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 a patent application with Chinese Invention Patent Application No. 201810946385.9 (the original application number of the parent case was 201480015555.1, and the international application number was PCT / NZ2014 / 000040), invention title "Nasal Cannula Assembly and Related Components", and application date March 14, 2014. Field of the Invention

[0002] This disclosure relates to devices and systems for providing gases for respiratory therapy to a patient. More particularly, this disclosure relates to a nasal cannula interface for providing gases to a patient via a nasal passage. Background of the Invention

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

[0004] A nasal cannula assembly generally consists of a symmetric or unilateral inlet fitting that passes over the upper lip. Projecting from this fitting are end-open prongs that extend into the patient's nostrils to deliver oxygen. Nasal cannulas have the advantage of being more comfortable and acceptable to most patients than face masks. A single-flow inlet nasal cannula has the advantage of being unobtrusive and is more suitable for delivering moisture than a dual-flow inlet style nasal cannula due to the advantages of flow rate and surface area for heat loss. However, a single-flow inlet is provided on one side of the cannula, i.e., the left or right side. For example, if the tube is on the left side, if the gas source is on the opposite or right side of the user, it requires a longer fitting and causes the tube to cross the body, making it difficult for the user to use.

[0005] When providing humidified gases to a patient, a heated breathing circuit (fitting) 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 on the patient interface from pulling, a circuit hanger is occasionally used. This is a large expandable metal arm used to bear the weight. It is also known in the art to clip a portion of the fitting to the patient's clothing or bedding. It has been found that both of these solutions are rather 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 forks on the face is very important because movement of these forks within the nostrils can cause severe irritation. The current method for holding a single-entry nasal cannula on the face is to use a simple elastic material strap around the back of the patient's head. This 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 forks to move within the nostrils, irritating this sensitive area.

[0007] References in this specification to patent specifications, other external documents, or other sources of information are generally provided to give background for discussing the features of the invention. Unless specifically stated otherwise, reference to these external documents should not be construed as an admission that such documents, or such sources of information, are prior art in any jurisdiction or form part of the common general knowledge in the art.

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

[0010] The nasal cannula interface described herein can advantageously be used to provide a wide range of gas concentrations and flow rates to a patient. The nasal cannula interface described herein also includes various features designed to improve patient comfort, safety, ease of use, and / or efficiency, reduce costs, and / or provide other benefits.

[0011] 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 user's cheeks when the system is in use, and a first nasal fork and a second nasal fork extending from the central body portion. The central body portion includes a patient-facing side and at least one retaining strap for cooperatively defining a cavity. The first nasal fork and the second nasal fork communicate with the cavity. The manifold receives a gas supply from a gas source and includes a gas inlet and a gas outlet. The manifold can be received within the cavity of the cannula such that the gas outlet is aligned with the first nasal fork and the second nasal fork. The at least one retaining strap defines a first lateral edge and a second lateral edge, and the first nasal fork and the second nasal fork are located between the first lateral edge and the second lateral edge.

[0012] In some embodiments, a 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 from the central body portion in opposite lateral directions and contacting a user's cheeks 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 lumen having inlets 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, respectively. 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 lumen of the cannula.

[0013] In some embodiments, a 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 lumen and a front-facing inlet of the lumen. The first nasal prong and the second nasal prong are in communication with the lumen. The manifold receives a gas supply from a gas source and includes a gas inlet and a gas outlet. The manifold is connectable to the cannula such that the gas outlet is aligned with the front-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 front-facing inlet of the cannula.

[0014] In some embodiments, a nasal cannula patient interface includes: a first nasal prong and a second nasal prong each having an inlet end and an outlet end, and at least one support portion configured to rest on a 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 for the patient interface.

[0015] In some embodiments, a 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 lumen in communication with the first nasal prong and the second nasal prong. An integrated headband includes a first section and a second section, wherein the first section and the second section extend from the central body portion in opposite lateral directions. 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 such 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 lumen of the cannula.

[0016] In some embodiments, the nasal cannula system includes a cannula that includes a central body portion, a first nasal prong, and a second nasal prong extending from the central body portion. The cannula defines a lumen that communicates with the first and second nasal prongs. The cannula defines a lateral slot. A headgear strap extends through the lateral 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 lumen of the cannula.

[0017] In some embodiments, the nasal cannula system includes a cannula that includes a central body portion, a first nasal prong, and a second nasal prong extending from the central body portion. The cannula defines a lumen that communicates with the first and second nasal prongs. The cannula defines a first opening at a first location in the lumen and a second opening at a second location in the lumen spaced from the first location. A valve body is movable within the lumen. A 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 a gas flow in the lumen from the gas source so as to block the second opening, such that the gas flow is directed to the first and second nasal prongs, and when the first end of the supply tube is connected to the second opening of the cannula, the valve body moves in response to a gas flow in the lumen from the gas source so as to block the first opening, such that the gas flow is directed to the first and second nasal prongs.

[0018] In some embodiments, the nasal cannula system includes a cannula that includes a central body portion, a first nasal prong, and a second nasal prong extending from the central body portion. The cannula defines a lumen that communicates with the first and second nasal prongs. The cannula defines a first opening at a first location in the lumen and a second opening at a second location in the lumen spaced from the first location. The cannula includes a first valve that selectively closes the first opening and a second valve that selectively closes the second opening. A supply tube has a first end connectable to either 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 second valve blocks the second opening, such that the gas flow from the gas source is directed to the first and second nasal prongs, and when the first end of the supply tube is connected to the second opening of the cannula, the first valve blocks the first opening, such that the gas flow is directed to the first and second nasal prongs.

[0019] In some embodiments, a nasal cannula system includes a cannula that includes a central body portion, a first nasal prong, and a second nasal prong extending from the central body portion. The cannula defines a lumen that communicates with the first and second nasal prongs. The cannula defines a first opening at a first end of the lumen and a second opening at a second end of the lumen. A supply tube has a first end including a first insert and a second end including a second insert. Each of the first insert and the second insert is positionable within the lumen to seal the first and second openings and deliver a gas flow from a gas source to the first and second nasal prongs. When the first end of the supply tube is connected to the cannula, the second end 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.

[0020] In some embodiments, a nasal cannula system includes a cannula that includes a central body portion, a first nasal prong, and a second nasal prong extending from the central body portion. The cannula defines a lumen that communicates with the first and second nasal prongs. A supply tube has a first end that is connectable to the lumen of the cannula and a second end that is connectable 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 the internal passage of the supply tube.

[0021] In some embodiments, a nasal cannula system includes a cannula that includes a lumen, and a first and second nasal prong that communicate with the lumen. A supply tube receives a gas flow from a gas source. The supply tube is connected to the cannula to supply the gas flow to the lumen of the cannula. A clip removably receives the cannula. A retention arrangement secures the clip to a 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.

[0022] In some embodiments, a nasal cannula system includes a cannula that includes a first nasal prong and a second nasal prong. The cannula defines a cavity that is in communication with the first nasal prong and the second nasal prong. The cannula defines a first opening at a first location of the cavity and a second opening at a second location of the cavity that is spaced apart from the first location. A supply tube assembly includes a clip that is releasably couplable to the cannula in either a first orientation or a second orientation. The supply tube assembly further includes a supply tube that is connectable to a gas supply from a gas source. The clip supports the supply tube and includes a sealing portion. When the clip is connected to the cannula in the first orientation, the supply tube is connected to the first opening of the cannula and extends from the cannula in a first direction, and the sealing portion at least substantially seals the second opening, and when the clip is connected to the cannula in the second orientation, the supply tube is connected to the second opening of the cannula and extends from the cannula in a second direction, and the sealing portion at least substantially seals the first opening.

[0023] In some embodiments, a nasal cannula system includes a cannula clip that includes a first nasal prong and a second nasal prong. The cannula defines a cavity that is in communication with the first nasal prong and the second nasal prong. A supply tube assembly includes a manifold having at least one manifold opening and a supply tube that is connectable to a gas supply from a gas source. The cannula clip is releasably couplable to the manifold in either a first orientation or a second orientation, wherein the manifold is received within the cavity of the cannula clip and the first prong and the second prong are aligned with the at least one manifold opening such that a gas flow is provided to the first prong and the second prong. When the cannula clip is connected to the manifold in the first orientation, the supply tube extends in a first direction relative to the first prong and the second prong, and when the cannula clip is connected to the manifold in the second orientation, the supply tube extends in a second direction relative to the first prong and the second prong.

[0024] In some embodiments, a nasal cannula system includes a cannula that includes a body defining a cavity, and a first nasal prong and a second nasal prong extending from the body and in communication with the cavity. A supply tube is coupled to the cannula and in communication with the cavity. The supply tube is connectable to a gas supply from a gas source to deliver a gas flow to the cavity and the first nasal prong and the second nasal prong. The first nasal prong and the second nasal prong are tiltable relative to the body of the cannula between at least a first position in which the first nasal prong and the second nasal prong are tilted in a first direction relative to the body and a second position in which the first nasal prong and the second nasal prong are tilted in a second direction relative to the body. A first surface of the body defines a patient-facing surface of the cannula in the first position, and a second surface of the body defines a patient-facing surface of the cannula in the second position, thereby effectively switching the side from which the supply tube extends from the cannula between the first position and the second position.

[0025] In some embodiments, a nasal cannula system includes a cannula that defines a lumen and includes a first nasal prong and a second nasal prong extending from the cannula and in communication with the lumen. A supply tube is coupled to the cannula and in communication with the lumen. The supply tube is connectable to a gas supply from a gas source to deliver a gas flow to the lumen 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 in which the first and second nasal prongs are oriented such that the openings of the prongs generally face a first direction relative to the cannula and a second position in which the first and second nasal prongs are oriented such that the openings of the prongs generally face a second direction relative to the cannula. A first surface of the cannula defines a patient-facing surface in the first position, and a second surface of the cannula defines the patient-facing surface in the second position, thereby effectively switching the supply tube from the side of the cannula from which it extends between the first position and the second position.

[0026] In some embodiments, a nasal cannula system includes a cannula that defines a patient-facing surface and includes a first nasal prong and a second nasal prong extending from the cannula and in communication with the lumen. A manifold supports rotation of the cannula about at least one axis between at least a first position and a second position opposite the first position. A supply tube is coupled to the manifold and in communication with the lumen. The supply tube is connectable to a gas supply from a gas source to deliver a gas flow to the lumen 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 from the side of the cannula from which it extends between the first position and the second position.

[0027] In some embodiments, a nasal cannula system includes a cannula that defines a lumen and includes a first nasal prong and a second nasal prong extending from the cannula and in communication with the lumen. A supply tube is coupled to the cannula and in communication with the lumen. The supply tube is connectable to a gas supply from a gas source to deliver a gas flow to the lumen and the first and second nasal prongs. A pressure line is in communication with the lumen and is configured to be connectable to a control unit or a display unit of the gas source to provide a signal indicative of the pressure in the lumen to the control unit or the display unit.

[0028] In some embodiments, a nasal cannula system includes a cannula body that defines a lumen and includes a first nasal prong and a second nasal prong extending from the cannula and in communication with the lumen. 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.

[0029] In some embodiments, a nasal cannula system includes a cannula body that defines a lumen and includes a first nasal prong and a second nasal prong that extend from the cannula and communicate with the lumen. The cannula body includes a central portion containing the first and second nasal prongs and first and second side portions that extend from each side of the central portion. The cannula body defines a patient-facing surface. The central portion is spaced forward from adjacent portions of the first and second side portions such that, in use, the patient-facing surface of the central portion is spaced from the patient's upper lip.

[0030] 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 a stretchable segment that allows the segment to be shaped by an external force and substantially retain the shape after removal of the external force.

[0031] In some embodiments, a nasal cannula system includes a cannula that defines a lumen and includes a first nasal prong and a second nasal prong that extend from the cannula and communicate with the lumen. A supply tube is coupled to the cannula and communicates with the lumen. The supply tube is connectable to a gas supply from a gas source to deliver a gas flow to the lumen and the first and second nasal prongs. A support arrangement supports the supply tube at a spaced position from the cannula. The support arrangement includes a fastener having a first portion coupled to the supply tube and a second portion at the spaced position.

[0032] In some embodiments, a nasal cannula system includes a cannula that defines a lumen and includes a first nasal prong and a second nasal prong that extend from the cannula and communicate with the lumen. A supply tube is coupled to the cannula and communicates with the lumen. The supply tube is connectable to a gas supply from a gas source to deliver a gas flow to the lumen and the first and second nasal prongs. A retention arrangement secures the cannula to the patient. A support arrangement supports the supply tube at a spaced position from the cannula, the spaced position being on the retention arrangement.

[0033] In some embodiments, a nasal cannula system includes a cannula that defines a lumen and includes a first nasal prong and a second nasal prong that extend from the cannula and communicate with the lumen. A supply tube is coupled to the cannula and communicates with the lumen. The supply tube is connectable to a gas supply from a gas source to deliver a gas flow to the lumen and the first and second nasal prongs. A support arrangement supports the supply tube at a spaced position from the cannula. The support arrangement includes a fastener that engages a piece of fabric at the spaced position.

[0034] In some embodiments, a nasal cannula system includes a cannula that defines a lumen and includes a first nasal prong and a second nasal prong that extend from the cannula and communicate with the lumen. A supply tube is coupled to the cannula and communicates with the lumen. The supply tube can be connected to a gas supply from a gas source to deliver a gas flow to the lumen and the first and second nasal prongs. A support supports the supply tube at a spaced position away from the cannula. The support includes at least one of the following: an armband that engages the supply tube, an adhesive pad that includes a fastener for releasably securing the supply tube to the adhesive pad, a generally U-shaped support that is positioned on a patient's shoulder and engages the supply tube, and a headcap strap that includes a strap that extends over the top of a patient's head and engages the supply tube.

[0035] In some embodiments, a retention arrangement for a nasal cannula assembly includes a headcap strap that includes a first ear loop and a second ear loop, each ear loop at least partially surrounding a patient's ear. A connecting portion connects the retention arrangement to the nasal cannula assembly. A strap portion extends between the first and second ear loops around the back of the patient's head.

[0036] In some embodiments, a retention arrangement for a nasal cannula includes a headcap strap that includes a strap portion. A first pad and a second pad contact a patient's first cheek and second cheek in 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.

[0037] In some embodiments, a retention arrangement for a nasal cannula includes a frame that includes a connecting portion that connects the retention arrangement to the nasal cannula. A first ear stem portion and a second ear stem portion extend rearwardly from opposite sides of the connecting portion. The ear stem portions are configured to be positioned above a patient's ears.

[0038] In some embodiments, a nasal cannula system includes a cannula that has a central portion that defines a lumen and includes a first nasal prong and a second nasal prong that extend from the central portion and communicate with the lumen. A first side portion and a second side portion extend in a lateral direction from opposite sides of the central portion. A supply tube is coupled to the cannula and communicates with the lumen. The supply tube can be connected to a gas supply from a gas source to deliver a gas flow to the lumen and the first and second nasal prongs. A first adhesive pad and a second adhesive pad are configured to adhesively secure to a patient's face and can be connected to the first and second side portions of the cannula by an adjustable fastening arrangement.

[0039] In some embodiments, a nasal cannula system includes a cannula that defines a lumen and includes a first nasal prong and a second nasal prong that extend from the cannula and communicate with the lumen. A modular retention arrangement secures the cannula to a patient. The cannula is configured to be used with any of the following retention arrangements: a set of adhesive pads attached to the patient's face, a headcap strap, and a halo-style headcap strap having a strap portion that extends over the top of the patient's head.

[0040] In some embodiments, a nasal cannula system includes a cannula that defines a lumen and includes a first nasal prong and a second nasal prong that extend from the cannula and communicate with the lumen. A modular retention arrangement secures the cannula to a patient. The retention arrangement includes a nasal pad coupled to the cannula and attachable to the patient's nose and a headcap strap that includes a clip configured to receive the cannula. The cannula can be secured to the patient using the nasal pad or the headcap strap.

[0041] In some embodiments, a retention arrangement for a nasal cannula includes a headcap strap that is connectable to the nasal cannula and is capable of being tensioned around a patient's head. The headcap 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.

[0042] In some embodiments, a retention arrangement for a nasal cannula includes a headcap strap that is connectable to the nasal cannula. At least one strap extends around the patient's head from one side of the cannula to the other side. A tension regulator tensions the headcap strap by changing the effective length of the at least one strap by tightening a portion of the at least one strap.

[0043] In some embodiments, a headcap strap for a nasal cannula includes a first portion that is connectable to the nasal cannula and a second elastic portion that is positioned behind the patient's head in use. A pad extends at least partially along the second elastic portion.

[0044] In some embodiments, a nasal cannula assembly includes a cannula that defines a lumen and includes a first nasal prong and a second nasal prong that extend from the cannula and communicate with the lumen. A headband surrounds the patient's head and is positioned above the ears in use. A first arm is coupled to a first side of the cannula and a second arm is coupled to a second side of the cannula. Upper end portions of each of the first arm and the second arm are attached to the headband.

[0045] In some embodiments, a nasal cannula system includes a cannula that defines an open cavity and includes a first nasal prong and a second nasal prong that extend from the cannula and communicate with the cavity. A manifold is configured to be removably coupled to the cannula and a portion of the manifold received within the cavity of the cannula. The manifold includes a first aperture and a second aperture that are aligned with the first nasal prong and the second nasal prong when the manifold is coupled to the cannula, and the manifold further includes a side opening configured to be coupled to a tube. An inner surface of the cavity of the cannula includes a first attachment portion and an outer surface of a portion of the manifold includes a second attachment portion. The first attachment portion and the second attachment portion can be configured to engage one another to secure the manifold to the cannula.

[0046] In some embodiments of the nasal cannula system, the first attachment portion and the second attachment portion include cooperating portions of a hook-and-loop material fastener. The nasal cannula system can further include an arrangement in which the cavity and the portion of the manifold have corresponding symmetric 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.

[0047] In some embodiments, a nasal cannula assembly includes a cannula that defines a cavity and a first nasal prong and a second nasal prong that extend from the cannula and communicate with the cavity. The cannula includes a first outer surface and a second outer surface that are substantially flat and extend along a length of the cannula. The cannula further includes a first end and a second end. A retention arrangement is coupled to the cannula and is configured to support the cannula on a patient's face. A tube can be coupled to the cannula adjacent to the first end or the 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 nasal prong and the second nasal prong 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 nasal prong and the second nasal prong extend into the patient's nostrils.

[0048] 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 nasal prong and the second nasal prong and the first outer surface is substantially the same as an angle between the first nasal prong and the second nasal prong and the second outer surface. In some embodiments, the first nasal prong and the second nasal prong extend outwardly from the cannula at a corner of the substantially triangular cross-sectional shape between the first outer surface and the second outer surface.

[0049] In some embodiments, the nasal cannula assembly includes a cannula body that defines a lumen and includes a first nasal prong and a second nasal prong that extend from the cannula and communicate with the lumen. The first nasal prong and the second nasal prong can be in a relaxed position without any substantial external force. An outer portion is configured to be movably coupled to the cannula body and configured to surround at least a portion of the cannula body. The outer portion defines at least one opening through which the first nasal prong extends, and the outer portion includes at least one edge that defines 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 deflect the first and second prongs from their relaxed positions.

[0050] In some embodiments of the nasal cannula assembly, the cannula body and the outer portion are substantially cylindrical and the outer portion extends circumferentially around the cannula body, and the outer portion is rotatable about the cannula body. Each of the first nasal prong and the second nasal prong can include a flexible base portion that is configured to allow the angle of extension of the prong from the cannula body to vary. The at least one opening can include a first opening and a second opening, and the at least one edge can 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 can 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 that extends into the slot. The protrusion can be configured to move within the slot, and the slot can have sidewalls that are configured to engage the protrusion and limit the amount of movement of the outer portion relative to the cannula body.

[0051] In some embodiments, a nasal cannula system includes a cannula that defines a lumen and includes at least one nasal prong that extends from the cannula and communicates with the lumen. A frame portion is configured to support the cannula, and at least one headband is coupled to the frame portion and is positioned around a patient's head in use. The cannula is slidably supported by the frame portion and is movable relative to the frame portion, the cannula including an opening through which the frame portion extends. The cannula system can include a tube support member supported by the frame portion or the headband, and the tube support member can be configured to support and selectively release a tube.

[0052] In some embodiments of the nasal cannula system, the tube support member is configured to support the tube loosely such that the tube is slidable within the support member. The tube support member may include a strip configured to wrap around the tube and a clip configured to couple the strip to the headband or frame portion. The frame portion may have a circular or rounded cross-section, and the cannula may be laterally movable relative to the frame portion and rotatable 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 being 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 may be supported.

[0053] In some embodiments, the nasal cannula system includes a cannula defining a cavity and including a first nasal prong and a second nasal prong extending from the cannula and in communication with the cavity. The cannula includes an opening extending through a portion of the cannula, and the headband is positioned around the patient's head in 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 the headband and vary its position along the headband.

[0054] 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 may be made of an elastic material and is configured to hold the cannula against the patient's face.

[0055] In some embodiments, the nasal cannula system includes a cannula that defines a cavity and includes at least one nasal prong extending from the cannula and in communication with the cavity. The cannula includes a first slot and a second slot. A first frame portion is configured to be slidably received by the first slot of the cannula, and a second frame portion is configured to be slidably received by the second slot of the cannula. At least one headband is coupled to the first frame portion and the second frame portion and is positioned around the patient's head 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.

[0056] In some embodiments of the nasal cannula system, the cannula includes a side opening configured to receive a supply tube, and the first and second frame portions are configured to allow the tube to pass therebetween. The nasal cannula system may further include a tube support member supported by the first and second frame portions and configured to slide relative to the first and second frame portions to position the supply tube relative to the first and second frame portions. The first and second frame portions may have a circular cross-section, and the first and second slots may be configured to hold 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 slots are located on the outer side of the cannula facing away from the patient. The cannula may include a flat surface facing the patient's face.

[0057] In some embodiments, a nasal cannula system includes a cannula that defines a lumen and includes at least one nasal prong extending from the cannula and in communication with the lumen. The cannula includes a slot, and a first frame portion is configured to be slidably received by the slot of the cannula. A second frame portion is fixedly coupled to the cannula. A first 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 and second frame portions and is positioned around the patient's head in use. The cannula is slidably supported by the first frame portion, and the turntables may be configured to rotate to move a section of the second frame portion and the cannula relative to the first frame portion. The first and second frame portions may be wires coated with a soft material. In some embodiments, the second frame portion is positioned above the first frame portion when the cannula system is worn by the patient.

[0058] 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 may be connectable to the nasal cannula at a third joint. The first, second, and third joints are configured to allow three-dimensional movement and to maintain the relative positions of the strap, first arm, second arm, and cannula unless moved by a user.

[0059] 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 may be coupled to a side of the cannula. In some embodiments, the first, second, and third joints are ball joints.

[0060] In some embodiments, a nasal cannula system includes a cannula defining a lumen and including at least one nasal prong extending from the cannula and in communication with the lumen. The cannula includes a groove and has a clamping portion extending from the cannula. A frame is configured to support the cannula and is coupled to a 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.

[0061] 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 pad member arranged to contact the patient's face during use. In some embodiments, the interface between the clamping portion and the frame opening permits the cannula to move laterally and rotate relative to the frame. The cannula system may further include a headband coupled to the frame and a tube support member supported by the headband or the frame.

[0062] In some embodiments, a nasal cannula system includes a cannula defining a lumen and including at least one nasal prong extending from the cannula and in communication with the lumen. The cannula has a first end portion and a second end portion. A first bellows section is coupled to the first end portion of the cannula and a second bellows section 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 bellows section and the second bellows section. In some embodiments, the cannula system further includes a first non-bellows coupled to the first bellows section and a second non-bellows coupled to the second bellows section. The first bellows section and the second bellows section can be supported by the headband.

[0063] In some embodiments, a prong arrangement for a nasal cannula includes a prong that includes a first prong portion including a first slot and a second prong portion including a first flange. The second prong portion is coupled to the first prong portion and the first flange extends longitudinally within the first slot. The first prong portion and the second prong portion 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 prong portion and the second prong portion can move toward and away from each other to adjust the outer dimensions of the prong.

[0064] In some embodiments of the prong arrangement, the first prong portion and the second prong portion each include a sealing member adjacent to the cannula, and the sealing members overlap each other and are configured to slide relative to each other. The prong may further include a size indicator configured to indicate the relative outer dimensions of the prong. In some embodiments, the prong includes a second slot and a second flange that extends longitudinally within the second slot. The first slot may include two sidewalls configured to limit the range within which the first flange can move within the first slot.

[0065] In some embodiments, the fork arrangement for a nasal cannula includes a fork that includes a first collapsible portion configured to couple to the cannula. The first collapsible portion includes a first passageway. A second collapsible portion is coupled to the first collapsible portion and has a second passageway. A third collapsible portion is coupled to the second collapsible portion and has a third passageway. The first, second, and third collapsible portions are configured to telescopically collapse and expand relative to each other such that the height of the fork can be adjusted.

[0066] In some embodiments of the fork arrangement, the third collapsible portion includes a top edge configured to form a seal with a patient's nostril. The outer dimension of the third collapsible portion can be greater than the outer dimension of the second collapsible portion, and the outer dimension of the second collapsible portion can be greater than the outer dimension of the first collapsible portion. The first, second, and third passageways can be coaxial.

[0067] In some embodiments, the fork arrangement for a nasal cannula includes a cannula defining a cavity, and the cannula includes a slot. A first fork extends from the cannula and is fixed relative to the cannula. A second fork extends from the cannula through the slot and is movable relative to the cannula. The second fork can move within the slot to adjust the distance between the first fork and the second fork.

[0068] In some embodiments of the fork arrangement, the second fork includes a pin, and the slot includes a plurality of notches configured to receive the pin when the second fork moves to discrete positions within the slot. The second fork can include ribs extending from the base of the fork, and the slot can include a plurality of grooves configured to receive the ribs. In some embodiments, the second fork includes a tab having a plurality of notches configured to engage the edge of the slot such that the second fork can be held in a plurality of discrete positions relative to the slot.

