Patient interface and components

Abstract

To provide a patient interface and components incorporated therein or forming a part thereof.SOLUTION: A component may be provided as a clip to support the gases supply tube to the interface, a buckle may be provided at the end of a headgear strap for releasable attachment to the interface, the manifold portion of the interface may be attachable to the interface such that it can be adjusted or re-orientated such that the associated gases supply conduit is re-routed to be on the left or right side of the interface (or user), and one or a pair of support side arms of the interface may be configured to be twisted or bent to more comfortably conform to the shape of the user's face where they are located in use; The portion of the manifold at the connection to the inner surface of the gas delivery tube can be configured to be a multi-piece manifold assembly.SELECTED DRAWING: Figure 1A

Description

[Technical Field]

[0001] The present disclosure relates to components for medical applications, particularly but not exclusively to medical breathing circuits, surgical inhalation systems, medical nutrition devices and / or medical monitoring devices, including components associated with or forming part of a patient interface for delivering gas to the airway of a user.

[0002] In one particular aspect, the present disclosure relates to components that receive tubing or cables, such as respiratory tubing used in the inspiratory and / or expiratory limbs of a breathing circuit, tubing associated with a surgical suction system, or tubing associated with a medical feeding device, cables associated with such devices, or cables associated with a medical monitoring device, or any combination of any two or more thereof.

[0003] In another aspect, the present disclosure relates to connectors such as releasable connectors that releasably connect two components together, including, but not limited to, releasable connectors that releasably connect the headgear of a patient interface to the patient interface itself.

[0004] In another aspect, the present disclosure relates generally to gas therapy and, more particularly, to a patient interface for delivering gas therapy. [Background technology]

[0005] In some medical applications, such as by providing assisted breathing or breathable gas to a human (or animal), the gas provided and inhaled is preferably delivered with humidity close to saturation levels and at a temperature close to body temperature (usually between 33° C. and 37° C.) Alternatively, the delivery of gas may be for the purpose of CPAP or BIPAP, where the gas may or may not be humidified before delivery to the human (or animal).

[0006] To facilitate delivery of gas to a patient under these favorable conditions, a respiratory tube (or medical tube) may be used, which includes a patient interface and components associated with such a tube or interface. Such a tube, interface, or other such components may take a variety of shapes and forms.

[0007] With respect to the tube, one commonly used form is a tube with a corrugated exterior.

[0008] In various cases, such tubes are advantageously placed or positioned in a fixed position relative to the patient or user. For example, the tubes may need to be held in place or supported so that the weight of the tube does not exert undesirable forces on the patient or user or other associated medical devices the patient or user may be using, such as a mask or other interface. It is beneficial to be able to position, support, and adjust the tubes between various further or supported positions relative to the patient or user.

[0009] Other medical applications, such as surgical suction systems, medical nutritional devices, and medical monitoring devices, similarly require the positioning of tubes that deliver nutrition, fluids, and / or gases, and / or cables that transmit patient information. It would also be beneficial to be able to position, support, and adjust the tubes and cables in such applications.

[0010] For other components, releasable connectors, such as two-part connectors of the type having a male and female part, can provide a useful solution for connecting two components together (e.g., one component is attached or attachable in some way to the male part, and another component is attached or attachable in some way to the female part). The disclosure herein provides further alternatives to such releasable connectors.

[0011] Medical breathing circuits that have a patient interface at the patient or user end often require multiple components to be connected together or attached to one another in a manner that allows for a configurable fit to the patient or user. For example, patient interfaces such as those in the form of full face masks, nasal masks, oral-nasal masks, or nasal cannulae typically utilize associated headgear or straps to hold the patient interface in place, or at least to hold some components together relative to the assembled state of the medical breathing circuit or patient interface itself.

[0012] In various instances, a person may wish to adjust a patient interface, remove it from a use position or associated headgear, or attach it to a use position or associated headgear. A releasable connector may be useful to allow such adjustment of the headgear or connection or disconnection from the patient interface. Ease of use and secure connection are important factors when considering this type of connector.

[0013] With regard to still other components that may be associated with, for example, a patient interface, a patient being treated for a respiratory disorder, such as chronic obstructive pulmonary disease (COPD), may have difficulty breathing effectively. This difficulty may be the result of a variety of causes, including lung tissue destruction, dysfunction of small airways, excessive phlegm accumulation, infection, genetic disorders, or heart failure. In some respiratory disorders, it is useful to provide the patient with a therapy that can improve the patient's ventilation. High-flow therapy may be provided to the patient using a respiratory treatment system that includes a gas source, a patient interface that can be used to deliver the gas to the patient's airways, and a conduit extending between the gas source and the patient interface. The gas may be heated and humidified before being delivered to the patient.

[0014] Regarding still other components that may be associated with the patient interface, for example, in many environments, the gas source may be located in a limited number of locations relative to the patient. Accordingly, the conduit extending from the gas source to the patient interface may be in an inconvenient or uncomfortable position, such as the patient's chest or neck. Furthermore, in some cases, the convenience or efficacy of the delivered therapy may be compromised if the conduit is not optimally oriented, at least relative to the patient interface. For example, excessive pulling or torqueing forces on the conduit may pull the patient interface away from the patient, the conduit may become dislodged from the patient interface or gas source, or the gas source may fall off a table or other support. Furthermore, the flow of gas through the patient interface may be noisy, which may irritate or cause discomfort to the patient. Summary of the Invention [Problem to be solved by the invention]

[0015] It is therefore an object of the present disclosure to provide further options or alternatives that go at least some way towards addressing the problems discussed above, or at least provide useful choices to the industry and / or the public. [Means for solving the problem]

[0016] References herein to patents, other external documents or other sources of information are generally for the purpose of providing a context for considering features of the present disclosure. Unless specifically stated otherwise, references to such external documents should not be construed as an admission that such documents or such sources are prior art or form part of the common general knowledge in the art in any jurisdiction.

[0017] Further aspects and advantages of the present disclosure will become apparent from the ensuing description, which is given by way of example only.

[0018] It is an object of the present disclosure to provide components for use in medical applications that will go some way to improving upon the above, or at least provide a useful option for the public or medical professionals.

[0019] In a first aspect, the present disclosure broadly provides: a body for receiving at least one tube and / or at least one cable; a fitting that removably engages the mounting portion of the patient interface; The present invention relates to a component (herein referred to as a "clip") comprising:

[0020] It should be understood that any of the following embodiments can be associated with any one of the first to fourth aspects of the present disclosure described above or below, either alone or in any combination of any two or more.

[0021] In at least some embodiments, the components are used in medical applications including, but not limited to, medical breathing circuits, surgical breathing circuits, nutritional devices and / or monitoring devices.

[0022] In at least some embodiments, the components are used with tubing in a medical supply circuit.

[0023] In at least some embodiments, the components hold or position tubing relative to a patient in a medical breathing circuit for the purpose of improving patient breathing or comfort, or for other related purposes, including, for example, improving stability of the patient interface on the patient when forces are applied to the patient interface and / or tubing. In relation to patient comfort, alternative positioning may allow, for example, a reduction in pressure or relocation of pressure applied to tubing, associated patient interfaces, and / or other components of the medical breathing circuit.

[0024] In at least some embodiments, the component is used with tubing in a medical breathing circuit; a main body for receiving a tube in a medical breathing circuit; and a fitting for releasably engaging a mounting portion of a patient interface associated with the tube.

[0025] In at least some embodiments, it is used with tubing in surgical suction systems or feeding devices and / or cables in monitoring devices.

[0026] In at least some embodiments, the components hold or position tubing of a surgical suction system or feeding device, and / or cables of a monitoring device relative to the patient for the purpose of improving patient comfort or for other related purposes, including, for example, improving stability of the patient interface on the patient when forces are applied to the patient interface and / or tubing and / or cables.

[0027] It should be understood that any reference to a tube below may alternatively be read as a reference to a cable, such as a cable in a medical monitoring device, as described herein.

[0028] In at least some embodiments, the body is movable along the length of the at least one tube and / or at least one cable or is fixed relative to the at least one tube and / or at least one cable. In at least some embodiments, the body is slidable along the length of the at least one tube and / or at least one cable and / or rotatable around the circumference of the at least one tube and / or at least one cable and / or rotatable along the length of the at least one tube and / or at least one cable. In at least some embodiments, the body is rotatable about the circumference of the at least one tube and / or at least one cable while remaining fixed relative to the end of the at least one tube and / or at least one cable.

[0029] In at least some embodiments, the body is configured to at least partially surround or surround the outer periphery of at least one tube and / or at least one cable.

[0030] In at least some embodiments, the body comprises at least one arm configured to at least partially surround or encircle a circumference of the at least one tube and / or at least one cable. In at least some embodiments, the at least one arm is shaped or curved to at least partially surround or encircle a circumference of the at least one tube and / or at least one cable. In at least some embodiments, the at least one arm is substantially deformation-resistant or resiliently flexible.

[0031] In at least some embodiments, the body comprises two arms configured to at least partially surround or, separately or together, surround the circumference of at least one tube and / or at least one cable. In at least some embodiments, the arms are shaped or curved to at least partially surround or surround the circumference of at least one tube and / or at least one cable. In at least some embodiments, at least one arm is substantially deformation-resistant or resiliently flexible.

[0032] In at least some embodiments, the body comprises an annular, substantially annular, square, substantially square, or linear portion configured to at least partially surround or surround the outer periphery of at least one tube and / or at least one cable.

[0033] In at least some embodiments, the inner surface of the body is engageable with one or more outer surface recesses of at least one tube, such as recesses in a corrugated tube or a tube with a helical concave region.

[0034] In at least some embodiments, the inner surface of the body comprises one or more protrusions engageable with one or more corresponding recesses in the at least one tube, hi at least some embodiments, the inner surface of the body comprises a first protrusion engageable with a first recess and a second protrusion engageable with the same or another recess.

[0035] In at least some embodiments, the body is pivotally, rotatably, or removably connected to the fixture, or any combination of any two or more thereof.

[0036] In at least some embodiments, the fitting comprises at least one arm or at least one protrusion configured to engage with a mounting portion of the patient interface. In at least some embodiments, the mounting portion is shaped to receive the at least one arm or at least one protrusion. In at least some embodiments, the arm engages with a corresponding protrusion on the mounting portion, optionally with a snap-fit. In at least some embodiments, the protrusion engages with a corresponding recess on the mounting portion, optionally with a snap-fit.

[0037] In at least some embodiments, at least one arm and / or at least one protrusion is substantially deformation resistant or resiliently flexible.

[0038] In at least some embodiments, the fixture is oriented in the same plane as the body.

[0039] In at least some embodiments, the fixture is rotated or angled relative to the body.

[0040] In at least some embodiments, at least one arm includes a protrusion or lug that engages with a corresponding protrusion or recess in the mounting portion, in at least some embodiments by a snap fit.

[0041] In at least some embodiments, the fixture comprises two arms configured to engage the mounting portion. In at least some embodiments, the mounting portion is shaped to receive them. In at least some embodiments, the mounting portion is similarly or identically shaped to receive them.

[0042] In at least some embodiments, the two arms extend from the body to define a space between them.

[0043] In at least some embodiments, the two arms extend from the same or substantially adjacent locations on the body. In at least some embodiments, each arm initially extends from the body in a direction away from the other arm. Alternatively, the arms extend from the body in a direction substantially toward the other arm, or each arm extends from the body in a direction substantially parallel to each other or to each respective arm.

[0044] In at least some embodiments, the arms are of substantially the same length or of different lengths.

[0045] In at least some embodiments, the fitting comprises two arms, one or both of which are shaped to engage, optionally by a snap fit, with a corresponding protrusion on the fitting portion.

[0046] In at least some embodiments, one or more arms include an angled portion that is shaped to engage a corresponding protrusion on the mounting portion, optionally with a snap fit.

[0047] In at least some embodiments, the fixture comprises two arms, each arm comprising an angled portion, each angled portion extending toward the other arm or into or toward the space between the arms.

[0048] In at least some embodiments, the fixture comprises two arms, each extending from the same or substantially adjacent locations on the body, each arm initially extending from the body in a direction away from the other arm, and each arm comprising an angled portion extending substantially toward the other arm or into or toward the space between the arms.

[0049] In at least some embodiments, the fitting comprises two arms, one arm comprising a protrusion or lug, or both arms comprising a protrusion or lug.

[0050] In at least some embodiments, the protrusions or lugs engage corresponding recesses in the mounting portion, in at least some embodiments by a snap fit.

[0051] In at least some embodiments, the fixture comprises two arms, with the protrusion or lug on the or each arm extending substantially toward the other arm or into or toward the space between the arms.

[0052] In at least some embodiments, the fixture comprises two arms, each extending from the same or substantially adjacent locations on the body, each arm initially extending away from the other arm, and each arm comprising a protrusion or lug extending substantially toward the other arm or into or toward the space between the arms. Alternatively, the fixture comprises two arms, each extending from the same or substantially adjacent locations on the body, each arm initially extending away from the body toward the other arm, and each arm comprising a protrusion or lug extending substantially outwardly or away from the other arm.

[0053] In at least some embodiments, the mounting portion includes one or more shaped protrusions and / or one or more slots or recesses configured to engage with the fixture. Alternatively, the mounting portion includes one or more slots, recesses, or openings in the female part of the mounting portion to accept engagement by the fixture. Additionally, the mounting portion or portions can include one or more sloped, chamfered, tapered, lead-in shaped portions or sections, or angled bosses in the female and male parts. Any one or more of these or other geometric shapes can be utilized on the mounting portion to aid in the insertion or orientation of the arm or arms for insertion into the mounting portion and / or can help provide a more fixed or secure retention of the arm or arms within the mounting portion. For example, the mounting portion can be shaped to provide for contact with the arm or arms and other parts of the fixture.

[0054] In at least some embodiments, the attachment portion is integral with the patient interface, in at least some embodiments where there is an ancillary component of the patient interface.

[0055] In at least some embodiments, the attachment portion is removably attachable to the patient interface, in at least some embodiments to an auxiliary component of the patient interface.

[0056] In at least some embodiments, the attachment portion is integral with or removably attachable to a strap that is attached or attachable to the patient interface.

[0057] In at least some embodiments, the attachment portion comprises a protrusion shaped to engage with a space defined between the arms of the fixture. Alternatively, the attachment portion comprises a female attachment portion or opening shaped to engage with an outer surface or protrusion of the arms of the fixture.

[0058] In at least some embodiments, the female fitting portion or opening is oriented or shaped to be offset or angled relative to the patient interface so that when the fitting on the body engages at or with the female fitting portion or opening, the tubing connected to the body is substantially aligned with the arm or frame of the patient interface. In at least some embodiments, the tubing thus follows the shape of the cannula frame arm, providing the visual appearance that the tubing enters or is connected to the manifold or fluid connection port of the patient interface in a "straight" fashion.

[0059] At least some embodiments include a protrusion shaped to engage and substantially fill the space between the arms of the fixture.

[0060] In at least some embodiments, the attachment portion comprises at least one protrusion configured to engage at least one arm of the attachment. In at least some embodiments, the attachment portion comprises a protrusion configured to engage each arm. In at least some embodiments, the one or more protrusions are configured to engage the arms via a snap fit.

[0061] In at least some embodiments, the mounting portion comprises at least one recess or slot or opening configured to engage the protrusion. In at least some embodiments, the mounting portion comprises recesses or slots or openings configured to engage each protrusion individually or jointly. In at least some embodiments, the one or more recesses or the one or more slots or openings are configured to engage the protrusion via a snap fit.

[0062] In at least some embodiments, the fitting provides sensory feedback to the operator upon engagement with the fitting portion, in at least some embodiments by a snap engagement.

[0063] In at least some embodiments, the fitting provides sensory feedback to the operator when a protrusion on the fitting engages with a recess on the mounting portion, in at least some embodiments by a snap engagement.

[0064] In at least some embodiments, the sensory feedback is audible feedback, tactile feedback, or both.

[0065] In at least some embodiments, the fitting is configured to emit a readily audible sound upon engagement with the fitting portion, in at least some embodiments by a snap fit.

[0066] In at least some embodiments, the attachment is configured to provide a tangible movement or emit a tangible vibration upon engagement with the attachment portion, in at least some embodiments by a snap engagement.

[0067] In at least some embodiments, the component further comprises at least one retainer portion that holds at least one accessory.

[0068] In at least some embodiments, the at least one accessory is at least one tube and / or at least one cable and / or at least one lanyard. For example, the at least one accessory can include a gas line, a gas monitoring line including but not limited to a gas sampling line or a line for measuring terminal tidal volume, a hydration tube, a feeding tube, a nasogastric tube, a cable including but not limited to an electrical cable or a sensor cable (such as a temperature probe cable), or a lanyard, or any combination of any two or more thereof.

[0069] In at least some embodiments, at least one accessory is a temperature probe cable.

[0070] In at least some embodiments, at least one retainer portion is annular, substantially annular, square, substantially square, or rectilinear portion that receives at least one accessory.

[0071] In at least some embodiments, the at least one retainer portion is a C-shaped portion that receives at least one accessory.

[0072] In at least some embodiments, the at least one retainer portion is an annular portion that receives at least one accessory.

[0073] In at least some embodiments, the at least one retainer portion is a recessed area of ​​the component.

[0074] In at least some embodiments, at least one retainer portion extends from the body.

[0075] In at least some embodiments, the patient interface is a nasal mask, an oral mask, an oral-nasal mask, a nasal cannula, or a full face mask.

[0076] In at least some embodiments, the patient interface is a nasal cannula.

[0077] In at least some embodiments, the patient interface comprises one or more head straps or two or more head straps, and in at least some embodiments, when two or more head straps are present, the two or more head straps independently comprise a single strap or two or more straps, any of which may be bifurcated.

[0078] In at least some embodiments, the tube is a medical breathing tube, including a corrugated tube or a tube with a helically concave region, such as a medical breathing tube as defined by International Standard ISO 5367:2000(E) (4th Edition, June 1, 2000).

[0079] In at least some embodiments, the tube is an inhalation tube.

[0080] In at least some embodiments, the tube is a nasogastric tube.

[0081] In at least some embodiments, the sensor is a sensor cable.

[0082] In at least some embodiments, the components include: a body for receiving at least one tube and / or at least one cable, in at least some embodiments a tube of a medical breathing circuit, the body comprising an annular, substantially annular, square, substantially square or straight portion configured to at least partially surround or surround an outer periphery of the at least one tube and / or at least one cable; 1. A fitting for removably engaging an attachment portion of a patient interface associated with at least one tube and / or at least one cable, the fitting comprising one or two arms extending from a body to define a space therebetween, each arm including an angled portion extending into or towards the space defined by the arm, whereby the arm is configured to engage the attachment portion of the patient interface, each angled portion engaging a corresponding protrusion on the attachment portion by a snap engagement. It is equipped with:

[0083] Alternatively, the components may be: a body for receiving at least one tube and / or at least one cable, such as a tube for a medical breathing circuit, the body comprising an annular, substantially annular, square, substantially square or straight portion configured to at least partially surround or surround an outer periphery of the at least one tube and / or at least one cable; a fitting for removably engaging an attachment portion of a patient interface associated with at least one tube and / or at least one cable, the fitting comprising at least one arm or alternatively a plurality of arms extending from a body to define a space therebetween, each arm comprising an angled or protruding portion extending outwardly or away from the arm, whereby the arm is configured to engage the attachment portion of the patient interface, each angled or protruding portion engaging a corresponding protrusion on the attachment portion by a snap fit. In one embodiment, the fitting comprises two arms.

[0084] In at least some embodiments, the components include: a body configured to receive at least one tube and / or at least one cable, at least in some embodiments a tube of a medical breathing circuit, the body being configured to at least partially surround or surround an outer periphery of the at least one tube and / or at least one cable, the body comprising an annular, substantially annular, square, substantially square or straight portion; a fitting for releasably engaging an attachment portion of a patient interface associated with at least one tube and / or at least one cable, the fitting comprising one or two arms extending from a body to define a space therebetween, each arm comprising a protrusion or lug extending into or towards the space defined by the arm, whereby the arms are configured to engage the attachment portion of the patient interface, each protrusion or lug engaging a corresponding recess in the attachment portion by a snap-fit; Equipped with.

[0085] Alternatively, the components may be: a body for receiving at least one tube and / or at least one cable, such as a tube of a medical breathing circuit, the body comprising an annular, substantially annular, square, substantially square or straight portion configured to at least partially surround or surround an outer periphery of the at least one tube and / or at least one cable; a fitting for releasably engaging an attachment portion of a patient interface associated with at least one tube and / or at least one cable, the fitting comprising at least one arm or alternatively a plurality of arms extending from a body to define a space therebetween, each arm comprising a protrusion or lug extending away from or outwardly of the arm, whereby the arm is configured to engage the attachment portion of the patient interface, each protrusion or lug engaging a corresponding recess in the attachment portion by a snap-fit; In one embodiment, the fixture comprises two arms.

[0086] In a second aspect, the present disclosure broadly relates to a tube, such as a tube used in a medical breathing circuit, wherein the tube (as described herein) is coupled to a component as described herein, which may be removably engaged with an attachment portion as described herein, which attachment portion is removably attachable to a patient interface of the medical breathing circuit.

[0087] In a third aspect, the present disclosure relates broadly to a patient interface (as described herein) for use in a medical breathing circuit, the patient interface comprising an attachment portion, such as an attachment portion described herein, integral with or removably attached to the patient interface, and a component, as described herein, removably engaging the attachment portion.

[0088] In a fourth aspect, the disclosure broadly relates to a method for manufacturing a semiconductor device, comprising: a patient interface as described herein, which may include an integral attachment portion as described herein; a mounting portion as described herein; assembly and / or use instructions; and any two or more of the above.

[0089] Various aspects and embodiments of the components described above as "clips" may be provided for use in connection with securing or holding or supporting a member (e.g., a breathing tube) to an attachment portion; for example, a patient interface (which may be in the form of a nasal cannula) may be provided with such "clips" that receive such components as described above. It will also be appreciated that such "clips" and each described attachment portion may be provided in combination with a side arm of a nasal cannula patient interface.

[0090] Additionally, the "clips" described above in relation to each of the first through fourth aspects may be provided integrated or in combination with one or more of the other aspects described below in relation to patient interfaces or components for assembling patient interfaces.

[0091] It is an object of the present disclosure to provide a connector, such as for use in a patient interface as part of a medical breathing circuit, that goes at least some way towards improving upon the above, or at least provides a useful option for the public or medical professionals.

[0092] In a fifth aspect, the present disclosure broadly provides a connector assembly comprising: a first connector component; a second connector part; a detent for securing the first connector part and the second connector part; For the first connector part and / or the second connector part, a locked position in which the detent is substantially prevented from moving to release the first connector part from the front second connector part; a free position in which the detent can be moved to release the first connector part from the second connector part; A slide that can be moved between The present invention relates to a connector (herein referred to as a "buckle") comprising:

[0093] It should be understood that any of the following embodiments can relate to any one of the aspects of the disclosure set forth above and below, either alone or in any combination of any two or more.

[0094] In some embodiments, the connector further comprises a biasing means for urging the slide towards the locked position.

[0095] In some embodiments, the biasing means comprises resilient legs.

[0096] In some embodiments, the biasing means comprises a pair of resilient legs. Alternatively, the legs move away from each other as the slide moves towards the free position. Alternatively, the legs move towards each other as the slide moves towards the free position.

[0097] In some embodiments, the biasing means and the detent are integrally formed together.

[0098] In some embodiments, the detent comprises a resilient arm. Optionally, the resilient arm is biased toward engagement with the first connector part.

[0099] In some embodiments, the detent comprises a pair of resilient arms. Optionally, the pair of resilient arms are biased toward engagement with the first connector part.

[0100] In some embodiments, the resilient arms are spaced apart and biased towards each other.

[0101] In some embodiments, the or each resilient arm comprises a protrusion that engages with a complementary notch in the first connector part.

[0102] In some embodiments, the slide comprises a protrusion that engages the biasing means. Optionally, the protrusion comprises an outer tapered surface.

[0103] In some embodiments, the slide comprises a protrusion that engages the detent to substantially prevent movement and release of the first connector part from the second connector part.

[0104] In some embodiments, the slide comprises two protrusions that engage detents to substantially prevent movement and release of the first connector part from the second connector part.

[0105] In some embodiments, the slide includes a stop for positioning the slide and the second connector part in a fixed configuration.

[0106] In some embodiments, the slide comprises a sleeve.

[0107] In some embodiments, the slide allows for movement from the fixed position to the free position with one hand operation.

[0108] In some embodiments, the first connector part includes a notch.

[0109] In some embodiments, the first connector part includes a pair of notches.

[0110] In some embodiments, the first connector part is a substantially planar component.

[0111] In some embodiments, the first connector part is a substantially rigid component.

[0112] In some embodiments, the first connector part comprises a clip.

[0113] In some embodiments the first connector part is located at the patient interface.

[0114] In some embodiments the first connector part is attached to or integrally formed with the patient interface or part of the patient interface.

[0115] In some embodiments, the first connector part is attached to or integrally formed with or as part of an arm of the patient interface, for example, the arm can be a side arm extending outward from a central manifold region or a nasal prong or pair of nasal prongs of a nasal cannula.

[0116] In some embodiments, the second connector part comprises a positioning mechanism for positioning the biasing means.

[0117] In some embodiments, the second connector part includes a guide mechanism for guiding the first connector part.

[0118] In some embodiments, the second connector part includes a guide mechanism for guiding the slide.

[0119] In some embodiments, the second connector part comprises a carrier carrying the detent and / or biasing means.

[0120] In some embodiments, the carrier has a slot formed therein and a head strap of the headgear has an opening, the slot and opening configured to receive the first connector part.

[0121] In a sixth aspect, the present disclosure broadly provides a method for manufacturing a semiconductor device comprising: a first connector part; a second connector part; a detent for securing the first connector part and the second connector part; For the first connector part, a locked position in which the detent is substantially prevented from moving to release the first connector part from the second connector part; a free position in which the detent can be moved to release the first connector part from the front second connector part; A slide that can be moved between The present invention relates to a connector comprising:

[0122] In a seventh aspect, the present disclosure broadly relates to a patient interface for use in a medical breathing circuit, the patient interface comprising the connector of the second aspect.

[0123] The sixth and / or seventh aspect may comprise one or more of the features described above in relation to the fifth aspect.

[0124] Various aspects and embodiments of the "buckles" and components described above may be provided for use in connection with securing or holding or supporting a member (e.g., a headgear or strap end to the end of a side arm of a patient interface, such as a nasal cannula). However, it will be appreciated that the "buckles" described above may also be utilized to provide releasable connection points between other features of a patient interface. It will also be appreciated that such "buckles" may be provided in combination with a side arm of a nasal cannula patient interface, or with the end of a headgear portion of a strap for connecting the headgear to the patient interface.

[0125] In further embodiments, a "clip" as described above may find particular application when used with a nasal cannula or a frame for a nasal cannula, allowing for relatively easy connection or attachment and disconnection or removal of headgear, since any conduits or tubes held or supported by the "clip" can be held or supported in a position, orientation, or orientation that avoids entanglement with the headgear. Furthermore, a "buckle" as described herein may also be connected to or disconnected from the end of an arm of a patient interface, such as a nasal cannula, since any tubes or conduits are effectively properly contained and supported in a position or orientation that avoids entanglement with the headgear and without interfering with the user's attempt to position and operate the releasable buckle.

[0126] Additionally, the "buckles" described above in connection with each of the fifth through seventh embodiments may be provided integrated or in combination with one or more of the other embodiments described below in connection with the patient interface or components for assembling the patient interface.

[0127] In many environments, a gas source may be positioned in a limited number of locations relative to the patient. Accordingly, the conduit extending from the gas source to the patient interface may be in an inconvenient or uncomfortable location, such as the patient's chest or neck. Furthermore, if the conduit is not optimally oriented, at least relative to the patient interface, the convenience or efficacy of the delivered therapy may be compromised. For example, excessive pulling or torqueing forces on the conduit may cause the patient interface to pull away from the patient, the conduit to become dislodged from the patient interface or gas source, or the gas source to fall off a table or other support.

[0128] Certain features, aspects and advantages of at least one of the embodiments disclosed herein apply to the eighth aspect, including the embodiment where the patient interface can include a rotatable assembly (herein a "swivel manifold") adapted to receive gas from a gas source.

[0129] In some embodiments, the patient interface can include a manifold adapted to receive gas rotatably secured to the frame, the manifold adapted to direct the gas to a user.

[0130] In some embodiments, the manifold may communicate gas to the frame in only some rotational orientations and / or may be rotationally locked in place relative to the frame in some rotational orientations.

[0131] In some embodiments, once the manifold is rotationally locked in place relative to the frame, a release mechanism can be used to "unlock" the patient interface, allowing further rotational movement of the manifold relative to the frame. The rotatable assembly can then allow the conduit coupled to the interface to be positioned in multiple orientations relative to the interface and / or gas source, thereby improving the convenience and / or efficacy of the delivered respiratory therapy.

[0132] Thus, in accordance with certain features, aspects, and advantages of at least one of the embodiments disclosed herein, a patient interface is disclosed. For example, in a ninth aspect, the present disclosure relates to a patient interface that can include a nasal cannula. The patient interface can include a frame adapted to be positioned on a user's face. The frame can include a gas chamber adapted to direct gas toward the user. The patient interface can also include a manifold rotatably secured to the frame and adapted to receive gas from a gas source. The manifold can be rotatably secured to the frame such that the range of rotational motion between the manifold and the frame is limited, for example, limited to less than 360 degrees of rotation.

[0133] In some embodiments, the range of rotational motion between the manifold and the frame may be limited to approximately 180 degrees.

[0134] In some embodiments, the frame can include stops that limit the range of rotational movement (eg, rotational movement of the manifold relative to the frame).

[0135] In some embodiments, the manifold can include an axle structure about which the manifold can pivot relative to the frame. In some such embodiments, the axle structure can protrude through an opening in the frame. In alternative embodiments, the frame can include an axle structure that protrudes through an opening in the manifold.

