Patent Description:
Apparatus to deliver breathable gas to a patient typically includes a positive airway pressure (PAP) device, an air delivery conduit or tube, and a patient interface. The patient interface contacts the patient's face in use to deliver pressurized breathable gas to the patient from the PAP device.

<CIT> relates to a mask system including an elbow provided to the sealing arrangement and adapted to be connected to an air delivery tube that delivers breathable gas to the patient. It is said that the elbow includes a flexible region that may be co-molded with a more rigid region and that the flexible region allows portions of the elbow to flex inwards when the patient pinches or squeezes these regions, enabling disengagement of the cushion connection end from the mask.

<CIT> discloses an elbow assembly for e.g. full facial mask, having an anti-asphyxia valve received within slot, and clip securing anti-asphyxia valve to elbow, where clip includes slot interlocked with protrusion provided to anti-asphyxia valve.

An aspect of the present technology relates to an elbow and a connector assembly adapted to receive gases from a flow generator and deliver the gases to a patient interface.

An aspect of the present technology relates to an elbow and a connector adapted to vent gases from a patient interface.

As aspect of the present technology is to have multiple functions in one part or component and/or manufactured together, e.g., quick release button(s)/member(s)/actuator(s), baffle and swivel all formed together, so patient is not required to disassemble; this may increase potential for reduced overall part costs.

An aspect of the present technology relates to a multi-axis elbow assembly that allows movement of a connected tube in two separate planes while substantially isolating drag forces from the tube.

Another aspect of the present technology relates to a method for manufacturing an elbow for a patient interface assembly, comprising providing a skeleton, e.g., of rigid or semi-rigid material and adapted to communicate air flow under pressure between an air delivery conduit and a mask; separately molding an anti-asphyxia valve (AAV) with a pull tab; and assembling the skeleton and the AAV by pulling the pull tab from inside the skeleton and through an opening in the skeleton to position, retain and/or seal the AAV relative to the skeleton. The method may include removing at least a portion of the pull tab once pulled through such that an outer flange of the AAV sits flush with an exterior elbow surface. The method may further comprise providing a flexible component to secure the AAV in position. The flexible component may form one or more release buttons or actuators on the elbow.

An embodiment of the invention relates to an elbow for a patient interface assembly, comprising a skeleton or frame, e.g., of rigid or semi-rigid material, and adapted to communicate air flow under pressure between an air delivery conduit and a mask; an anti-asphyxia valve (AAV) with a pull tab, whereby to assembly the AAV to the skeleton, the pull tab is inserted or guided inside the skeleton and pulled through an opening in the skeleton to position, retain and/or seal the AAV relative to the skeleton. At least a portion of an outer flange of the AAV, once the pull tab is pulled through, sits flush with an exterior elbow surface. The elbow may include a flexible component to secure the AAV in position and/or to form one or more release buttons or actuators on the elbow, the release buttons adapted to remove the elbow from a frame.

Another aspect of the technology relates to a swivel elbow and connector assembly for a patient interface for delivering pressurized breathable gas to a patient from a PAP device. According to one aspect, the swivel elbow and connector assembly is connected to a flexible patient interface structure, e.g. a cushion, through an aperture in the patient interface structure. According to another aspect, the swivel elbow and connector assembly includes a connector, for example a ring, which is attachable to and detachable from the patient interface structure at the aperture. The connector includes a plurality of slots for venting gases from the interior of the patient interface structure to the exterior of the patient interface structure.

Yet another aspect of the technology relates to a swivel elbow connected to the connector and slots to permit venting of gases between the ring and the swivel elbow. According to another aspect, the swivel elbow is connected to the connector and the slots permit venting of gases between the connector and the patient interface structure, e.g. cushion, and no venting occurs between the connector and the swivel elbow.

A further aspect of the technology relates to a swivel elbow and anti-asphyxia valve assembly having a diffuse vent. A still further aspect of the technology relates to a swivel elbow and anti-asphyxia valve assembly having a diffuse vent that may be molded in one piece. An even further aspect of the technology relates to a swivel elbow and anti-asphyxia valve assembly having a diffuse vent that may have engagement portions that, when pressed, permit engagement and disengagement of the swivel elbow and anti-asphyxia valve assembly from a patient interface, e.g. a mask.

According to an example of the technology, a swivel elbow and connector assembly for a patient interface system comprises a ring configured to be sealingly secured in an aperture of the patient interface system, the ring including a first side in an interior of the patient interface system and a second side at an exterior of the patient interface system when the ring is secured in the aperture, the ring comprising a plurality of vents configured to permit flow of gases from the interior to the exterior of the patient interface system; and an elbow swivelably secured in the ring. The ring comprises a first flange on the first side and a second flange on the second side, the first and second flanges defining a channel that sealingly engages the aperture of the patient interface system and the second flange comprises an angled surface that directs the flow of gases from the plurality of vents at an angle to the longitudinal axis of the ring.

According to another example of the technology, a patient interface system for delivering a flow of breathable gas to a user comprises a patient interface structure configured to sealingly engage the face of the user, the patient interface structure comprising an aperture; and a swivel elbow and connector assembly as disclosed herein.

According to another example of the technology, an elbow for delivering gases to a patient interface comprises a first connecting portion, a second connecting portion and a venting portion. The first connecting portion is adapted to receive a tube connection, the second connecting portion is adapted to receive a patient interface assembly, and the venting portion is proximal to the second connecting portion. The venting portion may be diffused about the perimeter of the second connecting portion. The elbow may further comprise a baffle to separate the venting portion from an incoming air stream from the first connecting portion.