[0069] In some embodiments, the fork for a nasal cannula includes a membrane having a substantially cylindrical shape and a plurality of ribs circumferentially coupled to the membrane around the membrane. The membrane and the ribs expand outward as the gas flow through the fork increases, and the outer diameter of the fork increases to form a seal with the patient's nostril. In some embodiments, the ribs are substantially fixed and do not bend or move relative to each other.

[0070] In some embodiments, a nasal cannula system includes a cannula defining a cavity and includes at least one nasal fork extending from the cannula and in communication with the cavity. A support member is coupled to the cannula and is configured to support the cannula. The support member is configured to extend upward from the cannula and to surround a patient's nose in use. The support member contacts a portion above the patient's nasal tip, and the support member includes a bendable material that can be shaped corresponding to the shape of the patient's face.

[0071] In some embodiments, the nasal cannula system further includes a headband configured to wrap around a patient's head, and the headband is removably coupled to the support member at one end and adjustably coupled to the support member at the other end. In some embodiments, the flexible material is a metallic 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 tube and the second tube of the cannula. The first tube may be supported by a first cushioning member and the second tube may be supported by a second cushioning member, and the first cushioning member and the second cushioning member may be configured to abut against a patient's face. In some embodiments, the nasal cannula system further includes a headband coupled to the first cushioning member and the second cushioning member and configured to extend around a patient's head. The first tube and the second tube may be removed from the cannula such that the cannula may be removed and rotated relative to the remainder of the system.

[0072] In some embodiments, the tube arrangement for a nasal cannula system includes a cannula body that includes an outer wall and an opening. The tube includes a longitudinal axis, and the outer wall includes a thin material that has been folded or rolled and sealed at an edge.

[0073] 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 further include a spring extending within the outer wall. The cannula body may also be coupled at its opening to a connector, and the connector may include a valve. In some embodiments, the cannula 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 a thermal insulation material, a spring extends within the outer wall, and a breathing tube extends within the spring.

[0074] In some embodiments of the tube arrangement, the outer wall is made of a thermal insulation material, a breathing tube extends within the outer wall, a spring extends within the breathing tube, and at least one pressure line tube body extends within the outer wall in addition to the breathing tube. Some embodiments may further include a breathing tube within the outer wall that has a cannula portion from which at least one nasal prong extends, and the cannula body is flexible such that it may bend around a patient's face. Each end of the cannula body may include a tab having a plurality of holes configured to receive pins located on a headband. Each end of the cannula body may include a connector configured to receive an inspiratory tube connector, and each connector includes a valve. In some embodiments, the outer wall is made of a breathable material.

[0075] In some embodiments, the tube arrangement for a nasal cannula system includes a tube that includes an outer wall and an opening. The tube includes a longitudinal axis, and the outer wall includes a thin material that has been folded or rolled up, and the outer wall includes one or more cut-out portions extending through the material. In some embodiments, one or more of the cut-out portions include tabs that can be pulled away from the tube, and the tabs are configured to engage a support device to suspend the tube.

[0076] In some embodiments of the tube arrangement, the tab includes a hole configured to receive a hook or hanger. The cut-out portions can include a plurality of slots that define a portion of the material that can be pulled away from the tube while remaining connected on both sides, and the pulled-away material can form a hook portion that can engage a hanger. In some embodiments, the cut-out portions can include two tabs that can be pulled away from the tube, and the ends of the tabs are configured to be joined together or attached to another structure. The tube can also include an inner tube and a spring within the inner tube.

[0077] In some embodiments, the cannula body arrangement for a nasal cannula system includes a 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 up, 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.

[0078] In some embodiments of the cannula body arrangement, the bead includes a cannula portion configured to receive a cannula having tines, and the cannula portion includes two holes extending through the film. The tube can include a first end and a second end, and the first end and the second end can be coupled to a connector having a valve. The first end and the second end each include a tab having a hole configured to be coupled to a headband. In some embodiments, the first edge and the second edge of the film are heat-sealed to form the tube. The bead can be printed or extruded onto the outer wall. The bead can have a pattern configured to create a curved region along the length of the tube. In some embodiments, the bead is on the inner side of the tube. The bead can include a heating element and a structural element printed on the film. In some embodiments, the first edge overlaps the second edge, and the first edge and the second edge can extend into the tube.

[0079] In some embodiments, the cannula body arrangement for a nasal cannula system includes a body having an outer wall. The outer wall includes a thin plastic film having a first edge and a second edge. Substantially flat sidewalls are coupled to the outer wall, and a retainer ring 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 and second edges are heat-sealed to the sidewall, and the sidewall is made of a fabric material.

[0080] In some embodiments, the cannula body arrangement includes a spring having a length and a cross-section with at least one substantially flat side. A tube surrounds the spring and the tube defines a passageway through which gas can pass. At least one nasal prong is coupled to the tube and in communication with the passageway.

[0081] In some embodiments of the cannula body arrangement, the spring has a V-shaped or triangular cross-section. The spring may include a folded metal sheet having cut-out portions along the length of the spring. The spring may include an intermediate section and first and second ends, and the cross-section of the intermediate section may be smaller than the cross-sections at the first and second ends. In some embodiments, the spring is a helical spring having a triangular cross-section. The spring may be a helical wire having a bent end extending in the direction of a 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 like a semi-circle.

[0082] In some embodiments, the cannula breathing tube arrangement includes a tube made at least in part of a foam material. The tube has a length and a substantially flat side extending along the length of the tube, and the tube defines a passageway. A spring passes through the passageway of the tube and extends along the length of the tube, and the spring is configured to prevent the tube from kinking.

[0083] In some embodiments of the cannula breathing tube arrangement, the tube includes a cavity extending along the length of the tube and a formable rod extending through the cavity. In some embodiments, the foam material is a closed-cell foam material. The tube may include a groove extending along the length of the tube, the groove being configured to receive a coupling member. In some embodiments, the coupling member is a mushroom-headed member configured to slide into the groove.

[0084] In some embodiments, the cannula body arrangement includes a body having a length and substantially flat sides extending along the length of the body. The body defines a passageway and has an inner surface. The body includes at least one rib located on the inner surface and extending along the length of the body, and the at least one rib is configured to provide structural support and prevent the body from kinking.

[0085] In some embodiments of the sleeve body arrangement, the at least one rib includes a plurality of ribs on the inner surface. The tube may include a rectangular cross-section and include a fabric material around the tube. In some embodiments, the tube has a substantially triangular cross-section, and in other embodiments, the tube has a substantially semi-circular cross-section.

[0086] In some embodiments, the sleeve body arrangement includes a sleeve body defining a passageway and having a terminus. A connector is coupled to the terminus of the sleeve body, and a supply tube is configured to be coupled to the connector of the sleeve body. A wire is configured to transfer heat dissipated from the supply tube. The sleeve body is configured to receive the wire into the passageway, and the wire is configured to transfer heat into the sleeve body.

[0087] In some embodiments of the sleeve body arrangement, the wire is insulated and flexible such that it can conform to the shape of the sleeve body. The wire may have sufficient rigidity to support the sleeve body.

[0088] In some embodiments, the sleeve and the tube arrangement includes a sleeve body having a length and defining a passageway. A heating element extends along the length of the sleeve body and is configured to transfer heat to a gas passing through the sleeve body. The sleeve includes at least one prong and is coupled to the sleeve body.

[0089] 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 a terminus and an electrical connector coupled to the terminus 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 such that a voltage can be applied through the polymer to generate heat. In some embodiments, the heating element is configured to provide structural support to the sleeve body. In some embodiments, the heating element wraps around the outer surface of the sleeve body.

[0090] In some embodiments of the sleeve body arrangement, the heating element includes a film having conductive strips, the film being wrapped around the sleeve body, and the conductive strips being configured to generate heat when current passes therethrough. In some embodiments, the heating element may be made of a positive temperature coefficient material configured such that its resistance increases with temperature, enabling a constant voltage power supply to energize the heating element. In some embodiments, the sleeve body is made of a flexible and lightweight material, the sleeve body being coupled to a connector that is coupled to a tube that is less flexible and heavier than the sleeve body, and the heating element extending substantially along the entire length of the sleeve body and the tube. The connector may include an opening configured to receive a temperature sensor, and the sleeve body may be configured to be removably attached to the sleeve.

[0091] In some embodiments, the sleeve body arrangement includes a sleeve body having a length and defining a first passageway. The sleeve body has an outer surface, and a spiral tube is wrapped around the outer surface of the sleeve body. The spiral tube defines a second passageway and has an inner wall adjacent to the sleeve body and an outer wall facing away from the sleeve body. A first opening extends through the sleeve body and through the inner wall of the spiral tube such that gas flowing inside the sleeve body can enter the spiral tube through the first opening.

[0092] In some embodiments of the sleeve body arrangement, the spiral tube includes a second opening extending through the outer wall of the spiral tube such that gas flowing in the spiral tube can escape into the surrounding environment. In some embodiments, the second opening is positioned at an opposite end of the sleeve body away from the first opening.

[0093] In some embodiments, the sleeve body arrangement includes a sleeve body having a length and defining a passageway. The sleeve body has an outer portion, and the outer portion includes a textile material and a heating element woven or knitted into the textile material. The heating element is configured to transfer heat to gas passing through the passageway.

[0094] In some embodiments of the sleeve body arrangement, the heating element is a wire configured to generate heat when current passes therethrough. In some embodiments, the heating element is made of a semi-rigid material that provides structural support to the sleeve body.

[0095] In some embodiments, a manifold for a sleeve assembly includes a manifold body that includes a connector portion having an inlet opening and configured to receive a tube. The manifold further includes a port configured to assist in measuring the pressure of a gas flow and an outlet portion configured to communicate with the port and configured to be coupled to a pressure sensor.

[0096] In some embodiments of the manifold, the port is a static pressure port located on the inner wall of the manifold, and the static pressure port is substantially parallel to the overall flow direction of the gas within the manifold. In some embodiments, the port is a total pressure port that is oriented in the overall flow direction and is configured to measure a combination of static pressure and dynamic pressure. In some embodiments, the port includes a shroud and is oriented in the overall flow direction.

[0097] In some embodiments, the nasal cannula assembly includes a cannula that defines a lumen and includes a first nasal prong and a second nasal prong that extend from the cannula and communicate with the lumen. The cannula further 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 the valve are configured such that a tube can extend through the valve, into the lumen, and through the second nasal prong.

[0098] 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 a tube extending therethrough. In some embodiments, the valve is a duckbill valve. Embodiments of the nasal cannula assembly can further include a removable cap coupled to the outer surface of the cannula and covering the opening. The cannula can also include two openings and two corresponding valves, where each of the valves is configured to receive 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 can be removed from the cannula.

[0099] In some embodiments, the nasal cannula assembly includes a cannula that defines a lumen and includes a first nasal prong that extends from the cannula and communicates 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 a tube can extend through the first groove and the second groove and be directed into a patient's nostril.

[0100] In some embodiments of the nasal cannula assembly, the first groove and the second groove are configured to receive a nasogastric tube. The first prong can include an outer surface, and the second groove can be located on the outer surface of the first prong and can extend longitudinally relative to the first prong. In some embodiments, the cannula includes a second prong and a third groove, the second prong includes a fourth groove, and the third groove and the fourth groove are aligned such that a portion of a tube can extend through the third groove and the fourth groove and be directed into a patient's nostril.

[0101] 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 that defines 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 such that the tube can extend through the opening and exit the distal end of the prong.

[0102] In some embodiments of the nasal cannula, the outer wall defines a passageway, and the flap is configured to block the passageway when the tube is inserted through the opening. In some embodiments, the flap is configured to align with and form at least a substantial seal with the outer wall when the tube is not inserted through the opening. The fork may further include a slit extending from the cut-out portion to the end of the fork, the slit being configured to allow the tube to selectively pass through the slit.

[0103] In some embodiments, the nasal cannula assembly includes a cannula that defines a lumen and includes a first nasal fork extending from the cannula and in communication with the lumen. The cannula includes an opening and a valve supported within the opening. An inner member is supported within the lumen and is movable relative to the cannula. The inner member includes a bore configured to receive a tube. The opening is positioned substantially below the first nasal fork, and the inner member is movable such that the bore is aligned with the valve, whereby the tube can extend through the valve and the bore and into the first fork.

[0104] In some embodiments of the nasal cannula assembly, the cannula includes a second opening having a second valve positioned substantially below a second nasal fork, and the inner member includes a second bore that can be aligned with the second valve and the second fork. In some embodiments, the inner member is substantially cylindrical and is configured to be coupled to a supply tube. The valve can be configured to form a seal when nothing extends therethrough.

[0105] In some embodiments, the nasal cannula assembly includes a cannula body having a first slot and a second slot. The assembly further includes a first sliding portion having a first fork coupled to a first tube and a second sliding portion having a second fork coupled to a second tube. A portion of the first sliding portion is configured to slide within the first slot, and a portion of the second sliding portion is configured to slide within the second slot. The first fork and the second fork are movable relative to the cannula body such that each of the first fork and the second fork 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.

[0106] In some embodiments, the nasal cannula assembly includes a cannula that defines a lumen and includes a first nasal fork extending from the cannula and in communication with the lumen. The assembly further includes a slider member that engages the outer surface of the cannula, and the slider member is configured to move relative to the cannula. The slider member is configured to selectively move along the outer surface of the cannula and over the first nasal fork.

[0107] In some embodiments of the nasal cannula assembly, the slider member includes a groove configured to receive a portion of a tube. In some embodiments, the first nasal fork is flexible and can fold under the slider member when the slider member is moved to cover the first nasal fork.

[0108] In some embodiments, the nasal cannula assembly includes a cannula that defines a lumen and includes a single nasal prong that extends from the cannula and is in communication with the lumen. The assembly further 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 upward along the side of the patient's nose from beneath the patient's nose.

[0109] In some embodiments of the nasal cannula assembly, the strap includes at least one groove configured to receive a tube. In some embodiments, the strap includes a hole positioned to align with the patient's nostrils when the strap is in use. The prong may include corrugations configured to allow the prong to bend and change shape. In some embodiments, the prong includes a tapered base portion configured to form a seal with the patient's nostrils. In some embodiments, the cannula is coupled to a 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 further 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 prong includes a tapered base portion that narrows towards the top and widens towards the bottom, and the prong includes a recess below the tapered portion, and the recess is configured to hold a portion of the strap adjacent the opening.

[0110] In some embodiments, the nasal cannula assembly includes a cannula that defines a lumen and includes a single nasal prong that extends from the cannula and is in communication with the lumen. The assembly further includes a frame having a bridging portion that extends away from the patient's face and creates 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 the bottom portion of the cannula. The tube is configured to extend from beneath the cannula and bend upward such that it extends above the frame.

[0111] 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 that extends through a groove. The frame may include pads 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 tube recess through which the tube may extend.

[0112] In some embodiments, the nasal cannula assembly includes a cannula frame having an upper extension portion, and the upper extension portion has a single prong and a prong opening in communication with the prong. The assembly further includes a retainer portion coupled to the extension portion and having a retainer opening aligned with the prong opening. The assembly further includes a manifold pivotally coupled to the retainer portion, and the manifold has a manifold opening aligned with the retainer opening and the prong opening. The manifold is configured to pivot relative to the cannula frame about an axis of the manifold opening, and gas can pass through the manifold and into the prong.

[0113] In some embodiments of the nasal cannula assembly, the cannula frame includes a lower extension portion, and the retainer portion includes a lower portion that engages a bottom portion of the manifold. In some embodiments, the bottom portion of the manifold includes a pin, and the lower portion of the retainer portion includes a hinge recess, and the pin is configured to be received within the hinge recess and the manifold is configured to pivot about the pin. In some embodiments, the manifold is configured to rotate approximately 180 degrees relative to the cannula frame such that the tubing coupled to the manifold can exit in the opposite direction.

[0114] In some embodiments, the nasal cannula assembly includes a cannula frame having an upper extension portion. The upper extension portion has a single prong and a prong opening in communication with the prong. The upper extension portion further has a bottom side. The assembly includes a tube rotatably coupled to the bottom side of the upper extension portion and in communication with the prong such that gas can pass from the tube through the prong opening and into the prong. The tube is configured to bend and rotate relative to the cannula frame.

[0115] In some embodiments, the nasal cannula assembly includes a cannula that defines a cavity and includes a single nasal prong extending from the cannula and in communication with the cavity. The assembly includes a cable configured to slidably support the cannula and a tube coupled to the cannula and configured to supply gas to the cavity. The position of the cannula can be adjusted by sliding the cannula along the cable.

[0116] In some embodiments of the nasal cannula assembly, the tube is tapered such that its cross-section is narrower closer to 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 can include an indented portion configured to hold the cannula in a selected position.

[0117] In some embodiments, the nasal cannula assembly includes a cannula frame having a bridging portion that extends away from the patient's face and creates a space between the bridging portion and the patient's face. The bridging portion supports a single nasal fork. The assembly includes a first tube coupled to the fork and extending downwardly from the fork. The cannula frame defines a recess through which a second tube may extend between the bridging portion and the patient's face in use.

[0118] In some embodiments of the nasal cannula assembly, the bridging portion includes a cutout portion configured to receive a portion of the first tube, causing the tube to bend and extend away from the assembly to the side of the patient. In some embodiments, the cannula frame includes a contact portion configured to contact the patient's face and includes a soft material.

[0119] In some embodiments, the nasal cannula assembly includes a cannula that defines a chamber and includes a single nasal fork extending from the cannula and in communication with the chamber. The cannula has a cannula opening in communication with the chamber, and the opening has an axis. The assembly further includes a manifold pivotally coupled to the cannula and configured to pivot about the axis of the cannula opening. The assembly further includes a tube coupled to the manifold and configured to supply gas to the manifold. The manifold includes a manifold opening that is aligned with the cannula opening and in communication with the chamber.

[0120] In some embodiments of the nasal cannula assembly, the cannula includes frame portions extending outwardly from the cannula that form one or more recesses between the cannula and the patient's face in use, and the one or more recesses are configured to receive a second tube. In some embodiments, the cannula includes a soft material on the side of the cannula facing the patient in use. In some embodiments, the cannula includes a recess on each side of the fork such that a second tube may extend between the manifold and the cannula.

[0121] For purposes of summarizing the present disclosure and the advantages achieved over the prior art, certain objects and advantages are described herein. It is to be understood, of course, that not all such objectives or advantages need be achieved in accordance with any particular embodiment. Thus, for example, those skilled in the art will recognize that the present disclosure may be embodied or carried out in a manner that achieves or optimizes one advantage or a group of advantages as taught or suggested herein, without necessarily achieving other objectives or advantages as may be taught or suggested herein. All such embodiments are intended to fall within the scope of the present disclosure. From the following detailed description with reference to the accompanying drawings, these and other embodiments will become readily apparent to those skilled in the art, and the present disclosure is not limited to any one or more of the specifically disclosed embodiments.

[0122] In some embodiments, the nasal cannula assembly includes:

[0123] A cannula portion, the cannula portion including a pair of tubular nasal forks for insertion into a patient's nostrils, and a manifold in fluid communication with the nasal forks, the manifold including an aperture at a left hand end of the manifold and an aperture at a right hand end of the manifold,

[0124] A connector, the connector being adapted to receive one end of a gas flow conduit and removably received in the aperture at the left hand end of the manifold and the aperture at the right hand end of the manifold, and

[0125] A plug, the plug being adapted to be removably received in the aperture at the left hand end of the manifold and the aperture at the right hand end of the manifold,

[0126] In use, the connector or the plug is fitted onto one of the apertures on the left and right sides of the manifold, and the plug is fitted onto the other of the apertures on the left and right sides of the manifold so as to configure the conduit to extend from the left or right side of the nasal cannula assembly.

[0127] Preferably the plug and the connector are separate parts.

[0128] Preferably the plug and the connector are joined or attached together by a transverse member to form a clip, optionally the transverse member being a connecting part.

[0129] Preferably the clip is integrally formed as a single piece.

[0130] Preferably the clip and the cannula portion are complementary adapted such that in use, the transverse member is resiliently deflected to fit the clip onto the cannula portion.

[0131] Preferably, the clip is fitted onto the cannula portion by pushing the clip onto the cannula portion in a direction perpendicular to the transverse direction of the cannula.

[0132] Preferably, the cannula portion includes a rigid member for engaging with the clip, and the forks are formed of an elastic material attached to the rigid member.

[0133] Preferably, the rigid member and the transverse member are adapted such that the transverse member is buckled to spread the plug and the connector apart when attaching the clip to the cannula portion.

[0134] Preferably, the clip is substantially in the shape of a 'C' or a 'U'.

[0135] Preferably, the plug and the connector each extend into the apertures at the ends of the manifold.

[0136] Preferably, the clip provides a positive force against the manifold so as to grip the manifold between the plug and the connector.

[0137] Preferably, the sleeve portion includes a recess portion sized and shaped to receive the transverse member.

[0138] Preferably, the sleeve portion including the manifold and the nasal fork is integrally formed.

[0139] Preferably, the elastic material is overmolded onto the rigid member.

[0140] Preferably, the sleeve portion includes a plurality of side arms, and the rigid member extends along these side arms.

[0141] Preferably, the rigid portion includes through holes in these side arms for the elastic material to extend through via an overmolding process or an assembly process.

[0142] Preferably, the rigid member includes a recess portion sized and shaped to receive the transverse member.

[0143] Preferably, the orifices at these ends of the manifold are formed in the rigid member.

[0144] Preferably, the transverse member is length-adjustable.

[0145] Preferably, the clip includes a first part and a second part, the first part includes one of the plug and the connector, and the second part includes the other of the plug and the connector, the first part includes a first transverse member and the second part includes a second transverse member, and

[0146] the first transverse member and the second transverse member are coupled together in a telescoping arrangement and include complementary features to set the transverse distance between the plug and the connector.

[0147] Preferably, the complementary features include a protrusion on one of the first part and the second part and a corresponding orifice in the other of the first part and the second part, the protrusion being received in the orifice to set the transverse distance between the plug and the connector.

[0148] Preferably, one of the first part and the second part includes a plurality of corresponding orifices, the protrusion being received in one of the plurality of orifices to set the transverse distance between the plug and the connector, the plurality of orifices providing a range of sleeve portion sizes.

[0149] Preferably, the clip is movably attached to the sleeve portion.

[0150] Preferably, the clip is rotatably coupled to the sleeve portion.

[0151] Preferably, the clip is rotatably coupled to the cannula portion on a rotation axis or in a sagittal plane parallel to the cannula to position the catheter to the left or right side of the nasal cannula assembly.

[0152] Preferably, the manifold is formed of a relatively rigid material, and the cannula portion includes an elastomeric material molded onto the manifold, the nasal forks are integrally formed of the elastomeric material, and the cannula portion includes a shaft extending from the manifold, and the clip is rotatably mounted on the shaft.

[0153] Preferably, the shaft is integrally formed with the manifold.

[0154] Preferably, the clip includes a keyway such that the clip can be removably mounted to the cannula portion.

[0155] Preferably, the cannula portion includes a flange at the end of the shaft to hold the clip on the shaft in a direction along the rotation axis.

[0156] Preferably, the end of the manifold is curved about a center of curvature on the rotation axis, and the plug and the connector each have a complementary curvature such that the clip can rotate on the rotation axis to position the connector at either end of the manifold.

[0157] Preferably, the overmolded elastomeric material covers the end of the manifold to provide a seal together with the plug and connector.

[0158] In some embodiments, the nasal cannula assembly includes an assembly such that when the plug and connector are joined or attached together by a transverse member to form a clip, the clip is assembled to the cannula portion by laterally pushing the clip into the manifold through one of the apertures at the left hand end and one of the apertures at the right hand end such that the connector is received in one of the apertures at the left hand end and one of the apertures at the right hand end, and the plug is received in the other of the apertures at the left hand end and one of the apertures at the right hand end to configure the catheter to extend from the left or right side of the nasal cannula assembly.

[0159] Preferably, the cannula portion includes a rigid member for engaging the clip, and the forks are formed of elastomeric members attached to the rigid member, and the cannula portion and the rigid member each include a side arm extending laterally from the manifold.

[0160] In some embodiments, the nasal cannula assembly includes:

[0161] A cannula portion including a pair of tubular nasal forks for insertion into a patient's nostrils,

[0162] A connector adapted to receive the end of a gas flow conduit,

[0163] A manifold that is attached to or integrally formed with the connector, the connector providing an inlet to the manifold, and the manifold having at least one outlet.

[0164] The cannula portion, which is movably attached to the manifold, will be attached to the manifold in two orientations so as to configure the conduit to extend from the left or right side of the nasal cannula assembly.

[0165] Preferably, the cannula portion is rotatable relative to the manifold about a substantially vertical axis.

[0166] Preferably, the manifold includes an open top as the outlet of the manifold, and the cannula portion is fitted above the open top such that the tines communicate with the connector.

[0167] Preferably, the manifold includes a lip on the surface of the manifold to which the cannula portion is connected.

[0168] Preferably, an axis extends from the manifold or the cannula portion, and the cannula portion rotates relative to the manifold on the axis.

[0169] In some embodiments, the nasal cannula assembly includes:

[0170] A cannula portion that includes a pair of tubular nasal tines for insertion into a patient's nostrils and left and right lateral arms for attaching a headgear.

[0171] A first conduit for providing a gas flow to one of the nasal tines and a second conduit for providing a gas flow to the other nasal tine.

[0172] A first fitting connecting the first conduit to one of the nasal tines and a second fitting connecting the second conduit to the other nasal tine, the fittings being adapted to allow the first and second conduits to be routed to the left or right side of the nasal cannula assembly, and

[0173] A left clip on the left lateral arm and a right clip on the right lateral arm.

[0174] In use, the first conduit is held by the left clip or the right clip so as to configure the first conduit to extend from the left or right side of the nasal cannula assembly, and the second conduit is held by the left clip or the right clip so as to configure the second conduit to extend from the left or right side of the nasal cannula assembly.

[0175] Preferably, the cannula portion is a unitarily formed part.

[0176] Preferably, each fitting is a flexible tube adapted to bend at least 90 degrees in any direction without substantial occlusion.

[0177] Preferably, these flexible tubes include circumferentially extending ribs such that bending of the flexible catheter segment does not cause collapse of the flexible catheter segment.

[0178] Preferably, each joint is a rotary joint.

