Device for regulating pressure

Abstract

A device for regulating pressure, the device including: a body having: an inlet; and a lumen in communication with the inlet; and one or more flow features, the one or more flow features including a flow restrictor for restricting flow through the lumen, wherein downstream of the flow restrictor is a protective portion that assists in protecting the restrictor from being impaired.

Description

Device for Regulating PressureCROSS-REFERENCE TO RELATED APPLICATION(S)[1] This application is based on and claims priority to United States of America Provisional Patent Application Nos. 63 / 515,028 and 63 / 589,614, respectively filed on 21 July 2023 and 11 October 2023, the contents of which are incorporated by reference in their entirety.TECHNICAL FIELD[2] The present disclosure relates to a device for regulating pressure and, in particular, a device that assists in regulating pressure of gas(es) supplied to a patient during respiratory therapy.BACKGROUND[3] Patients can have difficulties in breathing for a variety of reasons. For example, infants may have lung difficulties that require the assistance of a breathing system. In adults, collapsing airways may also require the assistance of a breathing system. A breathing assistance or respiratory therapy apparatus (collectively, eg, 'respiratory apparatus' or 'respiratory devices') may be used to deliver breathable gases such as supplementary oxygen or other gas(es). The flow of gas(es) may also flow through a humidification apparatus to deliver humidified gas(es) to a patient. A breathing assistance apparatus may also allow adjustment and control over characteristics of the gas(es) delivered to patients.[4] Any reference to or discussion of any document, act or item of knowledge in this specification is included solely for the purpose of providing a context for the present disclosure. It is not suggested or represented that any of these matters or any combination thereof formed at the priority date part of the common general knowledge, or was known to be relevant to an attempt to solve any problem with which this specification is concerned.SUMMARY[5] Aspects of the disclosure are summarised below. It will be noted that aspects and embodiments of the disclosure may be combined such that features and / or embodiments of one aspect may be used with features and / or embodiments of any other aspect where compatible.[6] In a first aspect, the present disclosure provides a device for regulating pressure, the device including: a body having: an inlet; and a lumen in communication with the inlet; and one or more flow features, the one or more flow features including a flow restrictor for restricting flow through the lumen, wherein downstream of the flow restrictor is a protective portion that assists in protecting the restrictor from being impaired.[7] In a second aspect, the present disclosure provides a device for regulating pressure, the device including: a body having: an inlet; and a lumen in communication with the inlet; and one or more flow features, the one or more flow features including a flow restrictor for restricting flow through the lumen, wherein a protective portion is located proximate a distal end of the one or more flow features to assist in protecting the one or more flow features from being impaired.[8] In a third aspect, the present disclosure provides an expiratory pressure device configured to vent exhaled gases from a patient interface assembly, the device comprising: a body comprising: an inlet; and a lumen in communication with the inlet, the lumen comprising a flow restrictor and an open distal end; and a protective portion, wherein the protective portion is configured to maintain an expiratory flow path from the open distal end.[9] In some embodiments, the protective portion is configured to maintain the expiratory flow path from the flow restrictor to atmospheric and / or ambient conditions.

[0010] In some embodiments, the protective portion is configured to maintain a pathway from the flow restrictor to atmospheric and / or ambient conditions.

[0011] In some embodiments, the protective portion projects away from the flow restrictor.

[0012] In some embodiments, the protective portion encompasses at least a portion of a distal end of the flow restrictor.

[0013] In some embodiments, the protective portion overhangs the flow restrictor.

[0014] In some embodiments, the protective portion extends in a direction that is in a similar direction from the inlet to the flow restrictor.

[0015] In some embodiments, the protective portion includes a radial surface that is configured to block matter from impairing the flow restrictor.

[0016] In some embodiments, the protective portion provides a first surface that extends transversely to an axial direction of the body.

[0017] In some embodiments, the protective portion includes a protective member. The protective member may include a plurality of protective members.

[0018] In some embodiments, the protective member has a free end distal from the flow restrictor.

[0019] In some embodiments, the protective member includes a projection.

[0020] In some embodiments, the projection projects from near part of the lumen forming the flow restrictor.

[0021] In some embodiments, the projection projects over the flow restrictor.

[0022] In some embodiments, the one or more flow features include an aperture.

[0023] In some embodiments, the open distal end includes an aperture. The aperture may include a plurality of apertures.

[0024] In some embodiments, the protective member includes the aperture.

[0025] In some embodiments, the aperture is in fluid communication with atmospheric and / or ambient conditions.

[0026] In some embodiments, the aperture is offset from the flow restrictor.

[0027] In some embodiments, the aperture is larger in area than the flow restrictor.

[0028] In some embodiments, an area ratio of the flow restrictor to the aperture is at least 1 :15.

[0029] In some embodiments, the area ratio of the flow restrictor to the aperture is at least 1 :20.

[0030] In some embodiments, the aperture forms the flow restrictor.

[0031] In some embodiments, the protective portion extends from the lumen at a location of the flow restrictor and terminates at the aperture.

[0032] In some embodiments, the protective member includes a secondary aperture. The secondary aperture may include a plurality of secondary apertures.

[0033] In some embodiments, the secondary aperture is in a different plane to the aperture.

[0034] In some embodiments, the protective member includes a tertiary aperture. The tertiary aperture may include a plurality of tertiary apertures.

[0035] In some embodiments, the tertiary aperture is on an opposing plane to a plane of the aperture.

[0036] In some embodiments, an area ratio of the flow restrictor to the secondary aperture and the tertiary aperture is at least 1 :2.

[0037] In some embodiments, the area ratio of the flow restrictor to the secondary aperture and the tertiary aperture is at least 1 :5.

[0038] In some embodiments, an area ratio of the flow restrictor to the aperture, the secondary aperture and the tertiary aperture is at least 1 : 20.

[0039] In some embodiments, the area ratio of the flow restrictor to the aperture, the secondary aperture and the tertiary aperture is at least 1 : 25.

[0040] In some embodiments, the protective member forms a cuff.

[0041] In some embodiments, the cuff is radially outward from a neck of the body.

[0042] In some embodiments, a shoulder connects the cuff to the neck of the body.

[0043] In some embodiments, the shoulder includes the tertiary aperture.

[0044] In some embodiments, the shoulder extenders substantially perpendicular to a longitudinal axis of the body.

[0045] In some embodiments, the protective member includes an expanding portion.

[0046] In some embodiments, the expanding portion is a cone shaped portion.

[0047] In some embodiments, the protective member includes a member extending near the one or more flow features.

[0048] In some embodiments, the member includes a rib that extend towards the one or more flow features. The member may include a plurality of ribs.

[0049] In some embodiments, the member is located inboard of the one or more flow features.

[0050] In some embodiments, the protective portion extends both downstream and upstream of the flow restrictors.

[0051] In some embodiments, in the event of the flow restrictor becoming impaired, flow will pass through another flow restrictor.

[0052] In a fourth aspect, the present disclosure provides a device for regulating pressure, the device including: a body having: an inlet; a lumen in communication with the inlet; and one or more flow features, the one or more flow features including a flow restrictor for restricting flow through the lumen, wherein in the event of one of the one or more flow features becoming impaired, flow will pass through another of the one or more flow features.

[0053] In a fifth aspect, the present disclosure provides a device for regulating pressure in respiratory therapy, the device including: a body having: an inlet; a lumen in communication with the inlet; and one or more flow features, the one or more flow features including a flow restrictor for restricting flow through the lumen, wherein the body is configured to releasably connect with a medical device.

[0054] In some embodiments, a protective portion is located proximate a distal end of the one or more flow features to assists in protecting the one or more flow restrictors from being impaired.

[0055] In some embodiments, the protective portion is located downstream of the one or more flow features.

[0056] In some embodiments, the protective portion projects away from the flow restrictor.

[0057] In some embodiments, the protective portion encompasses at least a portion of the distal end of the flow restrictor.

[0058] In some embodiments, the protective portion overhangs the flow restrictor.

[0059] In some embodiments, the protective portion extends in a direction that is in a similar direction from the inlet to the flow restrictor.

[0060] In some embodiments, the protective portion includes a protective member.

[0061] In some embodiments, the protective member has a free end distal from the flow restrictor.

[0062] In some embodiments, the protective member includes a projection.

[0063] In some embodiments, the projection projects from near part of the lumen forming the flow restrictor.

[0064] In some embodiments, the projection projects over the flow restrictor.

[0065] In some embodiments, the one or more flow features include an aperture. The one or more flow features may include a plurality of apertures.

[0066] In some embodiments, the protective member includes the aperture.

[0067] In some embodiments, the aperture is in fluid communication with atmospheric and / or ambient conditions.

[0068] In some embodiments, the aperture is offset from the flow restrictor.

[0069] In some embodiments, the aperture is larger in area than the flow restrictor.

[0070] In some embodiments, an area ratio of the flow restrictor to the aperture is at least 1 :15.

[0071] In some embodiments, the area ratio of the flow restrictor to the aperture is at least 1 :20.

[0072] In some embodiments, the aperture forms the flow restrictor.

[0073] In some embodiments, the protective portion extends from the lumen at a location of the flow restrictor and terminates at the aperture.

[0074] In some embodiments, the protective member includes a secondary aperture. The secondary aperture may include a plurality of secondary apertures.

[0075] In some embodiments, the secondary aperture is in a different plane to the aperture.

[0076] In some embodiments, the protective member includes a tertiary aperture. The tertiary aperture may include a plurality of tertiary apertures.

[0077] In some embodiments, the tertiary aperture is on an opposing plane to a plane of the aperture.

[0078] In some embodiments, an area ratio of the flow restrictor to the secondary aperture and the tertiary aperture is at least 1 :2.

[0079] In some embodiments, the area ratio of the flow restrictor to the secondary aperture and the tertiary aperture is at least 1 :5.

[0080] In some embodiments, an area ratio of the flow restrictor to the aperture, the secondary aperture and the tertiary aperture is at least 1 : 20.

[0081] In some embodiments, the area ratio of the flow restrictor to the aperture, the secondary aperture and the tertiary aperture is at least 1 : 25.

[0082] In some embodiments, the protective member forms a cuff.

[0083] In some embodiments, the cuff is radially outward from a neck of the body.

[0084] In some embodiments, a shoulder connects the cuff to the neck of the body.

[0085] In some embodiments, the shoulder includes the tertiary aperture.

[0086] In some embodiments, the shoulder extends substantially perpendicular to a longitudinal axis of the body.

[0087] In some embodiments, the protective member includes an expanding portion.

[0088] In some embodiments, the expanding portion is a cone shaped portion.

[0089] In some embodiments, the protective member includes a member extending near the one or more flow features. The member may include a plurality of members.

[0090] In some embodiments, the body includes an accessory port. The body may include a plurality of accessory ports.

[0091] In some embodiments, the accessory port is a sensor port.

