending from the cannula and communicating with the cavity. A modular retention arrangement secures the cannula to the patient. The cannula is configured for use with any of the retention arrangements selected from the group consisting of: a set of adhesive pads attached to the patient's face, a headgear strap, and a halo-style headgear strap having a strap portion extending over the top of the patient's head.

[0039] In some embodiments, a nasal cannula system includes a cannula defining a lumen and including first and second nasal prongs extending from the cannula and communicating with the lumen. A modular retention arrangement secures the cannula to the patient. The retention arrangement includes a nasal patch coupled to the cannula and attachable to the patient's nose and a headgear strap including a clip configured to receive the cannula. The cannula can be secured to the patient using either the nasal patch or the headgear strap.

[0040] In some embodiments, a retention arrangement for a nasal cannula includes a headgear strap connectable to the nasal cannula and capable of being tensioned around the patient's head. The headgear strap includes 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.

[0041] In some embodiments, a retention arrangement for a nasal cannula includes a headgear strap connectable to the nasal cannula. At least one strap extends around the patient's head from one side of the cannula to the other. A tensioning device tensions the headgear strap by changing the effective length of the at least one strap by tightening a portion of the at least one strap.

[0042] In some embodiments, a headgear strap for a nasal cannula includes a first portion connectable to the nasal cannula and a second elastic portion positioned behind the patient's head during use. The cushion extends at least partially along the second elastic portion.

[0043] In some embodiments, the nasal cannula assembly includes a cannula defining a cavity and including first and second nasal prongs extending from the cannula and communicating with the cavity. During use, a headband surrounds the patient's head and is positioned over the ears. 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. An upper end portion of each of the first and second arms is attached to the headband.

[0044] In some embodiments, the nasal cannula system includes a cannula defining an open cavity and including first and second nasal prongs extending from the cannula and communicating with the cavity. A manifold is configured to be removably coupled to the cannula, and a portion of the manifold is received in 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. The inner surface of the cavity of the cannula includes a first attachment portion and the outer surface of a portion of the manifold includes a second attachment portion. The first and second attachment portions can be configured to engage with each other so as to secure the manifold to the cannula.

[0045] In some embodiments of the nasal cannula system, the first attachment portion and the second attachment portion comprise cooperating portions of hook and loop material fasteners. The nasal cannula system may also include an arrangement in which the cavity and the portion of the manifold have corresponding symmetrical shapes, such that the portion of the outer surface of the manifold can be positioned within the cavity in a plurality of orientations. In some embodiments, the cavity and the portion of the manifold are circular or oval. In some embodiments, the first attachment portion and the second attachment portion are substantially flat.

[0046] In some embodiments, the nasal cannula assembly includes a cannula defining a cavity and first and second nasal prongs extending from the cannula and communicating with the cavity. The cannula includes first and second outer surfaces that are substantially flat and extend along the length of the cannula. The cannula also includes a first end and a second end. A retaining arrangement is coupled to the cannula and is configured to support the cannula on the patient's face. A tube may be coupled to the cannula adjacent to the first or second end of the cannula and is configured to communicate with the cavity. The cannula has a first position in which the first outer surface contacts the patient's face and the first and second nasal prongs extend into the patient's nostrils. The cannula has a second position in which the second outer surface contacts the patient's face and the first and second nasal prongs extend into the patient's nostrils.

[0047] In some embodiments of the nasal cannula assembly, the cannula has a substantially triangular cross-sectional shape. The nasal cannula assembly can be arranged such that an angle between the first and second nasal prongs and the first exterior surface is substantially the same as an angle between the first and second nasal prongs and the second exterior surface. In some embodiments, the first and second nasal prongs extend outwardly from the cannula at a corner of the substantially triangular cross-sectional shape between the first and second exterior surfaces.

[0048] In some embodiments, the nasal cannula assembly includes a cannula body defining a cavity and including first and second nasal prongs extending from the cannula and communicating with the cavity. The first and second nasal prongs can be in a relaxed position in the absence of any substantial external force. The 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 is movable 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 deviate the first and second prongs from their relaxed positions.

[0049] In some embodiments of the 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 rotate around the cannula body. Each of the first nasal prong and the second nasal prong may include a flexible base portion that is configured to allow the angle at which the prong extends from the cannula body to change. The at least one opening may include a first opening and a second opening, and the at least one edge may include 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 may extend through the first opening and the second nasal prong extends through the second opening. In some embodiments of the nasal cannula assembly, the outer portion includes a slot, and the cannula body includes a protrusion extending into the slot. The protrusion may be configured to move within the slot, and the slot may have sidewalls configured to engage the protrusion and limit the amount of movement of the outer portion relative to the cannula body.

[0050] In some embodiments, the nasal cannula system includes a cannula defining a lumen and including at least one nasal prong extending from the cannula and communicating with the lumen. A frame portion is configured to support the cannula, and at least one headband is coupled to the frame portion and positioned around the patient's head during use. The cannula is slidably supported by and movable relative to the frame portion, the cannula including an opening through which the frame portion extends. The cannula system may include a tube support member supported by the frame portion or the headband, and the tube support member may be configured to support and selectively release a tube.

[0051] In some embodiments of the 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 may include a strap configured to wrap around the tube and a clip configured to couple the strap to the headband or frame portion. The frame portion may have a circular or rounded cross-section, and the cannula may move laterally relative to the frame portion and may rotate relative to the frame portion. In some embodiments of the nasal cannula system, the interface between the cannula and the frame portion is a friction fit that allows the cannula to maintain its position relative to the frame portion when not moved by the user. The frame portion may include a plurality of notches configured to interact with the cannula and provide discrete locations along the frame portion where the cannula can be supported.

[0052] In some embodiments, the nasal cannula system includes a cannula defining a cavity and including first and second nasal prongs extending from the cannula and communicating with the cavity. The cannula includes an opening extending through a portion of the cannula, and the headband is positioned around the patient's head during use. The opening in the cannula is configured to receive the headband, such that the headband extends through the opening and supports the cannula, and the cannula is configured to slide relative to and reposition along the headband.

[0053] In some embodiments of the nasal cannula system, the cannula includes a flat outer surface configured to contact the patient's face when the first and second prongs are inserted into the patient's nostrils. The headband can be made of an elastic material and configured to hold the cannula against the patient's face.

[0054] In some embodiments, the nasal cannula system includes a cannula defining a cavity and including at least one nasal prong extending from the cannula and communicating with the cavity. The cannula includes a first slot and a second slot. The first frame portion is configured to be slidably received by the first slot of the cannula, and the second frame portion is configured to be slidably received by the second slot. At least one headband is coupled to the first frame portion and the second frame portion and is positioned around the patient's head when in use. The cannula is slidably supported by the first frame portion and the second frame portion and is selectively movable relative to the first frame portion and the second frame portion.

[0055] In some embodiments of the nasal cannula system, the cannula includes a side opening configured to receive a supply tube, and the first frame portion and the second frame portion are configured to allow the tube to pass therebetween. The nasal cannula system may further include a tube support member supported by the first frame portion and the second frame portion and configured to slide relative to the first frame portion and the second frame portion so as to position the supply tube relative to the first frame portion and the second frame portion. The first frame portion and the second frame portion may have a circular cross-section, and the first and second grooves may be configured to retain the first and second frame portions. In some embodiments of the nasal cannula system, the first frame portion is positioned above the second frame portion, and the first and second grooves are located on the outside of the cannula facing away from the patient. The cannula may include a flat surface facing the patient's face.

[0056] In some embodiments, the nasal cannula system includes a cannula defining a cavity and including at least one nasal prong extending from the cannula and communicating with the cavity. The cannula includes a slot, and the first frame portion is configured to be slidably received by the slot of the cannula. The second frame portion is fixedly coupled to the cannula. A first turntable and a second turntable are each coupled to both the first frame portion and the second frame portion. At least one headband is coupled to the first frame portion and the second frame portion and is positioned around the patient's head when in use. The cannula is slidably supported by the first frame portion, and the turntables can be configured to rotate so as to move a section of the second frame portion and the cannula relative to the first frame portion. The first frame portion and the second frame portion can be metal 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 the patient.

[0057] In some embodiments, a retention arrangement for a nasal cannula includes a strap configured to extend around a patient's head and a first arm pivotally coupled to the strap at a first joint. A second arm is pivotally coupled to the first arm at a second joint, and the second arm is connectable to the nasal cannula at a third joint. The first joint, the second joint, and the third joint are configured to allow three-dimensional movement and to maintain the relative positions of the strap, the first arm, the second arm, and the cannula unless moved by the user.

[0058] In some embodiments of the retention arrangement, the strap includes a stabilizing portion that is wider than the strap and is configured to contact the patient's head. The third joint can be coupled to a side of the cannula. In some embodiments, the first joint, the second joint, and the third joint are ball joints.

[0059] In some embodiments, the nasal cannula system includes a cannula defining a cavity and including at least one nasal prong extending from the cannula and communicating with the cavity. The cannula includes a slot and has a clamping portion extending from the cannula. A frame is configured to support the cannula and couple to the headband. The frame includes an opening configured to receive the clamping portion of the cannula, and the clamping portion is movable within the opening such that the cannula can assume different positions relative to the frame while being supported by the frame.

[0060] In some embodiments of the nasal cannula system, the cannula is positioned between the frame and the patient's face during use. The frame may include at least one cushion member arranged to contact the patient's face during use. In some embodiments, the interface between the clamping portion and the frame opening allows the cannula to move laterally and rotate relative to the frame. The cannula system may also include a headband coupled to the frame and a tube support member supported by the headband or the frame.

[0061] In some embodiments, the nasal cannula system includes a cannula defining a cavity and including at least one nasal prong extending from the cannula and communicating with the cavity. The cannula has a first end portion and a second end portion. A first bellows segment is coupled to the first end portion of the cannula and a second bellows segment is coupled to the second end portion of the cannula. The position of the cannula relative to the patient's face can be adjusted by expanding and compressing the first and second bellows segments. In some embodiments, the cannula system further includes a first non-bellows segment coupled to the first bellows segment and a second non-bellows segment coupled to the second bellows segment. The first and second bellows segments can be supported by a headband.

[0062] In some embodiments, a fork arrangement for a nasal cannula includes a fork comprising a first fork portion comprising a first slot and a second fork portion comprising a first flange. The second fork portion is coupled to the first fork portion and the first flange extends longitudinally within the first slot. The first and second fork portions are configured to extend away from the cannula and define a passageway, and the first flange is movable within the first slot such that the first and second fork portions can move toward and away from each other to adjust an outer dimension of the fork.

[0063] In some embodiments of the fork arrangement, the first and second fork portions each include a sealing member adjacent to the sleeve, and the sealing members overlap each other and are configured to slide relative to each other. The fork may further include a size indicator configured to indicate a relative external dimension of the fork. In some embodiments, the fork includes a second slot and a second flange, the second flange extending longitudinally within the second slot. The first slot may include two sidewalls configured to limit the range to which the first flange can move within the first slot.

[0064] In some embodiments, a fork arrangement for a nasal cannula includes a fork comprising a first collapsible portion configured to couple to a cannula. The first collapsible portion comprises 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 telescopically collapse and expand relative to each other such that the height of the fork can be adjusted.

[0065] In some embodiments of the prong arrangement, the third collapsible portion includes a top edge configured to form a seal with a patient's nostril. The outer dimensions of the third collapsible portion may be larger than the outer dimensions of the second collapsible portion, and the outer dimensions of the second collapsible portion may be larger than the outer dimensions of the first collapsible portion. The first, second, and third passageways may be coaxial.

[0066] In some embodiments, a prong arrangement for a nasal cannula includes 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 is movable within the slot to adjust the distance between the first prong and the second prong.

[0067] In some embodiments of the fork arrangement, the second prong includes a pin and the slot includes a plurality of notches configured to receive the pin when the second prong is moved to a discrete position within the slot. The second prong may include a rib extending from a base of the prong, and the slot may include a plurality of grooves configured to receive the rib. In some embodiments, the second prong includes a tab having a plurality of notches configured to engage an edge of the slot such that the second prong can be retained in a plurality of discrete positions relative to the slot.

[0068] In some embodiments, a prong for a nasal cannula includes a membrane having a substantially cylindrical shape and a plurality of ribs coupled to the membrane around its circumference. The membrane and ribs expand outward as gas flow through the prong increases, and the outer diameter of the prong increases to form a seal with the patient's nostril. In some embodiments, the ribs are substantially fixed and do not flex or move relative to each other.

[0069] In some embodiments, the nasal cannula system includes a cannula defining a lumen and including at least one nasal prong extending from the cannula and communicating with the lumen. 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 surround the patient's nose during use. The support member contacts a portion of the patient's nose above the tip of the nose and comprises a flexible material that can be shaped to conform to the patient's facial shape.

[0070] In some embodiments, the nasal cannula system further comprises a headband configured to wrap around the patient's head, and the headband is removably coupled to the support member at one end and adjustably coupled to the support member at another end. In some embodiments, the bendable material is a metal material and is located at an upper portion of the support member. The support member may include an attachment portion having a plurality of notches and the cannula may include an opening configured to receive the attachment portion. The notches may be configured to interact with the opening to couple the support member to the cannula and allow 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 may be supported by a first padded member and the second tube may be supported by a second padded member, and the first and second padded members may be configured to rest against the patient's face. In some embodiments, the nasal cannula system further comprises a headband coupled to the first and second padded members and configured to extend around the patient's head. The first and second tubes are removable from the sleeve so that the sleeve can be removed and rotated relative to the rest of the system.

[0071] In some embodiments, a tube arrangement for a nasal cannula system includes a cannula body 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 the edges.

[0072] In some embodiments of the tube arrangement, the outer wall is made of a fabric that provides thermal insulation. Embodiments of the tube arrangement may also include a spring extending within the outer wall. The tube body of the cannula may also be coupled to a connector at its opening, and the connector may include a valve. In some embodiments, the cannula tube body further includes an extruded tube extending within the outer wall. The outer wall may include a tab having one or more holes configured to couple to a headband. In some embodiments, the outer wall is made of an insulating material, a spring extends within the outer wall, and the breathing tube extends within the spring.

[0073] In some embodiments of the 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 one pressure line tube in addition to the breathing tube extends within the outer wall. Some embodiments may also include a breathing tube within the outer wall, the breathing tube having a cannula portion from which at least one nasal prong extends, the cannula tube body being flexible so that it can be bent around the patient's face. Each end of the cannula tube body may include a tab having a plurality of holes configured to receive pins located on the headband. Each end of the cannula tube body may include a connector configured to receive an inhalation tube connector, each connector including a valve. In some embodiments, the outer wall is made of a breathable material.

[0074] In some embodiments, a tube arrangement for a nasal cannula system includes a tube comprising an outer wall and an opening. The tube comprises a longitudinal axis, and the outer wall comprises a thin material that has been folded or rolled, and the outer wall comprises one or more cutout portions extending through the material. In some embodiments, the one or more cutout portions comprise a tab that can be pulled away from the tube, and the tab is configured to engage a support device to suspend the tube.

[0075] In some embodiments of the tube arrangement, the tab includes a hole configured to receive a hook or hanger. The cutouts may include a plurality of slots defining a portion of material that can be pulled away from the tube while remaining connected on both sides, and the pulled-away material may form a hook portion that can engage the hanger. In some embodiments, the cutouts may include two tabs that can be pulled away from the tube, with the ends of the tabs configured to couple together or to another structure. The tube may also include an inner tube and a spring within the inner tube.

[0076] In some embodiments, a cannula tube arrangement for a nasal cannula system includes a tube body having an outer wall, and the outer wall includes a film having a first edge and a second edge. The film is folded or rolled, and the first edge and the second edge are sealed together. A bead is positioned on the outer wall and is configured to provide structural support to the tube.

[0077] In some embodiments of the cannula tube body arrangement, the brace includes a cannula portion configured to receive a cannula having a fork, and the cannula portion includes two holes extending through the membrane. The tube may include a first end and a second end, and the first end and the second end may be coupled to a connector having a valve. The first end and the second end each include a tab having a hole configured to couple to a headband. In some embodiments, the first and second edges of the membrane are heat sealed to form the tube. The brace may be printed or extruded onto the outer wall. The brace may have a pattern configured to create a curved area along the length of the tube. In some embodiments, the brace is on the inside of the tube. The brace may include thermal elements and structural elements printed on the membrane. In some embodiments, the first edge overlaps the second edge, and the first and second edges may extend into the tube.

[0078] In some embodiments, a cannula tube arrangement for a nasal cannula system includes a tube body having an outer wall. The outer wall includes a thin plastic film having a first edge and a second edge. A substantially flat sidewall is coupled to the outer wall, and a brace is positioned on another wall and configured to provide structural support to the tube. The first edge is coupled to the sidewall and the second edge is also coupled to the sidewall such that a cavity exists between the outer wall and the sidewall. In some embodiments, the first edge and the second edge are heat sealed to the sidewall, and the sidewall is made of a fabric material.

[0079] In some embodiments, the cannula body arrangement includes a spring having a certain length and a cross-section with at least one substantially flat side. A tube surrounds the spring and defines a passageway through which gas can pass. At least one nose prong is coupled to the tube and communicates with the passageway.

[0080] In some embodiments of the cannula-tube arrangement, the spring has a V-shaped or triangular cross-section. The spring may comprise a folded sheet metal with cutouts along the length of the spring. The spring may comprise a middle section and a first end and a second end, and the cross-section of the middle section may be smaller than the cross-sections at the first and second ends. In some embodiments, the spring is a coil spring with a triangular cross-section. The spring may be a coiled wire with a curved end extending in the direction of the third side. The spring may also have a substantially triangular cross-section with curved sides. In some embodiments, the spring has a cross-section shaped similar to a semicircle.

[0081] In some embodiments, a cannula breathing tube arrangement includes a tube made at least partially of a foam material. The tube has a length and substantially flat sides 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 prevent the tube from kinking.

[0082] In some embodiments of a cannula breathing tube arrangement, the tube includes a lumen extending along the length of the tube and a formable rod extending through the lumen. In some embodiments, the foam material is a closed-cell foam material. The tube may 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-shaped head member configured to slide into the slot.

[0083] In some embodiments, the cannula tube arrangement includes a tube having a length and a substantially flat 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 prevent kinking of the tube.

[0084] In some embodiments of the cannula-body arrangement, the at least one rib comprises a plurality of ribs on the inner surface. The tube may 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 semicircular cross-section.

[0085] In some embodiments, the cannula arrangement includes a cannula body defining a passageway and having a distal end. A connector is coupled to the distal end of the cannula body, and a supply tube is configured to couple to the connector of the cannula body. A wire is configured to transfer heat dissipated from the supply tube. The cannula body is configured to receive the wire into the passageway, and the wire is configured to transfer heat into the cannula body.

[0086] In some embodiments of the cannula tube arrangement, the wire is insulated and bendable so that it can conform to the shape of the cannula tube. The wire may be sufficiently rigid to support the cannula tube.

[0087] In some embodiments, the cannula and the tube arrangement include a cannula body having a certain length and defining a passageway. The heating element extends along the length of the cannula body and is configured to transfer heat to the gas passing through the cannula body. The cannula includes at least one nose prong and is coupled to the cannula body.

[0088] In some embodiments of the sleeve and tube arrangement, the heating element is a coiled wire extending within the sleeve body. The sleeve body may include an end and an electrical connector coupled to the end of the sleeve body. In some embodiments, the electrical connector is also a tube connector configured to attach a second tube to the sleeve body. The heating element may be surrounded by a film. In some embodiments, the heating element includes two wires coupled to a conductive polymer, and the two wires are configured so that heat can be generated by applying a voltage through the polymer. In some embodiments, the heating element is configured to provide structural support to the sleeve body. In some embodiments, the heating element is wrapped around the outer surface of the sleeve body.

[0089] In some embodiments of the cannula-body arrangement, the heating element comprises a membrane having a conductive strip that is wrapped around the cannula body, and the conductive strip is configured to generate heat when an electric current is passed therethrough. In some embodiments, the heating element can be made of a positive temperature coefficient material configured such that its resistance increases with temperature, thereby enabling the heating element to be powered using a constant voltage power supply. In some embodiments, the cannula body is made of a flexible and lightweight material, the cannula body is coupled to a connector that is coupled to a less flexible and heavier tube than the cannula body, and the heating element extends substantially along the entire length of the cannula body and the tube. The connector can include an opening configured to receive a temperature sensor, and the cannula body can be configured to be removably attached to the cannula.

[0090] In some embodiments, the cannula arrangement includes a cannula body having a length and defining a first passageway. The cannula body has an outer surface, and a helical conduit is wrapped around the outer surface of the cannula body. The helical conduit defines a second passageway and has an inner wall adjacent to the cannula body and an outer wall facing away from the cannula body. A first opening extends through the cannula body and through the inner wall of the helical conduit, such that gas flowing within the cannula body can enter the helical conduit through the first opening.

[0091] In some embodiments of the cannula body 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 the opposite end of the cannula body from the first opening.

[0092] In some embodiments, the cannula arrangement includes a cannula body having a length and defining a passageway. The cannula body has an outer portion, and the outer portion includes a textile material and a heating element braided or woven into the textile material. The heating element is configured to transfer heat to gas passing through the passageway.

[0093] In some embodiments of the cannula tube arrangement, the heating element is a wire configured to generate heat when an electric 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.

[0094] In some embodiments, a manifold for a cannula assembly includes a manifold body including a connector portion having an inlet opening and configured to receive a tube. The manifold also includes a port configured to facilitate measuring a pressure of a gas stream and an outlet portion configured to communicate with the port and to couple to a pressure sensor.

[0095] In some embodiments of the manifold, the port is a static pressure port positioned on an inner wall of the manifold, the static pressure port being substantially parallel to the bulk flow direction of gas within the manifold. In some embodiments, the port is a total pressure port oriented in the bulk flow direction and configured to measure a combination of static and dynamic pressures. In some embodiments, the port includes a shroud and is oriented in the bulk flow direction.

[0096] In some embodiments, the nasal cannula assembly includes a cannula defining a cavity and including a first nasal prong and a second nasal prong extending from the cannula and communicating with the cavity. The cannula also includes an opening. A valve is supported within the opening and is configured to form a seal when nothing is inserted therethrough. The cannula and valve are configured such that a tube can extend through the valve, into the cavity, and through the second nasal prong.

[0097] In some embodiments of the nasal cannula assembly, the valve is located substantially below the second prong. The valve can be configured to form a seal around the tube extending therethrough. In some embodiments, the valve is a duckbill valve. Embodiments of the nasal cannula assembly may further include a removable cover coupled to the outer surface of the cannula and covering the opening. The cannula may also include two openings and two corresponding valves, wherein each of the valves is configured to receive a cannula body 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 side and the second side. In some embodiments, the second prong is removable from the cannula.

[0098] In some embodiments, a nasal cannula assembly includes a cannula defining a lumen and including a first nasal prong extending from the cannula and communicating with the lumen. The cannula includes a first groove and the first prong includes a second groove. The first groove is aligned with the second groove such that a portion of the tube can extend through the first and second grooves and be directed into the patient's nostril.

[0099] In some embodiments of the nasal cannula assembly, the first groove and the second groove are configured to accommodate a nasogastric tube. The first prong may include an outer surface, and the second groove may be located on the outer surface of the first prong and may 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 such that a portion of the tube can extend through the third and fourth grooves and be directed into the patient's nostril.

[0100] In some embodiments, the nasal cannula includes a nasal prong having an outer wall and a distal end. The outer wall includes a cutout 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 distal end of the prong.

[0101] In some embodiments of the 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 at least form a substantial seal with the outer wall when a tube is not inserted through the opening. The fork may further include a slit extending from the cutout portion to the end of the fork, the slit being configured to allow a tube to selectively pass through the slit.

[0102] In some embodiments, the nasal cannula assembly includes a cannula defining a cavity and including a first nasal prong extending from the cannula and communicating with the cavity. The cannula includes an opening and a valve supported within the opening. An inner member is supported within the cavity and is movable relative to the cannula. The inner member includes an aperture configured to receive a tube. The opening is positioned substantially below the first nasal prong, and the inner member is movable so that the aperture is aligned with the valve so that the tube can extend through the valve and the aperture and into the first prong.

[0103] In some embodiments of the nasal cannula assembly, the cannula includes a second opening having a second valve positioned substantially below the second nasal prong, and the inner member includes a second aperture that can be aligned with the second valve and the second prong. In some embodiments, the inner member is substantially cylindrical and configured to couple to the supply tube. The valve can be configured to form a seal when nothing extends therethrough.

[0104] In some embodiments, a nasal cannula assembly includes 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 the first tube and a second sliding portion having a second prong coupled to the 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 prong and the second prong are movable relative to the cannula body such that each of the first prong and the second prong 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.

[0105] In some embodiments, a nasal cannula assembly includes a cannula defining a cavity and including a first nasal prong extending from the cannula and communicating with the cavity. The assembly also includes a slider member engaging an outer surface of the cannula and 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.

[0106] In some embodiments of the nasal cannula assembly, the slider member includes a groove configured to receive a portion of the tube. In some embodiments, the first nasal prong is flexible and can be folded under the slider member when the slider member is moved to cover the first nasal prong.

[0107] In some embodiments, a nasal cannula assembly includes a cannula defining a cavity and including a single nasal prong extending from the cannula and communicating with the cavity. The assembly also includes a strap configured to support the prong and engage the patient's face. The strap includes an adhesive material configured to selectively couple the strap to the 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 and upward along the side of the patient's nose.

[0108] In some embodiments of the nasal cannula assembly, the strap includes at least one groove configured to receive the tube. In some embodiments, the strap includes holes positioned to align with the patient's nostrils when the strap is in use. The fork may include corrugations configured to allow the fork to bend and change shape. In some embodiments, the fork includes a tapered base portion configured to form a seal with the patient's nostrils. In some embodiments, the cannula is coupled to the tube, and the tube includes a support member configured to support the tube and selectively couple to the patient's face. The support member may also include a support portion configured to receive and support a nasogastric tube or other tube. Embodiments of the cannula assembly may further include a cheek pad configured to adhere to the patient's cheek and selectively couple to the support member. In some embodiments, the fork includes a tapered base portion that narrows toward the top and widens toward the bottom, and the fork includes a recess below the tapered portion, and the recess is configured to hold the strap portion adjacent to the opening.

