A securing device for an air circuit of a respiratory therapy system

Abstract

The invention relates to a device for attaching the air circuit of a respiratory therapy device providing air to a patient interface to the clothing of a patient. The securing device includes a body having first and second portions that are angled in respect of each other and which receives a portion of the air circuit. The body includes a securing means that attaches the device to the patient's clothing. The configuration of the body is such that a portion of the air circuit between the securing device and the respiratory therapy device is projected away from the patient's body.

Description

A SECURING DEVICE FOR AN AIR CIRCUIT OF A RESPIRATORY THERAPY SYSTEM1 CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to Singapore Patent Application No. 10202302328V, filed 17 August 2023, Singapore Patent Application No. 10202400613R, filed 6 March 2024, and Singapore Patent Application No. 10202401234Y, filed 29 April 2024, each of which is hereby incorporated by reference herein in its entirety.2 BACKGROUND OF THE TECHNOLOGY2.1 FIELD OF THE TECHNOLOGY

[0002] The present technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention and amelioration of respiratory-related disorders. The present technology also relates to medical devices or apparatus, and their use.2.2 DESCRIPTION OF THE RELATED ART2.2.1 Human Respiratory System and its Disorders

[0003] The respiratory system of the body facilitates gas exchange. The nose and mouth form the entrance to the airways of a patient.

[0004] The airways include a series of branching tubes, which become narrower, shorter and more numerous as they penetrate deeper into the lung. The prime function of the lung is gas exchange, allowing oxygen to move from the inhaled air into the venous blood and carbon dioxide to move in the opposite direction. The trachea divides into right and left main bronchi, which further divide eventually into terminal bronchioles. The bronchi make up the conducting airways, and do not take part in gas exchange. Further divisions of the airways lead to the respiratory bronchioles, and eventually to the alveoli. The alveolated region of the lung is where the gas exchange takes place, and is referred to as the respiratory zone. See “Respiratory Physiology”, by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0005] A range of respiratory disorders exist. Certain disorders may be characterised by particular events, e.g. apneas, hypopneas, and hyperpneas.

[0006] Examples of respiratory disorders include Obstructive Sleep Apnea (OSA), Cheyne-Stokes Respiration (CSR), respiratory insufficiency, Obesity Hypoventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD) and Chest wall disorders.2.2.2 Therapies

[0007] Various respiratory therapies, such as Continuous Positive Airway Pressure (CPAP) therapy, Non-invasive ventilation (NIV), Invasive ventilation (IV), and High Flow Therapy (HFT) have been used to treat one or more of the above respiratory disorders.4.6.1.1 Respiratory pressure therapies

[0008] Respiratory pressure therapy is the application of a supply of air to an entrance to the airways at a controlled target pressure that is nominally positive with respect to atmosphere throughout the patient’s breathing cycle (in contrast to negative pressure therapies such as the tank ventilator or cuirass).

[0009] Continuous Positive Airway Pressure (CPAP) therapy has been used to treat Obstructive Sleep Apnea (OSA). The mechanism of action is that continuous positive airway pressure acts as a pneumatic splint and may prevent upper airway occlusion, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA by CPAP therapy may be voluntary, and hence patients may elect not to comply with therapy if they find devices used to provide such therapy one or more of: uncomfortable, difficult to use, expensive and aesthetically unappealing.2.2.3 Respiratory Therapy Systems

[0010] These respiratory therapies may be provided by a respiratory therapy system or device. Such systems and devices may also be used to screen, diagnose, or monitor a condition without treating it.

[0011] A respiratory therapy system may comprise a Respiratory Pressure Therapy Device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.1.2.3.1 Patient Interface

[0012] A patient interface may be used to interface respiratory equipment to its wearer, for example by providing a flow of air to an entrance to the airways. The flow of air may be provided via a mask to the nose and / or mouth, a tube to the mouth or a tracheostomy tube to the trachea of a patient. Depending upon the therapy to be applied, the patient interface may form a seal, e.g., with a region of the patient's face, to facilitate the delivery of gas at a pressure at sufficient variance with ambient pressure to effect therapy, e.g., at a positive pressure of about 10 cmFLO relative to ambient pressure. For other forms of therapy, such as the delivery of oxygen, the patient interface may not include a seal sufficient to facilitate delivery to the airways of a supply of gas at a positive pressure of about 10 cmlFO. For How therapies such as nasal HFT, the patient interface is configured to insufflate the nares but specifically to avoid a complete seal. One example of such a patient interface is a nasal cannula.

[0013] CPAP therapy is highly effective to treat certain respiratory disorders, provided patients comply with therapy. If a mask is uncomfortable, or difficult to use a patient may not comply with therapy. Since it is often recommended that a patient regularly w'ash their mask, if a mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may not clean their mask and this may impact on patient compliance.

[0014] While a mask for other applications (e.g. aviators) may not be suitable for use in treating sleep disordered breathing, a mask designed for use in treating sleep disordered breathing may be suitable for other applications.

[0015] For these reasons, patient interfaces for delivery of CPAP during sleep form a distinct field.1.2.3.1.1 Seal-forming structure

[0016] Patient interfaces may include a seal-forming structure. Since it is in direct contact with the patient’s face, the shape and configuration of the seal-forming structure can have a direct impact the effectiveness and comfort of the patient interface.