[0092] In some embodiments, the sensor port is in communication with a sensor aperture that assist in avoiding flow jetting into the sensor port. The sensor aperture may comprise a plurality of sensor apertures.

[0093] In some embodiments, the sensor port is radially offset from the sensor aperture.

[0094] In some embodiments, the sensor aperture is radially offset from the flow restrictor.

[0095] In some embodiments, a cover is configured to close the accessory port.

[0096] In some embodiments, the cover is tethered to at least part of the body.

[0097] In some embodiments, one end of the body is tapered.

[0098] In some embodiments, the body includes a locking portion to releasably connect with the medical device.

[0099] In some embodiments, the locking portion include a protrusion that is configured to engage a recess of the medical device.

[0100] In some embodiments, the body includes a part mounting portion to allow a clip to be placed near the one or more flow features to assist in preventing the one or more flow features from being impaired.

[0101] In some embodiments, the part mounting portion includes a channel.

[0102] In a sixth aspect, the present disclosure provides a kit for a respiratory therapy system, the kit including: a plurality of devices, wherein one of the plurality of devices provides a different flow restriction compared to another of the plurality of devices.

[0103] In some embodiments, the plurality of devices are herein as described.

[0104] In a seventh aspect, the present disclosure provides a kit for a respiratory therapy system, the kit including: a device; and at least one or more of: a humidifier chamber; a patient interface; a tube; or a clip for attaching to the device

[0105] In some embodiments, the device is herein as described.

[0106] In some embodiments, the kit may include a flow generator.

[0107] In some embodiments, the tube is an inspiratory tube or expiratory tube.

[0108] In some embodiments, the expiratory tube is configured to connect to the patient interface.

[0109] In some embodiments, the device connects to the expiratory tube.

[0110] In an eighth aspect, the present disclosure provides a system including: a patient interface for delivering breathable gas to a patient; and a device in communication with the patient interface.

[0111] In some embodiments, the device is herein as described.

[0112] In some embodiments, the patient interface includes a seal forming structure configured to form a seal with a patient airway in use.

[0113] In some embodiments, the seal forming structure forms a seal with a patient's nasal and / oronasal.

[0114] In some embodiments, an inspiratory port or limb is in communication with the patient interface.

[0115] In some embodiments, an expiratory port or limb is in communication with the device and / or patient interface.

[0116] In a ninth aspect, the present disclosure provides a system including: a tube; and a device for regulating pressure in communication with the tube.

[0117] In some embodiments, the device is herein as described.

[0118] In some embodiments, the device is releasably connected to the tube and / or patient interface.

[0119] In some embodiments, the device is integrally formed with the tube and / or patient interface.

[0120] In some embodiments, the tube forms an expiratory limb.

[0121] In some embodiments, a sensor is in communication with the device to assist with regulating flow and / or pressure.

[0122] In some embodiments, wherein the sensor is a gas property sensor.

[0123] In a tenth aspect, the present disclosure provides a tube assembly including: a tube; and a device for regulating pressure in communication with the tube.

[0124] In some embodiments, the device is herein as described.

[0125] In some embodiments, the device is releasably connected to the tube.

[0126] In some embodiments, the device is integrally formed with the tube.

[0127] In an eleventh aspect, the present disclosure provides a patient interface assembly including: a patient interface; and a device in communication with an expiratory side of the patient interface, the device including: a body having: an inlet; and a lumen in communication with the inlet; and one or more flow features, the one or more flow features including a flow restrictor for restricting flow through the lumen, wherein downstream of the flow restrictor is a protective portion that assists in protecting the flow restrictor from being impaired.

[0128] In a twelfth aspect, the present disclosure provides a patient interface assembly including: a patient interface; and a device in communication with an expiratory side of the patient interface, the device including:a body having: an inlet; and a lumen in communication with the inlet, one or more flow features, the one or more flow features including a flow restrictor for restricting flow through the lumen; wherein a protective portion is located proximate a distal end of the one or more flow features to assists in protecting the one or more flow features from being impaired.

[0129] In a thirteenth aspect, the present disclosure provides a patient interface assembly including: a patient interface; and a device in communication with an expiratory side of the patient interface, the device including: a body having: an inlet; a lumen in communication with the inlet; and one or more flow features, the one or more flow features including a flow restrictor for restricting flow through the lumen, wherein in the event of one of the one or more flow features becoming at least partially obstructed, flow will pass through another of the one or more flow features.

[0130] In a fourteenth aspect, the present disclosure provides a patient interface assembly including: a patient interface; and a device in communication with an expiratory side of the patient interface, the device including: a body having: an inlet; a lumen in communication with the inlet; and one or more flow features, the one or more flow features including a flow restrictor for restricting flow through the lumen, wherein the body is configured to releasably connect with a medical device.

[0131] In some embodiments, the device is releasably connected to the patient interface.

[0132] In some embodiments, the device is integrally formed with the patient interface.

[0133] In a fifteenth aspect, the present disclosure provides a system including: a respiratory therapy device; and a device in fluid communication with the respiratory therapy device.

[0134] In some embodiments, the device is herein as described.

[0135] In some embodiments, the device is connected to an expiratory limb.

[0136] In some embodiments, the device is in fluid communication with a patient interface.

[0137] In some embodiments, the device and respiratory therapy device operate in conjunction to deliver a prescribed therapy pressure to a patient.

[0138] In some embodiments, the respiratory therapy device includes: a flow generator; a humidifier in fluid communication with the flow generator; a controller; and an at least one gases property sensor, wherein the controller is configured to control a flow rate and / or a pressure of a gas in a gas flow pathway based at least in part on an output of the at least one gases property sensor.

[0139] In some embodiments, in response to detecting a change in resistance to flow in the system, the controller is configured to adjust the flow rate so that pressure delivered to the patient remains substantially at the prescribed therapy pressure.

[0140] In a sixteenth embodiment, the present disclosure provides a patient interface assembly for delivering pressurised gas to a patient, the patient interface assembly comprising: a patient interface comprising a seal forming structure configured to form a seal with a patient airway in use, the seal forming structure having an inspiratory opening and an expiratory opening; an expiratory pressure device in fluid communication with the expiratory opening, the expiratory pressure regulator device comprising a lumen with a flow restrictor; and a protective portion configured to maintain an expiratory flow path from the expiratory pressure device.

[0141] In an embodiment, the inspiratory opening and the expiratory opening are located on opposing sides of the seal forming structure.

[0142] In an embodiment, the inspiratory opening and the expiratory opening are aligned.

[0143] In an embodiment, the seal forming structure includes a mask structure, nasal prongs or nasal pillows.

[0144] Further features and advantages of the present disclosure will become apparent from the following detailed description.BRIEF DESCRIPTION OF THE DRAWINGS

[0145] Various embodiments of the present disclosure will now be described, by way of examples only, with reference to the accompanying figures, in which:Figure 1 illustrates a perspective view of a device for regulating pressure, according to an embodiment of the present disclosure;Figure 2 illustrates a top view of the device shown in Figure 1 ;Figure 3 illustrates a cross sectional view of the device shown in Figure 2 along line a-a;Figure 4 illustrates a cross sectional view of the device shown in Figure 2 along line b-b ;Figure 5 illustrates a side view of a further device for regulating pressure, according to an embodiment of the present disclosure;Figure 6 illustrates a cross sectional side view of the further device shown in Figure 5;Figure 7 illustrates a cross sectional perspective view of the further device shown in Figure 5;Figure 8 illustrates a perspective view of the further device shown in Figure 5 connected to part of a connector from a tube, according to an embodiment of the present disclosure;Figure 9 illustrates a first cross sectional perspective view of the further device shown in Figure 8;Figure 10 illustrates a second cross sectional perspective view of the further device shown in Figure 8;Figure 11 illustrates a front cross-sectional view of the further device shown in Figure 5;Figure 12 illustrates a perspective view of a port cover, according to an embodiment of the present disclosure;Figure 13 illustrates a perspective view of a clip, according to an embodiment of the present disclosure;Figure 14 illustrates a perspective view of a further device for regulating pressure, according to an embodiment of the present disclosure;Figure 15 illustrates a side view of the further device shown in Figure 14;Figure 16 illustrates a cross sectional view of the further device shown in Figure 14;Figure 17 illustrates a top partial close-up perspective view of the further device shown in Figure 14;Figures 18 and 19 illustrate cross sectional view of the further device showing alternative outlet flow paths from the further device;Figure 20 illustrates a schematic view of a respiratory therapy system, according to an embodiment of the present disclosure;Figure 21 illustrates a schematic view of a further respiratory therapy system, according to an embodiment of the present disclosure;Figure 22 illustrates a perspective view of a nasal mask patient interface on a patient, according to an embodiment of the present disclosure; andFigure 23 illustrates a perspective of a nasal prongs patient interface on a patient, according to an embodiment of the present disclosure.DETAILED DESCRIPTION OF EMBODIMENTS

[0146] Positive airway pressure therapy (PAP) is a form of respiratory support that may be offered to patients having breathing difficulties. There are various types of PAP therapies. For instance, continuous PAP (CPAP) is a form of respiratory therapy in which a patient is supplied with a flow of gas via one or more conduits and a patient interface. The flow of gas may be provided by a gas source, for example, a gas source in the wall of a hospital or clinic, or by cylinders of compressed gas. Gas flow may be provided by other breathing assistance apparatuses, such as flow a generator or ventilator.

[0147] Bubble continuous positive airway pressure (bCPAP) is a type of CPAP which is utilised particularly for infant patients. The patient interface is connected to two conduits, an inspiratory conduit or limb, and an expiratory conduit or limb. The inspiratory conduit provides gas(es) to the patient via the patient interface. The expiratory conduit provides a passage for exhaled gases from the patient. The expiratory conduit is in communication with a bubble CPAP pressure regulator, or ‘bubbler’. The bubbler has a chamber to hold a column of water. Positive pressure is generated by placing the open end portion of the expiratory limb in the chamber at a known depth of water. The patient exhales against the set level of water pressure, creating positive end expiratory pressure (PEEP), which stents the airways open. The pressure provided can be controlled by varying the depth to which an end portion of the expiratory conduit is submerged in the column of water.

[0148] Regulating CPAP therapies in other ways, for example, without the use of a bubbler may provide alternative options to clinicians in tailoring patient treatments. However, regulating CPAP therapies without a bubbler provides other obstacles and challenges to overcome.

[0149] The present disclosure relates to a device for regulating pressure and, in particular, a device that minimises flow impairments(s), or provides redundancy in the event of flow impairments(s), whilst regulating positive end-expiratory pressure in a respiratory therapy system.

[0150] The device assists to regulate pressure by providing a restriction. The restriction may be static, or fixed. The device works with a respiratory therapy device, such as a flow generator, to maintain the pressure delivered to the patient within a desired range.

[0151] The device may be said to passively regulate pressure. The respiratory therapy device may actively regulate pressure in combination with the device.