[0109] In some embodiments, the nasal cannula assembly includes a cannula defining a cavity and including a single nasal prong extending from the cannula and communicating with the cavity. The assembly also includes a frame having a bridging portion that extends away from the patient's face and establishes a space between the bridging portion and the patient's face. The bridging portion is configured to support the cannula, and the bridging portion includes a groove, and a portion of the cannula is movable within the groove. A tube is coupled to the cannula and extends from a bottom portion of the cannula. The tube is configured to extend from below the cannula and bend upward so that it extends above the frame.

[0110] In some embodiments of the nasal cannula assembly, the cannula is supported by the frame and is positioned substantially within the space between the bridging portion and the patient's face when the cannula assembly is in use. In some embodiments, the bridging portion of the frame includes a cutout portion configured to receive a portion of the tube. In some embodiments, the cannula includes a gripping portion extending through a slot. The frame may include a pad configured to contact the patient's face when in use. In some embodiments, the frame includes one or more openings configured to receive a headband. In some embodiments, the bridging portion includes a tube arm that at least partially defines a tubular recess through which the tube can extend.

[0111] In some embodiments, the nasal cannula assembly includes a cannula frame having an upper extension portion, and the upper extension portion has a single fork and a fork opening in communication with the fork. The assembly also includes a retainer portion coupled to the extension portion and having a retainer opening aligned with the fork 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 fork 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 fork.

[0112] In some embodiments of the nasal cannula assembly, the cannula frame includes a lower extension, and the retainer portion includes a lower portion that engages the 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 is configured to pivot about the pin. In some embodiments, the manifold is configured to rotate approximately 180 degrees relative to the cannula frame so that the tubing coupled to the manifold can be exited in the opposite direction.

[0113] In some embodiments, a nasal cannula assembly includes a cannula frame having an upper extension. The upper extension has a single prong and a prong opening in communication with the prong. The upper extension also has a bottom side. The assembly includes a tube rotatably coupled to the bottom side of the upper extension 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 flex and rotate relative to the cannula frame.

[0114] In some embodiments, a nasal cannula assembly includes a cannula defining a cavity and including a single nasal prong extending from the cannula and communicating with the cavity. The assembly includes 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.

[0115] In some embodiments of the nasal cannula assembly, the tube is tapered so that its cross-section becomes narrower as it approaches the cannula. Some embodiments further include 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 configured to engage and couple to the attachment portion. In some embodiments, the cable may include a retracted portion configured to hold the cannula in a selected position.

[0116] In some embodiments, a nasal cannula assembly includes a cannula frame having a bridge portion that extends away from the patient's face and establishes 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 downwardly from the prong. The cannula frame defines a recess through which a second tube can extend between the bridge portion and the patient's face during use.

[0117] In some embodiments of the nasal cannula assembly, the bridge portion includes a cutout portion configured to receive a portion of the first tube, thereby causing the tube to bend and extend away from the assembly to the side of the patient. In some embodiments, the cannula frame includes a contact portion configured to contact the patient's face and includes a soft material.

[0118] In some embodiments, a nasal cannula assembly includes a cannula defining a cavity and including a single nasal prong extending from the cannula and communicating with the cavity. The cannula has a cannula opening communicating with the cavity, and the opening has an axis. The assembly also includes a manifold pivotally coupled to the cannula and configured to pivot around 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 communicating with the cavity.

[0119] In some embodiments of the nasal cannula assembly, the cannula includes a frame portion extending outwardly from the cannula, the frame portions forming one or more recesses between the cannula and the patient's face when in use, and the one or more recesses are configured to receive the second tube. In some embodiments, the cannula includes a soft material on the side of the cannula that faces the patient when in use. In some embodiments, the cannula includes a recess on each side of the fork so that the second tube can extend between the manifold and the cannula.

[0120] For the purpose of summarizing the present disclosure and the advantages achieved over the prior art, certain objects and advantages are described herein. Of course, it should be understood that not all such objects or advantages need to be achieved in accordance with any specific embodiment. Thus, for example, those skilled in the art will recognize that the present disclosure can be embodied or implemented 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 such 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 with reference to the accompanying drawings, and the present disclosure is not limited to any one or more specific disclosed embodiments.

[0121] In some embodiments, the nasal cannula assembly comprises:

[0122] a cannula portion comprising a pair of tubular nasal prongs for insertion into the patient's nostrils, and a manifold in fluid communication with the nasal prongs, the manifold comprising an orifice at a left-hand end of the manifold and an orifice at a right-hand end of the manifold,

[0123] a connector adapted to receive one end of a gas flow conduit and to be removably received in an aperture at the left-hand end of the manifold and an aperture at the right-hand end of the manifold, and

[0124] a plug adapted to be removably received in an aperture at the left-hand end of the manifold and an aperture at the right-hand end of the manifold,

[0125] In use, the connector or plug fits onto one of the orifices on the left and right sides of the manifold, and the plug fits onto the other of the orifices on the left and right sides of the manifold to configure the catheter to extend from the left or right side of the nasal cannula assembly.

[0126] Preferably the plug and connector are separate parts.

[0127] Preferably the plug and connector are coupled or attached together to form a clip by a cross member, optionally the cross member being the connecting portion.

[0128] Preferably the clip is integrally formed as a one-piece component.

[0129] Preferably the clip and sleeve portion are complementarily adapted such that, in use, the transverse member is resiliently deflected to fit the clip onto the sleeve portion.

[0130] Preferably, the clip is assembled onto the sleeve portion by pushing the clip onto the sleeve portion in a direction perpendicular to the transverse direction of the sleeve.

[0131] Preferably, the sleeve portion comprises a rigid member for engaging with the clip, and the prongs are formed of a resilient material attached to the rigid member.

[0132] Preferably, the rigid member and the cross member are adapted such that the cross member is flexed to disperse the plug and connector when the clip is attached to the sleeve portion.

[0133] Preferably, the clip is substantially 'C' or 'U' shaped.

[0134] Preferably, the plug and connector each extend into apertures in the ends of the manifold.

[0135] Preferably, the clip provides a positive force against the manifold so as to grip the manifold between the plug and the connector.

[0136] Preferably, the sleeve portion includes a recessed portion sized and shaped to receive the cross member.

[0137] Preferably, the sleeve portion including the manifold and nasal prongs are integrally formed.

[0138] Preferably, the resilient material is overmoulded onto the rigid member.

[0139] Preferably, the sleeve portion comprises a plurality of side arms and the rigid member extends along the side arms.

[0140] Preferably, the rigid portion comprises through holes in the side arms for the resilient material to extend through via an over-moulding process or an assembly process.

[0141] Preferably, the rigid member includes a recessed portion sized and shaped to receive the cross member.

[0142] Preferably, the apertures at the ends of the manifold are formed in the rigid member.

[0143] Preferably, the cross member is adjustable in length.

[0144] Preferably, the clip comprises a first portion and a second portion, the first portion comprising one of the plug and the connector and the second portion comprising the other of the plug and the connector, the first portion comprising a first cross member and the second portion comprising a second cross member, and

[0145] The first and second cross members are coupled together in a telescoping arrangement and include complementary features to set a lateral distance between the plug and the connector.

[0146] Preferably, the complementary features comprise a projection on one of the first and second parts and a corresponding aperture in the other of the first and second parts, the projection being received in the aperture to set the lateral distance between the plug and the connector.

[0147] Preferably, one of the first and second parts includes a plurality of corresponding apertures, the projection being received in one of the plurality of apertures to set the lateral distance between the plug and the connector, the plurality of apertures providing a range of sleeve portion sizes.

[0148] Preferably, the clip is removably attached to the sleeve portion.

[0149] Preferably, the clip is rotatably coupled to the sleeve portion.

[0150] Preferably, the clip is rotatably coupled to the cannula portion on an axis of rotation or parallel to a sagittal plane of the cannula to position the catheter to the left or right side of the nasal cannula assembly.

[0151] Preferably, the manifold is formed of a relatively rigid material and the sleeve portion comprises an elastomeric material molded onto the manifold, the nose prongs are integrally formed of the elastomeric material, and the sleeve portion comprises an axis extending from the manifold and the clip is rotatably mounted on the axis.

[0152] Preferably, the shaft is integrally formed with the manifold.

[0153] Preferably, the clip includes a keyway so that the clip can be removably mounted to the sleeve portion.

[0154] Preferably, the sleeve portion includes a flange at the end of the shaft to retain the clip on the shaft in an orientation along the axis of rotation.

[0155] Preferably, the end of the manifold is curved with a centre of curvature on the axis of rotation, and the plug and the connector each have complementary curvatures such that the clamp can be rotated on the axis of rotation to position the connector at either end of the manifold.

[0156] Preferably, the over-moulded elastomeric material covers the end of the manifold, thereby providing a seal with the plug and connector.

[0157] In some embodiments, the nasal cannula assembly includes, for example, an assembly whereby when the plug and connector are coupled or attached together by a transverse member to form a clip, the clip is assembled to the cannula portion by pushing the clip laterally into the manifold through one of the orifice at the left-hand end and the orifice at the right-hand end such that the connector is received in one of the orifice at the left-hand end and the orifice at the right-hand end and the plug is received in the other of the orifice at the left-hand end and the orifice at the right-hand end so as to configure the conduit to extend from the left or right side of the nasal cannula assembly.

[0158] Preferably, the sleeve portion comprises a rigid member for engaging with the clip, and the prongs are formed by a resilient member attached to the rigid member, with the sleeve portion and the rigid member each comprising a side arm extending laterally from the manifold.

[0159] In some embodiments, the nasal cannula assembly comprises:

[0160] a cannula portion comprising a pair of tubular nasal prongs for insertion into the patient's nostrils,

[0161] a connector adapted to receive an end of the gas flow conduit,

[0162] 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,

[0163] The cannula portion that is removably attached to the manifold will attach to the manifold in two orientations, configuring the catheter to extend from either the left or right side of the nasal cannula assembly.

[0164] Preferably, the sleeve portion is rotatable relative to the manifold about a substantially vertical axis.

[0165] Preferably, the manifold includes an open top that serves as the manifold outlet, and the sleeve portion fits over the open top such that the prongs communicate with the connector.

[0166] Preferably, the manifold includes a lip on a surface of the manifold to which the sleeve portion is connected.

[0167] Preferably, a shaft extends from the manifold or the sleeve portion, and the sleeve portion rotates relative to the manifold on the shaft.

[0168] In some embodiments, the nasal cannula assembly comprises:

[0169] a cannula portion comprising a pair of tubular nasal prongs for insertion into the patient's nostrils, and left and right lateral side arms for attachment of a headgear,

[0170] a first conduit for providing a flow of gas to one of said nasal prongs and a second conduit for providing a flow of gas to the other of said nasal prongs,

[0171] a first connector connecting the first conduit to one of the nasal prongs and a second connector connecting the second conduit to the other of the nasal prongs, the connectors being adapted to allow the first and second conduits to be routed to the left or right side of the nasal cannula assembly, and

[0172] a left clip on the left lateral side arm and a right clip on the right lateral side arm,

[0173] When in use, the first catheter is held by the left clip or the right clip so that the first catheter is configured to extend from the left side or the right side of the nasal cannula assembly, and the second catheter is held by the left clip or the right clip so that the second catheter is configured to extend from the left side or the right side of the nasal cannula assembly.

[0174] Preferably, the sleeve portion is an integrally formed part.

[0175] Preferably, each joint is a flexible tube adapted to bend at least 90 degrees in any direction without substantial occlusion.

[0176] Preferably, the flexible tubes include circumferentially extending ribs so that bending of the flexible conduit section does not cause the flexible conduit section to collapse.

[0177] Preferably, each joint is a rotary joint.

[0178] Preferably, each swivel rotates on an axis that is at an angle to the axis of the corresponding nasal prong such that rotation of the swivel allows the two conduits to be routed to the left or right without overlap.

[0179] Preferably, each swivel joint is a swivel elbow.

[0180] Preferably, each of said clamps comprises two channels or receptacles each for receiving one of the tubes.

[0181] Preferably, each flexible tube is integrally formed with the nasal prong.

[0182] Preferably, each clip is integrally formed with said side arm.

[0183] With respect to the above embodiments, reference to the manifold may be to an open cavity formed by the cannula portion, such as the 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 delivering gas to the open cavity. Such embodiments may also be referred to below.

[0184] In some embodiments, the nasal cannula system comprises:

[0185] a cannula body defining an open lumen and including at least one nasal prong extending from the cannula and communicating with the lumen; and

[0186] a manifold comprising a manifold body capable of receiving a gas supply tube, the manifold body being attachable to the sleeve in a first position and a second position, wherein the second position is different from the first position;

[0187] Wherein, the ends of the manifold body protrude into the open cavity of the sleeve body, and the sleeve body includes a recess for retaining the manifold body.

[0188] Preferably, wherein the manifold comprises a first side portion and a second side portion, wherein the first side portion and the second side portion extend from the manifold body and are adapted to be attached to a header.

[0189] Preferably, the recess of the sleeve body retains the first and second sides of the manifold.

[0190] Preferably, one end of the manifold includes a cap including a hinge region dividing the cap into an inner region and an outer region connected by a strap, and wherein the hinge region allows relative movement between the inner and outer regions at the strap.

[0191] In some embodiments, the nasal cannula comprises:

[0192] a cannula body defining an open lumen and including at least one (and preferably a pair) nasal prongs extending from the cannula and in fluid communication with the open lumen; and

[0193] a manifold comprising a manifold body engageable with a cannula for fluid connection with the open cavity, the manifold body orientable in a first operational position or a second operational position, wherein the first position and the second position are different from each other,

[0194] wherein the manifold body is adapted to receive a gas supply conduit at a first end of the manifold body or a gas inlet leading to the manifold body, the first end being adapted to engage one end of the open cavity so as to deliver gas to the open cavity, and the second end of the manifold body being adapted to form a seal or connection with the other end of the open cavity, the manifold body forming a housing for the open cavity.

[0195] Preferably, the sleeve body comprises at least one recess or at least one surface relief or area of ​​surface relief for retaining the manifold body in the engaged first or second operative position.

[0196] Preferably, the first end and the second end of the manifold body are connected to each other (the first end providing a gas inlet to the open cavity and the second end providing a plug or cap that substantially closes the open cavity), and a fluid delivery path is provided for supply gas from the first end of the manifold body to enter the open cavity and reach the terminal end of the at least one nasal prong.

[0197] Preferably, the first end and the second end of the manifold body are connected to each other by a connecting portion or a plurality of connecting portions.

[0198] Preferably, the connecting portion is one or more of at least one arm or at least one finger or at least one frame member.

[0199] Preferably, the first and second ends of the manifold body are integrally formed.

[0200] Preferably, the connecting portion or the cannula body, or both, at least partially defining the open cavity, include alignment features adapted to enable a predetermined geometric orientation of the manifold body relative to the cannula body for engagement therewith.

[0201] Preferably, the alignment feature may be an area or areas of associated convex and concave portions, or an area or areas of associated surface relief.

[0202] Preferably, the alignment feature is adapted to provide an audible response to engagement of the manifold with the cannula body when in the engaged first operative position or the engaged second operative position.

[0203] Preferably, the connecting portion of the manifold body connecting the first and second ends to each other extends through the interior region of the open cavity so that, in situ, the first end of the manifold body is adapted to engage with one end of the open cavity so as to deliver gas 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 that requires sealing to enable delivery of gas into the open cavity.

[0204] Preferably, the connecting portion extending through the interior 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.

[0205] Preferably, the connecting portion of the manifold body connecting the first and second ends to each other extends around an outer surface or outer region of the cannula body that at least partially defines the open cavity, so that, in situ, the first end of the manifold body is adapted to engage with one end of the open cavity to deliver gas 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 that requires sealing to enable delivery of gas to the open cavity.

[0206] Preferably, the connecting portion extending around the outer surface or 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.

[0207] Preferably, the gas supply conduit is located or substantially located around a side or region of the cannula body from which the first end of the manifold body is located or projects from the cannula body.

[0208] Preferably, the manifold is orientable or orientable relative to the cannula body such that the gas supply tube is positioned or located substantially to one side of a user in use.

[0209] Preferably, the first operational position allows the first end of the manifold body to be located at the left or right end of the cannula body defining the open cavity, and the second operational position allows the first end of the manifold body to be located at the corresponding right or left end of the cannula body defining the open cavity.

[0210] Preferably, the first operating position or the second operating position enables connection of the gas supply conduit to the first end of the manifold body from the left or right side.

[0211] Wherein, the sleeve body further comprises a plurality of side arms or side portions extending away from the sleeve body defining the open cavity, and in use, each of these side arms or side portions is adapted to extend at least partially along a portion of the user's face.

[0212] 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.

[0213] Optionally, the embodiments described above with respect to the first segment being formed from the first material and the second segment being formed from the second material are restated herein.

[0214] Preferably, the terminal ends of the side arms are adapted to receive connections thereto to the headgear.

[0215] Optionally, the headgear to be associated with the nasal cannula described herein may be a headgear as defined above as in any other embodiment described herein.

[0216] In some embodiments, a nasal cannula system comprises a nasal cannula assembly as defined in any of the above embodiments and a head cap attached to the nasal cannula assembly for attaching the nasal cannula assembly to a patient's head.

[0217] In some embodiments, there is a system for providing a flow of breathing gas to a user or patient, the system comprising a blower, a humidifier, the conduit, and a nasal cannula system as defined in the embodiments described herein.

[0218] In some embodiments, the headgear comprises:

[0219] A strap is provided at each end adapted to be attached to a patient interface and to extend around the patient's head to hold the patient interface in place on the patient's face, wherein at least a portion of the strap is configured to bifurcate into more than one strap extending around the patient's head.

[0220] Preferably, the strip includes a longitudinal frangible section extending along a portion of the strip, the longitudinal frangible section being to be torn by a user in order to separate that portion of the strip into more than one strap.

[0221] Preferably, the frangible section comprises a relatively thin section.

[0222] Preferably, the frangible section is a perforated section.

[0223] Preferably, the straps are separated by the frangible section.

[0224] Preferably, the strap includes finger holes at the frangible section to assist in separating the straps by tearing the frangible section.

[0225] Preferably, the strip includes an aperture at the end of the frangible section, the aperture including a rounded portion defining the end of the frangible section to prevent tearing of the strip beyond the frangible section.

[0226] Preferably, the hole is a pore.

[0227] Preferably, at least the portion of the strip is formed from a fabric forming the straps and the fabric is coated with a polymer which arranges the straps together, the coating providing the fragile sections between the straps, the coating being adapted to be torn to separate the straps.

[0228] Preferably, the straps are formed by making longitudinal cuts in the fabric along the portion of the strip, the polymer coating bridging the cuts to hold the straps together in a non-bifurcated configuration.

[0229] Preferably, the fabric is a foamed fabric.

[0230] Preferably, the straps are separated by a removable section of the strap including a lifting tab, the removable section being connected to the straps by the frangible section.

[0231] Preferably, the headgear includes a snap ring that is slidable along at least the portion of the strap that is configured to bifurcate.

[0232] Preferably, to bifurcate the strap to separate the bands, the clasp can be slid to the ends of the bands and the clasp can be slid to the midpoint of the bands to hold the bands together as a single strap.

[0233] Preferably, to bifurcate the strap to separate the bands, the clasp can be slid onto the end of the bands and the clasp can be slid onto the opposite end of the bands to hold the bands together as a single strap.

[0234] Preferably, each strap includes features that engage corresponding features on the collar, thereby holding the straps together in the non-bifurcated configuration.

[0235] Preferably, the straps include interlocking teeth that are separated or mated by sliding the clasp along the straps.

[0236] Preferably, the headgear includes a mesh extending between the straps, wherein in the non-bifurcated configuration the mesh is squeezed together or folded into a non-expanded configuration, and in the bifurcated configuration where the straps are spaced apart the mesh is expanded or unfolded to cover the area between the spaced apart straps.

[0237] Preferably, the head cap includes two clasps which, in a non-forked configuration, both slide toward the center of the strap to hold the straps together, and in a forked configuration, each clasp slides to the end of the straps so that the straps can be separated between the ends of the straps.

[0238] Preferably, each collar and the straps are complementarily adapted such that movement of each collar towards the ends of the straps forces the straps apart, thereby separating the straps into a forked configuration.

[0239] Preferably, each clasp includes two spaced apart flanges and three pins extending between the spaced apart flanges, the straps extending between the flanges, one of the pins being positioned between the straps and the other two pins being positioned on the outer edges of the straps, and the straps including cross portions near the ends of the straps.

[0240] Preferably, one or each strap may include a central tab or stop which limits the amount of movement of the collars along the straps.

[0241] Preferably, the portion of the strap configured to bifurcate extends, in use, from behind the patient's ears around the back of the patient's head.

[0242] Preferably, the ends of the straps are pivotally coupled together.

[0243] Preferably, the straps are arranged side-to-side in a non-bifurcated configuration.

[0244] Preferably, the straps are arranged side by side in a non-bifurcated configuration.

[0245] Preferably, the straps in the non-bifurcated configuration are held together by one or more of tearable stitching, a snap or snaps, buttons, clips, hook and loop fasteners, or magnets.

[0246] In some embodiments, there is headgear for securing a patient interface to a patient's face, the headgear comprising:

[0247] A strap, each end of the strap being adapted to be attached to a patient interface and extending around the patient's head to hold the patient interface in place on the patient's face, wherein the strap includes a non-stretching section and an stretchable section, the non-stretching section being adapted to be attached to the patient interface and to support a gas supply conduit coupled to the patient interface.

[0248] Preferably, each end of the strap is a non-stretch section adapted to be attached to the patient interface, and the stretchable section is an intermediate section extending between the non-stretch sections around the back of the patient's head.

[0249] Preferably, the non-expandable section is adapted to be attached to one side of the patient interface and the expandable section is adapted to be attached to an opposite side of the patient interface.

[0250] Preferably, the non-expandable section includes features for securing the catheter.

[0251] In some embodiments, there is headgear for securing a patient interface to a patient's face, the headgear comprising:

[0252] A strap includes a first stretchable section adapted to be attached to one side of the patient interface and a second stretchable section adapted to be attached to an opposite side of the patient interface, and a non-stretchable intermediate section extending between each end of the stretchable sections.

[0253] Preferably, the intermediate portion is an annular portion to which the ends of the expandable segments are attached.

[0254] Preferably, the head cap includes a first non-stretch sleeve and a second non-stretch sleeve each extending from the non-stretch middle section, and the first stretchable section extends along the interior of the first non-stretch sleeve, and the second stretchable section extends along the interior of the second non-stretch sleeve.

[0255] Preferably, the first non-stretching sleeve and the second non-stretching sleeve extend from the middle portion to the front of the patient's ear in use.

[0256] Preferably, the first and second expandable sections are not attached to the first and second non-expandable sleeves along the length of the sleeve from the intermediate portion.

[0257] Preferably, one or both sleeves are adapted to support a gas conduit to provide a flow of gas to the patient interface.

[0258] Preferably, the headgear comprises a lanyard connected to said sleeve adapted to secure the gas conduit.

[0259] Preferably, the lanyard is extendable.

[0260] Preferably, the non-stretching intermediate section is bifurcated to comprise two separate straps.

[0261] Preferably, the non-stretch section is configured to bifurcate into more than one strap extending around the patient's head.

[0262] Preferably, the headgear comprises a bifurcated section having two straps, and one of said straps is the non-stretching middle section.

[0263] Preferably, the headgear includes a first non-stretch 'Y' shaped connector connected between the first stretchable section and one end of the two straps and a second non-stretch 'Y' shaped connector connected between the second stretchable section and the opposite end of the two straps.

[0264] Preferably, one of the straps is a stretchable strap.

[0265] Preferably, the upper one of the two straps is the stretchable strap and the lower one of the two straps is the non-stretch strap.

[0266] Preferably, the non-stretch strap is adjustable in length.

[0267] Preferably, at least one of the straps is adjustable in length.

[0268] Preferably, the upper of the two straps is adjustable in length.

[0269] In some embodiments, there is a headgear for a patient interface comprising:

[0270] A stretch region, a non-stretch region, wherein the stretch region is located substantially away from the tube loading region.

[0271] In some embodiments, there is a head cap, interface and tube assembly comprising at least one stretch region, at least one non-stretch region, wherein the stretch region is positioned sufficiently away from the tube loading region, the stretch region being located behind the user's head when in use, wherein the tube is configured to attach to either side of the interface.

[0272] In some embodiments, there is a head cap, interface and tube assembly that includes at least one stretch region, at least one non-stretch region, wherein the stretch region is positioned sufficiently away from a tube loading region, wherein the tube loading region is the region where the tube is tethered to the head cap or interface.

[0273] In some embodiments, there is a nasal cannula for administering a gas source (e.g., a breathable gas) to a user (e.g., a patient), the nasal cannula comprising:

[0274] at least a first segment formed from a first material; and

[0275] at least a second segment formed from a second material;

[0276] The first section is relatively softer than the second section.

[0277] Preferably, the second material is the same as the first material (eg, may be the same material, but may be a different grade of that material having different characteristics, such as a different Shore hardness or other rating).

[0278] Preferably, the second material is different from the first material (eg, may be a different material having different characteristics such as a different Shore hardness or other rating).

[0279] Preferably, the segments may be formed integrally with each other.

[0280] Preferably, the segments are assembled to each other by using one or more mechanical fasteners or one or more chemical fastening systems (eg welding the first and second segments, or parts thereof, together by adhesive or plastic welding or ultrasonic welding).

[0281] Preferably, the first section provides a user-friendly or comfortable-touch component of the nasal cannula.

[0282] Preferably, the second section provides a structural or supportive or shape-defining component of the nasal cannula. Alternatively, the second section does not contact the user during use.

[0283] Preferably, the configuration or shape of the first section is at least partially defined by components or portions of the second section.

[0284] Preferably, the first section forms the patient contacting surface and the second section forms a frame to which the first section is attached.

[0285] Preferably, the first section encapsulates at least a portion of the second section.

[0286] Preferably, the second section is at least partially overmoulded by the first section.

[0287] Preferably, the first section is at least one arm or a pair of arms extending outwardly from a central body portion, said central body portion including at least one (or preferably, a pair) of nose prongs.

[0288] Preferably, headgear is connectable to the or each arm, the headgear extending substantially around the rear portion of the user's head.

[0289] Preferably, the first section is adapted to receive a manifold connection for delivering a source of gas to the nasal cannula or the body of the nasal cannula which is in fluid communication with a delivery system for delivering gas to the user, for example to one or both nostrils of the user via at least one nasal prong (or preferably, a pair of nasal prongs) when in use.