[0179] Preferably, each rotary joint rotates about an axis that is angled with respect to the axis of the corresponding nasal fork such that rotation of the rotary joint allows the two catheters to be routed to the left or right without overlap.

[0180] Preferably, each rotary joint is a rotary elbow.

[0181] Preferably, each of the clips includes two channels or receivers for receiving one of the tubes, respectively.

[0182] Preferably, each flexible tube is integrally formed with the nasal fork.

[0183] Preferably, each clip is integrally formed with the side arm.

[0184] Regarding the above embodiments, the reference to the manifold may be to an open cavity formed by the cannula portion such as the cannula body, and in such an embodiment, the connector forms a component to be engaged with the open cavity, and the connector forms a flow path for delivering gas to the open cavity. Such embodiments may also be referred to below.

[0185] In some embodiments, a nasal cannula system includes:

[0186] A cannula body that defines an open cavity and includes at least one nasal fork extending from the cannula and communicating with the cavity; and

[0187] A manifold that includes a manifold body capable of receiving a gas supply tube, the manifold body being attachable to the cannula at a first position and a second position, wherein the second position is different from the first position;

[0188] wherein ends of the manifold body project into the open cavity of the cannula body, and the cannula body includes a recess for holding the manifold body.

[0189] Preferably, the manifold includes a first side and a second side, wherein the first side and the second side extend from the manifold body and are adapted to be attached to a headgear.

[0190] Preferably, the recess of the cannula body holds the first side and the second side of the manifold.

[0191] Preferably, one end of the manifold includes a cap containing a hinge region that divides 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 region and the outer region at the strap.

[0192] In some embodiments, the nasal cannula comprises:

[0193] a cannula body that defines an open cavity and includes at least one (and preferably a pair) of nasal forks extending from the cannula and in fluid communication with the open cavity; and

[0194] a manifold that includes a manifold body adapted to engage the cannula for fluid connection with the open cavity, the manifold body being orientable in a first operating position or a second operating position, wherein the first position and the second position are different from each other,

[0195] wherein the manifold body is adapted to receive a gas supply conduit at a first end of the manifold body or at a gas inlet leading to the manifold body, the first end being adapted to engage one end of the open cavity to deliver gas to the open cavity, and a 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 an outer shell of the open cavity.

[0196] Preferably, the cannula body includes at least one recess or at least one surface undulation or surface undulation area for holding the manifold body in the engaged first operating position or second operating position.

[0197] 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 substantially closing the open cavity), and providing a fluid delivery path for supply gas from the first end of the manifold body to enter the open cavity and reach the terminal ends of the at least one nasal fork.

[0198] Preferably, the first end and the second end of the manifold body are connected to each other by one connecting portion or a plurality of connecting portions.

[0199] Preferably, the connecting portion is one or more of at least one arm or at least one finger or at least one frame member.

[0200] Preferably, the first end and the second end of the manifold body are integrally formed.

[0201] Preferably, the connecting portion or the cannula body or both that at least partially define 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.

[0202] Preferably, the alignment features can be one or more areas of associated convex and concave portions or one or more areas of associated surface undulations.

[0203] Preferably, the alignment feature is adapted to provide an audible response to the engagement of the manifold with the cannula body in a first engaged operating position or a second engaged operating position.

[0204] Preferably, the connecting portion of the manifold body that connects the first end and the second end to each other extends through the inner region of the open cavity such that, in situ, the first end of the manifold body is adapted to engage with one end of the open cavity 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 needs to be sealed to enable the delivery of gas into the open cavity.

[0205] Preferably, the connecting portion extending through the inner region of the open cavity is shaped or configured to engage with or be received by the relevant surface or region of the cannula body that defines the open cavity.

[0206] Preferably, the connecting portion of the manifold body that connects the first end and the second end to each other extends around the outer surface or outer region of the cannula body that at least partially defines the open cavity such that, in situ, the first end of the manifold body is adapted to engage with one end of the open cavity 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 needs to be sealed to enable the delivery of gas into the open cavity.

[0207] Preferably, the connecting portion extending around the outer surface or outer region of the cannula body is shaped or configured to engage with or be received by the relevant surface or region of the cannula body that defines the open cavity.

[0208] Preferably, the gas supply conduit is positioned or substantially located around the side or region of the cannula body from which the first end of the manifold body is positioned or protrudes.

[0209] Preferably, the manifold is orientable or can be oriented relative to the cannula body such that the gas supply tube is substantially positioned or located on the side of the user during use.

[0210] Preferably, the first operating position allows the first end of the manifold body to be located at the left or right end of the cannula body that defines the open cavity, and the second operating position allows the first end of the manifold body to be located at the corresponding right or left end of the cannula body that defines the open cavity.

[0211] Preferably, the first operating position or the second operating position enables the connection of the gas supply conduit to the first end of the manifold body from the left or right side.

[0212] Wherein, the cannula body further includes a plurality of side arms or sides, the side arms or sides extending away from the cannula body defining the open cavity, and in use, each of these side arms or sides is adapted to extend at least partially along a portion of the user's face.

[0213] Preferably, the nasal cannula as defined above includes a first section formed of a first material and a second section formed of a second material, wherein the first section is relatively softer than the second section.

[0214] Optionally, the embodiments described above regarding the first section formed of a first material and the second section formed of a second material are hereby reiterated.

[0215] Preferably, the distal ends of these side arms are adapted to receive the connection to the headgear thereon.

[0216] Optionally, the headgear associated with the nasal cannula described herein may be the headgear as defined above in any other embodiments described herein.

[0217] In some embodiments, the nasal cannula system includes a nasal cannula assembly as defined in any of the above embodiments and a headgear attached to the nasal cannula assembly for attaching the nasal cannula assembly to the patient's head.

[0218] In some embodiments, there is a system for providing a breathing gas flow to a user or patient, the system including a blower, a humidifier, the conduit, and the nasal cannula system as defined in these embodiments described herein.

[0219] In some embodiments, the headgear includes:

[0220] A strap, each end of the strap being adapted to attach to the patient interface and 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.

[0221] Preferably, the strap includes a longitudinal weak segment extending along a portion of the strap, the longitudinal weak segment to be torn by the user to divide that portion of the strap into more than one strap.

[0222] Preferably, the weak segment includes a relatively thin segment.

[0223] Preferably, the weak segment is a perforated segment.

[0224] Preferably, the straps are separated by the weak segment.

[0225] Preferably, the strip includes finger holes at the frangible section to assist in separating the straps by tearing the frangible section.

[0226] Preferably, the strip includes a hole at the end of the frangible section, the hole including a rounded portion defining the end of the frangible section to prevent the strip from being torn beyond the frangible section.

[0227] Preferably, the hole is a finger hole.

[0228] Preferably, at least that portion of the strip is formed of the fabric forming the straps, and the fabric is coated with a polymer that holds the straps together, the coating providing the frangible section between the straps and being adapted to be torn to separate the straps.

[0229] Preferably, the straps are formed by longitudinally cutting the fabric along that portion of the strip, and the polymer coating bridges the cut to hold the straps together in a non-bifurcated configuration.

[0230] Preferably, the fabric is a foamed fabric.

[0231] Preferably, the straps are separated by a removable section of the strip including a lifting tab, the removable section being connected to the straps by the frangible section.

[0232] Preferably, the headgear includes a retaining ring that is slidable along at least that portion of the strip configured to bifurcate.

[0233] Preferably, to bifurcate the strip to separate the straps, the retaining ring is slidable to the ends of the straps and the retaining ring is slidable to the midpoint of the straps to hold the straps together as a single strip.

[0234] Preferably, to bifurcate the strip to separate the straps, the retaining ring is slidable to the ends of the straps and the retaining ring is slidable to the opposite ends of the straps to hold the straps together as a single strip.

[0235] Preferably, each strap includes a feature that engages a corresponding feature on the retaining ring to hold the straps together in a non-bifurcated configuration.

[0236] Preferably, the straps include interlocking teeth that are separated or paired by sliding the retaining ring along the straps.

[0237] Preferably, the headgear includes a net extending between the straps, which in a non-bifurcated configuration is squeezed together or folded into a non-expanded configuration, while in a bifurcated configuration where the straps are spaced apart, the net is expanded or unfolded to cover the area between the spaced-apart straps.

[0238] Preferably, the headgear includes two retaining rings which, in a non-forked configuration, both slide towards the central position of the strip to hold the strips together, and in a forked configuration, each retaining ring slides to the ends of the strips such that the strips can be separated between the ends of the strips.

[0239] Preferably, each retaining ring and the strips are complementary adapted such that each retaining ring moving towards the ends of the strips forces the strips apart, thereby separating the strips into a forked configuration.

[0240] Preferably, each retaining ring includes two spaced-apart flanges and three pins extending between the spaced-apart flanges, the strips extending between the flanges, one of said pins being positioned between the strips and the other two pins being positioned on the outer edges of the strips, and the strips including a cross-over portion near the ends of the strips.

[0241] Preferably, one or each strip may include a central tab or stop that limits the amount of movement of the retaining rings along the strips.

[0242] Preferably, the portion of the strip configured to be forked extends around the back of the patient's head from behind the patient's ear during use.

[0243] Preferably, the ends of the strips are pivotally coupled together.

[0244] Preferably, the strips in the non-forked configuration are arranged edge-to-edge.

[0245] Preferably, the strips in the non-forked configuration are arranged side-by-side.

[0246] Preferably, the strips in the non-forked configuration are held together by one or more of a tearable stitch, one or more retaining rings, buttons, clips, hook-and-loop fasteners or magnets.

[0247] In some embodiments, there is a headgear for securing a patient interface to a patient's face, the headgear comprising:

[0248] a strip, each end of the strip being adapted to attach 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 strip includes a non-extensible segment and an extensible segment, the non-extensible segment being adapted to attach the patient interface and support a gas supply conduit coupled to the patient interface.

[0249] Preferably, each end of the strip is a non-extensible segment adapted to attach to the patient interface, and the extensible segment is an intermediate segment extending between non-extensible segments around the back of the patient's head.

[0250] Preferably, the non-extensible section is adapted to be attached to one side of the patient interface, and the extensible section is adapted to be attached to the opposite side of the patient interface.

[0251] Preferably, the non-extensible section includes features for securing the catheter.

[0252] In some embodiments, there is a headgear for securing the patient interface to the patient's face, the headgear comprising:

[0253] A strap including a first extensible section adapted to be attached to one side of the patient interface and a second extensible section adapted to be attached to the opposite side of the patient interface, and a non-extensible intermediate section extending between each end of these extensible sections.

[0254] Preferably, the intermediate portion is an annular portion to which the ends of these extensible sections are attached.

[0255] Preferably, the headgear includes a first non-extensible sleeve and a second non-extensible sleeve each extending from the non-extensible intermediate section, and the first extensible section extends along the interior of the first non-extensible sleeve, and the second extensible section extends along the interior of the second non-extensible sleeve.

[0256] Preferably, the first non-extensible sleeve and the second non-extensible sleeve extend from the intermediate portion in front of the patient's ears in use.

[0257] Preferably, the first extensible section and the second extensible section are not attached to the first non-extensible sleeve and the second non-extensible sleeve along the length of the sleeve from the intermediate portion.

[0258] Preferably, one or both sleeves are adapted to support a gas conduit for supplying a gas flow to the patient interface.

[0259] Preferably, the headgear includes a tether attached to the sleeve and adapted to secure the gas conduit.

[0260] Preferably, the tether is extensible.

[0261] Preferably, the non-extensible intermediate section is bifurcated to include two separate straps.

[0262] Preferably, the non-extensible section is configured to bifurcate into more than one strap extending around the patient's head.

[0263] Preferably, the headgear includes a bifurcated section having two straps, and one of said straps is the non-extensible intermediate section.

[0264] Preferably, the headgear includes a first non-extendable 'Y'-shaped connector connected between the first extendable section and one end of the two straps, and a second non-extendable 'Y'-shaped connector connected between the second extendable section and the opposite ends of the two straps.

[0265] Preferably, one of the straps is an extendable strap.

[0266] Preferably, the upper one of the two straps is the extendable strap, and the lower one of the two straps is the non-extendable strap.

[0267] Preferably, the non-extendable strap is length adjustable.

[0268] Preferably, at least one of the straps is length adjustable.

[0269] Preferably, the upper one of the two straps is length adjustable.

[0270] In some embodiments, there is a headgear for a patient interface, the headgear including:

[0271] An extendable region, a non-extendable region, wherein the extendable region is positioned sufficiently away from the tube loading region.

[0272] In some embodiments, there is a headgear, an interface, and a tube assembly including at least one extendable region, at least one non-extendable region, the extendable region being positioned sufficiently away from the tube loading region, the extendable region being located behind the user's head in use, wherein the tube is configured to be attached to either side of the interface.

[0273] In some embodiments, there is a headgear, an interface, and a tube assembly including at least one extendable region, at least one non-extendable region, the extendable region being positioned sufficiently away from the tube loading region, wherein the tube loading region is the region where the tube is fastened to the headgear or the interface.

[0274] In some embodiments, there is a nasal cannula for delivering a gas source (such as a breathable gas) to a user (such as a patient), the nasal cannula including:

[0275] At least a first section formed of a first material; and

[0276] At least a second section formed of a second material;

[0277] Wherein, the first section is relatively softer than the second section.

[0278] Preferably, the second material is the same as the first material (e.g., it can be the same material, but different grades of this material with different characteristics (such as different Shore hardness or other grades)).

[0279] Preferably, the second material is different from the first material (e.g., it can be a different material with different characteristics such as different Shore hardness or other grades).

[0280] Preferably, the segments can be formed integrally with each other.

[0281] Preferably, the segments are assembled together with each other by using one or more mechanical fasteners or one or more chemical fastening systems (e.g., welding the first segment and the second segment, or parts thereof, together by an adhesive or plastic welding or ultrasonic welding).

[0282] Preferably, the first segment provides a user-friendly or comfortable contact component of the nasal cannula.

[0283] Preferably, the second segment provides a structural or supportive or shape-defining component of the nasal cannula. Alternatively, the second segment does not contact the user during use.

[0284] Preferably, the configuration or shape of the first segment is at least partially defined by the components or parts of the second segment.

[0285] Preferably, the first segment forms a patient contact surface, and the second segment forms a frame to which the first segment is attached.

[0286] Preferably, the first segment encapsulates at least a part of the second segment.

[0287] Preferably, the second segment is at least partially overmolded by the first segment.

[0288] Preferably, the first segment is at least one arm or a pair of arms extending outward from a central body portion, and the central body portion includes at least one (or preferably, a pair of) nasal forks.

[0289] Preferably, the headgear can be connected to one or each arm, and the headgear extends substantially around the rear portion of the user's head.

[0290] Preferably, the first segment is adapted to receive a manifold connection for delivering a gas source to the nasal cannula or the body of the nasal cannula that is in fluid communication with a delivery system for delivering gas to the user, e.g., delivering to one or both nostrils of the user via at least one nasal fork (or preferably, a pair of nasal forks) during use.

[0291] Preferably, the second segment is adapted to receive a manifold connection for delivering a gas source to the nasal cannula or the body of the nasal cannula that is in fluid communication with a delivery system for delivering gas to the user, e.g., delivering to one or both nostrils of the user via at least one nasal fork (or preferably, a pair of nasal forks) during use.

[0292] Preferably, the manifold is a component having a material that is relatively rigid with respect to the first material, and the manifold can be connected to the relevant area of the nasal cannula or the body of the nasal cannula.

[0293] Preferably, the first section includes one or more surface undulating portions, and the one or more surface undulating portions of the first section can engage with one or more correspondingly or complementarily shaped or configured surface undulating portions of the associated second section.

[0294] Preferably, the first section includes at least one raised area that can be received by a relevant orifice or pawl area of the second section.

[0295] Preferably, the first section includes raised tabs or mushroom-shaped heads, and the second section includes relevant orifices that can receive these raised tabs or mushroom-shaped heads.

[0296] Preferably, the first section includes a cannula body portion that at least partially defines an open cavity, and the open cavity can receive a gas supply directed thereto via the manifold. The open cavity is in fluid communication with one or a pair of nasal forks.

[0297] Preferably, the first section and the second section are correspondingly or complementarily shaped or configured to jointly receive a manifold connection for delivering a gas source to be delivered to the user.

[0298] Preferably, the first section is at least partially a nasal cannula body that defines an open cavity.

[0299] In an alternative or additionally, the second section is at least partially around the nasal cannula body that defines an open cavity.

[0300] Preferably, the second section supports the first section in a predetermined configuration.

[0301] Preferably, the second section extends substantially about the length of the nasal cannula defined by the first section. Alternatively, the second section extends to a length longer than the nasal cannula defined by the first section. In another alternative, the second section extends to a length shorter than the nasal cannula defined by the first section.

[0302] Preferably, the nasal cannula includes a pair of side arms extending outward from a cannula body that at least partially defines an open cavity, and the open cavity can receive a gas source via a manifold connection, for example.

[0303] Preferably, the connection system for connecting the headgear is positioned substantially towards each end of these side arms, and the headgear is to be worn by the user during use.

[0304] Preferably, the connection system is part of the second section.

[0305] Preferably, the first section provides a gasket-type seal for the manifold connection or for a manifold that can be received by at least a portion of the first section, where at least a portion of the first section defines, for example, an open cavity of the cannula body.

[0306] Preferably, the second section provides a structure to which the manifold connection can be made, and the first section provides a seal for the manifold in making such a manifold connection, such as a fluid-type seal.

[0307] Preferably, the nasal cannula includes a body defining an open cavity that can be engaged by the manifold, a rear portion of the body being substantially adjacent to the septal region of the user during use, the rear portion being substantially compliant or deformable in response to pressure applied to the rear portion by the user.

[0308] 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, and wherein the open cavity is a distinct and separate region of the body.

[0309] In an alternative, the rear portion defines at least a portion of the wall of the open cavity.

[0310] Preferably, the rear portion is substantially elastified.

[0311] Preferably, the rear portion is elastically deformable.

[0312] Preferably, the body includes a hollow outer shell substantially adjacent to the septal region of the user.

[0313] Preferably, the body includes a pillow section substantially adjacent to the septal region of the user.

[0314] Preferably, the pillow section is a hollow region, i.e., a hollow region defined by the walls of the body, and is partitioned into open chambers (such as air supply chambers), and has a relatively thin wall or an elastified section in this region that is substantially adjacent to the user's septum during use. Alternatively, the pillow section is formed by the rear wall of an open cavity (or air supply chamber), the rear wall being a relatively thin wall or an elastified section in this region that is adjacent to the user's septum during use.

[0315] Preferably, the pillow section is formed of a material that can deform under pressure applied by the user during use.

[0316] As described above, in some configurations or embodiments, the nasal cannula interface can include a first section and a second section. The first section can include a relatively soft material. The second section can 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.

[0317] These segments can be assembled together by any manufacturing method. In some configurations, for example, one of these segments can be overmolded on top of another. 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.

[0318] Preferably, a nasal cannula as defined above can be used in combination with each of the other details described in this specification to provide a nasal cannula interface.

[0319] In some embodiments, a patient interface, such as a nasal cannula, includes a gas delivery mechanism (such as one or a pair of nasal forks that engage one or both nostrils of a user), and the gas delivery mechanism from its associated body, and extending from the body is a pair of side arms, the body and the side arms being connected in such a way that applying tension to these side arms directs the gas delivery mechanism to move away from a position that would otherwise exert force on the user's nasal spine.

[0320] In some embodiments, a nasal cannula includes a cannula body from which a nasal fork or a pair of nasal forks extends to engage one or both nostrils of a user, and a pair of side arms extends outwardly therefrom and to which a headgear system can be connected, the cannula body being reasonably comfortable for the user's face while still providing sufficient rigidity such that a force or tension applied to the outer portions of these side arms during use directs or promotes less force being exerted by the nasal fork or forks on the user's nasal spine region.

[0321] Preferably, in the region of the nasal fork or forks, continuous segments of material extend along each side arm and are connected (or mechanically coupled).

[0322] Preferably, the continuous segments of material are materials capable of transferring an applied force or tension from the side arms to the region of the nasal fork or forks.

[0323] Preferably, each of these side arms defines a preform or shape such that before a force or tension is applied from the headgear, these side arms curve outwardly away from the patient's face and extend further outwardly, such that these side arms extend further away from the gas delivery mechanism of the interface or away from a nasal fork or a pair of nasal forks.

[0324] Preferably, when these arms extend outwardly away from the gas delivery mechanism or a nasal fork or a pair of nasal forks, each of these side arms is substantially in contact with the user's face, wherein the less or the farther (or both) each of these side arms is in contact with the user's face, the farther these arms extend from the gas delivery mechanism or a nasal fork or a pair of nasal forks.

[0325] Preferably, these side arms define a preform or shape such that, in use, the force or tension applied to these side arms via the headgear facilitates (or directs) these side arms to a position with better facial contact with the user's face or cheek, and the body is facilitated (or directed) to move to a position where it engages less with, or applies force to, or is further away from the user's nasal spine region.

[0326] Preferably, these side arms are configured to facilitate the transfer or positioning or repositioning or distribution or redistribution of the force or tension applied to the nasal cannula by the headgear to the user's cheek in use, and away from the user's nasal spine region or away from the force or tension applied to the user's nasal spine region.

[0327] Preferably, each of these side arms is preformed or shaped such that, in use, applying a 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, an articulation point or flexion point (or flexure point) of the side arms on the user's face established in the cheek region, and to be urged away from the nasal fork or these nasal forks or another gas delivery mechanism applying force to the user's nasal spine region.

[0328] Preferably, the articulation point or flexion point (or flexure point) established in use is in the region at or around any one or more of the lower outer maxilla, upper outer maxilla, zygomatic arch, maxillary depression (or below the zygomatic arch) on the left or right side (or both) of the user.

[0329] In some embodiments, a connector is used to connect a breathing tube to a device (such as a humidifier, ventilator, or other gas source), or to connect to at least another breathing tube, and the connector includes:

[0330] an inner body and an outer body,

[0331] each of the inner body and the outer body has a first end and a second end,

[0332] the first ends of the inner body and the outer body are for receiving the terminal end of a first breathing tube, and the second ends of the inner body and the outer body are for connecting to another component (such as, for example, another breathing tube) or a device (such as, for example, a humidifier, or a ventilator or gas source),

[0333] wherein the first end of the inner body receives the terminal end of the first breathing tube and is in fluid connection therewith, and the inner body provides a lumen for fluid connection between the first end and the second end of the inner body,

[0334] and wherein the inner body is rotatable relative to the outer body.

[0335] Preferably, the inner body is adapted to rotate relative to the outer body.

[0336] Preferably, the outer body may include one or more surface undulation features. More preferably, such surface undulation features are provided as finger grips for the user in use.

[0337] Preferably, these 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).

[0338] 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 in use.

[0339] Preferably, the inner body is sleeved relative to the outer body.

[0340] Preferably, the connector as defined above may be provided as a connector for use with a gas supply tube for a nasal cannula or other patient interface as described in this specification.

[0341] Preferably, the second end of the outer body is adapted to be connected to another component and the outer body is non-rotatable relative to the connection established with such another component, for example, at the machine end of a breathing circuit.

[0342] The different references to tubes or conduits in this specification may optionally but not necessarily relate to the administration 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 be specifically applied to such breathing tubes used in delivering gas to a user or patient.

[0343] As used herein, the term "and / or" means "and" or "or" or both.

[0344] As used herein, "(s)" after a noun means the plural and / or singular form of the noun.

[0345] The sagittal plane of a nasal cannula or other patient interface is defined as the sagittal plane of the user that extends 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 including nasal forks for each nostril is positioned at the center between the two nasal forks.

[0346] The lateral direction with respect to a nasal cannula is the direction that extends between the left hand end and the right hand end of the cannula. This lateral direction is perpendicular to the direction that extends between the front and the back of the cannula. The sagittal plane of the cannula is perpendicular to this lateral direction.

[0347] The present invention relates to the foregoing and also contemplates various configurations, examples of which are given below only. Brief Description of the Drawings

[0348] 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.

[0349] Figure 1A Shows an exemplary embodiment of a nasal cannula assembly coupled to a patient;

[0350] Figure 1B Shows Figure 1A A partial front perspective view of the nasal cannula assembly of

[0351] Figure 1C Shows Figure 1A And 1B An exploded view of the nasal cannula assembly of

[0352] Figure 2A Shows a front perspective view of an exemplary embodiment of a nasal cannula assembly including a cannula and a manifold;

[0353] Figure 2B Shows Figure 2A A partial rear perspective view of the nasal cannula assembly of

[0354] Figure 3A Shows a front perspective view of an exemplary embodiment of a nasal cannula assembly including a cannula and a manifold;

[0355] Figure 3B Shows Figure 3A A partial rear perspective view of the nasal cannula assembly of

[0356] Figure 4 Shows Figure 3A And 3B A partial front perspective view of an alternative configuration of the nasal cannula assembly of

[0357] Figure 5A Shows a front perspective view of an exemplary embodiment of a nasal cannula assembly including a cannula without a manifold;

[0358] Figure 5B Shows Figure 5A A partial rear perspective view of the nasal cannula assembly of

[0359] Figure 6A Shows a front perspective view of an exemplary embodiment of a nasal cannula assembly including a cheek pad;

[0360] Figure 6B Shows Figure 6A A partial rear perspective view of the nasal cannula assembly of

[0361] Figure 7A Shows a front perspective view of an exemplary embodiment of a nasal cannula assembly including a cannula with an integrated headband;

[0362] Figure 7B Shows Figure 7A a partial rear perspective view of the nasal cannula assembly;

[0363] Figure 7C Shows an exemplary embodiment of a tether connector for a nasal cannula assembly;

[0364] Figure 8A Shows a front perspective view of an exemplary embodiment of a nasal cannula assembly including a cannula and a manifold;

[0365] Figure 8B Shows Figure 8A a partial rear perspective view of the nasal cannula assembly;

[0366] Figure 8C Shows Figure 8A and 8B an exploded view of the nasal cannula assembly;

[0367] Figure 9A Shows a front perspective view of an exemplary embodiment of a nasal cannula assembly including a cannula and a manifold;

[0368] Figure 9B Shows Figure 9A a partial rear perspective view of the nasal cannula assembly;

[0369] Figure 9C Shows Figure 9A and 9B a variation of the nasal cannula assembly;

[0370] Figure 10A Shows a side perspective view of an exemplary embodiment of a nasal cannula assembly including a cannula and a nasal strap attached to a patient's face;

[0371] Figure 10B Shows Figure 10A a partial rear perspective view of the nasal cannula assembly;

[0372] Figure 11 Shows Figure 10A and 10B an alternative configuration of the nasal cannula assembly;

[0373] Figure 12A Shows a partial front perspective view of an exemplary embodiment of a nasal cannula assembly including two cannulas;

[0374] Figure 12B Shows Figure 12A top, front, and side views of one of these cannulas;

[0375] Figure 12C shows a front perspective view of a nasal cannula assembly coupled to a patient Figure 12A ;

[0376] Figure 13A shows a front perspective view of an exemplary embodiment of a nasal cannula assembly including a cannula and a retainer

[0377] Figure 13B shows Figure 13A a partial side perspective view of a nasal cannula assembly

[0378] Figure 13C shows a front perspective view of a nasal cannula assembly coupled to a patient Figure 13A and 13B ;

[0379] Figure 14A shows a front perspective view of a nasal cannula assembly including a manifold and a cannula having a nasal flap

[0380] Figure 14B shows Figure 14A an exploded view of a nasal cannula assembly; and

[0381] Figure 14C shows a nasal cannula assembly coupled to a patient Figure 14A and 14B ;

[0382] Figure 15A -G shows an exemplary embodiment of a nasal cannula assembly having a shuttle valve

[0383] Figure 16A -F shows an exemplary embodiment of a nasal cannula assembly having a manifold with a one-way valve formed from an exhalation valve having a flap hinged loosely

[0384] Figure 16G -L shows an embodiment of a nasal cannula assembly having a manifold with a one-way valve formed from a different type of slit valve

[0385] Figure 17A and 17B show an exemplary embodiment of a nasal cannula assembly having a tube passing through the manifold to allow selective side switching of the tube exit side

[0386] Figure 18A and 18B show an exemplary embodiment of a nasal cannula assembly in which each fitting outlet hole is sealed by a film that can be pierced by the sharpened end of the supply tube

[0387] Figure 19Shows an exemplary embodiment of a manifold having a flexible tube that exits a front fitting outlet hole of the manifold.