[0136] Further, in accordance with certain features, aspects, and advantages of at least one of the embodiments disclosed herein, a patient interface is disclosed. In a tenth aspect, the patient interface can include a nasal cannula. The patient interface can include a frame adapted to be positioned on a user's face. The frame can include a gas chamber adapted to direct gas toward the user. The patient interface can also include a manifold rotatably secured to the frame and adapted to receive gas from a gas source. The patient interface can be configured such that non-rotational movement of the manifold relative to the frame is limited.

[0137] In some embodiments, the frame further comprises a post adapted to limit non-rotational movement of the manifold relative to the frame.

[0138] In some embodiments, the range of non-rotational movement of the manifold relative to the frame is limited in only some rotational orientations.

[0139] Further, in accordance with certain features, aspects, and advantages of at least one of the embodiments disclosed herein, a patient interface is disclosed. The patient interface can include a nasal cannula. In an eleventh aspect, the patient interface can include a frame adapted to be positioned on a user's face. The frame can include a gas chamber adapted to direct gas toward the user. The patient interface can also include a manifold rotatably secured to the frame and adapted to receive gas from a gas source. The patient interface can be configured to prevent further rotation of the manifold relative to the frame in at least one rotational orientation. The patient interface can be configured to lock the rotational orientation of the manifold relative to the frame after several rotational orientations have been achieved. The patient interface can include a release mechanism adapted to allow rotational movement of the manifold relative to the frame when the manifold is normally unable to rotate relative to the frame. The release mechanism can unlock the locked rotational orientation of the manifold relative to the frame. After unlocking, the patient interface can again allow rotation of the manifold relative to the frame.

[0140] In some embodiments, the release mechanism may comprise a manually depressible button. The button may be depressed to unlock the fixed rotational orientation. The button may be located on the frame. In some alternative embodiments, the button may be located within the frame.

[0141] In some embodiments, the manifold can include a boss adapted to rotatably move in a complementary track on the frame, and the track can include a detention area that can limit movement of the boss.

[0142] Furthermore, in accordance with certain features, aspects, and advantages of at least one of the embodiments disclosed herein, a patient interface is disclosed, which can include a combination of features disclosed above or elsewhere in this disclosure.

[0143] In some embodiments, a patient interface disclosed above or elsewhere in this disclosure can include a manifold including bosses adapted to rotatably move in complementary tracks in a frame.

[0144] In some embodiments, the patient interfaces disclosed above or elsewhere in this disclosure may include a manifold that is permanently and rotatably fixed to the frame.

[0145] In some embodiments, a patient interface disclosed above or elsewhere in this disclosure can include a manifold configured to cooperate with the frame to direct gas to the gas chamber only in some or certain orientations (e.g., rotational orientation of the manifold relative to the frame).

[0146] In some embodiments, a patient interface disclosed above or elsewhere in this disclosure can include a frame comprising a relatively rigid section and a relatively flexible section. In some such embodiments, the relatively flexible section of the frame can be overmolded onto a face-contacting portion of the relatively rigid section of the frame. In some such embodiments, the patient interface can include a nasal delivery element adapted to be inserted into one or more nostrils of the patient. The nasal delivery element can extend from the relatively flexible section of the frame.

[0147] In some embodiments, the patient interface disclosed above or elsewhere in this disclosure may further comprise a nasal delivery element adapted to be inserted into the nostrils of a user. The nasal delivery element may extend from the frame.

[0148] In a twelfth aspect, the present disclosure broadly provides a method for manufacturing a device comprising: The present invention relates to a patient interface comprising: a frame section adapted to be positioned on a user's face, the frame section including a gas chamber adapted to direct gas at the user and a nasal delivery element extending from the gas chamber adapted to be positioned within the user's nares; and a manifold rotatably secured to the frame section, the manifold configured to rotate relative to the frame section and including an axle structure about which rotational movement between the manifold and the frame section can occur.

[0149] In some embodiments, the axle structure protrudes through an opening in the frame section.

[0150] In some embodiments, the manifold is rotatably fixed to the frame section such that the range of rotational movement between the manifold and the frame section is limited.

[0151] In some embodiments, the frame sections include stops that limit the range of rotational movement.

[0152] In some embodiments, the patient interface further comprises nasal delivery elements extending from the gas chamber adapted to be positioned within the nostrils of the user.

[0153] In some embodiments, the frame section further comprises a track, the track configured to guide rotation of the manifold relative to the frame section.

[0154] In some embodiments, the interface further comprises a retention mechanism, the retention mechanism being disposed on the frame section and configured to retain the manifold in an actuated position such that a pneumatic seal is provided between the manifold and the gas chamber.

[0155] In some embodiments, the retention feature is a post extending outward from the frame section, the post configured to retain the manifold between the frame section and the post when the manifold is in the actuated position.

[0156] In some embodiments, the patient interface includes a retention mechanism configured to release the manifold from the actuated position to allow the manifold to rotate relative to the frame section.

[0157] In some embodiments, the release mechanism comprises a button, the button being disposed on the manifold, the button comprising a boss portion configured to engage with and move within a substantial portion of the track as the manifold rotates.

[0158] In some embodiments, the track includes one or more retention areas disposed at the ends of the track, and the bosses are configured to engage the retention areas to lock the manifold in the actuated position.

[0159] In some embodiments, the release mechanism comprises a release body movable within a recess in the manifold, the release body movable from an unactuated position to an actuated position, and the release body is in the unactuated position when the manifold is in the actuated position.

[0160] In some embodiments, the release body comprises one or more side arms, the recess comprises one or more end regions shaped to correspond to the one or more side arms, and the side arms are configured to move into the end regions to release the boss portion from the retention region and allow the manifold to rotate.

[0161] In some embodiments, the side arms are configured to flare outward to release the boss portion from the detent region.

[0162] In some embodiments, the side arms are configured to expand inwardly to release the boss portion from the retracted position.

[0163] In some embodiments, the patient interface further comprises at least one nasal delivery element extending from the gas chamber, each nasal delivery element adapted to be positioned within a nostril of the user.

[0164] In some embodiments, the at least one nasal delivery element comprises two nasal delivery elements.

[0165] In a thirteenth aspect, the present disclosure broadly provides a method for manufacturing a device comprising: a frame section adapted to be positioned on a user's face, the frame section including a gas chamber adapted to direct gas toward the user; a manifold rotatable relative to the frame section and adapted to receive gas from the gas source; a retention mechanism disposed on the frame section and / or the manifold and configured to limit non-rotational movement of the manifold relative to the frame section; The present invention relates to a patient interface comprising:

[0166] In some embodiments, the retention feature comprises a post adapted to retain the manifold.

[0167] In some embodiments, the retention mechanism restricts non-rotational movement of the manifold relative to the frame section in only some rotational orientations.

[0168] In some embodiments, the retention mechanism seals the gas passage extending between the manifold and the gas chamber in only some rotational orientations.

[0169] In some embodiments, the patient interface further comprises a nasal delivery element extending from the gas chamber, the nasal delivery element adapted to be positioned within one or more nostrils of the user.

[0170] In some embodiments, the manifold is rotatably fixed to the frame section.

[0171] In some embodiments, the retention mechanism is located on the frame section.

[0172] In some embodiments, the retention mechanism is integrally formed in the frame section.

[0173] In some embodiments, the retention mechanism is located on the manifold.

[0174] In some embodiments, the retention feature is integrally formed with the manifold.

[0175] In some embodiments, the retention feature comprises a first retention feature disposed on the manifold and a second retention feature disposed on the frame section.

[0176] In some embodiments, the first retention feature comprises a first hook having a generally vertically extending portion and a generally horizontally extending portion extending from the generally vertically extending portion in a direction toward the manifold, and the second retention feature comprises a second hook having a generally vertically extending portion and a generally horizontally extending portion extending from the generally vertically extending portion in a direction away from the manifold.

[0177] In some embodiments, the first retention feature comprises a first hook having a generally vertically extending portion and a generally horizontally extending portion extending from the generally vertically extending portion in a direction away from the manifold, and the second retention feature comprises a second hook having a generally vertically extending portion and a generally horizontally extending portion extending from the generally vertically extending portion in a direction towards the manifold.

[0178] In some embodiments, the first retention feature is integrally formed with the manifold.

[0179] In some embodiments, the second retention feature is integrally formed with the frame section.

[0180] In some embodiments, the first retention feature is integrally formed with the frame section.

[0181] In some embodiments, the second retention feature is integrally formed with the manifold.

[0182] In a fourteenth aspect, the present disclosure broadly provides a method for manufacturing a device comprising: a frame section adapted to be positioned on a user's face, the frame section including a gas chamber adapted to direct gas toward the user; a manifold rotatably rotatable relative to the frame section and adapted to receive gas from the gas source; A release mechanism; Equipped with the patient interface is configured such that the manifold is rotationally locked relative to the frame section in at least one rotational orientation of the manifold; The patient interface relates to a release mechanism adapted to unlock movement of the manifold relative to the frame section when the manifold is rotationally locked.

[0183] In some embodiments, the release mechanism comprises a button.

[0184] In some embodiments, the button is disposed on the manifold.

[0185] In some embodiments, the button is coupled to a release body that includes a boss configured to rotatably move within a track located on the frame.

[0186] In some embodiments, the track includes a detent area that locks the boss against rotational movement, and actuation of the button disengages the boss from the detent area.

[0187] In some embodiments, the release has an actuated state and an unactuated state, and actuation of the button transitions the release from the actuated state to the unactuated state.

[0188] In some embodiments, releasing the button transitions the release from an unactuated state to an actuated state.

[0189] In some embodiments, the release body comprises at least one side arm that, in a biased state, is forced around the protruding ledge section of the frame.

[0190] In some embodiments, the release mechanism comprises a lever or arm.

[0191] In some embodiments, a lever or arm is disposed on the frame.

[0192] In some embodiments, the lever or arm comprises a protruding portion and the manifold has a complementary recess, slot or opening that receives the protruding portion.

[0193] In some embodiments, the lever or arm is located on the manifold.

[0194] In some embodiments, the manifold comprises a flexible section or hinge.

[0195] In some embodiments, the lever or arm comprises a protruding portion and the frame has a complementary recess, slot or opening that receives the protruding portion.

[0196] In some embodiments, the lever or arm has an actuated state and an unactuated state, and actuation of the lever or arm transitions the lever or arm from the actuated state to the unactuated state.

[0197] In some embodiments, releasing the lever or arm transitions the lever or arm from an unactuated state to an actuated state.

[0198] In some embodiments, the lever or arm has a flexible section.

[0199] In some embodiments, the entire lever or arm is flexible.

[0200] In some embodiments, the manifold is rotatably fixed to the frame section.

[0201] In a fifteenth aspect, the present disclosure broadly provides a method for manufacturing a semiconductor device, comprising: a frame section adapted to be positioned on a user's face, the frame section including a gas chamber adapted to direct gas toward the user; a manifold rotatable relative to the frame section and adapted to receive gas from the gas source; a retention mechanism disposed on the frame section and configured to limit non-rotational movement of the manifold relative to the frame section; A release mechanism; Equipped with the patient interface is configured such that the manifold is rotationally locked relative to the frame section in at least one rotational orientation of the manifold; The patient interface relates to a release mechanism adapted to unlock movement of the manifold relative to the frame section when the manifold is rotationally locked.

[0202] In some embodiments, the retaining and releasing mechanisms are adapted to restrict non-rotational movement of the manifold relative to the frame sections and to unlock movement of the manifold relative to the frame sections when the manifold is rotationally locked.

[0203] In a sixteenth aspect, the present disclosure broadly provides a method for manufacturing a semiconductor device, comprising: a frame section adapted to be positioned on a user's face, the frame section including a gas chamber adapted to direct gas toward the user; a manifold fixed relative to the frame section and adapted to receive gas from the gas source; headgear adapted to secure the frame section to a user's head, the headgear comprising a bifurcated section; The present invention relates to a patient interface comprising:

[0204] In some embodiments, the bifurcated section rests on the back of the user's head.

[0205] In some embodiments, the bifurcated strap comprises a pair of straps connected by a bridge region.

[0206] In some embodiments, the bridge region is thinner than the straps or is completely frangible.

[0207] In a seventeenth aspect, the present disclosure broadly provides a method for manufacturing a semiconductor device, comprising: a frame section adapted to be positioned on a user's face, the frame section including a gas chamber adapted to direct gas toward the user; a manifold fixed relative to the frame section and adapted to receive gas from the gas source; headgear adapted to secure the frame section to a user's head, the headgear comprising a user-contacting section including a friction element; The present invention relates to a patient interface comprising:

[0208] In some embodiments, the user-contacting section rests on the back and / or sides of the user's head.

[0209] In some embodiments, the friction element comprises markings, which can be printed.

[0210] In an eighteenth aspect, the present disclosure broadly provides a method for manufacturing a semiconductor device, comprising: a frame adapted to be positioned on a user's face, the frame including a gas chamber adapted to direct gas toward the user; a manifold secured to the frame and adapted to receive gas from the gas source; headgear adapted to secure the frame to the head of a user; a headgear retention mechanism operable to tighten or loosen the headgear; Equipped with The present invention relates to a patient interface comprising: a headgear comprising markings adapted to inform a user regarding the tightness or fit of the headgear when used in cooperation with a headgear retention mechanism.

[0211] In some embodiments, headgear comprising such markings may be particularly contemplated to provide advantageous cooperation when used in combination with a "buckle" as described herein. The indication of fit or tightness of the headgear when held or secured on a user further provides one or more reference points for subsequent adjustment of the headgear to fit the user, including applied tightness or tension.

[0212] In some embodiments, the frame comprises a relatively rigid section and a relatively flexible section.

[0213] In some embodiments, the relatively flexible section of the frame is overmolded onto the face-contacting portion of the relatively rigid section of the frame.

[0214] In some embodiments, the patient interface further comprises a nasal delivery element adapted to be inserted into one or more nostrils of the patient, the nasal delivery element extending from the relatively flexible section of the frame.

[0215] In some embodiments, the patient interface further comprises a nasal delivery element adapted to be inserted into one or more nostrils of the patient, the nasal delivery element extending from the gas chamber.

[0216] Various aspects and embodiments of the component described above as a "swivel manifold" may be provided for use in connection with a component that forms part of a patient interface, such as, for example, a nasal cannula. However, it will be appreciated that the "swivel manifold" described above may also be utilized to provide a patient interface with an adjustable and side-interchangeable manifold or gas delivery element that is incorporated into, for example, a nasal cannula.

[0217] Additionally, the "swivel manifold" described above in relation to each of the eighth through eighteenth aspects may be provided integrated or in combination with one or more of the other aspects described below in relation to patient interfaces or components for assembling patient interfaces.

[0218] In a nineteenth aspect, there is a patient interface, such as a nasal cannula, comprising headgear in the form of at least one strap, said strap being splittable or bifurcated in use to provide upper and lower strap portions of said headgear in combination with any one or more of the aspects or embodiments as described herein.

[0219] In a twentieth aspect, there is provided a patient interface, such as a nasal cannula, wherein a manifold or manifold assembly is rotatably coupled or configured as a rotatable coupling to the patient interface or a frame portion of the patient interface, so that, in use, a gas supply conduit in fluid communication with the manifold can be directed to the left or right side of a user of the patient interface.

[0220] In a 21st aspect, there is provided a patient interface such as a nasal cannula, wherein a manifold or manifold assembly is of a push-fit type that can be received by a gas chamber of the patient interface, which receives the supply gas and directs it to one or more outlets, to be inserted into or removed from the gas chamber, the push-fit type manifold being fluidly connected to a gas supply conduit that supplies the supply gas during use, and the push-fit type manifold being receivable by the gas chamber from either or both the left and right sides of the patient interface, or connected to direct the gas supply conduit to the left or right side of a user of the patient interface.

[0221] In combination with the embodiments described herein, a "clip" as described herein can work particularly well with either a "swivel manifold" or "swivel" manifold assembly, or a push-fit type configuration of a manifold or manifold assembly, since the adjustable orientation of the manifold and associated gas delivery conduits allows for effective "side swapping" of the gas delivery conduits relative to the interface and user. This can improve user comfort and increase the likelihood of less interrupted therapy delivery to the user, who is less likely to interfere with the patient interface and associated components (which could disrupt therapy delivery) (i.e., the user could remove the interface or the tubing could become wrapped around or entangled with the user or an object nearby). For example, being able to swap the side on which a gas delivery or supply conduit is presented relative to the interface and user can facilitate improved operational or more optimal positioning by clipping the tubing to the "clip" onto a mounting or receiving portion of the "clip" on an arm or part of the interface. In some forms, the side arms of the nasal cannula interface can include such an attachment or receiving portion on each arm at approximately the same location on each arm, thereby allowing a "clip" to be connected to the side arm and hold the tube in the same location on each such arm.

[0222] The clips of the first to fourth aspects, or the buckles of the fifth to eleventh aspects, or the swivel manifolds of the eighth to eighteenth aspects, or the headgear of the nineteenth aspect, or the patient interface of the twentieth or twenty-first aspects may be combined with any one or more of the other aspects disclosed herein.

[0223] It is an object of the present disclosure to provide a patient interface that goes at least some way towards improving upon the above, or at least provides a useful option for the public or medical professionals.

[0224] In a twenty-second aspect, the present disclosure broadly provides a method for manufacturing a semiconductor device, comprising: a frame section adapted to be positioned on a user's face, the frame section comprising a gas chamber adapted to direct gas at the user and a nasal delivery element extending from the gas chamber adapted to be positioned within the user's nostrils; a manifold assembly operably securable to the frame section, the manifold assembly having a manifold and a manifold inlet, the manifold inlet having a tapered bore where an end proximal to the manifold has an area greater than an area of ​​an end of the bore distal to the manifold; The present invention relates to a patient interface comprising:

[0225] In some embodiments, the manifold assembly comprises a first component and a second component engageable with the first component; the first component forms at least a portion of the manifold, at least a portion of the manifold inlet, or at least a portion of the manifold and at least a portion of the manifold inlet; The second component forms at least a portion of the manifold, at least a portion of the manifold inlet, or at least a portion of the manifold and at least a portion of the manifold inlet.

[0226] In some embodiments, the first component has a manifold inlet portion and the second component is or has a manifold inlet portion, and the manifold inlet portion of the first component and the manifold inlet portion of the second component are engageable to form the manifold inlet.

[0227] In some embodiments, the manifold portion is formed by a first component having the manifold portion.

[0228] In some embodiments, the first component comprises at least one positioning feature and the second component comprises at least one complementary positioning feature.

[0229] In some embodiments, at least one positioning feature of the first component comprises a protrusion and at least one positioning feature of the second component comprises a complementary recess or opening.

[0230] In some embodiments, the first component has an internally threaded portion that corresponds to an externally threaded portion of the conduit or tube.

[0231] In some embodiments, the first component has a smooth, non-threaded portion.

[0232] In some embodiments, the second component has an internally threaded portion that corresponds to an externally threaded portion of the conduit or tube.

[0233] In some embodiments, the second component has a smooth, non-threaded portion.

[0234] In some embodiments, a fastening component may further be included.

[0235] In some embodiments, the fastening component comprises a collar.

[0236] In some embodiments, the collar is a substantially annular component.

[0237] In some embodiments, the collar has a tapered inner surface that engages an outer surface of the manifold inlet portion of the first component and an outer surface of the manifold inlet portion of the second component.

[0238] In some embodiments, the first component has a manifold portion and the second component has a manifold portion, and the manifold portion of the first component and the manifold portion of the second component are engageable to form at least a portion of the manifold.

[0239] In some embodiments, the manifold portion of the first component and the manifold portion of the second component are mateable to form the overall manifold.

[0240] Some embodiments may further comprise a third component engageable with the first component and / or the second component to form at least a portion of the manifold.

[0241] Some embodiments may further comprise a third component engageable with the first component and / or the second component to form an overall manifold.

[0242] In some embodiments, the first component has a manifold inlet portion that forms at least a portion of the manifold inlet.

[0243] In some embodiments, the first component has a manifold inlet portion that forms the entire manifold inlet.

[0244] In some embodiments, the first component forms at least a major portion of the manifold and the second component forms at least a major portion of the manifold inlet.

[0245] In some embodiments, the first component forms the entire manifold and the second component forms the entire manifold inlet.

[0246] In some embodiments, the first component has a manifold portion and a manifold inlet portion, the second component has a manifold portion and a manifold inlet portion, the manifold portion of the first component and the manifold portion of the second component are engageable to form at least a portion of the manifold, and the manifold inlet portion of the first component and the manifold inlet portion of the second component are engageable to form at least a portion of the manifold inlet.

[0247] In some embodiments, the first component forms at least a major portion of the manifold and the second component forms at least a portion of the manifold.

[0248] In some embodiments, a third component can be further included, the third component engageable with the second component to form at least a portion of the manifold inlet.

[0249] In some embodiments, the first component forms the entire manifold.

[0250] In some embodiments, the first component forms at least a portion of the manifold and the second component forms at least a major portion of the manifold inlet.

[0251] In some embodiments, a third component can be further included, the third component being engagable with the first component to form at least a portion of the manifold.

[0252] In some embodiments, the second component forms the entire manifold inlet.

[0253] In some embodiments, a portion of the first component comprises a relatively rigid material and another portion of the first component comprises a relatively soft and / or flexible material.

[0254] In some embodiments, the first component comprises a relatively rigid component.

[0255] In some embodiments, the first component comprises a relatively soft and / or flexible component.

[0256] In some embodiments, a portion of the second component comprises a relatively rigid material and another portion of the second component comprises a relatively soft and / or flexible material.

[0257] In some embodiments, the second component is a relatively rigid component.

[0258] In some embodiments, the second component is a relatively soft and / or flexible material.

[0259] In some embodiments, a portion of the second component comprises a relatively rigid material and another portion of the second component comprises a relatively soft and / or flexible material.

[0260] In some embodiments, one or more seals and / or gaskets may be further included.

[0261] In some embodiments, one or more seals and / or gaskets are integrally formed with the first component and / or the second component.

[0262] In some embodiments, the one or more seals and / or gaskets are separate components from the first and second components.

[0263] In some embodiments, the first component and the second component are integrally formed together by a living hinge.

[0264] In some embodiments, the first component and the second component are separate components.

[0265] In some embodiments, the first component is engaged with the second component.

[0266] In some embodiments, the first component is engaged with the second component by one or more of ultrasonic welding, RF welding, heat staking, stitching, adhesive, hook and loop fasteners, zip fasteners, clips, snap fits, and press fits.

[0267] In some embodiments, the manifold assembly is formed from a series of modular components.

[0268] In another embodiment, the manifold or manifold assembly provides a relatively smooth gas flow path within the manifold or manifold assembly, which flow path may have relatively reduced flow restriction, for example, which helps to minimize or reduce one or more of noise (e.g., noise of gas flow through the manifold or manifold assembly and / or into the gas chamber and delivery outlet of the patient interface), turbulence, flow separation from the connector at the downstream end of the gas supply tubing or conduit connected to the patient interface to the lead-in to the manifold or gas chamber, and / or facilitates manufacturing of such components.

[0269] In another embodiment, a manifold or manifold assembly as described above can provide a side-exchange manifold in combination with a patient interface such as a nasal cannula, for example, such a combination with a side-exchange manifold also allows the retraction to be left-right interchangeable since they are formed together.

[0270] Various aspects and embodiments of the components described above as "tapered manifold sections" may be adapted for use in connection with components that form part of a patient interface, such as, for example, a nasal cannula. However, the "tapered manifold sections" described above may be utilized to provide alternative lead-in or lumen sections for delivering gases to the manifold section of the patient interface, and may be integrated with a patient interface or manifold section, including, but not limited to, a "swivel manifold," for example, as part of a nasal cannula.

[0271] Additionally, the "tapered manifold portion" described above in relation to the twenty-second embodiment may be provided integrally or in combination with one or more of the other embodiments described below in relation to components for assembling a patient interface.

[0272] In a twenty-third aspect, the present disclosure relates to a patient interface for delivering supply gas to a patient, the patient interface comprising: a gas supply manifold that receives the supply gas and directs it to one or more outlets to the patient; and a pair of elongated side arms extending from opposite sides of the manifold to contact a user's face in use and help stabilize the interface on the user's face, each of the side arms comprising an upward curve or bend along their length (herein "twisted side arms").

[0273] More particularly, each side arm can have an inner first portion and an outer second portion extending upwardly at an angle relative to the inner first portion.

[0274] In at least some embodiments, at least a portion of the outer second portion extends at an angle between 20 degrees and 70 degrees relative to the inner first portion, or can be between about 5 degrees and about 85 degrees, or can be between about 10 degrees and about 80 degrees, about 15 degrees and about 75 degrees, about 25 degrees and about 65 degrees, about 30 degrees and about 60 degrees, about 35 degrees and about 55 degrees, or about 40 degrees and about 50 degrees.

[0275] In at least some embodiments, the side arms are shaped to engage the wearer's face below the cheekbones.

[0276] In a twenty-fourth aspect, the present disclosure relates to a patient interface for delivering supply gas to a patient, comprising: a gas supply manifold that receives the supply gas and directs it to one or more outlets to the patient; and a pair of elongated side arms extending from opposite sides of the manifold to contact a user's face in use and help stabilize the interface on the user's face, each of the side arms having an inner first portion extending laterally or laterally and rearwardly from the manifold at a first angle relative to the manifold, and an outer second portion extending from the first portion and rearwardly at a relatively shallow angle relative to the manifold, for example, the angle being relative to a reference line drawn through the manifold body extending from the left side to the right side (or vice versa) of the manifold body when considered from the top (or bottom) of the interface.

[0277] Typically, the side arms are flexible or semi-rigid side arms.

[0278] In at least some embodiments, the inner first portion of each of the side arms extends at an angle of between about 30 degrees, about 50 degrees, or about 70 degrees relative to the manifold, and the outer second portion extends from the first portion at an angle of between about 150 and about 170 or about 180 degrees relative to the angle of the inner first portion, or the outer second portion extends from the first portion at an angle of between about 30 degrees and about 10 degrees or about 0 degrees relative to the manifold or outer second portion.

[0279] In at least some embodiments, the side arms also include an upward curve or bend along their length, and in at least some embodiments, the outer second portion of each of said side arms extends upward at an angle relative to the inner first portion.

[0280] In at least some embodiments, the first and second portions of the elongated wing portion are joined by an intermediate curved portion.

[0281] In at least some embodiments, the side arms also include a partially twisted portion, whereby a cross-sectional shape taken orthogonally through the side arm is partially twisted counterclockwise or clockwise in the portion of the side arm closer to the outer end relative to the portion of the side arm closer to the manifold.

[0282] In at least some embodiments, the cross-sectional shape taken orthogonally through the side arms has a partial left or right twist of up to about 60 degrees, or up to about 45 degrees, or between about 2 degrees and about 20 degrees, or between about 2 degrees and about 50 degrees, the twist and orientation being when considered from a top or bottom view of the interface and the respective side arms.

[0283] In at least some embodiments, a major portion or all of the partial twist shape is in said second outer portion of each side arm.

[0284] In at least some embodiments, the cross-sectional area of ​​each side arm decreases along the length of the side arm.

[0285] In a twenty-fifth aspect, the present disclosure relates to a patient interface for delivering supply gas to a patient, comprising: a gas supply manifold that receives the supply gas and directs it to one or more outlets to the patient; and a pair of elongated side arms extending from opposite sides of the manifold to contact a user's face in use and help stabilize the interface on the user's face, each of the side arms comprising a partially twisted portion whereby a cross-sectional shape taken perpendicularly through the side arm is partially twisted counterclockwise or clockwise at a portion of the side arm nearer to its outer end relative to a portion of the side arm nearer to the manifold.

[0286] In at least some embodiments, the cross-sectional shape taken orthogonally through the side arm is partially twisted counterclockwise or clockwise by up to about 60 degrees, or up to about 45 degrees, or between about 2 degrees and about 20 degrees, or between about 2 degrees and about 50 degrees, depending on whether the side arm is being considered from a top or bottom view of the interface.

[0287] In at least some embodiments, a major portion or all of the partial twist shape is in said second outer portion of each side arm.

[0288] In at least some embodiments, the cross-sectional area of ​​each side arm decreases along the length of the side arm.

[0289] Typically, the patient interface also includes headgear, which may be formed from an elastic material, such as an elastic fabric material.

[0290] Typically, the distal end of each side arm includes formations configured to releasably mate with a complementary connector on the headgear.

[0291] As used in this specification and claims, the term "cheek" means any area of ​​a user's face adjacent to or at the cheekbone, and can include any area to the side and / or below the cheekbone, and / or any other area between the corresponding edges of the user's eyes, ears, and nose.

[0292] The terms "upward," "across," and "backward," as used herein with respect to an interface, mean (unless the context indicates otherwise) approximately vertical, laterally horizontal, and front-to-back horizontal through or with respect to the interface when worn by a user in an upright position.

[0293] Various aspects and embodiments of the components described above as "twisting side arms" may be provided for use in connection with components that form part of a patient interface, such as a nasal cannula, etc. However, it will be appreciated that the "twisting side arms" described above may also be utilized to provide alternative systems or forms of patient interfaces.

[0294] Additionally, the "twisting side arms" described above in relation to each of the 23rd to 25th embodiments may be provided integrated or in combination with one or more of the other embodiments described below in relation to components for assembling a patient interface.

[0295] Additionally, the disclosure herein relating to "clips" is provided in combination with patient interfaces, such as nasal cannulas, that include "torsion frame arms" as described herein.

[0296] In further embodiments, the twisted or bent or curved features of the frame or side arms of the patient interface can facilitate the relative positioning of the mounting or receiving portion to the "clip" such that, in use, the "clip" engaged with the side arm can provide the appearance or visual appearance of a tube or conduit supported or held by said "clip" being aligned with the side arm of the interface, or the tube or conduit is positioned and supported to extend away from the patient interface substantially parallel to the user's face, optionally without introducing additional loads to the manifold or manifold assembly or any section thereof. Preferably, the frame or side arms of the interface can be twisted to enable or facilitate the transfer of loads or applied forces away from such manifold sections thereon.