[0152] The device may include a protective portion to minimise matter from blocking parts of the device that may obstruct the flow path, for example, expiratory or venting flow path. If a flow path through or out of the device becomes at least partially blocked, flow will pass through one or more other flow paths offering less flow resistance compared to the at least partially blocked flow path. In addition, the device passively regulates pressure by providing a restriction. The device works with a respiratory therapy device, including a flow generator, to maintain the pressure within a desired range across a desired flow rate of gases. The flow generator actively regulates pressure in combination with the device.

[0153] Figure 1 illustrates a perspective view of a device 10a for regulating pressure, according to an embodiment of the present disclosure. In this regard, the use of a reference numeral followed by a lower case letter in this specification typically indicates alternative embodiments of a general element identified by the reference numeral. Thus, for example, device 10a is similar to but not identical to device 10b. Further, references to an element identified only by the numeral refer to all embodiments of that element. Accordingly, a reference to devices 10, for instance, is intended to include both the device 10a and the device 10b.

[0154] The device 10a includes a body 100a. The body 100a includes an inlet 200a, a lumen 300a, outlet(s) 400a, a flow restrictor 500a and a protective portion 600a. The outlet(s) 400a and the flow restrictor 500a form flow features 110a of the body 100a. The body 100a may include other parts connected thereto.

[0155] The inlet 200a is in fluid communication with the lumen 300a. The inlet 200a is located at one end of the body 100a. In this regard, the body 100a includes an inlet connector 250a. The inlet connector 250a includes a releasable connecting portion 260a. In this embodiment, the releasable connecting portion 260a includes a releasable connecting surface 270a. The releasable connecting surface 270a is in the form of a tapering cylindrical surface. The tapering cylindrical surface is configured to releasably connect with a tube whilst providing a substantially airtight seal. The tube may be an expiratory tube / limb. In other embodiments, the releasable connecting portion 260a may connect with an opening, outlet, for example expiratory or venting outlet, or expiratory limb of a patient interface.

[0156] The lumen 300a provides one or more flow paths from the inlet 200a to the outlet(s) 400a. The lumen 300a is substantially cylindrical in this embodiment but other shapes may be adopted. The lumen 300a tapers towards the flow restrictor 500a. The lumen 300a expands from the flow restrictor 500a towards the outlet(s) 400a. That is, part of the lumen 300a converges towards the axis 12a whilst another part diverges away from the axis 12a.

[0157] The tapering nature of the lumen 300a may assist with (for example): i) avoiding the collection of condensate; and / or ii) attenuating sound to reduce unwanted noise. However, as will appreciated, the lumen 300a may take other shapes.

[0158] The lumen 300a includes the flow restrictor 500a. The flow restrictor 500a is located between the inlet 200a and outlets 400a. The flow restrictor 500a restricts fluid flow through the lumen 300a. In the example shown in Figure 1 , the flow restrictor 500a is in the form of an aperture 510a. The flow restrictor 500a may take other forms, including being a separate restrictive component.

[0159] The flow restrictor 500a is the smallest cross-sectional area, or diameter, of the lumen 300a. The cross-sectional area of the outlet(s) 400a is larger than the flow restrictor 500a.

[0160] The (restrictive) aperture 510a may be approximately 3.15mm as a minimum in diameter. In some examples, the aperture 510a is between about 1 mm and 5mm or between about 2mm and 4mm, or between about 3mm and about 4mm. In some examples, the aperture 510a may be greater than about 3mm.

[0161] Being one relatively large aperture, the aperture 510a may be more difficult for substances with low viscosity to block compared to smaller holes (eg, flow features 110b). The shape of the aperture 510a may vary but it is in the form of a circular hole for this embodiment. That is, when the device 10a is viewed from an end, for example, the aperture 510a appears as a circular opening. The aperture 510a can be any shape and size that offers a desired resistance to flow to maintain the desired pressure to the patient. As further discussed below, the size and / or shape of the flow restrictor 500a is tuned to assist in providing a desired pressure, for example, PEEP. The desired pressure may be a parameter set by a user for the respiratory therapy system. For example, the pressure may be set at the respiratory therapy device. For a given respiratory therapy system with a given resistance to flow, smaller apertures 510a may generally provide a higher PEEP whilst larger apertures 510a provide lower PEEP. For example, to maintain a set PEEP, larger aperture 510a may require the flow generator of the respiratory therapy system to generate a higher pressure to allow flow to move through the system.

[0162] The flow restrictor 500a is sized to, amongst other things, enable adequate CO2 clearance. CO2 clearance is achieved by the flow rate passing through the system, including the patient interface, and out of the flow restrictor 500a. In an example, the flow rate may be a parameter set by the user, for example at the respiratory therapy device. In another example,the flow may be a respiratory therapy system determined value due to a pre-stored pressureflow relationship. For a given flow rate generated in the respiratory therapy system, smaller apertures 510a may provide a higher PEEP and larger aperture(s) 510a may provide a lower PEEP (as indicated above).

[0163] The flow restrictor 500a of the device is sized to enable adequate flow and pressure to be delivered to the patient. In an example, an area ratio of the size of the opening of the flow restrictor 500a to the opening of the outlet(s) 400a may be at least 1 : 20. In other examples, the area ratio of the size of the opening of the flow restrictor 500a to the opening of the one more outlets 400a may be between about 1 :1 and 1 :50, or between about 1 :10 and 1 :40, or between about 1 :15 and 1 :30.

[0164] The flow restrictor 500a may provide a resistance to flow between 1 cm H2O and 6cm H2O at 8 litres per minute (LPM) of flow. In some examples, the flow restrictor 500a may provide a resistance to flow between 1cm H2O and 40cm H2O between flows of about 1 LPM and 70 LPM.

[0165] The flow restrictor 500a may be sized to mitigate noise generation as flow passes through and out of the device 10a in use. The flow restrictor 500a may be sized such that the patient's inspiratory demand can be met, without creating too high a backpressure in the system. The back pressure must not exceed that which can be overcome by the flow generator in the system. This means for a desired CPAP range between 2cmH2O - 2OCIT1H2O, the flow generated must be sufficient to meet the patient's inspiratory demand.

[0166] Flow generators are discussed further below and may, for instance, operate by mechanical means. In the present disclosure, a flow generator may provide flow via a blower, ventilator, or the like. In other embodiments, gas may be sourced from other gas sources (e.g., pressurised containers, a wall source of gas etc); however, a flow generator may have advantages. For example, the flow generator reduces the risk of gases running out, as it sources ambient air (optionally in combination with supplemental / auxiliary gases, such as oxygen). Thus with a flow generator, there is less risk of disruption in therapy due to a gas source being empty.

[0167] The currently disclosed device 10 is generally intended for use with a flow generator which can operate with varied flow. The flow generator may adjust the flow as the patient is breathing to meet therapy pressure requirements. For example, the flow generator may vary flow to meet CPAP pressure requirements set by a user, such as clinician. The flow generatormay vary flow to provide gases to the patient at different pressures. For example, a first pressure, such as a set inspiratory airway pressure, on detection of a start of a spontaneous breathing cycle, and a second pressure, such as a set expiratory pressure, during expiration.

[0168] More broadly, the device 10 is part of a breathing assistance apparatus which may provide one or more respiratory therapies, e.g. PAP / CPAP and including variable flow CPAP. By way of further example, Figure 20 shows a breathing assistance apparatus with flow generator. The flow generator may comprise a blower. In another example, the flow generator may comprise a flow modulator such as a proportional valve or a flow meter used in combination with high pressure gas source. In a further example, the flow generator may comprise one or more of a piston or bellows. The flow generator may include other types of flow generators. The flow generator may be separately connected to a humidifier. Figure 21 shows a breathing assistance apparatus with an integrated flow generator and humidifier.

[0169] In a system such as shown in Figure 20 or 21 , the flow generator 2400a, 2400b generates flow and pressure to meet the patient respiratory requirements. For example, a desired pressure for PAP may be set, and the flow generator 2400 is controlled, such as by a controller (not shown) to achieve the set desired pressure. Downstream of the flow generator 2400a, 2400b may be respectively components comprising tubing 2450a, 2450b, humidifier 2500a, 2500b, inspiratory tube 2200a, 2200b, of which a portion may be a heated conduit 2250a, 2250b, expiratory tube 2300, patient interface 2100 and the device 10.

[0170] Each of these components may have an associated resistance to flow (RTF or RTQ). That is, the circuit comprising the components has a circuit RTF. In use, the flow generator 2400 operates to supply pressure that overcomes the circuit RTF in order to achieve the desired set pressure. In other words, the circuit RTF subtracted from the supplied pressure results in the pressure provided to the patient.

[0171] The respiratory therapy device, for example flow generator 2400, may have a controller and a gas property sensor 2600. The respiratory therapy device operates with the device 10. The restrictor 500 of the device 10 may be tuned to provide a set patient pressure and / or expiratory flow rate.

[0172] The patient may be prescribed a therapy pressure, which is delivered by the respiratory therapy device. If the resistance to flow through the respiratory therapy system changes, the sensor(s) 2600a, 2600b in the respiratory therapy device detects a change in pressure. The controller may adjust flow rate generated via the flow generator so that the pressure delivered topatient remains at the prescribed or desired level. The flow rate may be adjusted, for example by the controller increasing or decreasing the rpm of the blower in the flow generator 2400.

[0173] In other words, the controller is configured to control the flow generator 2400 according to pressure control, wherein pressure control comprises controlling the flow generator to provide the flow of gases at a set pressure. The flow of gases may be varied to provide the set pressure.

[0174] The flow controller may be configured to control the flow generator 2400 according to flow control, wherein flow control comprises controlling the flow generator to provide the flow of gases at a set flow rate. The pressure may be varied to provide the set flow rate.

[0175] The respiratory therapy device may allow adjustment and control over characteristics of the gases flow, including flow rate, pressure etc. Sensors 2600, such as flow sensors and / or pressure sensors, may be used to measure characteristics of the gases flow. In some examples, the respiratory therapy device is configured to be connected to and / or comprises at least one gases property sensor 26OO.The controller may be configured to calculate a determined flow rate and / or a determined pressure of the gases in a gases flow pathway, based at least partly on an output of the at least one gases property sensor 2600. The controller may be configured to generate one or more alarms based on the determined flow rate and / or determined pressure. The one or more alarms may comprise: a) an over pressure alarm; b) an elevated pressure alarm; c) a low pressure alarm; d) an excessive leak alarm; e) a blockage alarm; f) an apnea alarm; or g) any combination of a) to f).

[0176] The circuit RTF may be tuned to achieve a desired circuit RTF by varying the RTF of flow through the device 10. In the case where the device 10 is restrictor 500a, the RTF is determined by the size of the restrictor 500a.

[0177] PEEP is experienced by the patient at the end of the exhalation phase. With the above in mind, it will be appreciated that PEEP will also be determined at least in part by the associated flow area of the aperture 510a. The aperture 510a may be the restriction. That is, the sum total flow area of the aperture 510a will assist in obtaining the desired PEEP. The flow area of a number of smaller apertures 510a may be greater than one large aperture 510a. Accordingly, the larger flow area of the smaller apertures may provide a relatively lower predetermined PEEP.