[0388] Figure 20A -C shows an exemplary embodiment of a manifold snapped into a component fixture or clip.

[0389] Figure 21A -F shows an exemplary embodiment of a nasal cannula assembly having a removable fitting assembly and a manifold.

[0390] Figure 21G and 21H shows an exemplary embodiment of a nasal cannula assembly having a manifold receiving structure, a separate nasal fork insert, and a manifold.

[0391] Figure 22A -D shows an exemplary embodiment of a nasal cannula assembly having a manifold insert and a manifold receiving structure.

[0392] Figure 23A -C shows an exemplary embodiment of a nasal cannula assembly having a manifold insert that can be clamped onto a fitting assembly.

[0393] Figure 24A -C shows an exemplary embodiment of a nasal cannula assembly having forks formed with a corrugated shape around a base, the corrugated shape allowing the forks to be flexible.

[0394] Figure 24D -F shows an exemplary embodiment of forks formed with a corrugated geometry, the corrugated geometry allowing the forks to be flexible.

[0395] Figure 25A Shows an exemplary embodiment of a nasal cannula assembly including individually rotatable forks.

[0396] Figure 25B -C shows an exemplary embodiment of a nasal cannula assembly including a pair of nasal forks mounted on a vertical axis and rotatable as a unit.

[0397] Figure 26A -F shows an exemplary embodiment of a nasal cannula assembly configured to allow insertion of a removable fork insert in at least two orientations.

[0398] Figure 27A -D shows an exemplary embodiment of a nasal cannula assembly including a manifold rotatable about an axis extending in a generally front-to-back direction.

[0399] Figure 28A and 28B shows an exemplary embodiment of a nasal cannula assembly including a manifold and a supply tube that can be coupled to the cannula in at least two orientations.

[0400] Figure 29A Disclosed are exemplary embodiments of a respiratory assistance system having a nasal cannula assembly with pressure measurement capabilities.

[0401] Figure 29B -L shows an exemplary embodiment of a nasal cannula assembly having pressure measurement capabilities.

[0402] Figure 30A -I shows an exemplary embodiment of a nasal cannula assembly having features for addressing, alleviating, or minimizing patient discomfort, particularly in the upper lip area or vicinity thereof.

[0403] Figure 31A -F shows an exemplary embodiment of an adjustable or formable supply tube for a nasal cannula assembly.

[0404] Figure 32A -N shows an exemplary embodiment of a nasal cannula assembly having arrangements and features for handling the positioning of the supply tube.

[0405] Figure 33A -S shows an exemplary embodiment of an arrangement for providing support to the supply tube.

[0406] Figure 34A -K shows an exemplary embodiment of a headgear arrangement for securing the cannula to a patient's face.

[0407] Figure 35A -G shows an exemplary embodiment of a retention arrangement for a nasal cannula assembly.

[0408] 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.

[0409] Figure 37A Shows an exemplary embodiment of a headgear strap having a strap pad.

[0410] Figure 37B -E shows an exemplary embodiment of an adjustable headgear strap arrangement for a nasal cannula assembly.

[0411] Figure 38A -G shows an exemplary embodiment of an adjustable cannula and fork arrangement for a nasal cannula assembly.

[0412] Figure 39A -I shows an exemplary embodiment of a cannula and fork arrangement having adjustable alignment for a nasal cannula assembly.

[0413] Figure 40A -J shows an exemplary embodiment of an adjustable fork arrangement for a nasal cannula assembly.

[0414] Figure 41A -D shows an exemplary embodiment of a support arrangement for a nasal cannula assembly.

[0415] Figure 42A -O shows an exemplary embodiment of a heat insulation and pipe fitting arrangement for a nasal cannula assembly.

[0416] Figure 43A -O shows an exemplary embodiment of a pipe fitting arrangement for a nasal cannula assembly.

[0417] Figure 44A -G shows an exemplary embodiment of a pipe fitting arrangement for a nasal cannula assembly.

[0418] Figure 45A -Q shows an exemplary embodiment of a temperature regulation arrangement for a nasal cannula assembly.

[0419] Figure 46A -E shows an exemplary embodiment of a pressure measurement port arrangement for a nasal cannula assembly.

[0420] Figure 47A -O shows an exemplary embodiment of a nasal cannula arrangement configured to accommodate a nasogastric tube (NG) or a nasojejunal tube (NJ).

[0421] Figure 48A -S shows an exemplary embodiment of a single fork arrangement for a nasal cannula assembly.

[0422] Figure 49 Shows a breathing humidifier system that can be used with a nasal cannula assembly according to one or more embodiments of the present invention.

[0423] Figure 50A and 50B Shows a nasal cannula assembly including a cannula portion and a separate plug and catheter connector.

[0424] Figure 51 Shows a nasal cannula assembly including a cannula portion and a clip that includes a plug and a catheter connector for connecting a gas conduit to the cannula portion.

[0425] Figure 52A and 52B Shows a nasal cannula assembly including a cannula portion and a clip that includes a plug and a catheter connector for connecting a gas conduit to the cannula portion. The cannula portion includes a rigid member for engaging with the clip.

[0426] Figure 53A and 53B Shows a clip including a catheter connector and a plug for connecting a gas conduit to a cannula portion. The lateral distance between the plug and the connector is adjustable.Figure 53B is an exploded view.

[0427] Figure 54A to 54C Shows a nasal cannula assembly including a cannula portion and a clip that includes a plug and a conduit connector for attaching a gas conduit to the cannula portion. The clip is rotatably mounted to the cannula portion.

[0428] Figure 55A and 55B Shows a nasal cannula assembly including a cannula portion and a conduit connector including a manifold. The cannula portion is rotatably mounted to the manifold.

[0429] Figure 56A to 56C Shows a nasal cannula assembly including a cannula portion and a clip that includes a plug and a conduit connector for attaching a gas conduit to the cannula portion. The clip is laterally insertable into a manifold of the cannula portion.

[0430] Figure 57A Shows a cannula assembly including a pair of gas supply conduits and clips on each side of the cannula assembly, each conduit being connected to a nasal fork via a flexible tube section, and the clips for configuring the conduits to extend from the left or right side of the cannula.

[0431] Figure 57B and 57C Shows a nasal cannula assembly including a pair of gas supply conduits, each conduit being connected to a nasal fork via a swivel elbow.

[0432] Figure 58A Shows a bifurcatable strap for a headgear that includes a frangible section that bifurcates a portion of the strap into two separate straps.

[0433] Figure 58B Shows a bifurcatable strap in a non-bifurcated configuration in use.

[0434] Figure 58C Shows a bifurcatable strap in a bifurcated configuration in use.

[0435] Figure 58D Shows how a bifurcatable strap including a frangible section is separated to form a bifurcated portion including two separate straps.

[0436] Figure 58E Shows a bifurcatable strap in a non-bifurcated configuration.

[0437] Figure 58F Shows Figure 58E a cross-section of the strap.

[0438] Figure 58G Shows Figure 58A a cross-section of the strap.

[0439] Figure 59 Disclosed is a bifurcated strip for a headgear, which includes a lifting portion defined by a frangible segment for bifurcating a portion of the strip into two separate straps.

[0440] Figure 60A and 60B Disclosed is a bifurcated strip for a headgear, which includes a collar that is slidable along a bifurcated segment of the strip to configure the bifurcated segment into a bifurcated configuration or a non-bifurcated configuration.

[0441] Figure 61A to 61C Disclosed is a bifurcated strip for a headgear, which includes two collars that are slidable along a bifurcated segment of the strip to configure the bifurcated segment into a bifurcated configuration or a non-bifurcated configuration.

[0442] Figure 62 Disclosed is a bifurcated strip, wherein ends of the separate straps of the strip are pivotally coupled.

[0443] Figure 63 Disclosed is a headgear strip including a stretchable portion and a non-stretchable portion. The non-stretchable portion is bifurcated into two separate straps.

[0444] Figure 64 Disclosed is a headgear strip including a bifurcated portion, wherein at least one of the straps of the bifurcated portion is stretchable, and ends of the bifurcated straps are joined by a non-stretchable Y-shaped connector.

[0445] Figure 65 Disclosed is a headgear strip including a stretchable portion and a non-stretchable portion. The non-stretchable portion supports a gas supply conduit.

[0446] Figure 66 Disclosed is a headgear strip including a first non-stretchable segment attached to one side of a patient interface, a second non-stretchable segment attached to an opposite side of the patient interface, and a stretchable intermediate segment extending between the first non-stretchable segment and the second non-stretchable segment.

[0447] Figure 67 Disclosed is a headgear strip including a first stretchable segment attached to one side of a patient interface, a second non-stretchable segment attached to an opposite side of the patient interface, and a non-stretchable annular intermediate segment extending between the first non-stretchable segment and the second non-stretchable segment.

[0448] Figure 68 Disclosed is a headgear strip including a bifurcated portion, wherein at least one of the straps of the bifurcated portion is adjustable in length.

[0449] 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.

[0450] Figure 70 Is an exploded view of a segmented nasal cannula, where the segments are configured to mechanically fasten to each other.

[0451] Figure 71 Is in use Figure 70 An enlarged view of the mechanical fastening device of

[0452] Figure 72 Similar to the exploded view shown in Figure 70 But includes a clip-on gas flow supply tube.

[0453] Figure 73 Is similar to Figure 72 A perspective view of a segmented nasal cannula system, except that it has been assembled from these disassembled components into the cannula system.

[0454] Figure 74 Is a perspective view of a disassembled cannula system with a clip-on supply tube attachment.

[0455] Figure 75 Is a perspective view of an alternative disassembled cannula system (relative to Figure 74 ) with a clip-on supply tube attachment.

[0456] Figure 76 Is Figure 75 A perspective view of the cannula system of, except that it has been assembled from these disassembled components into the cannula system.

[0457] Figure 77 Is a perspective view of an alternative disassembled cannula system (relative to Figure 74 And 75 ) with a clip-on supply tube attachment.

[0458] Figure 78 Is a perspective view of a clip-on supply tube attachment with a hinged end cap.

[0459] Figure 79 Is Figure 78 A close-up view of the hinged end cap of

[0460] Figure 80 Is Figure 78 A top-down view of the clip-on supply tube of, where the hinged end cap has been moved towards the gas supply fitting.

[0461] Figure 81 Is Figure 78 A top-down view of the clip-on supply tube of, where the hinged end cap has been moved away from the gas supply fitting.

[0462] Figure 82 Is with Figure 78 A perspective view of an assembled cannula system with a clip-on supply tube attachment.

[0463] Figure 83 is an embodiment of a nasal cannula system, comprising a pair of nasal forks, a cannula body, a pair of side arms extending from the cannula body, a headgear connected to the side arms, a gas supply tube for providing a gas source in fluid communication with the pair of nasal forks, and a connector associated with the gas supply tube.

[0464] Figure 84 is another embodiment of a nasal cannula system, comprising a pair of nasal forks, a cannula body, a pair of side arms extending from the cannula body, a headgear connected to the side arms, a gas supply tube for providing a gas source in fluid communication with the pair of nasal forks, and a connector associated with the gas supply tube.

[0465] Figure 85 is through Figure 84 a cross-sectional view of the embodiment shown in, which cross-section shows how a first section of a first material can 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

[0467] Although certain embodiments and examples are described below, those skilled in the art will understand that the present disclosure extends beyond the specifically disclosed embodiments and / or uses and their obvious modifications and equivalents. Accordingly, it is intended that the scope of the present disclosure as disclosed herein should not be limited by any particular embodiment described below. The different features described herein can be used individually or in different combinations and sub-combinations in existing and / or modified respiratory interfaces.

[0468] Whether used in a hospital environment or in a home environment, a system for providing a gas flow to a patient or user can include four main device components. First, a blower for providing a pressurized gas flow to the patient. Second, an active humidifier that controls the temperature of a heater plate that heats a body of water to achieve a desired temperature and humidity of the gas flow. Third, a delivery conduit from the humidifier to the patient is also required, which can be heated to reduce condensation, or "rain". Fourth, a patient interface for delivering a pressurized and humidified gas flow to the patient, such as a nasal cannula designed to fit into the nasal cavity of a patient or user. In some cases, a pressurized gas flow without humidification can be provided to the patient, in which case the humidifier is an unnecessary device.

[0469] Reference 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 nasal cannula assembly 10020, which is connected to a humidified gas delivery passage or inspiratory conduit 100003 that in turn is connected to a humidifier 100008 (including a humidification chamber 100005), and the humidifier is supplied with gas from a blower 10015 or other suitable gas supply device. 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 (such as an aluminum base), which is in direct contact with a heating plate 100007 of humidifier 100008. Humidifier 100008 is equipped with a control device or electronic controller 100009, which may include a microprocessor that executes computer software commands stored in an associated memory based on the controller. The gas flowing through inspiratory conduit 100003 is delivered to the patient via nasal cannula assembly 100020.

[0470] Controller 100009 receives inputs from sources such as a user input device or dial 10010, and the user of the device can set, via the user input device or dial, for example, a predetermined desired value (preset value) of the humidity or temperature of the gas supplied to patient 100001. In response to the user setting a humidity or temperature value input via dial 10010 and other possible inputs (such as internal sensors that sense gas flow or temperature), or parameters calculated in the controller, controller 100009 determines when (or to what level) to supply energy to heating plate 100007 to heat the water 100006 within humidification chamber 10005. When the volume of water 100006 within humidification chamber 100005 is heated, water vapor begins to fill the chamber volume above the surface of the water and escapes from outlet 100004 of humidification chamber 100005, where gas (such as air) provided from a gas supply device or blower 10015 flows into the chamber through inlet 10016. It should be noted that it is possible to obtain a relationship between the humidity of the gas within humidification chamber 100005 and the temperature of heating plate 100007. Thus, it is possible to utilize the heating plate temperature in an algorithm or look-up table to determine the humidity of the gas.

[0471] The blower 10015 may be equipped with a variable speed pump or fan 100002 that draws in air or other gases through the blower inlet 10017. The speed of the variable speed pump or fan 100002 may be controlled by another control device or electronic controller 10018 (alternatively, the function of this controller 10018 may be performed by another controller 100009) in response to an input from the controller 100009 and a predetermined desired value (preset value) of pressure or fan speed set by the user via the turntable 10019.

[0472] The heating element 10011 may be provided within the conduit or pipe fitting 100003 to help prevent condensation of the humidified gas within the conduit. Such condensation is due to the temperature of the wall of the conduit being close to the ambient temperature (the temperature of the surrounding atmosphere), which is often lower than the temperature of the humidified gas within the conduit. The heater element effectively compensates for the gas energy loss 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.

[0473] Reference Figure 1A - 1C , exemplary embodiments of a nasal cannula assembly or system include a manifold 12 and a cannula 14. The cannula 14 includes nasal forks 20a and b, side straps 22, and a tubular orifice 24 defined by or surrounding and configured to receive the manifold 12 by a retaining strap 26. In some embodiments, the manifold is generally tubular and includes a circular inlet 16 and an elongated elliptical outlet 18. In use, the manifold 12 is coupled to the cannula 14 by inserting the manifold 12 into the orifice 24 such that the manifold outlet 18 is aligned with and in fluid communication with the nasal forks 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 that is configured to be connected to a gas source and supply gas from the gas source, such as a ventilator, gas tank, 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 by a connector 52.

[0474] The nasal cannula system may further include a securing mechanism for securing the cannula 14 in the correct operating position to the user's head. In the illustrated embodiment, the securing mechanism includes a headcap strap 40. The strap 40 may 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 during use. The tether 46 may be coupled to the supply tube 50 and / or the connector 52 via a tether connector 54 that also allows adjustment of the length of the tether. The tether 46 advantageously helps support the weight of the main delivery catheter 90 to reduce patient discomfort and the likelihood of displacement of the cannula 14. Further details regarding exemplary nasal cannula assemblies or systems can be found in U.S. Publication No. 2010 / 0192957, the entire contents of which are incorporated herein by reference. Different components and features of such nasal cannula assemblies may be selected and modified to achieve the various benefits described herein.

[0475] Reference Figure 2A and 2B , embodiments of a nasal cannula assembly or system include a cannula 114, a manifold 112, a headcap strap 140, a gas supply tube 150, and a tether 146. The cannula 114 may be formed of a thermoplastic silicone-like material and includes nasal forks 120a and b, side straps 122, and two spaced-apart manifold retaining portions or strips 126a and b that define / surround an aperture configured to receive the manifold 112. In some embodiments, the nasal forks 120a and b, the side straps 122, and the manifold retaining strips 126a and b are integrally formed. The cannula 114 is configured such that the manifold 112 can be inserted into the apertures of the manifold retaining strips 126a and b from either side, such that the manifold inlet 116 can be positioned on either side of the cannula 114. For example, when adjusting the headcap strap 140 and when adjusting the cannula 114 against the user's face to help achieve a more effective and / or comfortable fit, these side straps 122 may include flexure slots 128 that provide ventilation and allow the cannula 114 to be more easily bent or stretched. These flexure slots 128 may be generally vertical or diagonally inclined as shown. As shown in Figure 2B FIG. [FIGURE NUMBER NOT PROVIDED], the patient-facing and contacting side 130 of the cannula 114 may have a contoured surface to better and more comfortably conform to the patient's face, reduce the overall profile of the cannula system, and help align the supply tube 150. For example, a transition portion 132 positioned between the central body portion 134 of the cannula 114 and these side straps 122 may be curved toward the patient's face to rest against the nasolabial groove. These side straps 122 may gradually decrease in thickness toward the outer edges of these straps 122, creating a thin profile and helping to further reduce the cannula system profile.

[0476] The headgear strap 140 can be coupled to these side straps 122 via clips or buckles 142. These clips 142 can include apertures 144 such that the inner edge 145 of the clip 142 on the side closest to the center of the cannula 114 can engage corresponding undercuts on the side strap 122. As shown in 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 furthest from the center of the cannula 114 can include a buckle mechanism configured to receive the end of the headgear strap 140 and allow adjustment of the circumference of the headgear strap 140 to fit the patient's head. In some embodiments, the strap 140 can be flexible (e.g., elastic) to allow the strap 140 to accommodate a wide range of patient head sizes with minimal adjustment.

[0477] In use, the manifold 112 is coupled to the cannula 114 by inserting the manifold 112 into the aperture 124 and stretching the flexible cannula 114 around the manifold 112. As described above, the manifold 112 can be inserted into the apertures 124 of the manifold retaining straps 126a and b from either side such that the manifold inlet 116 and thus the supply tube 150 can be positioned on either side of the cannula 114. In some embodiments, the manifold 112 is made of a relatively rigid plastic material that can withstand relatively high loading conditions to protect the manifold 112 from being crushed. Additionally, the retaining straps 126a and b can be spaced apart from each other to provide support to the manifold 112 at spaced positions, which support can prevent or counteract unwanted movement (e.g., rotation or twisting) of the manifold 112 caused by forces acting on, for example, the supply tube 150. In some configurations, the outer lateral edges of the retaining straps 126a and b are spaced outwardly from the nasal forks 120a and b such that the nasal forks 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 can be substantially aligned with or spaced outwardly from the nasal forks 120a and b. Although a pair of retaining straps 126a and b are 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 slightly larger than the outer diameter of the supply tube 150 such 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 can have a reduced diameter compared to other supply tubes to allow this coupling. The end of the tube 150 opposite the manifold includes a connector 152 configured to couple the supply tube 150 to a main delivery conduit that is coupled to the gas source. In the illustrated embodiment, the connector 152 is a 22 mm tapered connector.

[0478] The cannula system can include a tether connector 154 which, in the illustrated embodiment, is located on the supply tube 150 proximal (closer to the patient) to the connector 152. The tether connector 154 can include a mechanism 155 for receiving the ends of the tether 146 on either side. For example, each side of the tether connector 154 can include three or more biasing slots or posts through which the ends of the tether 146 pass. These slots or posts can be internal to the tether connector 154 or exposed. This configuration advantageously allows adjustment of one or both ends of the tether when needed or desired and allows the weight of the connector 152 (and the main delivery loop 90) to be suspended or oriented in a vertical orientation or direction. In some embodiments, the tether 146 is inelastic. The tether 146 is fixed to the tether connector 154 via friction between the tether 146 and the slots or posts. The tether 146 can be ribbed to assist in fixing the tether 146 to the tether connector 154. However, the tether 146 and the tether connector 154 can be designed such that if the connector 154 is pulled too far away from the patient and / or pulled with sufficient force, the friction is overcome and the tether 146 is released from the tether connector 154 to prevent the tether 146 from bunching up or otherwise causing patient discomfort. The tether connector 154 can include a clip 156 to allow a patient or other person to better grip the tether connector 154 to adjust the connector 152 and / or easily remove it from the main delivery catheter 90.

[0479] Reference Figure 3A and 3B , a nasal cannula assembly or system includes a cannula 214, a manifold 212, a headgear strap 240, a gas supply tube 250, and a tether 246. The cannula 214 includes nasal forks 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 such that the manifold 212 can be inserted into the aperture of the manifold retaining strap 226 from either side such 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 wider compared to the retaining strap 26 shown in Figure 1A and 1B and the straps 126a and b shown in FIG. 2. The retaining strap 226 can include a window 227 that makes a portion of the manifold 212 visible. For example, the window indicates that the manifold 212 is properly inserted into the manifold retaining strap 226. The window 227 can display, for example, a brand, size, and / or other information printed, embossed, adhered, or otherwise presented on the visible portion of the manifold 212.

[0480] The cannula 214 is typically soft and flexible for patient comfort. By making these outer portions 223 of the side straps 222 thicker or otherwise strengthening them, such as via reinforcing ribs, the outer portions 223 of these side straps 222 can have increased strength. The reinforcing ribs can be positioned, for example, at the upper and / or lower edges of these side straps 222. The increased strength allows the headgear strap 240 to be directly coupled to the outer portions 223 of these side straps 222 without the need for additional clips, buckles, or other attachment mechanisms, and allows the cannula 214 and the side straps 222 to maintain their molded shape, preventing or deterring deformation during stretching. The outer portions 223 of these side straps 222 can include two or more slits or apertures through which the ends 243 of the headgear strap 240 can pass and be pulled through a desired length to obtain a circumference of the headgear strap 240 suitable for fitting the patient. These ends 243 of the headgear strap 240 can be folded back and removably secured to multiple portions of the headgear strap 240 near the outer portions 223 of these side straps 222 via a hook-and-loop closure. For example, a fabric section including hooks can be attached (e.g., sewn, adhered, etc.) to these ends 223 of the headgear strap 240, and a fabric section including loops can be attached (e.g., sewn, adhered, etc.) to multiple portions of the headgear strap 240 near the outer portions 223 of these side straps 222. Opposite sides of these ends 243 of the strap 240 visible when worn can include branding or other information printed, embossed, adhered, or otherwise attached thereto.

[0481] As shown in Figure 3B the rear or patient-facing side of these side straps 222 can include a recessed area 221 to accommodate those portions of the headgear strap 240 looped through these side straps 222 such that the headgear strap 240 does not significantly press on the patient's face. The segment of the headgear strap 240 configured to be placed against the back of the patient's head during use can include a padded segment 241 for patient comfort. The padded segment can be inserted between two halves of the headgear strap 240 or placed on top of or around the headgear strap 240.

[0482] In use, the manifold 212 is coupled to the cannula 214 by inserting the manifold 212 into an aperture defined by the manifold retention strap 226. The manifold 212 can be inserted into the aperture of the manifold retention strap 226 from either side such 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 slightly larger than the outer diameter of the supply tube 250 such 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.

[0483] The cannula system can further include a tether connector 254 that is located on the supply tube 250 proximal to 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 can include a mechanism 255 for adjustably receiving one end of the tether 246. For example, one side of the tether connector 254 can include two slits or apertures through which the end of the tether 246 can 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 over the patient's head. The tether connector 254 can also include a clip 256 to allow a patient or other person to better grip the tether connector 254 to adjust the connector 252 and / or to easily remove it from the main delivery conduit 90.