[0017] A patient interface may be partly characterised according to the design intent of where the seal -forming structure is to engage with the face in use. hi one form of patient interface, a seal-forming structure may comprise a first sub-portion to form a seal around the left naris and a second sub-portion to form a seal around the right naris. In one form of patient interface, a seal-forming structure may comprise a single element that surrounds both nares in use. Such single element may be designed to for example overlay an upper lip region and a nasal bridge region of a face. In one form of patient interface a seal-forming structure may comprise an element that surrounds a mouth region in use, e.g. by forming a seal on a lower lip region of a face. In one form of patient interface, a seal-forming structure may comprise a single element that surrounds both nares and a mouth region in use. These different types of patient interfaces may be known by a variety of names by their manufacturer including nasal masks, full-face masks, nasal pillows, nasal puffs and oro-nasal masks.

[0018] One type of seal-forming structure extends around the periphery of the patient interface, and is intended to seal against the patient's face when force is applied to the patient interface with the seal-forming structure in confronting engagement with the patient's face. The seal-forming structure may include an air or fluid filled cushion, or a moulded or formed surface of a resilient seal element made of an elastomer such as a rubber. With this type of seal-forming structure, if the fit is not adequate, there will be gaps between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face in order to achieve a seal.

[0019] Another type of seal-forming structure incorporates a flap seal of thin material positioned about the periphery of the mask so as to provide a self-sealing action against the face of the patient when positive pressure is applied within the mask. Like the previous style of seal forming portion, if the match between the face and the mask is not good, additional force may be required to achieve a seal, or the mask may leak. Furthermore, if the shape of the seal-forming structure does not match that of the patient, it may crease or buckle in use, giving rise to leaks.

[0020] A range of patient interface seal-forming structure technologies are disclosed in the following patent applications: WO 1998 / 004310; WO 2006 / 074513; WO 2010 / 135785.1.2.3.1.2 Positioning and Stabilising Structure

[0021] A seal-forming structure of a patient interface used for positive air pressure therapy is subject to the corresponding force of the air pressure to disrupt a seal. Thus a variety of techniques have been used to position the seal-forming structure, and to maintain it in sealing relation with the appropriate portion of the face. Several factors may be considered when comparing different positioning and stabilising techniques. These include: how effective the technique is at maintaining the seal-forming structure in the desired position and in sealed engagement with the face during use of the patient interface; how comfortable the interface is for the patient; whether the patient feels intrusiveness and / or claustrophobia when wearing the patient interface; and aesthetic appeal.

[0022] One technique is the use of one or more straps and / or stabilising harnesses. Many such harnesses suffer from being one or more of ill-fitting, bulky, uncomfortable and awkward to use.1.2.3.1.3 Pressurised Air Conduit

[0023] In one type of treatment system, a flow of pressurised air is provided to a patient interface through a conduit in an air circuit that fluidly connects to the patient interface at a location that is in front of the patient’s face when the patient interface is positioned on the patient’s face during use. The conduit may extend from the patient interface forwards away from the patient’s face.1.2.3.1.4 Pressurised Air Conduit used for Positioning / Stabilising the Seal-Forming Structure

[0024] Another type of treatment system comprises a patient interface in which a tube that delivers pressurised air to the patient’ s airways also functions as part of the headgear to position and stabilise the seal-forming portion of the patient interface at the appropriate part of the patient’s face. This type of patient interface may be referred to as having “conduit headgear” or “headgear tubing”. Such patient interfaces allow the conduit in the air circuit providing the flow of pressurised air from a respiratory pressure therapy (RPT) device to connect to the patient interface in a position other than in front of the patient’s face. One example of such a treatment system is disclosed in US Patent Publication No. US 2007 / 0246043, the contents of which arc incorporated herein by reference, in which the conduit connects to a tube in the patient interface through a port positioned in use on top of the pati ent’s head.

[0025] It is desirable for patient interfaces incorporating headgear tubing to be comfortable for a patient to wear over a prolonged duration when the patient is asleep, forman air-tight and stable seal with the patient’s face, while also able to fit a range of patient head shapes and sizes.1.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0026] A respiratory pressure therapy (RPT) device may be used individually or as part of a system to deliver one or more of a number of therapies described above, such as by operating the device to generate a flow of air for delivery to an interface to the airways. The flow of air may be pressure -controlled (for respiratory pressure therapies) or flow-controlled (for flow therapies such as HFT). Thus RPT devices may also act as flow therapy devices. Examples of RPT devices include a CPAP device and a ventilator.

[0027] The designer of a device may be presented with an infinite number of choices to make. Design criteria often conflict, meaning that certain design choices are far from routine or inevitable. Furthermore, the comfort and efficacy of certain aspects may be highly sensitive to small, subtle changes in one or more parameters.1.2.3.3 Air circuit

[0028] An air circuit is a conduit or a tube constructed and arranged to allow, in use, a flow of air to travel between two components of a respiratory therapy system such as the RPT device and the patient interface. In some cases, there may be separate limbs of the air circuit for inhalation and exhalation. In other cases, a single limb air circuit is used for both inhalation and exhalation.