According to still another example of the technology, a swivel elbow and anti-asphyxia valve assembly for a patient interface assembly comprises a first component including a first connection portion configured to be sealingly secured in an aperture of the patient interface system, a second connection portion configured to be connected to a swivel or a delivery conduit, one or more first supports between the first connection portion and the second connection portion, and a first aperture and a second aperture are provided between the one or more first supports; and a second component including a valve member, engagement members, and a flexible member, the valve member being between the one or more first supports of the first component and movable between a first position in which the valve member occludes the first aperture and a second position in which the valve member does not occlude the first aperture, the engagement members being configured to engage the one or more first supports when pressed by a user of the patient interface system, and the flexible member being connected to the engagement members and sealing the second aperture.

Other aspects, features, and advantages of the present technology will become apparent from the following detailed description when taken in conjunction with the accompanying drawings, which are a part of this disclosure and which illustrate, by way of example, principles of the technology.

The accompanying drawings facilitate an understanding of the various examples of this technology. In such drawings:.

The aspects and/or examples of the technology do not explicitly disclose all features defined in claim <NUM>.

The following description is provided in relation to several examples which may share common characteristics and features. It is to be understood that one or more features of any one example may be combinable with one or more features of the other examples. In addition, any single feature or combination of features in any of the examples may constitute additional examples.

The term "air" will be taken to include breathable gases, for example air with supplemental oxygen. It is also acknowledged that the PAP devices or blowers described herein may be designed to pump fluids other than air.

The present technology is adapted to provide an arrangement or assembly between a patient interface and a tube that may be adapted to decouple tube drag forces, provide a freedom of movement for the tube to enable a patient to position the tube in a desired position without disrupting the seal, vent exhausted gases and provide a compact, unobtrusive design that is aesthetically acceptable to patients.

The venting arrangement may diffuse the exhausted air to prevent air jetting on patients or their bed partners, and to reduce noise.

The venting arrangement may cooperate with the elbow or connector assembly to further diffuse exhaled air, for example the elbow may be provided with a ridge to deflect air in a diffused manner.

The elbow may be provided with one or more swivel connectors adapted to provide more degrees of movement and aid in decoupling tube drag forces.

The elbow may be referred to as an adaptor, connector or may be described as any element attach an air delivery tube to a patient interface.

Referring to <FIG>, a swivel elbow and connector assembly <NUM> according to an example of the technology comprises a vented elbow connector, or ring, <NUM> and a swivel elbow <NUM>. A sleeve <NUM> is provided between the vented elbow ring <NUM> and the swivel elbow <NUM>. The sleeve <NUM> is provided between a first end of the swivel elbow <NUM> and the vented elbow ring <NUM>. A swivel cuff <NUM> is provided to a second end of the swivel elbow <NUM> opposite the first end. The swivel cuff <NUM> comprises a swivel cuff annular engaging ring <NUM> that is received in an annular groove <NUM> of the swivel elbow <NUM> so that the swivel cuff <NUM> is rotatable, or swivelable, with respect to the swivel elbow <NUM>.

The second end portion of the swivel elbow <NUM> also includes a tapered flange <NUM> that is received in an annular groove <NUM> of the swivel elbow <NUM> to secure the swivel elbow <NUM> to the swivel elbow <NUM>. The swivel elbow <NUM> also includes an end portion <NUM> that is configured to be connected to an air delivery hose or conduit that is configured to deliver a flow of breathable gas generated by a flow generator, or blower.

Referring to <FIG>, the vented elbow ring <NUM> comprises an inner flange <NUM> and an outer flange <NUM>. A patient interface structure, e.g. cushion, <NUM> of a patient interface system may be fitted into a channel <NUM> of the vented elbow ring <NUM> defined by the flanges <NUM>, <NUM>. The cushion <NUM> may be a nasal cushion, a full face cushion, or a nasal pillows or prongs cushion. The patient interface system may also include, for example, a support structure, or frame, that supports the cushion <NUM>; a tube, conduit, or hose configured to deliver a flow of breathable gas to the cushion; and/or a patient interface positioning and stabilizing system (e.g. headgear). It should also be appreciated that the vented elbow ring <NUM> may be provided in, for example, the support structure or frame.

Referring to <FIG>, a cushion <NUM> usable with the swivel elbow and connector assembly <NUM> may include a sealing portion <NUM> having an upper lip engagement portion <NUM> that is supported by a supporting portion <NUM>. The sealing portion <NUM> is separated from the supporting portion <NUM> by a front gap in an area of a nose tip engagement portion <NUM>. The nose tip engagement portion <NUM> is flexible and can extend downward when contacted by a patient's nose, but will be limited in how far it can extend if it reaches the supporting portion <NUM>. The nose tip engagement portion <NUM> is extended in length from the aperture <NUM> to fit nose tips of different size, so that the nose tip of different patients may engage the nose tip engagement portion at different locations. A stem <NUM> supports the supporting portion <NUM> and the sealing portion <NUM>. The cushion <NUM> may be as disclosed in, for example, International Application <CIT> (<CIT>). However, it should be appreciated that the swivel elbow and connector assemblies disclosed herein may be used with other patient interface structures or systems, e.g. cushions, such as those disclosed in, for example, <CIT> or <CIT>.