[0290] Preferably, the second section is adapted to receive a manifold connection for delivering a source of gas to the nasal cannula or the body of the nasal cannula which is in fluid communication with a delivery system for delivering gas to the user, for example to one or both nostrils of the user via at least one nasal prong (or preferably, a pair of nasal prongs) when in use.

[0291] Preferably, the manifold is a component having a material that is relatively rigid relative to the first material, the manifold being connectable to the relevant region of the nasal cannula or the body of the nasal cannula.

[0292] Preferably, the first segment comprises one or more surface relief portions, the one or more surface relief portions of the first segment being engageable with one or more symmetrically or complementarily shaped or configured surface relief portions of the associated second segment.

[0293] Preferably, the first section includes at least one raised area receivable by an associated aperture or detent area of ​​the second section.

[0294] Preferably, the first section includes raised tabs or mushroom-shaped heads and the second section includes associated apertures that receive the raised tabs or mushroom-shaped heads.

[0295] Preferably, the first section comprises a cannula body portion at least partially defining an open cavity receivable a supply of gas directed thereto via a manifold, the open cavity being in fluid communication with one or a pair of nasal prongs.

[0296] Preferably, the first and second sections are commensurately or complementarily shaped or configured to collectively receive a manifold connection for delivering a source of gas to be delivered to a user.

[0297] Preferably, the first section is at least partially a nasal cannula body defining an open cavity.

[0298] In the alternative, or in addition, the second section at least partially surrounds the nasal cannula body defining an open lumen.

[0299] Preferably, the second segment supports the first segment in a predetermined configuration.

[0300] Preferably, the second segment extends substantially the same length as the nasal cannula defined by the first segment. Alternatively, the second segment extends to a length greater than the nasal cannula defined by the first segment. In another alternative, the second segment extends to a length less than the nasal cannula defined by the first segment.

[0301] Preferably, the nasal cannula includes a pair of side arms extending outwardly from a cannula body that at least partially defines an open lumen, which can receive a gas source, such as via a manifold connection.

[0302] Preferably, a connection system for connecting headgear that is to be worn by a user in use is located substantially towards each end of the side arms.

[0303] Preferably, the connection system is part of the second section.

[0304] Preferably, the first section provides a gasket-type seal to a manifold connection or to a manifold receivable by at least a portion of the first section, such as defining an open cavity of the cannula body.

[0305] Preferably, the second section provides structure to which a manifold connection can be made, and the first section provides a seal, such as a fluid-type seal, of the manifold in making such a manifold connection.

[0306] Preferably, the nasal cannula comprises a body defining an open cavity engageable by the manifold, a rear portion of the body being substantially adjacent the septum region of the user when in use, the rear portion being substantially compliant or deformable in response to pressure applied to the rear portion by the user.

[0307] 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, wherein the open cavity is a separate distinct area of ​​the body.

[0308] In the alternative, the rear portion defines at least a portion of a wall of the open cavity.

[0309] Preferably, the rear portion is substantially elasticized.

[0310] Preferably, the rear portion is elastically deformable.

[0311] Preferably, the body comprises a hollow housing substantially adjacent the septal region of the user.

[0312] Preferably, the body includes a pillow section that is substantially adjacent the septal region of the user.

[0313] Preferably, the pillow segment is a hollow area, i.e., a hollow area defined by the walls of the body and divided into an open chamber (e.g., a plenum chamber), and has a relatively thin wall or elasticized section in this area that is substantially adjacent to the user's septum during use. Alternatively, the pillow segment is formed by a rear wall, such as an open cavity (or plenum chamber), with the rear wall being a relatively thin wall or elasticized section in this area that is adjacent to the user's septum during use.

[0314] Preferably, the pillow segment is formed from a material capable of deforming under pressure applied by a user during use.

[0315] As described above, in some configurations or embodiments, the nasal cannula interface may include a first section and a second section. The first section may include a relatively soft material. The second section may include a relatively hard material. Preferably, the first section contacts the patient's face during use, while the second section does not contact the patient's face during use.

[0316] The segments can be assembled together using any manufacturing method. In some configurations, the segments can be overmolded one over the other, for example. In some configurations, the segments can be glued together using an adhesive. In some configurations, the segments can be assembled together using ultrasonic welding. In some configurations, the segments can be assembled together using one or more mechanical or other fasteners or fastening systems.

[0317] Preferably, a nasal cannula as defined above may be used in combination with each of the other details described in this specification to provide a nasal cannula interface.

[0318] In some embodiments, a patient interface, such as a nasal cannula, includes a gas delivery mechanism (e.g., one or a pair of nasal prongs that engage one or both nostrils of a user), and a body from which the gas delivery mechanism is associated, and extending from the body are a pair of side arms, the body and side arms being connected in a manner such that application of tension to the side arms directs the gas delivery mechanism to move away from a position that would otherwise apply force to the user's nasal spine.

[0319] In some embodiments, a nasal cannula includes a cannula body having a nasal prong or a pair of nasal prongs extending therefrom to engage one or both nostrils of a user and a pair of side arms extending outwardly therefrom and to which a headgear system can be connected, the cannula body being quite comfortable for the user's face while still providing sufficient rigidity so that forces or tensions applied to the more lateral portions of the side arms during use direct or encourage the nasal prong or prongs to exert less force on the user's nasal spine area.

[0320] Preferably, a continuous length of material extends along each side arm and is connected (or mechanically coupled) in the region of the nose prong or prongs.

[0321] Preferably, the continuous length of material is of a material capable of transferring applied force or tension from the side arms to the nose prong or region of the nose prongs.

[0322] Preferably, each of these side arms defines a preform or shape such that, prior to application of force or tension from the head cap, the side arms bend outwardly away from the patient's face, extending more outwardly so that the side arms extend further away from the gas delivery mechanism of the interface or away from a nasal prong or a pair of nasal prongs.

[0323] Preferably, each of the side arms is in substantial contact with the user's face as the arms extend outwardly away from the gas delivery mechanism or a nasal prong or a pair of nasal prongs, wherein each of the side arms is in less contact with the user's face or is further away (or both) the further the arms extend from the gas delivery mechanism or a nasal prong or a pair of nasal prongs.

[0324] Preferably, these side arms define a preform or shape so that when in use, the force or tension applied to these side arms via the head cap promotes (or guides) these side arms to a position with better facial contact with the user's face or cheeks, and the body is promoted (or guided) to move to a position with less engagement with the user's nasal spine area, or exerting force on this area, or further away from this area.

[0325] Preferably, these side arms are configured to facilitate the transfer or positioning or repositioning or distribution or redistribution of force or tension applied to the nasal cannula by the head cap to the user's cheeks and away from the user's nasal spine area or away from the force or tension applied to the user's nasal spine area when in use.

[0326] Preferably, each of these side arms is preformed or formed so that, in use, applying force or tension to these side arms requires these side arms, or at least a portion of these side arms, to move closer to the user's face, the hinge point or flexure point (or bend point) of the side arm on the user's face being established on the cheek area, and being urged away from the nasal prong or these nasal prongs or another gas delivery mechanism applying force on the user's nasal spine area.

[0327] Preferably, the hinge point or flexion point (or flexure point) established during use is at or around any one or more of the mandibular maxilla, mandibular maxilla, zygomatic arch, maxillary depression (or below the zygomatic arch) on the left or right side (or both) of the user.

[0328] In some embodiments, a connector for connecting a breathing tube to a device (such as a humidifier, ventilator, or other gas source), or for connecting to at least one other breathing tube, comprises:

[0329] inner body and outer body,

[0330] Each of the inner body and the outer body has a first end and a second end,

[0331] The first ends of the inner and outer bodies are configured to receive a terminal end of a first breathing tube, and the second ends of the inner and outer bodies are configured to connect to another component (such as, for example, another breathing tube) or device (such as, for example, a humidifier, or a ventilator or a gas source),

[0332] wherein the first end of the inner body receives the terminal end of the first breathing tube and is fluidically connected thereto, and the inner body provides a lumen for fluid connection between the first end and the second end of the inner body,

[0333] And wherein the inner body is rotatable relative to the outer body.

[0334] Preferably, the inner body is adapted to rotate relative to the outer body.

[0335] Preferably, the outer body may include one or more surface relief features. More preferably, such surface relief features provide a finger grip for the user when in use.

[0336] Preferably, the second ends of the inner body and / or the outer body are adapted to provide a connection system for connection to another breathing tube or to a device such as, for example, a humidifier, or a ventilator or a gas source.

[0337] Preferably, the terminal end of the first breathing tube connected to the first end of the inner body is longitudinally rotatable relative to the outer body during use.

[0338] Preferably, the inner body is nested relative to the outer body.

[0339] Preferably, a 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 herein.

[0340] Preferably, the second end of the outer body is adapted to be connected to another component, the outer body being non-rotatable relative to the connection established with the other component, for example at a machine end of a breathing circuit.

[0341] Various references to tubes or conduits in this specification may optionally, but not necessarily, refer to applications of such tubes or conduits typically understood as "breathing tubes," such as those mentioned in ISO 5367:2000(E) (Fourth Edition, 2000-06-01). It should be understood that these tubes or conduits of the present invention may relate to or have particular application to such breathing tubes used in delivering gases to a user or patient.

[0342] As used herein, the term "and / or" means "and" or "or" or both.

[0343] As used herein, "(s)" following a noun refers to the plural and / or singular form of the noun.

[0344] The sagittal plane of a nasal cannula or other patient interface is defined as the sagittal plane of the user extending through the cannula or patient interface when the cannula or patient interface is positioned on the user's face in use. For example, the sagittal plane of a nasal cannula that includes a nasal prong for each nostril is positioned centered between the two nasal prongs.

[0345] The transverse direction with respect to a nasal cannula is the direction extending between the left-hand end and the right-hand end of the cannula. The transverse direction is perpendicular to the direction extending between the front and back of the cannula. The sagittal plane of the cannula is perpendicular to the transverse direction.

[0346] The present invention relates to the foregoing and also contemplates a variety of configurations, only examples of which are given below. BRIEF DESCRIPTION OF THE DRAWINGS

[0347] These and other features, aspects and advantages of the present disclosure will be described with reference to the following drawings, which are illustrative and should not be limiting of the present disclosure.

[0348] Figure 1A An exemplary embodiment of a nasal cannula assembly coupled to a patient is shown;

[0349] Figure 1B Shown Figure 1A A partial front perspective view of a nasal cannula assembly;

[0350] Figure 1C Shown Figure 1A and 1B Exploded view of the nasal cannula assembly;

[0351] Figure 2A shows a front perspective view of an exemplary embodiment of a nasal cannula assembly including a cannula and a manifold;

[0352] Figure 2B Shown Figure 2A A partial rear perspective view of the nasal cannula assembly;

[0353] Figure 3A shows a front perspective view of an exemplary embodiment of a nasal cannula assembly including a cannula and a manifold;

[0354] Figure 3B Shown Figure 3A A partial rear perspective view of the nasal cannula assembly;

[0355] Figure 4 Shown Figure 3A and 3B A partial front perspective view of an alternative configuration of a nasal cannula assembly;

[0356] Figure 5A shows a front perspective view of an exemplary embodiment of a nasal cannula assembly including a cannula without a manifold;

[0357] Figure 5B Shown Figure 5A A partial rear perspective view of the nasal cannula assembly;

[0358] Figure 6A shows a front perspective view of an exemplary embodiment of a nasal cannula assembly including cheek pads;

[0359] Figure 6B Shown Figure 6A A partial rear perspective view of the nasal cannula assembly;

[0360] Figure 7A shows a front perspective view of an exemplary embodiment of a nasal cannula assembly including a cannula with an integrated headband;

[0361] Figure 7B Shown Figure 7A A partial rear perspective view of the nasal cannula assembly;

[0362] Figure 7C An exemplary embodiment of a lanyard connector for a nasal cannula assembly is shown;

[0363] Figure 8A shows a front perspective view of an exemplary embodiment of a nasal cannula assembly including a cannula and a manifold;

[0364] Figure 8B Shown Figure 8A A partial rear perspective view of the nasal cannula assembly;

[0365] Figure 8C Shown Figure 8A and 8B Exploded view of the nasal cannula assembly;

[0366] Figure 9A shows a front perspective view of an exemplary embodiment of a nasal cannula assembly including a cannula and a manifold;

[0367] Figure 9B Shown Figure 9A A partial rear perspective view of the nasal cannula assembly;

[0368] Figure 9C Shown Figure 9A and 9B Variations of nasal cannula assemblies;

[0369] Figure 10A shows a side perspective view of an exemplary embodiment of a nasal cannula assembly including a cannula and a nasal strip attached to a patient's face;

[0370] Figure 10B Shown Figure 10A A partial rear perspective view of the nasal cannula assembly;

[0371] Figure 11 Shown Figure 10A and 10B Alternative configurations of nasal cannula assemblies;

[0372] Figure 12A shows a partial front perspective view of an exemplary embodiment of a nasal cannula assembly including two cannulas;

[0373] Figure 12B Shown Figure 12A a top view, a front view, and a side view of one of these sleeves;

[0374] Figure 12C Demonstrates connectivity to patients Figure 12A A front perspective view of a nasal cannula assembly;

[0375] Figure 13A shows a front perspective view of an exemplary embodiment of a nasal cannula assembly including a cannula and a retainer;

[0376] Figure 13B Shown Figure 13A A partial side perspective view of a nasal cannula assembly;

[0377] Figure 13C Demonstrates connectivity to patients Figure 13A and 13B A partial front perspective view of a nasal cannula assembly;

[0378] Figure 14A shows a front perspective view of a nasal cannula assembly including a manifold and a cannula having a nasal valve;

[0379] Figure 14B Shown Figure 14A An exploded view of the nasal cannula assembly; and

[0380] Figure 14C Demonstrates connectivity to patients Figure 14A and 14B Nasal cannula assembly.

[0381] Figure 15A -G shows an exemplary embodiment of a nasal cannula assembly with a shuttle valve.

[0382] Figure 16A -F shows an exemplary embodiment of a nasal cannula assembly having a manifold with a one-way valve formed from an exhalation-type valve having a loosely hinged flap.

[0383] Figure 16G -L shows an embodiment of a nasal cannula assembly having a manifold with a one-way valve formed from different types of slit valves.

[0384] Figure 17A and 17B An exemplary embodiment of a nasal cannula assembly is shown having a tube passing through the manifold, allowing for selective side switching of the tube exit side.

[0385] Figure 18A and 18B An exemplary embodiment of a nasal cannula assembly is shown in which each tube outlet opening is sealed by a membrane that is pierceable by the sharpened end of the supply tube.

[0386] Figure 19An exemplary embodiment of a manifold is shown having a flexible tube that exits a front pipe outlet port of the manifold.

[0387] Figure 20A -C shows an exemplary embodiment of a manifold snapping into an assembly fixture or clip.

[0388] Figure 21A -F shows an exemplary embodiment of a nasal cannula assembly having a removable tubing assembly and a manifold.

[0389] Figure 21G and 21H An exemplary embodiment of a nasal cannula assembly having a manifold receiving structure, a separate nasal prong insert, and a manifold is shown.

[0390] Figure 22A -D shows an exemplary embodiment of a nasal cannula assembly having a manifold insert and a manifold receiving structure.

[0391] Figure 23A -C shows an exemplary embodiment of a nasal cannula assembly having a manifold insert that can be clipped onto a tube assembly.

[0392] Figure 24A -C shows an exemplary embodiment of a nasal cannula assembly having prongs formed with a corrugated shape around a base, the corrugated shape allowing the prongs to be flexible.

[0393] Figure 24D -F shows an exemplary embodiment of forks formed with a corrugated geometry that allows these forks to be flexible.

[0394] Figure 25A An exemplary implementation of a nasal cannula assembly including individually rotatable prongs is presented.

[0395] Figure 25B -C shows an exemplary embodiment of a nasal cannula assembly comprising a pair of nasal prongs mounted on a vertical axis and rotatable as a unit.

[0396] Figure 26A -F illustrates an exemplary embodiment of a nasal cannula assembly configured to allow insertion of a removable fork insert in at least two orientations.

[0397] Figure 27A -D illustrates an exemplary embodiment of a nasal cannula assembly including a manifold rotatable about an axis extending in a generally anterior-posterior direction.

[0398] Figure 28A and 28B Exemplary embodiments of a nasal cannula assembly are presented that include a manifold and a supply tube that can be coupled to the cannula in at least two orientations.

[0399] Figure 29A An exemplary embodiment of a breathing assistance system having a nasal cannula assembly with pressure measurement capability is presented.

[0400] Figure 29B -L shows an exemplary embodiment of a nasal cannula assembly with pressure measurement capability.

[0401] Figure 30A -I illustrates an exemplary embodiment of a nasal cannula assembly having features that address, alleviate, or minimize patient discomfort, particularly in or near the upper lip area.

[0402] Figure 31A -F illustrates an exemplary embodiment of an adjustable or formable supply tube for a nasal cannula assembly.

[0403] Figure 32A -N illustrates an exemplary embodiment of a nasal cannula assembly having arrangements and features that address positioning of the supply tube.

[0404] Figure 33A -S shows an exemplary embodiment of an arrangement for providing support to the supply tube.

[0405] Figure 34A -K shows an exemplary embodiment of a headgear arrangement for securing the cannula to the patient's face.

[0406] Figure 35A -G shows an exemplary embodiment of a retention arrangement for a nasal cannula assembly.

[0407] Figure 36A -K shows an exemplary embodiment of a retention arrangement, such as a headgear strap, that includes an indicator of tightness (such as strap tension).

[0408] Figure 37A An exemplary embodiment of a headgear strap with a strap pad is shown.

[0409] Figure 37B -E shows an exemplary embodiment of an adjustable headgear strap arrangement for a nasal cannula assembly.

[0410] Figure 38A -G shows an exemplary embodiment of an adjustable cannula and fork arrangement for a nasal cannula assembly.

[0411] Figure 39A -I shows an exemplary embodiment of a cannula and fork arrangement with adjustable alignment for a nasal cannula assembly.

[0412] Figure 40A -J shows an exemplary embodiment of an adjustable fork arrangement for a nasal cannula assembly.

[0413] Figure 41A -D shows an exemplary embodiment of a support arrangement for a nasal cannula assembly.

[0414] Figure 42A -O shows an exemplary embodiment of insulation and tubing arrangement for a nasal cannula assembly.

[0415] Figure 43A -O shows an exemplary embodiment of a tubing arrangement for a nasal cannula assembly.

[0416] Figure 44A -G shows an exemplary embodiment of a tubing arrangement for a nasal cannula assembly.

[0417] Figure 45A -Q shows an exemplary embodiment of a temperature regulation arrangement for a nasal cannula assembly.

[0418] Figure 46A -E shows an exemplary embodiment of a pressure measurement port arrangement for a nasal cannula assembly.

[0419] Figure 47A -O illustrates an exemplary embodiment of a nasal cannula arrangement configured to accommodate a nasogastric (NG) or nasojejunal (NJ) tube.

[0420] Figure 48A -S shows an exemplary embodiment of a single fork arrangement for a nasal cannula assembly.

[0421] Figure 49 A respiratory humidifier system is presented that may be used with a nasal cannula assembly according to one or more embodiments of the present invention.

[0422] Figure 50A and 50B A nasal cannula assembly is shown including a cannula portion and a separate plug and catheter connector.

[0423] Figure 51 A nasal cannula assembly is shown that includes a cannula portion and a clip containing a plug and a tube connector for connecting a gas tube to the cannula portion.

[0424] Figure 52A and 52B A nasal cannula assembly is shown that includes a cannula portion and a clip that includes a plug and a tube connector for connecting a gas tube to the cannula portion. The cannula portion includes a rigid member for engaging with the clip.

[0425] Figure 53A and 53B A clamp comprising a conduit connector and a plug for connecting a gas conduit to a cannula portion is shown. The lateral distance between the plug and the connector is adjustable. Figure 53B It is an exploded view.

[0426] Figures 54A to 54C A nasal cannula assembly is shown that includes a cannula portion and a clip that includes a plug and a tube connector for connecting a gas tube to the cannula portion. The clip is rotatably mounted to the cannula portion.

[0427] Figure 55A and 55B A nasal cannula assembly is shown that includes a cannula portion and a catheter connector including a manifold. The cannula portion is rotatably mounted to the manifold.

[0428] Figures 56A to 56C A nasal cannula assembly is shown comprising a cannula portion and a clip comprising a plug and a tube connector for connecting a gas tube to the cannula portion. The clip can be inserted laterally into a manifold of the cannula portion.

[0429] Figure 57A A cannula assembly is shown comprising a pair of gas supply conduits, each conduit connected to a nasal prong via a flexible tubing segment, and a clip on each side of the cannula assembly for configuring the conduits to extend from either the left or right side of the cannula.

[0430] Figure 57B and 57C A nasal cannula assembly is shown comprising a pair of gas supply conduits, each connected to a nasal prong via a swivel elbow.

[0431] Figure 58A A splittable strap for headgear is shown that includes a frangible section that allows a portion of the strap to split into two separate straps.

[0432] Figure 58B The forkable strip is shown in a non-forked configuration when in use.

[0433] Figure 58C The forkable strip is shown in a forked configuration for use.

[0434] Figure 58D It is shown how a bifurcated strip comprising a frangible section can be separated to form a bifurcated portion comprising two separate strips.

[0435] Figure 58E A forkable stripe is shown in a non-forking configuration.

[0436] Figure 58F Shown Figure 58E Cross section of the strip.

[0437] Figure 58G Shown Figure 58A Cross section of the strip.

[0438] Figure 59 A splittable strap for headgear is shown including a lift portion defined by a frangible section for allowing a portion of the strap to split into two separate straps.

[0439] Figure 60A and 60B A bifurcated strap for headgear is presented that includes a snap ring slidable along a bifurcated section of the strap to configure the bifurcated section into a bifurcated configuration or a non-bifurcated configuration.

[0440] Figures 61A to 61C A bifurcated strap for headgear is presented that includes two clasps slidable along a bifurcated section of the strap to configure the bifurcated section into a bifurcated configuration or a non-bifurcated configuration.

[0441] Figure 62 A splittable strap is shown wherein the ends of the separate straps of the strap are pivotally coupled.

[0442] Figure 63 A headgear strap is shown comprising an expandable portion and a non-expandable portion, the non-expandable portion being bifurcated into two separate straps.

[0443] Figure 64 A headgear strap is shown comprising a bifurcated portion wherein at least one strap of the bifurcated portion is stretchable and the ends of the bifurcated straps are joined by a non-stretching Y-connector.

[0444] Figure 65 A headgear strap is shown comprising an expandable portion and a non-expandable portion supporting a gas supply conduit.

[0445] Figure 66 A device comprising a first non-stretch segment attached to one side of a patient interface and a second non-stretch segment attached to an opposite side of the patient interface, and an expandable intermediate segment extending between the first and second non-stretch segments is shown.

[0446] Figure 67 A device comprising a first expandable segment attached to one side of a patient interface and a second non-expandable segment attached to an opposite side of the patient interface, and a non-expandable annular intermediate segment extending between the first and second non-expandable segments is shown.

[0447] Figure 68 A headgear strap is shown including a bifurcated portion, wherein at least one strap of the bifurcated portion is adjustable in length.

[0448] Figure 69 is a perspective view of a segmented nasal cannula system arranged and configured in accordance with certain features, aspects, and advantages of the present disclosure.

[0449] Figure 70 is an exploded view of a segmented nasal cannula, wherein the segments are configured to be mechanically fastened to one another.

[0450] Figure 71 is in use Figure 70 An enlarged view of the mechanical fastening device.

[0451] Figure 72 Similar to Figure 70 Exploded view shown in , but includes the clamp-on gas flow supply tube.

[0452] Figure 73 is similar to Figure 72 A perspective view of a segmented nasal cannula system, except that the cannula system has been assembled from these exploded components.

[0453] Figure 74 is a perspective view of an exploded cannula system with a clip-on supply tube attachment.

[0454] Figure 75 is a disassembled alternative cannula system with a clip-on supply tube attachment (vs. Figure 74 ) perspective view.

[0455] Figure 76 yes Figure 75 A perspective view of a cannula system, except that the cannula system has been assembled from these exploded components.

[0456] Figure 77 is a disassembled alternative cannula system with a clip-on supply tube attachment (vs. Figure 74 and 75 ) perspective view.

[0457] Figure 78 is a perspective view of a clamp-on supply tube attachment with a hinged end cap.

[0458] Figure 79 yes Figure 78 A close-up view of the hinged end cap.

[0459] Figure 80 yes Figure 78 A top-down view of a clamp-on supply tube in which the hinged end cap has been moved toward the gas supply fitting.

[0460] Figure 81 yes Figure 78 A top-down view of a clamp-on supply tube in which the hinged end cap has been moved away from the gas supply tube.

[0461] Figure 82 Is a Figure 78 A perspective view of the assembled cannula system of a clamp-on supply tube attachment.

[0462] Figure 83 An embodiment of a nasal cannula system includes a pair of nasal prongs, a cannula body, a pair of side arms extending from the cannula body, a head cap connected to the side arms, a gas supply tube for providing a gas source to be in fluid communication with the pair of nasal prongs, and a connector associated with the gas supply tube.

[0463] Figure 84 Another embodiment of a nasal cannula system includes a pair of nasal prongs, a cannula body, a pair of side arms extending from the cannula body, a head cap connected to the side arms, a gas supply tube for providing a gas source to be in fluid communication with the pair of nasal prongs, and a connector associated with the gas supply tube.

[0464] Figure 85 It passes through Figure 84 , which illustrates an example of how a first section of a first material may be provided in combination with a second section of a second material, in combination with an example of a pivoting or rotating manifold. DETAILED DESCRIPTION

[0465] Although certain embodiments and examples are described below, those skilled in the art will appreciate that the present disclosure extends beyond the specifically disclosed embodiments and / or uses and obvious modifications and equivalents thereof. Accordingly, it is intended that the scope of the present disclosure disclosed herein should not be limited by any specific embodiment described below. The various features described herein can be used individually or in various combinations and subcombinations in existing and / or improved respiratory interfaces.

[0466] Whether used in a hospital setting or in a home environment, a system for providing a flow of gas to a patient or user can include four main pieces of equipment. First, a blower for providing a pressurized flow of gas to the patient. Second, an active humidifier that controls the temperature of a heater plate that heats a body of water to achieve the desired temperature and humidity of the gas flow. Third, a transmission conduit from the humidifier to the patient is also required, which can be heated to reduce condensation, or "rainout." Fourth, a patient interface for delivering the pressurized humidified flow of gas to the patient, such as a nasal cannula designed to fit into the nasal cavity of the patient or user. In some cases, a pressurized flow of gas without humidification can be provided to the patient, in which case a humidifier is an unnecessary device.