[0029] Often plastics material such as silicone or the like are used to construct the air circuit. In some instances, the air circuit may include a corrugated or ribbed structure to its exterior to assist in providing a degree of control over its curvature and its ability to conform to underlying surfaces, such as bedding and items of furniture, or even the body of the patient. The ribbed structure can also minimise or eliminate the potential for kinks, which may inhibit the flow of air therethrough, to develop in the air circuit.

[0030] For sufficient clearance between the RPT device and the patient interface, the length of the air circuit can be 500 millimetres or more. This allows a degree of freedom, particularly as the patient moves their body, to ensure that the patient interface remains in good contact with the patient’s face. However, because of the length, and the material of construction, the air circuit can be relatively weighty.

[0031] Depending on the patient’ s body position, and the air circuit’ s point of attachment to the patient interface, this weight may cause drag upon the patient interface and affect the placement of the seal-forming structure. This may be even more pronounced for longer air circuits or where the air circuit is suspended.

[0032] In some instances, securing devices in the form of straps, to which a spring- biased clip is mounted, may be used to secure the air circuit to bedding or the patient’ s clothing while the patient interface is being worn. This can be used to create some slack in theportion of the air circuit between the patient interface and the securing device. Potential drag may then be confined to the portion of the air circuit between the securing device and the RPT device, so that optimal placement of the patient interface upon the face of the patient can be maintained even in the event of the patient’ s movement. However, a significant portion of the air circuit may still be in contact with the patient’ s body, and this may cause some discomfort. [0033 J In other instances, securing devices may be in the form of a clip attached to the air circuit and provided with a gripping or securing arrangement to facilitate attachment of the securing device to clothes or bedding. However, these may not be suitable for use with different material thicknesses. For example, a gripping means appropriate for use with lightweight sleeping clothes may not be suitable for use with bedding sheets. This may affect the overall functionality of the securing device, by being too loose to grip onto some materials or being unable to be engaged with other materials.1.2.3.4 Humidifier[0034J Delivery of a flow of air without humidification may cause drying of airways. The use of a humidifier with an RPT device and the patient interface produces humidified gas that minimizes drying of the nasal mucosa and increases patient airway comfort. In addition, in cooler climates, warm air applied generally to the face area in and about the patient interface is more comfortable than cold air.1.2.3.5 Data Management

[0035] There may be clinical reasons to obtain data to determine whether the patient prescribed with respiratory therapy has been “compliant”, e.g. that the patient has used their RPT device according to one or more “compliance rules”. One example of a compliance rule for CPAP therapy is that a patient, in order to be deemed compliant, is required to use the RPT device for at least four hours a night for at least 21 of 30 consecutive days. In order to determine a patient's compliance, a provider of the RPT device, such as a health care provider, may manually obtain data describing the patient's therapy using the RPT device, calculate the usage over a predetermined time period, and compare with the compliance rule. Once the health care provider has determined that the patient has used their RPT device according to the compliance rule, the health care provider may notify a third party that the patient is compliant.

[0036] There may be other aspects of a patient’s therapy that would benefit from communication of therapy data to a third party or external system.

[0037] Existing processes to communicate and manage such data can be one or more of costly, time-consuming, and error-prone.1.2.3.6 Vent technologies

[0038] Some forms of treatment systems may include a vent to allow the washout of exhaled carbon dioxide. The vent may allow a flow of gas from an interior space of a patient interface, e.g., the plenum chamber, to an exterior of the patient interface, e.g., to ambient.1.2.4 Screening, Diagnosis, and Monitoring Systems

[0039] Polysomnography (PSG) is a conventional system for diagnosis and monitoring of cardio-pulmonary disorders, and typically involves expert clinical staff to apply the system. PSG typically involves the placement of 15 to 20 contact sensors on a patient in order to record various bodily signals such as electroencephalography (EEG), electrocardiography (ECG), electrooculograpy (EOG), electromyography (EMG), etc. PSG for sleep disordered breathing has involved two nights of observation of a patient in a clinic, one night of pure diagnosis and a second night of titration of treatment parameters by a clinician. PSG is therefore expensive and inconvenient. In particular, it is unsuitable for home screening / diagnosis I monitoring of sleep disordered breathing.

[0040] Screening and diagnosis generally describe the identification of a condition from its signs and symptoms. Screening typically gives a true / false result indicating whether or not a patient’s SDB is severe enough to warrant further investigation, while diagnosis may result in clinically actionable information. Screening and diagnosis tend to be one-off processes, whereas monitoring the progress of a condition can continue indefinitely. Some screening / diagnosis systems are suitable only for screening / diagnosis, whereas some may also be used for monitoring.

[0041] Clinical experts may be able to screen, diagnose, or monitor patients adequately based on visual observation of PSG signals. However, there are circumstances where a clinical expert may not be available, or a clinical expert may not be affordable. Different clinical experts may disagree on a patient's condition. In addition, a given clinical expert may apply a different standard at different times.2 BRIEF SUMMARY OF THE TECHNOLOGY

[0042] The present technology is directed towards providing medical devices used in the screening, diagnosis, monitoring, amelioration, treatment, or prevention of respiratory disorders having one or more of improved comfort, cost, efficacy, ease of use and manufacturability.

[0043] A first aspect of the present technology relates to apparatus used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of a respiratory disorder.

[0044] Another aspect of the present technology relates to methods used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of a respiratory disorder.