[0484] One side of the tether connector 254 can include a release clip 257. One end of the tether 246 can include a mold that is configured to be inserted into the release clip 257 to secure the tether 246 to the tether connector 254. The release clip 257 is designed such that if, for example, the main delivery conduit, connector 252, supply tube 250, and / or tether connector 254 are pulled away from the patient with a force exceeding a certain threshold and the tether 246 exerts too much force on the patient's neck, the release clip 257 releases the tether 246 or disengages from the tether connector 254 to avoid patient injury or discomfort. This configuration advantageously allows the weight of the connector 252 (and the main delivery loop 90) to be suspended or oriented in a vertical orientation or direction. In some embodiments, the tether 246 is made of an inelastic material to improve the function of the release clip 257 and such that the weight of the main delivery conduit coupled to the connector 252 does not stretch the tether 246 and exert additional force on the patient's neck. In some embodiments, the release clip 257 allows the tether 246 to be easily looped around the patient's neck and then inserted into the release clip 257.

[0485] Figure 4shows a cannula system having cannula 314 and headgear strip 340 that in some respects are similar to the cannula 214 and headgear strip 240 shown in Figure 3A and 3B . However, the cannula system of Figure 4 does not have a manifold retaining strap and includes a reversible manifold 312. The manifold 312 can pivot or rotate or disengage from the cannula 314 and turn 180° such that the inlet 316 can be positioned on either side of the cannula 214.

[0486] As shown in Figure 5A and 5B , embodiments of a nasal cannula assembly or system include a cannula 414, a headgear strip 440, and a gas supply tube 450. The cannula 414 includes nasal forks 420a and b, side straps 422, and an inlet 416. In the illustrated embodiment, the end of the gas supply tube 450 is directly coupled to the inlet 416 of the cannula 414. The supply tube 450 can have a reduced diameter such that the end of the supply tube 450 can be received within the inlet 416. Using an adhesive (e.g., glue), mechanical interference features, and / or other means, the supply tube 450 can be secured to the cannula 414 by the cannula inlet 416 extending over the end of the supply tube 450. The cannula 414 further includes two gas paths 417a and b that extend from and are in fluid communication with the inlet 416 such that a first gas path 417a extends to and is in fluid communication with the first nasal fork 420a, and a second gas path 417b extends to and is in fluid communication with the second nasal fork 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 forks 420a and b such that the patient receives a balanced flow in both nostrils. The flow path has reduced, minimal, or no significant sudden transitions or sharp angles, which advantageously reduces or minimizes the flow resistance.

[0487] The ends of these side straps 422 may include apertures or slots 421 designed to receive the ends of the headgear strap 440. The headgear strap 440 may be formed of a highly elastic material that is capable of stretching substantially to allow the headgear strap 440 to adapt to and fit different patient head sizes, especially in cases such as in the illustrated embodiment where these side straps 422 do not include clips or buckles and allow adjustment of the circumference of the headgear strap 440. For example, the headgear strap 440 may be made of a material having a relatively flat force-extension curve such that the headgear strap 440 maintains the same or substantially the same tension over a range of extensions. The ends of the headgear strap 440 may include rigid material overmolded thereon to assist in securing the ends of the headgear strap 440 within these apertures 421. The strap 440 may also or alternatively be secured to the cannula 414 with an adhesive (e.g., glue), ultrasonic welding, and / or other means.

[0488] The cannula system includes a hose clamp 442 that is coupled (permanently or removably, fixedly or movably) to the headgear strap 440. The hose clamp 442 may be located on the side of the cannula 414 closest to the inlet 416 and may receive the supply tube 450 to assist in keeping the tube 450 out of the patient's mouth and face during use. The end of the supply tube 450 opposite the end coupled to the cannula inlet 416 may include a connector 452 configured to couple the supply tube 450 to the main delivery catheter. The cannula system may include a tether clamp 454 positioned on the supply tube 450 proximal to the connector 452. The tether clamp 454 may releasably clamp a tether worn around the patient's neck during use. Alternatively, the tether clamp 454 may be directly attached to, for example, the patient's gown or hospital gown, bedsheet, or another location in the vicinity to assist in supporting the weight of the main delivery catheter. In Figure 5A and 5B the nasal cannula system shown 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 and may advantageously assist in providing easier manufacturing and / or reducing costs.

[0489] Another embodiment of a nasal cannula assembly or system includes a cannula 514, a manifold 512, a gas supply tube 550, and a tether 546, as Figure 6A and 6BAs shown. The cannula 514 includes nasal forks 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 flexure zones 532 located in transition zones between the central body portion 534 of the cannula 514 and the cheek pads 522. These thin flexure zones 532 have a reduced cross-sectional thickness to allow the cheek pads 522 to move and adjust more easily relative to the central body portion 534, thereby improving the fit, positioning, and comfort of the cannula 514 on the patient's face. The rear or patient-facing side of the central body portion 534 may include soft and / or thin wall padding details 535. The padding 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 area that helps absorb the force of pressing the cannula 514 into the patient's face.

[0490] The rear surface of the cheek pad 522 includes an attachment pad 560 formed integrally with the cheek pad 522 or stitched or otherwise attached thereto. The attachment pad 560 may include a releasable and reattachable adhesive for attaching the cheek pad 522 to the patient's face. Alternatively, the attachment pad 560 may include a portion of a hook-and-loop fastener, for example, a fabric section including the hooks. A patch containing the other part of the fastener (e.g., the loops) may be attached to the patient's face at the desired location on the cheek and / or upper cheek to allow the attachment pad 560 to be releasably attached to the patient's face.

[0491] The manifold 512 includes an inlet 516 designed to receive a gas supply tube 550 and an outlet designed to be aligned with and in fluid communication with the nasal forks 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 strap 526 such that the outlet is aligned with the nasal forks 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 strap 526 from either side such that the manifold inlet 516 can be positioned on either side of the cannula 514. The retaining strap 526 may include a window 527 that makes a portion of the manifold 512 visible, for example, the window indicates that the manifold 512 is correctly inserted into the manifold retaining strap 526. The window 527 may display, for example, branding, size, and / or other information printed, embossed, adhered, or otherwise presented on the visible portion of the manifold 512.

[0492] In the illustrated embodiment, supply tube 550 is a small-diameter coiled tube. Other types of gas supply conduits are 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 tether retention connector 554 positioned on connector 552 or on supply tube 550 proximal to connector 552. One end of tether 546 may be integrally formed with or coupled to one side of tether retention connector 554. The opposite side of tether retention connector 554 may include a slot designed to receive free end 547 of tether 546. Free end 547 of tether 546 may include a series of protrusions or notches 548. These protrusions 548 may be pulled through the slot of tether retention connector 554 to adjust the circumference of tether 546, but resist sliding through the slot when not adjusted to assist in securing tether 546 at a desired circumference. Tether 546 may be made of an imprinted fabric such as white non-woven laminated polyethylene, which may advantageously help reduce the cost of the cannula system.

[0493] As Figure 7A - 7B An exemplary embodiment of the cannula system as shown includes cannula 614, gas supply tube 650, and tether 646. Cannula 614 includes nasal forks 620a and b, retention strap 626, and integrated headcap strip 640. In some embodiments, headcap strip 640 may include a break on one side such that headcap strip 640 includes a first segment 640a and a second segment 640b. The free end of one segment (first segment 640a in the illustrated embodiment) may include a slot 642 configured to receive the free end of the other segment (second segment 640b in the illustrated embodiment). A section of strip 640 near the free end of second segment 640b may include teeth 643 configured to engage the sides of slot 642 to help prevent second segment 640b from being pulled out of slot 642. The back portion 641 of headcap strip 640 (a portion of first segment 640a in the illustrated embodiment) may split into a double-strip configuration to assist in the stability of headcap strip 640 on the patient's head and / or to help distribute force over the patient's head and improve comfort.

[0494] In the illustrated embodiment, the end of the gas supply tube 650 is directly coupled to the cannula 614. The supply tube 650 may have a reduced diameter such that the end of the supply tube 650 can be received within the aperture defined by the retention strap 626. The supply tube 650 can be secured to the cannula 614 by stretching the manifold retention strap 626 over the end of the supply tube 650 using an adhesive (e.g., glue), mechanical interference features, and / or other means. The cannula system includes a hose clamp 642 that is coupled (permanently or removably, fixedly or movably) to the supply tube 650. The hose clamp 642 can include a hook configured to be placed on the headcap strap 640 to help keep the tube 650 away from the patient's mouth and face during use.

[0495] The end of the supply tube 650 opposite the end coupled to the cannula 614 can include a connector 652 configured to connect to the main delivery catheter. The cannula can further include a tether retention connector 654. The connector 652 can include a lower portion and an upper portion 653 that includes a gripping feature. In some embodiments, the connector 652 includes a reduced diameter section between the upper and lower portions to receive the tether retention connector 654. Alternatively, the upper and lower portions can be separate pieces. In use, the tether retention connector 654 is pressed onto a portion of the connector 652 and held in place between the upper and lower portions or within the reduced diameter section.

[0496] In the illustrated embodiment, the tether 646 is integrally formed with one side of the tether retention connector 654. Alternatively, the tether 646 can be coupled to the tether retention connector 654. The opposite side of the tether retention connector 654 can include a slot designed to receive the free end 647 of the tether 646. The free end 647 of the tether 646 can include a series of notches 648 along these sides. In use, the tether 646 is wrapped around the patient's neck and the free end 647 of the tether passes through the slot in the tether retention connector 654 to achieve the desired tether 646 circumference. These notches 648 allow the free end 647 of the tether 646 to be pulled through the slot in the tether retention connector 654 to adjust the circumference of the tether 646, but resist sliding through the slot when not being adjusted to assist in securing the tether 646 at the desired circumference. The tether 646 can be made of an imprinted fabric such as white non-woven laminated polyethylene, which can advantageously help reduce the cost of the cannula system.

[0497] In Figure 7CIn the alternative embodiment shown, the cannula system can include a connector 752, a tether connector 754 positioned on a supply tube 650 proximal to 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 loop 90) to be suspended or oriented in a vertical orientation or direction.

[0498] In some embodiments, such as in Figure 8A - 8C shown, the nasal cannula system includes a cannula 814, a manifold 812, a headcap strap 840, a gas supply tube 850, and a tether 846. The cannula 814 includes nasal forks 820a and b, and an inlet 824. As in Figure 8C shown, a flange 825 surrounds the perimeter of the inlet 824. The manifold 812 includes an inlet 816 configured to receive the supply tube 850 and an outlet 818. The outlet 818 of the manifold 812 includes a recess 819 configured to receive the flange 825 of the cannula 814. In some embodiments, the manifold 812 and the cannula 814 can be designed to have reduced dimensions so as to advantageously reduce the profile of the cannula system on the patient's face, thereby improving patient comfort and reducing the likelihood of obstructing the face or mouth in certain situations.

[0499] In use, the manifold 812 is coupled to the cannula 814 by inserting one side of the manifold 812 into the cannula 814 inlet 824 such that the flange 825 of the cannula 814 seats in the recess 819 of the manifold 812, and stretching the cannula 814 around the outlet 818 of the manifold 812 such that the flange 824 seats in the recess 819 that surrounds the entire perimeter of the cannula 814 outlet 824 and the manifold 812 outlet 818. The flange 824 and the corresponding recess 819 advantageously assist in securing the connection between the cannula 814 and the manifold 812 and also can help prevent air leakage at the connection. The manifold 812 can further include tabs 880 designed to fit into corresponding recesses or apertures 882 in the cannula 814 to further assist in securing the manifold 812 to the cannula 814 and indicating that the manifold 812 is correctly inserted into the cannula 814. As in Figure 8C shown, the manifold 812 is reversible, i.e., the manifold 812 can be coupled to the cannula 814 such that the manifold inlet 816 extends to either side of the cannula 814. The manifold 812 can include a grip 815 that advantageously assists the user in grasping the manifold 812 to couple the manifold 812 to the cannula 814 and / or remove it therefrom.

[0500] In the illustrated embodiment, the headgear strap 840 is directly coupled to the cannula 814, and the cannula system does not include clips, buckles, or other mechanisms that allow adjustment of the circumference of the strap 840. The sides of the cannula 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 cannula 814 using adhesives (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 and conform to different patient head sizes. For example, the headgear strap 840 may be made from a material having a relatively flat force-stretch curve such that the headgear strap 840 maintains the same or substantially the same tension over a range of stretch. The pitch of the headgear strap 840 material may be varied to adjust the tightness of the strap 840.

[0501] The gas supply tube 850 may be coupled at one end to the manifold 812 inlet 816 and at the opposite end to a connector 852 that is configured to couple the supply tube 850 to the main delivery catheter. The gas supply tube 850 may have a reduced diameter such that the end of the supply tube 850 can be inserted into the manifold inlet 816. In some embodiments, the connector 852 may include gripping details 856 to assist the user in more easily gripping the connector 852 to adjust the different components of the cannula system. In some embodiments, the gas supply tube 850 may include a pressure line 870. The pressure line 870 may be configured to transmit pressure feedback from the end of the supply tube 850 that is coupled to the manifold 812 to a pressure sensor and / or controller. The pressure line 870 may be integral with or coupled to the supply tube 850. In some embodiments, the pressure line 870 is located within the main flow path of the supply tube 850. In other embodiments, the pressure line 870 is located near the main flow path of the 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.

[0502] The cannula system may further include a tether connector 854 located on the supply tube 850 proximal to the connector 852. In some embodiments, the tether connector 854 is fixed relative to the tube 850. In other embodiments, the tether connector 854 may slide relative to the tube 850. The tether connector 854 may include an aperture or slot that receives the ends of the tether 846 on either side. In the illustrated embodiment, the tether connector 854 also serves as the point at which the pressure line 870 separates from the supply tube 850. In use, the tether 846 is wrapped around the patient's neck, and the ends of the tether 846 pass through the aperture or slot of the tether connector 854 to achieve the desired circumference of the tether 846. The ends of the tether 846 may include notches 848 along these sides. These notches 848 allow the tether 846 to be pulled through the slots of the tether connector 854 to adjust the circumference of the tether 846, but resist sliding through the slots when not adjusted to assist in fixing the tether 846 at the desired circumference. This configuration advantageously allows the weight of the connector 852 (and the main delivery loop 90 shown in Figure 1A ) to be suspended or oriented in a vertical orientation or direction. The tether 846 may be made of an imprinted fabric such as a white non-woven laminated polyethylene, which may advantageously help reduce the cost of the cannula system.

[0503] As shown in Figure 9A and 9B Exemplary embodiments of the cannula system include a cannula 914, a manifold 912, a headgear strap 940, and a gas supply tube 950. As shown, the cannula 914 may include a manifold aperture 924 configured to receive the manifold 912 and a headgear strap aperture 921 configured to receive the headgear strap 940. The manifold 912 may be inserted into the aperture of the cannula 914 from either side such that the manifold inlet 916 may be positioned on either side of the cannula 914. In the illustrated embodiment, the manifold 912 is generally cylindrical, and the manifold aperture 924 is thus also generally cylindrical. The manifold 912 may 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, a brand, size, or other information printed, imprinted, adhered, or otherwise presented on the visible portion of the manifold 912.

[0504] One end of the cylindrical manifold 912 is open and forms an inlet 916 configured to receive one end of the gas supply tube 950. The opposite end of the manifold 912 is closed, as shown in Figure 9B In some embodiments, the closed end of the manifold 912 includes a removable cap. In some such embodiments, a solid cap may be interchangeable with a cap 913 that may include a pressure line 970, such as in Figure 9CAs shown. As explained above, the manifold 912 can be inserted into the orifice of the cannula 914 from either side, such that the manifold inlet 916 can be positioned on either side of the cannula 914. Thus the cap 913 can also be located on either side of the cannula 914.

[0505] In the illustrated embodiment, the headgear strap 940 passes through the headgear strap orifice 921 of the cannula 914. In some embodiments, the headgear strap 940 is secured to the cannula 914 with an adhesive (e.g., glue), ultrasonic welding, or another mechanism. However, in some embodiments, the cannula 914 and the headgear strap 940 can slide 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 the retainer 943a and the opposite end of the segment of strap can be secured to the retainer 943b. The retainers 943a and b are coupled to the strap 940 and can slide thereon to allow adjustment of the circumference of the strap 940 to fit the patient's head. In some embodiments, the headgear strap 940 is made of a non-stretch material.

[0506] The cannula system can include a connector 952 on the supply tube 950 at the end opposite the manifold 912. The connector 952 can be configured to couple the supply tube 950 to a main supply conduit. The cannula system can further include a tether clip 954 that surrounds a proximal portion of the connector 952 or surrounds the supply tube 950 proximal to the connector 952. The tether clip 954 can releasably receive a tether. Alternatively, the tether clip 954 can be clipped directly to, for example, the patient's clothing or gown, bedding, or a tether placed around the patient's neck to help support the weight of the main supply conduit coupled to the connector 952.

[0507] As Figure 10A and 10BExemplary embodiments of the cannula system shown include cannula 1014, nose pad 1022, supply tube 1050, and nasal forks 1020a and b. Cannula 1014 is sized and shaped to be positioned on top of a patient's nose. For example, a portion of cannula 1014 may have a curved profile designed to conform to the curvature of the nose. Cannula 1014 may be secured to the patient's nose via nose pad 1022. In some embodiments, nose pad 1022 is similar to an adhesive bandage. A central portion of nose pad 1022 may include comfort pad 1035 configured to rest against the patient's nose during use and provide additional cushioning. An adhesive portion of nose pad 1022 extends from this central portion to adhere to multiple portions of the patient's cheek. A side of nose pad 1022 facing away from the patient's face includes attachment pad 1062 coupled (e.g., stitched, adhered, or otherwise attached) thereto. A side of cannula 1014 facing the patient includes a corresponding attachment pad 1060. For example, in some embodiments, attachment pads 1060, 1062 are components of a hook-and-loop fastener such as Velcro. Thus, attachment pads 1060, 1062 allow cannula 1014 to be removably attached to nose pad 1022.

[0508] In some embodiments, nose pad 1022 includes strip 1064 designed to help keep the patient's nasal passages open. In some embodiments, strip 1064 may be made of a flexible, spring-like metal biased toward a substantially straight state. When nose pad 1022 is placed across a curved nasal bridge, strip 1064 tends to straighten, thereby gently lifting the sides of the patient's nose and opening the nasal passages. In some embodiments, strip 1064 may be made of a shape memory material such as Nitinol, and heat from the patient's face causes strip 1064 to tend to return to a more straight state. Strip 1064 may be located on either side of nose pad 1022, i.e., on the side facing away from the patient or on the side facing the patient, e.g., between nose pad 1022 and comfort pad 1035. In some embodiments, nose pad 1022 may also be used as a blackhead remover. The patient contact side of nose pad 1022 may include an adhesive capable of bonding dust and / or other impurities in the patient's pores, such that they are removed together when nose pad 1022 is removed.

[0509] In the illustrated embodiment, the supply tube 1050 is a dual tube including two small diameter tubes extending between the main delivery catheter connector 1052 and the nasal forks 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 forks 1020a and b. In some alternative embodiments, the supply tube 1050 may include a single tube for a portion or all of its length. The single tube may split at the nasal forks 1020a and b or may split into two tubes distal to the nasal forks 1020a and b. As Figure 10A and 10B shown, the two supply tubes 1050 are passed down into a portion of the cannula 1014. The nasal forks 1020a and b extend downwardly from these supply tubes 1050 and the cannula 1014 and then turn approximately 180° and extend upwardly on the patient contact side of the cannula 1014. In the illustrated embodiment, the nasal forks 1020a and b are shaped or formed to hold their shape and orientation. In some embodiments, the nasal forks 1020a and b may include wires made of a shape memory material such as nitinol. The gas flow through the nasal forks 1020a and b or the heat radiated from the patient's face may cause the wires to assume and / or maintain the formed shape. When the cannula 1014 is coupled to the nasal sticker 1022, the nasal forks 1020a and b extend upwardly into the patient's nostrils.

[0510] In some alternative embodiments, such as Figure 11 shown, the cannula system may include nasal pillows 1120a and b instead of nasal forks. As shown, the supply tubes 1050 are passed down through a portion of the cannula 1014 and hang freely. The nasal pillows 1120a and b are coupled to the free ends of these supply tubes 1050. In some embodiments, the nasal pillows 1120a and b may be self-inflating pillows. In use, the nasal pillows 1120a and b turn upwardly and are inserted into the patient's nostrils, and the cannula 1014 is coupled to the nasal sticker 1022.

[0511] The cannula system may further include a cheek pad 1042. The cheek pad 1042 may include an adhesive strip that can be used to secure a portion of the supply tubes 1050 to the patient's cheek. The cheek pad 1042 may advantageously help keep the supply tubes 1050 out of the patient's mouth and help support some of the weight of the supply tubes 1050. The cheek pad 1042 may include branding or other information printed or otherwise displayed thereon. In some embodiments, the supply tubes 1050 include torsion-resistant springs, which may advantageously help allow manipulation of the tubes 1050, such as when positioning the cannula 1014 or cheek pad 1042 on the patient, without interrupting the gas supply.

[0512] Exemplary embodiments of the cannula system may include two cannulas 1220a and b, a nasal strip 1222, and supply tubes 1250a and b, as Figure 12A - 12C shown. The nasal strip 1222 may be similar to the nasal strip 1022 shown and described in the accompanying text. However, in Figure 10A and 10B the embodiment of, the cannula is separated into a right cannula 1214a and a left cannula 1214b. In some embodiments, the cannulas 1214a and b are symmetric rather than right-offset and left-offset. The right cannula 1214a includes an integrated nasal fork 1220a, and the left cannula 1214b includes an integrated nasal fork 1220b. The patient-facing surfaces of each cannula 1214a and b include attachment pads 1260a and b for removably attaching the cannulas 1214a and b to the attachment pads of the nasal strip 1222. In some embodiments, the nasal strip 1222 includes a strip 1264 that helps keep the patient's nasal passages open, as described with respect to Figure 12A - 12C and Figure 10A and 10B .

[0513] The supply tubes include small-diameter right 1250a and left 1250b supply tubes that extend from the main delivery catheter connector 1252 to the right 1214a and right 1214b cannulas. The supply tubes 1250a and b are received in the inlets 1224a and b of the cannulas 1214a and b. As shown, the supply tubes 1250a and b may loop around the patient's ears to help keep the tubes 1250a and b out of the patient's mouth and support some of the weight of the tubes 1250a and b. The tubes 1250a and b may include springs wound to help provide resistance to kinking and strength. In some embodiments, only one of the cannulas 1214a and b may be used for a given patient at a given time, if desired or needed.

[0514] As Figure 13A - 13CExemplary embodiments of the 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 nose forks 1320a and b. The retainer 1322 includes a cannula engagement portion 1321 and a nose 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 formed as part of the cannula 1314. In some embodiments, the cannula engagement portion 1321 has a formed shape configured to snap or clip onto the cannula 1314. The nose patch portion 1323 is designed to adhere across the patient's nose to assist in securing 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 desired to secure the cannula 1314 to the patient, the protective backing is peeled away to expose the adhesive strip. The retainer 1322 may be removed and replaced when needed during the course of treatment. In embodiments where the cannula engagement portion 1321 is formed as part of the cannula 1314, the adhesive strip may be removed and / or replaced when needed.

[0515] In some embodiments, the supply tube 1350 is a small-diameter coiled tube. The supply tube 1350 may be coupled at one end to a main delivery catheter connector 1352 and at an opposite end to the cannula 1314 inlet 1324. The diameter of the supply tube 1350 may be sized such that the supply tube 1350 can be inserted into the cannula inlet 1324 and the cannula 1314 that extends or otherwise forms or is positioned around the tube 1350, thereby securing the tube 1350 to the cannula 1314. The cannula system may also include a tether clip 1354 positioned on the connector 1352 or on the supply tube 1350 proximal to the connector 1352. The tether clip 1354 may releasably receive a tether placed around the patient's neck. Alternatively, the tether clip 1354 may be attached to, for example, the patient's clothing or gown, a sheet, or another location in the vicinity to assist in supporting the weight of the main delivery catheter.

[0516] As Figure 14A - 14CExemplary embodiments of the cannula system shown in the figure include cannula 1414, manifold 1412, and gas supply tube 1450. Cannula 1414 includes nasal forks 1420a and b, nasal flaps 1422a and b, and a manifold retention band 1426 that defines / surrounds an orifice 1424 configured to receive manifold 1412. In use, manifold 1412 is coupled to cannula 1414 by inserting manifold 1412 into orifice 1424 and stretching manifold retention band 1426 around manifold 1412. In the illustrated embodiment, the manifold includes an inlet or collar 1416 and two outlets 1418. In use, these outlets 1418 are aligned with and in fluid communication with nasal forks 1420a and b.

[0517] Nasal flaps 1422a and b extend from these sides of cannula 1414 and are configured to fold over the sides of the patient's nostrils. Nasal flaps 1422a and b may include thin sections proximate to manifold retention band 1426, allowing nasal flaps 1422a and b to bend easily and conform to the geometry of the nose. In some embodiments, each nasal flap 1422a and b includes an attachment pad 1460, which may be part of a hook-and-loop fastener. Attachment pad 1460 may be removably coupled to a corresponding attachment pad 1462, which may be the other part of the hook-and-loop fastener on the user's nose. Attachment pad 1462 may be attached to the outside of the patient's nostrils with an adhesive. In some embodiments, the attachment pads 1460 of these nasal flaps 1422a and b may be adhesive patches that adhere directly to the user's nose. In some embodiments, nasal flaps 1422a and b may include a stretchable material that retains its shape once deformed, such that nasal flaps 1422a and b remain substantially in place once folded. In such an arrangement, attachment pad 1460 may be a gripping pad that includes gripping material to grip the patient's skin and prevent unwanted movement of cannula 1414.

[0518] In some embodiments, supply tube 1450 is a small-diameter coiled tube. Supply tube 1450 may be coupled at one end to a main delivery catheter connector 1452 and at the opposite end to manifold inlet or collar 1416. In some embodiments, supply tube 1450 is permanently attached to collar 1416 and / or collar 1416 is permanently attached to manifold 1412. Alternatively, supply tube 1450 may be removably coupled to 1416 and / or collar 1416 may be removably coupled to manifold 1412. As in Figure 14BAs shown, the manifold 1412 can be inserted into the orifice 1424 of the cannula 1414 from either side such that the supply tube 1450 extends from either side of the cannula 1414. The cannula system can further include a tether clip 1454 positioned on the connector 1452 or on the supply tube 1450 proximal to the connector 1452. The tether clip 1454 can be releasably coupled to a tether placed around the patient's neck or can be attached to, for example, the patient's gown or hospital gown, a sheet, or another location in the vicinity to help support the weight of the main delivery catheter.