[0178] As indicated above, the desired PEEP is also based on flow generator settings and constraints. In other words, the flow generator may play a part in obtaining the desired PEEP. For example, a predetermined PEEP may be set and the flow generator can vary flow to achieve the desired PEEP, compensating for other factors including blockages.

[0179] At least a portion of the protective portion 600a may be located downstream from the flow restrictor 500a. The protective portion 600a assists in protecting the flow restrictor 500a from a blockage. The protective portion 600a is located proximate a distal end of the flow restrictor 500a. That is, further along the flow path from the flow restrictor 500a, in a flow direction moving away from the inlet 200a, the protective portion 600a provides a guard to deflect foreign material from entering the flow restrictor 500a. In this regard, at least part of the protective portion 600a is located further along the axis 12a in a direction away from the inlet 200a.

[0180] The protective portion 600a may project away from the flow restrictor 500a. In this example, the protective portion 600a encompasses a distal end of the flow restrictor 500a. In this regard, at least a portion of the protective portion 600a overhangs the flow restrictor 500a. That is, the protective portion 600a protrudes longitudinally away from the adjacent flow restrictor 500a.

[0181] The protective portion 600a may assist in mitigating the risk of matter entering, or items surrounding, the flow restrictor 500a in order to impair it. For example, material may not be able to follow path (a) into the flow restrictor 500a due to the nature of the protective portion 600a. On this basis, the protective portion 600a includes a protective member 605a. The protective member 605a has a free end distal from the flow restrictor 500a. The protective member 605a forms a projection in this example. The projection projects from near part of the body 100a forming the flow restrictor 500a.

[0182] The protective member 605a may include protective surface(s) 610a that assist in reducing directions for matter to travel and block the flow restrictor 500a. Protective surfaces 610a, may reduce likelihood for matter to follow the axis 12a to potentially enter the flow restrictor 500a. Furthermore, the protective portion 600a makes it more difficult for items, including blankets, fingers etc., to cover the device 10a in a manner that would block the flow restrictor 500a. In this scenario, blocking the flow restrictor 500a takes the form of not allowing gas to suitably pass therethrough to reach atmospheric and / or ambient conditions.

[0183] The protective surfaces 61 Oa include radial surface 620a. The radial surface 620a is substantially circular but, in other embodiments, it would be appreciated that the protective surfaces 610a may be a different shape. The protective surfaces 610a are located outboard from the flow restrictor 500a. That is, in this embodiment, protective surfaces 610a are located further away from the axis 12a compared to the flow restrictor 500a.

[0184] In this embodiment, the protective surfaces 610a extend both upstream and downstream of the flow restrictor 500a. That is, the protective surfaces 610a extend, for example, more towards the inlet 200a and the outlets 400a compared to the flow restrictor 500a.

[0185] A (primary or expiratory) flow direction through the device 10a is shown by the arrows on the axis 12a in Figure 1 . The arrows are pointing in a downstream or expiratory direction (ie, the direction from an inlet towards an outlet). The protective surfaces 610a extend beyond the flow restrictor 500a in an axial direction. The protective surfaces 610a also extend radially with respect to the axis 12a to surround the flow restrictor 500a. The protective surfaces 610a, in this example, are therefore also tubular. The tubular protective surface 610a may have a circular cross section where the cross section is taken perpendicular to the axis 12a. The protective surface 610a may form a quadrilateral cross-section.

[0186] A first surface 630a extends transversely to the radial surface 620a. More specifically, the first surface 630a extends substantially perpendicular to the radial surface 620a. The first surface 630a forms a radial ring on the end of the protective portion 600a. The shape of the first surface 630a, together with its distance from the flow restrictor 500a, may be varied as part of guarding the flow restrictor 500a from blockage.

[0187] As shown further in Figures 2 to 4, the protective surfaces 610a may include one or more members 640a that also assist in protecting the flow restrictor 500a from blockage. That is, the members 640a provide an obstruction for matter heading towards the flow restrictor 500a from the outlets 400a. The members 640a may also act as a safety feature by preventing the outlet(s) 400a from being incorrectly connected to other item(s). The members 640a are in the form of ribs in this embodiment.

[0188] The members 640a extend from an inner surface of the protective portion 600a towards the flow feature 110a in the form of the flow restrictor 500a. The members 640a extend from an inner surface of the radial surface 620a towards the flow restrictor 500a. That is, the members 640a extend from an inner surface of the protective portion 600a. As shown in Figure 2, the members 640a are equal distances apart around the protective portion 600a. The members640a include a tapering surface that is angled towards the flow restrictor 500a. In other embodiments, it would be appreciated that the number of members 640a may be more or less, and they could, for example, be randomly distributed as opposed to equal distances apart. The shape of the members 640a may also vary.

[0189] The protective portion 600a may include an outlet 400a. The protective portion 600a may terminate at the outlet 400a. The outlet 400a may comprise multiple outlets 400a. Outlet(s) 400a may form part of the protective portion 600a in the device 10a. The outlets (or apertures) 400a include one or more of both types of first outlet apertures 410a and second outlet apertures 420a. The first outlet aperture 410a is located at one end of the protective portion 600a. The first outlet aperture 410a is located at a terminal end of device 10a.The first surface 630a assists in defining the first outlet 410a. The first surface 630a may be annular.

[0190] The first outlet aperture 410a extends transversely to the axis 12a, in the same manner as the aperture 510a. The first outlet aperture 410a is substantially concentric with the aperture 510a and / or the inlet 200a. The first outlet aperture 410a is larger than the inlet 200a and each of the second outlet apertures 420a. In other embodiments, the first outlet aperture 410a may be smaller (in area) than the inlet 200a and / or second outlet aperture(s) 420a.

[0191] The second outlet apertures 420a are located in the outer surface(s) of the body 100a. More specifically, the second outlet apertures 420a are located in the protective surface(s)610a, namely radial surface 620a. The second outlet apertures 420a extend transversely to the first outlet aperture(s) 410a. In other words, the second outlet apertures 420a extend in a nonparallel manner to the first outlet aperture 410a.

[0192] The second outlet apertures 420a substantially extend in a manner that is parallel to the axis 12a. The first outlet apertures 410a extend perpendicular to the axis 12a. The second outlet apertures 420a are located between pairs of the members 640a. The second outlet apertures 420a assist in improving the robustness of the device 10a. The second outlet apertures 420a provide multiple flow paths for flow to exit the device 10a, in the event aperture 410a is fully or partially occluded. That is, in the event the first outlet aperture 410a is at least partially blocked, further flow can pass to the second outlet apertures 420a which (collectively) provide flow paths of lesser resistance compared to the at least partially blocked first outlet aperture 410a.

[0193] Providing multiple flow paths assists in maintaining the predetermined PEEP, and mitigates risk of high PEEP due to a blockage. The predetermined PEEP may be between 2cmH2O to 20cmH2O. As part of this range, the predetermined PEEP may also be between3cmH2O to 15cmH2O. Similarly, the first outlet aperture 410a may provide a suitable outlet in the event one or more of the second outlet apertures 420a are blocked.

[0194] Figure 5 illustrates a side view of a further example device 10b for regulating pressure. Like the device 10a, the device 10b includes a body 100b. The body 100b is substantially cylindrical. That is, the body 100b is substantially tubular about a central axis 12b.

[0195] The body 100b has sections of different outer diameters with respect to the central axis 12b. The body 100b includes an inlet 200b and a lumen 300b. The device 10b also includes flow features 110b having flow restrictor(s) 500b that form outlet(s) 400b. A protective portion 600b is also connected downstream of the flow features 110b. In this embodiment, the body 100b is integrally formed to include the inlet 200b, lumen 300b, flow features 110b and protection portion 600b but, in further embodiments, these parts may be releasably connected. The device 10b may also optionally include an accessory port 700b, connector cover 800b and a clip 1000b.

[0196] The inlet 200b is located at one end of the body 100b. The inlet 200b is substantially circular. The inlet 200b is configured to receive, or otherwise connect with, a component such as the terminal end of a tube. The inlet 200b may be configured to connect with an expiratory or venting port of the patient interface. The inlet 200b may be configured to connect with an expiratory limb of the patient interface.

[0197] The internal surface of the body 100b extending from the inlet 200b provides connecting features to engage the component, such as tube, patient interface. As shown further in Figures 6 to 7 and 9 to 10, the device 10b includes an inlet connector 250b that has a releasable connecting portion 260b.

[0198] The releasable connecting portion 260 includes a connecting surface 270b. The connecting surface 270b includes a protrusion in this example. The connecting surface 270b is configured to engage with one more parts of another component to provide a releasable locking connection. For instance, the connecting surface 270b may engage with one or more recesses to releasably connect thereto. The connecting surface 270b may also form one or more recesses in other examples. In this regard, the releasable connecting portion 260b may form a releasable locking portion (with associated locking surface(s)).

[0199] In Figures 8 to 10, the device 10b is releasably connected to part of a connector from a tube. The device 10b can be releasably connected in a manner that allows it to be disconnectedwhen desired. In the examples shown in Figures 9 and 10, the device 10b also provides alignment features 280b for aligning the device 10b into a certain orientation for connection with other component(s). In this embodiment, these components include one or more intermediate connectors.

[0200] In the example shown in Figures 9 and 10, an intermediate connector includes a connecting adapter with at least one locking finger. Each locking finger has a locking recess on an outer surface thereof. Each locking finger extends longitudinally from an end of a body of the adapter. In the example shown, each locking finger widens from its end to its base. The end of each locking finger may have a rounded or curved profile.

[0201] The alignment features 280b are configured to guide the locking fingers into position for engagement. In the example shown, the alignment features 280b comprise alignment tab(s) on an inner surface of the inlet end of the device. The alignment features 280b may take various forms, such as protrusion or ridge formed on the interior surface.

[0202] The alignment feature 280b may be configured to cause the connecting adapter to rotate until the locking tab of connecting surface 270b and locking recess are aligned.

[0203] In other embodiments, the locking arrangement for the device 10 may include a locking / engagement mechanism as described in WO2013 / 022356 and / or WO2017037660 (which are incorporated herein in their entirety). In further embodiments, the inlet 200b may be non-releasably connected to another component.

[0204] The lumen 300b extends from the inlet 200b to the flow features 110b. The flow features 110b comprise flow restrictors 500b that form outlets 400b for gases to exit the device 10b. The flow features 110b may comprise multiple apertures. That is, in an example embodiment of the device the flow restrictor(s) 500b may also be the outlet(s) 400b.