The stem <NUM> may receive the vented elbow ring <NUM>. The vented elbow ring <NUM> may be inserted into the aperture of the cushion <NUM> such that the stem <NUM> is sealingly located in the channel <NUM> between the flanges <NUM>, <NUM>. The sealing portion <NUM>, the stem <NUM>, and the supporting portion <NUM> may be a flexible material such as liquid silicone rubber material or another elastomeric material, e.g., TPE, gel or foam. The stem <NUM> and the supporting portion <NUM> may be formed together such as in a mold, and the sealing portion <NUM> may be formed separately and then joined together, e.g. such as by gluing. Alternatively, the stem <NUM> and the supporting portion <NUM> may be formed together such as in a mold, and then the sealing portion <NUM> may be bonded to the supporting portion <NUM> and the stem <NUM> in the mold.

The cushion <NUM> may comprise a flexible gusset <NUM>, which may include the supporting portion <NUM> and the stem <NUM>. The supporting portion <NUM> and the stem <NUM> may be formed as a single unitary element. The flexible gusset <NUM> may be constructed of a silicone with a hardness of about <NUM> to <NUM> Shore A, preferably about <NUM> Shore A. The flexible gusset <NUM> could also be made from polycarbonate, polypropylene, nylon, thermoplastic elastomer (TPE), Hytrel™, etc..

Referring again to <FIG>, the vented elbow ring <NUM> comprises a plurality of vent slots <NUM> that extend through the inner flange <NUM> across the channel <NUM> and through the outer flange <NUM>. As shown in <FIG>, the sleeve <NUM> includes a sleeve flange <NUM> provided between a flange <NUM> of the swivel elbow <NUM> and the flange <NUM> of the vented elbow ring <NUM>. As shown in <FIG>, the connection of the sleeve <NUM> between the swivel elbow <NUM> and the vented elbow ring <NUM> provides a plurality of vents <NUM> for the venting of exhalation gases from the interior of the cushion <NUM> to the exterior of the cushion <NUM> through the vent slots <NUM>.

The shape of the vent hole in one example of the present technology may be such that the cross section (e.g., round) is larger on or towards the inside (entry of air) compared to the smaller outside cross sections (e.g., diameter) where the air exits to atmosphere. Also, the exit point or region may be angled to diffuse air away from bed partner/bed clothes, e.g., not perpendicular.

A smooth transition may be provided at the vent passage to help reduce/ensure low noise providing vents along the swivel effectively increase overall length of vents, which may allow for laminar flow development, and result in less noise.

The first end portion of the swivel elbow <NUM> includes a tapered flange <NUM> that engages an annular surface <NUM> of the sleeve <NUM>. A cylindrical portion <NUM> of the sleeve <NUM> extends between the sleeve flange <NUM> and the tapered flange <NUM> of the swivel elbow <NUM>. The sleeve <NUM> in the swivel elbow <NUM> may be permanently assembled by the tapered flange <NUM> as shown in <FIG>, although it should be appreciated that the sleeve <NUM> may be under molded, co molded or otherwise formed with the swivel elbow <NUM> to reduce assembly costs.

Referring to <FIG>, the swivel elbow and connector assembly <NUM> may be provided with a plurality of vents <NUM>, for example, <NUM>-<NUM> vents, for example <NUM>-<NUM> vents, for example <NUM> vents, <NUM> vents or <NUM> vents. The cross sectional area of the vents may vary from, for example, <NUM> x <NUM>, for example, <NUM> x <NUM>, or <NUM> x <NUM>.

The sleeve flange <NUM>. and the flange <NUM> of the swivel elbow <NUM> may be provided at an angle that provides for venting of the exhalation gases from the interior of the cushion <NUM>, <NUM>° around the swivel elbow <NUM> and in direction away from the face of the patient. The sleeve <NUM> provides good diffusivity, and the vent path is contained and easily adjustable. The formation of the vents <NUM> by the sleeve <NUM> also reduces the noise of the venting from the interior of the cushion <NUM>.

Although the vented elbow ring <NUM> is shown in <FIG> as circular, it should be appreciated that the vented elbow ring may be, for example, elliptical in cross section, as show in <FIG> and <FIG>.

Referring to <FIG>, a swivel elbow and connector assembly <NUM> according to another example comprises a swivel elbow <NUM> and a connector, or ring, <NUM>. A cushion <NUM> comprises a flexible base <NUM> comprising an aperture for sealingly receiving the ring <NUM>. The flexible base may comprise a flange, or stem, <NUM> that is configured to be received in a channel <NUM> of the ring <NUM> that is defined between an inner flange <NUM> and an outer flange <NUM>. The cushion <NUM> may comprise nasal pillows <NUM> for sealingly engaging the nares of a patient or user and connectors <NUM> for connecting the cushion <NUM> to a patient interface structure positioning and stabilizing system (e.g. headgear). The cushion <NUM> may be as disclosed in, for example, International Application <CIT> (<CIT>). It should be appreciated that other cushions or patient interface structures may also be used with the assembly <NUM>, including rigid or semi-rigid patient interface support structures (e.g. frames).

The elbow <NUM> includes a first end <NUM> configured for connection to, for example, a delivery hose or conduit. The elbow includes a tapered flange <NUM> at a second end for securing the elbow <NUM> to the ring <NUM>. Intermediate the first and second ends, the elbow <NUM> includes an angled flange <NUM> having a plurality of vents <NUM> spaced around the flange <NUM>. The flange <NUM> is angled with respect to the longitudinal axis of the elbow <NUM>. The number and size of the vents may be as described above. It should also be appreciated that the vents <NUM> may be distributed around the angled flange <NUM> evenly or randomly. It should further be appreciated that the vents <NUM> may not extend around the entire circumference of the angled flange <NUM> of the elbow <NUM>, for example as shown in <FIG>.