[0519] Figures 15 - 18 illustrate embodiments of a nasal cannula assembly including a cannula, preferably the cannula including a pair of nasal forks. The cannula can be integrated with or connected to a separate supply conduit or fitting, for example, by any of the manifold arrangements disclosed herein. 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 a 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 manifolds in other embodiments disclosed herein. Additionally, in some embodiments, the cannula can include one or more fork exit holes in the middle of the cannula body, which are arranged to allow gas to exit into a pair of nasal forks. In some embodiments, the cannula can be a cannula having a hollow volume including at least one inlet, which can be positioned and shaped to attach to a supply fitting or conduit. In certain embodiments, the cannula can include inlets at each end of the cannula. The cannula can be configured to connect to or be integrated with a component fixture (e.g., a headcap strap). The cannula can be configured to be integrally or permanently connected to a supply tube or conduit, for example, by any of the manifold arrangements described herein or by a connector. In some embodiments, the cannula can be integrated with or be integral to a 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 stiff or rigid. Any of the cannula embodiments discussed herein can include attached or clip - type or sliding forks and / or fixed or angled / adjustable forks as described herein.

[0520] In some embodiments, the cannula may have fitting outlet holes at each end 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 fitting, which is connected to a humidifier, circuit, or other gas or flow supply device. The end not connected to the fitting may be selectively blocked. For example, the selective side switching of the device may be carried out by such a system in which when the first end is connected to the fitting to allow air to enter the manifold space of the cannula, the second end is blocked, and when the second end is connected to the fitting to allow air to enter the manifold space of the cannula, the first end is blocked. FIGS. 15-18 show embodiments of selective side switching in the manifold.

[0521] Figure 15A -D shows 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 "manifold"). In some embodiments, the manifold 1501 may have an opening, port, or inlet 1507, or preferably an opening 1507, on one side of the manifold 1501. Specifically, a first opening 1507 may be located at the first end of the manifold 1501, and a second opening 1507 may be located at the second end of the manifold 1501. In certain embodiments, a lightweight shuttle or valve body 1508, such as a ball or disk, may move freely (e.g., slide or roll) inside the manifold volume or hollow cavity 1509. Preferably, the shuttle 1508 has a diameter larger than that of the fork 1505 and the opening 1507 to prevent the shuttle 1508 from exiting the hollow cavity 1509.

[0522] In some embodiments, supply tube 1502 may be connected to one of these openings or inlets 1507. Supply tube 1502 may supply positive pressure generated from an air or gas stream from a humidifier or other device into hollow cavity 1509. The positive pressure generated from the air or gas stream pushes shuttle 1508 along hollow cavity 1509 until it blocks the opposite opening 1507. Blocking of the opposite opening 1507 prevents air from traveling through this opening 1507 while still allowing air to flow through these tines 1505. In some embodiments, supply tube 1502 may be attached to opening 1507 of manifold 1501 and the opposite opening 1507 is blocked by shuttle 1508. For example, to switch the side of supply tube 1502 relative to manifold 1501, supply tube 1502 may be removed from one opening 1507 and inserted into the opposite opening 1507 and shuttle 1508 will automatically switch sides. In some embodiments, opening 1507 may have a locally thin walled section 1510, preferably which defines an annular shape around opening 1507. Locally thin walled section 1510 may deform relative to at least one surrounding portion of manifold 1501 to assist in sealing hollow cavity 1509 at this end when shuttle 1508 is pushed towards this side. In certain embodiments, shuttle 1508 may be made of a relatively soft material, such as the material used to make compressible ear plugs (e.g., compressible PVC foam) to further assist in sealing hollow cavity 1509.

[0523] In some embodiments of nasal cannula assembly 1500, manifold 1501 has at least one nasal tine 1505, and preferably, a pair of nasal tines 1505. Preferably, nasal cannula assembly 1500 includes nasal tines 1505 positioned on or configured to be positioned on manifold 1501. In certain embodiments, these tines 1505 on manifold 1501 may be flexible or rotatable to allow nasal cannula assembly 1500 to be used in either orientation. The tines 1505 shown in FIG. 15 include a distal end 1521 and a proximal end 1522. The distal end 1521 of each nasal tine 1505 is configured to be placed inside a user's nose during use. The proximal end 1522 of each tine 1505 is configured to be attached to or flush with a tine outlet hole 1520 in manifold 1501 and manifold 1501, the tine outlet hole being in communication with the interior space of these tines 1505. In some embodiments, the tines 1505 are double nasal tines and are located in the middle of the manifold 1501 body.

[0524] 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 that is coupled to the end of the supply tube 1502 and is configured to be coupled to the manifold 1501. The connector 1530 can have a snap-fit arrangement with the opening 1507 of the manifold 1501. In some configurations, the connector 1530 can include a groove that is engaged by any one of these openings 1507 of the manifold 1501, and the thin wall section 1510 can facilitate sealing between the manifold 1501 and the connector 1530.

[0525] Figure 15E -G shows an alternative coupling arrangement between the supply tube 1502 and the manifold 1501 that incorporates an insert 1540 that facilitates connection between the supply tube 1502 and the manifold 1501. In some configurations, the manifold 1501 is made of a soft and / or stretchable material, which can increase user comfort. The insert 1540 can be made of a relatively hard material, which preferably has a hardness greater than that of the material of the manifold 1501, such that the insert 1540 can be positioned within one or both of the 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 fix 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 a recess or opening 1544 of the manifold 1501. In the illustrated arrangement, the protrusions 1542 are buttonhead or mushroom-headed protrusions having an enlarged head portion at the distal end of the shaft portion relative to the body of the insert 1540. When the inserts 1540 are assembled onto 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 assist in assembling the inserts 1540 into the manifold 1501 and the protrusions 1542 through the openings 1544.

[0526] The connector 1530 may be shaped or otherwise configured to engage the insert 1540 so as to securely connect the supply tube 1502 to the manifold 1501. In the illustrated arrangement, the connector 1530 includes at least one interlocking member, such as the resilient arm portions 1546. Preferably, the 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 the insert 1540. The illustrated connector 1530 includes a cylindrical base portion 1550 between the flange 1552 and the arm portions 1546. The flange 1552 has an enlarged diameter or circumferential dimension relative to the base portion 1550 to define a shoulder 1554 that may abut an end surface of the insert 1540 opposite the end surface engaged by the protrusions 1548. Thus, the linear distance between the shoulder 1554 and the protrusions 1548 may be substantially equal to the length of the insert 1540. In some configurations, the arm portions 1546 may flex 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 the manifold 1501 and a section of the insert 1540 are configured such that neither the insert 1540 nor the shuttle 1508 blocks the tines 1505.

[0527] Figure 16A -Figure F shows an embodiment of a nasal cannula assembly with a manifold that has one-way valves at each end. Similar to the embodiment discussed in FIG. 15, Figure 16A -Figure F shows a nasal cannula assembly 1600 having a manifold 1601 with nasal tines 1605 in an intermediate portion, a hollow cavity 1609, and an inlet or opening 1607 on each side of the manifold 1601. A supply tube 1602 may be attached to either opening 1607 of the manifold 1601. However, instead of a shuttle (e.g., valve body 1508) that seals the hollow cavity 1609 at one opening 1607 or in addition thereto, 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 being positioned against the one-way valve 1608. In certain embodiments, the opposing one-way valves 1608 remain sealed and thus air or gas flow from the supply tube 1602 will be directed toward the nasal tines 1605. In some embodiments, the one-way valve 1608 may be molded into the manifold 1601. In other embodiments, the one-way valve 1608 may be assembled as an insert configured to be inserted into the manifold 1601. In certain embodiments, the one-way valve 1608 may also function as a pressure blow-off safety valve to release excessive pressure.

[0528] Figure 16A-F shows an embodiment of a nasal cannula assembly 1600 having a manifold 1601 with a one-way valve 1608, the one-way valve 1608 being formed from an exhalation valve with a flap 1608a that is hinged loosely ( Figure 16E ). In some embodiments, the supply tube 1602 can be inserted through the one-way valve 1608 as shown in Figure 16C , thereby keeping the flap open together 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 airflow from the supply tube 1602, as shown in Figure 16D . The supply tube 1602 can be connected directly or through any suitable connector (such as any of these connectors disclosed herein) to the manifold 1601. The valve 1608 can have any suitable shape, such as circular ( Figure 16A -E) or rectangular ( Figure 16F ).

[0529] Figure 16G -L shows a nasal cannula assembly 1600 having a manifold 1601 with a one-way valve 1608, the one-way valve being formed from a different type of slit valve. Preferably, the one-way valve 1608 includes a stretchable material. In some embodiments, the one-way valve 1608 can be a slit valve ( Figure 16G and 16H ), and in particular can be a duckbill valve ( Figure 16I and 16J ), a joker valve or a tricuspid valve ( Figure 16K ), a slit-dome valve ( Figure 16L ), and / or any other slit valve known in the art. The supply tube 1602 can be connected directly or via a connector 1630 to the manifold 1601 through any suitable arrangement.

[0530] Figure 17 shows an embodiment of a nasal cannula assembly 1700 having a supply tube 1702 that passes through a manifold 1701 to permit selective side 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 end 1710 and the second end 1711 may have corresponding manifold inserts 1712, 1713 attached thereto. The manifold inserts 1712, 1713 may each have one or more manifold insert openings 1714 (e.g., a pair of openings 1714 on opposite sides of the inserts 1712, 1713) extending along a section of the manifold inserts 1712, 1713. Additionally, the inserts 1712, 1713 may each include a pair of spaced apart flanges 1716 that are positioned on opposite sides of these openings 1714 and are configured to create at least one substantial seal with the manifold 1701. A recess 1718 is defined between these flanges 1716 such that air or gas communication between these openings 1714 and these nasal forks 1705 is ensured regardless of the position of these openings 1714.

[0531] In certain embodiments, regardless, the tube exit side can be selectively chosen by pushing or pulling the supply tube 1702 to 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 that are 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 at 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 a gas or air supply circuit. In some embodiments, connecting the supply tube 1702 to the circuit may require a connector or adapter 1715 such that a proper fit to a humidifier or other gas or air supply can be achieved. Additionally, in other embodiments, the supply tube is connected to the gas or air supply circuit using a dedicated connection, 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 be aligned with the nostrils 1705 on the manifold. Additionally, in some embodiments, once the supply tube 1702 is pulled to the desired side of the manifold 1701, the manifold inserts 1712, 1713 can be held in place with a locking mechanism. In some embodiments, the locking mechanism can include a twist lock, press fit, screw, or any other locking mechanism known in the art.

[0532] Figure 18A and 18B illustrates an embodiment of a nasal cannula assembly in which each fitting outlet hole is sealed by a membrane or other pierceable member. Similar to the embodiment described with reference Figure 15A -G, Figure 18A and 18 illustrate a nasal cannula assembly 1800 having a manifold 1801 with nostrils 1805 in the middle portion, a hollow cavity (not shown), and openings 1807 on each side of the manifold 1801. A supply tube 1802 can be attached to either opening 1807 of the manifold 1801. In some embodiments, the openings 1807 of the manifold 1801 are sealed by a membrane 1810. The membrane 1810 can be a film, a pierceable film, 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, e.g., a sharpened point 1812 capable of piercing the membrane 1810 at any one of the openings 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 the circumferential edge ( Figure 18A ), or at or near the center ( Figure 18B). When the sharpening point 1812 is at or near the center, the distal portion 1811 may define one or more openings 1814 to allow air or gas to pass through the distal portion 1811. In some embodiments, the user may select the side on which the supply tube 1802 is positioned, and the distal portion 1811 of the supply tube 1802 may be used to pierce the membrane 1810 on this opening 1807. 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 may be replaceable or releasable. In some embodiments, the distal portion 1811 may include one or more barbs to assist in piercing the membrane 1810 and / or securing the distal portion 1811 within the manifold 1801. In some embodiments, these barbs or sharp segments may be removed prior to inserting the supply tube 1802, and the supply tube 1802 may be press-fitted into the opening 1807 of the manifold 1801. In some embodiments, the barbs or the distal portion 1811 may remain on the supply tube 1802 and may assist in securing the supply tube 1802 within the manifold 1801. In some embodiments, the distal portion 1811 may have a cap that prevents injury to the user or damage to the distal portion 1811 when not in use and ensures that the distal portion remains clean and sterile prior to use.

[0533] In some embodiments, selective side switching of the manifold and the nasal fork relative to the supply tube may be accomplished by operating the supply tube. Figure 19 An embodiment of the manifold 1901 is shown, in which the flexible supply tube 1902 exits the opening 1907 of the manifold 1901. In the arrangement shown, only one opening 1907 is provided since 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. The highly flexible tube may allow the supply tube 1902 to be routed to either side facing or away from the mouth. In some embodiments, a highly flexible tube member that can bend around a zero radius without substantial kinking or at least without completely occluding the internal passage of the tube is used. Preferably, the bending of the highly flexible tube does not cause substantial occlusion of the internal passage of the tube. In some embodiments, the highly flexible supply tube 1902 may 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 the nasal cannula assembly parts. In certain embodiments, the flexible supply tube 1902 may exit from the opening 1907 from the front of the manifold 1901 and may bend at least approximately 90 degrees to the left or right side of the face.

[0534] In addition, in some embodiments, the manifold may be configured to be inserted into the component fixture in either direction, thereby allowing the nasal cannula assembly to be used interchangeably with tubing from the right or left side of the patient. 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, by allowing the manifold 2001 to be inserted into the clip 2003 in at least two different orientations, the manifold 2001 can switch interchangeably the side on which the supply tube 2002 is positioned. In some embodiments, the manifold 2001 and the supply tube 2002 may be integrated into a 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 in place. The two available orientations of the supply tube 2002 are shown respectively in 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.

[0535] Additionally, in some embodiments, the manifold may be configured to be used with a clip-on supply tube. For example, Figure 21A -D shows a nasal cannula assembly 2100 having a separable supply tube assembly 2102 and a manifold 2101. In some embodiments, the nasal cannula assembly 2100 may include a manifold 2101 that includes a nasal fork 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 clip 2112, as in Figure 21AAs shown in -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 shape or a mating shape to receive 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, where the supply tube 2102 is positioned as desired in any orientation. In certain embodiments, the manifold receiving mechanism 2112 can have positioning and / or sealing details 2113 incorporated on the inner side of the manifold receiving structure 2112 or elsewhere on the structure to ensure a fixed connection and / or proper sealing with the manifold 2101. In some configurations, the sealing detail 2113 is a protrusion, such as a spherical protrusion. The sealing detail 2113 preferably seals one of these 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 against and be flush with the outer surface of the manifold 2101 surrounding the opening 2107 ( Figure 21C ), or can extend into the opening 2107 ( Figure 21D ).

[0536] In some embodiments, one or more stops 2104 can be molded into the manifold 2101 or otherwise fixed to the manifold 2101 to prevent or inhibit downward movement of the manifold receiving structure 2112 when being pulled during use. For example, as Figure 21A shown, 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 be slid upward relative to the manifold 2101 to remove and flip the side of the pipe fitting. In some configurations, as Figure 21E shown, multiple 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 fixing the manifold receiving structure 2112 to the manifold 2101. As Figure 21F shown, the manifold 2101 can include a recessed portion 2120 sized and shaped to receive the manifold receiving structure 2112. The recessed portion 2120 can be located in the front and side portions of the manifold 2101 and can have a depth suitable for accommodating the entire thickness of the manifold receiving structure 2112 such that the outer-facing surface of the manifold receiving structure 2112 is flush with or recessed into the outer surface of the manifold 2101. This arrangement assists in fixing the manifold receiving structure 2112 to the manifold 2101 and / or can inform the user how to correctly position and fix the manifold receiving structure 2112 to the manifold 2101. The recessed portion 2120 can be utilized alone or in combination with these recesses 2118.

[0537] Figure 21G and 21H 21H illustrates an embodiment of a nasal cannula assembly 2100 having a manifold receiving structure 2132, a separate nasal prong insert 2125, and a manifold 2121. In some embodiments, the manifold 2121 may not have a prong and an opening 2126 in the manifold 2121 that communicates with the prong insert 2125. The prong insert 2125 may be formed with prongs 2105 of different sizes such that appropriately sized prongs 2105 can be selected for different nose sizes and proper prong sizing for a patient can be ensured. In some embodiments, the manifold 2121 and the prong insert 2125 may be connected to the manifold receiving structure 2132, such as a C-clamp. In some embodiments, the manifold receiving structure 2132 may be used to hold the prong insert 2125 in place and to complementarily mate with the manifold 2121. Accordingly, the manifold receiving structure 2132 may include one or more openings 2128 that receive these prongs 2105. The manifold 2121 may include a recess 2134 that surrounds the opening 2126 and receives the base of the prong insert 2125. The manifold 2121 may also include recessed portions 2136 on its lateral sides that are configured to receive the manifold receiving structure 2132 and to assist in securing the manifold receiving structure 2132 to the manifold 2121. Although in the illustrated arrangement the opening 2126 is positioned on the upper surface of the manifold 2121, additionally or alternatively, the opening 2126 may be positioned on other portions of the manifold 2121 (e.g., the front surface).

[0538] 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 forks 2205 and openings 2207 at each end of the manifold insert 2201. The manifold insert 2201 may be made of a soft or flexible material. These forks 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 headcap 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 a supply tube 2202 on the side of the open end 2214 of the manifold receiving structure 2210 such that air or gas passes therethrough. In some embodiments, the manifold insert 2201 may be clipped or slid into the manifold receiving structure 2210. In some embodiments, the manifold receiving structure 2210 may have a circular or spherical boss or protrusion 2211 at one end 2213 of the manifold receiving structure 2210 that provides an effective radial seal to one opening 2207 of the manifold insert 2201 and aids in holding the manifold insert 2201 in place. The other end 2212 may include a connector 2214 that may be integral with or separate from the supply tube 2202 and engages 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 forks 2205 may be turned or tilted into a correct and comfortable configuration for the user. For example, in some embodiments, to flip the side of the tubing, 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 such that the supply tube 2202 faces the desired direction, and then the manifold insert 2201 with the forks 2205 is reassembled to point back towards the patient's nose.

[0539] Figure 23A-C shows an embodiment of a nasal cannula assembly having a manifold receiving structure or sleeve that can be clamped onto a supply fitting assembly, which includes a manifold. In some embodiments, the nasal cannula assembly 2300 includes a supply tube assembly 2311 that includes a manifold 2301 and a supply tube 2302. The nasal cannula assembly 2300 also includes a manifold receiving structure or sleeve 2310 that includes a pair of nasal forks 2305. The supply tube 2302 connects the manifold 2301 to an air or gas supply circuit. In some embodiments, the manifold receiving structure 2310 can be a generally tubular member, where an opening or slot 2313 extends along part or all of its length to form a 'C'-shaped section that can be clamped onto the manifold 2301. In some embodiments, the manifold 2301 can have a protruding portion 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 to fix 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 fixing device 2303 such as a head cap 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, and reconnected so that the supply tube 2302 faces the desired direction.

[0540] Figure 24A -F shows an embodiment of a flexible, tiltable, or direction-adjustable fork and an embodiment of a nasal cannula assembly 2400 having such a flexible, tiltable, or adjustable fork 2405. With such a fork 2405, the exit side of the supply tube 2402 can be changed by simply adjusting the direction of these forks 2405 and rotating the manifold / fitting assembly 2404 on the patient's face by 180 degrees.

[0541] Reference Figure 24A -C, in certain embodiments, these forks 2405 can be flexed to the side of the manifold 2401 desired for use. Specifically, the forks 2405 can be formed with a corrugated shape around the base of the forks 2405. Figure 24B and 24CAn embodiment is shown in which a prong 2405 having a corrugated shape 2408 formed around a base is provided such that the prong 2405 is flexible. In some embodiments, the corrugated shape 2408 includes at least one, and preferably, a plurality of corrugations. In the arrangement shown, two corrugations are provided; however, in other embodiments, three or more corrugations may be provided. These corrugations are shown as being annular in shape and having a semi-circular cross-section. These corrugations may have a reduced wall thickness relative to a portion of the manifold 2401 adjacent to these corrugations, or may have the same or a similar wall thickness. The corrugated shape 2408 allows the prong 2405 to be formed in any one of the directions desired for use. In some embodiments, the prongs 2405 may have a corrugated shape 2408 around the base that allows them to be tilted in any direction. In certain embodiments, the prongs 2405 may have one or more thickened segments or one or more reinforcing ribs 2407 such that the prongs favor certain tilting directions, thereby allowing the prong 2405 to bend in a first direction while preventing or inhibiting the prong 2405 from bending in a second direction that is substantially perpendicular to the first direction. In the arrangement shown, 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.

[0542] Figure 24D -F shows an embodiment of a prong 2405 that includes a collapsible corrugated bellows-like folding segment that may define a portion or substantially all of a section of the prong 2405. Preferably, the formation of these prongs 2405 having such a geometry allows these prongs 2405 to bend in any direction and maintain that shape. In some embodiments, the prongs 2405 may be compressed and extended to change the length of the prong 2405, as Figure 24D and 24E shown. In some embodiments, the prongs 2405 may expand from a compressed shape and bend to a desired direction or shape, as Figure 24F shown. For example, in certain embodiments, these prongs 2405 are packaged in a compressed form and are then inflated and bent to an appropriate direction and shape by a caregiver or user according to the configuration.

[0543] In some embodiments, the nasal cannula assembly may include rotatable prongs. Figure 25A -C shows an embodiment of a nasal cannula assembly 2500 having rotatable prongs. In some embodiments, the nasal cannula assembly 2500 may be flipped to change the side of the supply tube 2502, and in turn, these prongs 2505 may be rotated to face an appropriate orientation towards the patient's nose. Figure 25AAn embodiment of a nasal cannula assembly 2500 is shown that includes a rotatable fork 2505 individually. In some embodiments, the fork can rotate freely in a clockwise or counterclockwise direction relative to the manifold 2505. In some embodiments, when the manifold 2501 and the fork 2505 are formed as a unit, the fork 2505 can rotate to a limited extent.

[0544] Figure 25B and 25C An embodiment of a nasal cannula assembly 2500 is shown that includes a fork insert 2506 having a pair of forks 2505. Preferably, the fork insert 2506 is rotatable relative to the manifold 2501. The shown fork insert 2506 is mounted on a vertical axis 2508 and is rotatable about the vertical axis such that the forks 2505 rotate together. In some embodiments, the fork insert 2506 is a separate component from the manifold / plumbing assembly 2504, and the removable fork insert 2506 can allow different sized forks 2505 to be used for different nose sizes while using a single sized manifold 2501. Additionally, in some embodiments, the manifold 2501 can have a lip 2510 on the surface of the manifold to which the fork insert 2506 is connected. The fork insert 2506 can have a mating section 2511 complementary to the lip 2510. In some embodiments that include the lip 2510 on the manifold 2501, the fork insert 2506 can be lifted from the surface of the manifold 2501 and rotated about the vertical axis 2508 such that the forks 2505 can be repositioned to an appropriate orientation. The fork insert 2506 can rotate about the vertical central axis of the manifold 2501 or about an axis centrally located relative to an opening 2518 in the manifold 2501 that communicates with the nasal forks 2505, as Figure 25B shown, such that the forks 2505 switch the opening 2518 between two orientations.

[0545] In some embodiments, the manifold can have a fork exit hole in a central portion of the manifold that is configured to receive an insert or a clip-on attachment that includes the forks. Figure 26A-F shows an embodiment of a nasal cannula assembly 2600 configured to allow insertion of a removable fork insert 2606. In some embodiments, the fork insert 2606 can be pushed into an opening 2607 of a hollow manifold 2601. This allows the tines 2605 to be configured in a proper orientation for use by a patient within 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 headcap strap. For example, in some embodiments, the supply tube 2602 and the manifold 2601 are assembled together with the fixture 2603, and the nasal tines 2605 are held by the removable nasal fork insert 2606. The manifold / tube assembly 2604 and the assembly fixture 2603 can be symmetric such that it can be assembled onto the face in one orientation (e.g., Figure 26B ), or in an opposite orientation (e.g., Figure 26C ). In some embodiments, the assembly fixture 2603 and the manifold / tube assembly 2604 can be flipped to fit either orientation of the supply tube 2602 desired. For example, in certain embodiments, to switch sides, the supply tube 2602 is positioned, the nasal fork insert 2606 is removed, and the remainder of the manifold / tube assembly 2604 is flipped such that the supply tube 2602 faces the desired direction, and then the nasal fork insert 2606 is reinserted into the receiving opening 2607 of the manifold / tube assembly 2604 in the correct orientation pointing towards the patient's nose. Additionally, the nasal fork insert 2606 can have different sizes ( Figure 26D -F), and inserts of different sizes are interchangeable on the same assembly 2604 for use with and adaptation to different patient nose sizes, and to ensure proper fork size estimation for the patient.

[0546] In some embodiments, a nasal cannula assembly can 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 can be adjustable about two axes relative to the manifold and can be used with different fork sizes to allow the assembly to fit a number of patients. Specifically, referring to Figure 27A -D, the nasal cannula assembly 2700 includes a pivotable cannula 2714 that preferably incorporates a pair of nasal tines 2705. The cannula 2714 is pivotally coupled to a mold (headband mold) or manifold 2701 that can include sides 2722 extending from the cannula 2714 in opposite lateral directions. A suitable retention assembly (not shown), such as a headcap strap, can secure the manifold 2701 and the cannula 2714 to the patient. In some arrangements, the headcap strap is an elastic, highly stretchable strap that can assist or improve the seal between the manifold 2701 and the cannula 2714. The headcap strap can be integral with, integrated with, or separate from the manifold / mold 2701.