[0467] refer to Figure 49, shows a humidification circuit that can be used with a patient interface including the present invention. Patient 100001 is receiving humidified and pressurized gas through a nasal cannula assembly 10020, which is connected to a humidified gas delivery passage or inspiratory conduit 100003, which is in turn connected to a humidifier 100008 (including a humidification chamber 100005), which is supplied with gas from a blower 10015 or other suitable gas supply. Inspiratory conduit 100003 is connected to an outlet 100004 of humidification chamber 100005, which contains a volume of water 100006. Humidification chamber 100005 is preferably formed of a plastic material and may have a highly thermally conductive base (e.g., an aluminum base) that is in direct contact with a heater plate 100007 of humidifier 100008. The humidifier 100008 is equipped with a control device or electronic controller 100009, which may include a microprocessor based controller that executes computer software commands stored in an associated memory. Gas flowing through the inspiratory conduit 100003 is delivered to the patient by means of a nasal cannula assembly 100020.

[0468] Controller 100009 receives input from a source such as a user input device or dial 10010, by which a user of the device can, for example, set a predetermined desired value (preset value) for the humidity or temperature of the gas supplied to patient 100001. In response to the user input of the humidity or temperature value set via dial 10010 and other possible inputs (such as internal sensors sensing gas flow or temperature), or through parameters calculated in the controller, controller 100009 determines when (or to what level) to supply energy to heater plate 100007 to heat water 100006 within humidification chamber 100005. As the volume of water 100006 within humidification chamber 100005 is heated, water vapor begins to fill the volume of the chamber above the surface of the water and escapes from outlet 100004 of humidification chamber 100005, where a flow of gas (e.g., air) provided by gas supply or blower 10015 enters the chamber through inlet 10016. It should be noted that it is possible to derive a relationship between the humidity of the gas in the humidification chamber 100005 and the temperature of the heater plate 100007. It is therefore possible to utilise the heater plate temperature in an algorithm or look-up table to determine the humidity of the gas.

[0469] The blower 10015 may be equipped with a variable speed pump or fan 100002 that draws air or other gas through a blower inlet 10017. The speed of the variable speed pump or fan 100002 may be controlled by another control device or electronic controller 10018 (or, alternatively, the functions of this controller 10018 may be performed by another controller 100009) in response to input from the controller 100009 and a user setting a predetermined desired value (preset value) for pressure or fan speed via a dial 10019.

[0470] A heating element 10011 may be provided within the conduit or tubing 100003 to help prevent condensation of the humidified gas within the conduit. Such condensation occurs because the temperature of the conduit walls approaches the ambient temperature (i.e., the temperature of the surrounding atmosphere), which is often lower than the temperature of the humidified gas within the conduit. The heating element effectively compensates for energy losses in the gas due to conduction and convection during transport through the conduit. Thus, the conduit heater element ensures that the delivered gas is at an optimal temperature and humidity.

[0471] refer to Figures 1A-1C , an exemplary embodiment of a nasal cannula assembly or system includes a manifold 12 and a cannula 14. The cannula 14 includes nasal prongs 20a and b, side straps 22, and a tubular orifice 24 defined or surrounded by a retaining 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 orifice 24 so that the manifold outlet 18 is aligned with and in fluid communication with the nasal prongs 20a and b. The manifold inlet 16 is configured to be removably or permanently coupled 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 connect to and supply gas from a gas source, such as a ventilator, a gas tank, a wall outlet, and / or a humidifier that heats and / or humidifies the gas before it is delivered to the patient. The gas supply tube 50 may be coupled to the main delivery conduit 90 via a connector 52 .

[0472] The nasal cannula system may further include a securing mechanism for securing the cannula 14 to the user's head in the correct operating position. In the illustrated embodiment, the securing mechanism includes a head cap strap 40. The strap 40 can be coupled to the side straps 22 of the cannula 14. The nasal cannula system may also include a tether 46 that is placed around the patient's neck when in use. The tether 46 can be coupled to the supply tube 50 and / or connector 52 via a tether connector 54, which can also allow the length of the tether to be adjusted. The tether 46 advantageously helps support the weight of the main delivery catheter 90 to reduce patient discomfort and the possibility of displacement of the cannula 14. Further details about exemplary nasal cannula assemblies or systems can be found in U.S. Publication 2010 / 0192957, the entire contents of which are incorporated herein by reference. The different components and features of such nasal cannula assemblies can be selected and modified to achieve the various benefits as described herein.

[0473] refer to Figure 2A and 2B , an embodiment of a nasal cannula assembly or system includes a cannula 114, a manifold 112, a headgear strap 140, a gas supply tube 150, and a lanyard 146. The cannula 114 can be formed of a thermoplastic silicone-like material and includes nasal prongs 120a and b, a side strap 122, and two spaced manifold retaining portions or straps 126a and b that define / surround an orifice configured to receive the manifold 112. In some embodiments, the nasal prongs 120a and b, the side straps 122, and the manifold retaining straps 126a and b are integrally formed. The cannula 114 is configured such that the manifold 112 can be inserted into the orifice of the manifold retaining straps 126a and b from either side such that the manifold inlet 116 can be positioned on either side of the cannula 114. For example, the side straps 122 may include flex grooves 128 that provide ventilation and allow the sleeve 114 to bend or stretch more easily when adjusting the headgear straps 140 and when adjusting the sleeve 114 against the user's face to help achieve a more effective and / or comfortable fit. The flex grooves 128 may be generally vertical as shown or diagonally angled. Figure 2B , the 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, the transition portion 132 positioned between the central body portion 134 of the cannula 114 and the side straps 122 can be curved toward the patient's face to rest against the nasolabial folds. The side straps 122 can taper in thickness toward the outer edges of the straps 122, thereby creating a thin profile and helping to further reduce the profile of the cannula system.

[0474] The headgear straps 140 may be coupled to the side straps 122 via clips or buckles 142. The clips 142 may include apertures 144 so that the inner edges 145 of the clips 142 on the side nearest the center of the sleeve 114 may engage corresponding undercuts on the side straps 122. Figure 2B , these clips 142 do not substantially contact the patient's skin, thereby maintaining a smooth and more comfortable patient contact surface. The side of the clip 142 farthest from the center of the sleeve 114 may include a buckle mechanism configured to receive the end of the headgear strap 140 and allow the circumference of the headgear strap 140 to be adjusted to fit the patient's head. In some embodiments, the strap 140 may be flexible (e.g., elastic) to allow the strap 140 to accommodate a wide range of patient head sizes with minimal adjustment.

[0475] In use, manifold 112 is coupled to sleeve 114 by inserting manifold 112 into aperture 124 and stretching flexible sleeve 114 around manifold 112. As described above, manifold 112 can be inserted into aperture 124 of manifold retaining bands 126a and b from either side, allowing manifold inlet 116, and therefore supply tube 150, to be positioned on either side of sleeve 114. In some embodiments, manifold 112 is made of a relatively hard plastic material that can withstand relatively high load conditions to protect manifold 112 from crushing. Additionally, retaining bands 126a and b can be spaced apart from one another to provide support to manifold 112 at spaced-apart locations. This support can prevent or resist undesirable movement (e.g., rotation or twisting) of manifold 112, such as caused by forces acting on, for example, supply tube 150. In some configurations, the outer lateral edges of the retaining straps 126a and b are spaced outwardly from the nasal prongs 120a and b, such that the nasal prongs 120a and b are located between the lateral edges of the retaining straps 126a and b. In some configurations, the inner edges of the retaining straps 126a and b may be substantially aligned with or spaced outwardly from the nasal prongs 120a and b. Although a pair of retaining straps 126a and b is shown, other suitable retaining arrangements or structures are possible, such as a single retaining strap. In the illustrated embodiment, the manifold inlet 116 has an inner diameter that is slightly larger than the outer diameter of the supply tube 150, so that the tube 150 can be coupled to the manifold 112 by inserting the end of the tube 150 into the manifold inlet 116. The supply tube 150 may have a reduced diameter compared to other supply tubes to allow for this coupling. The end of the tube 150 opposite the manifold includes a connector 152 that is configured to couple the supply tube 150 to a main delivery conduit, which is coupled to the gas source. In the illustrated embodiment, the connector 152 is a 22 mm tapered connector.

[0476] The cannula system may include a tether connector 154, which, in the illustrated embodiment, is located on the supply tube 150 at the proximal end (closer to the patient) of the connector 152. The tether connector 154 may include a mechanism 155 for receiving the ends of the tether 146 on either side. For example, each side of the tether connector 154 may include three or more offset slots or posts through which the ends of the tether 146 pass. These slots or posts may be internal to the tether connector 154 or exposed. This configuration advantageously allows for adjustment of one or both ends of the tether as needed or desired, and allows the weight of the connector 152 (and the primary delivery circuit 90) to be suspended or directed in a vertical orientation or direction. In some embodiments, the tether 146 is non-elastic. The tether 146 is secured to the tether connector 154 via friction between the tether 146 and the slots or posts. The tether 146 may be ribbed to facilitate securing the tether 146 to the tether connector 154. However, the tether 146 and tether connector 154 can be designed so that if the connector 154 is pulled too far away from the patient and / or with sufficient force, the frictional forces are overcome and the tether 146 is released from the tether connector 154 to prevent the tether 146 from becoming blocked or otherwise causing discomfort to the patient. The tether connector 154 can include a clip 156 to allow the patient or another person to better grip the tether connector 154 in order to adjust the connector 152 and / or easily remove it from the main delivery catheter 90.

[0477] refer to Figure 3A and 3B , the nasal cannula assembly or system includes a cannula 214, a manifold 212, a headgear strap 240, a gas supply tube 250, and a lanyard 246. The cannula 214 includes nasal prongs 220a and b, side straps 222, and a manifold retaining strap 226 that defines or surrounds an aperture configured to receive the manifold 212. The cannula 214 is configured so that the manifold 212 can be inserted into the aperture of the manifold retaining strap 226 from either side so that the manifold inlet 216 can be positioned on either side of the cannula 214. In the illustrated embodiment, the manifold retaining strap 226 is positioned with respect to the manifold 212. Figure 1A and 1B The retention strip 26 is shown as being wider than the strips 126a and b shown in Figure 2. The retention strip 226 may include a window 227 that allows a portion of the manifold 212 to be visible, e.g., indicating that the manifold 212 is properly inserted into the manifold retention strip 226. The window 227 may display, for example, brand, size, and / or other information that is printed, embossed, adhered, or otherwise presented on a visible portion of the manifold 212.

[0478] The sleeves 214 are typically soft and flexible for patient comfort. The outer portions 223 of the side straps 222 can be given increased strength by making the outer portions 223 thicker or otherwise reinforcing them, such as via reinforcing ribs, which can be positioned, for example, at the upper and / or lower edges of the side straps 222. The increased strength allows the headgear straps 240 to be directly coupled to the outer portions 223 of the side straps 222 without the need for additional clips, buckles, or other attachment mechanisms, and allows the sleeves 214 and side straps 222 to maintain their molded shape, preventing or inhibiting deformation during extension. The outer portions 223 of the side straps 222 can include two or more slits or apertures through which the ends 243 of the headgear straps 240 can be passed and pulled through the desired length to obtain a headgear strap 240 circumference that is suitable for fitting the patient. The ends 243 of the headgear straps 240 can be folded back and removably secured via hook-and-loop closures to portions of the outer portions 223 of the headgear straps 240 proximate the side straps 222. For example, fabric sections including hooks can be attached (e.g., sewn, adhered, etc.) to the ends 223 of the headgear straps 240, and fabric sections including loops can be attached (e.g., sewn, adhered, etc.) to portions of the outer portions 223 of the headgear straps 240 proximate the side straps 222. Opposite sides of the ends 243 of the straps 240 that are visible when worn can include branding or other information printed, embossed, adhered, or otherwise attached thereto.

[0479] As in Figure 3B , the back or patient-facing side of the side straps 222 may include a recessed area 221 to accommodate the portions of the headgear strap 240 that are looped through the side straps 222 so that the headgear strap 240 does not significantly press on the patient's face. The segment of the headgear strap 240 that is configured to be placed against the back of the patient's head when in use may include a padded segment 241 for patient comfort. The padded segment may be inserted between the two halves of the headgear strap 240 or placed on top of or around the headgear strap 240.

[0480] In use, the manifold 212 is coupled to the cannula 214 by inserting the manifold 212 into the aperture defined by the manifold retaining band 226. The manifold 212 can be inserted into the aperture of the manifold retaining band 226 from either side, so that the manifold inlet 216 can be positioned on 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 that is slightly larger than the outer diameter of the supply tube 250, so that the tube 250 can be coupled to the manifold 212 by inserting the end of the tube 250 into the manifold inlet 216. The end of the tube 250 opposite the manifold 212 includes a connector 252 that is configured to couple the supply tube 250 to a main delivery conduit that is coupled to and in fluid communication with the gas source.

[0481] The cannula system may further include a tether connector 254 located on the supply tube 250 at the proximal end of the connector 252. In some embodiments, the tether connector 254 is color-coded to indicate size or other information. One side of the tether connector 254 may include a mechanism 255 for adjustably receiving one end of the tether 246. For example, one side of the tether connector 254 may include two slits or orifices through which the ends of the tether 246 may pass. This mechanism 255 allows the tether 246 to be easily placed around the patient's neck and coupled to the tether connector 254 without having to place the tether 246 on the patient's head. The tether connector 254 may also include a clip 256 to allow the patient or another person to better grip the tether connector 254 in order to adjust the connector 252 and / or easily remove it from the main delivery catheter 90.

[0482] One side of tether connector 254 may include a breakaway clip 257. One end of tether 246 may include a mold configured to be inserted into breakaway clip 257 to secure tether 246 to tether connector 254. Breakaway clip 257 is designed so that if tether 246 applies excessive force to the patient's neck, for example, due to the primary delivery catheter, connector 252, supply tube 250, and / or tether connector 254 being pulled away from the patient with a force exceeding a certain threshold, breakaway clip 257 releases tether 246 or disengages it from tether connector 254 to avoid injury or discomfort to the patient. This configuration advantageously allows the weight of connector 252 (and primary delivery circuit 90) to be suspended or oriented in a vertical orientation or direction. In some embodiments, tether 246 is made of an inelastic material to improve the function of breakaway clip 257 and prevent the weight of the primary delivery catheter coupled to connector 252 from stretching tether 246 and applying additional force to the patient's neck. In some embodiments, breakaway clip 257 allows lanyard 246 to be easily looped around the patient's neck and then inserted into breakaway clip 257 .

[0483] Figure 4Demonstrates a similar Figure 3A and 3B The sleeve 214 and headgear strap 240 of the sleeve 314 and headgear strap 340 are shown in FIG. However, Figure 4 The cannula system of FIG. 31 has no manifold retaining band and includes a reversible manifold 312 . The manifold 312 can be pivoted or rotated or disengaged from the cannula 314 and turned 180° so that the inlet 316 can be positioned on either side of the cannula 214 .

[0484] As in Figure 5A and 5B The embodiment of a nasal cannula assembly or system illustrated in FIG includes a cannula 414, a headgear strap 440, and a gas supply tube 450. The cannula 414 includes nasal prongs 420a and b, a side strap 422, and an inlet 416. In the illustrated embodiment, the distal end of the gas supply tube 450 is directly coupled to the inlet 416 of the cannula 414. The supply tube 450 may have a reduced diameter such that the distal end of the supply tube 450 can be received within the inlet 416. The supply tube 450 may be secured to the cannula 414 by extending the cannula inlet 416 over the distal 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 pathways 417a and b extending from and in fluid communication with the inlet 416, such that the first gas pathway 417a extends to and is in fluid communication with the first nasal prong 420a, and the second gas pathway 417b extends to and is in fluid communication with the second nasal prong 420b. The geometry of the gas paths 417a and b can be designed to balance the gas flow between the gas paths 417a and b and the nasal prongs 420a and b so that the patient receives a balanced flow in both nostrils. The flow paths have reduced, minimal, or no significant abrupt transitions or sharp angles, which advantageously reduces or minimizes flow resistance.

[0485] The ends of the side straps 422 can include apertures or slots 421 designed to receive the ends of the headgear straps 440. The headgear straps 440 can be formed from a highly elastic material that is capable of stretching to a significant extent to allow the headgear straps 440 to adapt to and fit different patient head sizes, particularly where, as in the illustrated embodiment, the side straps 422 do not include clips or buckles, allowing for adjustment of the circumference of the headgear straps 440. For example, the headgear straps 440 can be made from a material having a relatively flat force-extension curve, such that the headgear straps 440 maintain the same or substantially the same tension over a range of extensions. The ends of the headgear straps 440 can include a rigid material overmolded thereon to help secure the ends of the headgear straps 440 within the apertures 421. The straps 440 can also or alternatively be secured to the sleeve 414 using an adhesive (e.g., glue), ultrasonic welding, and / or other means.

[0486] The cannula system includes a tube clamp 442 coupled (permanently or removably, fixedly or removably) to the headgear strap 440. The tube clamp 442 can be located on the side of the cannula 414 nearest the inlet 416 and can receive the supply tube 450 to help keep the tube 450 away from the patient's mouth and face when in use. The 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 clamp 454 positioned on the supply tube 450 proximal to the connector 452. The lanyard clamp 454 can releasably clamp a lanyard worn around the patient's neck when in use. Alternatively, the lanyard clamp 454 can be attached directly to, for example, the patient's clothing or hospital gown, a bed sheet, or to another nearby location to help support the weight of the main delivery conduit. In Figure 5A and 5B The nasal cannula system shown in 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 costs.

[0487] Another embodiment of a nasal cannula assembly or system includes a cannula 514, a manifold 512, a gas supply tube 550, and a lanyard 546, as shown in FIG. Figure 6A and 6B. The cannula 514 includes nasal prongs 520a and b, a manifold retaining strap 526, and cheek pads 522. The cheek pads 522 are designed to be positioned on the patient's cheeks and / or upper cheeks during use. The cannula 514 includes thin flex zones 532 located in transition areas between the central body portion 534 of the cannula 514 and the cheek pads 522. The thin flex zones 532 have a reduced cross-sectional thickness to allow the cheek pads 522 to be more easily moved and adjusted relative to the central body portion 534, thereby improving the assembly, positioning, and comfort of the cannula 514 on the patient's face. The back side or patient-facing side of the central body portion 534 may include soft and / or thin wall cushioning details 535. The cushioning details 535 may include, for example, ribbed, corrugated, folded, or other surfaces designed to slightly space the central body portion 534 of the cannula 514 from the patient's face. This advantageously allows airflow between the central body portion 534 and the patient's face and provides a collapsible region that helps absorb the force of pressing the sleeve 514 into the patient's face.

[0488] The rear surface of cheek pad 522 includes an attachment pad 560 that is integrally formed with cheek pad 522 or sewn or otherwise attached thereto. Attachment pad 560 may include a releasable and reattachable adhesive that attaches cheek pad 522 to the patient's face. Alternatively, attachment pad 560 may include a portion of a hook-and-loop fastener, such as a fabric section including these hooks. A patch containing the remaining portion of the fastener (e.g., a loop) may be attached to the patient's face at the desired location on the cheek and / or upper cheek to allow attachment pad 560 to be releasably attached to the patient's face.

[0489] The manifold 512 includes an inlet 516 designed to receive a gas supply tube 550 and an outlet designed to align with and be in fluid communication with the nasal prongs 520a and b during use. The manifold 512 is coupled to the cannula 514 by sliding the manifold 512 into an aperture defined by the manifold retaining band 526 so that the outlet aligns with the nasal prongs 520a and b and stretching the cannula 514 around the edge of the manifold 512. The manifold 512 can be inserted into the aperture of the manifold retaining band 526 from either side, so that the manifold inlet 516 can be positioned on either side of the cannula 514. The retaining band 526 can include a window 527 that allows a portion of the manifold 512 to be visible, for example, indicating that the manifold 512 is correctly inserted into the manifold retaining band 526. The window 527 can display, for example, brand, size, and / or other information that is printed, embossed, adhered, or otherwise presented on a visible portion of the manifold 512.

[0490] In the illustrated embodiment, supply tube 550 is a small-diameter spiral tube. Other types of gas supply conduits are also possible. The end of supply tube 550 opposite the end coupled to manifold 512 may include a connector 552 configured to connect to the main delivery conduit. The cannula system may include a lanyard retention connector 554 positioned on connector 552 or on supply tube 550 proximal to connector 552. One end of lanyard 546 may be integrally formed with or coupled to one side of lanyard retention connector 554. The opposite side of lanyard retention connector 554 may include a slot designed to receive a free end 547 of lanyard 546. The free end 547 of lanyard 546 may include a series of protrusions or notches 548. These protrusions 548 can be pulled through the slots of lanyard retention connector 554 to adjust the circumference of lanyard 546, but resist sliding through the slots when not adjusted to assist in securing lanyard 546 at the desired circumference. The lanyard 546 may be made of an embossed fabric, such as white non-woven laminated polyethylene, which may advantageously help reduce the cost of the cannula system.

[0491] like Figures 7A-7B The exemplary embodiment of the cannula system shown in includes a cannula 614, a gas supply tube 650, and a lanyard 646. The cannula 614 includes nose prongs 620a and b, a retaining strap 626, and an integrated headgear strap 640. In some embodiments, the headgear strap 640 may include a break on one side such that the headgear strap 640 includes a first segment 640a and a second segment 640b. The free end of one segment (the first segment 640a in the illustrated embodiment) may include a slot 642 configured to receive the free end of another segment (the second segment 640b in the illustrated embodiment). The section of the strap 640 proximate the free end of the second segment 640b may include teeth 643 configured to engage the sides of the slot 642 to help prevent the second segment 640b from being pulled out of the slot 642. The rear portion 641 of the headgear strap 640 (part of the first section 640a in the illustrated embodiment) may be split into a dual strap configuration to assist in stabilizing the headgear strap 640 on the patient's head and / or to help distribute forces across the patient's head and improve comfort.

[0492] 650 is coupled to the cannula 614. In the illustrated embodiment, the distal end of the gas supply tube 650 is coupled directly to the cannula 614. The supply tube 650 can have a reduced diameter such that the distal end of the supply tube 650 can be received within the orifice defined by the retaining band 626. The supply tube 650 can be secured to the cannula 614 using an adhesive (e.g., glue), mechanical interference features, and / or other means by the manifold retaining band 626 stretched over the distal end of the supply tube 650. The cannula system includes a tube clamp 642 coupled (permanently or removably, fixedly or removably) to the supply tube 650. The tube clamp 642 can include a hook configured to be placed on the headgear strap 640 to help retain the tube 650 away from the patient's mouth and face during use.

[0493] The end of the supply tube 650 opposite the end coupled to the cannula 614 may include a connector 652 configured to connect to the main delivery catheter. The cannula may further include a lanyard retention connector 654. The connector 652 may include a lower portion and an upper portion 653 including a gripping feature. 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 may be separate pieces. In use, the lanyard retention connector 654 is pressed onto a portion of the connector 652 and is held in place between the upper and lower portions or in the reduced diameter section.

[0494] In the illustrated embodiment, the lanyard 646 is integrally formed with one side of the lanyard retention connector 654. Alternatively, the lanyard 646 may be coupled to the lanyard retention connector 654. The opposite side of the lanyard retention connector 654 may include a slot designed to receive the free end 647 of the lanyard 646. The free end 647 of the lanyard 646 may include a series of notches 648 along these sides. In use, the lanyard 646 is wrapped around the patient's neck, and the free end 647 of the lanyard is passed through the slot of the lanyard retention connector 654 to achieve the desired circumference of the lanyard 646. These 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 adjusted to assist in securing the lanyard 646 at the desired circumference. The lanyard 646 may be made of an embossed fabric, such as white non-woven laminated polyethylene, which may advantageously help reduce the cost of the cannula system.

[0495] exist Figure 7CIn an alternative embodiment shown in , the cannula system can include a connector 752, a tether connector 754 positioned on the supply tube 650 at the proximal end of the connector 752, and a separate tether 746. The tether connector 754 includes two slots that receive the ends of the tether 746. Both ends of the tether 746 can include a series of notches 748 similar to the notches 648 described herein to allow adjustment of one or both ends of the tether 746. This configuration advantageously allows the weight of the connector 752 (and the main delivery circuit 90) to be suspended or oriented in a vertical orientation or direction.

[0496] In some embodiments, for example, Figures 8A-8C As shown in FIG, the nasal cannula system includes a cannula 814, a manifold 812, a headgear strap 840, a gas supply tube 850, and a lanyard 846. The cannula 814 includes nasal prongs 820a and b, and an inlet 824. As shown in FIG. Figure 8C , a flange 825 surrounds the periphery of the inlet 824. The manifold 812 includes an inlet 816 and an outlet 818 configured to receive the supply tube 850. The outlet 818 of the manifold 812 includes a recess 819 configured as the flange 825 of the cannula 814. In some embodiments, the manifold 812 and the cannula 814 can be designed with reduced dimensions to advantageously reduce the profile of the cannula system on the patient's face, thereby improving patient comfort and reducing the possibility of obstruction of the face or mouth in certain situations.

[0497] In use, the manifold 812 is coupled to the sleeve 814 by inserting one side of the manifold 812 into the sleeve 814 inlet 824 such that the flange 825 of the sleeve 814 seats in the recess 819 of the manifold 812, and extending the sleeve 814 around the manifold 812 outlet 818 such that the flange 824 seats in the recess 819 around the entire perimeter of the sleeve 814 outlet 824 and the manifold 812 outlet 818. The flange 824 and corresponding recess 819 advantageously help secure the connection between the sleeve 814 and the manifold 812 and may also help prevent air leakage at the connection. The manifold 812 may further include a tab 880 designed to fit into a corresponding recess or aperture 882 on the sleeve 814 to further help secure the manifold 812 to the sleeve 814 and indicate that the manifold 812 is correctly inserted into the sleeve 814. As shown in Figure 8C , the manifold 812 is reversible, i.e., the manifold 812 can be coupled to the cannula 814 such that the manifold inlet 816 extends on either side of the cannula 814. The manifold 812 can include a grip 815 that advantageously assists a user in gripping the manifold 812 in order to couple and / or remove the manifold 812 to and / or from the cannula 814.