[0205] In the example shown in Figures 6 to 7 and 9 to 10, the lumen 300b is substantially cylindrical and reduces in size (or diameter) towards the flow features 110b. The flow features 110b include a plurality of outlets (or (outlet) apertures) 400b / flow restrictors 500b in a wall of the body 100b. The flow features 110b are tuned to provide a predetermined PEEP. That is, the shape of the flow features 110b are configured to provide a certain resistance for restricting flow through the lumen 300b. That is, the flow features 110b provide a desired pressure drop to regulate the flow through at least part of the lumen 300b.

[0206] The flow features 110b provide a plurality of apertures spaced around an axis 12b. In this regard, if one or more of the flow features 110b becomes at least partially blocked, flow can pass through one or more other flow features 110b (offering a flow path of less resistance). This also reduces the risk of over pressurising flow to the patient. The predetermined PEEP may not be substantially affected in this scenario and, as such, the device 10b provides further redundancy in the event of a blockage.

[0207] In addition, the flow generator may vary the flow to keep the desired PEEP. That is, in practice, should the flow features 110b become blocked, the flow generator may be controlled to reduce flow into the system 1000. By reducing the flow, the pressure is prevented from increasing to above a setpoint or an acceptable range. In order to mitigate risk of a blockage of the flow features 110b, the protective portion 600b extends downstream of the flow features110b. That is, the protective portion 600b extends, for example, from near the flow features 110b in a direction away from the inlet 200b that is parallel with the axis 12b.

[0208] The protective portion 600b includes a protective member 605b. The protective member 605b has a free end distal from the flow features 110b. The protective member 605a forms a projection in this example. The projection projects from near part of the body 100a forming the flow features 110b. The protective member 605b may include a member 640b. The member 640b is positioned inboard from the flow features 110b. The member 640b may be located closer to the axis 12b compared to the flow features 110b.

[0209] At one end, the member 640b extends linearly away from the flow features 110b. In this regard, the member 640b extends parallel with the axis 12b. In the example shown, the member 640b is substantially cylindrical. The protective member 605b includes protective surfaces 610b.

[0210] At another end of the member 640b distal to the inlet 200b, a radial surface 620b is located. The radial surface 620b is formed from a part projecting from the member 640b. The radial surface 620b is located further away from the axis 12b compared to surfaces of the member 640b. Accordingly, the radial surface 620b has a greater diameter compared to the member 640b. Adjacent the radial surface 620b is a first surface 630b that extends transversely to the radial surface 620b and / or the member 640b. The first surface 630b, together with the radial surface 620b and member 640b, assist in guarding the flow features 110b from blocking. For example, matter would be prevented from taking flow path (b) into the flow features 110b. In addition, blocking from, for example, fingers, bedding and so forth is minimised with the protective portion 600b.

[0211] In the embodiment of at least Figures 5 to 7, the restrictor 500b forms the outlet 400b. Outlet 400b allows flow to exit the device 10b to atmosphere.

[0212] The outlet(s) 400b are on a first face that is perpendicular to the axis 12b. The first face is spaced apart from a second face of the protective portion 600b. In the embodiment shown, the first face and second face are axially offset and opposite to each other. First and second faces are spaced apart by member 640b. In the embodiment shown, member 640b forms a neck that connects the first face and the second face.

[0213] The distance between the first face and the second face is dimensioned such that fluids (such as gases, condensate) may exit the device 10b. The distance may be sufficiently small to mitigate risk of objects such as bedding or a user’s fingers, to enter and block the outlets 400b. The distance between the first face and the second face may be, for example, less than about 10mm or less than about 5mm or less than about 2mm.

[0214] As also shown in Figures 6 to 10, the protective portion 600b includes the accessory port 700b, but it may be located in other parts of the body 100b. The accessory port 700b may be used as a sensor port in this embodiment; however, other uses may be adopted. The accessory port 700b may be a sampling port. The accessory port 700b may be substantially circular. The accessory port 700b may be tapered. The accessory port 700b is in fluid communication with a plurality of accessory apertures 750b. The accessory apertures 750b are in fluid communication with the lumen 300b. The member 640b may house the accessory port 700b and the accessory aperture 750b.

[0215] In the example shown in Figure 11 , the accessory apertures 750b are located inboard from the flow features 110b. The accessory apertures 750b are therefore, in this example, radially offset from the flow features 110b. The accessory apertures 750b are positioned around the axis 12b at equal distances apart. In other words, the distance between adjacent apertures 750b, around the axis 12b, are substantially equal. The accessory apertures 750b assist in preventing gases jetting into the accessory port 700b. That is, the accessory apertures 750b are positioned in a manner that slows down the flow into the accessory port 700b. This gives a better indicator of pressure at the patient as dynamic flows are minimised. In this embodiment, the accessory apertures 750b are outboard of the accessory port 700b. This therefore forces the flow to travel along a non-linear path into the accessory port 700b, restricting the flow. In other embodiments, other forms of resistance may be applied to the flow entering the accessory port 700b.

[0216] In order to shut the accessory port 700b when its use is not required, at least part of the port cover 800b may be used. As one example, the port cover 800b in Figure 12 includes a sealing portion 810b, protrusion 820b, a tether 830b and a connecting portion 840b. The sealing portion 810b is located on the protrusion 820b in this embodiment. The sealing portion 810b is configured to seal against wall(s) of the accessory port 700b. This prevents airflow from escaping the accessory port 700b. The protrusion 820b is configured to be inserted into the accessory port 700b in order to: i) releasably retain it; and ii) keep the sealing portion 810b engaged with the walls of the accessory port 700b. The protrusion 820b is tapered. To attach the port cover 800b to part of the body 100b, the connecting portion 840b may be placed over at least part of the body 100b. A tether 830b connects the connecting portion 840b to the sealing portion 810b and / or protrusion 820b.

[0217] Figure 13 illustrates an example of a clip 1000. The clip 1000 includes a body 1010 that is configured to be received into a part mounting portion 120b of the body 100b. The part mounting portion 120b is in the form of a clip receiving portion in this embodiment. The part mounting portion 120b is located between part of the protective portion 600b and a main portion of the body 100b. The member 640b assists in forming the part mounting portion 120b. The part mounting portion 120b provides a channel to receive the clip 1000.

[0218] The clip 1000 includes a first arm 1100, a second arm 1200 and a clip locking portion 1300. The first arm 1100 and the second arm 1200 are resiliently flexible such that they can: i) expand over the part mounting portion 120b; and ii) retract to be positioned in the channel formed by the part mounting portion 120b. Once on the part mounting portion 120b, the clip locking portions 1300, on the end of the arms 1100, 1200, can be interlinked. This assists in preventing the clip 1000 in falling from the clip receiving portion 120b. In addition, once on the part mounting portion 120b, the clip 1000 also assists in preventing matter from blocking the flow features 110b.

[0219] Furthermore, a locating portion 1400 on the clip may be used to releasably attach the device 10 in a particular location. For example, the locating portion 1400 may be used to releasably attach the device 10 to a patient bed. In this regard, the clip 1000 clip can provide tube management - either to bedding or the like, or connection to an inspiratory tube, tube connector or the patient interface itself, to avoid the expiratory tube hanging unwantedly into certain spaces. The clip 1000 shown is one example only. Other clips could be adopted, including a ring that’s able to fit on, rotate about the part mounting portion 120b, and prevent blocking of the flow features 110b.

[0220] Figures 14 to 17 illustrate a perspective view of a further device 10c having a body 100c, according to an embodiment of the present disclosure. The device 10c includes an inlet 200c, a lumen 300c, (primary, secondary and tertiary) outlet(s) 400c, a flow restrictor 500c and a protective portion 600c. The outlet(s) 400c and / or the flow restrictor 500c form flow features110c of the body 100c.

[0221] The inlet 200c is configured to be connected to a further part (not shown). For example, the further part can include an expiratory port or expiratory tube / limb. The further part is adapted to communicate gas flow to the inlet 200c. The inlet 200c includes an inlet connector 250c. The inlet connector 250c includes a connecting portion 260c. The connecting portion 260c is configured to provide a releasable connection in this embodiment but this may be fixed in further examples. The connecting portion 260c includes connecting surface(s) 270c. The connecting surface(s) 270c are adapted to releasably connect to the further part (as part of communicating gas flow).

[0222] In the example shown in Figures 16, 18-19, the connecting portion 260c also includes alignment feature(s) 280c. The alignment features 280c assist in aligning the connecting portion 260c with the further part, as part of releasably connecting the device 10c with the further part. It can be appreciated that connecting portion 260c is an example only and any connecting portion having features to permit engagement / connection with the further part may be an option. The further part may be an expiratory tube 2300 or expiratory or venting port.

[0223] The lumen 300c provides a gas flow pathway from the inlet 200c to the outlet(s) 400c. The lumen 300c includes a number of sections where the diameter therebetween is different. The lumen 300c reduces towards the flow restrictor 500c, as shown further in Figure 16. The lumen 300c may taper inwardly from the inlet 200c towards the flow restrictor 500c.

[0224] The flow restrictor 500c may be configured to deliver effective therapy for a given patient, using a given respiratory therapy apparatus. The flow restrictor 500c may be configured, for example by sizing of one or more features, to achieve a predictable / desired pressure range from a given flow rate. Ideally, the respiratory therapy apparatus, including the flow restrictor 500c, may conserve energy / resources, e.g. avoid excessive use of 02 (if added in conjunction with the ambient air stream). This may require appropriate ramp up and ramp down from the flow generator to compensate.

[0225] With this in mind, the flow restrictor 500c has an outlet in the form of aperture 510c. Size of the aperture 510 can be configured to suit patient requirements and / or components of the respiratory therapy system.

[0226] If the aperture 510c is oversized, the flow generator may be required to provide higher flow rate(s) to meet patient inspiratory demand, which may lead to inefficiencies in the system. For example, a flow generator motor may need to operate at higher speeds to achieve desired pressure, and / or where the system has supplementary oxygen added to the gases stream, a larger amount of oxygen may be required to achieve a similar fraction of inspired oxygen in the patient.

[0227] Under sizing the aperture 510c may cause overpressure of the system and / or to the patient. Whilst a lower flow rate from the flow generator may achieve a desired PEEP, if the flow is too low, the therapy may not be as effective.

[0228] By way of example only, the size of the aperture 510c may be such that, when a flow generator is set to deliver 8L / min, approximately 3cmH2O of pressure is delivered at the patient interface (e.g. mask, prongs etc). In other words, the size of the aperture 510c may be set to deliver a desired PEEP for a given flow rate. Accordingly, finding a suitable pressure drop across the flow restrictor 500c is advantageous. The size of the aperture 510c may range between 2mm to 4mm and anywhere in between, including 2.1 mm to 3.9mm, 2.2mm to 3.8mm, 2.3mm to 3.7mm, 2.4mm to 3.6mm, 2.5mm to 3.5mm, 2.6mm to 3.4mm, 2.7mm to 3.3mm and 2.8mm to 3.3mm. It would also be appreciated that the aperture 510c may be considered as an outlet.