[0045] An aspect of certain forms of the present technology is to provide methods and / or apparatus that improve the compliance of patients with respiratory therapy.

[0046] One form of the present technology comprises a positioning and stabilising structure configured to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient’ s head. The positioning and stabilising structure includes at least one strap.

[0047] One form of the present technology comprises a patient interface comprising a plenum chamber, a seal-forming structure, and a positioning and stabilising structure.

[0048] One form of the present technology comprises patient interface comprising a plenum chamber pressurisable to a therapeutic pressure of at least 4 cmH2O above ambient air pressure. The plenum chamber includes at least one plenum chamber inlet port sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient. The patient interface also comprises a seal-forming structure that is constructed and arranged to form a seal with a region of the patient’s face surrounding an entrance to the patient’s airways. The seal-forming structure has a hole therein such that the flow of air at said therapeutic pressure is delivered to at least an entrance to the patient’ s nares. The sealforming structure is constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient’s respiratory cycle in use. The patient interface also comprises a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient’s head.

[0049] Another aspect of one form of the present technology is a series of modular elements that may be interconnected in order to form different styles of patient interfaces.

[0050] In one form, there are at least two versions or styles of each modular element. The versions or styles may be interchangeably used with one another in order to form different modular assemblies.

[0051] One form of the present technology comprises a securing device for an air circuit for a respiratory therapy system, the securing device including: a body configured with a channel therethrough, wherein the channel has a longitudinal length and wherein, in use, the channel receives a portion of a length of the air circuit, and wherein along its longitudinal length the channel has a first portion and a second portion, wherein the second portion is at an angle relative to the first portion, and wherein the body has a first side having an inner curvature and a second side having an outer curvature, and a securing means provided to the body.

[0052] In examples, the second portion of the channel is angled relative to the first portion of the channel at an angle ranging from between, and including, 5° to 75°. Preferably,the second portion of the channel is angled relative to the first portion of the channel at an angle ranging from between, and including, 5° to 45°.

[0053] In examples, the body is integrally formed with the securing means.

[0054] In examples, the body is formed from robust plastics material. In one example, the body may be formed from a thermoplastic polymer, preferably polypropylene. In other examples, the body may be formed from polycarbonate, reinforced nylon, or other plastics material which is capable of slight deformation upon application of a force, but is able to return to its original shape once the force has been removed.

[0055] In alternative examples, the body is provided as two halves which are arranged to be connected to each other along the length dimension.

[0056] In alternative examples, the body is provided as two halves, in which a first pair of opposing edges are pivotally hinged to each other along the length dimension.

[0057] In examples, the securing means is a separate component configured to be mounted or otherwise attached to the body.

[0058] In examples, the securing means comprises a first arm and a second arm, and a connection member adapted for removably connecting the securing means to the body.

[0059] In examples the connection member is a C-shaped clip shaped to be received by the second side of the body, al least partially around the circumferential axis of the body.

[0060] In examples the second arm is connected to the connection member via the first arm.

[0061] In examples, the first arm is connected to second arm at a first connection point and the connection member al a second connection point, the first and second connection points being offset from each other.

[0062] In examples, the securing means is configured to be rotatable relative to the body.

[0063] In examples, the securing means is provided to the second side of the body.

[0064] In examples, the securing means is provided to the second side of the first portion of the body.

[0065] In examples, the securing means is provided to the second side of the second portion of the body.

[0066] In examples, the securing means is provided with a first arm arising from the body and a second arm substantially perpendicular to the first arm.

[0067] In examples, the securing means is a clip, wherein the clip has a mouth leading to an opening or recess defined by a portion of the surface of the body and a portion of the surface of the clip, wherein the portion of the surface of the body and the portion of the surface of the clip substantially oppose each other.

[0068] In examples, the securing means is a clip, wherein the clip has a mouth leading to an opening or recess defined by a first portion of the surface of the clip and a second portion of the surface of the clip, wherein the first portion and the second portion substantially oppose each other.

[0069] In examples, the securing means is a clip, wherein the clip has a first mouth leading to a first opening or recess defined by a first portion of the surface of the clip and a second portion of the surface of the clip, and a second mouth leading to a second opening or recess defined by a third portion of the surface of the clip and a fourth portion of the surface of the clip wherein the first portion and the second portion substantially oppose each other and the third portion and the fourth portion substantially oppose each other.

[0070] In examples, the opposing first and second portions and opposing third and fourth portions may be configured with a complementary contoured gripping surface that, in use, contacts a portion of a material of an item of clothing or bedding to which the securing device is to be attached.

[0071] In examples, the mouth of the clip may be configured with protrusions that are complementary to protrusions provided to a portion of the surface of the body.

[0072] In examples, a surface of the clip may be configured with protrusions that interlock with complementary features provided to a portion of the surface of the body.

[0073] In examples, the securing means includes a pair of jaws, wherein at least one of the pair of jaws is pivotally mounted to the other of the pair of jaws.

[0074] In examples, the pair of jaws are comprised of a first gripping member and a second gripping member operatively linked to each other via a hinge portion.

[0075] In examples, one of the first gripping member and the second gripping member may be integrally formed with the body.

[0076] In examples, the pair of jaws may be linked to the body of the securing device via a length of filamentary material.

[0077] In examples, the body has a C-shaped cross-sectional profile with an opening to the channel defined by a slot along the length of the body.