[0297] In a 26th aspect, in a broad sense, a frame adapted to be positioned on a user's face, the frame including a gas chamber adapted to direct gas toward the user; a manifold assembly adapted to receive gas from a gas source, the manifold assembly and frame being adapted such that the manifold assembly can engage the frame from both the left and right hand sides of the frame to deliver gas to the gas chamber; The present invention relates to a patient interface comprising:

[0298] In some embodiments, the manifold assembly comprises an inlet that interfaces with or is attached to a conduit and an outlet or opening to communicate with the gas chamber.

[0299] In some embodiments, the frame comprises a first gas inlet on a left-hand side of the gas chamber and a second gas inlet on a right-hand side of the gas chamber, and the manifold assembly is adapted to be inserted into the gas chamber via both the first and second gas inlets.

[0300] In some embodiments, the manifold assembly includes sealing surfaces at or towards each end of the manifold assembly that seal against the first and second gas inlets.

[0301] In some embodiments, the frame or the manifold assembly comprises a resilient material that forms a seal between the manifold assembly and the frame to substantially prevent gas flow through the first gas inlet and the second gas inlet between the frame and the manifold assembly.

[0302] In some embodiments, the frame comprises a resilient material within the gas chamber that contacts the sealing surface of the manifold assembly.

[0303] In some embodiments, the elastic material is integrally formed with the face-contacting portion of the frame.

[0304] In some embodiments, the manifold assembly outlet faces rearward when the manifold assembly is fitted into the frame.

[0305] In some embodiments, the resilient face-contacting portion of the frame is not supported by the manifold assembly in the upper lip region, such that the face-contacting portion in the region of the manifold outlet provides a cushion that rests against the user's upper lip.

[0306] In some embodiments, the patient interface comprises clips for securing tubing and / or cables to the patient interface as described by or in one or more of the other aspects of the invention described herein.

[0307] In some embodiments, the patient interface comprises one or more buckles or connectors that attach the headgear to the frame as by or as described in one or more of the other aspects of the invention described herein.

[0308] In some embodiments, the patient interface comprises headgear that secures the frame to the user's head according to or as described in one or more of the other aspects of the invention described herein.

[0309] In some embodiments, the manifold assembly comprises a manifold inlet as described in one or more of the other aspects of the invention described herein.

[0310] In some embodiments, headgear may be provided with slits extending along or through the cross section, such that said slits can be opened or split in use.

[0311] In some embodiments, headgear can be provided that includes two side straps that extend toward the rear of the user's head and two rear strap portions, namely an upper rear strap portion and a lower rear strap portion, that allow the patient interface to be held on the user's face in use while maintaining one or a pair of nasal prongs within the nares for delivering supplied gas and / or to reduce any pressure on the user's nose, nasal septum, or underside of the philtrum.

[0312] In some embodiments, the upper and lower rear strap portions of the headgear can be configured to be movable relative to one another and to allow for automatic or self-adjusting fit to the head, the headgear fitting in place to minimize force against the nasal septum while maintaining the prongs in the nose.

[0313] In further embodiments, a conduit or tube can be provided in combination with any one or more of the above aspects of other embodiments. Such a conduit or tube is provided to provide gas to a patient interface or to be in fluid communication or connection with a manifold or manifold assembly. Such a conduit can be formed of a breathable or flexible type. Such a gas conduit can also be shatter-resistant and / or made of a material that can reduce or minimize the generation of noise when the conduit is moved or bent, sometimes referred to as a "crinkling" sound. In this embodiment, the conduit can comprise an elongated film spirally wrapped with an elongated reinforcing member that forms the lumen of the conduit. The conduit can also be of a type that is extruded to form the conduit. In various embodiments, breathable materials can be used in the construction of the conduit to help drain any accumulated condensation (e.g., from "rainout") in the conduit. In various embodiments, the reinforcing member can help prevent or reduce crushing and / or kinking of the tube, or at least the likelihood of crushing and / or kinking during use. The lumen of the conduit can comprise an internal bore that is substantially smooth to reduce resistance to flow and / or minimize surface features on which condensation can accumulate or pool.

[0314] It should be understood that any of the following embodiments can relate to any one or more of the aspects of the disclosure set forth above, alone or in any combination of any two or more, or combinations of the various embodiments described herein to provide assemblies and combinations.

[0315] The term "comprising" as used in this specification and claims means "consisting at least in part of." When interpreting sentences in this specification and claims that include the term "comprising," there may also be other features present in each sentence than the feature preceding this term. Related terms such as "comprise" and "comprised" should be interpreted in the same way.

[0316] Reference to a range of numbers disclosed herein (e.g., 1 to 10) is intended to incorporate reference to every rational number within that range (e.g., 1, 1.1, 2, 3, 3.9, 4, 5, 6, 6.5, 7, 8, 9, and 10) and any range of rational numbers within that range (e.g., 2 to 8, 1.5 to 5.5, and 3.1 to 4.7); therefore, all subranges of every range explicitly disclosed herein are hereby expressly disclosed. These are merely examples of what is specifically intended, and all possible combinations of numerical values ​​between the lowest and highest values ​​recited should be considered as if they were also explicitly stated herein.

[0317] The present disclosure can also be broadly stated as consisting in any and all combinations of the parts, elements and features, individually or collectively, referred to or shown in the specification of this application, and any two or more of said parts, elements or features, and where reference is made herein to specific wholes that have known equivalents in the art to which the present disclosure pertains, such known equivalents are deemed to be incorporated herein as if individually set forth.

[0318] As used herein, the term "(plural)(s)" following a noun refers to the plural and / or the singular form of that noun.

[0319] As used herein, the term "and / or" means "and" or "or," or where the context allows, both.

[0320] The present disclosure contemplates the above and the following structures, of which the following are merely examples.

[0321] Various embodiments of the present disclosure will now be described, by way of example only, and with reference to the following drawings, in which: [Brief explanation of the drawings]

[0322] [Figure 1A] 1 shows a schematic setup of a humidification system that delivers a flow of humidified gas to a patient interface worn by a user. [Figure 1B] 1 shows a schematic representation of one form of medical circuit provided to a user when providing a source of humidified breathing gas; [Figure 2] FIG. 1 shows a perspective view of a patient interface. [Figure 3A] FIG. 1 shows a perspective view of a portion of a patient interface. [Figure 3B] FIG. 3B shows a perspective view of the portion shown in FIG. 3A with the manifold removed. [Figure 4A-C] 10 illustrates how the frame of the patient interface can be rotatably secured to the manifold. [Figure 5] 1 shows a portion of the frame of the patient interface. [Figure 6] 1 shows a portion of the frame of the patient interface. [Figure 7A] FIG. 2 shows a top perspective view of the manifold. [Figure 7B] FIG. 9B shows a bottom perspective view of the manifold shown in FIG. 9A. [Figure 8A] 13 illustrates the use of a rotation assembly of the patient interface. [Figure 8B] 13 illustrates the use of a rotation assembly of the patient interface. [Figure 8C] 13 illustrates the use of a rotation assembly of the patient interface. [Figure 8D] 13 illustrates the use of a rotation assembly of the patient interface. [Figure 8E]13 illustrates the use of a rotation assembly of the patient interface. [Figure 9] 1 illustrates the use of a patient interface in a respiratory treatment system. [Figure 10A] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 10B] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 10C] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 10D] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 10E] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 10F] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 10G] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 10H] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 10I] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 11A] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 11B] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 11C] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 11D] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 11E] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 11F] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 12A] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 12B] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 12C]10 illustrates an alternative embodiment of components for a patient interface. [Figure 12D] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 12E] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 13A] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 13B] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 13C] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 13D] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 14A] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 14B] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 14C] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 15A] 10 illustrates an alternative embodiment of a component for the patient interface of the manifold assembly. [Figure 15B] 10 illustrates an alternative embodiment of a component for the patient interface of the manifold assembly. [Figure 15C] 10 illustrates an alternative embodiment of a component for the patient interface of the manifold assembly. [Figure 15D] 10 illustrates an alternative embodiment of a component for the patient interface of the manifold assembly. [Figure 16A] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 16B] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 16C] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 17A] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 17B]10 illustrates an alternative embodiment of components for a patient interface. [Figure 17C] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 18A] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 18B] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 18C] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 19A] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 19B] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 19C] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 20A] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 20B] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 20C] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 20D] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 20E] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 20F] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 20G] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 21A] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 21B] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 21C] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 22A] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 22B]10 illustrates an alternative embodiment of components for a patient interface. [Figure 22C] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 23A] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 23B] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 24A] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 24B] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 24C] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 24D] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 24E] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 25A] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 25B] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 25C] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 25D] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 25E] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 26A] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 26B] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 26C] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 26D] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 27] 10 illustrates an alternative embodiment of components for a patient interface. [Figure 28A]FIG. 1 is a perspective view of a patient interface. [Figure 29] FIG. 2 is a top perspective side view of the manifold assembly of the first embodiment. [Figure 30] FIG. 30 is a side bottom perspective view of the manifold assembly of FIG. 29. [Figure 31] 30 is a side top perspective view of the manifold assembly of FIG. 29, showing the opposite side of that shown in FIG. 29. [Figure 32] FIG. 30 is a side top perspective view of a first component of the manifold assembly of FIG. 29. [Figure 33] FIG. 33 is an end perspective view of the first component of FIG. 32. [Figure 34] FIG. 30 is a top perspective view of a second component of the manifold assembly of FIG. 29. [Figure 35] FIG. 35 is a bottom perspective view of the second component of FIG. 34. [Figure 36] FIG. 35 is a top view of the second component of FIG. 34. [Figure 37] FIG. 35 is an underside view of the second component of FIG. 34. [Figure 38] FIG. 30 is a partial cross-sectional view of the manifold assembly of FIG. 29. [Figure 39] FIG. 10 is an exploded view of a manifold assembly according to a second embodiment. [Figure 40] FIG. 10 is an exploded view of a manifold assembly according to a third embodiment. [Figure 41] FIG. 10 is an exploded view of a manifold assembly according to a fourth embodiment. [Figure 42] FIG. 10 is an exploded view of a manifold assembly according to a fifth embodiment. [Figure 43] FIG. 10 is an exploded view of a manifold assembly according to a sixth embodiment. [Figure 44] FIG. 13 is an exploded assembly view of a manifold assembly according to a seventh embodiment. [Figure 45] FIG. 13 is an exploded view of a manifold assembly according to an eighth embodiment. [Figure 46] FIG. 13 is a partial exploded assembly view of the manifold assembly of the ninth embodiment. [Figure 47] FIG. 23 is an exploded view of the manifold assembly of the tenth embodiment. [Figure 48] FIG. 23 is an exploded assembly view of the manifold assembly of the eleventh embodiment. [Figure 49] FIG. 23 is a perspective view of a manifold assembly according to a twelfth embodiment. [Figure 50] FIG. 50 is an exploded view of the manifold assembly of FIG. 49. [Figure 51] FIG. 23 is an exploded view of the manifold assembly of the thirteenth embodiment. [Figure 52] FIG. 23 is an exploded view of the manifold assembly of the fourteenth embodiment. [Figure 53] FIG. 22 is an exploded sectional view of the manifold assembly of the fifteenth preferred embodiment. [Figure 54] FIG. 22 is a cross-sectional view of a manifold assembly according to a sixteenth embodiment. [Figure 55] FIG. 22 is a cross-sectional view of a manifold assembly according to a seventeenth embodiment. [Figure 56] FIG. 22 is a cross-sectional view of a manifold assembly according to an eighteenth embodiment. [Figure 57] FIG. 20 is an exploded cross-sectional view of a manifold assembly according to a nineteenth embodiment. [Figure 58] 20 shows a manifold assembly according to a twentieth embodiment. [Figure 59] 20 shows a manifold assembly according to a twentieth embodiment. [Figure 60] 21 shows a manifold assembly according to a twenty-first embodiment. [Figure 60A] 21 shows a manifold assembly according to a twenty-first embodiment. [Figure 61] 10 illustrates another embodiment of a manifold assembly. [Figure 62] 22 shows a manifold assembly according to a twenty-second embodiment. [Figure 63] 22 shows a manifold assembly according to a twenty-second embodiment. [Figure 64] FIG. 23 is a cross-sectional view of a manifold assembly according to a twenty-third embodiment. [Figure 65] FIG. 24 is a cross-sectional view of a manifold assembly according to a twenty-fourth embodiment. [Figure 66] FIG. 25 is a perspective view of a manifold assembly according to a twenty-fifth embodiment. [Figure 67] 26 shows a manifold assembly according to a twenty-sixth embodiment. [Figure 68] 26 shows a manifold assembly according to a twenty-sixth embodiment. [Figure 69] FIG. 27 is a cross-sectional view of a manifold assembly according to a twenty-seventh embodiment. [Figure 70] FIG. 28 is a cross-sectional view of a manifold assembly according to a twenty-eighth embodiment. [Figure 71] FIG. 29 is a perspective view of a manifold assembly according to a twenty-ninth embodiment. [Figure 72] 30 shows a manifold assembly according to a thirtieth embodiment. [Figure 73] 30 shows a manifold assembly according to a thirtieth embodiment. [Figure 74] 13 shows a manifold assembly according to a thirty-first embodiment. [Figure 75] 32 shows a manifold assembly according to a thirty-second embodiment. [Figure 76A] 33 shows a manifold assembly according to a thirty-third embodiment. [Figure 76B] 33 shows a manifold assembly according to a thirty-third embodiment. [Figure 76C] 33 shows a manifold assembly according to a thirty-third embodiment. [Figure 77] FIG. 34 is a cross-sectional view of a manifold assembly according to the thirty-fourth embodiment. [Figure 78] FIG. 35 is a cross-sectional view of a manifold assembly according to the thirty-fifth embodiment. [Figure 79] FIG. 36 is a cross-sectional view of a manifold assembly according to the thirty-sixth embodiment. [Figure 80] FIG. 37 is a cross-sectional view of a manifold assembly according to the thirty-seventh embodiment. [Figure 81] FIG. 38 is a cross-sectional view of a manifold assembly according to the thirty-eighth embodiment. [Figure 82]FIG. 10 is a perspective view of one embodiment of a component attached to a mounting portion. [Figure 83] FIG. 83 is a side view of the embodiment of FIG. 82. [Figure 84] FIG. 10 is a perspective view of another embodiment. [Figure 85] FIG. 10 is a perspective view of another embodiment. [Figure 86] FIG. 10 is a perspective view of another embodiment. [Figure 87] FIG. 10 is a perspective view of another embodiment. [Figure 88] FIG. 10 is a perspective view of another embodiment. [Figure 89] FIG. 10 is a perspective view of another embodiment. [Figure 90] FIG. 89 is a cross-sectional view of the embodiment of FIG. [Figure 91] FIG. 10 is a perspective view of another embodiment. [Figure 92] FIG. 10 is a perspective view of another embodiment. [Figure 93] FIG. 10 is a perspective view of another embodiment. [Figure 94] FIG. 10 is a perspective view of another embodiment. [Figure 95] FIG. 10 is a perspective view of another embodiment. [Figure 96] FIG. 10 is a perspective view of another embodiment. [Figure 97] FIG. 10 is a perspective view of another embodiment. [Figure 98] FIG. 10 is a perspective view of another embodiment. [Figure 99] FIG. 10 is a perspective view of another embodiment. [Figure 100] FIG. 10 is a perspective view of another embodiment. [Figure 101] FIG. 10 is a perspective view of another embodiment. [Figure 102] FIG. 10 is a perspective view of another embodiment. [Figure 103] 1A-C are perspective views of a further embodiment in (A) open configuration, (B) closed configuration, and (C) open configuration. [Figure 104] FIG. 10 is a perspective view of another embodiment. [Figure 105] FIG. 10 is a perspective view of another embodiment. [Figure 106] 1A and 1B are perspective views of another embodiment showing (A) a first component and (B) an alternative component. [Figure 107] FIG. 10 is a perspective view of another embodiment. [Figure 108] FIG. 10 is a perspective view of another embodiment. [Figure 109] 1A and 1B are perspective views of another embodiment showing (A) the component body and fitting disassembled and (B) the component body and fitting assembled. [Figure 110] FIG. 10 is a perspective view of another embodiment. [Figure 111] 10A and 10B are perspective views of another embodiment with (A) no tube in place and (B) tube in place. [Figure 112] FIG. [Figure 113] FIG. 10 is a perspective view of another embodiment of a component attached to a mounting portion. [Figure 114] FIG. 114 is a perspective view of the embodiment of FIG. 113 attached to a mounting portion integral with an auxiliary portion of a patient interface. [Figure 115] FIG. 114 is a front view of the embodiment of FIG. 113 attached to a mounting portion integral with an auxiliary portion of a patient interface. [Figure 116] 1A, 1B, and 1C are perspective views of three embodiments of a component comprising at least one retainer portion. [Figure 117] FIG. 10 is a cross-sectional view of components attached to a patient interface. [Figure 118] FIG. 118 is a cross-sectional perspective view of the cross-sectional view of FIG. 117. [Figure 119] FIG. 119 is a perspective view of the embodiment of FIGS. 117 and 118. [Figure 120] FIG. 120 is another perspective view of the embodiment of FIG. [Figure 121] (A) A front view of the embodiment of Figures 117 to 120 not yet attached to the attachment portion integrated with the auxiliary portion of the patient interface, and (B) a front view of the embodiment of Figures 117 to 120 attached to the attachment portion integrated with the auxiliary portion of the patient interface. [Figure 122] FIG. 1 is a perspective view of a patient interface incorporating a first embodiment of a connector. [Figure 123] FIG. 123 is a perspective view of an embodiment of the connector of FIG. 122. [Figure 124] 124 is a cross-sectional view of the connector of FIG. 123 before the clip engages with the detent. [Figure 125] 124 is a cross-sectional view of the connector of FIG. 123 showing the initial stage of the clip engaging the detent. [Figure 126] FIG. 124 is a cross-sectional view of the connector of FIG. 123, showing the slide in a locked position. [Figure 127] FIG. 124 is a cross-sectional view of the connector of FIG. 123, showing the slide in a free position. [Figure 128] 124 is a cross-sectional view of the connector of FIG. 123 showing the clip removed from the carrier. [Figure 129] 1 is a cross-sectional view of one half of the slide of the first embodiment. FIG. [Figure 130] FIG. 4 is a cross-sectional view of the other half of the slide of the first embodiment. [Figure 131] FIG. 2 is a perspective view of a support body according to the first embodiment. [Figure 132] FIG. 1 is a perspective view of a clip according to a first embodiment. [Figure 133] FIG. 10 is a cross-sectional view of the connector of the second embodiment before the clip engages the detent. [Figure 134] 124 is a cross-sectional view of the connector of FIG. 123 showing the initial stage of the clip engaging the detent. [Figure 135] FIG. 134 is a cross-sectional view of the connector of FIG. 133, showing the slide in a locked position. [Figure 136] FIG. 134 is a cross-sectional view of the connector of FIG. 133, showing the slide in a free position. [Figure 137] 134 is a cross-sectional view of the connector of FIG. 133 showing the clip removed from the carrier. [Figure 138] FIG. 10 is a cross-sectional view of one half of a slide according to a second embodiment. [Figure 139]FIG. 10 is a front perspective view of a support body according to a second embodiment. [Figure 140] FIG. 10 is a rear perspective view of the support body of the second embodiment. [Figure 141] FIG. 10 is a cross-sectional view of the connector of the third embodiment showing the slide in a locked position. [Figure 142] FIG. 142 is a cross-sectional view taken along line AA in FIG. 141. [Figure 143] 143 is a cross-sectional view taken through line AA of FIG. 141 showing an alternative cutout to that of FIG. 142. [Figure 144] FIG. 142 is a cross-sectional view taken along line BB in FIG. 141. [Figure 145] FIG. 10 is a perspective view of an alternative embodiment of a clip. [Figure 146] FIG. 1 is a perspective view of a patient interface illustrating the assembly and combination of features of several embodiments described herein. [Figure 147] FIG. 147 is a rear perspective view of the patient interface of FIG. 146. [Figure 148] FIG. 147 is an exploded perspective view of a frame portion and manifold assembly of the patient interface of FIG. 146; [Figure 149] 147 is a front view of the frame portion of the patient interface of FIG. 146, showing the manifold assembly of the patient interface positioned for assembly with the frame portion from both the left and right sides. [Figure 150] FIG. 147 is a rear perspective view of the manifold assembly of the patient interface of FIG. 146; [Figure 151] FIG. 1 is a front and slightly superior view of a preferred embodiment of a patient interface of the present invention including a head strap. [Figure 152] 152 is a top oblique view of the embodiment of FIG. 151, but without the head strap. [Figure 153] FIG. 153 is a top view of the embodiment of FIGS. 151 and 152 without a head strap. [Fig. 154] FIG. 154 is a view from below of the embodiment of FIGS. 151-153 without the head strap. [Figure 155] 1 illustrates an embodiment of a patient interface (or a frame thereof). [Figure 156] 1 illustrates an embodiment of a patient interface (or a frame thereof). [Figure 157] 1 illustrates an embodiment of a patient interface (or a frame thereof). [Figure 158] 1 illustrates an embodiment of a patient interface (or a frame thereof). [Figure 159] 1 illustrates an embodiment of a patient interface (or a frame thereof). [Figure 160] 1 illustrates an embodiment of a patient interface (or a frame thereof). [Figure 161] 1 illustrates an embodiment of a patient interface (or a frame thereof). DETAILED DESCRIPTION OF THE INVENTION

[0323] As used herein, the terms "medical circuit" and "breathing circuit" are used to indicate the general field of the present disclosure. It should be understood that "circuit" is intended to include open circuits that do not form a completely closed circuit. For example, high-flow delivery systems can be provided, which can include, but are not limited to, ventilator-driven systems, as well as CPAP systems, which can typically consist of a single inspiratory breathing tube between a blower and a patient interface. The term "breathing circuit" is intended to include such "open circuits." Similarly, the term "medical circuit" is intended to include both breathing circuits and inhalation circuits, which are also typically "open." Similarly, the term "medical tubing" is intended to be interpreted as flexible tubing suitable for use in medical circuits of the type described above, connecting components of the medical circuit and providing a low-resistance gas path between the components of the medical circuit.

[0324] Condensation or rainout can be a particular problem in the field of medical circuits, particularly breathing circuits, including anesthesia circuits, where highly humidified breathing gas comes into contact with the walls of relatively cool components. Referring to FIG. 1B, a humidified ventilation system is shown in which a patient 3100 receives humidified and pressurized gas through a patient interface 3102 connected to a humidified gas delivery pathway or inspiratory breathing tube 3103. It will be appreciated that the patient interface 3102 can take the form of, for example, without limitation, a nasal mask, an oral mask, an oronasal mask, a nasal cannula, an endotracheal tube, or a full face mask.

[0325] It should be understood that the delivery system may also be continuous, variable, or bi-level positive airway pressure, or numerous other forms of respiratory therapy. The inspiratory tube 3103 is connected to the outlet 3104 of a humidification chamber 3105, which contains a volume of water 3106. The inspiratory tube 3103 may include a heater or heater wire (not shown), which heats the humidified gas within the tube to reduce the formation of condensation. The humidification chamber 3105 is heated by a heater plate 3107 in the humidifier base 3108. The humidifier base 3108 is provided with an electronic controller, which may comprise a microprocessor-based controller that executes computer software commands stored in an associated memory.

[0326] In response to user-set humidity or temperature values ​​entered, for example, via dial 3110 and / or other inputs, the controller determines when (or to what level) to energize the heater plate 3107 to heat the water 3106 in the humidification chamber 3105. As the water is heated, water vapor begins to fill the chamber above the water surface and exit through the humidification chamber outlet 3104. A flow of gas (e.g., air) is provided from a gas supply or ventilator 3115, which enters the chamber 3105 through inlet 3116 and may include a fan, blower, etc. 3121 to provide the gas flow. Exhaled gases from the patient's mouth are returned to the ventilator via a return expiratory breathing tube 3130, which may also include a heater or heater wire (not shown), which heats the humidified gas in the inhalation breathing tube to reduce condensation formation.

[0327] Preferably, the medical tubing (e.g., the inhalation breathing tube 3103 and / or the exhalation breathing tube 3130) is highly crush-resistant, highly resistant to flow restriction when bent (e.g., less than a 50% increase in resistance to flow when bent around a 1-inch cylinder), highly kink-resistant, highly resistant to length / volume changes under varying internal pressures (e.g., resistance to compliance), highly leak-resistant (e.g., less than 25 ml / min at 6 kPa), low flow resistance (e.g., less than a 0.2 kPa increase in pressure at maximum rated flow rate), and electrically safe given the potentially oxygen-rich operating environment (e.g., resistant to sparks within the tubing).

[0328] International Standard ISO 5367:2000(E) (4th Edition, June 1, 2000) is an example of how some of these desirable parameters are measured and quantified, and is incorporated herein by reference in its entirety. The components described herein preferably meet or exceed some or all of these standards. Furthermore, references to medical tubing include respiratory tubing as defined in the above ISO standard.

[0329] According to certain features, aspects, and advantages of the present disclosure, components are provided as accessories for use with medical tubing and / or cables, particularly for use with medical breathing circuits, surgical inhalation systems, medical nutrition devices, and / or medical monitoring devices, or any combination of any two or more thereof.

[0330] The component is positionable around the exterior of at least one tube and / or at least one cable, such as respiratory tubing used in the inspiratory and / or expiratory limbs of a breathing circuit, or tubing associated with a surgical suction system, or tubing associated with a nutritional device, and / or cables associated with such systems and / or cables associated with a medical monitoring device, and has particular application to positioning, locating, and supporting such medical tubing and / or cable relative to a user or user-associated equipment (e.g., a user or patient interface, such as a mask, nasal cannula, etc., as briefly described above). The component may be an auxiliary component that may be attached or attachable to a patient interface, or an auxiliary part of a patient interface. The component does not itself form part of a flow path through which gases or nutrients pass.

[0331] Being able to position medical tubing and / or cables relative to a user has several advantages. Being able to help support the weight of medical tubing and / or cables connected to equipment associated with a user has numerous advantages, including, but not limited to, reducing weight transferred to the user or equipment associated with the user (which may affect the efficacy of treatment being provided to the user), or the overall comfort experienced by the user when using such equipment.

[0332] Furthermore, as a user moves or repositions their body relative to the medical tubing and / or cables or associated equipment, strain can be transmitted to the tubing and / or cables or through the associated equipment to the user. It is useful to relatively quickly and effectively reposition or reposition the tubing and / or cables to again provide support. Several features, aspects, and advantages of the present disclosure at least seek to provide, or go some way toward providing, alternative components that facilitate such advantages. For example, one such example may enable the use of "clips" to ensure that tubing or conduits do not interfere with the side interchangeability of an adjustable or reorientable manifold relative to the patient interface. Other combinations of "clips" with "twist frame arms," ​​"swivel manifolds," and "tapered leads," along with "buckles," can all be provided in combination with one another.

[0333] Such components may be utilized to position or locate inspiratory or expiratory medical tubing or other tubing associated with such medical circuits, and / or cables as described above. Particular applications may have use in hospital settings, including, but not limited to, in the field of obstructive sleep apnea, as well as for suction and / or patient delivery and / or patient monitoring required in surgery.

[0334] In one aspect of the disclosure, with reference to FIGS. 82 and 83 , a component 2200 is provided for use with at least one tube and / or at least one cable, such as a tube in a medical breathing circuit (not shown). Any reference to a tube below includes a reference to a cable. The component 2200 comprises an at least substantially annular body, optionally an annular body, that receives the tube, the tube passing through the body 2210 such that the body at least partially surrounds and can surround the outer circumference of the tube. The body 2210 can also be, for example, square, substantially square, or another rectilinear form (not shown). The tube can be positioned loosely within the body 2210, the tube resting on only a portion of the inner surface of the body 2210, or the body 2210 can hold the tube lightly or tightly, such as with a light interference fit or an interference fit. In one embodiment, during use, body 2210 is generally easily movable along the length of the tube, while retaining the tube rigidly enough to prevent undesired movement of the tube within body 2210. For example, body 2210 may be slidable along the length of the tube or rotatable around or along the tube. Alternatively, body 2210 may be fixed in place on the tube. Body 2210 receives tube 2210 by an operator threading the tube through body 2210 and positioning body 2210 at a desired location along the length of the tube relative to intended attachment portion 2240.

[0335] In various embodiments (as described below), the inner surface of the body can include one or more protrusions (not shown) that can engage with one or more corresponding recesses in a tube, such as recesses in a corrugated tube or a tube with a helically concave region. The inner surface of the body can include a first protrusion that can engage with a first recess and a second protrusion that can engage with the same or another recess. In such embodiments, the body 2100 can be wrapped over the tube.

[0336] Component 2200 includes a fitting 2220 that is integral with or non-movably secured to body 2210. Alternatively, fitting 2220 can be pivotally, rotatably, and / or removably secured to body 2210 (e.g., as described below in connection with FIGS. 89 and 90 ). Fitting 2220 is configured to snap fit or engage with mounting portion 2240 to securely and removably hold component 2200 in place. In one embodiment, fitting 2200 includes a pair of arms 2230 extending from body 2210 that form a corresponding male connector, i.e., a female connector shaped to engage with mounting portion 2240. The arms 2230 can extend from the body 2210 at the same location or at adjacent locations, at any suitable angle, for example, substantially parallel to an imaginary radial line (not shown) extending from the center of the body 2210, or at an angle of about 30 to about 50 degrees from the imaginary radial line extending from the center of the body 2210, so that the tips of the arms substantially oppose each other and form a pair of jaws adapted to engage the mounting portion 2240, as shown in FIGS. 82 and 83 . The arms 2230 include protrusions 2235 that engage corresponding recesses 2245 in the mounting portion 2240. The protrusions 2235 and corresponding recesses 2245 are shaped to hold the fitting 2220 in place on the mounting portion 2240 and to provide sensory feedback to the operator, as described below. The mounting portion 2240 can be shaped to guide the protrusions 2235 into the recesses 2245 and facilitate engagement of the fitting 2220 with the mounting portion. For example, the mounting portion 2240 can include a curved protrusion 2246 extending from the body of the mounting portion 2240, the curved protrusion 2246 being shaped to center the mounting portion 2240 between the arms 2230 and to displace the arms 2240 when the mounting fixture 2220 engages the mounting portion 2240.