[0498] In the illustrated embodiment, the headgear strap 840 is directly coupled to the sleeve 814, and the sleeve system does not include clips, buckles, or other mechanisms that allow for adjustment of the circumference of the strap 840. The sides of the sleeve 814 may include apertures or slots 821 designed to receive the ends of the headgear strap 840. These ends of the strap 840 may also be secured to the sleeve 814 using an adhesive (e.g., glue), ultrasonic welding, and / or other means. The headgear strap 840 may be formed from a highly elastic material that is capable of stretching to a large extent to allow the strap 840 to adapt to and fit different patient head sizes. For example, the headgear strap 840 may be made from a material having a relatively flat force-extension curve so that the headgear strap 840 maintains the same or substantially the same tension over a range of extensions. The pitch of the headgear strap 840 material may be varied to adjust the tightness of the strap 840.

[0499] Gas supply tube 850 can be coupled to manifold 812 inlet 816 at one end and to a connector 852 at an opposite end, which is configured to connect supply tube 850 to the main delivery conduit. Gas supply tube 850 can have a reduced diameter so that the end of supply tube 850 can be inserted into manifold inlet 816. In some embodiments, connector 852 can include gripping details 856 to help a user more easily grip connector 852 to adjust various components of the cannula system. In some embodiments, gas supply tube 850 can include a pressure line 870. Pressure line 870 can be configured to transmit pressure feedback from the end of supply tube 850 coupled to manifold 812 to a pressure sensor and / or controller. Pressure line 870 can be integral with or coupled to supply tube 850. In some embodiments, pressure line 870 is located within the main flow path of supply tube 850. In other embodiments, pressure line 870 is located adjacent to the main flow path of supply tube 850. For example, in some embodiments, the supply tube 850 may be a spiral bubble tube, and the pressure line 870 may be located within the hollow spiral of the spiral bubble supply tube 850 .

[0500] The cannula system may further include a lanyard connector 854 located on the supply tube 850 proximal to the connector 852. In some embodiments, the lanyard connector 854 is fixed relative to the tube 850. In other embodiments, the lanyard connector 854 can slide relative to the tube 850. The lanyard connector 854 may include an aperture or slot on either side to receive the end of the lanyard 846. In the illustrated embodiment, the lanyard connector 854 may also serve as a point for separating the pressure line 870 from the supply tube 850. In use, the lanyard 846 is wrapped around the patient's neck, and the ends of the lanyard 846 are passed through the aperture or slot of the lanyard connector 854 to achieve the desired circumference of the lanyard 846. The end of the lanyard 846 may include a notch 848 along the sides. The notches 848 allow the lanyard 846 to be pulled through the slots of the lanyard connector 854 to adjust the circumference of the lanyard 846, but resist sliding through the slots when not adjusted to assist in securing the lanyard 846 at the desired circumference. This configuration advantageously allows the connector 852 (and the Figure 1A The weight of the primary delivery loop 90 in the cannula is suspended or oriented in a vertical orientation or direction. The lanyard 846 can be made of an embossed fabric such as a white non-woven laminated polyethylene, which can advantageously help reduce the cost of the cannula system.

[0501] As in Figure 9A and 9B 914. The exemplary embodiment of the cannula system shown in FIG. 914 includes a cannula 914, a manifold 912, a head cap strip 940, and a gas supply tube 950. As shown, the cannula 914 may include a manifold orifice 924 configured to receive the manifold 912 and a head cap strip orifice 921 configured to receive the head cap strip 940. The manifold 912 can be inserted into the orifice of the cannula 914 from either side so that the manifold inlet 916 can be positioned on either side of the cannula 914. In the illustrated embodiment, the manifold 912 is generally cylindrical, and the manifold orifice 924 is therefore also generally cylindrical. The manifold 912 can be substantially hollow to allow gas flow. The cannula 914 may include a window 927 that makes a portion of the manifold 912 visible, for example, the window indicates that the manifold 912 is correctly inserted into the manifold cannula 914. The window 927 may display, for example, brand, size, or other information that is printed, embossed, adhered, or otherwise presented on a visible portion of the manifold 912 .

[0502] One end of the cylindrical manifold 912 is open and forms an inlet 916 configured to receive one end of a gas supply tube 950. The opposite end of the manifold 912 is closed, as shown in FIG. Figure 9B In some embodiments, the closed end of the manifold 912 includes a removable cap. In some such embodiments, the solid cap may be interchangeable with a cap 913 that may include a pressure line 970, such as in Figure 9CAs explained above, the manifold 912 can be inserted into the aperture of the sleeve 914 from either side, so that the manifold inlet 916 can be positioned on either side of the sleeve 914. Therefore, the cap 913 can also be located on either side of the sleeve 914.

[0503] In the illustrated embodiment, the headgear strap 940 is threaded through the headgear strap aperture 921 of the sleeve 914. In some embodiments, the headgear strap 940 is secured to the sleeve 914 with an adhesive (e.g., glue), ultrasonic welding, or another mechanism. However, in some embodiments, the sleeve 914 and the headgear strap 940 are slidable relative to each other. The headgear strap 940 can be a single segment of strap. One end of a segment of strap can be secured to a clasp 943a and the opposite end of the segment of strap can be secured to a clasp 943b. The clasps 943a and b are coupled to the strap 940 and can slide thereon to allow the circumference of the strap 940 to be adjusted to fit the patient's head. In some embodiments, the headgear strap 940 is made of a non-stretch material.

[0504] The cannula system can include a connector 952 on the supply tube 950 at an end opposite the manifold 912. The connector 952 can be configured to couple the supply tube 950 to the main supply conduit. The cannula system can further include a lanyard clip 954 that wraps around a proximal portion of the connector 952 or around the supply tube 950 at the proximal end of the connector 952. The lanyard clip 954 can releasably receive a lanyard. Alternatively, the lanyard clip 954 can be clipped directly to, for example, the patient's clothing or hospital gown, bedding, or a lanyard placed around the patient's neck to help support the weight of the main supply conduit coupled to the connector 952.

[0505] like Figure 10A and 10BThe exemplary embodiment of the cannula system shown in FIG includes a cannula 1014, a nasal patch 1022, a supply tube 1050, and nasal prongs 1020a and b. The cannula 1014 is shaped and sized to be positioned on the top of the patient's nose. For example, a portion of the cannula 1014 may have a curved profile designed to conform to the curvature of the nose. The cannula 1014 can be secured to the patient's nose via the nasal patch 1022. In some embodiments, the nasal patch 1022 resembles an adhesive bandage. The central portion of the nasal patch 1022 may include a comfort pad 1035 configured to rest against the patient's nose during use and provide additional cushioning. An adhesive portion of the nasal patch 1022 extends from the central portion for adhesion to various portions of the patient's cheek. The side of the nasal patch 1022 facing away from the patient's face includes an attachment pad 1062 coupled thereto (e.g., sewn, adhered, or otherwise attached). The patient-facing side of the cannula 1014 includes a corresponding attachment pad 1060. For example, in some embodiments, the attachment pads 1060 , 1062 are components of a hook and loop fastener, such as Velcro. Thus, the attachment pads 1060 , 1062 allow the cannula 1014 to be releasably attached to the nose patch 1022 .

[0506] In some embodiments, the nasal strip 1022 includes a strip 1064 designed to help keep the patient's nasal passages open. In some embodiments, the strip 1064 can be made of a flexible, spring-like metal that is biased toward a substantially straight position. When the strip 1022 is placed across a curved nasal bridge, the strip 1064 tends to straighten, thereby gently lifting the sides of the patient's nose and opening the nasal passages. In some embodiments, the strip 1064 can be made of a shape-memory material such as Nitinol, and heat from the patient's face causes the strip 1064 to tend to return to a straighter position. The strip 1064 can be located on either side of the nasal strip 1022, i.e., on the side facing away from the patient or the side facing the patient, for example, between the strip 1022 and the comfort cushion 1035. In some embodiments, the nasal strip 1022 can also function as a blackhead removal strip. The patient-contacting side of the strip 1022 can include an adhesive that can bind to dust and / or other impurities in the patient's pores, thereby removing them when the strip 1022 is removed.

[0507] In the illustrated embodiment, the supply tube 1050 is a double tube comprising two small diameter tubes extending between the main delivery catheter connector 1052 and the nasal prongs 1020a and b. The cannula system may include an adapter 1053 designed to receive the small diameter supply tube 1050 and couple to the main delivery catheter connector 1052. The adapter 1053 may be integrally formed with, attached to, or proximal to the connector 1052. Each of these supply tubes 1050 may be integrally formed with or attached to one of the nasal prongs 1020a and b. In some alternative embodiments, the supply tube 1050 may comprise a single tube over a portion or all of its length. The single tube may split at the nasal prongs 1020a and b or may split into two tubes distal to the nasal prongs 1020a and b. As Figure 10A and 10B As shown in the figure, the two supply tubes 1050 are conveyed downwardly into a portion of the cannula 1014. The nasal prongs 1020a and b extend downwardly from these supply tubes 1050 and the cannula 1014, and then turn approximately 180° to extend upwardly on the patient contacting side of the cannula 1014. In the illustrated embodiment, the nasal prongs 1020a and b are formed or shaped to maintain their shape and orientation. In some embodiments, the nasal prongs 1020a and b may include a wire made of a shape memory material such as Nitinol. The flow of gas through the nasal prongs 1020a and b or the heat radiated from the patient's face may cause the wire to adopt and / or maintain the formed shape. When the cannula 1014 is coupled to the nasal patch 1022, the nasal prongs 1020a and b extend upwardly into the patient's nostrils.

[0508] In some alternative embodiments, for example Figure 11 As shown in , the cannula system may include nasal pillows 1120a and b instead of nasal prongs. As shown, the supply tubes 1050 are passed downward through a portion of the cannula 1014 and are allowed to hang freely. The nasal pillows 1120a and b are coupled to the free ends of the supply tubes 1050. In some embodiments, the nasal pillows 1120a and b may be self-inflating pillows. During use, the nasal pillows 1120a and b are turned upward and inserted into the patient's nostrils, and the cannula 1014 is coupled to the nasal patch 1022.

[0509] The cannula system may further include cheek pads 1042. Cheek pads 1042 may include adhesive strips that can be used to secure a portion of the supply tubes 1050 to the patient's cheek. Cheek pads 1042 can advantageously help keep the supply tubes 1050 away from the patient's mouth and help support some of the weight of the supply tubes 1050. Cheek pads 1042 can include branding or other information printed or otherwise displayed thereon. In some embodiments, the supply tubes 1050 include torsion springs that can advantageously help allow manipulation of the tubes 1050, such as when positioning the cannula 1014 or cheek pads 1042 on the patient, without interrupting the gas supply.

[0510] An exemplary embodiment of a cannula system may include two cannulas 1220a and b, a nose patch 1222, and supply tubes 1250a and b, as shown in FIG. Figures 12A-12C As shown in . The nose patch 1222 can be similar to Figure 10A and 10B The nose patch 1022 shown in and described in the accompanying text. Figures 12A-12C In some embodiments, the cannula is separated into a right cannula 1214a and a left cannula 1214b. In some embodiments, the cannula 1214a and b are symmetrical rather than right- and left-biased. The right cannula 1214a includes an integrated nasal prong 1220a, and the left cannula 1214b includes an integrated nasal prong 1220b. The patient-facing surface of each cannula 1214a and b includes an attachment pad 1260a and b to removably attach the cannula 1214a and b to the attachment pad of the nasal patch 1222. In some embodiments, the nasal patch 1222 includes a strip 1264 that helps keep the patient's nasal passages open, as described with respect to Figure 10A and 10B As stated.

[0511] The supply tubes include right 1250a and left 1250b supply tubes of small diameter extending from the main delivery conduit connector 1252 to the right 1214a and right 1214b cannulas. These supply tubes 1250a and b are received in the inlets 1224a and b of these cannulas 1214a and b. As shown, these supply tubes 1250a and b can be looped around the patient's ears to help these tubes 1250a and b leave the patient's mouth and support some of the weight of these tubes 1250a and b. These tubes 1250a and b may include a spring that is coiled to help provide kink resistance and strength. In some embodiments, only one of these cannulas 1214a and b can be used at a given time for a certain patient when needed or desired.

[0512] like Figures 13A-13CAn exemplary embodiment of a cannula system shown in may include a cannula 1314, a retainer 1322, and a supply tube 1350. The cannula 1314 may have a minimal size and profile. In the illustrated embodiment, the cannula 1314 includes a generally cylindrical body having an inlet 1324 and integrally formed nasal prongs 1320a and b. The retainer 1322 includes a cannula engagement portion 1321 and a nasal patch portion 1323. In some embodiments, the cannula engagement portion 1321 is attached to the cylindrical body of the cannula 1314 with an adhesive such as glue. In some embodiments, the cannula engagement portion 1321 is molded as part of the cannula 1314. In some embodiments, the cannula engagement portion 1321 has a molded shape configured to snap or clip onto the cannula 1314. The nasal patch portion 1323 is designed to adhere across the patient's nose to help secure the cannula 1314 to the patient. The patient-facing side of the nose patch portion 1323 may include an adhesive strip covered by a protective backing 1366 for storage. When it is necessary to secure the cannula 1314 to the patient, the protective backing is peeled off to expose the adhesive strip. The retainer 1322 can be removed and replaced as needed during treatment. In embodiments where the cannula engagement portion 1321 is formed as part of the cannula 1314, the adhesive strip can be removed and / or replaced as needed.

[0513] In some embodiments, supply tube 1350 is a small-diameter spring-loaded tubing. Supply tube 1350 can be coupled to a primary delivery catheter connector 1352 at one end and to an inlet 1324 of cannula 1314 at an opposite end. The diameter of supply tube 1350 can be sized so that supply tube 1350 can be inserted into cannula inlet 1324 and cannula 1314 stretched or otherwise formed or positioned around tube 1350, thereby securing tube 1350 to cannula 1314. The cannula system can also include a lanyard clip 1354 positioned on connector 1352 or on supply tube 1350 proximal to connector 1352. Lanyard clip 1354 can releasably receive a lanyard placed around the patient's neck. Alternatively, lanyard clip 1354 can be attached to, for example, the patient's clothing or hospital gown, a bed sheet, or another nearby location to help support the weight of the primary delivery catheter.

[0514] like Figures 14A-14CThe exemplary embodiment of the cannula system shown in FIG includes a cannula 1414, a manifold 1412, and a gas supply tube 1450. The cannula 1414 includes nasal prongs 1420a and b, nasal valves 1422a and b, and a manifold retaining band 1426 that defines / surrounds an orifice 1424 configured to receive the manifold 1412. In use, the manifold 1412 is coupled to the cannula 1414 by inserting the manifold 1412 into the orifice 1424 and stretching the manifold retaining band 1426 around the manifold 1412. In the illustrated embodiment, the manifold includes an inlet or collar 1416 and two outlets 1418. In use, the outlets 1418 are aligned with and in fluid communication with the nasal prongs 1420a and b.

[0515] The nasal valves 1422a and 1422b extend from the sides of the cannula 1414 and are configured to fold over the sides of the patient's nostrils. The nasal valves 1422a and 1422b may include a thin section proximal to the manifold retaining band 1426, allowing the valves 1422a and 1422b to be easily bent and conform to the geometry of the nose. In some embodiments, each nasal valve 1422a and 1422b includes an attachment pad 1460, which may be part of a hook-and-loop fastener. The attachment pad 1460 may be removably coupled to a corresponding attachment pad 1462, which may be another part of the hook-and-loop fastener on the user's nose. The attachment pad 1462 may be attached to the outside of the patient's nostril using an adhesive. In some embodiments, the attachment pads 1460 of the nasal valves 1422a and 1422b may be adhesive patches that adhere directly to the user's nose. In some embodiments, the nasal valves 1422a and 1422b may include a malleable material that retains its shape once deformed, allowing the nasal valves 1422a and 1422b to remain substantially in place once folded. In such an arrangement, the attachment pad 1460 can be a gripping pad including a gripping material to grip the patient's skin and prevent unwanted movement of the cannula 1414.

[0516] In some embodiments, the supply tube 1450 is a small diameter spring tube. The supply tube 1450 can be coupled to the main delivery conduit connector 1452 at one end and to the manifold inlet or collar 1416 at the opposite end. In some embodiments, the supply tube 1450 is permanently attached to the collar 1416 and / or the collar 1416 is permanently attached to the manifold 1412. Alternatively, the supply tube 1450 can be removably coupled to 1416 and / or the collar 1416 can be removably coupled to the manifold 1412. As in Figure 14B, manifold 1412 can be inserted into aperture 1424 of cannula 1414 from either side, such that supply tube 1450 extends from either side of cannula 1414. The cannula system can further include a lanyard clip 1454 positioned on connector 1452 or on supply tube 1450 proximal to connector 1452. Lanyard clip 1454 can be releasably coupled to a lanyard placed around the patient's neck, or can be attached to, for example, the patient's clothing or hospital gown, a bed sheet, or another nearby location to help support the weight of the main delivery catheter.

[0517] Figures 15-18 illustrate embodiments of a nasal cannula assembly including a cannula, preferably including a pair of nasal prongs. The cannula can be integrated with a supply conduit or tubing, for example, via any manifold arrangement disclosed herein, or can be connected to a separate supply conduit or tubing. In some configurations, the cannula has a tubular shape having a first end, a second end, and a body extending between the first and second ends and coupled to the supply tube at one of these ends. Thus, the cannula body can define a hollow "manifold" volume, which is at least partially defined by the manifold in other embodiments disclosed herein. Additionally, in some embodiments, the cannula can include one or more prong outlet ports in the middle of the cannula body, which are arranged to allow gas to exit into a pair of nasal prongs. In some embodiments, the cannula can be a hollow volume containing at least one inlet, which can be positioned and shaped to attach to a supply conduit or conduit. In certain embodiments, the cannula can include an inlet at each end of the cannula. The cannula can be configured to connect to or integrate with an assembly fixture (e.g., a headgear strap). The cannula can be configured to be integrally connected or permanently connected to a supply tube or conduit, for example, by any manifold arrangement described herein or by a connector. In some embodiments, the cannula can be integrated or integral with the tube, thereby creating a cannula / tube assembly or structure. In certain embodiments, the cannula can be flexible to allow bending or manipulation of the cannula. In other embodiments, the manifold can be relatively hard or rigid. Any cannula embodiment discussed herein may include an attachment or clip-on or sliding fork and / or a fixed or tilted / adjustable fork as described herein.

[0518] In some embodiments, the cannula may have a tubing outlet hole on each of the first and second ends of the cannula. In some embodiments, the first end or the second end may be configured to connect to the supply conduit or tubing, which is connected to a humidifier, a circuit, or other gas or flow supply device. The end not connected to the tubing may be selectively blocked. For example, selective side switching of the device can be performed by a system in which the second end is blocked when the first end is connected to the tubing, thereby allowing air to enter the manifold space of the cannula, and the first end is blocked when the second end is connected to the tubing, thereby allowing air to enter the manifold space of the cannula. Figures 15-18 illustrate embodiments of selective side switching in the manifold.

[0519] Figure 15A Figure 1-D illustrates an embodiment of a nasal cannula assembly incorporating a shuttle valve that selectively occludes one end of the cannula or manifold (hereinafter referred to as the "manifold"). In some embodiments, manifold 1501 can have an opening, port, or inlet 1507, or preferably, an opening 1507, on one side of manifold 1501. Specifically, first opening 1507 can be positioned at a first end of manifold 1501, and second opening 1507 can be positioned at a second end of manifold 1501. In certain embodiments, a lightweight shuttle or valve body 1508, such as a ball or disc, can freely move (e.g., slide or roll) within a manifold volume or hollow cavity 1509. Preferably, shuttle 1508 has a larger diameter than fork 1505 and opening 1507 to prevent shuttle 1508 from exiting hollow cavity 1509.

[0520] In some embodiments, supply tube 1502 can be connected to one of these openings or inlets 1507. Supply tube 1502 can supply positive pressure generated by the flow of air or gas from a humidifier or other device into hollow cavity 1509. The positive pressure generated by the flow of air or gas pushes shuttle 1508 along hollow cavity 1509 until it blocks the opposite opening 1507. Blocking the opposite opening 1507 prevents air from traveling through this opening 1507 while still allowing air to flow through the prongs 1505. In some embodiments, supply tube 1502 can be attached to an opening 1507 of manifold 1501, and the opposite opening 1507 blocked by shuttle 1508. For example, to switch the side of supply tube 1502 relative to manifold 1501, supply tube 1502 can be removed from one opening 1507 and inserted into the opposite opening 1507, and shuttle 1508 will automatically switch sides. In some embodiments, the opening 1507 can have a partially thin-walled section 1510 that preferably defines an annular shape around the opening 1507. The partially thin-walled section 1510 can be deformed relative to at least one surrounding portion of the manifold 1501 to assist in sealing the hollow cavity 1509 at this end when the shuttle 1508 is pushed to this side. In some embodiments, the shuttle 1508 can be made of a relatively soft material, such as a material used to make compressible earplugs (e.g., compressible PVC foam), to further assist in sealing the hollow cavity 1509.

[0521] In some embodiments of the nasal cannula assembly 1500, the manifold 1501 has at least one nasal prong 1505, and preferably, a pair of nasal prongs 1505. Preferably, the nasal cannula assembly 1500 includes nasal prongs 1505 positioned or configured to be positioned on the manifold 1501. In some embodiments, the prongs 1505 on the manifold 1501 can be flexible or rotatable to allow the nasal cannula assembly 1500 to be used in either orientation. The prongs 1505 shown in Figure 15 include a distal end 1521 and a proximal end 1522. The distal end 1521 of each nasal prong 1505 is configured to be placed in the user's nose during use. The proximal end 1522 of each prong 1505 is configured to attach to or be flush with the manifold 1501 and the prong outlet hole 1520 in the manifold 1501, which is in communication with the interior space of the prongs 1505. In some embodiments, the fork 1505 is a double nose fork and is located in the middle of the manifold 1501 body.

[0522] The supply tube 1502 can be coupled to the manifold 1501 by any suitable arrangement. For example, the supply tube 1502 can include a connector 1530 coupled to an end of the supply tube 1502 and configured to couple to the manifold 1501. The connector 1530 can have a snap-fit ​​arrangement with the openings 1507 of the manifold 1501. In some configurations, the connector 1530 can include a groove that is engaged by any of the openings 1507 of the manifold 1501, and the thin-walled section 1510 can facilitate sealing between the manifold 1501 and the connector 1530.

[0523] Figure 15E -G shows an alternative coupling arrangement between the supply tube 1502 and the manifold 1501, which incorporates an insert 1540 that facilitates the connection between the supply tube 1502 and the manifold 1501. In some configurations, the manifold 1501 is constructed of a soft and / or stretchable material, which can increase user comfort. The insert 1540 can be constructed of a relatively hard material, preferably having a hardness greater than that of the material of the manifold 1501, so that the insert 1540 can be positioned within one or both openings 1507 of the manifold 1501 with a relatively tight fit therebetween. In some configurations, the manifold 1501 and the insert 1540 can create at least one substantial seal therebetween at least at the expected operating pressure of the nasal cannula system 1500. The insert 1540 can include one or more interference features that secure the insert 1540 relative to the manifold 1501 via complementary interference features of the manifold 1501. For example, the insert 1540 can include at least one protrusion, and preferably a pair of opposing protrusions 1542, that engage recesses or openings 1544 of the manifold 1501. In the illustrated arrangement, the protrusions 1542 are button- or mushroom-shaped protrusions having an enlarged head portion distal to the shaft portion relative to the body of the insert 1540. When the inserts 1540 are assembled to the manifold 1501, the openings 1544 can engage the shaft portions of the protrusions 1542. The soft and / or stretchable material of the manifold 1501 can facilitate assembly of the inserts 1540 into the manifold 1501 and passage of the protrusions 1542 through the openings 1544.

[0524] Connector 1530 can be shaped or otherwise configured to engage insert 1540 to securely connect supply tube 1502 to manifold 1501. In the illustrated arrangement, connector 1530 includes at least one interlocking member, such as a resilient arm portion 1546. Preferably, connector 1530 includes a pair of resilient arm portions 1546. Each arm portion 1546 includes an engagement protrusion 1548 that engages a portion (e.g., an end surface) of insert 1540. The illustrated connector 1530 includes a cylindrical base portion 1550 between a flange 1552 and the arm portions 1546. Flange 1552 has an enlarged diameter or circumferential dimension relative to base portion 1550 to define a shoulder 1554 that can abut an end surface of insert 1540 opposite the end surface engaged by the protrusions 1548. Thus, the linear distance between shoulder 1554 and protrusion 1548 can be substantially equal to the length of insert 1540. In some configurations, the arm portions 1546 can bend toward the central axis of the connector 1530 to facilitate passage of the arm portions 1546 through the interior space of the insert 1540. Preferably, a section of manifold 1501 and a section of insert 1540 are configured such that neither the inserts 1540 nor the shuttle 1508 obstruct the forks 1505.

[0525] Figure 16A -F shows an embodiment of a nasal cannula assembly with a manifold having a one-way valve at each end. Similar to the embodiment discussed in FIG. 15 , Figure 16A Figure 1-F shows a nasal cannula assembly 1600 having a manifold 1601 with nasal prongs 1605 in the middle, a hollow cavity 1609, and inlets or openings 1607 on each side of the manifold 1601. The supply tube 1602 can be attached to either opening 1607 of the manifold 1601. However, instead of or in addition to a shuttle (e.g., valve body 1508) sealing the hollow cavity 1609 at one opening 1607, a one-way valve 1608 is used. In some embodiments, the one-way valve 1608 is positioned at one opening 1607 of the hollow cavity 1609 of the manifold 1601, and the supply tube 1602 is positioned within the opening 1607 by being pushed through the one-way valve 1608 or positioned against the one-way valve 1608. In some embodiments, the opposing one-way valve 1608 remains sealed, and thus the flow of air or gas from the supply tube 1602 will be directed toward the nasal prongs 1605. In some embodiments, the one-way valve 1608 can be molded into the manifold 1601. In other embodiments, the one-way valve 1608 can be assembled as an insert configured to be inserted into the manifold 1601. In certain embodiments, the one-way valve 1608 can also function as a pressure-blowout safety valve to release excess pressure.

[0526] Figure 16A-F shows an embodiment of a nasal cannula assembly 1600 having a manifold 1601 with a one-way valve 1608 formed from an exhalation-type valve having a loosely hinged flap 1608a ( Figure 16E ). In some embodiments, the supply tube 1602 can be Figure 16C The one-way valve 1608 shown in FIG is inserted, thereby keeping the flap open along with the supply tube 1602. In some embodiments, the supply tube 1602 is placed against the one-way valve 1608, and the valve 1608 is kept open by the air flow from the supply tube 1602, as shown in FIG. Figure 16D The supply tube 1602 can be connected to the manifold 1601 directly or through any suitable connector (such as any of those disclosed herein). The valve 1608 can have any suitable shape, such as a circular ( Figure 16A -E) or rectangular ( Figure 16F ).