[0078] In examples, the slot is configured to allow a portion of a length of the air circuit to be forced therethrough to locate the air circuit in the channel of the body.

[0079] In examples, at least one side of the slot is configured with a flange or lip along its length.

[0080] In examples, the flange or lip increases in width from its respective ends to form a point.

[0081] Another aspect of one form of the present technology is an air circuit for a respiratory therapy system, the air circuit including:a tube configured and arranged to be connected to one or both of a respiratory therapy device or a patient interface; and a securing device, the securing device including: a body configured with a channel therethrough, wherein the channel has a longitudinal length and wherein, in use, the channel receives a portion of the length of the air circuit, and wherein along its longitudinal length the channel has a first portion and a second portion, wherein the second portion is at an angle relative to the first portion, and wherein the body has a first side having an inner curvature and a second side having an outer curvature, and a securing means provided to the body.

[0082] Another aspect of one form of the present technology is a respiratory therapy system, the system including: a respiratory therapy device; a patient interface comprising a plenum chamber and a seal-forming structure, the patient interface also comprising a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on a patient’ s head, wherein the seal-forming structure is constructed and arranged to form a seal with a region of the patient’s face surrounding an entrance to the patient’s airways for sealed delivery of a flow of air at a therapeutic pressure of at least 6 cmHiO above ambient air pressure throughout the patient’s respirator cycle in use; an air circuit; and a securing device for the air circuit, the securing device including: a body configured with a channel therethrough, wherein the channel has a longitudinal length and wherein, in use, the channel receives a portion of the length of the air circuit, and wherein along its longitudinal length the channel has a first portion and a second portion, wherein the second portion is at an angle relative to the first portion, and wherein the body has a first side having an inner curvature and a second side having an outer curvature, and a securing means provided to the body.

[0083] In examples, the respiratory therapy system includes a plurality of securing devices for the air circuit.

[0084] In examples, at least one of the plurality of securing devices is provided in a different dimension to at least one other of the plurality of securing devices.

[0085] In examples, at least one of the plurality of securing devices is provided with a securing means having a different configuration / architecture to at least one other of the plurality of securing devices.

[0086] An aspect of one form of the present technology is a method of manufacturing apparatus.

[0087] An aspect of certain forms of the present technology is a medical device that is easy to use, e.g. by a person who does not have medical training, by a person who has limited dexterity, vision or by a person with limited experience in using this type of medical device.

[0088] An aspect of one form of the present technology is a portable RPT device that may be carried by a person, e.g., around the home of the person.

[0089] An aspect of one form of the present technology is a patient interface that may be washed in a home of a patient, e.g., in soapy water, without requiring specialised cleaning equipment. An aspect of one form of the present technology is a humidifier tank that may be washed in a home of a patient, e.g., in soapy water, without requiring specialised cleaning equipment.

[0090] The methods, systems, devices and apparatus described may be implemented so as to improve the functionality of a processor, such as a processor of a specific purpose computer, respiratory monitor and / or a respiratory therapy apparatus. Moreover, the described methods, systems, devices and apparatus can provide improvements in the technological field of automated management, monitoring and / or treatment of respiratory conditions, including, for example, sleep disordered breathing.

[0091] Of course, portions of the aspects may form sub-aspects of the present technology. Also, various ones of the sub-aspects and / or aspects may be combined in various manners and also constitute additional aspects or sub-aspects of the present technology.

[0092] Other features of the technology will be apparent from consideration of the information contained in the following detailed description, abstract, drawings and claims.3 BRIEF DESCRIPTION OF THE DRAWINGS

[0093] The present technology is illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings, in which like reference numerals refer to similar elements including:3.1 RESPIRATORY THERAPY SYSTEMS

[0094] Fig. 1 A shows a system including a patient 1000 wearing a patient interface 3000, in the form of nasal pillows, receiving a supply of air at positive pressure from an RPT device 4000. Air from the RPT device 4000 is humidified in a humidifier 5000, and passes along an air circuit 4170 to the patient 1000. A bed partner 1100 is also shown. The patient is sleeping in a supine sleeping position.

[0095] Fig. IB show's a system including a patient 1000 wearing a patient interface 3000, in the form of a nasal mask, receiving a supply of air at positive pressure from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000, and passes along an air circuit 4170 to the patient 1000.

[0096] Fig. 1C shows a system including a patient 1000 wearing a patient interface 3000, in the form of a full-face mask, receiving a supply of air at positive pressure from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000, and passes along an air circuit 4170 to the patient 1000. The patient is sleeping in a side sleeping position.3.2 PATIENT INTERFACE

[0097] Fig. 2 shows one example of a patient interface in the form of the nasal mask of Fig. IB.

[0098] Fig. 3 shows one example of a patient interface in the form of conduit headgear.3.3 SECURING DEVICE

[0099] Fig. 4 shows a further example of a securing device for an air circuit in accordance with an aspect of the present invention.

[0100] Fig. 5 shows a further example of a securing device for an air circuit in accordance with an aspect of the present invention.

[0101] Fig. 6 shows a further example of a securing device for an air circuit in accordance with an aspect of the present invention.

[0102] Fig. 7 shows a further example of a securing device for an air circuit in accordance with an aspect of the present invention.