[0337] It should be understood that the relative arrangement of arms 2230, protrusions 2235, recesses 2245, and / or protrusions 2246 can be varied to provide a desired degree of retention. Removal of component 2200 from mounting portion 2240 can be achieved by an operator with a twisting, sliding, or pulling action that separates protrusions 2235 from recesses 2245.

[0338] Figure 84 shows an alternative embodiment of the component 2200 of Figures 82 and 83, wherein the component 21200 includes a fitting 21220 that is rotated or canted, e.g., at an angle of about 30 degrees to about 70 degrees, relative to the open face or end F1 of the body 21210. That is, an imaginary axis (not shown) disposed between and parallel to the projections 21235 of the fitting 21220 is at a non-parallel angle relative to an axis extending axially through the center of the body 21210. While rotated or canted as shown, the open face or end F2 of the fitting 21220 can remain coplanar with the open face or end F1 of the body 21210.

[0339] In use, a patient (e.g., self-care at home or otherwise), a nurse, or an operator, such as a physician, may desire non-visual confirmation that engagement of the attachment 2220 with the attachment portion 2240 is complete because in some cases visual confirmation is not possible due to, for example, lighting levels, the patient's posture, or the speed at which engagement must be completed. Such desired non-visual confirmation may include sensory feedback, including audible feedback, tactile feedback, or both, that the attachment has fully and correctly engaged with the attachment portion and is being held in place. Thus, the attachment 2220 may provide sensory feedback to the operator when it engages with the attachment portion 2240, optionally via a snap fit or snap engagement. The attachment 2220 may provide sensory feedback to the operator when the protrusion 2235 of the attachment 2220 engages with the recess 2245 of the attachment portion, optionally via a snap fit or snap engagement. It should be understood that the relative positioning of the arm 2230, protrusion 2235, and recess 2245 may be varied to provide desired sensory feedback. It should also be understood that such a configuration providing non-visual confirmation of engagement can be used with any of the embodiments described herein, including, but not limited to, the embodiments of Figures 93, 94, 98-102, 105-110, and 113-115.

[0340] In use, when component 2200 is installed, arms 2230 are deformed apart by mounting portion 2240 and protrusions 2235 "snap" into engagement with recesses 2245 due to the resilience of the material used to manufacture mounting fixture 2220 and / or mounting portion 2240.

[0341] The component 2200 can include at least one retainer portion, as described below with respect to FIG.

[0342] 85 and 86, multiple attachment portions 2240 are present on the patient interface 2260 and may be integral to, permanently attached to, or removably attached to the patient interface 2260. One or more attachment portions 2240 may be integral to or removably attached to an auxiliary portion of the patient interface, such as an arm 2270 or wing that forms part of the support structure of the patient interface 2240 but is not directly involved in the function of the breathing circuit. The patient interface 2260, such as a nasal cannula, has auxiliary left and right sides, such as left and right arms 2270 that generally rest on the patient's face, particularly the cheeks, with attachment portions 2240 located on either side of nasal prongs 2280. This configuration allows attachment to either or both attachment portions of the component 2200, such that tubing (not shown) can be attached to the manifold 2290, routed through the left or right side of the patient interface, and easily routed to the other side as needed for treatment, patient positioning, patient comfort, device positioning, device stability, etc. 85 and 86, the manifold 2290 is shown threaded onto the right side of the operator (left side of the patient) of the bilateral patient interface 2260. While the opposite, staggered configuration is not shown, it should be understood that the manifold 2290 could easily be threaded onto the left side of the operator (right side of the patient) of the bilateral patient interface 2260. It should be understood that any of the embodiments of the components described herein, and any of the combinations of components and mounting portions described herein, can be used with such a patient interface.

[0343] 87 and 88, a component 2300, 21300 comprises a substantially C-shaped body 2310, 21310 having an opening 2315, 21315 and one or two fittings 2320, 21320. The body 2310, 21310 receives a tube (not shown) through the opening 2315, 21315 and at least partially surrounds the outer periphery of the tube. The body 2310, 21310 receives the tube, for example, by pressing the body 2310, 21310 against the tube in an attachment direction D. The body 2310, 21310 is substantially C-shaped such that the two diverging arms that terminate in the body portion 2316, or that form a shoulder 21317, pass through and at least partially surround the circumference of the tube to retain the tube within the body 2310, 21310, for example, to the extent that the body 2310, 21310 extends more than about 50%, or alternatively less than 100%, of the circumference of the tube. For example, as shown in FIG. 87, in use the body portion 2316 extends in one direction around the circumference of the tube, and as shown in FIG. 88, in use the shoulder 21317 extends in both directions. Each fitting 2320, 21320 includes an arm 2330, 21330 positioned substantially tangentially to the body 2310, 21310 and spaced apart from the body 2310, 21330. As shown in Figures 87 and 88, the arms 2330, 21330 initially project from the body 2310, 21310 adjacent the mouth 2315, 21315 in a direction away from the mouth and then extend substantially tangentially to and spaced apart from the body 2310, 21310. Each arm 2330, 21330 may include a cuff or detent in the form of a protrusion 2340, 21340 extending from the distal end of the arm 2320, 21320 substantially towards the body 2310, 21310. In use, the arms 2330, 21330 operate similarly to a clip on a pen to receive, for example, a head strap, lanyard of the patient interface, or releasably engage with a slot on the patient interface that is shaped to receive the arm, as generally shown in Figures 106-108 below.The protrusions 2340, 21340 serve to minimize unintentional removal of the component from its engagement location. In either embodiment, the inner surface of the body can include locating features for locating the component in the tube, such as one or more protrusions 2350 that can engage with one or more corresponding recesses in the tube, such as recesses in a corrugated tube or a tube with a helical concave region.

[0344] 89 and 90 , a component 2400 includes a substantially C-shaped body 2410 having an opening 2415 and a fitting 2420. The body 2410 receives a tube (not shown) through the opening 2415 and at least partially surrounds the outer periphery of the tube. The body 2410 receives the tube, for example, by pressing the body 2410 against the tube in an attachment direction D. The body 2410 is substantially C-shaped such that bifurcated arms or jaws 2416 terminating in the body portion pass through and at least partially surround the outer periphery of the tube to hold the tube within the body 2410, for example, to the extent that they extend around more than about 50%, alternatively less than 100%, of the circumference of the tube. The fitting 2420 includes arms 2430 positioned substantially tangentially to and spaced apart from the body 2410. 89 and 90 , the fitting 2420 is attached to the body 2410 by a substantially T-shaped protrusion 2421 that projects from the body 2410 and engages a corresponding opening 2422 in the fitting 2420 such that the body 2410 and fitting 2420 are rotatable relative to one another. An arm 2430 projects from the fitting 2420 and extends substantially tangentially to and spaced apart from the body 2410. The arm 2430 may include a turn-up or stop in the form of a protrusion 2440 that extends from a distal end of the arm 2430 substantially toward the body 2410. The fitting 2420, and therefore the arm 2430, is located on an opposite side of the body 2410 relative to the mouth 2415. In use, the arm 2430 operates similarly to a clip on a pen, for example, to receive a head strap, lanyard, or releasably engage with a slot on the patient interface that is shaped to receive the arm, as generally shown in Figures 106-108, described below. The protrusion 2440 serves to minimize unintentional removal of the component from its engagement location. The fixture 2420 of this embodiment can be modified to include more than one arm, as described in connection with later embodiments.

[0345] 91 and 92, a component 2500, 21500 is of substantially similar configuration to component 2400 of FIGS. 89 and 90, and the fitting 2520, 21520 may be integral with the body 2510, 21510 (as shown), non-rotatably secured (not shown), or rotatably secured to the body 2510, 21510, similar to the configuration shown in FIGS. 89 and 90. The substantially C-shaped body 2510, 21510 includes a mouth 2515, 21515, bifurcated arms terminating in jaws 2516a, 2516b, 21516, and a fitting 2520, 21520. The body 2510, 21510 receives a tube (not shown) through the mouth 2515, 21515 and at least partially surrounds the outer periphery of the tube. The body 2510, 21510 receives a tube, for example, by pressing the body 2510, 21510 against the tube in an attachment direction D. The body 2510, 21510 is shaped such that the arms or jaws 2516a, 2516b, 21516 terminating in the body portion pass through and at least partially surround the circumference of the tube to retain the tube within the body 2510, 21510, for example, to the extent that the body 2510, 21510 extends more than about 50%, or alternatively less than 100%, of the circumference of the tube. The fixture 2520, 21520 includes multiple arms 2530, 21530 oriented substantially parallel to one another, with one or more arms extending in the same or opposite directions relative to one another. The arms 2530, 21530 protrude from the body 2510, 21510, typically on the opposite side of the body 2510, 21510 from the mouth 2515, 21515, in a position that does not obstruct access to the mouth 2515, 21515. FIG. 91 shows a component 2500 with two arms 2530 that extend substantially tangentially to the body 2510, substantially parallel to each other, and that extend in opposite directions from each other, with one arm 2530 protruding from the body 2510 at a point substantially opposite the jaw 2516a and the other arm 2530 protruding from the body at a point substantially opposite the jaw 2516b. As shown, the arms 2530 are located on the body 2510 and extend in a direction transverse or perpendicular to the attachment direction D of the tube component 2500.As shown in FIG. 92, the component 21500 can include three arms 21530 arranged in an alternating pattern, with a first arm extending in a first direction, a second arm extending in an opposite direction and positioned adjacent to and parallel to the first arm, and a third arm extending in the same direction as the first arm and positioned adjacent to and parallel to the second arm. In use, a head strap or lanyard of a patient interface is routed through or wrapped around the arms 2530, 21530. Alternatively, particularly with respect to the embodiment of FIG. 91, the component 2500 is placed on a strap or lanyard such that the strap lanyard rests between and parallel to the arms 2530, and the component 2500 is rotated approximately 90 degrees to orient each arm 2530 to engage the strap or lanyard. The arms 2530, 21530 may include a turn-up or stop in the form of a protrusion (not shown) extending from the tip of each arm 2530, 21530 substantially towards the body 2510, 21510.

[0346] 93, a component 2600 includes a substantially C-shaped body 2610 having an opening 2615 and a fitting 2620. The body 2610 receives a tube (not shown) through the opening 2615 and at least partially surrounds the outer circumference of the tube. The body 2610 receives the tube, for example, by pressing the body 2610 against the tube in an attachment direction D. The body 2610 is shaped such that bifurcated arms or jaws 2616 (or 21616, for example, as shown in FIG. 94) terminating in the body portion pass through and at least partially surround the outer circumference of the tube to retain the tube within the body 2610, for example, to the extent that the body 2610 extends more than about 50%, alternatively less than 100%, of the circumference of the tube. The inner surface of the body can include locating features for locating components in the tube, such as one or more protrusions 2650 that can engage with one or more corresponding recesses in the tube, such as recesses in a corrugated tube or a tube with a helically concave region. The fitting 2620 includes two arms 2630 that extend substantially tangentially to the body 2610 and from the body 2610, in a direction away from the mouth 2615. Each arm 2630 projects from the body 2610 at a point substantially opposite the jaws 2616 and includes a protrusion or recess 2631. Each protrusion or recess 2631 engages with a corresponding protrusion or recess 2641 in the mounting portion 2640. The mounting portion 2640 can be shaped to guide the arms 2630 into position so that the protrusions or recesses 2631 precisely engage with the corresponding protrusions or recesses 2641, and so that, in use, the arms 2630 do not need to be directly aligned with the protrusions or recesses 2641 to achieve precise engagement. For example, the mounting portion 2640 can include a wall or protrusion 2642 that is shaped or positioned to guide the arm 2630 into position. The mounting portion 2640 can further include a recessed area 2643 adjacent to and between the protrusion or recess 2641 that is shaped to guide the arm 2630 into position.The mounting portion 2640 is generally quadrilateral-sided hexahedron, e.g., a rectangular parallelepiped, in shape with protrusions or recesses 2641 formed on opposing sides and a recessed area 2643 formed on the side of the mounting portion that is immediately adjacent the body 2610 when the body 2610 is in place on the mounting portion 2640. The mounting portion 2640 can be integral with, permanently attached to, or removably attached to a patient interface (not shown). Removable attachment of the mounting portion 2640 can include, for example, an interference or snap fit connection, or a slot to receive a head strap (not shown).

[0347] 94, a component 21600 comprises a substantially C-shaped body 21610 as described for the embodiment of FIG. 93. The inner surface of the body 21610 can comprise locating features for locating the component in the tube, such as one or more protrusions 21650 (or, for example, 23650 as shown in FIG. 100) engageable with one or more corresponding recesses in the tube, such as a corrugated tube, or a recess in the tube with a helically concave region. The fitting 21620 (or, for example, 27620 or 27620′) comprises a protrusion 21660 (or, for example, 27661 or 27661′) extending from the body 21610, which may be substantially T-shaped in cross section, and can comprise a disk or other enlarged head connected at its center to the body 21610 by a short protrusion 21661, for example, a cylindrical protrusion, as shown. The protrusion 21660 projects from the body 21610 at a location substantially opposite the mouth 21615 and engages with a corresponding T-shaped slot 21662 in the mounting portion 21640. The mounting portion 21640 can be shaped to guide the protrusion 21660 into position so that the protrusion 21660 properly engages with the corresponding slot 21662. For example, the mounting portion 21640 can include a tapered or V-shaped recess 21663 (interface zone) at the mouth of the slot 21662 so that, in use, the protrusion 21660 does not have to be directly aligned with the enlarged portion of the slot 21662 to achieve proper engagement. As shown, the mounting portion 21640 is generally hexahedral with quadrilateral sides, e.g., a rectangular parallelepiped, with one face having a substantially T-shaped mouth of a slot 21662 that receives a protrusion 21660 that is substantially T-shaped in cross section, and an elongated portion of the slot 21662 that receives the protrusion 21661 extending into the immediately adjacent face such that the body 21610 protrudes from that face when the protrusion 21660 engages the slot 21662. If the protrusion 21660 is disk-shaped, it will be rotatable within the slot 21662, and thus the body 21610 will be rotatable about the axis of the cylindrical protrusion 21661.The mounting portion 21640 may be integral with, permanently attached to, or removably attachable to a patient interface (not shown). Removable attachment of the mounting portion 21640 may include, for example, an interference or snap-fit ​​connection (not shown), or a slot for receiving a head strap. It should be understood that the slot 21662 in FIG. 94 and the equivalent configurations 24662, 29662 in FIGS. 101 and 109 below comprise an inner track that slidably receives the protrusion 21660 and an outer track that slidably receives the protrusion 21661 but is narrower than the inner track. In the “locked” or “retained” position, the protrusion 21660 is at or near the end of the inner track opposite the mouth of the slot, and the protrusion 21661 extends from the protrusion through the outer track to support the body 21610 in position. When the body 21610 is pulled or pushed in a direction perpendicular to the track, it does not move substantially relative to the mounting portion in which the slot 21662 is formed.

[0348] 95-97, a component 2700, 21700, 22700 is configured substantially similar to the embodiment of FIGS. 87 and 89-92 and includes a body 2710, 21710, 22710, fittings 2720, 21720, 22720, one or more arms 2730, 21730, 22730, and optional protrusions 2740, 21740, similar to the embodiment of FIGS. 82-84, except that the body 2710, 21710, 22710 is substantially annular or annular. The arms 2730, 21730, 22730 protrude from the body 2710, 21710, 22710 and extend substantially tangentially to and spaced apart from the body 2710, 21710, 22710. Each arm 2730, 21730, 22730 may include a cuff or stop in the form of a protrusion 2740, 21740 that extends from the distal end of the arm 2730, 21730, 22730 substantially toward the body 2710, 21710, 22710. The arms 2730, 21730, 22730 may be configured as described for the embodiments of Figures 87 and 89-92.

[0349] 98 , the component 22200 includes a fitting 22220 that is integral with or secured to the body 22210. The fitting 22220 may be permanently, pivotally, rotatably, and / or removably secured to the body 22210 (e.g., as described above in connection with FIGS. 89 and 90 ). The fitting 22220 is configured to snap fit or engage with the mounting portion 22240 to securely and removably hold the component 22200 in place. In one embodiment, the fitting 22200 includes a pair of arms 22230 extending from the body 22210 that form a female connector shaped to engage with a corresponding male connector, i.e., the mounting portion 22240. The arms 22230 can extend from the body 22210 at any suitable angle. The arms 22230 can extend substantially parallel to each other and to an imaginary radial line (not shown) extending from the center of the body 22210, such that the tips of the arms are substantially opposed to each other and form a pair of jaws adapted to engage with the mounting portion 22240, as shown in FIG. 98 . The arms 22230 include a protrusion 22235 that engages with a corresponding recess 22245 in the mounting portion 22240. The protrusion 22235 and the corresponding recess 22245 are shaped to hold the fitting 22220 in place on the mounting portion 22240 while also providing sensory feedback to the operator, as described above. The mounting portion 22240 can be shaped as described above. The mounting portion 22240 can be present in a patient interface (not shown) and can be integral with, permanently attached to, or removably attached to the patient interface. The mounting portion 22240 includes a slot 22264 that receives a head strap.

[0350] In another embodiment, referring to FIG. 99, a component 22600 is configured substantially similar to the embodiment of FIG. 94 and, like the embodiment of FIGS. 82-84, includes a body 22610 and a fitting 22620 that engages with a mounting portion 22640, except that the body 22610 is at least substantially annular or is annular. The fitting 22620 includes a ball 22680 that may be spaced from the body 22610 by a protrusion (not shown) and engages with a corresponding recess 22690 in the mounting portion 22640 to form a ball joint. The body 22610 is rotatable relative to the mounting portion 22640 about the ball joint. The mounting portion 22640 may be integral with the patient interface, permanently attached to the patient interface, or removably attachable. The removable attachment of the attachment portion 22640 can include, for example, an interference or snap fit connection, or a slot to receive a head strap (not shown).

[0351] In another embodiment, referring to FIG. 100 , a component 23600 is configured substantially similar to the embodiment of FIG. 93 , comprising a body 23610 and a fitting 23620 engaging a mounting portion 23640 comprising a slot 23664, except that the body 23610 is pivotally engaged within the mounting portion 23640. The mounting portion 23640 is an open box or frame within which the body 23610 is disposed with arms 23630 that pivotally engage opposing interior walls of the box or frame. The arms 23630 may engage through aligned pairs of projections and recesses on each arm and corresponding locations on the interior walls of the mounting portion 23640, as described and illustrated for the embodiment of FIG. 93 . Alternatively, the arms 23630 may be pivotally attached using a pin 23645 located between opposing walls of the mounting portion 23640. In FIG. 100 , the body 23610 is shown in a stowed position. In use, the body 23610 pivots out of the mounting portion 23640 to receive a tube (not shown).

[0352] 101 , a component 24600 is configured substantially similar to the embodiment of FIG. 94 and includes a body 24610 and a fitting 24620 that engages a mounting portion 24640, except that the mounting portion 24640 is either an arm or head strap of a patient interface or is integral therewith. The fitting 24620 includes a protrusion 24660 extending from the body 24610 that is substantially T-shaped in cross section and may include a disk or other enlarged head connected to the body 24610 substantially at its center by a protrusion 24661, as shown. The protrusion 24660 projects from the body 24610 at a point substantially opposite the mouth 24615, the protrusion 24660 engaging a corresponding suitably shaped slot 24662 in the mounting portion 24640. An interface zone 24663 is adjacent to and connected to the slot 24662 and receives the disc or enlarged head, allowing the disc to enter the narrower slot 24662 so that when fully inserted, the disc 24660 is held in place within the mounting portion 24640, with the protrusion 24661 extending through the slot 24662, as described in connection with FIG. 94 above. A tube T is shown engaged within the body 24610.

[0353] 102, a component 25600 is configured substantially similar to the embodiment of FIG. 101 and includes a body 25610, a protrusion 25660, and an attachment portion 25640 that is, or is integral with, an arm or head strap of a patient interface. The protrusion 25660 extends from the body 25610 at a point substantially opposite the aperture 25615 and engages with a corresponding suitably shaped slot or loop 25662 in or on the attachment portion 25640. A tube T is shown engaged within the body 25610.

[0354] 103 , the arm or head strap of the patient interface 2800 comprises a first protrusion or wing 2810 and a second protrusion or wing 2820, which alone or together surround the outer circumference of the tube T and are shown in an open position (A), (C) and a closed position (B) with respect to the tube T. In one embodiment, the first protrusion or wing 2810 and the second protrusion or wing 2820 are secured in the closed position (B) using known connectors, such as hook-and-loop fasteners, press-fit or snap-fit ​​connectors, or similar connectors known in the art. In another embodiment, the first protrusion or wing 2810 and the second protrusion or wing 2820 comprise a deformable material that substantially retains its shape after being deformed around the tube T.

[0355] 104, an arm or head strap of a patient interface 21805 includes an attachment portion 21840 that receives a component 21800. The component 21800 includes an at least substantially annular body 21810, e.g., an annular body such as a sleeve, that receives a tube T, the tube passing through the body 21810 such that the body at least partially surrounds, and may surround, the outer periphery of the tube T. The body 21810 and attachment portion 21840 each include corresponding sections of hook-and-loop fastener or equivalent adhesive material that allow for a releasable connection. In use, the component 21800 containing the tube T can be positioned in the attachment portion 21840 by a user pressing the body 21810 against the attachment portion 21840, where it can be easily removed and repositioned.

[0356] In another embodiment, referring to FIG. 105 , a component 26600 is configured substantially similar to the embodiment of FIGS. 94 and 101 , including at least a substantially annular body, e.g., an annular body 26610, and a fitting 26620 that engages with a mounting portion 26640, except that the mounting portion is integral with an arm or other portion of a patient interface. The fitting 26620 includes a protrusion 26660 extending from the body 26610 that is shaped to engage with a correspondingly shaped recess or slot in the mounting portion 26640, as described below. It should be understood that as an alternative to the illustrated body 26610, the body 26610 can instead include any of the alternative body features described herein. Alternative embodiments are described below in connection with FIGS. 106-109 . Unless otherwise noted below, the features and functionality of the embodiments of Figures 106-110 should be considered the same as for the embodiment of Figure 105, with like reference numerals indicating like parts with the addition of 1000 or with the addition of 1000 and a prime (') (e.g., component 26600 is identified as components 27600 and 27600' in Figure 106 and 8600 in Figure 107). The various embodiments of Figures 105-109 are configured to provide sensory feedback as described above.

[0357] 105 , the orifice 26670 is shaped to receive the conical or frusto-conical projection 26660, with the narrowest portion of the projection 26660 initially engaging the orifice 26670. The orifice 26670 in the mounting portion 26640 includes a plurality of resiliently flexible flanges 26690 spaced around the periphery of the orifice and projecting into the center of the orifice 26670. In use, the flanges 26690 deform from a rest position, allowing the projection 26660 to travel a certain depth into the orifice 26670. Once the projection 26660 reaches that depth, the flanges 26690 return to their rest position, holding the projection 26660 in place within the orifice 26670, and the projection 26661 extends from the orifice between the flanges 26690 to support the body 26610 in place. In some embodiments, sensory feedback is provided by the flanges 26690 returning to their rest position to hold the protrusions 26660 in place within the orifices 26670 .

[0358] 106, elongated bars 27671a, 27671b are mounted on or in mounting portion 27690, such as in recess 27671c. Recess 27671c comprises a cutout or notch in mounting portion 27690, bars 27671a, 27671b span a space defined by the walls of recess 27671c, each end of bars 27671a, 27671b engages an opposing wall of recess 27671c, bar 27671a is spaced apart from bar 27671b, and bars 27671a, 27671b are both spaced apart from any further walls of recess 27671c. 106(A), protrusion 27660 is shaped to fit behind or between one or both of bars 27671 a, 27671 b, thereby being held in place by bars 27671 a, 27671 b, and protrusion 27661 extends beyond or between one or both of bars 27671 a, 27671 b to support the body in place. Referring to FIG. 106(B), protrusion 27660′ is triangular in cross section, or conical or frusto-conical, and shaped to be wedged between bars 27671 a, 27671 b. Either protrusion 27660' can be resiliently deformed from a rest configuration, or bars 27671a, 27671b can be resiliently deformed or deflected from a rest position, allowing protrusion 27660' to be forced into position between bars 27671a, 27671b. Once protrusion 27660' is in place, either protrusion 27660' or bars 27671a, 27671b return to their rest configuration or position, and protrusion 27660' is held in position between bars 27671a, 27671b, with protrusion 27661' extending between bars 27671a, 27671b and supporting body 27610' in position.

[0359] 107 , the protrusion 28600 and the protrusion 28661 together are substantially L-shaped, with the protrusion 28661 extending substantially tangentially from the body 28610 such that the protrusion 28600 is also positioned substantially tangentially relative to and spaced apart from the body 28610. In use, the slot 28672 receives the protrusion 28600 and the protrusion 28661 extends outwardly from the mounting portion 28640 to support the body 28610 in place.

[0360] 108 , the protrusion 28600′ and the protrusion 28661′ together are substantially T-shaped, with the protrusion 28661′ extending from the center of the body 28610′ and extending radially from the body 28610′, such that the protrusion 28600′ is positioned laterally relative to the protrusion and spaced apart from the body 28610′. In use, the slot 28672′ or 28672a′ receives the protrusion 28600′, and the protrusion 28661′ extends outwardly from the mounting portion 28640′ to support the body 28610′ in position. Optionally, the mounting portion 28640′ surrounding the slots 28672′, 28672a′ is resiliently deformable from a rest position to allow the protrusion 28660′ to move into position within the slots 28672′, 28672a′.

[0361] 109(B), slot 29662 has an interface zone 29663 that receives protrusion 29660 of fitting 29620 and allows protrusion 29660 to enter slot 29662 so that, when fully inserted, protrusion 29660 is held in place within mounting portion 29640, and protrusion 29661 extends into slot 29662 to hold body 29610 in place. Referring to FIG. 109(A), body 29610' and fitting 29620' comprise separate pieces. Body 29610' includes slot 29611' through which protrusion 29660' can be inserted from the interior of the body. The fitting 29620' is held in place within the body 29610' by the feet 29661a' of the projections 29661' abutting the inner wall of the body 29610', so that in use, when the body 29610' receives a tube (not shown), at least the presence of the tube prevents the fitting 29620' from becoming dislodged from the body 29610'. Figure 109(A) shows component form 29600' and Figure 109(B) shows component form 29620.

[0362] 110 illustrates a snap-fit ​​or interference-fit connector that can be used in any embodiment of the present disclosure, for example to hold the attachment portion in place on the patient interface or head strap 2940. The connector 2900 is secured to a suitable location on the attachment portion or is integrated into the attachment portion at a suitable location for attaching the attachment portion to the patient interface or head strap 2940. The connector 2900 includes a protrusion 2910 that engages and is removably retained within an orifice 2920, for example, by a snap-fit ​​or interference-fit connection, as is known in the art. The orifice 2920 can be formed directly in the patient interface 2940 or, as shown, located on a support 2930 that is attached to the head strap 2940.

[0363] 111 , the patient interface or head strap 2940 includes a flap 2950 of suitable material for retaining the tube T. As shown in FIG. 111(A), the flap 2950 is formed by cutting or molding a U-shaped slot in the head strap 2940. The flap 2950 may extend, for example, from one edge of the side of an arm of the patient interface 2940 or from one edge of the lay-flat section of the head strap 2940, and may be wrapped around the outer periphery of the tube T and secured in place at a suitable location on the patient interface or head strap 2940 by known methods such as hook-and-loop fasteners or a snap-fit ​​or interference-fit connection, as shown in FIG. 111(B). Alternatively, the lay-flat portion of the head strap 2940 may be formed with two lateral slits that pass completely through the head strap 2940, allowing the tube T to be passed through each slit and held in place. In another embodiment, the flap 2950 comprises a deformable material that substantially retains its shape after being deformed around the T.

[0364] 112 , a patient interface or head strap 2940 includes a loop 2970 of material suitable for retaining a tube T. The loop 2970 comprises an elongated piece of material that is attached by each end longitudinally to the patient interface or head strap 2940 such that the loop 2970 is accessible from above or below the patient interface or head strap 2940, for example, when used with a seated patient. Alternatively, the loop 2970 may be integrally formed in the patient interface or head strap 2940 or may be formed by cutting parallel elongated slits longitudinally in the arms of the patient interface or flat-laying portions of the straps of the head strap 2940.

[0365] In another embodiment, with reference to FIGS. 113-115 , a component 23200 for use with a tube (not shown) is provided. The component 23200 comprises an at least substantially annular body, e.g., an annular body 23210 that receives a tube as described above. The body 23210 can be, for example, square, substantially square, or another rectilinear form (not shown). The component 23200 includes a fitting 23220 that is integral with or secured to the body 23210. The fitting 23220 can be non-movably, pivotably, rotatably, and / or removably secured to the body 23210 as described above. The fitting 23220 is configured to snap fit or engage with a mounting portion 23240 to securely and removably hold the component 23200 in place.

[0366] In one embodiment, the fitting 23220 comprises a pair of arms 23230 extending from the body 23210 to form a female connector shaped to engage a corresponding male connector, i.e., mounting portion 23240. The arms 23230 can extend from the body 23210 at the same or substantially adjacent locations and at any suitable angle, for example, substantially parallel to an imaginary radial line (not shown) extending from the center of the body 23210, or at an angle of, for example, about 30 to about 50 degrees from the imaginary radial line extending from the center of the body 23210, such that the distal ends of the arms are substantially opposed to each other as shown in FIGS. 113 and 114 to form a pair of jaws adapted to engage with the mounting portion 23240. The arms 23230 comprise angled portions 23237 that engage corresponding protrusions 23247 on the mounting portion 23240. The angled portion 23237 and corresponding protrusion 23247 are shaped to hold the attachment 23220 in place on the attachment portion 23240, as described above, while also providing sensory feedback to the operator. The attachment portion 23240 can be shaped to guide the angled portion 23237 over the protrusion 23247 and aid in the attachment 23220 engaging the attachment portion 23240. For example, the attachment portion 23240 can include a shaped upper surface 23246 extending from the body of the attachment portion 23240 that is shaped to center the attachment portion 23240 between the arms 23230 and to displace the arms 23230 and / or angled portion 23237 when the attachment 23220 engages the attachment portion 23240.