[0527] Figure 16G -L shows a nasal cannula assembly 1600 having a manifold 1601 with a one-way valve 1608 formed from different types of slit valves. Preferably, the one-way valve 1608 comprises a stretchable material. In some embodiments, the one-way valve 1608 can be a slit valve ( Figure 16G and 16H ), in particular for duckbill valves ( Figure 16I and 16J ), Joker valve or tricuspid valve ( Figure 16K ), Slit-Dome Valve ( Figure 16L ), and / or any other slit valve known in the art. Supply tube 1602 can be connected to manifold 1601 directly or via connector 1630 by any suitable arrangement.

[0528] FIG17 illustrates an embodiment of a nasal cannula assembly 1700 having a supply tube 1702 that passes through a manifold 1701 to allow for selective switching of the exit side of the supply tube 1702 relative to the manifold 1701. In some embodiments, the supply tube 1702 may have a first end 1710 and a second end 1711. The first and second ends 1710, 1711 may have corresponding manifold inserts 1712, 1713 attached thereto. Each of the manifold inserts 1712, 1713 may have one or more manifold insert openings 1714 extending along a length of the manifold insert 1712, 1713 (e.g., a pair of openings 1714 on opposing sides of the inserts 1712, 1713). Additionally, each of the inserts 1712, 1713 may include a pair of spaced-apart flanges 1716 positioned on opposing sides of the openings 1714 and configured to create at least a substantial seal with the manifold 1701. A recess 1718 is defined between these flanges 1716 so that air or gas communication between these openings 1714 and these nose prongs 1705 is ensured regardless of the position of these openings 1714.

[0529] In some embodiments, however, the tube exit side can be selectively selected by pushing or pulling the supply tube 1702 toward any desired side. In some embodiments, when the supply tube 1702 is pulled or pushed to one side, the manifold inserts 1712, 1713 on the opposite side seal against the manifold 1701, and the manifold inserts 1712, 1713 pulled through on that side can be connected to the gas or air supply circuit. For example, if the supply tube 1702 is pulled through the manifold 1701 and the manifold insert 1712 seals against the manifold 1701, the manifold insert 1713 on the opposite end will be connected to the gas or air supply circuit ( Figure 17B). Alternatively, if the tube 1702 is pulled through the manifold 1701 and the manifold insert 1713 seals against the manifold 1701, the manifold insert 1712 at the opposite end will be connected to the gas or air supply circuit. In some embodiments, connecting the supply tube 1702 to the circuit may require a connector or adapter 1715 so that proper assembly for connection to a humidifier or other gas or air supply can be achieved. Additionally, in other embodiments, a dedicated connection is used to connect the supply tube to the gas or air supply circuit, thereby eliminating the need for an adapter or connector 1715. In some embodiments, when the manifold inserts 1712, 1713 are positioned inside the manifold 1701, the manifold insert openings 1714 can align with the nose prongs 1705 on the manifold. Additionally, in some embodiments, once the supply tube 1702 is pulled to the desired side of the manifold 1701, a locking mechanism can be used to hold the manifold inserts 1712, 1713 in place. In some embodiments, the locking mechanism may include a twist lock, a press fit, a screw, or any other locking mechanism known in the art.

[0530] Figure 18A and 18B An embodiment of a nasal cannula assembly is shown in which each tube outlet hole is sealed by a membrane or other pierceable member. Figure 15A -G described embodiment, Figure 18A 18 shows a nasal cannula assembly 1800 having a manifold 1801 having a nasal prong 1805 in a middle portion, a hollow cavity (not shown), and openings 1807 on each side of the manifold 1801. The supply tube 1802 can be attached to either opening 1807 of the manifold 1801. In some embodiments, the opening 1807 of the manifold 1801 is sealed by a membrane 1810. The membrane 1810 can be a membrane, a pierceable membrane, or other pierceable material known in the art. In some embodiments, the connector or end portion 1811 of the supply tube 1802 includes a piercing portion, for example, a sharpened point 1812 capable of piercing the membrane 1810 at either opening 1807 of the manifold 1801 into which the supply tube 1802 is inserted. The sharpened point 1812 can be located at any suitable location, such as at or near a circumferential edge ( Figure 18A ) or at or near the center ( Figure 18B). When the sharpened point 1812 is at or near the center, the end portion 1811 may define one or more openings 1814 to allow air or gas to pass through the end portion 1811. In certain embodiments, the user can select the side in which the supply tube 1802 is positioned and can pierce the membrane 1810 over this opening 1807 with the end portion 1811 of the supply tube 1802. In some embodiments, the membrane 1810 is a single-use arrangement such that once the membrane 1810 is pierced on one side, the membrane 1810 cannot be resealed. However, in some embodiments, the membrane 1810 can be replaceable or releasable. In some embodiments, the end portion 1811 may include one or more barbs to assist in piercing the membrane 1810 and / or securing the end portion 1811 within the manifold 1801. In some embodiments, these barbs or sharp segments can be removed before the supply tube 1802 is inserted and the supply tube 1802 can be press-fitted into the opening 1807 of the manifold 1801. In some embodiments, barbs or tip portions 1811 can remain on supply tube 1802 and can help secure supply tube 1802 within manifold 1801. In some embodiments, tip portion 1811 can have a cap to prevent injury to the user or damage to tip portion 1811 when not in use and to ensure that the tip portion remains clean and sterile prior to use.

[0531] In some embodiments, selective side switching of the manifold and nose prong relative to the supply tube can be accomplished by operating the supply tube. Figure 19 An embodiment of a manifold 1901 is shown in which a flexible supply tube 1902 exits the manifold 1901 through an opening 1907. In this illustrated arrangement, only one opening 1907 is provided, as the flexible supply tube 1902 is used for selective side switching. However, in other arrangements, two or more openings 1907 may be provided. In some embodiments, the supply tube 1902 attached to and / or exiting the manifold 1901 may be a highly flexible tube. This highly flexible tube may allow the supply tube 1902 to be routed to either side, facing toward or away from the mouth. In some embodiments, highly flexible tubing is used that can bend around a zero radius without substantially kinking or at least without completely occluding the tube's internal passageway. Preferably, bending of the highly flexible tube does not cause substantial occlusion of the tube's internal passageway. In some embodiments, the highly flexible supply tube 1902 can exit from the front of the manifold 1901 and be routed to either side of the patient without disassembling the nasal cannula assembly 1900 and / or without moving any of its components. In certain embodiments, the flexible supply tube 1902 can exit the front of the manifold 1901 through the opening 1907 and can bend at least about 90 degrees to the left or right side of the face.

[0532] Furthermore, in some embodiments, the manifold can be configured to be inserted into the assembly fixture in either orientation, thereby allowing the nasal cannula assembly to be used interchangeably with tubing from either the patient's right or left side. Figure 20A -C shows an embodiment of a nasal cannula assembly 2000 including a manifold 2001 that snaps into a manifold fixture or clip 2003. In some embodiments, the manifold 2001 can interchangeably switch the side on which the supply tube 2002 is positioned by allowing the manifold 2001 to be inserted into the clip 2003 in at least two different orientations. In some embodiments, the manifold 2001 and the supply tube 2002 can be integrated into one manifold / tubing assembly 2004. For example, to change the direction in which the supply tube 2002 extends relative to the patient's nose, the manifold / tubing assembly 2004 can be unclamped from the clip 2003, flipped approximately 180 degrees, and then clamped back. The two available orientations of the supply tube 2002 are shown at Figure 20A and 20B The clip 2003 may be coupled to a retention arrangement, such as any suitable type of headgear strap 2040, including those disclosed herein or other suitable arrangements.

[0533] Additionally, in some embodiments, the manifold can be configured for use with clamp-on supply tubes. For example, Figure 21A -D shows a nasal cannula assembly 2100 having a detachable supply tube assembly 2102 and a manifold 2101. In some embodiments, the nasal cannula assembly 2100 may include a manifold 2101 comprising a nasal prong 2105 and two openings 2107 at each end of the manifold 2101. In some embodiments, the manifold 2101 may be connected to a supply tube assembly 2111. In some embodiments, the supply tube assembly 2111 may include a supply tube 2102 and a manifold receiving structure 2112. The manifold receiving structure 2112 may be assembled to the supply tube 2102 during manufacture or may be connected to the supply tube 2102 prior to use. In certain embodiments, the manifold receiving structure 2112 may be a 'C' shaped manifold receiving structure or a clip 2112, as in Figure 21A-D, or the manifold receiving structure 2112 can have any shape that allows for complementary coupling with the manifold 2101. In some embodiments, the manifold 2101 has a complementary or matching shape that receives the manifold receiving structure 2112, which can be slid onto, clipped onto, or otherwise attached to the manifold 2101 by any means known in the art, with the supply tube 2102 positioned to face in any desired manner. In certain embodiments, the manifold receiving mechanism 2112 can have locations and / or sealing details 2113 incorporated on the inside of the manifold receiving structure 2112, or elsewhere on the structure, to ensure a secure connection and / or proper seal with the manifold 2101. In some configurations, the sealing detail 2113 is a protrusion, such as a knob. The sealing detail 2113 preferably seals one of the openings 2107 and the end portion 2130 of the supply tube 2102, which can be defined by the manifold receiving structure 2112 or can be a separate component that engages the other opening 2107. The end portion 2130 can rest flush against the outer surface of the manifold 2101 surrounding the opening 2107 ( Figure 21C ), or may extend into opening 2107 ( Figure 21D ).

[0534] In some embodiments, one or more stops 2104 can be molded into, or otherwise secured to, the manifold 2101 to inhibit or prevent downward movement of the manifold receiving structure 2112 when pulled during use. Figure 21A As shown in FIG, a pair of stops 2104, each defining a stop surface, can be formed on each side of the manifold 2101. In some embodiments, the manifold receiving structure 2112 can slide upward relative to the manifold 2101 to remove and flip the side of the tube. In some configurations, such as Figure 21E As shown in , portions of the manifold receiving structure 2112, such as the end portion 2116, can engage complementary portions, such as the recess 2118 of the manifold 2101, to assist in securing the manifold receiving structure 2112 to the manifold 2101. Figure 21F As shown in FIG, the manifold 2101 may include recessed portions 2120 sized and shaped to receive the manifold receiving structure 2112. The recessed portions 2120 may be located on the front and side portions of the manifold 2101 and may have a depth suitable for accommodating the full thickness of the manifold receiving structure 2112, such that the outward-facing surface of the manifold receiving structure 2112 is flush with or recessed within the outer surface of the manifold 2101. This arrangement aids in securing the manifold receiving structure 2112 to the manifold 2101 and / or may inform the user how to properly position and secure the manifold receiving structure 2112 to the manifold 2101. The recessed portions 2120 may be utilized alone or in combination with the recesses 2118.

[0535] Figure 21G and 21H An embodiment of a nasal cannula assembly 2100 is shown having a manifold receiving structure 2132, a separate nasal prong insert 2125, and a manifold 2121. In some embodiments, the manifold 2121 can be free of prongs and openings 2126 in the manifold 2121 that communicate with the prong insert 2125. The prong insert 2125 can be formed with prongs 2105 having different sizes so that the appropriately sized prongs 2105 can be selected for different nose sizes and ensure the correct prong sizing for the patient. In some embodiments, the manifold 2121 and the prong insert 2125 can be connected to the manifold receiving structure 2132, such as a C-clamp. In some embodiments, the manifold receiving structure 2132 can be used to hold the prong insert 2125 in place and will complementarily mate with the manifold 2121. Thus, the manifold receiving structure 2132 can include one or more openings 2128 to accommodate these prongs 2105. The manifold 2121 may include a recess 2134 surrounding the opening 2126 and accommodating the base of the fork insert 2125. The manifold 2121 may also include recessed portions 2136 on its lateral sides that are configured to accommodate the manifold receiving structure 2132 and assist in securing the manifold receiving structure 2132 to the manifold 2121. Although the opening 2126 is positioned on the upper surface of the manifold 2121 in the illustrated arrangement, the opening 2126 may additionally or alternatively be positioned on other portions of the manifold 2121 (e.g., the front surface).

[0536] Figure 22A-D shows an embodiment of a nasal cannula assembly 2200 having a manifold insert 2201 and a manifold receiving structure 2210. In some embodiments, the manifold insert 2201 may include nasal prongs 2205 and openings 2207 on each end of the manifold insert 2201. The manifold insert 2201 may be made of a soft or flexible material. The prongs 2205 on the manifold insert 2201 may be flexible or rigid. In some embodiments, the manifold insert 2201 may be inserted into the manifold receiving structure 2210. In some embodiments, the manifold receiving structure 2210 may be attached to or integrated with an assembly fixture 2203, such as a headgear strap. The manifold receiving structure 2210 has a closed end 2213 and an open end 2214. In some embodiments, the manifold receiving structure 2210 may be attached to the supply tube 2202 on the side of the open end 2214 of the manifold receiving structure 2210 to allow air or gas to pass through. In some embodiments, the manifold insert 2201 can be clipped or slid into the manifold receiving structure 2210. In some embodiments, the manifold receiving structure 2210 can have a rounded or spherical boss or protrusion 2211 at one end 2213 of the manifold receiving structure 2210 that provides an effective radial seal against one opening 2207 of the manifold insert 2201 and helps hold the manifold insert 2201 in place. The other end 2212 can include a connector 2214 that can be integral with or separate from the supply tube 2202 and engage the other opening 2207 of the manifold insert 2201. In some embodiments, once the manifold insert 2201 is placed within the manifold receiving structure 2210, the manifold insert 2201 and / or the prongs 2205 can be turned or tilted to the correct, comfortable configuration for the user. For example, in some embodiments, to flip the tube sideways, the manifold insert 2201 is removed and the remainder of the nasal cannula assembly, including the manifold receiving structure 2210, the assembly fixture 2203 and / or the supply tube 2202, is flipped so that the supply tube 2202 faces the desired direction, and the manifold insert 2201 with the fork 2205 is reassembled to point back toward the patient's nose.

[0537] Figure 23A-C shows an embodiment of a nasal cannula assembly having a manifold receiving structure or sleeve that can be clipped onto a supply tube assembly, which includes a manifold. In some embodiments, the nasal cannula assembly 2300 includes a supply tube assembly 2311, which includes a manifold 2301 and a supply tube 2302. The nasal cannula assembly 2300 also includes a manifold receiving structure or sleeve 2310, which includes a pair of nasal prongs 2305. The supply tube 2302 connects the manifold 2301 to the air or gas supply circuit. In some embodiments, the manifold receiving structure 2310 can be a generally tubular member with an opening or slot 2313 extending along part or all of its length to form a 'C' shaped section that can be clipped onto the manifold 2301. In some embodiments, the manifold 2301 can have a protrusion or rib 2312 that is complementary to the opening or slot 2313 of the 'C' shaped manifold receiving structure 2310, such that the rib 2312 can be received in the slot 2313. Advantageously, such an arrangement helps secure or lock the manifold receiving structure 2310 in place on the manifold 2301. In some embodiments, the supply tube assembly 2311 can be attached to or integrated within an assembly fixture 2303, such as a headgear strap. For example, in some embodiments, to reverse the direction of the supply tube 2302, the manifold receiving structure 2310 is removed or unclamped from the manifold 2301, flipped over, and reattached so that the supply tube 2302 faces the desired direction.

[0538] Figure 24A -F shows an embodiment of flexible, tilted or directionally adjustable prongs and an embodiment of a nasal cannula assembly 2400 having such flexible, tilted or adjustable prongs 2405. With such prongs 2405, the exit side of the supply tube 2402 can be changed by simply adjusting the direction of these prongs 2405 and rotating the manifold / tubing assembly 2404 on the patient's face 180 degrees.

[0539] refer to Figure 24A -C, In certain embodiments, the prongs 2405 can be bent to the side of the manifold 2401 as desired for use. Specifically, the prongs 2405 can be formed with a corrugated shape around the base of the prongs 2405. Figure 24B and 24CAn embodiment of a prong 2405 is shown with a corrugated shape 2408 formed around the base, imparting flexibility to the prong 2405. In some embodiments, the corrugated shape 2408 includes at least one, and preferably multiple, corrugations. In the illustrated arrangement, two corrugations are provided; however, in other embodiments, three or more corrugations may be provided. The corrugations are shown as annular in shape with a semicircular cross-section. These corrugations may have a reduced wall thickness relative to the portion of the manifold 2401 adjacent to them, or they may have the same or similar wall thickness. The corrugated shape 2408 allows the prong 2405 to be shaped in any desired orientation for use. In some embodiments, the prong 2405 may have a corrugated shape 2408 around the base, allowing them to tilt in any direction. In certain embodiments, the prong 2405 may have one or more thickened sections or one or more reinforcing ribs 2407 to bias the prongs toward a particular tilting direction, thereby allowing the prong 2405 to bend in a first direction while discouraging or preventing the prong 2405 from bending in a second direction that is substantially perpendicular to the first direction. In the illustrated arrangement, two reinforcing ribs 2407 are provided on each side of each prong 2405 and extend in a substantially radial direction relative to the prong 2405.

[0540] Figure 24D -F shows an embodiment of a fork 2405 comprising a collapsible corrugated accordion-like folded section, which section may define a portion or substantially all of a section of the fork 2405. Preferably, the formation of the forks 2405 having such a geometry allows the forks 2405 to bend in any direction and retain such shape. In some embodiments, the forks 2405 can be compressed and extended to change the length of the forks 2405, such as Figure 24D and 24E In some embodiments, the fork 2405 can be expanded from a compressed shape and bent into a desired direction or shape, such as Figure 24F For example, in some embodiments, the prongs 2405 are packaged in a compressed form and are then expanded and bent into the appropriate orientation and shape by a caregiver or user depending on the configuration.

[0541] In some embodiments, the nasal cannula assembly may include a swivel fork. Figure 25A -C shows an embodiment of a nasal cannula assembly 2500 with rotating prongs. In some embodiments, the nasal cannula assembly 2500 can be flipped to change the side of the supply tube 2502, and the prongs 2505 can then be rotated to face the appropriate orientation toward the patient's nose. Figure 25AAn embodiment of a nasal cannula assembly 2500 is shown that includes a separately rotatable fork 2505. In some embodiments, the fork can freely rotate in a clockwise or counterclockwise direction relative to the manifold 2505. In some embodiments, when the manifold 2501 and fork 2505 are constructed as a unit, the fork 2505 can rotate to a limited extent.

[0542] Figure 25B and 25C An embodiment of a nasal cannula assembly 2500 is shown that includes a fork insert 2506 having a pair of prongs 2505. Preferably, the fork insert 2506 is rotatable relative to the manifold 2501. The fork insert 2506 is shown mounted on a vertical axis 2508 and rotatable about the vertical axis so that the prongs 2505 rotate together. In some embodiments, the fork insert 2506 is a separate component from the manifold / tubing assembly 2504, and the removable fork insert 2506 can allow for the use of different sized prongs 2505 for different nose sizes while using a single sized manifold 2501. Additionally, in some embodiments, the manifold 2501 can have a lip 2510 on a surface of the manifold 2501 to which the fork insert 2506 is connected. The fork insert 2506 can have a mating section 2511 that is complementary to the lip 2510. In some embodiments that include a lip 2510 on the manifold 2501, the fork insert 2506 can be lifted from the surface of the manifold 2501 and rotated about a vertical axis 2508 so that the forks 2505 can be repositioned to the proper orientation. The fork insert 2506 can rotate about the vertical center axis of the manifold 2501 or about an axis centrally located relative to an opening 2518 in the manifold 2501 that communicates with the nose forks 2505, as shown in FIG. Figure 25B , causing the fork 2505 to switch the opening 2518 between two orientations.

[0543] In some embodiments, the manifold may have a fork outlet aperture in a central portion of the manifold that is configured to receive an insert or clip-on attachment comprising the forks. Figure 26A-F shows an embodiment of a nasal cannula assembly 2600 configured to allow insertion of a removable prong insert 2606. In some embodiments, the prong insert 2606 can be pushed into the opening 2607 of the hollow manifold 2601. This allows the prongs 2605 to be configured in the appropriate orientation for use with the patient in the same manifold 2601 and / or manifold / tube assembly 2604. The manifold 2601 and / or manifold / tube assembly 2604 can be connected to an assembly fixture 2603, such as a headgear strap. For example, in some embodiments, the supply tube 2602 and manifold 2601 are assembled together with the fixture 2603, and the nasal prongs 2605 are held by the removable nasal prong insert 2606. The manifold / tube assembly 2604 and the assembly fixture 2603 can be symmetrical so that it can be moved in one orientation (e.g., Figure 26B ) or relative directions (e.g. Figure 26C ) is assembled onto the face. In some embodiments, the assembly fixture 2603 and the manifold / tube assembly 2604 can be flipped to accommodate either orientation of the supply tube 2602 as desired. For example, in some embodiments, to switch sides, the supply tube 2602 is positioned, the nasal prong insert 2606 is removed, and the remainder of the manifold / tube assembly 2604 is flipped so that the supply tube 2602 faces the desired direction, and the nasal prong insert 2606 is then reinserted into the receiving opening 2607 of the manifold / tube assembly 2604 in the correct orientation pointing toward the patient's nose. Additionally, the nasal prong insert 2606 can be of different sizes ( Figure 26D -F) and different sized inserts are interchangeable on the same assembly 2604 to accommodate and accommodate different patient nose sizes and ensure the correct prong size estimation for the patient.

[0544] In some embodiments, a nasal cannula assembly may include a manifold, a supply tube, and a cannula that is removable from the manifold and / or adjustable about at least one axis relative to the manifold. The cannula may be adjustable about two axes relative to the manifold and available with different fork sizes to allow the assembly to fit a wide range of patients. Specifically, with reference to Figure 27A -D, the nasal cannula assembly 2700 includes a pivoting cannula 2714 preferably in combination with a pair of nasal prongs 2705. The cannula 2714 is pivotally coupled to a mold (headgear mold) or manifold 2701 that may include sides 2722 extending in opposite lateral directions from the cannula 2714. A suitable retention assembly (not shown), such as a headgear strap, may secure the manifold 2701 and cannula 2714 to the patient. In some arrangements, the headgear strap is an elastic, high-stretch strap that may assist or improve the seal between the manifold 2701 and the cannula 2714. The headgear strap may be integral, integrated, or separate from the manifold / mold 2701.

[0545] Preferably, the manifold 2701 defines a conduit or channel 2709 that allows air or gas to be transferred from the supply tube 2702 to the cannula 2714. The channel 2709 can be defined by the mold from which the manifold 2701 and the side straps 2722 are constructed (e.g., a single integrated structure) or can be defined by separate components. The supply tube 2702 can be coupled to the manifold 2701 by any suitable arrangement, such as a mandibular expander arrangement or any other arrangement disclosed herein. A clip 2742 can secure the supply tube 2702 to the side straps 2722. The end of the supply tube 2722 opposite the manifold 2701 can include a connector 2752 that allows the supply tube 2722 to be coupled to an air or gas source.

[0546] In some embodiments, the sleeve 2714 can be rotated about an axis extending in a generally anterior-posterior direction relative to the manifold 2701 or about a generally horizontal axis lying in the sagittal plane. Preferably, the sleeve 2714 can be rotated at least 180 degrees so that the prongs 2705 can be moved from the top ( Figure 27A The cannula 2714 can be rotated to the bottom (in a different orientation), thereby effectively changing the side from which the supply tube 2702 exits. In some embodiments, the cannula 2714 is coupled to the manifold 2701 via a ball joint 2726, such that the cannula 2714 can also rotate about an axis extending in a generally transverse direction or a generally horizontal axis existing in the frontal plane. Such an arrangement not only provides for a simple change in the side from which the supply tube 2702 exits, but also allows for adjustment of the orientation of the nasal prong 2705 relative to the manifold 2701, thereby increasing patient comfort and / or accommodating a wider range of patients.

[0547] In some embodiments, the size of these prongs 2705 is adjustable. Figure 27B and 27C As shown in FIG, the ball joint 2730 can be separated from the fork portion 2732 of the sleeve 2714. Several fork portions 2732 can be included in the kit or several different sizes of nose forks 2705 can be provided to make them available. For example, three different fork portions 2732 are shown in FIG. Figure 27C , which includes three different sized prongs 2705. An appropriate or desired one of these available prong portions 2732 can be coupled to the ball joint portion 2730, for example, via a snap fit or other suitable arrangement. Alternatively, two or more sleeves 2714 can be provided, each having a different sized prong 2705. Thus, with such an arrangement, the sleeve 2714 can be constructed as a single piece.

[0548] However, it is not necessary that the sleeve 2714 can rotate along multiple axes, or even rotate through an arc. Instead, the sleeve 2714 can have discrete adjustment positions relative to the manifold 2701. Preferably, there is provided Figure 27A2701 and 180 degrees of rotation of the sleeve 2714 so that the exit side of the supply tube 2702 can be switched. If desired, other discrete position options can be provided. The sleeve 2714 and the manifold 2701 may include interfering surface features to assist in securing the sleeve 2714 in a desired position relative to the manifold 2701. For example, Figure 27D , the sleeve 2714 may include one or more teeth 2760 or other protrusions that engage corresponding recesses of the manifold 2701. In the illustrated arrangement, the sleeve 2714 includes a plurality of teeth 2760 on each lateral side of the ball joint 2726, which may extend in a radial direction relative to the ball joint 2726. Other suitable arrangements may also be used.

[0549] In some embodiments, as Figure 28A , a nasal cannula assembly 2800 includes a manifold 2801 that can be coupled to a cannula 2814 in at least two orientations to allow for easy switching of the exit side of a supply tube 2802. The cannula 2814 can include a central portion having a prong 2805 and side portions 2822 on each lateral side of the central portion. The manifold 2801 can include side portions 2812 that overlap with the side portions 2822 of the cannula 2814. These side portions 2812 and 2822 can facilitate a secure connection between the manifold 2801 and the cannula 2814. For example, the side portions 2812 or 2822 of one or both of the manifold 2801 and the cannula 2814 can include a coupler or coupling mechanism that couples or assists in coupling the manifold 2801 and the cannula 2814. In the illustrated arrangement, the sides 2812 of the sleeve 2814 include a first portion 2830 of a coupler (e.g., a hook-and-loop fastener), and the sides 2822 of the sleeve 2814 include a second portion 2832 of a coupler (e.g., a hook-and-loop fastener). One or both of the sides 2812 of the manifold 2801 include tabs 2850 that provide a finger grip surface to facilitate removal of the manifold 2801 from the sleeve 2814. Additionally, one or both of the sides 2812 may include flexion slots 2828 that facilitate flexion of the sides 2812, which may assist in removing the manifold 2801 from the sleeve 2814 and also facilitate conforming the manifold 2801 to the shape of the sleeve 2814.