[0103] Fig. 7A shows a further example of a securing device for an air circuit in accordance with an aspect of the present invention.

[0104] Fig. 8 shows a further example of a securing device for an air circuit in accordance with an aspect of the present invention.

[0105] Fig. 9 shows a further example of a securing device for an air circuit in accordance with an aspect of the present invention.

[0106] Figs. 10A and 10B show a further example of a securing device for an air circuit in accordance with an aspect of the present invention.

[0107] Fig. 11 shows a further example of a securing device for an air circuit in accordance with an aspect of the present invention.

[0108] Figs. 12A and 12B show a further example of a securing device for an air circuit in accordance with an aspect of the present invention.

[0109] Figs. 13A and 13B show a further example of a securing device for an air circuit in accordance with an aspect of the present invention.

[0110] Fig. 14 shows a further example of a securing device for an air circuit in accordance with an aspect of the present invention.

[0111] Fig. 15 shows a further example of a securing device for an air circuit in accordance with an aspect of the present invention.

[0112] Fig. 16 shows a further example of a securing device for an air circuit in accordance with an aspect of the present invention.

[0113] Figs. 17A and 17B show a further example of a securing device for an air circuit in accordance with an aspect of the present invention.

[0114] Fig. 18 shows a further example of a securing device for an air circuit in accordance with an aspect of the present invention.

[0115] Figs. 19A and 19B show a further example of a securing device for an air circuit in accordance with an aspect of the present invention.

[0116] Figs. 20A and 20B show a further example of a securing device for an air circuit in accordance with an aspect of the present invention.4 DETAILED DESCRIPTION OF EXAMPLES OF THE TECHNOLOGY

[0117] Before the present technology is described in further detail, it is to be understood that the technology is not limited to the particular examples described herein, which may vary. It is also to be understood that the terminology used in this disclosure is for the purpose of describing only the particular examples discussed herein, and is not intended to be limiting.

[0118] The following description is provided in relation to various examples which may share one or more common characteristics and / or features. It is to be understood that one or more features of any one example may be combinable with one or more features of another example or other examples. In addition, any single feature or combination of features in any of the examples may constitute a further example.4.1 THERAPY

[0119] In one form, the present technology comprises a method for treating a respiratory disorder comprising applying positive pressure to the entrance of the airways of a patient 1000.

[0120] In certain examples of the present technology, a supply of air at positive pressure is provided to the nasal passages of the patient via one or both nares.

[0121] In certain examples of the present technology, mouth breathing is limited, restricted or prevented.4.2 RESPIRATORY THERAPY SYSTEMS

[0122] In one form, the present technology comprises a respiratory therapy system for treating a respiratory disorder. The respiratory therapy system may comprise an RPT device 4000 for supplying a flow of air to the patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800.4.3 PATIENT INTERFACE

[0123] A non-invasive patient interface 3000, such as the nasal mask as shown in Fig. 2, in accordance with one aspect of the present technology comprises the following functional aspects: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilisingstructure 3300, a vent 3400, one form of connection port 3600 for connection to air circuit (4170 in Fig. IB), and a forehead support 3700. In some forms a functional aspect may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use the seal-forming structure 3100 is arranged to surround an entrance to the airways of the patient so as to maintain positive pressure at the entrance(s) to the airways of the patient 1000. The sealed patient interface 3000 is therefore suitable for delivery of positive pressure therapy.4.3.1 Seal-forming structure

[0124] In one form of the present technology, a seal-forming structure 3100 provides a target seal-forming region, and may additionally provide a cushioning function. The target seal-forming region is a region on the seal-forming structure 3100 where sealing may occur. The region where sealing actually occurs- the actual sealing surface- may change within a given treatment session, from day to day, and from patient to patient, depending on a range of factors including for example, where the patient interface was placed on the face, tension in the positioning and stabilising structure and the shape of a patient’s face.

[0125] In one form the target seal-forming region is located on an outside surface of the seal-forming structure 3100.

[0126] In certain forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material, e.g. silicone rubber.

[0127] A seal-forming structure 3100 in accordance with the present technology may be constructed from a soft, flexible, resilient material such as silicone.

[0128] In certain forms of the present technology, a system is provided comprising more than one a seal -forming structure 3100, each being configured to correspond to a different size and / or shape range. For example the system may comprise one form of a seal-forming structure 3100 suitable for a large sized head, but not a small sized head and another suitable for a small sized head, but not a large sized head.4.3.1.1 Sealing mechanisms

[0129] In one form, the seal-forming structure includes a sealing flange utilizing a pressure assisted sealing mechanism. In use, the sealing flange can readily respond to a system positive pressure in the interior of the plenum chamber 3200 acting on its underside to urge it into tight sealing engagement with the face. The pressure assisted mechanism may act in conjunction with clastic tension in the positioning and stabilising structure.

[0130] In one form, the seal-forming structure 3100 comprises a sealing flange and a support flange. The sealing flange comprises a relatively thin member with a thickness of less than about 1mm, for example about 0.25mm to about 0.45mm, w'hich extends around the perimeter of the plenum chamber 3200. Support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the marginaledge of the plenum chamber 3200, and extends at least part of the way around the perimeter. The support flange is or includes a spring-like element and functions to support the sealing flange from buckling in use.