[0367] It should be understood that the relative arrangement of the arm 23230, angled portion 23237, protrusion 23247 and / or surface 23246 can be varied to provide a desired degree of retention. Removal of the component 23200 from the mounting portion 23240 can be achieved by an operator by a twisting, sliding or pulling action that separates the angled portion 23237 from the protrusion 23247.

[0368] 114 , the mounting portion 23240 may be integral with a patient interface, such as a sub-component or arm 23270 of the patient interface comprising an upper surface 23241 and a lower surface 23242. The mounting portion 23240 is formed in or on the upper surface 23241 and slots 23249 a, 23249 b are formed on either side of the mounting portion 23240 to receive the arm 23230 and / or angled portion 23237 when the fitting 23220 engages the mounting portion 23240. When mounted to the mounting portion 23240, no portion of the component 23200 extends past the lower surface 23242.

[0369] 115, multiple attachment portions 23240 can be present on the patient interface 23260 or may be integral with the patient interface 23260. Optionally, one or more attachment portions 23240 are integral with auxiliary parts of the patient interface, such as arms 23270 or wings that form part of the support structure of the patient interface 23240 but are not directly involved in the function of the breathing circuit. The patient interface 23260, such as a nasal cannula, has auxiliary left and right sides, such as left and right arms 23270 that generally rest on the patient's face, particularly the cheeks, with the attachment portions 23240 located on either side of the nasal prongs 23280. With this configuration, as described above in connection with Figures 85 and 86, component 23200 can be attached to either or both mounting portions, and tubing (not shown) can be attached to either port 23290a, 23290b such that it is threaded to the left or right side of the interface and easily threaded to the other side as needed for treatment, patient positioning, patient comfort, device positioning, etc.

[0370] 116(A), 116(B), and 116(C), a component 24200 comprises an at least substantially annular body 24210 and a fitting 24220 integral with or secured to the body 24210. The component 24200 is configured and used as described above in connection with the component 23200. The body 24210 comprises at least one retainer portion 24215, 24225, 24235 that receives at least one accessory. The at least one accessory can be at least one tube and / or at least one cable and / or at least one lanyard. For example, the at least one accessory may include a gas line, a gas monitoring line, including but not limited to a gas sampling line or a line for measuring tidal volume at its end, a hydration tube, a feeding tube, a nasogastric tube, a cable, including but not limited to an electrical cable (e.g., for powering a heater) or a sensor cable (such as a temperature probe or pressure sensor cable), or a lanyard, or any combination of any two or more thereof. The at least one retainer portion may be a circular, substantially circular, square, substantially square, or straight portion that receives the at least one accessory. As shown in FIG. 116(A), in one embodiment, the retainer portion 24215 includes a substantially C-shaped body 24216 having an opening 24217. The body 24216 receives a tube or cable (not shown) through the opening 24217 and at least partially surrounds the outer periphery of the tube or cable. The body 24216 receives the tube or cable, for example, by pressing the body 24216 against the tube or cable in an attachment direction D. The body 24216 is substantially C-shaped such that the two bifurcated arms pass around and at least partially surround the circumference of the tube or cable to the extent that the body 24216 extends around more than about 50%, and alternatively less than 100%, of the circumference of the tube or cable to retain the tube or cable within the body 24216. The retainer portion 24215 can extend from the body 24210 at a location substantially opposite the fitting 24220.Additionally or alternatively, as shown in FIG. 116(B), the retainer portion 24225 is a substantially annular portion that receives at least one accessory. The retainer portion 24225 can extend from the body 24210 at a location substantially opposite the fitting 24220 (not shown) or at a location that does not otherwise interfere with the operation of the fitting 24220. Additionally or alternatively, as shown in FIG. 116(C), the body 24210 can include multiple retainer portions 24215, 24225, 24235, each of which extends from the body 24210 at a location that does not interfere with the operation of the fitting 24220. Additionally or alternatively, the retainer portion can include a recessed area of ​​the component 24200 or the body 24210 (not shown).

[0371] One or more of the retainer portions of component 24200 can be incorporated into any of the embodiments of components described herein.

[0372] In another embodiment, referring to FIGS. 117, 118, 119, 120, and 121(A)-(B), a component 23300 for use with a tube (not shown) is provided. The component 23300 may be an annular body 23310 having at least a substantially annular opening to receive the tube as described above. The body 23310 may also be, for example, square, substantially square, or another rectilinear form (not shown). The outer surface may be provided with different geometries for easier holding or gripping by a user or for particular aesthetic purposes. For example, the outer surface of the body may be any shape or geometry, and the inner surface of the body may be configured to receive the tube.

[0373] The component 23300 can include a fitting 23320 that is integral with or secured to the body 23310. The fitting 23320 can be non-movably, pivotably, rotatably, and / or removably secured to the body 23310, as described above. The fitting 23320 can be configured to snap fit or engage with the mounting portion 23340 to securely and removably hold the component 23300 in place.

[0374] In one embodiment, the fitting 23300 comprises a pair of arms 23330 extending from the body 23310 to form a male connector that is shaped to mate with a corresponding female connector, i.e., fitting portion 23340. The arms 23330 can extend from the body 23310 at the same point, at substantially adjacent points, or at separated points. The arms can extend from the body to provide parallel arms, arms that extend towards each other, or arms that extend away from each other.

[0375] One or more of the arms may include a tapered section or angled walls to facilitate retention by the or each arm's mounting portion, which may be retained longitudinally (i.e., for insertion or removal or moving in and out of the mounting portion) and / or laterally (i.e., when the arm moves sideways relative to the mounting portion). A combination of features of the tapered section or angled walls of the arms and / or the mounting portion may enable retention.

[0376] For example, in some embodiments, the arm may include a retraction mechanism, which may be created or formed by one or more sloped surfaces on the arm instead of an angled or protruding portion.

[0377] The arms or angled or protruding portions of the arms may include chamfered or beveled portions to create or provide such lead-in. There may be additional angled or notched or beveled surfaces on the mounting portion to receive or guide such arms. The arms may also include surface relief features to enhance their retention with the mounting portion or parts of the mounting portion.

[0378] Additionally, the mounting portion or one or more of the mounting portions can include one or more slopes, notches, or tapered lead-in shapes or sections, or angled bosses on the female and male portions. Any one or more of these, or other geometries, can be utilized on the mounting portion to aid in the insertion or orientation of the arm(s) for insertion into the mounting portion and / or to provide a more secure or more reliable retention of the arm(s) within the mounting portion. For example, the mounting portion, along with the arm(s), can be shaped to provide for contact with other components of the fixture.

[0379] 117 and 118 show the tips of the arms engaging the mounting portion 23340. It will be appreciated that such arms 23330 can extend from the body parallel to one another or at an angle (whether towards or away from one another). The arms, or at least a portion of the arms, can be deflected when inserted into and retained by the mounting portion.

[0380] The arm 23330 can include an angled or protruding portion 23337 that can engage with a corresponding protrusion 23347 on the mounting portion 23340. The angled or protruding portion 23337 and corresponding protrusion 23347 can be shaped to hold the fitting 23320 in place on or within the mounting portion 23340, as described above, while also providing sensory feedback to the operator. The mounting portion 23340 can be shaped to guide the angled or protruding portion 23337 over and / or into the protrusion 23347 to aid in engagement of the fitting 23320 with the mounting portion 23340. In some embodiments, the shape or geometry of the arm or angled or protruding portion can also be used to help guide the arm within the mounting portion for proper insertion and / or retention.

[0381] For example, the mounting portion 23340 can include a shaped upper surface 23346 extending from or around the body of the mounting portion 23340 that is shaped to effectively center, align, or guide the arm 23330 when the arm 23330 is engaged with the mounting portion 23340. The shaped upper surface 23346 can be, for example, a shaped perimeter region that extends around the mounting portion 23340, which, in this embodiment, provides an opening (i.e., the female mounting portion 23340). The upper shaped surface 23349 is configured to direct, guide, deflect, or deflect the arm 23330 and / or the angled or protruding portion 23337 when the fitting 23320 engages the mounting portion 23340. The upper molded surface 23349 shown in Figures 117 and 118 is the surface of the mounting portion that provides a reaction surface upon which the arms or angled or protruding portions can engage or contact.

[0382] It should be understood that the relative arrangement of the arm 23330, angled or protruding portion 23337, protrusion 23347 and / or surface 23346 can be varied to provide a desired degree of retention. Removal of the component 23300 from the mounting portion 23340 can be achieved by the operator with a twisting or sliding or pulling action that separates the angled or protruding portion 23337 from the protrusion 23347.

[0383] For example, the shape or angle of the arm or angled or protruding portion can be configured to aid in retracting the arm into the mounting portion. The shape or angle of the arm can help guide the arm into the mounting portion when the cannula is in use. In one embodiment, a user can align the tube with the arm so that the tube is axially aligned with the arm. The mounting portion can be provided as part of the patient interface so that it is angled or offset, and the shape and angle of the arm can help retract and guide the arm into the mounting portion, which can help make insertion of the mounting tool / arm into the mounting portion easier and / or faster.

[0384] The arms are shaped to fit over the mounting portion, which prevents the tube clip from wobbling or moving, and the top surface of the mounting portion acts as a stop to prevent the arms from being pushed in too far.

[0385] 117 and 118 , the mounting portion 23340 may be integral with an auxiliary portion or arm 23270 of a patient interface, optionally a patient interface (such as, but not limited to, a nasal cannula), which may comprise an upper surface 23341 and a lower surface 23342. The mounting portion 23340 is formed in or within the upper surface 23341, with a slot or opening 23349 formed by the mounting portion 23340 to receive the arm 23330 and / or the angled or protruding portion 23337 when the fitting 23320 engages the mounting portion 23340. When attached to the mounting portion 23340, optionally, no portion of the component 23300 extends past the lower surface 23342.

[0386] For example, there may be multiple attachment portions spaced or positioned around the patient interface along the length of the arms of the nasal cannula interface. While FIGS. 121A and 121B show a single attachment portion on each side arm, it is contemplated that the patient interface may be provided with additional attachment portions, or at least provision for additional attachment portions, such as along the arms of the nasal cannula. In this manner, customization of the attachment portion location and thereby tubing retention is possible. Considering such an embodiment, the body or tubing clip may be attached or attachable to multiple different locations along the patient interface, such as the nasal cannula frame arms. Alternatively, the attachment portion may itself be an auxiliary component that may be removably attachable or clipped or positioned at different locations on headgear that may be associated with the patient interface. The attachment portion may clip or connect to a lanyard, clothing, or any other mechanism around the patient to retain the tubing.

[0387] In at least some embodiments, the attachment portion or opening in the attachment portion can be oriented or shaped to be offset or angled relative to the patient interface, such as an arm or nasal cannula, so that when the attachment on the body engages with or with the female attachment portion or opening, the tubing connected to the body is substantially aligned with the arm or frame of the patient interface. In at least some embodiments, the tubing thus follows the shape of the cannula frame arm, providing the visual appearance that the tubing enters or connects to the manifold or fluid connection port of the patient interface in a "straight" orientation or alignment.

[0388] 119 and 120 provide further perspective views of component 23300.

[0389] 121(A) and (B), there can be multiple attachment portions 23340 on the patient interface 23360, which can be integral to or formed as part of the patient interface 23360. One or more attachment portions 23340 are integrated with auxiliary components of the patient interface, such as arms 23370 or wings that form part of the support structure of the patient interface 23360 but are not directly involved in the function of the breathing circuit. The patient interface 23360, such as a nasal cannula, can have auxiliary left and right sides, such as left and right arms 23370 that generally rest on the patient's face, particularly (but not limited to) the cheeks, with the attachment portions 23340 located on either side of the nasal prongs 23380. This configuration allows attachment to either or both of the component 23300 mounting portions 23340 (or other mounting portions, not shown, which may be provided or spaced along each or both of the side arms 23370), allowing tubing (not shown) to be attached to either of the ports 23390a, 23290b and routed to the left or right side of the interface, as described above in connection with Figures 85 and 86, and easily routed to the other side as needed for treatment, patient positioning, patient comfort, device positioning, etc.

[0390] FIG. 121(A) shows the patient interface 23360 with the component 23300 not yet positioned in the installation position within the mounting portion 23340. FIG. 121(B) shows the patient interface with the component 23300 in the installation position. It will be understood that for the purposes of these figures only, a pair of components 23300 are shown connected to each of the optional positioned or positioned mounting portions 23340 along each of the left and right arms 23370. In use, a single component 23300 holding a tube (not shown) may be utilized to connect to a single mounting portion 23340. Then, if the patient or user wishes to reposition or reposition the tube from the breathing circuit, the component 23300 can be disengaged from the mounting portion 23340 and moved to another of the available mounting portions 23340, and then the tube can be held in place again.

[0391] In some embodiments, more than one component may be utilized to hold, support, or secure a tube, for example, multiple attachment points may be provided and may be used for multiple tubes, such as gas delivery tabs, feeding tubes, or other tubes or wires used as part of a patient interface or for monitoring or controlling patient care or treatment, or for patient care or treatment monitoring or control.

[0392] It will be understood that component 23300 can be reconfigured to optionally include at least a retainer portion, such as those labeled as members 24215, 24225, 24235 in Figures 116(A) to 116(C) for receiving at least one accessory.

[0393] Components of the present disclosure can be provided in combination with at least one tube and / or at least one cable. Accordingly, the present disclosure also relates broadly to tubes or cables, such as for use in a medical breathing circuit, where the tube or cable (as described herein) comprises a component as described herein, which may be removably engaged with an attachment portion as described herein, and the attachment portion is removably attachable to a patient interface, such as in a medical breathing circuit.

[0394] Additionally, components of the present disclosure may be provided in combination with a patient interface. Accordingly, the present disclosure also relates broadly to patient interfaces (as described herein), such as for use in medical breathing circuits, that include an attachment portion as described herein, and that are integral to, permanently attached to, or removably attached to the patient interface, and that have components as described herein removably engaged with the attachment portion.

[0395] Additionally, components of the present disclosure can be provided in combination with tubing and / or patient interfaces and / or instructions for use. Accordingly, the present disclosure also broadly relates to kits including any two or more of the components as described herein and patient interfaces as described herein, which may include an integrated attachment portion as described herein, an attachment portion as described herein, and instructions for assembly and / or use.

[0396] The components described herein and their associated attachment portions (whether separate or integral with the components) can be formed from any suitable material that enables the characteristics described herein, including, for example, medical grade materials and / or suitable polymeric materials.

[0397] Any one or more features from any embodiment can be combined with any one or more features from any one or more other embodiments.

[0398] As noted above, the terms "medical circuit" and "breathing circuit" are used herein to indicate the general field of the present disclosure.

[0399] Referring to Fig. 122, there is shown a patient interface 3102 for use in a medical breathing circuit. The patient interface 3102 comprises a pair of connectors. A first preferred embodiment connector 3200 will now be described with reference to Figs. 123 to 132. The connector 3200 has a first connector part in the form of a clip 3201, a second connector part in the form of a carrier 3203, a detent 3205 for securing the clip and carrier together, a biasing means 3207, and a slide 3209. The slide 3209 is movable relative to the clip 3201 and / or carrier 3203 between a fixed position and a free position. In the fixed position, the detent 3205 is substantially prevented from moving to release the clip 3201 from the carrier 3203. In the free position, the detent 3205 can be moved to release the clip 3201 from the carrier 3203. A biasing means 3207 urges the slide towards the locked position.

[0400] In the preferred embodiment shown, the biasing means 3207 and the detent 3205 are integrally formed together. The biasing means 3207 includes a pair of resilient legs 3208, and the detent includes a pair of resilient arms 3211. The arms and legs are substantially deformation resistant or resiliently flexible. The arms 3211 are flexible to allow for insertion of the clip 3201 when the slider 3209 is in the locked position, as described below. The arms and legs extend from the body portion 3210.

[0401] As will be described in more detail below, the resilient legs 3208 urge the slide toward the locked position. The legs extend in the same direction from the body portion 3210 and are the same length as each other. The sides 3208a of each leg are slightly tapered so that the free end 3208b of each leg is narrower than the end 3208c where it joins the body portion 3210. The free end 3208b of each leg is rounded. The sides, top surface 3208d, and bottom surface 3208e of each leg are substantially planar.

[0402] The resilient arms 3211 are spaced apart and extend from the body portion 3210 in the same direction as the legs 3208. The arms are the same length as each other and longer than the legs. The arms 3211 are biased toward each other. As will be described in more detail below, when the clip 3201 is inserted into the carrier 3203, the pair of resilient arms 3211 are biased toward engaging with the notches in the clip.

[0403] Each arm has a straight portion closest to the body portion 3210 that extends into an arcuate portion 3212. The arcuate portion 3212 allows the arm 3211 to bend when the slide 3209 is in the locked position and the clip 3201 is inserted into the carrier 3203. The arcuate portion 3212 is concave when viewed from the position of the slide. The arcuate portion 3212 is narrower than the straight portion. The sides, top, and bottom of each arm are substantially planar. The top and bottom surfaces act as bearing surfaces between the slide 3209 and the carrier subassembly by the biasing means 3207 / detent 3205.

[0404] Each resilient arm 3211 includes a protrusion 3215 that engages with a complementary notch in the clip 3201. The protrusion 3215 is at the free end of each arm. Each protrusion 3215 has a generally triangular shape as shown in FIG. 124, and the notch has a complementary triangular shape to ensure secure engagement between the protrusion and the notch. In an alternative embodiment, the notch may be a shoulder.

[0405] The slide 3209 has a biasing means and a protrusion 3217 that engages a stop 3227, or a stop 3327 as shown in FIG. 138, to position the slide and carrier 3203 in a fixed configuration. Another stop can be provided near the stop 3227 to control the extent of movement of the slider in its free position. Additional stops are possible, or the stop 3227 can be extended. In the preferred embodiment shown, the slide 3209 is a sleeve. The sleeve has a first inner surface and a second, spaced-apart inner surface opposite the first surface. The stop 3227 is formed on the first surface, and the protrusion 3217 is formed on the second surface. In alternative embodiments, the stop and protrusion can be formed on the same surface. FIGS. 124-128 are cross-sectional views through the center plane of the connector. Accordingly, the figures show the protrusion, stop, and biasing means.

[0406] As shown in Figures 124-128, the protrusion 3217 is centrally located within the slide 3309. The protrusion 3217 has two outer tapered surfaces 3219 with rounded noses 3221.

[0407] The stop has a wedge-shaped profile when viewed from the side, as shown in FIG. 130. The stop cooperates with a slot in the carrier. When the slide is in the locked position, the surface of the stop engages the surface of the slot, preventing the slide from moving past the locked position. The wedge shape of the stop facilitates assembly of the slide to the carrier.

[0408] The slide 3209 has two protrusions 3223 that engage detents and move to substantially prevent the clip 3201 from being released from the carrier 3203. The protrusions are generally semicircular in shape, as shown in FIGS. 124-128. The slide 3209 has a pair of longitudinally extending rails 3225. The slide can have scalloped portions for a user to grip the slider. The slider can be mated with a soft sleeve component to provide the user with a better grip for manipulating the connector, which can also be more comfortable for the patient against their skin. The sleeve can be overmolded or co-molded with the sleeve, or can be a separately formed component that is assembled with the slider.

[0409] The clip 3201 is a substantially planar and rigid component. The clip 3201 includes a pair of notches 3213. The notches 3213 are positioned toward the nose section 3201a of the clip 3201 and are generally triangular in shape. A first side 3213a of the notch 3213, which is closest to the nose of the clip 3201, is at a steeper angle than a second side 3213b of the notch 3213. The first side is relatively steep to help prevent the clip 3201 from being removed when the slide is in the locked position.

[0410] 145, the clip 3201 may be asymmetric. In particular, one side 3201b is flat and the other side 3201c is curved. When this alternative embodiment is used, the carrier 3203 is oriented relative to the clip 3201 to ensure that the graphics on the carrier 3203 are always visible to the user and / or the soft material / shape is always positioned towards the patient.

[0411] The clip 3201 may be attachable to or may be integrally formed with the mask frame of the patient interface 3102 or other part of the patient interface, such as one or both arms of a comma interface configuration of a nasal cannula.

[0412] The carrier has one or more openings 3303a that attach to headgear straps and is adapted to carry a combined detent / biasing means, as shown in FIG. 139. The carrier 3203 has a locating mechanism for locating the biasing means. In particular, the carrier has a protrusion 3229 spaced from a flat surface 3230. When assembled with the combined detent / biasing means, the body portion 3210 fits snugly within the space between the protrusion and the flat surface.

[0413] The carrier 3203 also has a pair of guide mechanisms 3231 that guide the clip 3201 .

[0414] The carrier 3203 further has a pair of guide mechanisms 3233 that guide the clip 3201. Each guide mechanism 3233 prevents the clip 3201 from being released when the slide 3209 is in the locked position. A detent cam between the guide mechanisms 3233 and the protrusions 3223 on the slide 3209 prevents the clip 3201 from being removed without first releasing the slide 3209. Additionally, angled surfaces at the entrance of the guide mechanisms 3233 aid in inserting the clip 3201 into the assembly by guiding / aligning the clip to the correct position.

[0415] The carrier may advantageously be provided at the terminal end of a portion of the headgear or strap or other related part for the headgear that is used to secure or hold the headgear or head strap on the user's head. Thus, the clip 3201 as a male part is provided on or as part of the patient interface, and the carrier 3203 is provided on or as part of a part or component of the headgear or head strap. With this arrangement, the slide 3209 can be pulled away from the interface by the user, thereby moving the slide and associated detent from the locked position to the free position.

[0416] 124-128, a method of connecting the clip 3201 and carrier 3203 will now be described. Figure 124 is a cross-sectional view of the connector of Figure 123 before the clip 3201 engages with the detent 3205. The slide 3209 is biased to a locked position.

[0417] 125, there is shown the initial stage of clip 3201 engaging detent 3205. Clip 3201 is inserted between carrier guide features 3233. Clip 3201 is guided / aligned into the correct position by the angled surfaces of each of guide features 3233.

[0418] When the slide 3209 is in a locked position and the clip 3201 is inserted into the carrier 3203, the arcuate portion 3212 allows the arm 3211 to bend. In particular, the arm 3211 bends laterally away from the clip 3201. The arm can bend into a curved shape as shown, where the arcuate portion 3212 is convex when viewed from the position of the slide. Alternatively, the arm can flex or bend to a less curved position, or to a position where the arcuate portion 3212 is still concave, but less concave than that shown in FIG. 127.

[0419] FIG. 126 is a cross-sectional view of the connector of FIG. 123 showing the slides in a locked position. In this position, the protrusions 3215 of the arms 3211 engage with the notches 3213 of the clip 3201. When in the position shown in FIG. 126, the arms 3211 are prevented from moving unless the slide 3209 is moved. In particular, the arms 3211 cannot move toward each other because the clip 3201 is positioned between them. The arms 3211 cannot move away from each other because the protrusions 3223 of the slide 3209 prevent the arms from moving laterally outward. The protrusions 3233 also prevent the protrusions 3215 of the arms 3211 from flexing rearward and disengaging from the clip 3201.

[0420] FIG. 127 is a cross-sectional view of the connector of FIG. 123 showing the slide 3209 in a free position, allowing the clip 3201 to be removed. The slide 3209 moves to the free position, allowing the detent 3205 to move. In the free position, the end 3235 of the slide 3209 closest to the carrier 3203 abuts the shoulder 3237 of the carrier, preventing the slide 3209 from moving too far back. The arcuate portion of the resilient arm provides a clearance space into which the protrusion of the slide can move when the slide moves to the free position. The legs 3208 (also indicated by 3408, e.g., in FIG. 141 ) of the biasing means are moved away from each other by the protrusion, and the arms 3211 are also moved away from each other by the clip 3201. The legs 3208 are substantially deformation-resistant or resiliently flexible and are urged toward each other, acting against the tapered surfaces of the protrusions to return the slider to the locked position. After moving the slide, the protrusions 3223 have moved into the free space provided by the arcuate portions 3212 of the arms 3211, allowing the arms to move freely. By pulling on the clip 3201, the arms 3211 flex away from each other, releasing the clip 3201 from the carrier 3203.

[0421] FIG. 128 is a cross-sectional view of the connector of FIG. 123 showing the clip 3201 removed from the carrier 3203. FIG.

[0422] The connectors of the present disclosure can be provided in combination with a patient interface. Thus, the present disclosure broadly relates to a patient interface (as described herein) for use in a medical breathing circuit, wherein the patient interface 3102 includes a connector as described herein, which is integral to, permanently attached to, or removably attached to the patient interface 3102 for connecting the patient interface to headgear.

[0423] The connectors 3200, 3300 may be formed from any suitable material that allows for the characteristics described herein, including, for example, medical grade materials and / or suitable polymeric materials.

[0424] A second embodiment of the connector will now be described with reference to Figures 133 to 140. Hereinafter, unless otherwise stated, the features and functions of the connector should be considered to be the same as those described for the first embodiment above, and like reference numerals will indicate like parts with the addition of 100.

[0425] The connector 3300 has a first connector part in the form of a clip 3301, a second connector part in the form of a carrier 3303, a detent 3305 for securing the clip and carrier together, a biasing means 3307, and a slide 3309. The slide 3309 is movable relative to the clip 3301 and / or carrier 3303 between a fixed position and a free position. In the fixed position, the detent 3305 is substantially prevented from moving to release the clip 3301 from the carrier 3303. In the free position, the detent 3305 can be moved to release the clip 3301 from the carrier 3303. The biasing means 3307 urges the slide towards the fixed position.

[0426] In the second embodiment, the biasing means 3307 and the detent 3305 are integrally formed together. The biasing means 3307 includes a pair of resilient legs 3308, and the detent 3305 includes a pair of resilient arms 3311. The legs 3308 extend from the body portion 3310 (or 3410 as shown, for example, in FIGS. 141, 144) in generally opposite directions relative to the direction of the arms. The legs 3308 are the same length as each other. The free end 3308b of each leg 3308 is enlarged compared to the remainder of the leg. The free end 3308b of each leg 3308 is rectangular.

[0427] The slide 3309 has a pair of protrusions 3317 that engage with the biasing means 3307. The protrusions 3317 are positioned near the periphery of the slide, as shown in Figure 138. The protrusions 3317 each have a tapered surface 3319.

[0428] The carrier 3303 has a single opening for attaching a strap and is adapted to carry the combined detent 3305 / biasing means 3307, as shown in FIG. 122. The carrier 3303 has a locating mechanism for locating the biasing means. In particular, the carrier 3303 has legs 3329. When assembled with the combined detent 3305 / biasing means 3307, the free ends of the legs fit snugly within the space between the protrusion and the flat surface.

[0429] 133 to 138, a method of connecting the clip 3301 and carrier 3303 of the second embodiment will now be described. Figure 133 is a cross-sectional view of the connector of Figure 123 before the clip 3301 engages with the detent 3305. The slide 3309 is biased into a locked position.

[0430] FIG. 134 is a cross-sectional view of the connector of FIG. 133 showing the initial stage in which clip 3301 is engaged with detent 3305.

[0431] FIG. 135 is a cross-sectional view of the connector of FIG. 133 showing the slide 3309 in a locked position. In this position, the protrusions 3315 on the arms engage with notches in the clip 3301. The arms 3311 are prevented from moving when in the position shown in FIG. 135 unless the slide 3309 is moved. In particular, the arms 3311 cannot move toward each other because the clip 3301 is disposed between them. The arms 3311 cannot move away from each other because the protrusions 3323 on the slide 3309 prevent the arms 3311 from moving laterally outward. Each arm is prevented from flexing by engaging the protrusions 3333.

[0432] Figure 136 is a cross-sectional view of the connector of Figure 133 showing the slide 3309 in a free position so that the clip 3301 can be removed. The legs 3308 are moved towards each other by the protrusion 3317, and the arms 3311 are also moved away from each other by the clip 3301. The legs 3308 are substantially deformation-resistant or resiliently flexible and are biased away from each other, acting on the tapered surfaces of the protrusions to return the slide 3309 to the locked position.

[0433] FIG. 137 is a cross-sectional view of the connector of FIG. 133 showing the clip 3301 removed from the carrier 3303.

[0434] A third embodiment of the connector will now be described with reference to Figures 141 to 144. Unless otherwise stated below, the features and functions of the connector should be considered to be the same as those described for the first embodiment above, and like reference numerals indicate like parts with the addition of 200.

[0435] FIG. 141 is a cross-sectional view of the third embodiment of the connector, showing the slide 3409 in a locked position. In this embodiment, the clip 3401 has multiple notches 3413. The notches 3413 may be evenly or unevenly spaced along the length of the clip. The carrier 3403 and head strap 3450 have spaces through which the clip can extend, if needed. Slots 3403a are formed in the carrier 3403, and the head strap may be a hollow component or a component with an opening to receive the clip 3401. The multiple notches 3413, together with the slots 3403a formed in the carrier and hollow head strap, allow the connector to provide some adjustability of the connector.

[0436] Figure 142 is a cross-sectional view taken through line AA in Figure 141. Figure 143 is a cross-sectional view taken through line AA in Figure 141 with the same features and functionality as the connector in Figure 142 with the addition of '. Figure 143 shows slot 3403a' formed in carriage 3403'.

[0437] FIG. 144 is a cross-sectional view through line BB of FIG. 141, showing the relative positions of the components using this alternative embodiment in a fixed position.

[0438] Any one or more features from any embodiment can be combined with any one or more features from any one or more other embodiments.

[0439] The carrier has been described as a separate component in contrast to the combined detent / biasing means component. Alternatively, the carrier may be integrally formed with the detent / biasing means component.

[0440] The biasing means has been described as comprising a pair of resilient legs. Alternatively, the biasing means may comprise a single leg or three or more legs. In a further alternative, the leg biasing means may comprise any other type of spring element that acts as a return mechanism for the slider.