A radial flange <NUM> may surround the angled flange <NUM> that engages the outer flange <NUM> of the ring <NUM>. The ring <NUM> is secured between the tapered flange <NUM> and the radial flange <NUM>. The elbow <NUM> may further comprise a baffle <NUM> to separate the venting portion <NUM> from an incoming flow of breathable gas from the first end <NUM>, although it may be circular or have other shapes as well.

Referring to <FIG>, the ring <NUM> may have an elliptical configuration (e.g. elliptical cross section). A circular radial flange <NUM> may be provided on the ring <NUM> to form a sealing interface with the radial flange <NUM> of the elbow <NUM>. As also shown in <FIG>, the vents <NUM> may not be provided around the entire circumference of the elbow, for example the lower portion <NUM> of the angled flange <NUM> may not include vents <NUM>, and/or the angled flange <NUM> may have a reinforced portion <NUM> between vents <NUM>. As shown in <FIG>, the baffle <NUM> of the elbow <NUM> also has an elliptical configuration that provides venting portions <NUM> and non-venting portion <NUM> to the elbow <NUM>.

Referring to <FIG>, a double swivel elbow and connector assembly <NUM> according to a example comprises a ball and socket connection i.e. a ball joint vented elbow ring <NUM>, a ball joint swivel elbow <NUM> swivelably connected to the ball joint vented elbow ring <NUM>, and a swivel cuff <NUM> swivelably connected to the ball joint swivel elbow <NUM>. The ball joint vented elbow ring <NUM> includes a plurality of vent slots <NUM> extending around the periphery of the elbow ring <NUM>. As shown in <FIG>, the slots <NUM> extend through an inner flange <NUM> of the elbow ring <NUM> and through an outer flange <NUM> of the elbow ring <NUM>. A cushion <NUM> having an aperture may be received in a channel <NUM> between the inner flange <NUM> and the outer flange <NUM>. When the elbow ring <NUM> is positioned in the aperture of the cushion <NUM>, vent holes are created between the vent slots <NUM> in the elbow ring <NUM> and the cushion <NUM>. The cushion <NUM> is secured to the double swivel elbow and connector assembly <NUM> when the stem <NUM> of the cushion is received in the channel <NUM> of the vented elbow ring <NUM>. As used herein, the term "sealingly secured" means that the flow of breathable gas delivered to the patient interface system, e.g. cushion, through the swivel elbow will not pass from the interior to the exterior of the patient interface system through the vents in the absence of exhalation by the patient or wearer of the patient interface system.

Referring to <FIG>, the vented elbow ring <NUM> includes an annular surface <NUM> that may be flush or in line with an annular surface <NUM> of the ball joint swivel elbow <NUM> when the double swivel elbow and connector assembly <NUM> is in the position or configuration shown in <FIG>, i.e., with the elbow pointing generally downward. As shown in <FIG>, the ball joint swivel elbow <NUM> includes an arcuate annular, or partially spherical, outer surface <NUM> that is swivelably contained by an arcuate annular, or partially spherical, inner surface <NUM> of the vented elbow ring <NUM>. The vented elbow ring <NUM> and the ball joint swivel elbow <NUM> thus act as a ball joint connection between the vented elbow ring <NUM> and the swivel elbow <NUM>. The inner surface <NUM> and the outer surface <NUM> have radii of curvature that are approximately equal. The substantially equal radii of curvature may be achieved by molding the vented elbow ring <NUM> and the swivel elbow <NUM> together, without the vented elbow ring <NUM> and the swivel elbow <NUM> chemically bonding or mechanically bonding in the mold, e.g., by shrinkage. The inner surface <NUM> and the outer surface <NUM> are engaged essentially over the area of contact between the surfaces so that no or little gas flows between the ring <NUM> and the elbow <NUM>.

The swivel elbow <NUM> may swivel from the position shown in <FIG>, in which the annular surface <NUM> is flush with the annular surface <NUM> of the vented elbow ring <NUM> and the longitudinal axes of the ring <NUM> and the elbow <NUM> are co-linear, to the position shown in <FIG>, <FIG>, in which the annular surfaces <NUM>, <NUM> are not flush and the longitudinal axes are at an angle to each other. An annular junction <NUM> between the arcuate annular outer surface <NUM> of the swivel elbow <NUM> and the end portion of the swivel elbow <NUM> limits the swiveling of the elbow <NUM> within the vented elbow ring <NUM>, as shown in <FIG>, <FIG>.

Referring to <FIG>, the end portion of the swivel elbow <NUM> includes an annular groove <NUM> that receives a tapered annular engaging ring <NUM> of the swivel cuff <NUM>. A tapered flange <NUM> of the swivel elbow <NUM> engages the tapered annular engaging ring <NUM> of the swivel cuff <NUM> to retain the swivel cuff <NUM> to the swivel elbow <NUM>. As shown in <FIG> and <FIG>, the swivel cuff <NUM> includes an angled groove <NUM> that allows the swivel cuff <NUM> to rotate from the position shown in <FIG> to the position shown in <FIG>.

Referring to <FIG> and <FIG>, the pivoting of the swivel cuff <NUM> allows a longitudinal axis of the double swivel elbow and connector assembly <NUM> to rotate through an angle a of, for example, <NUM>-<NUM>°, for example <NUM>°.