[0229] At least a portion of the protective portion 600c is located downstream from the flow restrictor 500c. This assists in protecting the flow restrictor 500c from a blockage and, more specifically, the aperture 510c from blockage. The protective portion 600c includes a protective member 605c. The protective portion 600c may generally project away from the flow restrictor 500c. In this regard, the protective member 605c forms a projection. The protective portion 600c may overhang the flow restrictor 500c and may encompass a least a portion of the flow restrictor 500c. The protective member 605c has a free end distal from the flow restrictor 500c. The protective member 605c includes protective surface(s) 610c.

[0230] In the example shown in Figures 14-19, the protective surface(s) 610c include radial surface(s) 620c. At least part of the radial surface(s) 620c may diverge away from the flow restrictor 500c, in a downstream direction. As shown in Figure 15, at least part of the radialsurfaces 620c diverge away from the axis 12c. In this regard, the protective member 605c includes an expanding portion 607c. The expanding portion 607c is generally cone shaped. The protective member 605c may be considered a cuff projecting from part of the body 100c.

[0231] In some embodiments, the protective surface(s) 610c may be a quadrilateral or other polygonal shapes. In some embodiments, the protective surface 610c may be a constant cross- sectional shape throughout its length.

[0232] In the example shown in Figure 15, the protection portion 600c includes a member 640c. The member 640c extends over at least part of the flow restrictor 500c. The member 640c extends substantially from one side of the protective portion 600c to another side of the protective portion 600c. That is, the member 640c extends, for example from one side of the radial surface(s) 620c to another side of the radial surface(s) 620c.

[0233] The member 640c includes a first edge 642c. The first edge 642c extends at least partly above / outwardly from another portion of the protective surface(s) 610c. That is, the first edge 642c extends a distance 'a' above a first surface 630c of the protective portion 600c. The distance 'a' is approximately 2mm in this embodiment but this may vary. The first edge 642c extends outwardly with reference to the first surface 630c.

[0234] The first surface 630c may be substantially planar. In this regard, the member 640c prevents occlusion of the aperture 410c. The first edge 642c may be arcuate in shape, for example, and may have a convex curvature or be parabolic. The nature of the first edge 642c assists in: i) preventing occluding the outlet(s) 400c with a finger or other surface(s); and ii) other components being incorrectly connected to the outlet(s) 400c. In other words, the member 640c stops undesirable connections with the device 10c and potential obstructions to maintain the desired PEEP.

[0235] The member 640c also includes a second edge 644c. The second edge 644c includes a portion that is offset from the aperture 510c. The portion of the second edge 644c is offset from the flow restrictor 500c (or aperture 510c) by a distance 'b' (in a downstream direction). Distance 'b' is selected based on a compromise between noise and flow resistance. When distance 'b' is shorter, noise is reduced but flow resistance is increased. On the other hand, increasing distance 'b' can provide less flow resistance but more noise. The second edge 644c provides a recess in the member 640c. As shown in Figure 16, the recess is symmetrical about the flow restrictor 500c. As shown further in Figures 17 to 19, the second edge 644c projects partly over the flow restrictor 500c.

[0236] The member 640c may take a variety of shapes. In the example shown in Figures 14-19, the member extends linearly between opposing radial surfaces 620c and / or towards the opening 400c. However, in other examples, the member 640c may extend linearly and / or non- linearly. For instance, the member 640c could form: i) an 'S' shape; ii) a shape having both linear and curved surfaces; and / or iii) a zig-zag shape.

[0237] As shown further in Figures 18 and 19, flow may exit the device 10c in a variety of ways. That is, the device 10c provides multiple outlets 400c (or apertures) which assist in reducing a risk of blockage of the device 10c. The outlets 400c provide a larger opening area compared to the flow restrictor 500c. The outlets 400c include first aperture(s) 410c, second aperture(s) 420c and third aperture(s) 430c. The first aperture 410c is located at one end of the protective portion 610a. The member 640c separates / divides the first aperture 410c.

[0238] In the example shown, the first aperture 410c provides a vent orifice. In one or more examples, the first aperture 410c may be considered an open distal end of the lumen 300c. It would be appreciated that the vent orifice can be designed in a variety of shapes and provide the same function. During use, a primary outlet for the device 10c is the aperture 510c, which directs gas flow to first aperture 410c. As shown in Figure 18, flow proceeds substantially in an axial direction out of the first aperture 410c (from the flow restrictor 500c). The axial direction generally follows the axis 12c. The device 10c normally provides a primary vent orifice in the form of the first aperture 410c where gas primarily exits. When the first aperture 410c is restricted - other aperture(s) in the protective portion 600c may provide an exhaust pathway but these do not necessarily always operate as 'outlet(s)'.

[0239] With the above in mind, the second apertures 420c extend transversely to the first aperture 410c. That is, the second apertures 420c substantially extend in a different plane to the first aperture 410c. The second apertures 420c extend through the sidewall(s) of the protective portion 610c. The second apertures 420c include two apertures on opposite sides of the protective portion 610c. As shown in Figure 19, the second apertures 420c provide a secondary pathway for gas flow to exit the device 10c and may further assist when the first aperture 410c is at least partially blocked. In further examples, it will be appreciated that the second apertures 420c may be a single aperture.

[0240] The third apertures 430c are located at an opposite end of the protective portion 600c to the first aperture 410c. The third apertures 430c extend through a proximal end of the protective portion 600c. That is, the third apertures 430c provide outlets in one end of the protective member 605c. The third apertures 430c extend transversely to the sidewalls of the protectivemember 605c. The third apertures 430c are located substantially adjacent to the flow restrictor 500c (or a neck 130c of the body 100c). In this regard, the third apertures 430c are located at a similar position along the axis 12c as the flow restrictor 500c.

[0241] As shown in Figure 19, the third apertures 430c provide a tertiary flow path for flow to exit the device 10c. By way of example only, in cases where the first aperture 410c and / or the second apertures 420c are blocked, the third apertures 430c may provide an alternative pathway to exhaust gas flow. As part of exhausting gas flow through the third apertures 430c, the gas flow turns and is directed towards the inlet 200c. In other words, the gas flow is redirected / turned approximately 180°.

[0242] As indicated above, the third apertures 430c may be located between a side wall of the protective member 605c and a neck 130c of the body 100c. The third apertures 430c may be located on a shoulder 650c connecting the protective member 605c to the neck 130c of the body 100c. The protective portion 600c has a larger cross-sectional area compared to the neck 130c. The shoulder 650c may extend substantially perpendicular to the axis 12c. The third apertures are relatively small. The size and location of the third apertures may assist to make the third apertures difficult to obstruct.

[0243] The (neck 130c of the) body 100c also includes a part mounting portion 120c. The part mounting portion 120c provides a channel to receive the clip 1000. The width and nature of the channel is such that, upon receiving the clip 1000, gas flow can still escape from the third apertures 430c.

[0244] Figure 20 illustrates an example system 2000a for providing respiratory therapy. As indicated above, the system 2000a is configured to provide a form of PAP therapy. Variable flow CPAP, a form of PAP, may be used with the device 10 in this embodiment. The system 2000a includes a patient interface 2100a, an inspiratory limb 2200a, an expiratory limb 2300a, a flow generator 2400a and a humidifier 2500a. In this example, the device 10 is connected to the expiratory limb 2300a to form a tube assembly. The device 10 is releasably connected to the expiratory limb 2300a but, in further embodiments, it may be integrally formed. In other embodiments, the device 10 may be connected to, for example, the patient interface 2100a directly to form a patient interface assembly. In this embodiment, the device 10 may be releasably connected, or integrally formed with, the patient interface 2100a.

[0245] The patient interface 2100a is configured to form a seal with a patient airway. The patient interface 2100a may be a mask, nasal pillows or prongs that seal with at least patientnares. The patient interface may be an oral interface, a nasal interface or an oro-nasal interface. The patient interface may or may not mechanically seal with the patient airways. In the example shown, the patient interface 2100a includes a cushion component. The cushion component is attached to a frame (not shown). The cushion component will generally include a sealing portion and, in the case of prong versions, the prong(s) themselves may provide a sealing portion. The cushion portion in a mask is generally that part that contacts a patient face. In other embodiments, a patient interface may be adopted as shown in, for example, International Patent Application Nos. PCT / NZ2002 / 000180, PCT / NZ2019 / 050073 or PCT / IB2020 / 058973 (which are incorporated herein in their entirety).

[0246] The inspiratory limb 2200a and the expiratory limb 2300a are tubes that are configured to be connected to the patient interface 2100a. One or both limbs 2200a, 2300a may be heated to prevent or minimise condensation. In some embodiments, one or both limbs 2200a, 2300a may be partially unheated to improve patient safety. For instance, an unheated section of the inspiratory limb 2200a may be located inside an incubator.

[0247] The flow generator 2400a generates an air flow that is carried to the humidifier 2500a. In further embodiments, the flow generator 2400a and humidifier 2500a can form a single unit but they are separate in this embodiment. The humidifier 2500a may also be removed in other embodiments. The inspiratory limb 2200a is connected to an outlet of a humidifier 2500a (i.e. the outlet of the humidification chamber), which contains a volume of water. As the volume of water within the humidification chamber is heated by a heater plate in the humidifier 2500a, water vapor begins to fill the volume of the chamber above the water's surface. The water vapor can heat and / or humidify a flow of gas (for example, air) into the chamber through an inlet of the chamber. The heated and humidified gas is passed out of an outlet of the humidification chamber into the inspiratory limb 2200a.

[0248] The humidified gas can pass through the inspiratory conduit 2200a to a patient interface, such as the patient interface 2100a, attached and / or sealed around the patient's mouth, nose, and / or nares. The inspiratory limb 2200a provides the patient with a flow of gas that may be ambient air, oxygen, a mixture of the two, or a mixture of ambient air and other auxiliary gas(es). The gas may include medicaments, which may be added through nebulization. The flow of gas through the inspiratory limb 2200a can be delivered at a varying flow rate to achieve the desired PEEP. In this regard, the varying flow rate may also stabilise to a substantially constant flow as part of achieving the desired PEEP. In some embodiments, a setup has a flow of gas supplied by a wall source. The wall source can deliver the gas at the target flow rate so as to maintainthe flow rate of gas delivered to the patient. However, typically the flow of gas will be delivered by a flow generator.

[0249] As indicated above, the inspiratory limb 2200a may contain a heater, such as one or more heater wires, which heat the walls of the conduit to promote a substantially constant humidity profile along the inspiratory limb 2200a and therefore reduce condensation of the humidified gas within the inspiratory limb 2200a. The system 2000a (e.g., the breathing assistance apparatus / flow generator etc) can supply power to heat the inspiratory limb 2200a and the heater plate, such as through input from one or more sensors in the system. Excess gas can flow through the expiratory limb 2300a to the device 10.