[0441] The detent has been described as having a pair of resilient arms. Alternatively, the detent may have a single arm or three or more arms. The clip has been described as having a pair of notches. Alternatively, the clip may have a single notch or two or more notches. The number and location of the notches corresponds to the number and location of complementary protrusions on the resilient arms.

[0442] The biasing means has been described as having two legs that move away from each other and are biased toward each other to lock the slider in place. Alternatively, the legs can be deformed in other directions to provide a similar return action. For example, the legs can twist or bend along their length.

[0443] The features and characteristics of the legs can be modified to suit the application, i.e., to adjust the force on the slide as it moves between the locked and free positions. Features and characteristics that can be selected or designed to be modified include the leg angle, leg thickness, and lug angle.

[0444] In a further alternative embodiment, the combined detent / biasing means component may be formed of two pieces, each having an arm and a leg and held in place relative to the carrier by a locating mechanism. In a further alternative embodiment, the detent / biasing means may be a single leg and arm combination that acts on only one side of the clip. In this embodiment, the connector has a locating mechanism that mates and locks the detent / biasing means in place with guides and / or abutment mechanisms to ensure that the connector components are accurately positioned relative to one another taking into account the forces acting on the components by the arms / legs.

[0445] The biasing means and detent have been described as being integrally formed together. Alternatively, they may be separately formed components that may or may not be connected together.

[0446] Embodiments of the connector have been described as having a biasing means that urges the slider toward the locked position. In alternative embodiments, the connector may not have a biasing means, and the slider may be held in the free and / or locked position by other suitable mechanisms. For example, the connector may have one or more catches that hold the slider in the free and / or locked position. Such catches may automatically engage the slider and / or carrier, or may be user-controlled mechanisms.

[0447] The carrier of the first embodiment is shown with two openings for receiving the strap, and the second embodiment is shown with a single opening. Either embodiment can have one or two openings. Alternatively, in either or both embodiments, the carrier can be integrally formed with the strap.

[0448] Referring to the non-limiting exemplary embodiment shown in Figure 2, a patient interface 100 is shown. As shown, the patient interface 100 comprises a nasal cannula. In some alternative forms, the patient interface 100 may comprise a sealing or non-sealing interface. For example, the patient interface 100 may comprise a nasal mask, an oral mask, an oral-nasal mask, a full face mask, a nasal pillow mask, a nasogastric tube, a combination of the above, or some other gas delivery system or device.

[0449] FIG. 9 illustrates the use of the patient interface 100 in a respiratory treatment system 400. The respiratory treatment system 400 includes a flow generator 404. The flow generator 404 receives gas from a gas inlet 402 and forces it through a humidifier 406. The humidifier 406 heats and humidifies the gas. The heated and humidified gas passes through a gas outlet 408. The gas travels from the gas outlet 408 to a gas conduit 410. The gas conduit 410 includes a heater 414 that reduces or prevents condensation of moisture along the walls of the gas conduit 410. The heater 414 may include resistive heating wire. The respiratory treatment system 400 includes a controller 416 that controls the operation of the flow generator 404. The controller 416 also controls the operation of the humidifier 406. The respiratory treatment system 400 includes an input / output module 418. The input / output module (I / O) 418 allows a user to interact with and set parameters for the flow generator 404 and / or humidifier 406, as well as receive information regarding the operation of the respiratory treatment system 400 and its components. The I / O module 418 may include, for example, buttons, knobs, dials, switches, levers, a touchscreen, a speaker, a display, and / or other input or output elements. In some embodiments, the humidifier 406 may not be present. In some embodiments, the gas conduit 410 may not have a heater 414.

[0450] With further reference to FIG. 2 , the patient interface 100 includes a frame portion 102. The frame portion 102 includes a contact region 104 that contacts a user during use. At least a portion of the contact region 104 is located under the user's nose or under the nostrils during use (e.g., on the upper lip). The frame portion 102 also includes a non-contact region 107 that faces away from the user during use. In the illustrated form, the non-contact region 107 is formed from a relatively hard or rigid material (e.g., polycarbonate and / or polypropylene) that provides support for the frame portion 102. The contact region 104 includes a relatively soft, flexible, and pliable material (including, but not limited to, foam, gel-based material, silicone, and / or thermoplastic elastomer) that can be positioned against the user's face. The contact region 104 is overmolded or co-molded onto the non-contact region 107. A soft or flexible material may be used in contact region 104 to improve comfort for the user, forming a soft, pillow-like structure that rests in contact with the patient. In some forms, contact region 104 may be secured to non-contact region 107 by other means, including, but not limited to, adhesives, ultrasonic welding, and / or mechanical fasteners. In some forms, frame portion 102 may comprise only a single material.

[0451] The frame portion 102 also includes a gas chamber 109 within the frame portion 102 that can receive gas from a gas source. Gas received in the gas chamber 109 can be directed to the user through the gas delivery element 105. The gas delivery element 105 delivers gas to the user substantially or entirely through the nose and includes a first nasal delivery element 105A and a second nasal delivery element 105B, such as nasal prongs adapted to fit within the user's nostrils. In the illustrated configuration, the nasal delivery elements 105A, 105B can engage the nares. In some alternative configurations, the nasal delivery elements 105A, 105B can seal with the nares, or the nasal delivery elements 105A, 105B can have different sealing qualities (e.g., the first nasal delivery element 105A can be adapted to sealingly engage one nostril, while the second nasal delivery element 105B may not sealingly engage the other nostril). In further alternatives, the gas delivery element 105 may comprise only a single nasal delivery element, or may comprise only one or more openings that transmit gas to the user's nose, mouth and / or tracheal airways.

[0452] The frame portion 102 includes a first side arm 106 and a second side arm 108. The first side arm 106 and the second side arm 108 extend laterally from the frame portion 102 on substantially opposite sides of the frame portion 102, although in some forms they can extend in other directions or from other sides. The first side arm 106 and the second side arm 108 help support the frame portion 102 and generally rest on the patient's face (e.g., on or adjacent to the cheeks). The side arms 106, 108 include a headgear retention mechanism 118 adapted to retain headgear 124. As shown, the headgear retention mechanism 118 includes a buckle 120. The buckles 120 are adapted to hold buckle carriers 122, which each include a pair of slots 123 through which sections of headgear 124 can be looped and secured, for example, by using hook-and-loop fasteners present on the sections of headgear 124. In some forms, the buckles 120 can be made from a relatively hard or rigid material, and the buckles 120 can include an overmolded layer of a relatively soft material. The relatively soft material can be present on the side of the buckle 120 that contacts the user's face during use. The headgear retention mechanism 118, the buckles 120, and corresponding features of the patient interface 100 can be the same as or similar to those described in commonly owned U.S. Patent Application No. 62 / 013912, which is incorporated herein by reference in its entirety. In some forms, the side arms may not be present, or only the first side arm 106 or the second side arm 108 may be present, and the headgear 124 may interface with the frame portion 102 at the other portion of the frame portion 102.

[0453] In some forms, headgear 124 can be secured to frame section 102 in other ways, for example, headgear 124 can be overmolded, co-molded, or ultrasonically or RF (radio frequency) welded onto frame section 102, stitched to frame section 102, or adhered with an adhesive. In some forms, other retention structures can be used, such as, for example, hook and loop fasteners, zip fasteners, domes, hooks, or clips. In a further alternative, headgear 124 can be integrally formed with frame section 102.

[0454] As shown, headgear 124 includes a central strap portion 125 adapted to be positioned generally around the back of the user's head (e.g., over the crown and / or occipital regions of the head) and first and second side strap portions 126, 128 extending generally laterally from central strap portion 125 and adapted to be positioned generally on the sides of the user's head (e.g., over the cheeks, cheekbones, temporal and / or sphenoid regions of the head). Central strap portion 125 includes a pair of straps 130, 132 connected by one or more bridge sections 136. Bridge section 136 is adapted to be breakable or splittable by the user to allow the straps to bifurcate. For example, the bridge section 136 can be thin or structurally weak (e.g., the bridge section 136 can have a smaller thickness, material strength, and / or structural integrity than the straps 130, 132), such that if the straps 130, 132 are pulled apart by a force exceeding a threshold level of force, the bridge section 136 can split, allowing the straps 130, 132 to move further apart (e.g., the straps 130, 132 can be capable of a greater level of movement away from each other). The greater level of movement may enable the straps 130, 132 to support different regions of the head. For example, a first strap 130 can be used to support a mid-temporal section of the head, and a second strap 132 can be used to support a mid-occipital section of the head.

[0455] Bifurcated straps may allow for a greater level of adaptability to different user anatomies or may allow for a greater level of user comfort. Bifurcated straps may also facilitate improved stability of the headgear 124 (e.g., by preventing excessive movement of the patient interface 100 away from the head). In some forms, the central strap portion 125 may include three or more straps. For example, the central strap portion 125 may include three or four straps. In some such forms, some or all of adjacent pairs of three or more straps may be joined by a bridge section. In some forms, the central strap portion 125 may include only a single strap and may not have a bifurcated component. In some forms, the bridge section 136 may be formed from a different material than the remainder of the central strap portion 125 (e.g., a softer, more fragile, or less durable material than the straps 130, 132). In some forms, the bridge section 136 may serve to support the remainder of the central strap portion 125. In some forms, bridge section 136 may be stiffer, more durable, or stronger than straps 130, 132. In some forms, first strap portion 126 and / or second strap portion 128 may also be bifurcated, either separately from or in conjunction with central strap portion 125, or first side strap portion 126 and / or second side strap portion 128 may comprise two or more straps. Optionally, the upper and lower rear strap portions of the headgear may be movable relative to one another and configured to allow automatic or self-adjusting fit to the head, with the headgear snapping into place to minimize force against the nasal septum while maintaining the prongs in the nose.

[0456] In the illustrated form, the headgear 124 includes guides or markings 134. In the illustrated form, the markings 134 are present on the first side strap portion 126 and the second side strap portion 128 and can help indicate to the user how tight or loose the headgear fit (e.g., when used with the buckle carrier 122). After the side strap portions 126, 128 are looped through the slots 123 of the buckle carrier 122, the side strap portions 126, 128 can be pulled through the buckle carrier 122 until the desired markings 134 are visible on the buckle carrier 122 or along the surface of the side strap portions 126, 128. The markings 134 help guide the user to properly fasten the headgear. In particular, the markings 134 can help guide the user to evenly position the headgear 124 between the buckles 120 so that the center strap portion 125 and the side strap portions 126, 128 are accurately or optimally positioned on the user's head, and can also help the user understand that the portions 125, 126, 128 are in the correct or optimal position. For example, if the same markings 134 are shown on the buckle carriers 122 that secure each side strap portion 126, 128, the correct or optimal position for the portions 125, 126, 128 is communicated to the user. The markings 134 include numbers 1 through 7 in sequence, where seeing a "1" on the buckle carrier 122 indicates a "tight" fit and seeing a "7" on the buckle carrier 122 indicates a "loose" fit.

[0457] If the fit is uncomfortable and undesirable, the user can pull or push the side strap portions 126, 128 through the buckle carrier 122 (e.g., after first loosening the strap portions previously secured with hook-and-loop fasteners) until a comfortable or desired fit (which may be designated by different markings 134) is achieved. The looped straps can then be resecured, for example, with hook-and-loop fasteners as described above or elsewhere herein. In alternative forms, the markings 134 can include printed alphanumeric characters (e.g., "S" for small, "M" for medium, "L" for large, "T" for snug, etc.), symbols (e.g., !, ?, %, *, **, ***), images, indentations, protrusions, or other information-carrying elements. The markings 134 are present on the exterior surfaces of the side strap portions 126, 128. Alternatively, the markings 134 can be covered with a transparent layer (e.g., an overmolded or bonded resin) to maintain a substantially smooth surface or a single texture along the surface covered with the markings 134. In a further alternative, the markings 134 can be present on other sections of the headgear 124.

[0458] In the illustrated embodiment, the headgear 124 includes friction elements 138. The friction elements 138 help prevent unwanted sliding of the headgear 124 around the user's head (e.g., due to greasy or slick hair, or due to oil or sweat on the user's head). Once the headgear 124 is correctly positioned on the user's head, the friction elements 138 can help prevent unwanted repositioning of the headgear 124 during use. As shown, the friction elements 138 include printed circles or dots on both straps 130, 132 in the central strap region 125 and on portions of the side strap sections 126, 128, although the friction elements 138 can alternatively or additionally be present elsewhere on the headgear. In some embodiments, the friction elements 138 can have printed shapes of other geometric shapes, such as triangles or rectangles. In some embodiments, the friction elements 138 can have a pattern or grid of lines. In some forms, the friction elements 138 can include other structures, including but not limited to, protrusions, recesses, ledges, or grooves, instead of or in addition to printed shapes.

[0459] The patient interface 100 also includes a manifold 114 that receives gas from a gas source through a manifold inlet 116. The manifold inlet 116 is in pneumatic communication with the gas chamber 109 of the frame portion 102 in at least some orientations or configurations. The manifold inlet 116 communicates with a gas source through a gas conduit 146 that interfaces with the gas source via a gas source connector 148. The gas source connector 148 may be adapted to pivot or engage in a rotational motion with respect to the conduit 146 and / or the gas source. In some alternative configurations, the gas source connector 148 may interface with a gas humidifier or other respiratory therapy device that may be in pneumatic communication with the gas source. A conduit clip 142 may be present on the gas conduit 146. FIG. 2 shows an example of the conduit clip 142. The conduit clip 142 includes a protrusion 144 that can engage with a recess or opening present in one or both of the first and second side arms 106, 108 of the frame portion 102. The conduit clip 142 can help support the gas conduit 146 by holding it in a set position relative to the frame portion 102 and prevent undesirable forces from being exerted on the manifold 114. The conduit clip 142 and corresponding features of the patient interface can be the same as or similar to the clips disclosed in commonly owned U.S. Patent Application No. 62 / 013957, which is incorporated herein by reference in its entirety. The patient interface 100 also includes a release mechanism 200 that includes a button 202 and a retention mechanism 300, each of which is described in further detail below in this disclosure with reference to the accompanying drawings or elsewhere.

[0460] Several components of the patient interface 100, including the buckle 120, buckle carrier 122, gas source connector 148, and button 202, are contacts operable by a user. The surfaces of the contacts can include the same color, color pattern, texture, or symbol (e.g., red, green, blue, yellow, stripes, polka dots, ridges, hand icons) or can have a color, color pattern, texture, or symbol (e.g., safety orange, hot pink, bright yellow, zigzag, wavy surface) that stands out from the color, color pattern, texture, or symbol used on other parts of the patient interface 100. Using similar or distinctive colors, color patterns, textures, or symbols to indicate the contacts can help a user understand the location and use of the various configurable parts of the patient interface 100.

[0461] 3A and 3B show an exemplary, non-limiting embodiment of the central section of the patient interface 100. As shown and described elsewhere in this disclosure, the frame portion 102 comprises a relatively hard or rigid section 150 and a relatively soft or flexible section 152. The manifold 114 may be rotatably fixed to the frame portion 102, for example, or may be fixed such that the manifold 114 can rotate or pivot relative to the frame portion 102, or vice versa, thereby allowing the frame portion 102 to rotate or pivot relative to the manifold 114. The manifold 114 may be rotatably fixed such that the range of rotational motion between the manifold 114 and the frame portion 102 can be a full 360 degrees. In other embodiments, the range of rotational motion may be limited to less than 360 degrees.

[0462] For example, the range of rotational motion between the manifold 114 and the frame portion 102 may be limited to at or about 90 degrees, 100 degrees or about 100 degrees, 110 degrees or about 110 degrees, 120 degrees or about 120 degrees, 130 degrees or about 130 degrees, 140 degrees or about 140 degrees, 150 degrees or about 150 degrees, 160 degrees or about 160 degrees, 170 degrees or about 170 degrees, 180 degrees or about 180 degrees, 190 degrees or about 190 degrees, 200 degrees or about 200 degrees, 210 degrees or about 210 degrees, 220 degrees or about 220 degrees, 230 degrees or about 230 degrees, 240 degrees or about 240 degrees, 250 degrees or about 250 degrees, 260 degrees or about 260 degrees, 270 degrees or about 270 degrees, 180 degrees or about 180 degrees.

[0463] In the illustrated configuration, the manifold inlet 116 is only substantially in air communication with the gas chamber 109 when the manifold inlet 116 is positioned above or near the first frame gas inlet 110 or the second frame gas inlet 112 of the frame portion 102, but in some configurations the manifold inlet 116 can be substantially in air communication with the gas chamber 109 of the frame portion 102 in more or fewer orientations.

[0464] As shown most clearly in FIG. 3B , the rigid section 150 of the frame portion 102 includes an axle structure 154 that facilitates rotational movement between the manifold 114 and the frame portion 102. The axle structure 154 includes a protrusion that can be forced through a complementary opening in the manifold 114. In a preferred embodiment, the axle structure 154 is used to permanently and rotationally couple the manifold 114 and the frame portion 102. In some alternative embodiments, the axle structure 154 may allow for separation of the manifold 114 and the frame portion 102. In some such embodiments, the manifold 114 and the frame portion 102 can only be separated when the axle structure 154 is oriented in a center position or when the manifold 114 is rotatably oriented in several positions relative to the frame portion 102. In some embodiments, the axle structure 154 may include other features that allow rotational movement between the manifold 114 and the frame portion 102.

[0465] 4A-4C, the axle structure 154 is secured to the frame portion 102. The axle structure 154 may be integrally formed with the frame portion 102. Alternatively, the axle structure may be attached by other methods, including, but not limited to, adhesive and one or more of hook and loop fasteners, complementary grooves and ridges, or hooks.

[0466] The axle structure 154 includes a protruding section 154A and a base 154B, although in some embodiments, the base 154B may be absent. The protruding section 154A includes a first leg 154A1 and a second leg 154A2. The legs 154A1 and 154A2 include heads 154A3 and 154A4 with sloped top and flat bottom sections. As shown in the sequence illustrated in FIGS. 4A-4C, when the protruding section 154A is forced through the opening 156 of the manifold 114, the heads 154A3 and 154A4 of the legs 154A1 and 154A2 are forced inward toward each other as the wall of the manifold 114 defining the opening 156 passes along the sloped top sections of the heads 154A3 and 154A4 (see FIG. 4B). After the heads 154A3, 154A4 pass through the opening 156, the heads 154A3, 154A4 move outward or snap back to their default position (see FIG. 4C ). The axle structure 154 is then set in place, and the flat bottom sections of the heads 154A3, 154A4 make it difficult to remove (e.g., permanently). It should be understood that in some forms, the manifold 114 can instead include the axle structure 154, and the frame portion 102 can include the opening 156. In some forms, the manifold 114 and the frame portion 102 can each include both the opening and the axle structure. It should also be understood that in some forms, the protruding section 154A can include only a single leg, or the protruding section 154A may not include any legs. The protruding section 154A can simply include a unitary structure that is flexible or pliable enough to be forced through the opening 156.

[0467] 3A-3B, as described above, the frame portion 102 includes a retention feature 300. The retention feature 300 helps prevent undesired non-rotational movement (e.g., bending) of the manifold 114 relative to the frame portion 102, which may occur due to forces generated by the conduits 146, for example, as described elsewhere in this disclosure with reference to FIG. 2. In the illustrated embodiment, the retention feature 300 includes posts 302 that prevent lateral movement of the manifold 114 relative to the frame portion 102 when the manifold 114 substantially covers the frame inlets 110, 112 (i.e., when the manifold is in an operative position to deliver gas). In some alternative embodiments, structures other than posts 302 can be used to prevent other movement of the manifold relative to the frame portion. These alternative embodiments are described in more detail below. Additionally, the retention mechanism 300 helps maintain a sealed gas passageway (e.g., a gas passageway that is not substantially directly exposed to the ambient environment outside the patient interface 110) between the gas chamber 109 of the frame portion 102 and the manifold inlet 116 by directing the manifold 114 toward the frame inlets 110, 112, or at least by ensuring that the manifold 114 does not substantially move away from the frame inlets 110, 112 in some rotational orientations.

[0468] Additionally, the retention mechanism 300, which prevents movement of the manifold 114, helps maintain a sealed gas passage between the gas chamber 109 and the manifold 116 when the manifold 114 is in the operating position. The retention mechanism 300 further prevents rotational movement of the manifold 114 relative to the frame portion 102 in several rotational orientations. In particular, the retention mechanism 300 is configured to retain the manifold 114 between the frame 102 and the post 302. The manifold is retained by a friction fit that holds the manifold in the operating position. The friction fit that holds the manifold 114 is high enough to hold the manifold in the operating position when the interface 100 is in use, but the user can overcome the friction fit when attempting to rotate the manifold. Such retention mechanism 300 is part of the rigid section 150 of the frame portion 102, although in some forms, other sections of the frame portion 102 can include the retention mechanism 300.

[0469] Referring again to FIG. 3B and the non-limiting exemplary embodiment shown in FIGS. 5 and 6, the frame portion 102 also includes a recessed track 204 adjacent the frame inlets 110, 112. The track 204 includes a detent area 206. The track 204 acts as a channel through which a complementary boss 226 (see FIG. 7B) of the release mechanism 200 of the manifold 114 can move, thereby facilitating rotation of the manifold 114 relative to the frame portion 102. The boss 226 has a range of motion indicated by the dotted line M as shown in FIGS. 5 and 6, exhibiting approximately 180 degrees of rotational freedom (FIG. 5) or approximately 360 degrees of rotational freedom (FIG. 6). In use, when entering the track 204, the boss 226 is encouraged into the track 204 from the lead-in section 208A (FIG. 5) or 208B (FIG. 6). In some alternative embodiments, the lead-in sections 208A, 208B may not be present. The boss 226 then travels along the track 204 and enters the retention area 206. The naturally outwardly biased boss 226 moves into the retention area 206. Further rotational movement of the manifold 114 relative to the retention area 102 is prevented by the retention of the boss 226 in the retention area 206.

[0470] 7A and 7B demonstrate further aspects of a release mechanism 200 for the manifold 114. The release mechanism 200 includes a manual button 202. The button 202 can be depressed by sliding it in a direction substantially parallel to the longitudinal axis of the manifold. The button is depressed until it hits a button stop 210. The button stop 210 is integrally formed with the manifold 114. Alternatively, the button 202 can be a separate piece secured to the manifold 114.

[0471] 7B shows the underside 127 of the manifold 114 (manifold inlet 116, not shown). The underside 127 includes a recess 212 in which a release body 214 is located. The release body 214 is inserted into the recess 212 and is connected to the button 202.

[0472] In the preferred embodiment shown, the release mechanism includes a pair of resilient side arms 216A, 216B. The side arms 216A, 216B are substantially deformation-resistant or resiliently flexible. As will be described in more detail below, the resilient side arms 216A, 216B urge the button toward the locked position. The side arms 216A, 216B extend in the same direction from the release body 214 and are the same length as each other. The sides of each side arm 216A, 216B are slightly tapered so that the free end of each side arm is narrower than the end where it joins the release body 214. The free end of each side arm is rounded. The sides, top, and bottom of each side arm are substantially flat.

[0473] The walls of the underside 127 of the manifold 114 that define the recess 212 include side stops 220A, 220B against which elbows 218A, 218B on side arms 216A, 216B of the release body 214 abut to position the release body in the locked configuration. The recess 212 includes end regions 222A, 222B separated by a protrusion or ledge section 223 on the underside 127 of the manifold 114. As shown in FIG. 7B , the protrusion 223 is centered within the recess 212. The protrusion 223 has two outer tapered surfaces with rounded noses.

[0474] As shown, when button 202 is depressed, release body 214 is urged forward or toward protrusion 223, and side arms 216A, 216B splay outward into end regions 222A, 222B (as indicated using arrows B1 and B2 shown in FIG. 7B ) as they travel along the outer tapered surface of protrusion or ledge section 223. Protrusion or ledge section 223 serves to bias release body 214 rearward, thereby forcing side arms 216A, 216B to retract when button 202 is released until elbows 218A, 218B again abut side stops 220A, 220B.

[0475] Release body 214 also includes boss 226, as described above and elsewhere in this disclosure with reference to Figures 5 and 6. Boss 226 can also serve to bias side arms 216A, 216B outwardly into end regions 222A, 222B as they move along track 208 (which includes tracks 280A and 208B). This is further demonstrated with reference to Figures 8A-8E.

[0476] 8A-8E, operation of the release mechanism 200 is illustrated. FIG. 8A illustrates the operative or default state of the patient interface 100, in which the manifold inlet 116 is positioned over the frame inlet 112. In the illustrated position, the manifold inlet 116 is positioned in fluid communication with the gas chamber 109. In the illustrated position, as in FIG. 8B, the manifold 114 is held in operative condition by a friction fit with the retention mechanism 300 and release mechanism 200 in a locked position. The locked position was described above and is achieved when the boss 226 is positioned in the retention region 206. Curved arrows R1 and R2 demonstrate the rotational torque force applied to the manifold 114.

[0477] During operation of the release mechanism 200 and / or the retention mechanism 300, movement of the button 202 or other components can provide sensory feedback to the operator regarding whether the retention mechanism 300 and the release mechanism 200 are locked or secured. The sensory feedback can be audible, tactile, visual, or a combination of two or more types of feedback. For example, the release mechanism 200 can provide feedback by a protrusion on the button 202 or release body 214 engaging a recess, opening, or abutment surface on the manifold 114. The boss 226 described above can provide sensory feedback. The button 202 or release body 214 can have two or more protrusions that engage two or more recesses, openings, or abutment surfaces. The retention mechanism 300 can provide feedback by a protrusion on the manifold 114 engaging a recess, opening, or abutment surface on the frame portion 102. For example, the manifold 114 can have a protrusion, and the button 202 or release body 214 can have a recess, opening, or abutment surface. In other alternative embodiments, complementary protrusions and recesses may be on other combinations of components of the manifold 114 assembly, such as the manifold 114 and frame portion 102. In alternative embodiments, the button 202 or release body 214 may have the protrusion and the manifold 114 may have the recess, opening, or abutment surface. Additionally, the position of the components provides visual feedback to the operator.

[0478] Figure 8B shows a cross-section of the patient interface 100 along section plane AA, as indicated using a dotted line in Figure 8A. As shown, the boss 226 is retained within the retention area 206 of the track 204, and torque forces applied to the manifold 114 along arrows R1 and R1 do not promote rotational movement between the manifold 114 and the frame section 102. As shown in Figure 8C, when the button 202 is depressed (e.g., along arrow A), the boss 226 is forced outward (e.g., along arrow B) from the retention area 206 of the track 204 as the side arms 216A, 216B of the release body 214 expand into the end areas 222A, 222B around the protrusion or ledge section 223 (see Figure 7B). 8D-8E, boss 226 can be moved out of retention area 206 by depressing button 202, resulting in torque forces along arrows R1 and R2 effecting rotational movement between manifold 114 and frame section 102 about axle structure 154. The configuration shown in FIGS. 8A-8E allows for a 180-degree range of rotational movement between manifold 114 and frame section 102. In alternative configurations, the manifold shown in FIG. 6 can be used to allow for a 360-degree range of rotational movement between manifold 114 and frame section 102.

[0479] The manifold has been described as a separate component to the combined release body / side arm component. Alternatively, the manifold can be integrally formed with the release body / side arm component.

[0480] The release mechanism has been described as comprising a pair of resilient side arms. Alternatively, the biasing means may comprise a single arm or three or more arms. In a further alternative, the biasing means may comprise any other type of spring element that acts as a return mechanism for the slider.

[0481] The biasing means has been described as two side arms that move away from each other and are biased toward each other to force the button into the locked position. Alternatively, the side arms can be deformed in other directions to provide a similar return action. For example, the side arms can twist or bend along their length. Figure 27 is a schematic diagram illustrating an alternative embodiment, in which the arms move toward each other and are biased away from each other to bias the button into the locked position. Rather than splaying around a protrusion or bulging section, the arms are directed inward by two tapered surfaces 2623.

[0482] The features and characteristics of the side arms can be modified to suit the application, i.e., to adjust the force on the slide as it moves between the locked and free positions. Features or characteristics that can be selected or designed to be modified include the angle of the side arms, the thickness of the side arms, and the angle of the lugs.

[0483] The release body and side arm have been described as being integrally formed together. Alternatively, they may be separately formed components that may or may not be connected together.

[0484] Embodiments of the patient interface have been described as having a biasing means that urges the button toward the locked position. In alternative embodiments, the patient interface may not have a biasing means, and the button may be held in each of the positions by other suitable mechanisms. For example, the patient interface may have one or more catches that hold the button in the desired position. Such catches may automatically engage the button and / or manifold, or may be a mechanism controlled by the user.

[0485] 10A-10I illustrate an alternative embodiment of a manifold assembly, specifically an alternative release and retention mechanism. This embodiment is a combined release and retention mechanism 900. The retention mechanism 900 includes posts 902 that substantially prevent lateral movement of the manifold 114 relative to the frame section 102 when the manifold 114 substantially covers the frame inlets 110, 112. Each post has a reinforcing rib or gusset 904 that increases the rigidity of the post to reduce or prevent non-rotational movement between the manifold 114 and the frame section 102. This alternative retention mechanism may include two or more ribs or gussets associated with each post. Each rib or gusset may be wider or thinner than the gusset shown in the accompanying drawings and / or may have a different shape. The release mechanism includes a lever 905 separated from the manifold by a web section 906. The levers 905 have protruding portions 907 shaped to engage complementary grooves, recesses, slots or openings 908 in the frame portion 1122. The complementary grooves, recesses, slots or openings are formed in the posts 902. The manifold 114 is released by the user pressing the levers toward the center of the manifold so that the protruding portion of each lever 905 disengages from the recess, slot or opening, and rotating the manifold.

[0486] 11A-11F illustrate an alternative embodiment of a manifold assembly, and in particular an alternative retention mechanism. The retention mechanism 1000 includes an arm 1002 that substantially prevents lateral movement of the manifold 114 relative to the frame portion 102 when the manifold 114 substantially covers the frame inlets 110, 112. The arm substantially prevents lateral movement by engaging with other features of the patient interface, described below. The arm 1002 is attached to the frame portion 102, for example, by a flexible, integrally formed hinge. The arm 1002 has a slot 1003 shaped to engage with a complementary outwardly extending flange 1004. The arm further includes a protruding portion 1007 extending toward the manifold 114. The manifold 114 has a complementary recess, slot, or opening 1006 that receives the protruding portion. The recesses, slots or openings 1006 are preferably formed in the flange, but could be formed in another portion of the frame portion. The manifold is released by the user pushing the top of the arm 1002 towards the manifold, causing the protruding portion 1007 to disengage from the recesses, slots or openings, allowing the manifold to rotate.