[0550] Manifold 2801 and sleeve 2814 may include mating structures that create a seal between the two components. For example, manifold 2801 may include a protrusion 2860 that defines a cavity in communication with supply tube 2802 and includes at least one, and preferably a pair of, openings 2862 that allow air or gas communication with fork 2805 when manifold 2801 is assembled onto sleeve 2814. Protrusion 2860 engages opening 2864 of sleeve 2814 and preferably defines at least one substantial seal therewith. This seal may be created by contact or engagement (e.g., a lip and groove) between protrusion 2860 and opening 2864, or a separate sealing member (e.g., a peripheral seal or O-ring) may be used.

[0551] The cannula 2814, and thus the manifold 2801, can be secured to the patient using a securing device such as a headgear strap 2840. In some embodiments, the headgear strap 2840 is a non-stretch strap coupled to the side portions 2822 of the cannula 2814. The ends of the headgear strap 2840 can be heat welded to the side portions 2822 and can include the second parts 2832 of the coupler between the manifold 2801 and the cannula 2814. The headgear strap 2840 can include an adjuster 2842 suitable to allow adjustment of the circumference of the headgear strap 2840. In other arrangements, a stretchable headgear strap 2840 can be used.

[0552] refer to Figure 28B The cannula 2814 can be a composite structure and include a frame member 2870 constructed from a relatively rigid material and a body 2872 constructed from a relatively flexible material. For example, the frame 2870 can be a rigid plastic or metal material that is deformable and substantially retains its shape once deformed. The frame 2870 can be external to the body 2872, or the body 2872 can be molded onto the frame 2870. Preferably, the frame 2870 is located within the side portions 2822 of the cannula 2814 and can be molded to bridge the central portion containing the prongs 2805 that exit the nose, thereby reducing pressure just below the nose and distributing pressure applied to the patient across the side portions 2822, thereby increasing comfort. The frame 2870 can also surround or partially or completely define the opening 2864, rather than extending into or beyond the side portions 2822.

[0553] refer to Figure 29A In some embodiments of a respiratory assistance system utilizing a nasal cannula system 2900, it is desirable to be able to measure the pressure in the flow path near the patient (e.g., on or near the cannula or manifold 2901) for the purposes of at least one or both of: 1) monitoring the pressure delivered to the patient; and 2) pressure feedback control of the blower flow source (e.g., the blower and humidifier 2990). Figure 29AA basic arrangement for providing pressure feedback control is shown. Specifically, pressure line 2910 connects manifold 2901 (or manifold / cannula assembly—hereinafter "manifold") to a flow source control system, which may be part of blower / humidifier 2990. Using such an arrangement, flow source 2990 can utilize information about the pressure at or near manifold 2901, provided by pressure line 2910 during operation of flow source 2990, to adjust the pressure of the supply to achieve a desired delivery pressure at the patient. Advantageously, this arrangement can compensate for factors that may cause the delivery pressure to differ from that expected, such as, for example, the length, cross-sectional area, or other geometry of supply tube 2902. Pressure line 2910 can be connected to a pressure gauge or alternative readout, if pressure monitoring is necessary or desired.

[0554] refer to Figure 29B , a pressure line 2910 can be passed through the wall of the manifold 2901 and terminate within the manifold space of the manifold 2901. In the illustrated arrangement, the terminal end 2912 of the pressure line 2910 is perforated with a plurality of holes 2914 so that if some of the holes 2914 are blocked due to condensation, the other holes 2914 remain functional so that the pressure within the manifold 2901 can be transmitted to the pressure source 2990. The terminal end 2912 of the pressure line 2910 can be positioned anywhere within the manifold 2901, for example, without limitation, between the supply tube 2902 and the prongs 2905 along the flow path of the supply air or gas.

[0555] refer to Figure 29C , pressure line 2910 may allow direct or indirect communication between manifold 2901 and pressure source 2990 . Figure 29C The arrangement separates manifold chamber 2909 of manifold 2901 from pressure chamber 2916, which is in direct communication with or sensed by pressure line 2910. For example, a flexible diaphragm seal 2918 (or other movable membrane or member, such as a floating piston or sliding piston) separates manifold chamber 2909 from pressure chamber 2916, thereby preventing condensation from entering pressure line 2910 and keeping pressure line 2910 clean.

[0556] refer to Figure 29DPressure line 2910 may include a pressure sensor 2930 that can sense the pressure within manifold chamber 2909. Pressure sensor 2930 may be located within manifold 2901, such as a plug configured to engage and / or close one end of manifold 2901. In some embodiments, a barrier, such as a wall or membrane 2918, is positioned between pressure sensor 2930 and manifold chamber 2909. Membrane 2918 may be of any suitable type, such as an ultra-thin silicone membrane. Pressure sensor 2930 may be of any suitable type, such as an electric pressure sensor. Pressure sensor 2930 can be pushed upward against membrane 2918, which can conform to the shape of pressure sensor 2930, allowing pressure to be measured without direct contact with air or gas flow, thereby preventing condensation from accumulating on pressure sensor 2930. Furthermore, with such an arrangement, membrane 2918 can be configured to close and seal the end of manifold 2901, allowing nasal cannula assembly 2900 to be used with or without pressure sensor 2930.

[0557] refer to Figure 29E The membrane 2918 may be a self-sealing slit valve through which the pressure line 2910 and / or pressure sensor 2930 may be inserted, if desired. Advantageously, the self-sealing slit valve 2918 may be closed in the absence of the pressure line 2910 and / or pressure sensor 2930, so that no substantial leakage occurs if it is removed. Thus, the nasal cannula assembly 2900 may function with or without the pressure line 2910 and / or pressure sensor 2930.

[0558] refer to Figure 29F , the pressure line 2910 and the supply tube 2902 can be integrated into one connector 2931 that can be connected to the manifold 2901, thereby allowing simultaneous connection of both the pressure line 2910 and the supply tube 2902. Advantageously, such an arrangement simplifies installation of the nasal cannula assembly 2900 by avoiding the need to connect multiple tubes or components to the manifold 2901.

[0559] refer to Figure 29G , the pressure line 2910 can be connected as an optional accessory in series with the supply tube 2902. The pressure line 2910 can include a plug portion 2932 connected to the manifold 2901, and the supply tube 2902 can be connected to the plug portion 2932. Alternatively, referring to Figure 29H , the pressure line 2910 can be connected as an optional accessory separately from the supply tube 2902, for example on the opposite side of the manifold 2901 from the supply tube 2902. The pressure line 2910 can have a plug portion 2932 that replaces the plug 2934 of the manifold 2901.

[0560] refer to Figure 29IA small blower 2940 or other source of air or gas may be connected to the pressure line 2910 to apply a small flow of air or gas through the pressure line 2910, preferably sufficient to drive off some or all of any condensation that has accumulated inside the pressure line 2910. The flow of air through the pressure line 2910 may be provided intermittently or continuously and may be taken into account by the control system in calculating the pressure within the manifold 2901.

[0561] refer to Figure 29J A flexible membrane seal 2918 (or other removable barrier) can separate the manifold chamber 2909 from the pressure measurement chamber 2916 to prevent or block condensation from entering the pressure line 2910 and keep the pressure line 2910 clean. If the pressure measurement feature is not utilized and therefore the pressure line 2910 is not needed, the opening or port 2942 of the manifold 2901 that receives the pressure line 2910 can remain open and function as a vent to the pressure measurement chamber 2916. Alternatively, the port 2942 can be closed, for example, with a suitable plug, if desired.

[0562] In some embodiments, reference Figure 29K For example, electrical wiring 2944 is incorporated into the spiral support 2946 of the supply tube 2902. The electrical wiring 2944 can be connected to the electric pressure sensor 2930 installed in the manifold 2901. The wiring 2944 (or additional wiring) can also be used to heat the supply tube 2902. In some arrangements, the wiring 2944 can be switched between measuring pressure and temperature readings and heating.

[0563] refer to Figure 29L , the spiral reinforcement 2946 of the supply tube 2902 can be hollow or otherwise contain a channel for a pressure line (similar to the pressure line 2910 disclosed herein). With such an arrangement, there is no need to use an additional pressure line (e.g., 2910). The spiral reinforcement 2946 can be connected to a chamber of the manifold 2901 at one end and to an operating system for an air or gas source, or a pressure monitor or pressure gauge 2948 at the other end.

[0564] In some embodiments, the nasal cannula assembly includes features that improve patient comfort. Discomfort may occur for some patients using certain nasal cannula assemblies. For example, two types of discomfort include: 1. a warm, damp, clammy sensation when the cannula / manifold contacts the upper lip, which can be caused by moisture from sweating and the circulation of warm, humid air in this area, and 2. pain and numbness associated with pressure applied by the cannula / manifold to the upper lip. Some embodiments of the nasal cannula assembly 3000 address, at least to some extent, one or both of these types of discomfort.

[0565] refer to Figure 30A Holes, depressions, or recesses 3020 of any desired shape can be cut or otherwise formed in the sleeve or manifold (hereinafter "sleeve") material, allowing fresh air to reach the skin, helping to keep the area cool and reducing moisture accumulation. In some embodiments, the holes, depressions, or recesses 3020 can be cut or formed in areas that do not cause leakage of therapeutic airflow from the sleeve 3014. For example, the holes, depressions, or recesses 3020 are provided in the sides 3022 of the sleeve 3014 rather than in the central portion containing the prongs 3005. In the illustrated arrangement, the holes 3020 are provided completely through the sides 3022 of the sleeve 3014. The holes, depressions, or recesses 3020 can also improve the flexibility of the sleeve 3014, allowing it to more easily conform to the shape of the patient's lips and more evenly distribute pressure for improved comfort.

[0566] refer to Figure 30B , the cannula 3014 may also include a small bump or protrusion 3030 on the rear or patient-facing surface of the cannula 3014. The bump 3030 holds some or all of the remaining rear or patient-facing surface of the cannula 3014 away from the patient's lips, allowing fresh air to reach the skin, helping to keep the area cool and reduce moisture accumulation. The bump 3030 may be provided on the entire rear surface as shown, or on only a portion of the rear surface, for example, as similar to Figure 30A on these sides 3022 of the sleeve 3014.

[0567] refer to Figure 30C , grooves 3040 may be cut or otherwise formed in the rear surface of the sleeve 3014. These grooves 3040 allow fresh air to reach the skin, helping to keep the area cool and reduce moisture accumulation. In some embodiments, these grooves 3040 extend in a generally vertical direction or perpendicular to the lateral direction of the sleeve 3014. Additionally, these grooves 3040 may extend partially through the sleeve 3014, leaving one end closed, or may extend completely through the sleeve 3014, leaving both ends open, such as Figure 30C These grooves 3040 may also improve the flexibility of certain portions (eg, side portions 3022) or all of the sleeve 3014, allowing it to more easily conform to the shape of the patient's lips and to more evenly distribute pressure for improved comfort.

[0568] refer to Figure 30DIn some embodiments, the sleeve 3014 may include a sleeve-lip bridge arrangement, wherein the sleeve 3014 is shaped so that it curves away from the face at the upper lip, thereby reducing pressure or completely avoiding any contact with the upper lip, thereby improving fresh air circulation in this area and reducing (e.g., to little or no) pressure on the lips. This pressure is instead applied by the side portions 3022 and absorbed by the cheeks, which are less sensitive to pressure. In some arrangements, the prongs 3005 are mounted horizontally and inversely on the inside of the sleeve 3014 and curve upward into the nostrils. This design has the added benefit of allowing for the removal of mustaches.

[0569] Preferably, such embodiments of the cannula 3014 have a certain rigidity, which can be accomplished by any suitable construction or arrangement, such as using a relatively hard material for the cannula 3014 ( Figure 30D -F), reinforcing ribs, or structural members such as internal ( Figure 30G ) or external ( Figure 30H ) wire or strip 3050, the structural member being malleable for adjustment to suit an individual patient. The cannula 3014 may be of any suitable arrangement, such as having and integrally or directly connected to the supply tube 3002, or, for example, by utilizing a manifold 3001 connected to the supply tube 3002 and received within the cannula 3014.

[0570] refer to Figure 30I In some embodiments, a comfort pad or insert 3060, such as a gel pad or other type of cushion, may be provided on the rear, or patient-facing, surface of the cannula 3014. At least the rear surface of the cannula 3014, which contacts the patient's upper lip, may be made of a soft gel material or may include a soft gel pad 3060. In some arrangements, the gel pad may be molded to the shape of the patient's lip to create a relatively large contact surface area, thereby evenly distributing pressure across the skin. The pad 3060 may deform as the headgear strap or other retention mechanism (not shown) is tightened, adapting to the geometry of the patient's face and preventing the occurrence of localized pressure areas. The pad 3060 preferably occupies a substantial portion, such as substantially all, of the rear surface. The pad 3060 may be scented to make the cannula 3014 more pleasant.

[0571] In some embodiments of the nasal cannula assembly, the supply tube can be manually shaped or positioned and maintained in such shape or position or substantially maintained in such shape or position. One of the main benefits of some nasal cannula assemblies, such as the Optiflow® nasal cannula assembly sold by Fisher & Paykel Healthcare, Inc., is that one can eat, drink, and talk while receiving treatment. In some cases, the shape or position in which the supply tube exits the cannula can restrict these activities. Therefore, in some embodiments, it may be desirable to be able to shape or position the supply tube as desired. Any suitable arrangement or technique may be used to shape or position the tubing, such as with reference to Figure 31A -F those described herein.

[0572] refer to Figure 31A and 31B , the supply tube 3102 may include an internal axially ductile wire or strip 3150. The supply tube 3102 may be assembled or formed with an internal axially ductile wire or strip 3150 that can be deformed into a variety of shapes. Preferably, the hardness of the wire is significantly greater than the hardness of the supply tube 3102 so that the shape is maintained or substantially maintained after forming. The wire or strip 3150 may be contained within the supply tube 3102 or otherwise coupled to the supply tube in any suitable manner. For example, Figure 31A As shown in FIG, the wire or strip 3150 may be embedded in the wall of the supply tube 3102, outside the supply channel of the supply tube 3012. Alternatively, as shown in FIG. Figure 31B As shown in , a wire or strip 3150 can be provided within the supply channel or inner bore of the supply tube 3102. In such an arrangement, it may be desirable to construct the wire or strip 3150 from a suitable (e.g., inert) material or to coat the wire or strip 3150 with such a material so as to be resistant or suitable for contact with the supply air or gas. Figure 31C Wire or strip 3150 can be, for example, a ductile, helically coiled wire or strip that is wound in a spiral fashion around the circumference of supply tube 3102. Wire or strip 3150 can be covered or contained within another material (e.g., plastic) to form a bead 3152. Bead 3152 can impart a tube structure (e.g., a reinforcing bead) that is also formable or shaped, or at least substantially maintains the shape or form of the adjusted supply tube 3102. Advantageously, with such an arrangement, bead 3152 coiled around the exterior of supply tube 3102 keeps it out of the path of air or gas.

[0573] refer to Figure 31D and 31E, the supply tube 3102 can be in the form of an accordion bellows having a section or substantially integral accordion bellows 3160 that can, if desired, be used to set one or both of the length and position of the supply tube 3102. The bellows 3160 can be manufactured so that when the supply tube 3102 is compressed in the length or axial direction, the bellows 3160 will each fold into themselves. Figure 31D The supply tube 3102 is shown in an axially compressed orientation, and Figure 31E The supply tube 3102 is shown in an axially non-compressed or elongated position. The supply tube 3102 may be connected to the cannula 3114 by any suitable arrangement, such as directly or via a suitable connector. Figure 31F Alternatively, the supply tube 3102 may comprise a section or substantially an entirety constructed as a ball-and-socket chain. Specifically, at least one section of the supply tube 3102 is constructed from a plurality of separate segments or members 3162 or the like that together form a sealed or substantially sealed yet still positionable or formable tube. Preferably, each segment 3162 includes a ball end 3164 at one end and a socket 3166 at the other end. Thus, the multiple segments 3162 can be assembled together with the ball end 3164 of one segment 3162 positioned within the socket 3166 of an adjacent segment 3162. In some arrangements, the assembly of the ball end 3164 within the socket 3166 can be such that each segment 3162 can rotate or move relative to the adjacent segment 3162, yet provide sufficient friction for a seal or substantial seal and remain in place or substantially in place once adjusted. If desired, additional structure or arrangements, such as sleeves extending over the segments 3162, may be used to retain the segments 3162 in an assembled condition or to assist in retaining or sealing the segments 3162. Advantageously, these and similar embodiments may allow the supply tube 3102 to be positioned out of the patient's path in order to reduce or minimize interruptions to eating, drinking, and talking while treatment is being administered.

[0574] In some existing nasal cannula assemblies, the supply tube hangs down from its attachment point to the cannula or manifold, often just above the corner of the mouth. Such an arrangement can cause, among other problems, the supply tube to hang very close to the mouth, which can be troublesome for the patient because it interferes with eating, drinking, and talking. In addition, the weight of the supply tube so hung close to the nose tends to drag downward on one side of the cannula or manifold, thereby pulling it out of the nose. This is particularly practical in high-flow treatments, where relatively large supply tubes are required that cannot be comfortably routed behind the patient's ears as is the case with smaller, low-flow systems. Therefore, some embodiments route the supply tube exiting the nasal cannula assembly further away from the patient's nose and / or mouth, thereby partially or completely addressing both of the above-mentioned problems.

[0575] refer to Figure 32A -C. A portion 3250 of a coupler, such as a hook-and-loop fastener, is provided on the supply tube 3202 of the nasal cannula assembly 3200. For example, portion 3250 may be a sheath of hook-and-loop material. Sheath 3250 may be coupled to the supply tube 3202 via any suitable arrangement and may or may not be removable from the supply tube 3202. In the illustrated embodiment, sheath 3250 is permanently attached to the supply tube 3202. Sheath 3250 may be movable along the supply tube 3202 or may be provided in a fixed position on the supply tube 3202, preferably spaced apart from the manifold or cannula 3214 (hereinafter "cannula"). Sheath 3250 may be secured to another portion 3252 of the hook-and-loop fastener or other coupler, which may be appropriately positioned to align with sheath 3250 and, preferably, direct the vertically hanging portion of the supply tube 3202 away from the patient's nose or mouth. Preferably, the other portion 3252 of the coupler is a pad relative to the other portion of the hook and loop fastener of the sheath 3250. In one arrangement, as Figure 32A As shown in FIG, pads 3252 are provided on each side of the headgear strap 3240 or other retaining mechanism of the nasal cannula assembly 3200. Thus, the supply tube 3202 can be routed to either side of the patient's face as desired and supported to hang down at a distance from the patient's nose and / or mouth. In another arrangement, as in FIG, Figure 32C , the pad 3252 is an adhesive pad positioned on the patient's face, preferably at a distance from the nose and / or mouth (e.g., such as the cheek). In such an arrangement, the pad 3252 can be applied only to the desired side of the face for the desired routing of the supply tube 3202.

[0576] Additionally or alternatively, other suitable mechanisms for similarly securing the supply tube 3202 may be used. Figure 32D-F shows several mechanical fastening mechanisms for securing the supply tube 3202 so that the downwardly hanging portion is spaced from the patient's nose and / or mouth. Preferably, a first portion 3250 of the mechanical fastener is positioned on the supply tube 3202 in a permanent or removable manner and in a fixed or removable manner. A second portion 3252 of the mechanical fastener is positioned on a portion of the nasal cannula assembly 3200, such as the headgear strap 3240 (or, in another arrangement, the side 3222 of the cannula 3214). Thus, in a manner similar to Figure 32A In the arrangement of -C, the first portion 3250 of the mechanical fastener can be coupled to the second portion 3252 so that the supply tube 3202 can be supported away from the patient's nose or mouth. Figure 32D In the invention, the mechanical fasteners are buttons and loops. Figure 32E In the embodiment, the mechanical fastener is a popper dome or other snap-fit ​​arrangement. Figure 32F , the mechanical fastener is a hook that can engage the supply tube 3202 and the headgear strap 3240. Thus, in such an arrangement, the first portion 3250 and the second portion 3252 of the mechanical fastener are formed from a single component. Thus, these portions 3250 and 3252 can be permanently coupled to each other and can be removed from one or both of the supply tube 3202 and the headgear strap 3240 or other portions of the nasal cannula assembly 3200.

[0577] In some embodiments, the supply tube 3202 can be secured by a permanent fixture provided on a portion of the nasal cannula assembly 3200, particularly on cannula designs with extended or large sides 3222, such as the headgear strap 3240 or the side 3222 of the cannula 3214. For example, the fixture can be a permanent ring 3260 on the headgear strap 3240. Preferably, a permanent ring 3260 is present on each side of the headgear strap 3240 to allow the supply tube 3202 to be routed to either side. The supply tube 3202 can be passed through either ring 3260 to provide support and positioning for the supply tube 3202. The ring 3260 can be injection molded or die cut, for example, or formed by any other suitable process. Figure 32G A ring 3260 is shown, which is a hoop or loop positioned generally in the plane of the headgear strap 3240. The ring 3260 is shown extending below the headgear strap 3240; however, it can also be provided above the headgear strap 3240. Preferably, the ring 3260 is rotatable relative to the headgear strap 3240 to better accommodate the supply tube 3202 and any other components, such as, for example, the pressure measuring tube 3210. The headgear strap 3240 can include a portion that spaces the ring 3260 away from a circumferential portion of the headgear strap 3240 to facilitate rotation of the ring 3260. Figure 32H An integrally molded ring 3260 is shown positioned alongside the headgear strap 3240. Figure 32I A loop 3260 is shown formed by a segment 3262 of a headgear strap 3240 that is defined by a pair of spaced apart slits 3264 that allow the segment 3262 to be pulled away from an adjacent portion of the headgear strap 3240 to form a passage therewith. The slits 3264 can be generally parallel to each other and oriented in a generally vertical direction or in an axial direction along the perimeter defined by the headgear strap 3240, as shown. However, in other arrangements, the slits 3264 can be non-parallel and oriented in other directions.

[0578] In some embodiments, the ring 3260 can be a breakaway ring to facilitate positioning of the supply tube 3202 within the ring 3260. Preferably, at least one breakaway ring 3260 is present on each side of the cannula assembly 3200, such as on the headgear strap 3240. The supply tube 3202 can be clipped into any of the rings 3260. The rings 3260 can be breakaway via any suitable arrangement, such as, for example, a hook and loop fastener ( Figure 32J ), die-cut or otherwise formed tab slot arrangements ( Figure 32K ), popper domes or other snap-fit ​​arrangements ( Figure 32L ), injection molded or otherwise formed or mushroom-shaped head with recessed arrangement ( Figure 32M ), or push-on clips ( Figure 32N ). The ring 3260 can be broken at any location, such as in the central portion of the ring 3260 or on the headgear strap 3240. Preferably, any of these arrangements for managing the supply tube 3202 can be used or modified to manage the pressure line 3210 in addition to or as an alternative to the supply tube 3202.

[0579] The circuit (e.g., cannula or manifold) that delivers air or gas to the patient interface is suitably long so as to reach between the flow source and the patient. The mass of this long circuit (without some circuit support device) causes the load to be transferred directly to the patient interface. The load of the circuit can cause the cannula to move and be pulled away from the patient's nostrils, thereby interrupting treatment. It may also be uncomfortable for the patient to directly support the load of the circuit on the face. The circuit includes the supply tube described herein (e.g., supply tube 50 of FIG. 1 ) and also includes other conduits (e.g., the main delivery conduit and / or Figure 8A To address this problem, several techniques or arrangements can be used to support at least a portion of the load or mass of the circuit, such as incorporating Figure 33A -S described.

[0580] Figure 33A-H shows a support device 3350 that can be coupled to a portion of the circuit (generally 3352 ) by coupling to the patient's clothing, bed sheet, or other fabric or thin material and using them to support at least a portion of the load or mass of the circuit 3352 . Figure 33A and 33B A support device 3350 is shown attached to a loop 3352 by any suitable arrangement and comprising a two-part dome 3354 which sandwiches a comforter / garment 3356 between parts 3354a and b when assembled, for example via a snap-fit ​​arrangement.

[0581] refer to Figure 33C -F, the support device 3350 may include a clip and post (e.g., mushroom-shaped head) arrangement 3354 that clamps bedding / clothing 3356 between the clip 3354a and the post or mushroom-shaped head 3354b when the clip 3354a is assembled to the post or mushroom-shaped head 3354b. Any portion of the support device 3350 may be attached to the loop 3352 by any suitable arrangement. In the illustrated arrangement, the post or mushroom-shaped head 3354b is secured to the sleeve 3352 by a sleeve 3360. If desired, the clip 3354a may be coupled to the sleeve 3360 by a tether 3362. The clip 3354a may be of any suitable arrangement capable of fixedly engaging and disengaging with the post or mushroom-shaped head 3354b with the clothing, sheet, or other fabric or material 3356 therebetween. For example, Figure 33C A simple C-shaped spring clip 3354a is shown. Figure 33D A clip 3354a is shown that is capable of engaging the post or mushroom head 3354b in a radial or axial direction relative to the post or mushroom head 3354b. Figure 33E A hinged clip 3354a is shown which may have a snap fit arrangement or other mechanism connecting the non-hinged ends of the clip 3354a. Figure 33F A clip 3354a is shown with a resilient retaining portion 3364. The clip 3354a is shown as a hinged clip, but may also be non-hinged. Alternatively, the clip 3354a may be completely replaced with a resilient member.

[0582] In some embodiments, reference Figure 33G , the support device may include a tag 3350 coupled to a loop 3352 and including a buttonhole feature 3366 that can be attached to an existing button 3368 of a patient's shirt or other garment. Alternatively, a specific garment or other piece of material may be provided with a specific button 3368 that engages the buttonhole feature 3366. The tag 3350 may feature a tear feature (e.g., a slit, score line, or weakened portion) 3370 that will tear before the patient's shirt or other article supports the button 3368.