The double swivel elbow and connector assembly <NUM> allows for swiveling of the connection of an air delivery tube or conduit to the swivel cuff end portion <NUM> in two directions. For example, as shown in <FIG>, the swivel cuff <NUM> may swivel from the position shown in <FIG> to the position shown in <FIG> while the swivel elbow <NUM> remains in a position such that the annular surface <NUM> of the swivel elbow is flush with the annular surface <NUM> of the vented elbow ring <NUM>. The transition from the alignment shown in <FIG> to the alignment shown in <FIG> is shown in <FIG> as a central axis of the swivel cuff <NUM> rotates through the angle α of, for example, <NUM>°. The swiveling of the cuff <NUM> from the position shown in <FIG> to the position shown in <FIG> allows a short air delivery tube or conduit to straighten out thereby reducing torque forces applied to the vented elbow ring <NUM> and cushion <NUM>. In other masks without this swivel, if the tube is pulled in a direction that is perpendicular to the central axis of the elbow, because the elbow has an L shaped configuration and no swivel, it cannot rotate to be in line with the tube; therefore this pulling force is directly applied to the mask and can disrupt the seal. The ball joint (or ball and socket connection) design allows the elbow and the swivel to re-align depending on the forces being exerted by the tube.

The double swivel elbow and connector assembly <NUM> also permits the swivel elbow <NUM> to swivel with respect to the vented elbow ring <NUM>, for example, from the position shown in <FIG> to the position shown in <FIG>. The pivoting or swiveling of the swivel elbow <NUM> is limited by the annular junction <NUM> between the arcuate annular outer surface <NUM> of the swivel elbow <NUM> and the end portion of the swivel elbow <NUM>. The swivel elbow <NUM> may also swivel from the position shown in <FIG> to the position shown in <FIG> while the swivel cuff <NUM> may also pivot or swivel with respect to the swivel elbow <NUM>.

Referring to <FIG>, a triple swivel elbow and connector assembly <NUM> according to another example comprises a second swivel cuff <NUM> swivelably connected to the end portion of the swivel cuff <NUM>. The second swivel cuff <NUM> comprises a tapered annular engaging ring <NUM> that is received in an annular groove <NUM> in the end portion of the swivel cuff <NUM>. A tapered flange <NUM> is provided at the end of the swivel cuff <NUM> to engage and retain the annular engaging ring <NUM> of the second swivel cuff <NUM>. The second swivel cuff <NUM> includes an annular groove <NUM> that receives the tapered flange <NUM> of the swivel cuff <NUM>. The second swivel cuff <NUM> includes an end portion <NUM> that is configured to receive an air delivery tube or conduit for receiving a flow of breathable gas provided by a flow generator, or blower, for delivery into a patient interface including the cushion <NUM>.

The swivel cuff <NUM> and the swivel elbow <NUM> of the examples shown in <FIG> are swivelable in the same manner as described with respect to the example disclosed in <FIG>. As shown in <FIG> and <FIG>, the pivoting of the swivel cuff <NUM> allows a longitudinal axis of the triple swivel elbow and connector assembly <NUM> to rotate through an angle β of, for example, <NUM>-<NUM>°, for example <NUM>°. Although the second swivel cuff <NUM> is shown as including an annular groove <NUM> that receives the tapered flange <NUM> of the swivel cuff <NUM>, it should be appreciated that the second swivel cuff <NUM> may be provided with an angled groove similar to the angled groove <NUM> of the first swivel cuff <NUM> to permit the second swivel cuff <NUM> to swivel through an angle similar to the manner in which the swivel cuff <NUM> swivels with respect to the swivel elbow <NUM>.

Referring to <FIG>, a swivel elbow and anti-asphyxia valve assembly <NUM> according to an example of the technology may be provided having a diffuse vent. The assembly may also include engagement portions, e.g. buttons or actuators, for engaging and disengaging the assembly <NUM> to a patient interface, e.g. a mask. The assembly <NUM> may be molded in one piece. This arrangement is advantageous as the patient is not required to dismantle the component (thereby preventing potential loss of components or misalignment when reassembling), the cost of the component may be lower, and the anti-asphyxia valve may be positioned such that it cannot be tampered with or accidentally removed.

The assembly <NUM> may comprise a first elbow component, base moulding, collar or skeleton portion <NUM>, as shown in <FIG>. The skeleton portion <NUM> may provide the underlying structure of the assembly <NUM> to support the assembly in an open or patent position. As shown in <FIG>, the skeleton portion <NUM> may include vent holes <NUM> adapted to permit the exit of exhausted gases from a patient interface as per previously described examples. As shown in <FIG>, the skeleton portion <NUM> may further comprise a baffle <NUM> adapted to separate the incoming gases from the outgoing gases in the assembly <NUM> as per previously described examples.

The skeleton portion <NUM> may also include a first connection region <NUM> comprising engagement tabs <NUM> for interfacing or connecting with a patient interface, for example. The first connection region <NUM> may be substantially arcuate or define a first arcuate region when viewed from the front. The skeleton portion <NUM> may also include a second connection region <NUM> for interfacing or connecting with a tube or swivel, for example. The skeleton portion <NUM> may further include a stop <NUM> to position the assembly <NUM> with respect to a mask, for example, and prevent the assembly <NUM> from travelling through the connection with the mask or insertion of the assembly <NUM> into the mask.

The skeleton portion <NUM> may be formed of a relatively rigid, or stiff, material so that the structure may remain open to permit the flow of gases. Stiffer materials may minimize the noise of the air exiting the vent holes. The skeleton portion <NUM> may be formed of, for example, polycarbonate, polypropylene, or nylon. A rigid material may also assist in maintaining the assembly <NUM> in an open position under certain loads, e.g. the patient lying on the assembly. A rigid material may also be easier for the user to connect and disconnect from the mask, tube and/or swivel.