[0547] Preferably, the manifold 2701 defines a conduit or passageway 2709 that permits air or gas to transfer from the supply tube 2702 to the cannula 2714. The passageway 2709 may be defined by the mold (e.g., a single integrated structure) from which the manifold 2701 and the side strap 2722 are constructed or may be defined by separate components. The supply tube 2702 may be coupled to the manifold 2701 by any suitable arrangement (such as the mandibular expander arrangement or any other arrangement disclosed herein). A clip 2742 may secure the supply tube 2702 to the side strap 2722. The end of the supply tube 2722 opposite the manifold 2701 may include a connector 2752 that permits coupling of the supply tube 2722 to an air or gas source.

[0548] In some embodiments, the cannula 2714 may rotate about an axis that extends generally anteroposteriorly relative to the manifold 2701 or about a generally horizontal axis that lies in the sagittal plane. Preferably, the cannula 2714 may rotate at least 180 degrees such that the tines 2705 may rotate from a top ( Figure 27A orientation) to a bottom, thereby providing an effective change in the exit side of the supply tube 2702. In some embodiments, the cannula 2714 is coupled to the manifold 2701 by a ball joint 2726 such that the cannula 2714 may also rotate about an axis that extends generally laterally or about a generally horizontal axis that exists in the frontal plane. Such an arrangement not only provides a simple change in the exit side of the supply tube 2702, but also permits adjustment of the orientation of the nasal tines 2705 relative to the manifold 2701, thereby increasing patient comfort and / or accommodating more patients.

[0549] In some embodiments, the size of the tines 2705 is adjustable. For example, as Figure 27B and 27C shown, the ball joint 2730 may be separated from the tine portion 2732 of the cannula 2714. A number of tine portions 2732 may be included in a kit or a number of different sized nasal tines 2705 may otherwise be provided and made available. For example, three different tine portions 2732 are shown in Figure 27C which includes three different sized tines 2705. A suitable or desired one of the available tine portions 2732 may be coupled to the ball joint portion 2730, for example, via a snap fit or other suitable arrangement. Alternatively, two or more cannulas 2714 may be provided, each having different sized tines 2705. Thus, with such an arrangement, the cannula 2714 may be constructed as a single piece.

[0550] However, it is not necessary for the cannula 2714 to rotate about multiple axes or even to rotate through an arc. Instead, the cannula 2714 may have discrete adjustment positions relative to the manifold 2701. Preferably, there is provided in Figure 27AThe at least one position shown in and the 180-degree rotation of the sleeve 2714 enable the exit side of the supply tube 2702 to be switched. If desired, other discrete position options may be provided. The sleeve 2714 and the manifold 2701 may include interference surface features that assist in fixing the sleeve 2714 in the desired position relative to the manifold 2701. For example, as Figure 27D shown, the sleeve 2714 may include one or more teeth 2760 or other protrusions that engage corresponding depressions 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 employed.

[0551] In some embodiments, as Figure 28A shown, the nasal cannula assembly 2800 includes a manifold 2801 that can be coupled to the cannula 2814 in at least two orientations to allow for easy switching of the exit side of the supply tube 2802. The cannula 2814 may include a central portion having forks 2805 and sides 2822 on each lateral side of the central portion. The manifold 2801 may include sides 2812 that overlap the sides 2822 of the cannula 2814. These sides 2812 and 2822 may facilitate a fixed connection between the manifold 2801 and the cannula 2814. For example, one or both of the sides 2812 or 2822 of the manifold 2801 and the cannula 2814 may include a coupler or coupling mechanism that couples or assists in coupling the manifold 2801 and the cannula 2814. In the illustrated arrangement, these sides 2812 of the cannula 2814 include a first component 2830 of a coupler (e.g., a hook-and-loop fastener), and these sides 2822 of the cannula 2814 include a second component 2832 of a coupler (e.g., a hook-and-loop fastener). One or both of these sides 2812 of the manifold 2801 include tabs 2850 that provide a finger grip surface for facilitating removal of the manifold 2801 from the cannula 2814. Additionally, one or both of these sides 2812 may include a flexure slot 2828 that facilitates flexure of these sides 2812, which may assist in removing the manifold 2801 from the cannula 1814 and also facilitates conforming the manifold 2801 to the shape of the cannula 2814.

[0552] The manifold 2801 and cannula 2814 may include mating structures that create a seal between the two components. For example, the manifold 2801 may include a projecting portion 2860 that defines a cavity in communication with the supply tube 2802, and includes at least one and preferably a pair of openings 2862 that allow air or gas communication with the fork 2805 when the manifold 2801 is assembled onto the cannula 2814. The projecting portion 2860 engages an opening 2864 of the cannula 2814 and preferably, together with it, defines at least one substantial seal. The seal may be created by contact or engagement (e.g., a lip and groove) between the projecting portion 2860 and the opening 2864, or a separate sealing member (e.g., a perimeter seal or O-ring) may be used.

[0553] Fastening means such as a headgear strap 2840 may be used to fasten the cannula 2814 and thus the manifold 2801 to the patient. In some embodiments, the headgear strap 2840 is a non-extensible strap that is coupled to the sides 2822 of the cannula 2814. The ends of the headgear strap 2840 may be heat welded to the sides 2822 and may include the second components 2832 of a coupler between the manifold 2801 and the cannula 2814. The headgear strap 2840 may include an adjuster 2842 that is suitable for allowing adjustment of the circumference of the headgear strap 2840. In other arrangements, an extensible headgear strap 2840 may be used.

[0554] Reference Figure 28B , the cannula 2814 may be a composite structure and include a frame member 2870 constructed from a relatively rigid material and a body 2872 constructed from a relatively soft material. For example, the frame 2870 may be a rigid plastic or metallic material that may be deformable and that substantially retains its shape once deformed. The frame 2870 may be external to the body 2872, or the body 2872 may be molded onto the frame 2870. Preferably, the frame 2870 is located in the sides 2822 of the cannula 2814 and may be molded to bridge a central portion containing the fork 2805 that exits the nose, to reduce the pressure just under the nose and to spread the pressure applied to the patient over the sides 2822, thereby increasing comfort. The frame 2870 may also surround or partially or completely define the opening 2864, rather than extending into or in addition to the sides 2822.

[0555] Reference 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 at least one or both of the following purposes: 1) monitoring the pressure delivered to the patient; and 2) pressure feedback control of a blower flow source (e.g., a blower and humidifier 2990). Figure 29AShows a basic arrangement for providing pressure feedback control. Specifically, the pressure line 2910 connects the manifold 2901 (or manifold / sleeve assembly - the "manifold" hereinafter) to a flow source control system, which can be part of a blower / humidifier 2990. With such an arrangement, the flow source 2990 can utilize information about the pressure at or near the manifold 2901 provided by the pressure line 2910 during the operation of the flow source 2990 to regulate the pressure of the supply to achieve the desired delivery pressure at the patient. Advantageously, such an arrangement can compensate for a plurality of factors that may cause the delivery pressure to be different from what is expected, such as the length, cross-sectional area, or other geometry of the supply tube 2902. As long as pressure monitoring is required or desired, the pressure line 2910 can be connected to a pressure gauge or an alternative reader.

[0556] Reference Figure 29B , the pressure line 2910 can be passed through the wall of the manifold 2901 and terminated within the manifold space of the manifold 2901. In the shown arrangement, the end terminal 2912 of the pressure line 2910 is perforated to form a plurality of holes 2914 such that if some of these holes 2914 are blocked due to condensation, the other holes 2914 still function, so that the pressure within the manifold 2901 can be transmitted to the pressure source 2990. The end terminal 2912 of the pressure line 2910 can be positioned anywhere within the manifold 2901, for example but not limited to, between the supply tube 2902 and the forks 2905 along the flow path of the supplied air or gas.

[0557] Reference Figure 29C , the pressure line 2910 can allow direct or indirect communication between the manifold 2901 and the pressure source 2990. Figure 29C The arrangement separates the manifold chamber 2909 of the manifold 2901 from the pressure chamber 2916, which is in direct communication with the pressure line 2910 or directly sensed by the pressure line. For example, a flexible diaphragm seal 2918 (or other movable membrane or member, such as a floating piston or a sliding piston) separates the manifold chamber 2909 from the pressure chamber 2916 to prevent condensate from entering the pressure line 2910 and keep the pressure line 2910 clean.

[0558] Reference Figure 29D, the pressure line 2910 may include a pressure sensor 2930 that can sense the pressure within the manifold chamber 2909. The pressure sensor 2930 may be located within the manifold 2901, such as a plug configured to engage and / or close one end of the manifold 2901. In some embodiments, a spacer, such as a wall or membrane 2918, is positioned between the pressure sensor 2930 and the manifold chamber 2909. The membrane 2918 can be of any suitable type, such as an ultra-thin silicone membrane. The pressure sensor 2930 can be of any suitable type, such as an electrical pressure sensor. The pressure sensor 2930 can be pushed upward against the membrane 2918, which can conform to the shape of the pressure sensor 2930 in order to measure the pressure without directly contacting the air or gas flow, thereby avoiding condensate accumulation on the pressure sensor 2930. Additionally, with such an arrangement, the membrane 2918 can be constructed to close and seal the end of the manifold 2901 such that the nasal cannula assembly 2900 can be used with or without the pressure sensor 2930.

[0559] Reference Figure 29E , the membrane 2918 can be a self-sealing slit valve through which the pressure line 2910 and / or the pressure sensor 2930 can be inserted if desired. Advantageously, in the absence of the pressure line 2910 and / or the pressure sensor 2930, the self-sealing slit valve 2918 can be closed such that there is no substantial leakage if it is removed. Thus, the nasal cannula assembly 2900 can function with or without the pressure line 2910 and / or the pressure sensor 2930.

[0560] Reference Figure 29F , the pressure line 2910 and the supply tube 2902 can be integrated in a 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 the installation of the nasal cannula assembly 2900 by avoiding the need to connect multiple tubes or components to the manifold 2901.

[0561] Reference 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 that is connected to the manifold 2901, and the supply tube 2902 can be connected to the plug portion 2932. Alternatively, reference Figure 29H , the pressure line 2910 can be connected as an optional accessory that leaves the supply tube 2902 separately, such as on the opposite side of the manifold 2901 from where the supply tube 2902 exits. The pressure line 2910 can have a plug portion 2932 that replaces the plug 2934 of the manifold 2901.

[0562] Reference Figure 29I, A small blower 2940 or other air or gas source may be connected to the pressure line 2910 to apply a small air or gas flow through the pressure line 2910, preferably sufficient to expel some or all of any condensate that has accumulated inside the pressure line 2910. The airflow 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.

[0563] Reference Figure 29J , A flexible diaphragm seal 2918 (or other movable barrier) may separate the manifold chamber 2909 from the pressure measurement chamber 2916 to prevent or inhibit condensate from entering the pressure line 2910 and to keep the pressure line 2910 clean. If the pressure measurement feature is not utilized and thus the pressure line 2910 is not required, the opening or port 2942 of the manifold 2901 that receives the pressure line 2910 may remain open and function as a vent to the pressure measurement chamber 2916. Alternatively, if desired, for example in the case of a suitable plug, the port 2942 may be closed.

[0564] In some embodiments, reference Figure 29K , For example, electrical wiring 2944 is incorporated within the helical stays 2946 of the supply tube 2902. The electrical wiring 2944 may be connected to an electrical pressure sensor 2930 mounted within the manifold 2901. The wiring 2944 (or additional wiring) may also be used to heat the supply tube 2902. In some arrangements, the wiring 2944 may switch between taking pressure and temperature readings and heating.

[0565] Reference Figure 29L , The helical reinforcement 2946 of the supply tube 2902 may be hollow or otherwise contain a passageway that serves as a pressure line (similar to the pressure line 2910 disclosed herein). With such an arrangement, there will be no need to use an additional pressure line (e.g., 2910). The helical reinforcement 2946 may be connected at one end to the chamber of the manifold 2901 and at the other end to the operating system of an air or gas source, or a pressure monitor or pressure gauge 2948.

[0566] In some embodiments, the nasal cannula assembly includes features that improve patient comfort. There may be discomfort for certain patients using certain nasal cannula assemblies. For example, two types of discomfort include: 1. The heat, dampness, and wet cold sensation when the cannula / manifold contacts the upper lip, which may be caused by moisture from sweating and the circulation of warm, moist gas in this area, and 2. The pain and numbness associated with the pressure exerted by the cannula / manifold on the upper lip. Some embodiments of the nasal cannula assembly 3000 address at least one or both of these types of discomfort to some extent.

[0567] Reference Figure 30A , holes, depressions or indentations 3020 of any desired shape can be cut or otherwise formed in the cannula or manifold (hereinafter "cannula") material, which allows fresh air to reach the skin, helps keep the area cool and reduces the accumulation of moisture. In some embodiments, these holes, depressions or indentations 3020 can be cut or formed in areas that do not cause leakage of the therapeutic airflow from the cannula 3014. For example, these holes, depressions or indentations 3020 are provided in these sides 3022 of the cannula 3014 rather than in the central portion containing these forks 3005. In the illustrated arrangement, holes 3020 that completely pass through these sides 3022 of the cannula 3014 are provided. These holes, depressions or indentations 3020 can also improve the flexibility of the cannula 3014, allowing it to more easily conform to the shape of the patient's lip and distribute pressure more evenly, so as to improve comfort.

[0568] Reference Figure 30B , the cannula 3014 may also include small bumps or protrusions 3030 on the rear or patient-facing surface of the cannula 3014. The bumps 3030 keep some or all of the remaining rear or patient-facing surface of the cannula 3014 away from the patient's lip, allowing fresh air to reach the skin, helping keep the area cool and reducing moisture accumulation. The bumps 3030 can be provided on the entire rear surface as shown, or only on a part of the rear surface, such as on these sides 3022 of the cannula 3014 similar to Figure 30A .

[0569] Reference Figure 30C , grooves 3040 can be cut or otherwise formed in the rear surface of the cannula 3014. These grooves 3040 allow fresh air to reach the skin, help keep the area cool and reduce moisture accumulation. In some embodiments, these grooves 3040 extend in a generally vertical direction or perpendicular to the transverse direction of the cannula 3014. Additionally, these grooves 3040 can extend partially through the cannula 3014 such that one end is closed, or can extend completely through the cannula 3014 such that both ends are open, as shown in Figure 30C . These grooves 3040 can also improve the flexibility of certain parts (e.g., sides 3022) or all of the cannula 3014, allowing it to more easily conform to the shape of the patient's lip and distribute pressure more evenly, so as to improve comfort.

[0570] Reference Figure 30D-H. In some embodiments, the cannula 3014 may include a cannula lip bridging arrangement, where the cannula 3014 is shaped such that it curves away from the face at the upper lip, thereby reducing pressure or completely avoiding any contact with the upper lip, resulting in an improvement in fresh air circulation in the area and reducing (e.g., little or no) pressure on the lip. The pressure is instead applied by these sides 3022 and absorbed by the cheeks, which are less sensitive to pressure. In some arrangements, these forks 3005 are horizontally reversely mounted on the inner side of the cannula 3014 and curve upward into the nostrils. This design has the additional benefit of allowing the clearing of mustaches.

[0571] 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 harder material for the cannula 3014 ( Figure 30D -F), reinforcing ribs, or structural members such as internal ( Figure 30G ) or external ( Figure 30H ) wires or strips 3050, which are malleable for adjustment to fit the individual patient. The cannula 3014 can be any suitable arrangement, such as having and integrating or directly connecting a supply tube 3002, or for example by utilizing a manifold 3001 that is connected to the supply tube 3002 and received within the cannula 3014.

[0572] Referring Figure 30I , in some embodiments, a comfort pad or insert 3060, such as a gel pad or other type of pad, may be provided on the rear or patient-facing surface of the cannula 3014. At least the rear surface of the cannula 3014 that contacts the patient's upper lip may be made of a soft gel material or may include a soft gel pad 3060, which in some arrangements may be shaped to the shape of the patient's lip to create a relatively large contact surface area, thereby evenly distributing the pressure across the skin. The pad 3060 may deform as the headgear strap or other retention mechanism (not shown) is tightened to adapt to the geometry of the patient's face and prevent the occurrence of local pressure areas. The pad 3060 preferably occupies a substantial portion of this rear surface, such as substantially all of it. The pad 3060 may be scented to make the odor of the cannula 3014 more pleasant.

[0573] In some embodiments of the nasal cannula assembly, the supply tube can be manually shaped or positioned and held or substantially held in that 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 Limited, is that eating, drinking, and speaking are possible while being treated. In some cases, the shape or position of the supply tube exiting the cannula can restrict these activities. Thus, in some embodiments, it may be desirable to be able to shape or position the supply tube as desired. Any suitable arrangement or technique can be used to shape or position the tube member, such as those described herein with reference to Figure 31A -F.

[0574] Referring to Figure 31A and 31B , the supply tube 3102 can include an internal axial extensible wire or strip 3150. The supply tube 3102 can be assembled or formed with an internal axial extensible 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 such that the shape is held or substantially held after being formed. The wire or strip 3150 can be included within the supply tube 3102 or otherwise coupled to the supply tube in any suitable manner. For example, as shown in Figure 31A , the wire or strip 3150 can be embedded in the wall of the supply tube 3102, outside of the supply passage of the supply tube 3012. Alternatively, as shown in Figure 31B , the wire or strip 3150 can be provided within the supply passage or 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 coat the wire or strip 3150 with the material in order to be resistant or suitable for contact with the supplied air or gas. Referring to Figure 31C , the wire or strip 3150 can be, for example, an extensible helically coiled wire or strip coiled around the circumference of the supply tube 3102 in a helical manner. The wire or strip 3150 can be covered or contained within another material (e.g., plastic) to form a bead 3152. The bead 3152 can impart a tube structure (e.g., a reinforcing bead) that is also shapeable or formable or at least substantially holds the shape or form of the adjusted supply tube 3102. Advantageously, with such an arrangement, the bead helix 3152 coiled around the outside of the supply tube 3102 keeps it out of the air or gas path.

[0575] Referring to Figure 31D and 31E, the supply tube 3102 can be in the form of a folded bellows having one or substantially an entire section of folded corrugations 3160, which, if desired, can be used to set one or both of the length and position of the supply tube 3102. These corrugations 3160 can be manufactured such that the supply tube 3102 is compressed in length or the axial direction, and each of these corrugations 3160 will fold into them. Figure 31D shows the supply tube 3102 in an axially compressed orientation, and Figure 31E shows the supply tube 3102 in an axially uncompressed or elongated position. The supply tube 3102 can be connected to the cannula 3114 by any suitable arrangement, such as directly or via a suitable connector. Refer to Figure 31F , alternatively, the supply tube 3102 can include one or substantially an entire section constructed as a ball-and-socket chain. Specifically, at least one section of the supply tube 3102 is composed of a plurality of individual segments or members 3162 or the like, which together form a sealed or substantially sealed yet still positionable or formable tube. Preferably, one end of each segment 3162 includes a ball end 3164, while the other end includes a socket 3166. Thus, a plurality of 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 fitting of the ball end 3164 within the socket 3166 can be such that each segment 3162 can rotate or move relative to an adjacent segment 3152, yet provide sufficient frictional force for sealing or substantially sealing and remain in place or substantially in place once adjusted. If desired, additional structures or arrangements, such as sleeves extending over these segments 3162, can be used to hold these segments 3162 in an assembled state or assist in holding or sealing these segments 3162. Advantageously, these and similar embodiments can allow the supply tube 3102 to be positioned outside the path of the patient in order to reduce or minimize interruptions to eating, drinking, and speaking during treatment.

[0576] In some existing nasal cannula assemblies, the supply tube hangs down from its attachment point all the way to the cannula or manifold, often just above the corners of the mouth. Such an arrangement can cause, among other problems, the hanging of the supply tube very close to the mouth, which can be troublesome for the patient as it interferes with eating, drinking, and speaking. Additionally, the weight of the supply tube hanging down close to the nose tends to drag down one side of the cannula or manifold, pulling it out of the nose. This is particularly practical in high-flow therapy, where a relatively large supply tube is required and cannot be routed comfortably behind the patient's ear as in the case of smaller low-flow systems. Accordingly, some embodiments route the supply tube out of the nasal cannula assembly to move it further away from the patient's nose and / or mouth, thus partially or fully addressing the above two problems.

[0577] Reference 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, the portion 3250 can be a sheath of hook-and-loop material. The sheath 3250 can be coupled to the supply tube 3202 by any suitable arrangement and can be removable or non-removable from the supply tube 3202. In the illustrated embodiment, the sheath 3250 is permanently attached to the supply tube 3202. The sheath 3250 can be moved along the supply tube 3202 or can be provided at a fixed position on the supply tube 3202, preferably at a position spaced apart from the manifold or cannula 3214 (the "cannula" hereinafter). The sheath 3250 can be secured to another portion 3252 of a hook-and-loop fastener or other coupler that can be suitably positioned to align with the sheath 3250 and preferably keep the vertical 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 of the other portion of the hook-and-loop fastener relative to the sheath 3250. In one arrangement, as Figure 32A shown in, pads 3252 are provided on each side of the headcap strip 3240 or other retaining mechanism of the nasal cannula assembly 3200. Accordingly, the supply tube 3202 can be routed to either side of the patient's face as desired and be supported to hang at a spaced position away from the patient's nose and / or mouth. In another arrangement, as shown in Figure 32C the pads 3252 are adhesive pads positioned on the patient's face preferably at a spaced position away from the nose and / or mouth (such as the cheek). In such an arrangement, the pads 3252 can be applied only to the desired side of the face for the desired routing of the supply tube 3202.

[0578] In addition to or in lieu of this, other suitable mechanisms for similarly securing the supply tube 3202 can be used. Figure 32D-F shows several mechanical fastening mechanisms for securing the supply tube 3202 such that the downwardly hanging portion is spaced apart from the patient's nose and / or mouth. Preferably, the first part 3250 of the mechanical fastener is positioned on the supply tube 3202 in a permanent or removable manner and in a fixed or movable manner. The second part 3252 of the mechanical fastener is positioned on a part of the nasal cannula assembly 3200, such as the headgear strap 3240 (alternatively, in another arrangement, the side 3222 of the cannula 3214). Thus, in a manner similar to Figure 32A -C's arrangement, the first part 3250 of the mechanical fastener can be coupled to the second part 3252 such that the supply tube 3202 can be supported away from the patient's nose or mouth. In Figure 32D , the mechanical fastener is a button and a loop. In Figure 32E , the mechanical fastener is a popper dome or other snap-fit arrangement. In 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 part 3250 and the second part 3252 of the mechanical fastener are formed by a single component. Thus, these parts 3250 and 3252 can be permanently coupled to each other and removed from one or both of the supply tube 3202 and the headgear strap 3240 or other parts of the nasal cannula assembly 3200.

[0579] In some embodiments, the supply tube 3202 can be fixed by a permanent fixing device provided on a part of the nasal cannula assembly 3200 - especially on a cannula design with an extended or large side 3222, such as the headgear strap 3240 or the side 3222 of the cannula 3214. For example, the fixing device can be a permanent loop 3260 on the headgear strap 3240. Preferably, permanent loops 3260 are 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 loop 3260 to provide support and positioning of the supply tube 3202. The loop 3260 can be injection molded or die cut, for example, or formed by any other suitable process. Figure 32G A loop 3260 is shown, which is a hoop or ring generally positioned in the plane of the headgear strap 3240. The shown loop 3260 extends below the headgear strap 3240; however, it can also be provided above the headgear strap 3240. Preferably, the loop 3260 can be rotated relative to the headgear strap 3240 to better accommodate the supply tube 3202 and any other components, such as the pressure measurement tube 3210. The headgear strap 3240 can include portions that space the loop 3260 apart from the circumferential portion of the headgear strap 3240 to facilitate rotation of the loop 3260. Figure 32H A molded-integral loop 3260 positioned beside the headgear strap 3240 is shown.Figure 32I Shows a loop 3260 formed by a section 3262 of the headgear strip 3240, the section being defined by a pair of spaced slits 3264 which permit the section 3262 to be pulled away from an adjacent portion of the headgear strip 3240 to form a passage therewith. These slits 3264 may be generally parallel to each other and oriented in a generally vertical direction or an axial direction along the perimeter defined by the headgear strip 3240, as shown. However, in other arrangements, these slits 3264 may not be parallel and may be oriented in other directions.

[0580] In some embodiments, the loop 3260 may be a breakable loop to facilitate positioning of the supply tube 3202 within the loop 3260. Preferably, at least one breakable loop 3260 is present on each side of the cannula assembly 3200, e.g., on the headgear strip 3240. The supply tube 3202 may be clipped into either loop 3260. The loop 3260 may be breakable via any suitable arrangement, such as a hook and loop fastener ( Figure 32J ), die cut or otherwise formed tab slot arrangement ( Figure 32K ), popper dome or other snap fit arrangement ( Figure 32L ), injection molded or otherwise formed or mushroom head and recess arrangement ( Figure 32M ), or push-in clip ( Figure 32N ). The loop 3260 may be broken at any location, such as in the central portion of the loop 3260 or on the headgear strip 3240. Preferably, any of these arrangements for managing the supply tube 3202 may be used or modified for managing a pressure line 3210 in addition to or in place of the supply tube 3202.

[0581] The circuit (e.g., cannula or manifold) for delivering air or gas to the patient interface is suitably long such that it reaches between the source of flow and the patient. The mass of this long circuit (without some circuit support means) causes the load to be directly transferred onto the patient interface. The load on the circuit may 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 of FIG. 1 and / or Figure 8A pressure line 872). To address this problem, several techniques or arrangements may be used to support at least a portion of the load or mass of the circuit, as described in connection with Figure 33A -S.

[0582] Figure 33A-H shows a support device 3350 that can be coupled to a portion of the circuit (usually 3352), which is coupled to the patient's clothing, sheets, or other fabric or thin material, and uses them to support at least a portion of the load or mass of the circuit 3352. Figure 33A and 33B shows a support device 3350 attached to the circuit 3352 by any suitable arrangement and including two-part domes 3354 that, when assembled via a snap-fit arrangement for example, clamp the bedding / clothing 3356 between parts 3354a and b.