[0131] In one form, the seal-forming structure may comprise a compression sealing portion or a gasket sealing portion. In use the compression sealing portion, or the gasket sealing portion is constructed and arranged to be in compression, e.g. as a result of elastic tension in the positioning and stabilising structure.

[0132] In one form, the seal-forming structure comprises a tension portion. In use, the tension portion is held in tension, e.g. by adjacent regions of the sealing flange.

[0133] In one form, the seal-forming structure comprises a region having a tacky or adhesive surface.

[0134] In certain forms of the present technology, a seal-forming structure may comprise one or more of a pressure-assisted scaling flange, a compression scaling portion, a gasket sealing portion, a tension portion, and a portion having a tacky or adhesive surface.4.3.1.2 Nose bridge or nose ridge region

[0135] In one form, the non-invasive patient interface 3000 comprises a seal-forming structure that forms a seal in use on a nose bridge region or on a nose-ridge region of the patient's face.

[0136] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal in use on a nose bridge region or on a nose-ridge region of the patient's face.4.3.1.3 Upper lip region

[0137] In one form, the non-invasive patient interface 3000 comprises a seal-forming structure that forms a seal in use on an upper lip region (that is, the lip superior) of the patient's face.

[0138] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal in use on an upper lip region of the patient's face.4.3.1.4 Chin-region

[0139] In one form the non-invasive patient interface 3000 comprises a seal -forming structure that forms a seal in use on a chin-region of the patient's face.

[0140] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal in use on a chin-region of the patient's face.4.3.1.5 Forehead region

[0141] In one form, the seal -forming structure that forms a seal in use on a forehead region of the patient's face. In such a form, the plenum chamber may cover the eyes in use.4.3.1.6 Nasal pillows

[0142] In one form the seal-forming structure of the non-invasive patient interface 3000 comprises a pair of nasal puffs, or nasal pillows, each nasal puff or nasal pillow being constructed and arranged to form a seal with a respective naris of the nose of a patient.

[0143] Nasal pillows in accordance with an aspect of the present technology include: a frusto-cone, at least a portion of which forms a seal on an underside of the patient's nose, a stalk, a flexible region on the underside of the frusto-cone and connecting the frusto-cone to the stalk. In addition, the structure to which the nasal pillow of the present technology is connected includes a flexible region adjacent the base of the stalk. The flexible regions can act in concert to facilitate a universal joint structure that is accommodating of relative movement both displacement and angular of the frusto-cone and the structure to which the nasal pillow is connected. For example, the frusto-cone may be axially displaced towards the structure to which the stalk is connected.4.3.1.7 Nose-only Masks

[0144] In one form, the patient interface 3000 comprises a seal-forming structure 3100 configured to seal around an entrance to the patient’s nasal airways but not around the patient's mouth. The seal-forming structure 3100 may be configured to seal to the patient’s lip superior. The patient interface 3000 may leave the patient’s mouth uncovered. This patient interface 3000 may deliver a supply of air or breathable gas to both nares of patient 1000 and not to the mouth. This type of patient interface may be identified as a nose-only mask.

[0145] One form of nose-only mask according to the present technology is what has traditionally been identified as a “nasal mask”, having a seal-forming structure 3100 configured to seal on the patient’s face around the nose and over the bridge of the nose. A nasal mask may be generally triangular in shape. In one form, the non-invasive patient interface 3000 comprises a seal-forming structure 3100 that forms a seal in use to an upper lip region (e.g. the lip superior), to the patient’s nose bridge or at least a portion of the nose ridge above the pronasale, and to the patient's face on each lateral side of the patient’s nose, for example proximate the patient’s nasolabial sulci. The patient interface 3000 shown in Fig. IB has this type of seal-forming structure 3100. This patient interface 3000 may deliver a supply of air or breathable gas to both nares of patient 1000 through a single orifice.4.3.1.8 Nose and Mouth Masks

[0146] In one form, the patient interface 3000 comprises a seal-forming structure 3100 configured to seal around an entrance to the patient’s nasal airways and also around the patient’s mouth. The seal-forming structure 3100 may be configured to seal to the patient’s face proximate a chin region. This patient interface 3000 may deliver a supply of air or breathable gas to both nares and to the mouth of patient 1000. This type of patient interface may be identified as a nose and mouth mask.

[0147] One form of nose-and-mouth mask according to the present technology is what has traditionally been identified as a “full-face mask”, having a seal-forming structure 3100 configured to seal on the patient’s face around the nose, below the mouth and over the bridge of the nose. A nose-and-mouth mask may be generally triangular in shape. In one form the patient interface 3000 comprises a seal-forming structure 3100 that forms a seal in use to a patient’s chin-region (which may include the patient’s lip inferior and / or a region directly inferior to the lip inferior), to the patient’s nose bridge or at least a portion of the nose ridge superior to the pronasale, and to cheek regions of the patient's face. The patient interface 3000 shown in Fig. 1C is of this type. This patient interface 3000 may deliver a supply of air or breathable gas to both nares and mouth of patient 1000 through a single orifice. This type of seal-forming structure 3100 may be referred to as a “nose-and-mouth cushion”.4.3.2 Plenum chamber

[0148] The plenum chamber 3200 has a perimeter that is shaped to be complementary to the surface contour of the face of an average person in the region where a seal will form in use. In use, a marginal edge of the plenum chamber 3200 is positioned in close proximity to an adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal -forming structure 3100 may extend in use about the entire perimeter of the plenum chamber 3200. In some forms, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single homogeneous piece of material.