As shown in <FIG>, the skeleton portion <NUM> may further comprise supports, arms or interconnecting regions <NUM> adapted to connect the first connection region <NUM> with the second connection region <NUM>. The supports <NUM> may also form the boundaries of a first aperture <NUM> and a second aperture <NUM>. The supports <NUM> may be flexible and resilient, i.e. the supports <NUM> may return to their original shape after deformation. The first aperture <NUM> may be structured and arranged to receive an anti asphyxia valve or other valve. The second aperture <NUM> may be structured and arranged to receive a flexible member or web. The second aperture <NUM> may extend to an opening, gap or relief <NUM> at the first connection region <NUM>, as shown in <FIG>.

Referring to <FIG>, the vent holes <NUM> may be positioned on a surface <NUM> that is generally circular or rounded to better diffuse exiting air streams. The surface <NUM> may be tapered to prevent moisture build up on the elbow - this can cause vent whistle i.e. air exiting the vent holes to create a high pitched whistle-like noise. The vent holes <NUM> may be scattered around the surface <NUM> to diffuse the air flow. It should be appreciated that the vent holes <NUM> may be uniformly spaced around the surface <NUM>, or provided as otherwise described herein.

The skeleton portion <NUM> may further include second supports or stops <NUM> adapted to receive a button or other engagement mechanism. The second supports <NUM> may be adapted to transmit a force from an engagement feature or mechanism, such as a button, to the skeleton portion <NUM>. The second supports <NUM> may also reinforce or provide a foundation for an engagement feature or mechanism, such as a button, such that when the button is pressed it does not collapse, rather it transmits a force to the skeleton portion <NUM>. The second supports <NUM> may be an alignment feature to align the skeleton portion <NUM> in a tool or mold. The second supports <NUM> may form a surface for a second component, for example an over-mould, to abut or be formed against.

The skeleton portion <NUM> may be over-moulded or otherwise formed with a second component also referred to as a flexible portion or deformable region) <NUM>, e.g. an assembly over-mould. For example, the skeleton portion <NUM> may be moulded in a first tool and then transferred to a second tool for over-moulding with the second component <NUM>, or could be done all in one tool. That is, second component <NUM> may be chemically, mechanically or otherwise formed to the skeleton portion <NUM>. The second component <NUM> may be formed of a relatively flexible material, such as thermoplastic elastomer (TPE), silicone, gel or other material.

The second component <NUM> may include engagement portions <NUM>, a flexible member or web <NUM>, a lip <NUM> and a valve member <NUM>. The engagement portions <NUM> may be, for example, buttons, grips, tabs or other arrangements adapted to receive a pressing force or other motion from a patient or clinician. The engagement portions <NUM> may be supported and/or reinforced by the second supports <NUM>. The engagement portions <NUM> may, when pressed, squeeze towards one another thereby displacing the first supports <NUM> inwards. The first supports <NUM> may then deform the first connection region <NUM> from a first, resting position (e.g. a circular shape) to a second, pressed position (e.g. an oval or elliptical shape). The gap or relief <NUM> may be adapted to permit the first connection region <NUM> to flex. This change in shape may move the engagement tabs <NUM> from a first, engaged position, to a second, disengaged position. The gap or relief <NUM> may form a second arcuate region, such that when combined with the first arcuate region of the first connection region <NUM>, the two components form a circle and hence a cylinder.

The flexible member or web <NUM> may be connected to the engagement portions <NUM> and also seal the second aperture <NUM>. The flexible member <NUM> may be in the form of a membrane or other readily deformable shape, as when engagement portions <NUM> are pressed, the flexible member <NUM> may buckle or bend.

The lip <NUM> may be formed about and positioned around the perimeter of the first aperture <NUM>. The lip <NUM> may be adapted to prevent objects from entering the first aperture <NUM>. The lip <NUM> may also serve as a blank off for molding elbow assembly <NUM>.

The valve member <NUM>, as shown in <FIG>, may be positioned within the body of the elbow assembly <NUM>, i.e. between the first supports <NUM>. The valve member <NUM> may act as an anti-asphyxia valve, i.e. when air is delivered from the second connection region <NUM> to the first connection region <NUM>, the valve member <NUM> may move into a first position (not shown) to occlude the first aperture <NUM>; and when there is no air being delivered from the second connection region <NUM> to the first connection region <NUM>, the valve member <NUM> may move to a second position (<FIG>) that does not occlude the first aperture <NUM>, thereby permitting the patient to receive air from atmosphere through the first aperture <NUM>. The valve member <NUM> may be a flap. The valve member <NUM> may be integrally formed with the second component <NUM>, e.g. through a living hinge attached to the lip. It should be appreciated that the valve member <NUM> may be formed separately from the second component <NUM> and attached to the second component <NUM>. The valve member <NUM> may be larger than the first aperture <NUM>, so as to occlude the first aperture <NUM> when air is delivered from the second connection region <NUM> to the first connection region <NUM>.

The valve member <NUM>, the lip <NUM>, the engagement portions <NUM>, and the flexible member <NUM> may be formed from the same material in a single piece. Alternatively, one or more of these components may be formed separately and/or from an alternative material.

In an exemplary embodiment of the invention, e.g., shown in <FIG> an elbow <NUM> may be formed or constructed in a multi-step process, e.g., three step process, to achieve a single component with multiple functions. The elbow <NUM> may comprise a skeleton or frame <NUM>, e.g., constructed of rigid or semi-rigid material, and adapted to communicate air flow from an air delivery tube to a mask. The skeleton <NUM> may be first formed or molded in a tool. Skeleton <NUM> may be constructed of a polymer such as polypropylene, polycarbonate, and nylon.