[0487] 12A-12E illustrate an alternative embodiment of a manifold assembly, specifically an alternative release and retention mechanism. This embodiment is a combined release and retention mechanism. The retention mechanism 1100 includes a molded flange 1101 that substantially prevents lateral movement of the manifold 114 relative to the frame portion 112 when the manifold 114 substantially covers the frame inlets 110, 112. The flange 1101 substantially prevents lateral movement by engaging a recess, described below. The flange 1101 has a first horizontally extending portion 1101a, followed by a vertically extending portion 1101b, followed by another horizontally extending section 1101c. The flange sections form a generally C-shaped flange 1101 that surrounds a flange 1103 that extends outwardly of the frame portion 102. This form further includes an arm 1102 having a lower portion shaped to engage a complementary groove recess, slot, or opening (not visible) in the frame portion 102. Either a portion of the arm or the entire arm is flexible to allow the arm to move as needed. The recess, slot, or opening is preferably formed in the flange, but could also be formed in the manifold 114. The manifold 114 is released by the user pushing the upper portion of the arm toward the manifold, causing the lower portion of the lever to disengage from the recess, slot, or opening, allowing the manifold to rotate.

[0488] 13A-13D show an alternative embodiment of a manifold assembly, specifically an alternative release and retention mechanism. This embodiment has separate release and retention mechanisms. The retention mechanism 1200 includes a triangular ridge 1201 on the frame portion that engages with a complementary triangular channel 1202 in the manifold. When engaged, the channel and ridge act to substantially prevent lateral movement of the manifold 114 relative to the frame portion 1122 when the manifold 114 substantially covers the frame inlets 110, 112. The release mechanism includes an arm 1204 having a lower portion shaped to engage with a complementary groove recess, slot, or opening 1205 in the frame portion 1122. The arm further includes a protruding portion that extends toward the manifold 114. The manifold 114 is released by a user pressing the free end of the arm toward the manifold, causing the lower portion of the lever to disengage from the recess, slot, or opening, allowing the manifold to rotate. A portion of each arm or the entire arm is flexible to allow the arm to move as required.

[0489] 14A-14C illustrate an alternative embodiment of a manifold assembly, specifically an alternative release and retention mechanism. This form is a combined release and retention mechanism 1300. The retention mechanism includes a molded lever 1301 that substantially prevents lateral movement of the manifold 114 relative to the frame portion 1122 when the manifold 114 substantially covers the frame inlets 110, 112. The lever 1301 has a vertically extending portion 1301a with two generally oppositely extending arms 1301b, 1301c. One of the arms extends toward the manifold, and the other arm extends away from the manifold. One of the arms 1301b extends substantially perpendicular to the vertically extending portion 1301a, while the other arm 1301c extends generally parallel to the portion of the frame portion from which the vertically extending portion extends. The lever sections form a generally T-shaped side mechanism. A portion of each lever, or the entire lever, is flexible to allow the arm to move as needed. The first arm is shaped to engage a complementary flange on the manifold 114. The manifold 114 is released by the user pushing the second arm 1301b toward the frame portion 1122, causing the arm to disengage from the manifold and allowing the manifold to rotate.

[0490] 15A-15D illustrate an alternative embodiment of a manifold assembly, specifically an alternative release and retention mechanism. This embodiment is a combined release and retention mechanism. The combined mechanism 1400 includes a pair of levers 1401 that substantially prevent lateral movement of the manifold 114 relative to the frame portion 1122 when the manifold 114 substantially covers the frame inlets 110, 112. Each lever 1401 extends at an approximately 45-degree angle from the top of the manifold 112. Each lever is positioned near a flexible section or hinge 1402 of the manifold. One, or preferably both, sides of the manifold have a protruding portion shaped to engage a complementary groove, recess, slot, or opening in the frame portion 1122. In the illustrated embodiment, the non-inlet end of the manifold has a protruding portion 1403, while the inlet end of the manifold does not have a protruding portion. The protruding portion 1403 engages one of the frame inlets 110, 112 that is not in communication with the manifold inlet. The manifold 114 is released by the user pressing the levers toward each other, for example, in the direction of the arrows in Figure 15B, causing the protruding portion of each arm to disengage from the recesses, slots, or openings, allowing the manifold to rotate.

[0491] 16A-16C show an alternative embodiment of the manifold assembly, and in particular an alternative release mechanism. The release mechanism includes arms 1504 having protruding portions 1505 or shaped portions that engage complementary grooved recesses, slots, or openings 1506 in the frame portion 1122. The manifold 114 is released by the user pulling the free end of the arm toward the manifold, causing the protruding portions 1505 of the arms 1504 to disengage from the recesses, slots, or openings, allowing the manifold to rotate. A portion of each arm, or the entire arm, is flexible to allow the arms to move as needed.

[0492] 17A-17C illustrate an alternative embodiment of a manifold assembly, specifically an alternative release mechanism. The release mechanism 1600 includes a pair of arms 1601 separated from the manifold by a C-shaped slot. Each arm 1601 has a tab extending perpendicularly from the manifold 114. Each arm is flexible, at least rotationally. A portion of each arm, or the entire arm, is flexible to allow the arm to move as needed. One or preferably both arms of the manifold have a protruding portion 1602 shaped to engage with a complementary groove, recess, slot, or opening 1603 in the frame portion 1122. The manifold 114 is released by a user pressing the arms toward each other in a rotational motion, such as in the direction of the arrows in FIG. 17A, disengaging the protruding portions of each arm from the recesses, slots, or openings and allowing the manifold to rotate.

[0493] 18A-18C show an alternative embodiment of a manifold assembly, and in particular an alternative release mechanism. Release mechanism 1700 (or 2000, as shown, for example, in FIGS. 21A-21C) includes a pair of arms 1701 separated from the manifold by a laterally extending slot 1702. Each arm 1701 has a tab 1703. One or preferably both tabs 1703 on the manifold have a protruding portion shaped to engage with a complementary groove, recess, slot, or opening 1704 in frame portion 1122. The manifold 114 is released by the user pressing the tabs toward each other and toward the center of the manifold, causing the protruding portion of each tab to disengage from the recess, slot, or opening, allowing the manifold to rotate.

[0494] 19A-19C illustrate an alternative embodiment of a manifold assembly, specifically another alternative retention mechanism. FIGS. 19A-19C also illustrate a release mechanism similar to that of FIGS. 18A-18C. The retention mechanism encloses the manifold on all four sides. In particular, the frame portion has legs 1810 on each side, and the manifold has corresponding legs 1811. A pair of arms 1801 (or 2001, e.g., as shown in FIGS. 21A-21C) are provided, each having an associated tab 1803 (or 2003, e.g., as shown in FIGS. 21A-21C). The arms and tabs are separated from one another by a pair of laterally extending slots 1802 (or 2002, e.g., as shown in FIGS. 21A-21C). 18A-18C, the embodiment of Figures 19A-19C has protruding portions on preferably both tabs 1803 of the manifold that are shaped to engage complementary grooves, recesses, slots, or openings 1804 (or 2004, for example, as shown in Figures 21A-21C) in the portion designated as 102. The manifold 114 is released by the user pressing the tabs toward each other and toward the center of the manifold, causing the protruding portions of each tab to disengage from the recesses, slots, or openings, allowing the manifold to rotate.

[0495] Figures 21A-21C show an alternative embodiment of a manifold assembly, and in particular another alternative retention mechanism. Figures 21A-21C also show a release mechanism similar to the release mechanisms of Figures 18A-18C and 19A-19C. In particular, the manifold has a pair of generally parallel legs 2011, 2012 on each side, and the frame portion has corresponding legs 2010. Each leg 2010 has a first vertically extending portion 2010a followed by a horizontally extending portion 2010b.

[0496] 20A-20G show an embodiment in which the manifold and manifold inlet are formed by first and second components joined together by a fastening component.

[0497] More specifically, FIG. 20A shows a manifold portion 5000 having a tapered lead-in portion for delivering gas to the manifold portion, with the tapered lead-in portion being defined by an assembly of first and second components 5007 and a fastening collar 5006, along with a release mechanism 5002 in the form of a button that can be actuated by the user.

[0498] FIG. 20B shows a rear perspective view of FIG. 20A, particularly the axle structure identified as member 5005.

[0499] 20C shows a portion of the nasal cannula interface 5001 having nasal prongs 5004 that are utilized to deliver or direct a flow of gas to the nostrils of the user's nose. This exploded view shows some details of the release mechanism 5002 and one of a pair of side arms 5003 (the other side arm is not shown).

[0500] Figure 20B shows a first part of the retention mechanism 5020, and Figure 20C shows the other part 5021. Each of these parts may cooperate or engage, whereby their engagement facilitates more secure positioning of the manifold portion 5000 with the frame 5009 of the patient interface.

[0501] 20D is an exploded view of various parts and components that can be assembled together to form one embodiment of a patient interface, where a swivel manifold is provided, allowing it to pivot relative to the frame, but also locking it in place, which can be achieved by one or a combination of retention and operable release mechanisms that can be activated by the user or caregiver.

[0502] 20D illustrates a relatively soft, pliable, or flexible component, or component or material that is more comfortable for contact with a user's skin, identified as member 5008. Such component 5008 can include at least a pair of side arms 5003, a pair of nasal prongs 5004, and an attachment portion receiving or positioning portion 5011 provided to receive or position an attachment portion 5010. A relatively more rigid, less flexible, or more structural element, such as a frame, i.e., member 5009, can be coupled to component 5008. Component 5008 can be overmolded or otherwise received, connected, attached, or combined with frame portion 5009, such combination providing stability for at least a particular size or shape of the patient interface while still providing comfort to the user from the soft, pliable, or otherwise more flexible material component 5008. A manifold portion 5000 can be coupled or attached to frame portion 5009 to facilitate pivoting. The manifold portion 5000 can be assembled from multiple parts or components.

[0503] FIG. 20E shows a patient interface 6000 in which a manifold portion is provided on a first side of the interface for gas tubing connection. Note that a tube clip or tube securement system, labeled as member 5012, is provided, which is held or secured in place using or by mounting portion 5010. While the gas delivery tube is not shown in its original position, it can be seen in FIG. 20E that the gas tube extends through the tube clip 5012 to one side of the manifold and patient interface. Each end of the side arms can include a clip or other connection system 5013 to engage or facilitate engagement with a headgear system or other securement system to secure the patient interface in place on the user's face. The headgear is not shown, but can be headgear suitable for operation with nasal cannulas.

[0504] Figure 20F shows the manifold section 5000 in a partial rotation or pivot as the manifold rotates or pivots about the axle structure. Figure 20G shows the manifold section in a reoriented position after a 180° pivot or rotation. Note that the ports available for gas tubing connection have been relocated from one side of the interface to the other. This relocation of the gas connection ports provides certain advantages in terms of both patient comfort and user ease of use, as well as potentially improving the delivery of more consistent therapy to the patient.

[0505] Figure 20A shows a front perspective view of a manifold component including a release mechanism. In the embodiment shown in Figures 24A-24E, the fastening component includes a collar 2305. The collar 2305 is a substantially annular component having a tapered inner surface for engaging the outer surface of the manifold inlet portion of the first component and the outer surface of the manifold inlet portion of the second component. The retention and release mechanisms are similar to those shown and described in connection with Figures 2-8E.

[0506] Many of the above-described embodiments have been described as having a single protruding portion shaped to engage a complementary groove, recess, slot, or opening. Alternatively, the manifold assembly can have two or more protruding portions.

[0507] In addition to retention mechanisms, components of the patient interface can be modified to increase movement of some of the components while reducing movement of others. Various modifications will now be described with reference to Figures 22a-23b.

[0508] FIGS. 22a and 22b illustrate an alternating arrangement of relatively hard or rigid sections 150, 150′ and relatively soft or flexible sections 152, 152′. In FIG. 22b, the cross-section of the relatively hard or rigid section 150 is larger than in FIG. 22a, thereby increasing the torsional stiffness of the frame to resist undesired movement between the manifold and the frame. Referring to FIGS. 22a and 22b, the manifold can include one or more gussets or ribs. Frame portions with various ribs and / or gussets provide additional torsional resistance to the frame portions, preventing, or at least substantially inhibiting, undesired movement of the manifold relative to the frame portions. Preventing relative movement prevents, or at least substantially inhibits, gas leakage from the joint between the manifold 114 and the frame inlet 110, 112. FIG. 22 illustrates a relatively hard or rigid section 150 and a relatively soft or flexible section 152 implemented as part of a patient interface, such as a nasal cannula.

[0509] 23A and 23B, the frame can have one or more notches 2200 or sections removed from the frame to facilitate hinged or pivoting of the frame or portions of the frame rather than providing movement between the frame and the manifold. The notches can be triangular, rectangular, or semicircular notches.

[0510] Referring to Figures 24a-24e, a further retention mechanism is shown. In this embodiment, the manifold 2301 and manifold inlet 2303 are formed together from first and second components along with a fastening component. In the preferred embodiment shown in Figures 24a-24e, the fastening component comprises a collar 2305. The collar 2305 is a substantially annular component having a tapered inner surface for engaging the outer surface of the manifold inlet portion of the first component and the outer surface of the manifold inlet portion of the second component.

[0511] The retention mechanism 2300 includes molded hooks 2307 on the frame that substantially prevent lateral movement of the manifold 114 relative to the frame portion 112 when the manifold 114 substantially covers the frame inlets 110, 112. The hooks 2307 substantially prevent lateral movement when engaged with complementary hooks 2309 on the collar 2305. The hooks 2307 have a first generally vertically extending portion 2307a followed by a generally horizontally extending portion 2307b. The hooks 2307 shown in Figures 24a-24e face away from the manifold 114, i.e., the generally horizontally extending portion 2307b extends away from the manifold 114 from the generally vertically extending portion 2307a. However, it will be appreciated that the hooks can extend towards the manifold, ie, the generally horizontally extending portion 2307b extends towards the manifold 114 from the generally vertically extending portion 2307a.

[0512] The collar has a molded hook 2309 with a first generally vertically extending portion 2309a followed by a generally horizontally extending portion 2309b. One of the collar hook and the frame hook engages with the other of the collar hook and the frame. In particular, the horizontal portion of each hook is received in the space (2307c and 2309c) of the complementary hook, such that the surfaces of each horizontal portion abut one another. The hook 2309 shown in FIGS. 24a-24e faces toward the manifold 114; i.e., the generally horizontally extending portion 2309b extends from the generally vertically extending portion 2309a toward the manifold 114 when assembled. However, the hook can extend away from the manifold; i.e., the generally horizontally extending portion 2309b extends from the generally vertically extending portion 2309a away from the manifold 114. It will further be appreciated that the direction in which the hooks 2309 of the collar face is determined by the direction in which the hooks 2307 of the frame face.

[0513] 26a-26d, a further retention feature is shown. This feature is similar to the retention feature shown in FIGS. 24a-24e, and like numerals are used to indicate like parts with the addition of 200. One difference is that molded hook 2507 on frame portion 112 faces toward the manifold, with generally horizontally extending portion 2507b extending from generally vertically extending portion 2507a toward manifold 114. However, it will be understood that the hook can extend away from the manifold, i.e., generally horizontally extending portion 2507b extending away from manifold 114 from generally vertically extending portion 2507a.

[0514] The manifold has a molded hook 2509 with a first generally vertically extending portion 2509a followed by a generally horizontally extending portion 2509b. One of the manifold hook and the frame hook engages with the other of the manifold hook and the frame hook. The frame portion 112 includes two hooks 2507, one on each side of the frame. The hooks are identical to each other but face toward each other; i.e., the hooks are mirror images. The manifold 114 also has two hooks that are identical to each other and face away from each other, allowing the manifold to pivot relative to the frame. In particular, the horizontal portion of each hook is received within the space of a complementary hook, so that the surfaces of each horizontal portion abut each other. The hooks 2509 shown in Figures 26a-26d face away from the center of the manifold 114; i.e., the generally horizontally extending portion 2509b extends from the generally vertically extending portion 2509a toward the manifold 114 when assembled. However, it will be appreciated that the hooks can extend toward the center of the manifold, i.e., the generally horizontally extending portion 2509b extends from the generally vertically extending portion 2509a toward the manifold 114. It will further be appreciated that the direction in which the hooks 2509 of the manifold face is determined by the direction in which the hooks 2507 of the frame face.

[0515] Any one or more of the above-described embodiments can have one or more legs, flanges, tabs, ridges, or hooks on the manifold 114 that securely engage with complementary legs, flanges, tabs, ridges, hooks, recesses, grooves, openings, or slots on the frame. Additionally or alternatively, the features can be on the frame and securely engage with complementary features on the manifold. The secure engagement of the features prevents, or at least substantially prevents, gas leakage from the junction between the manifold 114 and the frame inlets 110, 112.

[0516] 25A-25E, a further embodiment of a patient interface is shown. In this embodiment, the frame has a relatively rigid section 2401 and a relatively flexible section 2403. The relatively flexible section of the frame may be overmolded onto the relatively rigid section. Alternatively, the relatively flexible section may be a separately formed component that is assembled with the relatively rigid section. The relatively flexible section has a shape and configuration that follows the shape and configuration of the relatively rigid section of the frame. The relatively flexible section has a pair of openings 2404 that correspond to the frame inlets 110, 112.

[0517] The relatively flexible section has raised sections 2405 that form a deformable lip seal around the periphery of each of the openings 2404. The lip seal forms a seal between the manifold 114 and the frame portion 112 when the manifold substantially covers the frame inlets 110, 112. The seal prevents, or at least substantially prevents, gas leakage from the junction between the manifold 114 and the frame inlets 110, 112.

[0518] The features and functions of the embodiment shown in Figures 24a-24e can be combined with the features and functions of the embodiment shown in Figures 25a-25e to provide a patient interface having a seal at the inlet with a secure retention mechanism. Additionally, the features and functions of the embodiment shown in Figures 26a-26d can be combined with the features and functions of the embodiment shown in Figures 25a-25e.

[0519] The patient interface may be formed from any suitable material that allows for the characteristics described herein, including, for example, medical grade materials and / or suitable polymeric materials.

[0520] Any one or more features from any embodiment can be combined with any one or more features from any one or more other embodiments.

[0521] For example, embodiments in which some regions or components are strengthened to reduce migration can be combined with embodiments in which other regions or components are weakened to increase migration. Nevertheless, the above-described embodiments can be provided as integrated parts or portions, or as parts or portions that can be assembled to form part of a patient interface, particularly but not limited to, a nasal cannula.

[0522] Referring to Figure 28a, there is shown a patient interface 11 for use in a medical breathing circuit. The patient interface 11 includes a frame section 13 adapted to be positioned on the face of a user and a manifold assembly 15 operably securable to the frame section. The frame section 13 includes a gas chamber, not visible in Figure 28a, adapted to direct gas to the user and a pair of nasal delivery elements 17 extending from the gas chamber, adapted to be positioned within the user's nares.

[0523] Referring to the embodiment shown in FIGS. 29-38, a manifold assembly 11100 (or, for example, 11900 as shown in FIG. 46 or 13400 as shown in FIG. 61) includes a manifold 11101 and a manifold inlet 11103. The manifold inlet has a tapered lumen 11105, in which the end 11107 proximal to the manifold 11101 has a larger area than the end 11109 of the lumen distal to the manifold. Referring to FIG. 38, the lumen tapers gradually from the proximal end 11109 of the manifold 11101 to the distal lumen end 11109 of the manifold. In alternative embodiments, the taper may be non-gradual, i.e., one may have sections with a taper that differs from the taper of adjacent sections. In that alternative embodiment, the non-gradual taper is preferably relatively smooth, with a transition between taper angles. The transition of the lumen into the manifold cavity is relatively smooth to facilitate smooth gas flow from the conduit through the inlet lumen into the manifold cavity. In the illustrated embodiment, this reduces noise in the gas flow from the manifold inlet to the manifold. Referring to Figure 38, the smooth transition reduces resistance to gas flow, reducing pressure and / or flow velocity drop.

[0524] The manifold assembly 11100 comprises a first component 11111 (or, for example, 12211 as shown in Figures 49 and 50, or 13011 as shown in Figure 57) and a second component 11113 (or, for example, 12213 as shown in Figures 49 and 50) that is engageable with the first component. The manifold assembly is formed from a series of modular components that allow relatively simple fixture designs to be used to provide a smooth transition between the manifold inlet and the manifold. In particular, the use of a modular design allows a combination of relatively simple components to be assembled together to form more complex shapes. The components are mateable such that the first component 11111 forms at least a portion of the manifold 11101 (or 12201, e.g., as shown in FIGS. 49 and 50, or 13011, as shown in FIG. 57), at least a portion of the manifold inlet 11103 (or 12203, e.g., as shown in FIGS. 49 and 50), or at least a portion of the manifold 11101 and at least a portion of the manifold inlet 11103. Further, the components are mateable such that the second component forms at least a portion of the manifold 11101, at least a portion of the manifold inlet 11103, or at least a portion of the manifold 11101 and at least a portion of the manifold inlet 11103. That is, there are multiple different embodiments of the first component 11101 and the second component 11113, such that each component forms part or all of the manifold 11101 or the manifold inlet 11103. The manifold assembly 11100 may further comprise additional components that form the manifold 11101 or the manifold inlet 11103, fasten the first and second components together, and / or provide a seal between the first and second components, each of which variations is described in more detail below with reference to the accompanying drawings.

[0525] 29-38, a first component 11111 has a first manifold inlet portion 11115, and a second component 11113 is or has a second manifold inlet portion. In the embodiment shown in FIG. 29, the second component 11113 is the second manifold inlet portion. The manifold inlet portion 11115 of the first component 11111 and the manifold inlet portion of the second component 11113 are engageable to form a manifold inlet 11103.

[0526] The first component 11111 includes at least one locating feature and the second component includes at least one complementary locating feature. In the embodiment shown in Figure 29, the locating feature on the second component includes a protrusion 11117 and the at least one locating feature on the first component includes a complementary recess 11119. Additionally, the first and second components include complementary abutment surfaces 11121 extending around a portion of the periphery of each of the components.

[0527] The first component 11111 has a manifold portion 11122 that forms the manifold 11101. In the illustrated embodiment, the manifold portion 11122 forms the entire manifold 11101.

[0528] The first component has an internally threaded portion 11123 that corresponds to the externally threaded portion of the conduit or tubing (not shown). The first component also has a smooth, unthreaded portion 11125. The second component 11113 has an internally threaded portion 11126 that corresponds to the externally threaded portion of the conduit. The second component also has a smooth, unthreaded portion 11129.

[0529] The manifold assembly 11100 further includes a third component that acts as a fastening component. In the embodiment shown in FIG. 29, the fastening component includes a collar 11127. The collar 11127 is a substantially annular component having a tapered inner surface for engaging the outer surfaces of the manifold inlet portions of the first and second components. The inner surface is tapered so that the collar can be assembled more easily in one direction than the other. Furthermore, during assembly, when the collar is placed over the manifold inlet portions of the first and second components, the tapered surface has a wedging action such that the force exerted by the collar against the manifold inlet portions increases as the collar moves toward its assembled position.

[0530] During assembly, engagement of the collar 11127 with the manifold inlet portion of the first or second component can provide sensory feedback to the operator. For example, a protrusion on the collar 11127 can engage with a recess, opening, or abutment surface on the first or second component, preferably via a snap-fit. The collar 11127 can have two or more protrusions that engage with two or more recesses, openings, or abutment surfaces. In alternative embodiments, the first and / or second component can have the protrusion and the collar can have the recess, opening, or abutment surface.

[0531] The sensory feedback may be audible, tactile, visual, or a combination of two or more types of feedback. The manifold assembly is configured to emit an easily audible sound when the collar engages, preferably by a snap fit, with the manifold inlet portion of the first and / or second component. In the illustrated embodiment, the collar is configured to provide a easily tactile movement or emit a easily tactile vibration when the collar engages, preferably by a snap fit, with the first and / or second component.

[0532] 39-46 show several alternative embodiments of the manifold assembly. In these embodiments, the first component has a manifold inlet portion and a manifold portion, and the second component is the manifold inlet portion. Except as otherwise noted below, the features and functions of the manifold assembly should be considered the same as those described for the first embodiment above, and like reference numerals indicate like parts, increased by 100 or 200 relative to the above-described embodiment.

[0533] The embodiment of Figure 39 has a first component 11211 with a manifold portion 11222 and a manifold inlet portion 11215 that form a manifold 11201. The second component is a manifold inlet portion 11231. The manifold inlet 11203 (or, for example, 11303 as shown in Figure 40, or 11403 as shown in Figure 41, or 11503 as shown in Figure 42) is formed by the second component and the manifold inlet portion 11215 of the first component 11211. The manifold inlet portion 11213 has an integrally formed flange 11232. The flange 11232 mates with the manifold portion 11222 of the first component 11211 to form the manifold. This embodiment includes surface relief features in the form of channels 11234 that may be mateable with corrugations on an associated conduit or tube (not shown). The surface relief features position and / or seal or bond the components and conduits together. The surface relief features provided a sealed air passage and connection between the conduit and the manifold 11201. Other suitable features include pins and / or bosses with complementary recesses.

[0534] The embodiment of Figure 40 has a first component 11311 with a manifold portion 11322 and a manifold inlet portion 11315 that form the manifold 11301, i.e., the first portion forms part of the manifold and the manifold inlet. The second component 11313 is the manifold inlet portion without the manifold portion. The manifold inlet portion 11313 has a surface (not visible) that engages with a surface 11335 of the manifold portion 11322.

[0535] The embodiment of Figure 41 has a first component 11411 with a manifold portion 11422 and a manifold inlet portion 11415 that form the manifold 11401. A second component 11413 is a relatively soft material, preferably TPE, that forms the manifold inlet and manifold inlet portion 11415 of the first component 11411. The second component 11413 covers the conduit or tube 11437 and is joined to the first component.

[0536] The embodiment of Figure 42 has a first component 11511 with a manifold portion 11522 and a manifold inlet portion 11515 that form a manifold 11501; i.e., the first portion forms the manifold and a portion of the manifold inlet. The second component is a manifold inlet portion 11513. The manifold inlet portion 11513 has an integrally formed flange 11532 (or 11632, for example, as shown in Figure 43). The flange 11532 mates with the manifold portion 11522 of the first component 11511 to form the manifold 11501.

[0537] The embodiment of FIG. 43 is a modification of the embodiment of FIG. 42, in which a conduit or tube 11637 is incorporated into the manifold inlet portion 11613 .

[0538] The embodiment of Figure 44 has a first component 11711 with a manifold portion 11722 and a manifold inlet portion 11715 that form a manifold 11701. The second component is a manifold inlet portion 11713. The manifold inlet portion 11713 has an integrally formed protrusion 11732 that engages a surface 11735 of the manifold portion 11722.

[0539] The embodiment of Figure 45 has a first component 11811 with a manifold portion 11822 and a manifold inlet portion 11815 that form a manifold. The second component is a manifold inlet portion 11813, with the first component forming a portion of the manifold inlet and the second component being a portion of the manifold inlet. The manifold inlet portion 11813 has an integrally formed flange 11832 that engages with the manifold portion 11822 of the first component 11811 to form the manifold. This embodiment includes a protrusion 11817 on one of the first and second components and a complementary hook 11818 on the other of the first and second components. This embodiment also includes pins and / or bosses along with complementary recesses.

[0540] The embodiment of Figure 46 includes a first component 11911 including a manifold portion 11922 and a manifold inlet portion 11915 that form a manifold 11901. The second component is a manifold inlet portion 11913 (including portions 11913a and 11913b). The manifold inlet portion 11913 has an integrally formed flange 11932 that engages with the manifold portion 11922 of the first component 11911 to form the manifold 11901. This embodiment also includes a pin and / or boss 11917 with a complementary recess 11918. The manifold assembly further includes a fourth component that acts as a fastening component. In the embodiment shown in Figure 46, the fastening component includes a collar 11927 that engages with the outer surfaces of the manifold inlet portions 11913a, 11913b.

[0541] With reference to the embodiment shown in Figures 47-50, the first component is a manifold portion and the second component comprises a manifold portion. The manifold portion of the first component and the manifold portion of the second component are mateable to form at least a portion of the manifold. In the embodiment shown in Figures 48-51, the manifold portion of the first component and the manifold portion of the second component are mateable to form the entire manifold.

[0542] 47, the first component has a manifold inlet portion that forms at least a portion of the manifold inlet 12003. In particular, the first component has a manifold inlet portion that forms the entire manifold inlet 12003, i.e., the first component forms the manifold inlet 12003 and a portion of the manifold, and the second component forms the remainder of the manifold 12001. The manifold assembly has flexible resilient legs 12017 that are received by the openings 12018.

[0543] The embodiment of Figure 48 is similar to the embodiment of Figure 47 with the addition of complementary hooks 12117 and protrusions 12118 that can be engaged to assemble the manifold.

[0544] The embodiment of Figures 49 and 50 is one in which the manifold is split through a vertically extending plane that intersects the axis of the axle 12241 when viewed from the position of Figure 49. This embodiment includes pins and / or bosses 12217 with complementary recesses 12219 that engage the first component to the second component.

[0545] In an alternative embodiment, the manifold assembly further comprises a third component engageable with the first component and / or the second component to form at least a portion of the manifold. In a further alternative embodiment, the patient interface further comprises a third component engageable with the first component and / or the second component to form the entire manifold.

[0546] 51-57, the first component forms at least a major portion of the manifold, and the second component forms at least a major portion of the manifold. In the embodiment shown in Figures 51-57, the first component forms the entire manifold, and the second component forms the entire manifold inlet.