[0250] The flow generator 2400a generates a constant pressure that makes inspiration easier for a patient. In order to ensure the patient experiences enough PEEP to prevent the airways from collapsing, multiple devices 10 may be provided in order to allow selection of the preferred resistance in the system 2000. That is, different devices 10 may be swapped in-and-out of the system 2000a to achieve a preferred PEEP for a particular patient. Accordingly, the system 2000a can be tuned, based on the flow restrictor 500, for the patient's benefit. The tuning may be achieved by (for instance): i) the outlet area of the aperture(s) of flow restrictor 500; ii) geometry on either side of the aperture(s); iii) geometry inside and outside the body 100; iv) surface texture; and / or v) material acting as a restrictor (e.g., filter material etc.). The PEEP may also be varied via the flow generator 2300 (e.g., the flow generator can run higher / lower flow to achieve a particular PEEP).

[0251] The system 2000a of Figure 20 may be particularly suited to delivering variable flow CPAP. Variable flow CPAP is a form of respiratory therapy in which a patient (typically an infant) is supplied with a flow of gas at a set pressure via a patient interface. Variable flow CPAP may also be known as single limb CPAP. In contrast to bubble CPAP where the flow rate of the delivered gases is constant, in variable flow CPAP the pressure of the delivered gases is controlled (and the flow rate is variable). The expiratory limb 2300a is in communication with a pressure regulator.

[0252] The pressure regulator may be an expiratory orifice (i.e. the device 10) which is configured to provide for a flow restriction. The expiratory orifice being connected to the expiratory limb 2300a allows for any exhaled gases to be exhausted away from the patient 3000. This means that in cases where the patient 3000 is a neonate or infant located in an incubator, exhaled gases can be exhausted external to the incubator. In some examples, the expiratory orifice may be provided elsewhere in the system than on the expiratory limb 2300a,for example on the patient interface 2100b as shown in Figure 21. The patent interface 2100b is connected to the inspiratory limb 2200b.

[0253] Also of note in Figure 21 is that the flow generator 2400b and humidifier 2500b are integrated into one unit. This is advantageous as it means fewer separate components are needed in the system 2000b and reduces the number of interconnections between devices, which simplifies its setup, and simplifies usability for a clinician. Further the system 2000b occupies less space because there are less separate components connected by tubes. Further still, a single controller can be provided which controls the therapy provided to the user (i.e. humidity, flow, pressure etc.). Having a single user interface to control the flow generator and humidifier may also simplify usability as well. The integrated humidifier 2500b and flow generator 2400b of Figure 15 can be used in conjunction with any of the embodiments of the device 10 and system described herein.

[0254] The system 2000a of Figure 20 may also be suited to delivering asynchronous and / or synchronous Nasal Intermittent Positive Pressure Ventilation therapy. Nasal Intermittent Positive Pressure Ventilation is a form of respiratory therapy in which a patient (typically an infant) is supplied with a flow of gas at a set inspiratory airway pressure during at least part of an inspiratory phase of a breathing cycle, and a set expiratory airway pressure during at least part of an expiratory phase of a breathing cycle. In asynchronous Nasal Intermittent Positive Pressure Ventilation provision of the set inspiratory airway pressure and expiratory airway pressure is independent of any spontaneous breathing of the patient. In synchronous Nasal Intermittent Positive Pressure Ventilation provision of the set inspiratory airway pressure may be synchronized with at least the start of a breathing cycle (i.e. the start of inhalation). In other words, the provision of inspiratory airway pressure may be triggered by the start of a breathing cycle.

[0255] The systems 2000 may utilise suitable patient interfaces, such as the patient interfaces 2100c, 2100d, respectively shown in Figure 22 and 23, for example. The patient interfaces 2100c, 21 OOd respectively include a seal forming structure 2110c, 2110d. The seal forming structure 2110c, 2110d may be received in a frame. The seal forming structure 2110c, 2110d may form a substantially gas-tight seal with the frame. The seal forming structure 2110c, 2110d may be removably attachable with the frame.

[0256] Seal forming structure 2110c includes a mask 2112. The mask 2112 is configured to provide a seal with at least the nasal passages. Seal forming structure 2110d includes nasalprongs 2114d. The nasal prongs 2114d are configured to substantially seal with the nasal passages of a patient.

[0257] Seal forming structures 2110c, 2110d respectively include an inspiratory opening 2120c, 2120d and an expiratory opening 2130c, 2130d. The inspiratory opening 2120c, 2120d is located on one side of the seal forming structure 2110c, 2110d. The expiratory opening 2130c, 2130d is located on an opposing side of the seal forming structure 2110c, 2110d. The inspiratory openings 2120c, 2120d respectively align with the expiratory openings 2130c, 2130d.

[0258] It will be appreciated that a frame / seal forming structure opening may be inspiratory or expiratory depending on direction of gas flow. For example, an opening will be an inspiratory opening if it is the opening that receives flow of gas from the flow generator. An opening will be an expiratory opening if it is the opening through which exhaled or expiratory gases exit the patient interface. The device 10 of the present disclosure is for attachment at a terminal end of the expiratory flow path.

[0259] In the examples shown in Figures 22 and 23, the frame similarly has a pair of openings on either side. These frame openings may generally align with or encompass the inspiratory / expiratory openings of the seal forming structure.

[0260] The inspiratory opening 2120c, 2120d is configured to be in fluid communication with the inspiratory tube. Inspiratory tube may connect to seal forming structure and / or frame. Similarly, expiratory opening 2130c, 2130d is configured to be in fluid communication with expiratory tube or expiratory port.

[0261] The device 10 is configured to be in fluid communication with expiratory opening 2130c, 2130d. The device 10 may connect to the patient interface at expiratory opening. The device 10 may connect at a distal or expiratory end of the expiratory tube. In each arrangement, expiratory gases and / or condensate are vented to atmosphere via expiratory flow path and away from the patient. Other suitable patient interfaces may be utilised with the device 10. For example, a device 10 subject of this disclosure may be attached to the expiratory limb of CRAP midline interfaces. An example of a CPAP midline interface is the Fisher & Paykel Healthcare FlexiTrunk nasal CPAP interface.

[0262] As indicated above, the devices 10 may provide protective portions 600 that assists in preventing the flow features 110 from becoming blocked. This allows the system 2000 to bemore robust and provides further design options for the flow resistors 500 to tune the devices 10 to reach a predetermined PEEP. The addition of the clip 1000 may also assist in preventing the flow features 110 from becoming blocked, whilst offering the ability to conveniently connect the devices 10 to another fixture. The ability of the flow features 110 to also channel flow to other flow features 110 when at least one flow feature 110 becomes blocked, also improves the reliability of the system in maintaining a suitable PEEP.

[0263] The ability to also releasably connect the device 10 to other medical devices provides, for example, a convenient way to swap the devices 10 whilst tuning the system 2000 to the predetermined PEEP for a patient. This allows the devices 10 to be provided in a kit that provides versatility to healthcare professionals. In a similar manner, the accessory port 700 improves the versality of the system 2000 and allows, for example, sensors to be added to better control the breathing of a patient.

[0264] In addition, in comparison to using bubble CPAP, including the bubbler having a volume of water, the device 10 may have: i) less components which means lower cost for user(s); ii) less waste; iii) less condensate in the system 2000 overall as longer tubes may not be required; iv) less sloshing; v) better transportation capability; vi) a larger range of pressures available - a bubbler is limited by the volume of water; vii) bubbling / oscillatory effect can be controlled by the flow generator - motor oscillating can achieve this; and viii) better for kangaroo care as there is no heavy expiratory tube connected to the interface / patient.

[0265] In this specification, adjectives such as left and right, top and bottom, hot and cold, first and second, and the like may be used to distinguish one element or action from another element or action without necessarily requiring or implying any actual such relationship or order. Where context permits, reference to a component, an integer or step (or the alike) is not to be construed as being limited to only one of that component, integer, or step, but rather could be one or more of that component, integer or step.

[0266] In this specification, the terms ‘comprises’, ‘comprising’, ‘includes’, ‘including’, or similar terms are intended to mean a non-exclusive inclusion, such that a method, system or apparatus that comprises a list of elements does not include those elements solely, but may well include other elements not listed.

[0267] The above description relating to embodiments of the present disclosure is provided for purposes of description to one of ordinary skill in the related art. It is not intended to be exhaustive or to limit the disclosure to a single disclosed embodiment. As mentioned above,numerous alternatives and variations to the present disclosure will be apparent to those skilled in the art from the above teaching. Accordingly, while some alternative embodiments have been discussed specifically, other embodiments will be apparent or relatively easily developed by those of ordinary skill in the art. The present disclosure is intended to embrace all modifications, alternatives, and variations that have been discussed herein, and other embodiments that fall within the spirit and scope of the above description.Item List:

Claims

CLAIMS1 . A device for regulating pressure, the device including: a body having: an inlet; and a lumen in communication with the inlet; and one or more flow features, the one or more flow features including a flow restrictor for restricting flow through the lumen, wherein downstream of the flow restrictor is a protective portion that assists in protecting the flow restrictor from being impaired.

2. A device for regulating pressure, the device including: a body having: an inlet; and a lumen in communication with the inlet; and one or more flow features, the one or more flow features including a flow restrictor for restricting flow through the lumen, wherein a protective portion is located proximate a distal end of the one or more flow features to assist in protecting the one or more flow features from being impaired.

3. An expiratory pressure device configured to vent exhaled gases from a patient interface assembly, the expiratory pressure device comprising: a body comprising: an inlet; and a lumen in communication with the inlet, the lumen comprising a flow restrictor and an open distal end; and a protective portion, wherein the protective portion is configured to maintain an expiratory flow path from the open distal end.

4. The device of claim 3, wherein the protective portion is configured to maintain the expiratory flow path from the flow restrictor to atmospheric and / or ambient conditions.

5. The device of any one of claims 1 to 4, wherein the protective portion projects away from the flow restrictor.

6. The device of any one of claims 1 to 5, wherein the protective portion encompasses at least a portion of a distal end of the flow restrictor.

7. The device of any one of claims 1 to 6, wherein the protective portion includes a radial surface.

8. The device of any one of claims 1 to 7, wherein the protective portion provides a first surface that extends transversely to an axial direction of the body.

9. The device of any one of claims 1 to 8, wherein the protective portion includes a protective member.

10. The device of claim 9, wherein the protective member has a free end distal from the flow restrictor.11 . The device of claim 9 or 10, wherein the protective member includes a projection.

12. The device of claim 11 , wherein the projection projects from near part of the lumen forming the flow restrictor.

13. The device of any one of claims 1 to 12, wherein the one or more flow features include an aperture.

14. The device of any one of claims 3 to 12, wherein the open distal end includes an aperture.

15. The device of claim 13 or 14, wherein the protective member includes the aperture.

16. The device of any one of claims 13 to 15, wherein the aperture is larger in area than the flow restrictor.

17. The device of any one of claims 13 to 16, wherein an area ratio of the flow restrictor to the aperture is at least 1 :15.

18. The device of any one of claims 13 to 17, wherein the area ratio of the flow restrictor to the aperture is at least 1 :20.