The elbow <NUM> may further comprise an AAV (anti-asphyxia valve) <NUM> having a flap <NUM> adapted to provide the patient with access to atmospheric gas should a flow generator fail to deliver air to the mask. The AAV <NUM> may be formed or molded within the skeleton <NUM> or formed or molded and then subsequently assembled to the skeleton <NUM>. For example, as shown in <FIG>, the AAV <NUM> may be molded and then pulled through an opening <NUM> in the skeleton. A pull tab <NUM> of the AAV may enable the AAV <NUM> to be pulled through the opening <NUM> so as to position, retain and/or seal the AAV relative to the skeleton. The pull tab <NUM> may be a sacrificial component that once utilized (e.g., pulled through the opening) it may be cut off (such that an outer surface <NUM> of an outer flange <NUM> is substantially flush with the elbow surface) as shown in <FIG> or otherwise removed (e.g., once an inner flange <NUM> is pulled and anchored against the inner surface of the skeleton, further applied force will tear the pull tab away from the AAV, possibly assisted by a perforation(s) between pull tab and outer flange <NUM>). Alternatively the AAV <NUM> may be molded in the opening <NUM> and extending through the skeleton <NUM> without the need for pull tab <NUM>. The AAV <NUM> may include an inner flange <NUM> to seal the AAV <NUM> against the inner wall <NUM> of the skeleton <NUM>.

The elbow <NUM> may comprise a flexible component <NUM> (<FIG>) adapted to secure the AAV <NUM> in position and/or form one or more release buttons <NUM> of the elbow <NUM>. For example, the flexible component <NUM> may be a silicone or TPE which is molded over the skeleton <NUM> to form the outer portions of the release buttons <NUM>, thereby allowing the release buttons <NUM> to flex; and may be molded over the AAV <NUM> at the opening <NUM> to seal and hold the AAV <NUM> in position relative to the skeleton <NUM>.

The arrangement may have one or more of the following advantages:.

Referring to <FIG>, a patient interface system <NUM> for delivering a flow of breathable gas to a patient may include a swivel elbow <NUM>, a swivel or ring or connector <NUM>, and a cushion <NUM> for sealingly engaging the patient's airways. Although the cushion. <NUM> as shown includes nasal pillows or prongs or puffs, it should be appreciated that other cushions may be provided, for example a nasal cushion or a full face cushion. The swivel <NUM> may be removably attachable to the cushion <NUM> by a bayonet type connection <NUM> that includes detents <NUM> on the swivel <NUM> to engage with tabs <NUM> on the cushion <NUM>. Vents <NUM> are provided between the elbow <NUM> and the swivel <NUM>. The vents <NUM> may include slots provided on the elbow surface to create venting gaps between the elbow <NUM> and the swivel <NUM>. It should be appreciated that the slots may be provided in the swivel instead of the elbow, or that slots may be provided in both the elbow and the swivel.

Referring to <FIG>, according to another example a patient interface system <NUM> may include a swivel elbow <NUM>, a swivel or ring or connector <NUM>, and a cushion <NUM>. The swivel <NUM> may be connected to a ring <NUM> that is attached to the cushion <NUM> at <NUM>. The ring <NUM> may be permanently or removably attached to the cushion <NUM>. For example, the cushion <NUM> may be overmoulded to the ring <NUM> or the cushion <NUM> and the ring <NUM> may be attached by adhesive. As another example, the cushion <NUM> and the ring <NUM> may be press fit together.

The elbow <NUM> may be removably attached to the swivel <NUM> or the elbow may be permanently attached to the swivel <NUM>. The elbow <NUM> may have flexible buttons <NUM> provided between grooves <NUM> formed in the elbow <NUM>. The buttons <NUM> may be pressed or flexed to connect and disconnect the elbow <NUM> from the swivel <NUM>.

Vents <NUM> are provided between the elbow <NUM> and the swivel <NUM>. The vents <NUM> may include slots provided on the elbow surface to create venting gaps between the elbow <NUM> and the swivel <NUM>. It should be appreciated that the slots may be provided in the swivel instead of the elbow, or that slots may be provided in both the elbow and the swivel.

Referring to <FIG>, a patient interface system <NUM> according to another example may include a swivel elbow <NUM>, a swivel or ring or connector <NUM>, and a cushion <NUM>. The cushion <NUM> may be permanently or removably connected to the swivel <NUM> at <NUM>. The elbow <NUM> may be press fit to the swivel <NUM> and be releasable by pressing buttons <NUM> provided between grooves <NUM> as per grooves <NUM>. Grooves <NUM> are made air tight by either being thinned regions of material or an over-molded second material (e.g., TPE, silicone). The elbow <NUM> may further include slots <NUM> to vent exhaled gases and a baffle <NUM> to reduce noise and increase exhaust gas washout.

Referring to <FIG> and <FIG>, an elbow <NUM> according to an example of the technology may include slots <NUM> to vent exhaled gases and a baffle <NUM> to reduce noise and increase exhaust gas washout. An aperture <NUM> may be provided in the elbow <NUM> to permit the patient to breathe in the event that the flow of breathable gas is interrupted or stopped. An AAV flap <NUM> is provided to close the aperture <NUM> when a flow of breathable gas is in the elbow <NUM> (i.e. the flow of breathable gas biases the flap <NUM> into a closed position to cover the aperture <NUM>). As shown in <FIG> and <FIG>, the AAV flap <NUM> is in the open position. The elbow <NUM> may be moulded from, for example, a rigid material to improve vent flow noise and to prevent the slots <NUM> from occluding. The AAV flap <NUM> may be formed of, for example, a flexible material to enable movement of the AAV flap <NUM> from the open to the closed position under the influence of the flow of breathable gas.