[0583] refer to Figure 33H The support device includes a clip 3350 having a portion 3372 that surrounds a loop 3352 and a portion 3374 that can grip bedding, clothing, or other fabric or thin material. In the illustrated arrangement, the clip 3350 includes two arms that can intersect with each other and move relative to each other between an open position and a closed position. Portion 3372 is defined by the portion of the arms extending between their intersection or connection point and the point at which they intersect. Portion 3374 is defined by the distal portions of the arms. The clip 3350 may include a finger grip portion 3376 that facilitates squeezing the clip 3350 to move it to the open position. Additionally, the clip 3350 may include a retaining, gripping, or friction-enhancing feature or traction element 3378 (e.g., a knob or protrusion) that helps prevent the bedding, clothing, or other material from being released from between the arms of the clip 3350 when in the closed position.

[0584] In other arrangements, the support device may include a lanyard 3380 that can be placed around the patient's neck or another body part or object and used to support at least a portion of the loop 3352. Figure 33I , Lanyard 3380 can be used with Figure 33H 3374, so that it can also be used to pass a lanyard 3380 and / or another support device therethrough. The lanyard 3380 can be used in place of, or in conjunction with, clamping the patient's clothing, bedding, or another piece of material.

[0585] The lanyard 3380 may have any suitable configuration. Figure 33J The lanyard 3380 may include a series of buckles, hook and loop fasteners, or other fasteners 3384 that may be used to adjust the length of the lanyard 3380. Additionally, these fasteners 3384 may be used as breakaway features to avoid or minimize discomfort or injury to the patient that may result from the lanyard 3380 becoming caught on something.

[0586] refer to Figure 33K, the tether 3380 can be centered about the loop 3352, with attachment points on opposite sides of the loop 3352. The ends of the tether 3380 can be received within a support device 3350 that can surround the loop 3352. Preferably, the ends of the tether 3380 pass through the support device 3350 in a substantially axial direction relative to the loop 3352 (which assists in keeping the support device 3350 upright, with the axis of the loop 3352 in a generally vertical orientation or generally aligned with the patient's body) and reducing or preventing awkward side angles when hanging from the patient's neck. In the illustrated arrangement, the support device 3350 is a connector between the supply tube and the main delivery catheter. A slider or other retaining device 3386 on the tether can be used to adjust and allow for asymmetric positioning.

[0587] refer to Figure 33L and 33M , the support device may include a strap 3350 that can engage the loop and is also attached to the patient's body or equipment near the patient. The strap 3350 can be permanently connected to the loop or removable from the loop. In one arrangement, the strap 3350 is a strap of fabric, plastic, or a combination thereof coated with a thin layer of metal, and is secured to the loop, for example, by a loop 3390 that surrounds the loop. The strap 3350 can be deformable so that it can be secured to the patient's arm, bed frame, or other object. The strap 3350 can have a first layer 3392 that defines the loop 3390 and a second layer 3394 that includes a deformable material so that the strap 3350 can be deformed and substantially maintain its shape. In another arrangement, the second layer 3394 includes a bistable spring or similar element that can be straightened and maintain its shape, but once the spring or other element begins to bend, it tends to collapse into a loop or coil. Such an arrangement can be opened to allow fitment and then collapsed around a patient's arm, bed frame, or another suitable object and, once fitted, provide sufficient retention force to maintain the circuit.

[0588] refer to Figure 33N -P, the support device may include a fastener 3350 having a first portion 3350a attached to the loop 3352 and a second portion 3350b that can be attached to another object (such as a bed frame or other equipment). These portions 3350a and 3350b can be coupled to support the loop 3352. Figure 33N In an arrangement, one portion 3350a of the hook and loop fastener 3350 is attached to the loop 3352, for example, by being wrapped around the loop 3352, and another portion 3350b of the hook and loop fastener 3350 is attached (e.g., via an adhesive) to an object such as a bed frame or other equipment. These portions 3350a and 3350b can be coupled to each other to provide support to the loop 3352. Figure 33OIn the arrangement of , portion 3350b includes a non-adhesive segment that can be looped on loop 3352 and then connected to the adhesive segment to provide a more secure support. In an alternative arrangement, portion 3350a on loop 3352 can be omitted. Figure 33P In an arrangement as shown, portion 3350b can be formed into or provided on an armband 3395 that can be wrapped around the patient's arm (or another object). Armband 3395 can be an endless loop, or, as shown, can be breakable or separable and selectively secured in the loop by a suitable fastener 3396 (e.g., a hook and loop fastener).

[0589] refer to Figure 33Q and 33R , the support device 3350 can be or include a shoulder-worn support that can be looped around the patient's shoulder to support the loop 3352. A portion 3350a of the support 3350 can include a flexible or formable generally U-shaped section that defines an opening that can receive and engage the loop 3352. Another portion 3350b of the support 3350 can include a flexible or formable generally U-shaped portion that can receive and engage the patient's shoulder or upper arm.

[0590] refer to Figure 33S , the support device 3350 can be part of or supported by the headgear strap 3340 or other cannula support device or arrangement. With such an arrangement, the headgear strap 3340 can be used to support at least a portion of the weight of the circuit 3352. For example, the support device portion 3350 of the headgear strap 3340 can extend directly over and rest against the top of the patient's head, and then continue downward to the clip 3398 or the like to engage the circuit 3352, so that the support device portion 3350 of the headgear strap 3340 helps support the weight of the circuit 3352.

[0591] Some embodiments relate to a retention assembly for use with or integrated with the nasal cannula assembly. In many existing systems, the cannula is secured to the face using a single elastic headband or by looping one or more supply tubes around the ears. In some such designs, the cannula is not ideally secured to the patient's face and can shift or move from the desired position. A number of factors can cause the cannula to shift from its ideal position, including: the weight of the air or gas supply circuit can cause the cannula to dangle in this orientation, causing the cannula to slide as the patient moves around during sleep, and the small surface area of ​​a single elastic headband may be insufficient to secure the cannula. Over time, the headband can slide downward, further reducing its security on the face. Consequently, with some existing systems, the cannula can easily become unsecured, especially over extended periods of time. Furthermore, cannula assemblies that rely on suspending one or more supply tubes from the ears as a secondary means of securement often have the supply tubes taped to the patient's face. This technique is time-consuming and does not allow for easy readjustment.

[0592] refer to Figure 34A and 34B , the nasal cannula assembly 3400 includes a cannula 3414 and a retention arrangement 3450, which can be separate components or assemblies or can be integrated with each other. In the illustrated arrangement, hook and loop strips 3452 extend from the left and right sides of the cannula 3414, respectively. These hook and loop strips 3452 can be passed through openings or slots 3454 located in annular or circular ear pads 3456. These ear pads 3456 can be made of any suitable material that preferably provides a soft and comfortable feel to the patient while being strong enough to handle the forces applied when the headgear straps 3440 are tightened. The shape of these ear pads 3456 can be annular (e.g., circular) or any other geometric shape that allows for an anatomical fit and, in at least some configurations, partially or completely surrounds the patient's ears.

[0593] The ear pads 3456 are, in turn, connected to a headgear strap 3440. The headgear strap 3440 may also have hook and loop strips 3458 coupled thereto or integrated therewith, which may be passed through additional openings 3454 in the ear pads 3456. The headgear strap 3440 may have any suitable arrangement, such as a bi-varicated strap, and is preferably made of or incorporated with a non-stretch material. In some configurations, the sleeve assembly 3400 is provided with one or more pre-assembled components. For example, three of the four hook and loop strips 3452, 3458 pass through the slots 3454 in the ear pads 3456. In such an arrangement, the patient or caregiver would wear the sleeve assembly 3400 by constraining it around the head with the straps, thereby ensuring that the ears are inside the holes of the ear pads 3456. The patient or caregiver then passes the open hook and loop strip (or multiple strips in other arrangements) through the ear pads 3456 and tightens them until they feel comfortable.

[0594] Advantageously, with such an arrangement, the cannula 3414 will be more secure on the patient's head than with existing arrangements. For example, the patient's ears will inhibit or prevent the ear pads 3456 from sliding out of position and, therefore, the cannula 3414 from moving out of its intended position. This is particularly beneficial for sleeping patients, as natural body movements during sleep will not affect the delivery of therapy through the cannula 3414. The foam (or other material) ear pads 3456 can also provide more comfort to the patient, as they act as a cushion if the patient sleeps on their side. The double spiral strap 3440 will also help improve the security of the cannula 3414 by increasing the area over which the cannula 3414 is attached to the head. The increased surface area will inhibit or prevent the headgear strap 3440 from sliding down and reducing the security of the cannula 3414 on the face.

[0595] refer to Figure 34C and 34D, the sleeve retention arrangement 3450 incorporates friction pads 3460 into the headgear strap 3440. These friction pads 3460 are preferably positioned on the patient's cheeks, or on portions of the face proximal to the cheeks, and direct the line of action or force from the headgear strap 3440 away from the ears. In some arrangements, the friction pads 3460 are made of or include a soft material that allows for a comfortable fit on the face while providing sufficient friction to allow the headgear strap 3440 to change direction relative to a lateral direction or relative to the lateral sides 3422 of the sleeve 3414 or the lateral portions 3440a of the headgear strap 3440. These friction pads 3460 preferably have a thickness that allows the sleeve 3414 to gently ride across the patient's skin, creating less pressure on the skin. Such pads 3460 will have the added benefit of preventing the sleeve 3414 from moving on the face, as greater friction forces will need to be overcome to initiate movement. If desired, the pads 3460 may be attached to the headgear straps 3440 by any suitable arrangement, such as, for example, stitching, adhesive.

[0596] Advantageously, this arrangement for attaching the sleeve 3414 to the patient's head is more secure than many prior arts and arrangements. For example, these friction pads prevent or prevent the sleeve 3414 from easily moving on the face, which is experienced by many prior arrangements. In addition, by raising the sleeve 3414 from the skin by means of the thickness of the friction pads 3460, the pressure on the upper lip felt by the patient will be reduced, thereby making the sleeve 3414 more comfortable to wear. Comfort can also be increased by using these friction pads 3460 to spread the force of the headgear strip 3440 over a larger area on the face, which prevents or prevents localized indentations on the skin. By directing the line of action of the headgear strip 3440 away from the ears, a more comfortable position of the headgear strip 3440 can be achieved because the ears will not be compressed by the force of the headgear strip 3440 passing over them.

[0597] refer to Figure 34E, the cannula assembly 3400 includes a cannula 3414, a supply tube 3402 and a retaining arrangement 3450. During installation, the retaining arrangement 3450 is strapped to the head using the ear as an anchor point. Preferably, the headgear strap 3440 is divided into two parts 3440a and 3440b, which can be connected to each other by a suitable fastening arrangement, such as, for example, a hook and loop fastener 3466. Preferably, the fastening arrangement 3466 is adjustable so that the circumference of the headgear strap 3440 is adjustable. Preferably, each part 3440a, 3440b of the headgear strap 3440 includes an ear loop 3456, which includes an opening that can be placed over the patient's ear. In use, the cannula assembly 3400 is applied to the patient by first hanging the assembly 3400 over the ear via these ear loops 3456 and positioning these prongs 3405 of the cannula 3414 in the correct position. Once the sleeve 3414 is in place, the two portions 3440a, 3440b of the headgear strap 3440 can be coupled using a fastener arrangement 3466. Preferably, the fastener arrangement 3466 allows the circumference of the headgear strap 3440 to be adjusted to a suitable tightness, such that the headgear strap 3440 supports the sleeve 3414 substantially independently of the engagement of the ear loops 3456 with the patient's ears. In some arrangements, once the headgear strap 3440 is adjusted (e.g., tightened), the ear loops 3456 do not contact the patient's ears and / or apply any significant force thereto. Preferably, the headgear strap 3440 (which may include the ear loops 3456) is made of, or incorporates, a material that slightly stretches to provide a relatively constant force on the face when the headgear strap 3440 is adjusted (e.g., by securing the fastener arrangement 3466). In some arrangements, the loop section of the hook and loop fastener 3466 is positioned closer to the head than the hook portion to prevent the hook material from sticking or snagging the patient's hair. In some arrangements, the material used to make the headgear strap 3440 is thick enough to allow the sleeve 3414 to hang over the patient's ear when passed through the ear hole 3456.

[0598] Advantageously, this arrangement for attaching the cannula 3414 is more secure than many prior art techniques and arrangements. For example, the ears will block or prevent the headgear strap 3440 from moving out of position and block or prevent the cannula 3440 from moving from its desired position. This is particularly beneficial for a sleeping patient because natural body movements during sleep will not affect the delivery of therapy through the cannula 3414. These ear loops 3456 allow the cannula assembly 3400 to be more easily applied, and the cannula 3414 can be positioned without securing the headgear strap 3440 by hanging it from the patient's ears. A caregiver or patient can move the cannula 3414 back and forth until the correct positioning is achieved, and then easily secure the headgear strap 3440 using the fastening mechanism 3466. Advantageously, the headgear strap 3440 will inhibit or prevent the sleeve 3414 from sliding downwardly because a larger surface area of ​​the strap 3440 is in contact with the head, and these ear loops 3456 will serve as anchor points if the headgear strap 3440 might move downwardly due to external forces.

[0599] refer to Figure 34F , the sleeve assembly 3400 includes a retention arrangement 3450 that includes a headgear strap frame 3440 and a flexible mesh portion 3468 supported by the frame 3440. In some arrangements, at least a portion of the frame 3440 may be constructed from a substantially non-stretchable material or may be otherwise constructed to be substantially non-stretchable. The mesh portion 3468 may be in the form of a mesh and is preferably constructed from a material that is at least slightly stretchable. Such an arrangement creates a hybrid stretch / non-stretch headgear that can be applied by sliding it over the head and positioning it until the ears are within the openings of the ear loops 3456 of the frame 3440. These ear loops 3456 may partially or completely surround the patient's ears. The frame 3440 can be adjusted using an adjustment mechanism 3470 that may include adjustment tabs 3472 that are used to shorten the circumference of the mesh portion 3468 of the retention arrangement 3450. In such an arrangement, a portion (e.g., the rear portion) of the ear loops 3456 to which the mesh portion 3468 is attached can be constructed of a stretchable material or can be at least flexible relative to other portions of the frame 3440 to facilitate adjustment of the mesh portion 3468. In an alternative arrangement, the frame 3440 can also be constructed of a material that is at least slightly stretchable. In such an arrangement, the adjustment mechanism 3470 can optionally be omitted, as the stretching would allow the retention arrangement 3450 to accommodate a variety of patient sizes.

[0600] In at least some configurations, the flexible mesh portion 3468 conforms to the shape of the patient's head and increases the friction and surface area between the retention arrangement 3450 and the patient. As a result, a much more secure fit is provided. This arrangement for securing the cannula 3414 is much more secure than many existing methods and arrangements. The large area in contact with the head will provide friction that resists movement of the cannula due to movement during normal activities or during sleep. Additionally, by spreading the force over a large area, the illustrated arrangement tends to reduce localized pressure on the back of the head that is experienced with many current methods and arrangements.

[0601] refer to Figure 34G and 34H Cannula assembly 3400 includes a cannula 3414, a supply tube 3402, and a retaining arrangement 3450. In the illustrated arrangement, cannula 3414 is mounted to a generally U-shaped frame 3440, which is configured to fit the patient's face in a manner similar to eyeglasses. Accordingly, frame 3440 preferably supports cannula 3414 and includes rearwardly extending ear stem portions 3440a and 3440b that extend along the sides of the patient's head, preferably extending at least to the patient's ears. Frame 3440 is preferably substantially rigid to retain its shape, yet flexible enough to allow the ear stem portions 3440a and 3440b to move apart, making it adaptable to a range of head sizes. In a preferred arrangement, the ends (or portions) of the ear stem portions 3440a and 3440b are generally straight, and frame 3440 relies on its resilience to secure it to the patient's face. Such an arrangement can accommodate a wider range of face sizes. However, in an alternative arrangement, the frame 3440 can include multiple sections that at least partially wrap around (e.g., behind) the ears. Optional pads 3474 can be provided where the frame 3440 contacts the head (e.g., above the ears). Advantageously, the sleeve assembly 3400 can be easily applied and removed with one hand, for example, in a manner similar to a pair of glasses. Furthermore, since no strap is applied to the back of the head, there will be less relative force on the upper lip that could cause discomfort.

[0602] refer to Figure 34I and 34J, the cannula assembly 3400 includes a cannula 3414, a supply tube 3402, and a retention arrangement 3450. In the illustrated arrangement, a pair of adhesive pads 3480 are mounted on the patient, with one pad 3480 applied to each cheek. The cannula 3414 is attached to the adhesive pads 3480 by any suitable arrangement. In these illustrated arrangements, the cannula 3414 is attached to the pads 3480 by an adjustable and removable system so that the position and force of the cannula 3414 on the face can be adjusted or fine-tuned after the adhesive of the pads 3480 has been set. Advantageously, with such an arrangement, the cannula 3414 can be temporarily removed without removing the adhesive pads 3480. These adjustable systems can be any suitable arrangements, such as utilizing hook and loop fasteners 3482 ( Figure 34I ) or other reusable fastener 3480 to be adjustably coupled to the sleeve 3414. Reference Figure 34J , the pads 3480 can be adjustably secured to the sleeve 3414 using ratchet-type adjustable fasteners 3484. The ratchet-type adjustable fasteners 3484 can be integral with the pads 3480 and / or sleeve 3414 as shown, or can be a separate component or separate part coupled to the pads 3480 and / or sleeve 3414. Advantageously, the use of adhesive pads 3480 means that no strap is applied to the back of the head, so there will be less relative force on the upper lip to cause discomfort.

[0603] refer to Figure 34K , alternative adjustable fasteners 3486 are shown for adjustably coupling the sleeve 3414 to the pads 3480. However, in other arrangements, the fasteners 3486 may have a single position relative to the sleeve 3414, and any adjustment may be accounted for by placing the pads 3480 on the patient. Preferably, the pads 3480 include posts or knobs 3488 that clip into openings or recesses 3490 on the sleeve 3414. This arrangement may also be reversed. The knobs 3488 may have any shape, as long as the recesses 3490 in the sleeve 3414 are of complementary design. The shape of the pads 3480 may be any suitable arrangement so that they conform to facial geometry. The illustrated pads 3480 are generally hourglass shaped. However, other suitable shapes may also be used. The recesses 3490 in the sleeve 3414 allow for adjustment on the face. To increase the holding force, the notches 3490 closer to the prongs 3405 can be clipped into the knobs 3488 on the adhesive pad 3480. Any suitable number of notches 3490 can be provided to allow a range of adjustment forces and / or to accommodate a range of head sizes.

[0604] Advantageously, such an arrangement eliminates or reduces the localized pressure typically associated with the use of a tightening strap. Furthermore, it reduces or prevents marking on the skin caused by wearing the headgear straps for extended periods of time. Furthermore, it makes it easier to apply and remove the cannula 3414 because the headgear straps do not have to be passed over the head. This is particularly beneficial for patients who sleep on their backs.

[0605] refer to Figure 35A -D, in some embodiments, the nasal cannula assembly is a modular system that provides several different retention arrangements. A variety of cannulas are used on patients in a range of different environments, including from intensive care units (ICUs) to general hospital wards to homes. In view of these different use environments, a modular system in which the patient / caregiver can select the type of retention used may be desirable. In some embodiments, the cannula assembly 3500 includes a cannula 3514, a supply tube 3502, and a retention arrangement 3550. The cannula 3514 includes sides 3522 of any shape. In the illustrated arrangement, the sides 3522 include enlarged, generally oval pads. The sides 3522 can allow the cannula 3514 to be coupled to several types of retention arrangements 3550 by any suitable fasteners, such as, for example, hook and loop fasteners. In one arrangement, as Figure 35A As shown in FIG, the sleeve 3514 can be coupled to a halo-type headgear strap assembly 3540, which includes at least one strap 3552 extending around the sides of the patient's head and a second strap 3554 extending over the top of the patient's head. In some arrangements, as shown, the headgear strap assembly 3540 can include a pair of straps 3552 extending around the sides of the head, with one strap 3552 positioned above the ears and the other strap 3552 positioned below the ears. If desired, padding can be provided on one or more of the straps 3552 and 3554. The straps 3552 and 3554 can include suitable fasteners, such as hook-and-loop fasteners 3556, that allow the headgear strap assembly 3540 to be applied, removed, or adjusted. The halo-type headgear strap assembly 3540 can include end portions that utilize complementary portions of the fasteners of the side portions 3522. This form of retention may be desirable for patients who are non-compliant with treatment. This larger, complex head cap may inhibit or prevent the cannula 3514 from moving away from the face and further make it difficult to remove the cannula 3514 by pulling on it.

[0606] In other arrangements, such as Figure 35B, these side portions 3522 allow the sleeve 3514 to be coupled to a headgear strap 3540 or a set of adhesive pads 3580 that may be the same or similar to any other strap or pad disclosed herein (or may have any other suitable arrangement). The headgear strap 3540 may include end portions that utilize complementary portions of the fasteners of the side portions 3522 and may be used for patients who do not want the pads 3580 to stick to their cheeks or who are undergoing intermittent treatment on a regular basis. The headgear strap 3540 may have a single size or be adjustable. The adhesive pads 3580 may also utilize complementary portions of the fasteners of the side portions 3522 and may have a shape that is complementary or compatible with the side portions 3522. This type of retention may be desirable for patients who are compliant or receiving treatment for an extended period of time.

[0607] refer to Figure 35C and D, each side of the retention arrangement 3550 and each of these side portions 3522 of the sleeve 3514 can include more than one pad, such as, for example, two pads (a double-thread arrangement). Such an arrangement includes a total of four hook and loop (or other) fastener locations, which can reduce the load experienced by each fastener and spread that load over a larger area of ​​the patient's head for increased comfort. Additionally, the spaced-apart locations at which the retention force is applied to the sleeve 3514 can result in greater stability of the sleeve 3514 on the patient's face. Figure 35C In these illustrated arrangements, the sleeve 3514 is coupled to a halo-type headgear strap 3540, which is similar to Figure 35A The strip 3540. Figure 35D , a non-halo headgear strap 3540 may be employed that may include two straps, or other numbers of straps, such as one or more than two straps. This form of retention arrangement 3550 may also be applied to the face using an adhesive pad or other suitable retention arrangement.

[0608] With many existing systems, if the patient accidentally removes the sleeve, the headgear is further tightened or the sleeve is taped to the face. Figure 35A These arrangements of the -D provide the caregiver or patient with the flexibility to choose which retention method is desired, needed, or best suited to a particular situation. By using the desired retention level, comfort for the patient can be increased because the method used to secure the cannula to a non-compliant patient does not have to be used on a compliant patient. Another benefit of the demonstrated modular system is that it allows the user to choose which retention method is more comfortable for them. This gives the patient / user more control over the treatment and can lead to better patient / user satisfaction and compliance.

[0609] refer to Figure 35E-G, illustrates another modular retention arrangement 3550. The illustrated retention arrangement 3550 includes a lightweight, relatively small cannula 3514 that can be adhered to the patient's nose via an adhesive pad or strip 3590. The supply tube 3502 is coupled to the cannula 3514 via any suitable arrangement, such as any of the coupling arrangements disclosed herein. In this illustrated arrangement, the adhesive strip 3590 is attached to, integrated with, or monolithic with the cannula 3514 and is configured to extend to the top portion of the patient's nose, preferably at or above the tip of the nose, when the prongs 3505 are positioned in the patient's nostrils. The adhesive strip 3590 can be adhered to the patient's nose to hold the cannula 3514 in place. Alternatively, the strip 3590 can be adhered to the patient indirectly, such as using a fastener (e.g., a hook-and-loop fastener) that connects the strip 3590 to a separate adhesive pad. This retention arrangement 3550 may be desirable for patients who are compliant and aware of the treatment they are undergoing.

[0610] For non-compliant patients, or in other appropriate circumstances, the adhesive pad or strip 3590 can be removed (e.g., cut away) and the cannula 3514 can be inserted into a cannula holder 3592 that cooperates with the headgear strap 3540. The entire assembly can now be used as a standard cannula. The cannula holder 3592 can be any suitable arrangement for retaining the cannula 3514 when desired. For example, the cannula holder 3592 can include any type of snap-fit ​​arrangement that can include a support portion 3594 (e.g., a semi-cylindrical or other shaped tray) and a retaining portion 3596 (e.g., a clip). The headgear strap 3540 can be non-adjustable, adjustable, or can be any suitable arrangement, such as those that are the same or similar to any of the straps disclosed herein.

[0611] refer to Figure 36A -K, in some embodiments, the cannula retention arrangement 3650 is configured to facilitate achieving a desired tightness or holding force, which can be a range of values ​​(preferably, relatively narrow). In many existing arrangements of cannulas secured by a headgear strap, the tightness (tension) of the strap and the resulting holding force applied to the cannula are very dependent on the specific user and can therefore vary widely. If the cannula is applied too tight, marks will be left on the skin due to the headgear strap, and the headge...

Claims

1. A patient interface, comprising: gas delivery mechanism; a body connected to the gas delivery mechanism; a pair of side arms extending from the body over the cheek region of the patient during use; and a continuous length of material extending along each of the pair of side arms and extending through the body to connect the pair of side arms, the continuous length of material being capable of transferring an applied force or tension from the pair of side arms to the gas delivery mechanism; wherein the body and the side arm are connected by a continuous section of material such that tension is applied to the side arm to direct the gas delivery mechanism to move away from a position where it would otherwise apply force to the patient's nasal spine; wherein the body and the pair of side arms are formed of a first material and the continuous material segment is formed of a second material; wherein the second material is more rigid than the first material; and wherein the body is configured to receive the supply tube from the left or right side; Therein, the gas delivery mechanism does not provide a seal at the patient's nostrils.

2. A patient interface according to claim 1, wherein The first material is softer than the second material.

3. The patient interface of claim 1 , wherein: The body is formed from a first material, and at least a rear portion of the body that is contactable with the patient's face is shaped to substantially conform to the contours of the patient.

4. The patient interface of claim 1 , wherein: The first material is overmolded onto the second material.

5. The patient interface of claim 1 , wherein: The continuous length of material forms a frame or skeleton to which the first material is to be attached.

6. The patient interface of claim 1 , wherein: A continuous length of material forms a hinge region on each side arm, wherein the hinge region is located along the length of the side arm.

7. A patient interface according to claim 6, wherein: The hinge region is adjacent to the body.

8. The patient interface of claim 1 , wherein: The continuous length of material is constructed or shaped to bridge or extend away from a central portion of the patient's face.

9. The patient interface of claim 1 , wherein: The end of each side arm is connected to the headgear.

10. A patient interface according to claim 9, wherein The head cap includes a bifurcated strap.

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