19. The device of any one of claims 13 to 15, wherein the aperture forms the flow restrictor.

20. The device of any one of claims 13 to 19, wherein the protective portion extends from the lumen at a location of the flow restrictor and terminates at the aperture.21 . The device of any one of claims 13 to 20, wherein the protective member includes a secondary aperture.

22. The device of claim 21 , wherein the secondary aperture is in a different plane to the aperture.

23. The device of any one of claims 13 to 22, wherein the protective member includes a tertiary aperture.

24. The device of claim 23, wherein the tertiary aperture is on an opposing plane to a plane of the aperture.

25. The device of claim 23 or 24 when dependent on claim 21 , wherein an area ratio of the flow restrictor to the secondary aperture and the tertiary aperture is at least 1 :2.

26. The device of any one of claims 23 to 25 when dependent on claim 21 , wherein the area ratio of the flow restrictor to the secondary aperture and the tertiary aperture is at least 1 :5.

27. The device of any one of claims 23 to 24 when dependent on claim 21 , wherein an area ratio of the flow restrictor to the aperture, the secondary aperture and the tertiary aperture is at least 1 : 20.

28. The device of any one of claims 23 to 25 when dependent on claim 21 , wherein the area ratio of the flow restrictor to the aperture, the secondary aperture and the tertiary aperture is at least 1 : 25.

29. The device of any one of claims 1 to 26 when dependent on claim 9, wherein the protective member forms a cuff.

30. The device of claim 29, wherein the cuff is radially outward from a neck of the body.31 . The device of claim 29 or 30, wherein a shoulder connects the cuff to the neck of the body.

32. The device of any one of claims 29 to 31 when dependent on claim 23, wherein the shoulder includes the tertiary aperture.

33. The device of any one of claims 1 to 32, wherein the protective member includes an expanding portion.

34. The device of any one of claims 1 to 33 when dependent on claim 9, wherein the protective member includes a member extending near the one or more flow features.

35. The device of claim 34, wherein the member includes a rib that extend towards the one or more flow features.

36. The device of claim 34 or 35, wherein the member is located inboard of the one or more flow features.

37. The device of any one of claims 1 to 36, wherein the protective portion extends both downstream and upstream of the flow restrictors.

38. The device of any one of claims 1 to 37, wherein in the event of the flow restrictor becoming impaired, flow will pass through another flow restrictor.

39. A device for regulating pressure, the device including: a body having: an inlet; a lumen in communication with the inlet; and one or more flow features, the one or more flow features including a flow restrictor for restricting flow through the lumen, wherein in the event of one of the one or more flow features becoming impaired, flow will pass through another of the one or more flow features.

40. A device for regulating pressure in respiratory therapy, the device including: a body having: an inlet; a lumen in communication with the inlet; and one or more flow features, the one or more flow features including a flow restrictor for restricting flow through the lumen,wherein the body is configured to releasably connect with a medical device.41 . The device of claim 39 or 40, wherein a protective portion is located proximate a distal end of the one or more flow features.

42. The device of any one of claims 39 to 41 , wherein the protective portion is located downstream of the one or more flow features.

43. The device of any one of claims 39 to 41 , wherein the protective portion projects away from the flow restrictor.

44. The device of any one of claims 39 to 43, wherein the protective portion encompasses at least a portion of the distal end of the flow restrictor.

45. The device of any one of claims 39 to 44, wherein the protective portion overhangs the flow restrictor.

46. The device of any one of claims 39 to 45, wherein the protective portion includes a protective member.

47. The device of claim 46, wherein the protective member has a free end distal from the flow restrictor.

48. The device of claim 46 or 47, wherein the protective member includes a projection.

49. The device of claim 48, wherein the projection projects from near part of the lumen forming the flow restrictor.

50. The device of any one of claims 39 to 49, wherein the one or more flow features include an aperture.51 . The device of claim 50, wherein the protective member includes the aperture.

52. The device of claim 50 or 51 , wherein the aperture is in fluid communication with atmospheric and / or ambient conditions.

53. The device of any one of claims 50 to 52, wherein the aperture is offset from the flow restrictor.

54. The device of any one of claims 50 to 53, wherein the aperture is larger in area than the flow restrictor.

55. The device of any one of claims 50 to 54, wherein an area ratio of the flow restrictor to the aperture is at least 1 :15.

56. The device of any one of claims 50 to 55, wherein the area ratio of the flow restrictor to the aperture is at least 1 :20.

57. The device of any one of claims 50 to 52, wherein the aperture forms the flow restrictor.

58. The device of any one of claims 50 to 57, wherein the protective portion extends from the lumen at a location of the flow restrictor and terminates at the aperture.

59. The device of any one of claims 50 to 58, wherein the protective member includes a secondary aperture.

60. The device of claim 59, wherein the secondary aperture is in a different plane to the aperture.61 . The device of any one of claims 50 to 60, wherein the protective member includes a tertiary aperture.

62. The device of claim 61 , wherein the tertiary aperture is on an opposing plane to a plane of the aperture.

63. The device of claim 61 or 62 when dependent on claim 59, wherein an area ratio of the flow restrictor to the secondary aperture and the tertiary aperture is at least 1 :2.

64. The device of any one of claims 61 to 63 when dependent on claim 59, wherein the area ratio of the flow restrictor to the secondary aperture and the tertiary aperture is at least65. The device of any one of claims 61 to 64 when dependent on claim 59, wherein an area ratio of the flow restrictor to the aperture, the secondary aperture and the tertiary aperture is at least 1 : 20.

66. The device of any one of claims 61 to 65 when dependent on claim 59, wherein the area ratio of the flow restrictor to the aperture, the secondary aperture and the tertiary aperture is at least 1 : 25.

67. The device of any one of claims 39 to 66 when dependent on claim 46, wherein the protective member forms a cuff.

68. The device of claim 67, wherein the cuff is radially outward from a neck of the body.

69. The device of claim 68, wherein a shoulder connects the cuff to the neck of the body.

70. The device of claim 69 when dependent on claim 61 , wherein the shoulder includes the tertiary aperture.71 . The device of any one of claims 39 to 70 when dependent on claim 46, wherein the protective member includes an expanding portion.

72. The device of any one of claims 39 to 71 when dependent on claim 46, wherein the protective member includes a member extending near the one or more flow features.

73. The device of any one of claims 1 to 72, wherein the body includes an accessory port.

74. The device of claim 73, wherein the accessory port is a sensor port.

75. The device of claim 86, wherein the sensor port is in communication with a sensor aperture that assist in avoiding flow jetting into the sensor port.

76. The device of any one of claims 1 to 75, wherein one end of the body is tapered.

77. The device of any one of claims 1 to 76, wherein the body includes a part mounting portion to allow a clip to be placed near the one or more flow features to assist in preventing the one or more flow features from being impaired.

78. The device of claim 77, wherein the part mounting portion includes a channel.

79. A kit for a respiratory therapy system, the kit including: a plurality of devices as recited in any one of claims 1 to 78, wherein one of the plurality of devices provides a different flow restriction compared to another of the plurality of devices.

80. A kit for a respiratory therapy system, the kit including: a device of any one of claims 1 to 78; and at least one or more of: a humidifier chamber; a patient interface; a tube; or a clip for attaching to the device.81 . The kit of claim 80, wherein the tube is an inspiratory tube or expiratory tube.

82. A system including: a patient interface for delivering breathable gas to a patient; and a device of any one of claims 1 to 78 in communication with the patient interface.

83. The system of claim 82, wherein the patient interface includes a seal forming structure configured to form a seal with a patient airway in use.

84. A system including: a tube; and a device of any one of claims 1 to 78 in communication with the tube.

85. The system of claim 84, wherein a sensor is in communication with the device to assist with regulating flow and / or pressure.

86. The system of claim 85, wherein the sensor is a gas property sensor.

87. A tube assembly including: a tube; and a device of any one of claims 1 to 78 in communication with the tube.

88. A patient interface assembly including:a patient interface; and a device in communication with an expiratory side of the patient interface, the device including: a body having: an inlet; and a lumen in communication with the inlet; and one or more flow features, the one or more flow features including a flow restrictor for restricting flow through the lumen, wherein downstream of the flow restrictor is a protective portion that assists in protecting the flow restrictor from being impaired.

89. A patient interface assembly including: a patient interface; and a device in communication with an expiratory side of the patient interface, the device including: a body having: an inlet; and a lumen in communication with the inlet, one or more flow features, the one or more flow features including a flow restrictor for restricting flow through the lumen, wherein a protective portion is located proximate a distal end of the one or more flow features to assists in protecting the one or more flow features from being impaired.

90. A patient interface assembly including: a patient interface; and a device in communication with an expiratory side of the patient interface, the device including: a body having: an inlet; a lumen in communication with the inlet; and one or more flow features, the one or more flow features including a flow restrictor for restricting flow through the lumen, wherein in the event of one of the one or more flow features becoming at least partially obstructed, flow will pass through another of the one or more flow features.91 . A patient interface assembly including:a patient interface; and a device in communication with an expiratory side of the patient interface, the device including: a body having: an inlet; a lumen in communication with the inlet; and one or more flow features, the one or more flow features including a flow restrictor for restricting flow through the lumen, wherein the body is configured to releasably connect with a medical device.

92. A system including: a respiratory therapy device; and a device of any one of claims 1 to 78 in fluid communication with the respiratory therapy device.

93. The system of claim 92, wherein the device is connected to an expiratory limb.

94. The system of claim 92 or 93, wherein the device is in fluid communication with a patient interface.

95. The system of any one of claims 92 to 94, wherein the device and respiratory therapy device operate in conjunction to deliver a prescribed therapy pressure to a patient.

96. The system of any one of claims 92 to 95, wherein the respiratory therapy device includes: a flow generator; a humidifier in fluid communication with the flow generator; a controller; and an at least one gases property sensor, wherein the controller is configured to control a flow rate and / or a pressure of a gas in a gas flow pathway based at least in part on an output of the at least one gases property sensor.

97. The system of claim 96, wherein in response to detecting a change in resistance to flow in the system, the controller is configured to adjust the flow rate so that pressure delivered to the patient remains substantially at the prescribed therapy pressure.

98. A patient interface assembly for delivering pressurised gas to a patient, the patient interface assembly comprising: a patient interface comprising a seal forming structure configured to form a seal with a patient airway in use, the seal forming structure having an inspiratory opening and an expiratory opening; an expiratory pressure device in fluid communication with the expiratory opening, the expiratory pressure regulator device comprising a lumen with a flow restrictor; and a protective portion configured to maintain an expiratory flow path from the expiratory pressure device.

99. The patent interface assembly of claim 98, wherein the inspiratory opening and the expiratory opening are located on opposing sides of the seal forming structure.

100. The patent interface assembly of claim 98 or 99, wherein the seal forming structure includes a mask structure, nasal prongs or nasal pillows.

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