Referring to <FIG>, an elbow and tube connector assembly <NUM> may include an elbow <NUM> and a tube connector <NUM> that clips into the inner surface of the elbow <NUM>. Clipping the tube connector <NUM> into the elbow <NUM> reduces the overall visual bulk of the assembly <NUM> and may also create a tube-specific fitting such that only tubes <NUM> provided by a certain manufacturer or provided can be used with the elbow <NUM>.

The elbow <NUM> may include a lip or flexible element <NUM> adapted to engage with an outer surface, e.g. a groove, <NUM> of the tube connector <NUM> to ensure a more robust seal. The tube connector <NUM> may also include a series of ridges <NUM> adapted to engage with the inner surface of the elbow <NUM>, thereby causing a seal, while avoiding increased friction between the tube connector <NUM> and the elbow <NUM> to permit rotation of the components relative to one another.

Referring to <FIG>, a tube and elbow connector assembly may <NUM> include a swivel elbow <NUM>, a tube connector <NUM> and a swivel or connector or ring <NUM>. The assembly <NUM> may be used to connect the elbow <NUM>, such as the elbow disclosed in, for example, <CIT>, to a short retractable tube, having a length of, for example <NUM>, such as disclosed in, for example, <CIT>.

The assembly <NUM> may reduce rotational / torque forces between the tube and the elbow. For example, as disclosed in <CIT>, a patient interface system may include a "pillow cushion" that is adhesively applied to the patient's face. As the patient interface system has no headgear, it therefore has little to no resistance to rotational forces being applied to the pillow cushion. The patient interface system may include a decoupling gusset, a ring elbow and a short, retractable tube attached to the elbow. A longer tube, e.g. a <NUM> tube, may be connected to the short, retractable tube by a swivel. As the short, retractable tube is stretched, it may rotate almost a full revolution. This in turn rotates the elbow and distorts the pillow cushion and may pull the prongs or pillows out of the nose. In the patient interface of <CIT>, the short, retractable tube assembly is designed to be 'semi-permanent' and have minimal leak through the tube-elbow interface. As such, there is no ability to rotate at the short, retractable tube and elbow interaction site and the elbow acts as a solid fixture and increases the torque onto the cushion.

By altering the location of the swivel in the patient interface system, for example by placing the swivel between the short, retractable tube and the elbow, all the rotational forces of both the longer tube and the short, retractable tube would be rotationally decoupled from the cushion.

By copying the geometry of the external surface of the elbow, and the internal surface of the short tube cuff and offsetting each by, for example, <NUM>, preferably <NUM>, there would be clearance between both parts. As the tube is stretched and starts to rotate, the surface with the least resistance will swivel. The swivel may either 'fuse' (i.e. not rotate) on one side, and rotate <NUM>% on the other, or take up <NUM>% of the rotation on either side so that the cushion would only experience a tensile force.

Referring to <FIG>, a tube and elbow connector assembly <NUM> according to another example includes an elbow <NUM> connectable to a tube or tube cuff <NUM> by a swivel component <NUM>, <NUM> made by, for example, overmoulding a first swivel component <NUM> over a second swivel component <NUM> in a mould assembly to form a freely rotating swivel in a smaller footprint, i.e. minimising the extension of the elbow length. The internal geometry of the cuff <NUM> and the external geometry of the elbow <NUM> were replicated to ensure a tight fit with no leak, yet the shrinkage of the in-mould assembly would allow a smooth rotation. The swivel components <NUM>, <NUM> form a two part swivel moulded as one.

Referring to <FIG>, a tube cuff-to-tube cuff connector <NUM> assembly may also provide a swivel configured to join cuffs <NUM>, <NUM> of short tubes with no multiplication of the torque forces. A cuff connector <NUM> may be provided between two short tubes of, for example, <NUM> in length, rather than one <NUM> tube with <NUM>% clockwise torque force. The cuff connector <NUM> connects the two short tubes, and each the two short tubes may be wound in different directions, (i.e. <NUM>% clockwise, <NUM>% anti-clockwise) to cancel each other's torque out.

Claim 1:
A connector (<NUM>) for a patient interface system, comprising:
a first portion (<NUM>) adapted to removably connect to a patient interface, the first portion being formed from a relatively rigid or stiff material;
a vent formed on the first portion (<NUM>);
a flexible portion (<NUM>) adapted to flex to permit engagement and disengagement of the first portion (<NUM>), the flexible portion (<NUM>) being formed from a relatively flexible material; and
an anti asphyxia valve (<NUM>) comprising an outer flange (<NUM>), an inner flange (<NUM>), and a flap (<NUM>) extending from the inner flange (<NUM>), the valve (<NUM>) being secured to the first portion (<NUM>) at the outer flange (<NUM>) and the inner flange (<NUM>),
wherein the outer flange (<NUM>) of the valve (<NUM>) is received in an opening (<NUM>) in the first portion (<NUM>) so that an outer surface of the outer flange (<NUM>) is substantially flush with an outer surface of the first portion (<NUM>),
wherein the flexible portion (<NUM>) comprises a pair of opposing buttons (<NUM>) that are configured to be inwardly flexed to allow disengagement of the connector (<NUM>) from the patient interface,
wherein the first portion (<NUM>) forms a skeleton over-moulded by or otherwise formed with the flexible portion (<NUM>), and
wherein the inner flange (<NUM>) is configured to seal the anti-asphyxia valve (<NUM>) against the inner wall of the skeleton.