[0583] Reference Figure 33C -F, the support device 3350 can include a clip and post (e.g., mushroom head) arrangement 3354 that, when the clip 3354a is assembled onto the post or mushroom head 3354b, clamps the bedding / clothing 3356 between the clip 3354a and the post or mushroom head 3354b. Any part of the support device 3350 can be attached to the circuit 3352 by any suitable arrangement. In the illustrated arrangement, the post or mushroom head 3354b is fixed to the sleeve 3352 by a sleeve 3360. If desired, the clip 3354a can be coupled to the sleeve 3360 by a tether 3362. The clip 3354a can be any suitable arrangement capable of fixedly engaging and disengaging from the post or mushroom head 3354b with the clothing, sheet, or other fabric or material 3356 therebetween. For example, Figure 33C shows a simple C-shaped resilient clip 3354a. Figure 33D shows a clip 3354a 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 shows a hinged clip 3354a that can have a snap-fit arrangement or other mechanism for joining the unhinged ends of the clip 3354a. Figure 33F shows a clip 3354a having an elastic retaining portion 3364. The clip 3354a is shown as a hinged clip, but can also be unhinged. Alternatively, the clip 3354a can be entirely replaced with an elastic member.

[0584] In some embodiments, reference Figure 33G , the support device can include a tag 3350 coupled to the circuit 3352 and including a buttonhole feature 3366 that can be attached to an existing button 3368 on the patient's shirt or other clothing. Alternatively, a specific piece of clothing or other material can be equipped with a specific button 3368 that engages the buttonhole feature 3366. The tag 3350 can feature a tear-away feature (e.g., slit, score, or weakened portion) 3370 that will tear away before the patient's shirt or other item supports the button 3368.

[0585] Reference Figure 33H , the support device includes a clip 3350 having a portion 3372 around a loop 3352 and a portion 3374 that can grip bedding, clothing, or other fabric or thin material. In the arrangement shown, the clip 3350 can have two arms that cross each other and are movable relative to each other between an open position and a closed position. The portion 3372 is defined by a portion of the arms that extends between their intersection or connection point with each other and the point where they cross each other. The portion 3374 is defined by the end portions of the arms. The clip 3350 can include a finger grip portion 3376 that facilitates squeezing of the clip 3350 to move the clip to the open position. Additionally, the clip 3350 can include retention, gripping, or friction-enhancing features or traction elements 3378 (e.g., knobs or protrusions) that assist in preventing bedding, clothing, or other material from being released between the arms of the clip 3350 when in the closed position.

[0586] In other arrangements, the support device can include a tether 3380 that can be placed around a patient's neck or another body part or object and is used to support at least a portion of the loop 3352. Reference Figure 33I , the tether 3380 can be used in conjunction with Figure 33H the clip 3350. For example, the clip 3350 can be a dual-purpose clip having at least one opening or hole 3382, such as in the center of the arms within the portion 3374, such that it can also be used to allow the tether 3380 and / or another support device to pass through it. The tether 3380 can be used instead of or in conjunction with gripping a patient's clothing, bedding, or another piece of material.

[0587] The tether 3380 can have any suitable configuration. For example, reference Figure 33J , the tether 3380 can include a series of snap fasteners, hook-and-loop fasteners, or other fasteners 3384 that can be used to adjust the length of the tether 3380. Additionally, these fasteners 3384 can serve as detachment features to avoid or minimize patient discomfort or injury that could result from the tether 3380 becoming snagged on something.

[0588] Reference Figure 33K, the tether 3380 can be centered around the loop 3352, where the attachment points are on opposite sides of the loop 3352. These ends of the tether 3380 can be received within a support device 3350 that can surround the loop 3352. Preferably, these ends of the tether 3380 pass through the support device 3350 in a generally axial direction relative to the loop 3352 (which aids in keeping the support device 3350 upright, where the axis of the loop 3352 is in a generally vertical orientation or generally aligned with the patient's body), and reduces or prevents awkward side angles when hanging down from the patient's neck. In the arrangement shown, the support device 3350 is a connector between the supply tube and the main delivery catheter. A slider or other retention device 3386 on the tether can be used to adjust and allow for asymmetric positioning.

[0589] Reference Figure 33L and 33M , the support device can include a strap 3350 that can engage the loop and is also attached to the patient's body or a device near the patient. The strap 3350 can be permanently attached 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 the strap is secured to the loop, for example, by a loop 3390 that surrounds the loop. The strap 3350 can be deformable such that it can be secured to the patient's arm, a 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 such that the strap 3350 can be deformed and substantially retain its shape. In another arrangement, the second layer 3394 includes a bistable spring or similar element that can be straightened and hold 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 for fitment and then collapse around the patient's arm, a bed frame, or another suitable object, and once assembled, can provide sufficient holding force to hold the loop.

[0590] Reference Figure 33N -P, the support device can 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 device. These portions 3350a and 3350b can be coupled to support the loop 3352. In Figure 33N the arrangement, one portion 3350a of the hook-and-loop fastener 3350 is attached to the loop 3352, for example, by wrapping around the loop 3352, and the other portion 3350b of the hook-and-loop fastener 3350 is attached to an object such as a bed frame or other device (e.g., via an adhesive). These portions 3350a and 3350b can be coupled to each other to provide support for the loop 3352. In Figure 33OIn the arrangement, portion 3350b includes a non-adhesive segment that can loop around loop 3352 and then be connected to the bonding segment to provide more secure support. In an alternative arrangement, portion 3350a on loop 3352 can be dispensed with. In Figure 33P the arrangement, portion 3350b can be formed in or provided on armband 3395, which can be wound around a patient's arm (or another object). Armband 3395 can be an endless loop or, as shown, can be detachable or separable and selectively secured in a loop by a suitable fastener 3396 (e.g., a hook-and-loop fastener).

[0591] Referring Figure 33Q and 33R , the support device 3350 can be or include a shoulder-worn support that can loop around a patient's shoulder to support loop 3352. A portion 3350a of the support device 3350 can include a flexible or formable generally U-shaped segment that defines an opening that can receive and engage loop 3352. Another portion 3350b of the support device 3350 can include a flexible or formable generally U-shaped portion that can receive and engage a patient's shoulder or upper arm.

[0592] Referring Figure 33S , the support device 3350 can be part of or supported by the headgear strip 3340 or other cannula support device or arrangement. With such an arrangement, the headgear strip 3340 can be used to support at least a portion of the weight of loop 3352. For example, the support device portion 3350 of the headgear strip 3340 can extend directly over the top of a patient's head and rest against it and then continue downward to a clip 3398 or the like to engage loop 3352 such that the support device portion 3350 of the headgear strip 3340 aids in supporting the weight of loop 3352.

[0593] Some embodiments relate to a retention assembly for use with or integrated with the nasal cannula assembly. In many existing systems, a single elastic headband is used to hold the cannula on the face or the cannula is held on the face by looping one or more supply tubes over the ears. In some such designs, the cannula is not secured to the patient's face in an optimal manner and may be permitted to shift or move from the desired position. Many factors can cause the cannula to move from its ideal location, some of which include: the weight of the air or gas supply circuit can cause the cannula to hang in this direction, the cannula will slide as the patient moves back and forth during sleep, and the small surface area of a single elastic headband may not be sufficient to secure the cannula. Over time, the headband can slide downward, further reducing the security of the headband on the face. Thus, for some existing systems, the cannula may be prone to becoming unsecured, especially after an extended period of time. Additionally, as a secondary means of fixation, cannula assemblies that rely on ear suspension of one or more supply tubes often have one or more supply tubes that are adhered to the patient's face with tape. This technique is time-consuming and does not allow for easy readjustment.

[0594] Reference Figure 34A and 34B , nasal cannula assembly 3400 includes cannula 3414 and 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 cannula 3414, respectively. These hook-and-loop strips 3452 can pass through openings or slots 3454 located in annular or circular ear pads 3456. These ear pads 3456 can be made of any suitable material, preferably a material that provides a soft and comfortable feel to the patient while being strong enough to withstand the forces applied when tightening the headcap strap 3440. The shape of these ear pads 3456 can be annular (e.g., circular) or any other geometric shape that allows for anatomical fit and, in at least some configurations, partially or fully surrounds the patient's ear.

[0595] These ear pads 3456 are in turn connected to the headcap strip 3440. The headcap strip 3440 may also have a hook-and-loop strip 3458 attached to or integrated therewith, which may pass through additional openings 3454 in these ear pads 3456. The headcap strip 3440 may have any suitable arrangement, such as a bi-varicated strap, and is preferably made of or incorporates a non-stretch material. In some configurations, the cannula 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 these ear pads 3456. In such an arrangement, the patient or caregiver will don the cannula assembly 3400 by restraining it around the head with the strap, thereby ensuring that the ears are inside the holes in these ear pads 3456. The patient or caregiver then passes the open hook-and-loop strip (or multiple strips in other arrangements) through these ear pads 3456 and tightens it until it feels comfortable.

[0596] Advantageously, with such an arrangement, the cannula 3414 will be more secure on the patient's head compared to existing arrangements. For example, the patient's ears will prevent or stop the ear pads 3456 from slipping out of position and thus prevent or stop the cannula 3414 from moving away from the intended position. This is particularly beneficial for a sleeping patient as natural body movements during sleep will not affect the delivery of treatment through the cannula 3414. The foam (or other material) ear pads 3456 may also provide more comfort to the patient as they act as a cushion in the case where the patient sleeps on their side. The bi-varicated strap 3440 will also help to improve the security of the cannula 3414 by increasing the area by which the cannula 3414 is attached to the head. The increased surface area will prevent or stop the headcap strip 3440 from slipping down and reducing the security of the cannula 3414 on the face.

[0597] Reference Figure 34C and 34D, the cannula retention arrangement 3450 incorporates the friction pads 3460 into the headcap strap 3440. These friction pads 3460 are preferably positioned on the patient's cheeks, or on multiple portions of the face adjacent to the cheeks, and direct the line of action or force from the headcap 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 headcap strap 3440 to change direction relative to the transverse direction or relative to the lateral sides 3422 of the cannula 3414 or the transverse portion 3440a of the headcap strap 3440. These friction pads 3460 preferably have a thickness that allows the cannula 3414 to gently span across the patient's skin, creating less pressure on the skin. Such pads 3460 will have the additional benefit of preventing the cannula 3414 from moving on the face, as greater friction will need to be overcome for initial movement. If desired, these pads 3460 can be attached to the headcap strap 3440 by any suitable arrangement, such as stitching, adhesives.

[0598] Advantageously, this arrangement for attaching the cannula 3414 to the patient's head is more secure than many prior art and arrangements. For example, these friction pads prevent or inhibit the cannula 3414 from easily moving on the face, which is an issue experienced by many existing arrangements. Additionally, by raising the cannula 3414 from the skin by means of the thickness of the friction pads 3460, the pressure felt by the patient on the upper lip will be reduced, thereby making the wearing of the cannula 3414 more comfortable. Comfort can also be increased by spreading the force of the headcap strap 3440 over a larger area of the face using these friction pads 3460, which prevents or inhibits local indentations on the skin. By directing the line of action of the headcap strap 3440 away from the ears, a more comfortable position of the headcap strap 3440 can be achieved, as the ears will not be compressed by the force of the headcap strap 3440 passing over them.

[0599] Reference Figure 34E, the cannula assembly 3400 includes a cannula 3414, a supply tube 3402, and a retention arrangement 3450. During installation, the retention arrangement 3450 is strapped to the head using the ears as anchor points. 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 a hook-and-loop fastener 3466. Preferably, the fastening arrangement 3466 is adjustable such 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 suspending the assembly 3400 over the ears via these ear loops 3456 and positioning the tines 3405 of the cannula 3414 in the correct position. Once the cannula 3414 is in place, the two parts 3440a, 3440b of the headgear strap 3440 can be joined using the 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 cannula 3414, substantially independently of the engagement of the ear loops 3456 with the patient's ears. In some arrangements, once the headgear strap 3440 has been adjusted (e.g., tightened), the ear loops 3456 do not contact the patient's ears and / or do not apply any significant force thereto. Preferably, the headgear strap 3440 (which may include the ear loops 3456) is made of or incorporates a material which mildly stretches when the headgear strap 3440 is adjusted (such as by securing the fastener arrangement 3466) to provide a relatively constant force over the face. In some arrangements, the loop portion of the hook-and-loop fastener 3466 is positioned closer to the head than the hook portion to prevent the hook material from sticking to or snagging the patient's hair. In some arrangements, the material used to make the headgear strap 3440 is thick enough to allow the cannula 3414 to hang on the patient's ears when passing through the ear holes 3456.

[0600] Advantageously, this arrangement for attaching the cannula 3414 is more secure than many prior art arrangements. For example, the ears will prevent or inhibit the headgear strap 3440 from moving out of position and will prevent or inhibit the cannula 3440 from moving away from its desired position. This is particularly beneficial for a sleeping patient because natural body movements during sleep will not affect the delivery of treatment 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 prevent or inhibit the cannula 3414 from sliding downward because the greater surface area of the strap 3440 contacts the head, and these ear loops 3456 will act as anchor points when the headgear strap 3440 may move downward due to an external force.

[0601] Reference Figure 34F , the cannula assembly 3400 includes a retention arrangement 3450 that includes a headgear strap frame 3440 and a flexible web 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 otherwise be configured to be substantially non-stretchable. The web portion 3468 may be in the form of a net and is preferably constructed from a material that is at least slightly stretchable. Such an arrangement results in 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. An adjustment mechanism 3470 that may include adjustment tabs 3472 can be used to adjust the frame 3440, and the adjustment tabs are used to shorten the circumference of the web 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 web portion 3468 is attached may be constructed from a stretchable material or may be flexible at least relative to other portions of the frame 3440 to facilitate adjustment of the web portion 3468. In an alternative arrangement, the frame 3440 may also be made from a material that is at least slightly stretchable. In such an arrangement, the adjustment mechanism 3470 may optionally be omitted because the stretchability will allow the retention arrangement 3450 to fit a variety of patient sizes.

[0602] In at least some configurations, the flexible web 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 of contact with the head will provide a frictional force that resists movement of the cannula during normal activities or during sleep. Additionally, by spreading the force over a large area, the illustrated arrangement tends to reduce local pressure on the back of the head, which is experienced by many current methods and arrangements.

[0603] Reference Figure 34G and 34H , the cannula assembly 3400 includes a cannula 3414, a supply tube 3402, and a retention arrangement 3450. In the illustrated arrangement, the cannula 3414 is mounted to a generally U-shaped frame 3440 that is configured to fit the patient's face in a manner similar to glasses. Thus, preferably, the frame 3440 supports the cannula 3414 and includes ear bar portions 3440a and 3440b that extend rearwardly and extend along the sides of the patient's head, preferably at least to the patient's ears. The frame 3440 preferably has substantial rigidity to maintain its shape, but has sufficient flexibility to allow the ear bar portions 3440a and 3440b to move apart from each other such that the frame 3440 is adapted to a range of head sizes. In a preferred arrangement, the ends of the ear bar portions 3440a and 3440b (or portions on the ears) are generally straight, and the frame 3440 relies on the elasticity of the frame 3440 to secure the frame 3440 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 portions that at least partially wrap around the ears (e.g., behind). Optional pads 3474 can be provided where the frame 3440 contacts the head (e.g., above the ears). Advantageously, the cannula assembly 3400 can be easily applied and removed with one hand, for example, in a manner similar to a pair of glasses. Additionally, since there is no application strap behind the head, there will be a relatively smaller discomfort-causing force on the upper lip.

[0604] Reference 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 the illustrated arrangements, the cannula 3414 is attached to the pads 3480 by an adjustable and removable system such 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 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 arrangement, such as using hook-and-loop fasteners 3482 ( Figure 34I ), or other reusable fasteners 3480 to be adjustably coupled to the cannula 3414. Referring Figure 34J , a ratchet-type adjustable fastener 3484 can be used to fix the pads 3480 to the cannula 3414 in an adjustable manner. The ratchet-type adjustable fastener 3484 can be integrated with the pads 3480 and / or the cannula 3414 as shown, or can be a separate assembly or separate component coupled to the pads 3480 and / or the cannula 3414. Advantageously, the use of the adhesive pads 3480 means that there is no application strip behind the head, and thus there will be a relatively smaller discomfort-causing force on the upper lip.

[0605] Referring Figure 34K , an alternative adjustable fastener 3486 is shown for adjustably coupling the cannula 3414 to the pads 3480. However, in other arrangements, the fastener 3486 can have a single position relative to the cannula 3414, and any adjustment can be addressed by placing the pads 3480 on the patient. Preferably, the pads 3480 include posts or knobs 3488 that are clamped in openings or notches 3490 in the cannula 3414. This arrangement can also be reversed. The knobs 3488 can have any shape as long as the notches 3490 in the cannula 3414 are of complementary design. The shape of the pads 3480 can be any suitable arrangement such that they conform to the facial geometry. The illustrated pads 3480 are generally hourglass-shaped. However, other suitable shapes can also be used. The notches 3490 in the cannula 3414 allow for adjustment on the face. To increase the retention force, the notches 3490 closer to the forks 3405 can be clamped into the knobs 3488 on the adhesive pads 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.

[0606] Advantageously, such an arrangement removes or reduces the local pressure that typically exists due to the use of a cinching strap. Additionally, it also reduces or prevents the marks on the skin caused by long-term wearing of the headgear strap. Moreover, it is also easier to apply and remove the cannula 3414 because the headgear strap does not have to cross over the head. This is particularly beneficial for patients who sleep on their backs.

[0607] Reference 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 the intensive care unit (ICU) to the general ward to the home. Given these different usage environments, a modular system in which the patient / caregiver can select the form 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, these sides 3522 include enlarged, generally oval pads. These sides 3522 may allow the cannula 3514 to be coupled to several types of retention arrangements 3550 by any suitable fastener, such as a hook-and-loop fastener. In one arrangement, as Figure 35A shown, the cannula 3514 may be coupled to a halo-type headgear strap assembly 3540 that includes at least one strap 3552 that extends around the sides of the patient's head and a second strap 3554 that extends over the top of the patient's head. In some arrangements, as shown, the headgear strap assembly 3540 may include a pair of straps 3552 that extend around the sides of the head, and one strap 3552 may be positioned above the ear and the other strap 3552 may be positioned below the ear. If desired, pads may be provided on one or more of these straps 3552 and 3554. These straps 3552 and 3554 may include suitable fasteners, such as hook-and-loop fasteners 3556, which allow the application, removal, or adjustment of the headgear strap assembly 3540. The halo-type headgear strap assembly 3540 may include end portions that utilize complementary portions of the fasteners on these sides 3522. This form of retention may be desirable for non-compliant patients. This larger, more complex headgear may prevent or stop the cannula 3514 from moving away from the face and may further make it difficult to remove the cannula 3514 by pulling on it.

[0608] In other arrangements, as Figure 35BAs shown, these sides 3522 allow the cannula 3514 to be coupled to a headgear strip 3540 or a set of adhesive pads 3580 that may be the same as or similar to any other strip or pad disclosed herein (or may have any other suitable arrangement). The headgear strip 3540 may include end portions that utilize complementary portions of fasteners on these sides 3522 and may be used for patients who do not want the pads 3580 to adhere to the cheeks or for intermittent treatment on a regular basis. The headgear strip 3540 may have a single size or be adjustable. These adhesive pads 3580 may also utilize complementary portions of fasteners on these sides 3522 and may have a shape that is complementary or compatible with these sides 3522. This type of retention may be desirable for patients who comply with or receive treatment for an extended period of time.

[0609] Reference Figure 35C and D, each side of the retention arrangement 3550 and each of these sides 3522 of the cannula 3514 may include more than one pad, such as two pads (a bi-layer 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 can spread the load over a larger area of the patient's head to increase comfort. Additionally, applying the retention force to these spaced-apart locations on the cannula 3514 can result in greater stability of the cannula 3514 on the patient's face. In Figure 35C the arrangements shown, the cannula 3514 is coupled to a halo-type headgear strip 3540, which is similar to Figure 35A the strip 3540 of Figure 35D As shown in, a non-halo-type headgear strip 3540 may be employed, which may include two strips, or any other number of strips, such as one or more than two strips. This form of the retention arrangement 3550 may also be applied to the face using adhesive pads or other suitable retention arrangements.

[0610] For many existing systems, if the patient inadvertently removes the cannula, the headband is further tightened or the cannula is taped to the face. Figure 35A -D, these arrangements provide the caregiver or patient with the flexibility to choose which retention form is desired, needed, or most suitable for a particular situation. By using the desired level of retention, comfort for the patient can be increased because the methods used to secure the cannula to non-compliant patients do not have to be used on compliant patients. Another benefit of the modular system shown is that it allows the user to choose which retention method is more comfortable for them. This gives the patient / user more control over their treatment and can lead to better patient / user satisfaction and compliance.

[0611] Reference Figure 35E-G shows another modular retention arrangement 3550. The shown retention arrangement 3550 includes a lightweight and smaller 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 by any suitable arrangement such as any of these coupling arrangements disclosed herein. In the shown arrangement, the adhesive strip 3590 is attached to, integrated with, or made integral with the cannula 3514 and is configured to extend to the top portion of the patient's nose when the tines 3505 are positioned in the patient's nostrils, preferably at or on the tip of the nose. 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 indirectly adhered to the patient, such as using a fastener (e.g., hook and loop fastener) that couples the strip 3590 to a separate adhesive pad. This retention arrangement 3550 may be desirable for compliant patients who are aware of the treatment being performed.

[0612] ...

Claims

1. A nasal cannula system, comprising: a cannula that defines a patient-facing surface and a lumen and includes a first nasal prong and a second nasal prong extending from the cannula and in communication with the lumen, the first and second nasal prongs being configured not to provide a seal at the patient's nostrils; a manifold that supports the cannula to rotate about at least one axis between at least a first position and a second position opposite the first position; a supply tube coupled to the manifold and in communication with the lumen, the supply tube being connectable to a gas supply from a gas source to deliver a gas flow to the lumen and the first and second nasal prongs; wherein 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.

2. The nasal cannula system according to claim 1, wherein, The first position is a first relative position of the cannula with respect to the manifold, and the second position is a second relative position of the cannula with respect to the manifold, wherein the cannula is pivotally coupled to the manifold to rotate relative to the manifold between the first and second relative positions about the at least one axis between the cannula and the manifold.

3. The nasal cannula system according to claim 1 or 2, wherein, The cannula is capable of rotating relative to the manifold about an axis extending in a generally anteroposterior direction or a generally horizontal axis located in the sagittal plane.

4. The nasal cannula system according to claim 1 or 2 or 3, wherein, The cannula is capable of rotating relative to the manifold by at least 180 degrees to provide an effective change in the supply tube exit side.

5. The nasal cannula system according to claim 1 or 2, wherein, The cannula is capable of rotating relative to the manifold about a substantially vertical axis.

6. The nasal cannula system according to claim 5, wherein, The manifold includes an open top as a manifold outlet, wherein the cannula is assembled above the open top such that the first and second nasal prongs communicate with a connector adapted to receive one end of a gas flow conduit and provide an inlet for the manifold, wherein the manifold is attached to or integrally formed with the connector.

7. The nasal cannula system according to any one of the preceding claims, wherein, The cannula and the manifold include interference surface features for assisting in fixing the cannula in a desired position relative to the manifold.

8. The nasal cannula system according to any one of claims 1 to 4 and according to claim 7, wherein, The interference surface features include depressions and protrusions preferably in the form of teeth, the protrusions being configured to engage corresponding depressions.

9. The nasal cannula system according to any one of claims 5 to 6 and according to claim 7, wherein, The interference surface features include lips and complementary mating segments, preferably grooves.

10. The nasal cannula system according to any one of the preceding claims, wherein, The cannula includes a prong portion and a connecting portion separated from each other.

11. The nasal cannula system according to claim 10, wherein, The prong portion is selectable from at least two different sizes of prong portions including at least two different sizes of prongs, and the prong portion can be coupled to the connecting portion for use.

12. The nasal cannula system according to any one of claims 1 to 9, wherein, The cannula is constructed as a single piece.

13. The nasal cannula system according to any one of the preceding claims, wherein, The cannula is removable from the manifold.

14. The nasal cannula system according to any one of the preceding claims, wherein, An axis extends from the manifold or the cannula, and the cannula rotates relative to the manifold on the axis.

15. The nasal cannula system according to any one of the preceding claims, further comprising a retention assembly for fixing the manifold and the cannula to a patient.

16. A nasal cannula system, comprising: A cannula, the cannula including a central body portion, a first prong and a second prong extending from the central body portion, the central body portion defining a cavity and an anterior-facing inlet of the cavity, wherein the first prong and the second prong communicate with the cavity and are configured not to provide a seal at the patient's nostrils; A manifold that receives a gas supply from a gas source, the manifold including a gas inlet and a gas outlet, wherein the manifold is connectable to the cannula such that the gas outlet is aligned with the anterior-facing inlet of the cannula and the gas inlet faces a lateral direction; A supply tube that is connected to the gas inlet of the manifold and is positioned in front of the anterior-facing inlet of the cannula.

17. The nasal cannula system according to claim 16, wherein, The manifold is a rotatable manifold that can be positioned in a first orientation with the gas inlet facing a first lateral direction and a second orientation with the gas inlet facing a second lateral direction.

18. A nasal cannula assembly, comprising: A cannula that defines a cavity and includes a prong extending from the cannula and communicating with the cavity, wherein the prong is configured not to provide a seal at the patient's nostrils, the cannula having a cannula opening located on the front side of the cannula and communicating with the cavity, the cannula opening having an axis; A manifold pivotally coupled to the cannula and configured to pivot about an axis of the cannula opening; A tube that is coupled to the manifold and configured to supply gas to the manifold; wherein the manifold includes a manifold opening that is aligned with the cannula opening and communicates with the cavity.

19. The nasal cannula assembly according to claim 18, wherein the axis of the cannula opening is an axis extending in a generally anterior-posterior direction or a generally horizontal axis located in the sagittal plane of the user.

20. A cannula assembly, comprising: A cannula portion and a catheter clamp, wherein the cannula portion includes a manifold and a prong having two orifices, wherein the orifices are in fluid communication with the prong and the prong is configured not to provide a seal at the patient's nostrils, wherein the catheter clamp is rotatably attached to the cannula portion about a rotation axis that is generally located in the sagittal plane of the user or parallel to the sagittal plane to position the catheter of the cannula assembly to the left or right side of the cannula assembly.

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