[0547] The embodiments of Figures 51-53 have manifold inlets 12403, 12503, 12603 (or, for example, 12703 as shown in Figure 54, or 12803 as shown in Figure 55) that are snap-fit ​​to the manifolds 12401, 12501, 12601. The embodiment of Figure 51 has manifold inlets integrally formed with the conduits or tubes.

[0548] The embodiments of Figures 54 and 55 show alternative methods of attaching conduits or tubes to the manifold inlets. The embodiment of Figure 54 has a smooth bore conduit 12737, and the manifold inlet has a smooth inner surface 12739 that engages with the bore 12743 of the conduit. Alternatively, the inner surface of the manifold inlet can have surface features that engage with valleys or crests of the conduit, for example if the conduit is corrugated or threaded.

[0549] The embodiment of Figure 55 is similar to the embodiment shown in Figure 54, except that the first component of the manifold inlet is formed from a relatively rigid material and the second component of the manifold inlet is formed from a relatively flexible or resilient material that snaps onto the manifold inlet and / or conduit 12837 (or 13337 as shown, for example, in Figure 60A).

[0550] The embodiment of Figure 56 has a first component 12911 with a manifold portion 12922 and a manifold inlet portion 12915 that form the manifold 12901. A second component 12913 is a relatively soft material, preferably TPE, that forms the manifold inlet portion 12915 and the manifold inlet 12903 of the first component 12911. The second component 12913 covers a conduit or tube 12937 and joins it to the first component 12911. This embodiment also includes O-rings 12941 that seal the second component 12913 to each of the conduit 12937 and the manifold inlet portion 12915.

[0551] The embodiment of Figure 57 is similar to the embodiment of Figure 51 except that the manifold inlet is a separate and distinct component to the conduit or tube. The manifold inlet is a snap fit with the manifold, with ribs 13017 engaging channels 13019 in the manifold.

[0552] 58 and 59, a first component 13111 (or 13311 as shown, for example, in FIG. 60A) has a manifold portion 13122 and a manifold inlet portion 13115, and a second component 13113 has a manifold portion 13131 and a manifold inlet portion 13133. The manifold portion 13131 of the first component 13111 and the manifold portion 13133 of the second component 13113 are engageable to form at least a portion of the manifold 13101. The manifold inlet portion 13115 of the first component 13111 and the manifold inlet portion 13133 of the second component 13113 are engageable to form at least a portion of the manifold inlet 13103.

[0553] The embodiment of Figures 58 and 59 has a manifold inlet 13103 and a manifold 13101. In this embodiment, a first component 13111 and a second component 13113 form one half of the manifold and one half of the manifold inlet. The first component 13111 and the second component 13113 are substantially similar components. The first component 13111 can be a mirror image of the second component 13113. In this embodiment, the manifold assembly 13100 is divided horizontally along a plane that coincides with the longitudinal axis of the manifold assembly. The plane can be located higher or lower than the plane when viewed from the position of Figure 58. In alternative embodiments, the manifold assembly can further include an additional component that secures the first and second components together at the axle. The additional component can include a flexible or elastic material.

[0554] 60-75, the patient interface includes first and second components that form at least a portion of the manifold inlet, and a third component that forms at least a portion of the manifold. In the illustrated embodiment, the third component forms the entire manifold.

[0555] The embodiment of Figures 60 and 60a has a two-piece manifold inlet 13303, where two pieces fit together and are engageable with other components (not shown) to form a manifold assembly. A first component (not shown) forms at least a portion of the manifold or the entire manifold. A second component 13303a and a third component 13303b engage to form the manifold inlet 13303. In this embodiment, the first and second components of the manifold inlet fit over a flange 13328 of the manifold. The manifold assembly further includes a fourth component that acts as a fastening component. In the embodiment shown in Figure 60, the fastening component includes a collar 13327 that is or includes a shrink-wrap material.

[0556] The embodiment of Figure 61 has a first component 13411 with a manifold portion 13422 that forms the entire manifold 13401. The second component is manifold inlet portion 13413a, and the third component is manifold inlet portion 13413b. The manifold assembly further includes a fourth component that acts as a fastening component. In the embodiment shown in Figure 45, the fastening component includes a collar 13427 having internal threads that mate with complementary external threads on the manifold inlet portions 13413a, 13413b.

[0557] The embodiment of Figures 62 and 63 has a two-piece manifold inlet 13503, where two pieces fit together and are engageable with other components (not shown) to form a manifold assembly. A first component 13511 forms at least a portion of the manifold 13501 or the entire manifold 13501. A second component 13503a (or, for example, 13703a as shown in Figure 64 or 13803a as shown in Figure 65) and a third component 13503b (or, for example, 13703b as shown in Figure 64 or 13803b as shown in Figure 65) engage to form the manifold inlet 13503. In this embodiment, the first and second components of the manifold inlet fit over a flange 13528 of the manifold. The manifold assembly further includes a fourth component that acts as a fastening component. In the embodiment shown in Figure 62, the fastening component includes a thread collar 13527 that engages with threads on the component that forms the manifold inlet.

[0558] The embodiment of Figure 66 is similar to the embodiment of Figure 60. One difference is that the manifold assembly includes two or more rings 13927 that act as fastening components.

[0559] Figures 64 and 65 show cross sections of an embodiment having a two-piece inlet.

[0560] The embodiment of Figures 67 and 68 has a manifold inlet formed by a first component 14003a, 14103a and a second component 14003b, 14103b.

[0561] The embodiment of Figure 69 has a manifold inlet formed by a first component 14203a and a second component 14203b, along with a third component 14227 and a fourth component 14228 connecting the first and second components.

[0562] The embodiment of Figure 70 has a two-piece manifold inlet 14303, where two pieces fit together and are engageable with other components (not shown) to form a manifold assembly. The manifold inlet 14303 has a first component 14303a (or 14403a, for example, as shown in Figure 71) and a second component 14303b (or 14403b, for example, as shown in Figure 71) that engage to form the manifold inlet 14303. The manifold assembly further comprises a third component that acts as a fastening component. In the embodiment shown in Figure 70, the fastening component includes a patch 14327.

[0563] The embodiment of FIG. 71 is similar to the embodiment of FIG. 70, except that this embodiment has two patches, each of which is relatively small 14427.

[0564] The embodiment of Figures 72 and 73 is similar to the embodiment of Figure 60. In this embodiment, tubing 14527 holds the components of the manifold inlet together. The manifold inlet 14503 is a snap fit with the manifold 14501.

[0565] The embodiment of Figure 75 has a two-piece manifold inlet 14803, where two parts fit together to form a manifold assembly and are engageable with other components (not shown). The manifold inlet 14803 has a second component 14303a and a third component in the form of a collar 14827 that mate to form the manifold inlet 14803. The collar 14827 may be longer than shown in Figure 75. The manifold inlet 14803 has a curved lip 14845 that can be received by an annular recess in the manifold (not shown). The manifold assembly also has a relatively soft material, preferably TPE, covering the manifold inlet 14803.

[0566] Referring to the embodiments shown in Figures 76a-81, several alternative ways of connecting the manifolds and manifold inlets together are shown.

[0567] The embodiment of Figures 76a-76c includes a connector 14947 or 14947' extending between the first component 14911 and the second component. The connector is formed of two halves with an integrally formed living hinge 14948 / 14948' between the halves. The two halves are joined by complementary ribs 14917 / 14917' and channels 14918 / 14918'. When the connector of Figures 76a-76c is assembled with the manifold 14901 and manifold inlet, the manifold is spaced from the manifold inlet.

[0568] The embodiment of Figure 77 has a snap fit between the manifold inlet 15003 and the manifold 15001. The embodiment of Figure 78 is assembled by pushing the manifold inlet 15103 through the opening in the manifold 15101 from the inside of the manifold.

[0569] The embodiment of Figure 79 has a manifold inlet 15203 with a relatively thin wall. The manifold inlet 15203 has a flange that engages with the side wall of the manifold 15201 to form a seal. The manifold assembly further includes a collar 15227 that engages with a protrusion 15249 on the manifold inlet 15203. That engagement secures the manifold inlet to the manifold and prevents it from sliding relative to the manifold.

[0570] The embodiment of Figure 80 shows an assembly in which the manifold inlet 15303 is pushed through an opening in the manifold 15301. The manifold inlet 15303 has an annular recess adapted to receive the manifold flange 15317. When assembled, a seal is formed between the manifold 15301 and the manifold inlet 15303.

[0571] The embodiment of Figure 81 is a snap fit between the manifold 15401 and the manifold inlet 15403. The manifold inlet 15403 can have an annular groove or annular rib 15451 that engages with a complementary feature on the manifold. In the embodiment shown, the surface of the rib 15451 engages the sidewall of the manifold 15401.

[0572] Any of the above-described embodiments can have a first component, where a portion of the component is a relatively rigid material and another portion of the first component is a relatively soft and / or flexible material. The first component can include a relatively rigid component. Alternatively, the first component can include a relatively soft and / or flexible component. A portion of the second component can include a relatively rigid material and another portion of the second component can include a relatively soft and / or flexible component. The second component can be a relatively rigid component. Alternatively, the second component can be a relatively soft and / or flexible component. The manifold assembly can include one or more seals and / or gaskets for at least substantially sealing connections between the components of the manifold assembly. The seals can be integrally formed with the first component and / or the second component. Alternatively, the seals are separate components from the first component and the second component.

[0573] The first and second components can be integrally formed by a living hinge. Alternatively, the first and second components can be separate components. If the manifold assembly includes a third, fourth, or additional component, two or more or all of the components can be integrally formed. One example is by a living hinge configuration. Alternatively, all of the components can be separate, distinct components.

[0574] When assembled, the first component engages the second component by one or more of ultrasonic welding, RF welding, stitching, an adhesive, a hook-and-loop fastener, a zip fastener, a clip, a snap fit, and a press fit. When a third or additional component engages the first and / or second component, the third or additional component engages the complementary component by one or more of ultrasonic welding, RF welding, stitching, an adhesive, a hook-and-loop fastener, a zip fastener, a clip, a snap fit, and a press fit. Additionally or alternatively, the complementary surfaces of two or more of the components are shaped to have a tight, snug fit to form a seal between the components.

[0575] Preferably, the conduit or tube is a medical respiratory tube, including a corrugated tube or a tube with a spirally concave surface region, such as a medical respiratory tube as defined by International Standard ISO 5367:2000(E) (4th Edition, June 1, 2000). Preferably, the conduit or tube is an inhalation tube.

[0576] Any one or more features from any embodiment can be combined with any one or more features from any one or more other embodiments. For example, a patient interface, such as but not limited to a nasal cannula, alone or in combination, can comprise or include, as an integral component or part or portion, any one or more of the features of the embodiments as described herein.

[0577] For further embodiments, patient interfaces are described below with reference to in-hospital respiratory care systems for use by adults and / or in children, with the understanding that the patient interface and / or headgear embodiments described may alternatively be used to deliver CPAP therapy or other therapies as described herein.

[0578] It will be understood that various aspects of the present invention may be applied to any form of patient interface, including but not limited to partial nasal masks (which cover the nose), direct nasal masks that include nozzles or pillows that enter or engage the wearer's nares, oral masks (which cover the mouth), or full face masks (which cover the nose and mouth), although the mouthpiece will be described in terms of a nasal cannula. Similarly, various aspects of the present invention may be applied to any form of headgear, although these will be described in terms of a head strap.

[0579] Referring to FIG. 1A, a ventilation and humidification system (respiratory system 8810) such as may be used in the present invention is shown. In such a system 8810, a patient 8820 is provided with a humidified gas flow through a patient interface 88100. The patient interface 88100 is held in an operative position on the patient's face using associated headgear 88200. The interface 88200 is connected to a humidified gas carrying passage or inspiratory conduit 8830. The inspiratory conduit 8830 is connected (directly or indirectly) at one end to the patient interface 88100 and at the other end to the outlet of a humidifier 8840. In a preferred embodiment, the inspiratory conduit is connected to the patient interface via an extension tube / conduit 88300. The humidifier 8840 receives and humidifies gas provided by a gas source 8850, which preferably includes a blower 8851. The humidifier 8840 may comprise a humidification chamber 8841 filled with water 8842 and heating means 8843 for heating the water to humidify the gas path through the humidifier. A controller 8852 may be provided to control and potentially modify one or more properties of the supplied gas, including but not limited to the pressure profile of the gas, the flow profile of the gas at the patient interface, the temperature of the gas, and / or the humidity of the gas. It will be understood that the control functions depend on the purpose and use of the respiratory system 8810. For example, in a preferred application for in-hospital respiratory care, the flow rate of the supplied gas is monitored and controlled according to the patient's needs, but the pressure of the respiratory gas is not necessarily monitored and controlled. In alternative embodiments, such as the use of the invention in CPAP, the pressure profile of the supplied gas may be monitored and controlled.

[0580] 151-154, a preferred form of patient interface 88100 is shown. The patient interface 88100 is configured to deliver respiratory gases from a gas supply and humidification source (not shown) to a patient, and headgear 88200 is configured to support and hold the patient interface against the patient's face in use. The patient interface 88100 of a preferred embodiment is in the form of a nasal cannula 88100 that is adapted to couple to an inspiratory conduit 88300 and includes at least one, but preferably two, nasal prongs 88111 and 88112 that are adapted to fit within the patient's nares to deliver a flow of gas to the patient. The headgear 88200 is in the form of a head strap 88200 that is adapted to extend along the patient's cheeks, above the ears, and around the back of the head in use, and may be adjustable in length to customize the size of the strap for the patient. The gas delivery tube, shown as item 88300, is preferably a breathable tube.

[0581] The nasal cannula 88100 provides a patient interface suitable for delivering high airflow, high humidity gas flow to the patient's nasal passages / nares. In some forms, the cannula is adapted to deliver high flow rates of gas over a wide flow rate range (e.g., preferably about 8 L / min or about 30 L / min, or possibly higher, such as 10 L / min to 50 L / min or up to 60 L / min or up to about 80 L / min, depending on other preferred therapeutic applications). In some forms, the cannula is adapted to deliver gas at relatively low pressures.

[0582] The nasal cannula 88100 comprises a face mount portion 88105 including at least one, but preferably a pair of tubular nasal prongs 88111 and 88112 integrally molded or removably attached to the body 106 having the face mount portion 88105, and a gas flow manifold portion 88110 removably attached or integrally formed with the conduit 88300. The gas flow manifold portion 88110 is connectable, such as by being insertable into the body 106 of the face mount portion 88105 from either of two opposing horizontal directions, i.e., from either the left or right side. In this manner, the position or orientation of the gas flow manifold portion 88110 is reversible relative to the body 88106 and the face mount portion 88105. In other words, the user can choose to have the manifold portion 88110 (and essentially the conduit 88300 extending therefrom) extend from either the left or right side of the cannula 88100, depending on what is most convenient, for example, depending on which side of the user a gas source or ventilator is located. In an alternative embodiment, the gas flow manifold 88110 is attached to the body 88106 and face mount 88105 by a swivel mount, whereby the gas flow manifold portion 88110 is a permanent or semi-permanent part of the nasal cannula 88100, but can pivot about an axle portion and thereby rotate relative to the body 88106 and face mount 88105 to move the conduit 88300 from the left side to the right side or vice versa, i.e., change the side of the manifold inlet 88120.

[0583] The face mounting portion 88105 of the body 88106 can be formed from a soft, flexible material, such as silicone or other cannula materials known in the art. The nasal prongs 88111 and 88112 are preferably flexible and can be formed from a layer of silicone thin enough to achieve this characteristic. The gas flow manifold portion 88110 can be formed from polycarbonate, high-density polyethylene (HDPE), or any other suitable plastic material known in the art. The face mounting portion 88105 provides a soft interface component to the patient for comfortable delivery of gas flow through the nasal prongs 88111 and 88112, while the gas flow manifold portion 88110 fluidly couples the conduit 88300 to the nasal prongs 88111 and 88112 via the body 88106.

[0584] The nasal prongs 88111 and 88112 can be curved to extend into the patient's nostrils during use and provide a smooth flow path for gas. The inner surfaces of the prongs 88111 and 88112 can be smooth to reduce noise. The bases of the prongs 88111 and 88112 can include curved surfaces to provide a smoother gas flow, thereby reducing noise levels during operation. The nasal prongs 88111 and 88112 are substantially hollow and tubular in shape. The nasal prongs 88111 and 88112 may have a consistent or variable diameter or end area along their length, but are preferably shaped to fit the contours of the nostrils. Each prong 88111 / 88112 has an elongated opening at its tip. In an alternative embodiment, the nasal prongs 88111 and 88112 can have a tapered profile, with a relatively wider end at the base portion 88118 and a relatively narrower end at the openings 88111a and 88112a. The openings 88111a and 88112a can be drilled to direct gas flow to the patient's nares. The face mount 88105, the body 88106, and particularly the nasal prongs 88111 and 88112 are preferably designed not to seal around the patient's nares to avoid excessive and potentially harmful buildup of pressure during high-flow treatments. Accordingly, the nasal prongs 88111 and 88112 are sized to maintain a sufficient gap between the outer surfaces of the prongs 88111 and 88112 and the patient's skin to avoid sealing the gas path between the cannula 88100 and the patient.

[0585] The face mount portion 88105 of the body 88106 is shaped to generally follow the contours of the patient's face around the upper lip area. The face mount portion 88105 is shaped or pre-shaped to be able to conform to the contours of the user's face in the area of ​​the face where the cannula will be located, and / or is flexible to fit, accommodate, and / or correspond to the contours of the user's face.

[0586] The face mount 88105 comprises an elongated base portion of a body 88106 from which extend nasal prongs 88111 and 88112 and two side arms 88113 and 88114 extending laterally from either side. The side arms 88113 and 88114 are integrally formed with the base portion, but may alternatively be separate pieces.

[0587] A pair of elongated side arms 88113 and 88114 extend laterally from either side of the generally centrally located main body portion 88106 or face mounting portion 88105 for contacting the user's face in use to help stabilize the main body on the user's face, the side arms having any one or more of the following features:

[0588] Referring particularly to FIG. 151 , the side arms 88113 and 88114 also include upward bends along their lengths. In particular, the outer second portion 88113a / 88114a of each of the side arms extends upward at an angle relative to the inner first portion 88114b. In at least some embodiments, the first and second portions 88114b / 88114a of the side arms are joined by an intermediate curved portion 88114c. Thus, the side arms can be shaped to engage the wearer's face below the cheekbones.

[0589] 153 and 154, the side arms include an inner first portion 88114d extending laterally and rearwardly from a generally centrally located body portion 88106 or face mount portion 88105 at a first angle relative to the body 88106, and an outer second portion 88114e extending rearwardly from the first portion 88114d and at a relatively shallow angle relative to the body portion 88106. The inner first portion 88114d of each side arm can extend at an angle relative to the body portion 88106, for example, between 30 degrees and about 50 degrees or about 70 degrees, and the outer second portion 88114e can extend at an angle relative to the body portion 88106, for example, between about 150 degrees and about 170 degrees or about 180 degrees.

[0590] 152-154, the side arms also include a partial twist, whereby a cross-sectional shape taken orthogonally through the side arms is partially twisted, either counterclockwise or clockwise, in portions of the wing or side arm portions closer to the outer ends of the side arms than those closer to the body 88106, depending on whether the side arms are viewed as a top or bottom view of the patient interface, and whether the left or right arm is being considered. The cross-sectional shape taken...

Claims

1. a body adapted to receive and at least partially surround at least one tube and / or at least one cable, optionally in a medical breathing circuit or the like; a fitting for removably engaging a mounting portion of a patient interface, the fitting comprising at least one arm or at least one protrusion configured to engage the mounting portion of the patient interface; A component comprising:

2. 2. The component of claim 1, wherein the body is movable along the length of the at least one tube and / or the at least one cable, fixed relative to the at least one tube and / or the at least one cable, and / or rotatable about a circumference of the at least one tube and / or the at least one cable.

3. 3. The component of claim 1 or 2, wherein the body comprises an annular, substantially annular, square, substantially square or straight section configured to at least partially surround or surround an outer periphery of the at least one tube and / or the at least one cable.

4. 4. The component of any one of claims 1 to 3, wherein the body is pivotally, rotatably or removably connected to the fitting, or any combination of any two or more thereof.

5. 5. A component according to any one of claims 1 to 4, wherein the fitting comprises two arms, one or both of which are shaped to engage, optionally by a snap fit, with a corresponding protrusion on the fitting part.

6. The component of claim 5 , wherein the one or more arms include angled or protruding portions shaped to engage, optionally with a snap fit, with a corresponding protrusion on the mounting portion.

7. 6. The component of claim 5, wherein the mounting includes two arms, each extending from the same or substantially adjacent locations on the body, each arm extending from the body in a direction toward the other arm, and each arm including a protrusion or lug extending substantially outwardly or away from the other arm.

8. A component according to any preceding claim, wherein the mounting portion comprises one or more slots or recesses or openings as female components of the mounting portion to accept engagement by the fitting.

9. The component of any one of claims 1 to 8, wherein the attachment portion is integral with a patient interface.

10. 10. The component of any one of claims 1 to 9, wherein the fitting is configured to provide a tangible movement or emit a tangible vibration when engaged, optionally by a snap fit, with the mounting portion.

11. 11. A patient interface for use in a medical breathing circuit, comprising: an attachment portion integral to or removably attached to the patient interface; and a component according to any one of claims 1 to 10 that removably engages with the attachment portion.

12. a first connector part; a second connector part; a detent for securing the first connector part and the second connector part; to the first connector part and / or the second connector part a locked position in which the detent is substantially prevented from moving to release the first connector part from the second connector part; a free position in which the detent can be moved to release the first connector part from the second connector part; A slide that can be moved between A connector comprising:

13. The connector of claim 12 further comprising biasing means for urging said slide toward said locked position.

14. The connector of claim 13, wherein the biasing means comprises a pair of resilient legs.

15. The leg portion is a) the slides move away from each other as they move towards the free position; 15. The connector of claim 14, wherein b) the slides move toward each other as they move toward the free position.

16. 16. The connector of claim 12, wherein the detent comprises a pair of resilient arms spaced apart from and biased towards each other and biased towards engaging the first connector part, the or each resilient arm comprising a protrusion that engages with a complementary notch in the first connector part.

17. 17. The connector of any one of claims 12 to 16, wherein the slide comprises a protrusion that engages the detent to substantially prevent movement and release of the first connector part from the second connector part.

18. A connector according to any one of claims 12 to 17, wherein the slide includes a stop for positioning the slide and the second connector part in the fixed configuration.

19. The connector of any one of claims 12 to 18, wherein the first connector part comprises a plurality of notches.

20. The connector according to any one of claims 12 to 19, wherein the second connector part has a positioning mechanism for positioning the biasing means and a guide mechanism for guiding the first connector part, and has the slide.

21. A connector according to any one of claims 12 to 20, wherein the second connector part comprises a carrier that carries the detent and / or the biasing means.

22. 22. The connector of claim 21, wherein the carrier has a slot formed therein and a head strap of headgear has an opening, the slot and the opening configured to receive the first connector part.

23. 23. A connector according to any one of claims 12 to 22, wherein the first connector part is located on a patient interface and is attached or attachable to the second connector part and is part of headgear or a headgear or system that secures the patient interface in position around a user's head.

24. a frame section adapted to be positioned on a user's face, the frame section comprising a gas chamber adapted to direct gas toward the user and a nasal delivery element extending from the gas chamber adapted to be positioned within the user's nares; a manifold rotatably fixed to the frame section, the manifold configured to rotate relative to the frame section and including an axle structure about which rotational movement between the manifold and the frame section can occur; and A patient interface comprising:

25. 25. A patient interface according to claim 24, wherein the manifold is rotatably fixed to the frame section such that a range of rotational movement between the manifold and the frame section is limited, the frame section comprising a stop that limits the range of rotational movement.

26. 26. A patient interface according to claim 24 or 25, further comprising a retention mechanism, the retention mechanism being disposed on the frame section, the retention mechanism being configured to retain the manifold in an actuated position such that a pneumatic seal is provided between the manifold and the gas chamber.

27. 27. A patient interface according to claim 26, wherein the retention feature is a post extending outward from the frame section, the post configured to retain the manifold between the frame section and the post when the manifold is in the actuated position.

28. 28. A patient interface according to claim 26 or 27, wherein the retention feature comprises a first retention feature disposed on the manifold and a second retention feature disposed on the frame section.

29. 29. A patient interface according to any one of claims 24 to 28, wherein the patient interface comprises a release mechanism configured to release the manifold from an actuated position to allow the manifold to rotate relative to the frame section.

30. 30. A patient interface according to claim 29, wherein the release mechanism comprises a button, the button being disposed on the manifold, the button comprising a boss portion configured to engage with and move within a substantial portion of a track as the manifold rotates.

31. 31. A patient interface according to claim 29 or 30, wherein the release mechanism comprises a release body, the release body movable within a recess in the manifold, the release body movable from an unactivated position to an activated position, the release body being in the unactivated position when the manifold is in the activated position.

32. 32. A patient interface according to claim 31 , wherein the release body comprises one or side arms, the recess comprises one or more end regions shaped to correspond to the one or more side arms, the side arms configured to move into the end regions to release the boss portion from the retention region and allow the manifold to rotate.

33. 33. A patient interface according to any one of claims 24 to 32, wherein the manifold is a manifold assembly operably securable to the frame section, the manifold assembly having a manifold and a manifold inlet, the manifold inlet having a tapered lumen wherein an end proximal to the manifold has an area greater than an area of ​​an end of the lumen distal to the manifold.

34. the manifold assembly comprising a first component and a second component engageable with the first component; the first component forms at least a portion of the manifold, at least a portion of the manifold inlet, or at least a portion of the manifold and at least a portion of the manifold inlet; 34. A patient interface according to claim 33, wherein the second component forms at least a portion of the manifold, at least a portion of the manifold inlet, or at least a portion of the manifold and at least a portion of the manifold inlet.

35. 35. A patient interface according to claim 34, wherein the first component has a manifold inlet portion and the second component is or has a manifold inlet portion, the manifold inlet portion of the first component and the manifold inlet portion of the second component being engageable to form the manifold inlet.

36. 35. A patient interface according to claim 33 or 34, wherein the first component includes at least one positioning feature and the second component includes at least one complementary positioning feature.

37. 37. A patient interface according to any one of claims 34 to 36, wherein the at least one positioning feature of the first component comprises a protrusion and the at least one positioning feature of the second component comprises a complementary recess or opening.

38. A patient interface according to any one of claims 34 to 37, wherein the first component has an internal threaded portion that corresponds to an external threaded portion of a conduit or tube.

39. A patient interface according to any one of claims 34 to 38, wherein the second component has an internal threaded portion that corresponds to an external threaded portion of a conduit or tube.

40. A patient interface according to any one of claims 34 to 39, wherein the manifold assembly further comprises a fastening component in the form of a collar, the collar being a substantially annular component.

41. 41. A patient interface according to claim 40, wherein the collar has a tapered inner surface that engages an outer surface of the manifold inlet portion of the first component and an outer surface of the manifold inlet portion of the second component.

42. 35. A patient interface according to claim 34, wherein the first component has a manifold portion and the second component has a manifold portion, the manifold portion of the first component and the manifold portion of the second component being engageable to form at least a portion of the manifold.

43. 1. A patient interface for delivering supply gas to a patient, comprising: a gas supply manifold that receives and directs supply gas to one or more outlets to the patient; and a pair of elongated side arms extending from opposite sides of the manifold to contact a user's face in use and help stabilize the interface on the user's face, each of the side arms including an upward curve or bend along their length.

44. 44. A patient interface according to claim 43, wherein each side arm has an inner first portion and an outer second portion extending upwardly at an angle relative to the inner first portion.

45. 45. A patient interface according to claim 44, wherein at least a portion of the outer second portion extends at an angle of between 20 degrees and 70 degrees relative to the inner first portion.

46. 44. A patient interface according to claim 43, comprising: a gas supply manifold that receives and directs supply gas to one or more outlets to a patient; and a pair of elongated side arms extending from opposite sides of the manifold to contact a user's face in use and help stabilize the interface on the user's face, each of the side arms having an inner first portion extending laterally and rearwardly from the manifold at a first angle relative to the manifold, and an outer second portion extending rearwardly from the first portion at a relatively shallow angle relative to the manifold.

47. 47. A patient interface according to claim 46, wherein the inner first portion of each of the side arms extends at an angle of between about 30 degrees or about 50 degrees and about 70 degrees relative to the manifold and the outer second portion extends from the first portion at an angle of between about 150 degrees and about 170 degrees or about 180 degrees relative to the manifold.

48. 48. A patient interface according to claim 46 or 47, wherein the side arms include an upward curve or bend along their length and a partial twist whereby an orthogonal cross-sectional shape through the side arm is partially twisted counterclockwise in a portion of the side arm closer to the outer end compared to a portion of the side arm closer to the manifold.

49. A patient interface according to any one of claims 43 to 48, wherein a distal end of each side arm comprises formation configured to releasably mate with a complementary connector on the headgear.

50. 50. A patient interface according to any one of claims 43 to 49, comprising headgear in the form of at least one strap which, in use, is separable or bifurcated to provide upper and lower strap portions of the headgear.

51. 51. A patient interface according to any one of claims 43 to 50, wherein the manifold is rotatably coupled or configured as a rotatable connection to the patient interface or a frame portion of the patient interface, whereby, in use, a gas supply conduit in fluid communication with the manifold can be directed to the left or right side of a user of the patient interface.

52. 51. A patient interface according to any one of claims 43 to 50, wherein the manifold is a push-fit type receivable by a gas chamber of the patient interface that receives the supply gas and directs it to the one or more outlets to be inserted into or removed from the gas chamber, the push-fit type manifold being in fluid communication with a gas supply conduit that supplies the supply gas in use, the push-fit type manifold being receivable by the gas chamber from either or both of the left and right sides of the patient interface, or connected to direct the gas supply conduit to the left or right side of a user of the patient interface.

53. A patient interface according to any one of claims 43 to 52, further comprising a component according to any one of claims 1 to 11.

54. A patient interface according to any one of claims 43 to 53, further comprising a component according to any one of claims 12 to 23.

55. A patient interface according to any one of claims 43 to 54, further comprising a component according to any one of claims 24 to 42.

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