[0149] In certain forms of the present technology, the plenum chamber 3200 does not cover the eyes of the patient in use. In other words, the eyes are outside the pressurised volume defined by the plenum chamber. Such forms Lend to be less obtrusive and / or more comfortable for the wearer, which can improve compliance with therapy.

[0150] In certain forms of the present technology, the plenum chamber 3200 is constructed from a transparent material, e.g. a transparent polycarbonate. The use of a transparent material can reduce the obtnisiveness of the patient interface, and help improve compliance with therapy. The use of a transparent material can aid a clinician to observe how the patient interface is located and functioning.

[0151] In certain forms of the present technology, the plenum chamber 3200 is constructed from a translucent material. The use of a translucent material can reduce the obtrusiveness of the patient interface, and help improve compliance with therapy.

[0152] In some forms, the plenum chamber 3200 is constructed from a rigid material such as polycarbonate. The rigid material may provide support to the seal-forming structure.

[0153] In some forms, the plenum chamber 3200 is constructed from a flexible material (e.g., constructed from a soft, flexible, resilient material like silicone, textile, foam, etc.). For example, in examples then may be formed from a material which has a Young's modulus of 0.4 GPa or lower, for example foam. In some forms of the technology the plenum chamber3200 may be made from a material having Young's modulus of O.IGPa or lower, for example rubber. In other forms of the technology the plenum chamber 3200 may be made from a material having a Young's modulus of 0.7MPa or less, for example between 0.7MPa and0.3MPa. An example of such a material is silicone.4.3.3 Positioning and stabilising structure

[0154] The seal-forming structure 3100 of the patient interface 3000 of the present technology may he held in sealing position in use by the positioning and stabilising structure3300. The positioning and stabilising structure 3300 may comprise and function as “headgear” since it engages the patient's head in order to hold the patient interface 3000 in a sealing position. Examples of a positioning and stabilising structure may be shown in Figs. I A to IC as well as in Fig. 2.

[0155] In one form the positioning and stabilising structure 3300 provides a retention force at least sufficient to overcome the effect of the positive pressure in the plenum chamber3200 to lift off the face (i.e., Fplenum).

[0156] In one form the positioning and stabilising structure 3300 provides a retention force to overcome the effect of the gravitational force on the patient interface 3000.

[0157] In one form the positioning and stabilising structure 3300 provides a retention force as a safety margin to overcome the potential effect of disrupting forcesibn the patient interface 3000, such as from tube drag, or accidental interference with the patient interface.

[0158] In one form of the present technology, a positioning and stabilising structure 3300 is provided that is configured in a manner consistent with being worn by a patient while sleeping. In one example the positioning and stabilising structure 3300 has a low profile, or cross-sectional thickness, to reduce the perceived or actual bulk of the apparatus. In one example, the positioning and stabilising structure 3300 comprises at least one strap having a rectangular cross-section. In one example the positioning and stabilising structure 3300 comprises at least one flat strap.

[0159] In one form of the present technology, a positioning and stabilising structure 3300 is provided that is configured so as not to be too large and bulky to prevent the patient from lying in a supine sleeping position with a back region of the patient’s head on a pillow.

[0160] In one form of the present technology, a positioning and stabilising structure 3300 is provided that is configured so as not to be too large and bulky to prevent the patient from lying in a side sleeping position with a side region of the patient’s head on a pillow.

[0161] In one form of the present technology, a positioning and stabilising structure 3300 is provided with a decoupling portion located between an anterior portion of the positioning and stabilising structure 3300, and a posterior portion of the positioning and stabilising structure 3300. The decoupling portion does not resist compression and may be, e.g. a flexible or floppy strap. The decoupling portion is constructed and arranged so thatwhen the patient lies with their head on a pillow, the presence of the decoupling portion prevents a force on the posterior portion from being transmitted along the positioning and stabilising structure 3300 and disrupting the seal.

[0162] In one form of the present technology, a positioning and stabilising structure 3300 comprises a strap constructed from a laminate of a fabric patient-contacting layer, a foam inner layer and a fabric outer layer. In one form, the foam is porous to allow moisture, (e.g., sweat), to pass through the strap. In one form, the fabric outer layer comprises loop material to engage with a hook material portion.

[0163] In certain forms of the present technology, a positioning and stabilising structure 3300 comprises a strap that is extensible, e.g. resiliently extensible. For example the strap may be configured in use to be in tension, and to direct a force to draw a seal-forming structure into sealing contact with a portion of a patient’s face. In an example the strap may be configured as a tic.4.3.3.1 Conduit headgear4.3.3.1.1 Conduit headgear tubes

[0164] Referring now to Fig. 3, in some forms of the present technology, the positioning and stabilising structure 3300 comprises one or more headgear tubes 3350 that deliver pressurised air received from a conduit forming pari of the air circuit 4170 from the RPT device to the patient’s airways, for example through the plenum chamber 3200 and sealforming structure 3100. In the form of the present technology illustrated in Fig. 3, the positioning and stabilising structure 3300 comprises two tubes 3350 that deliver air to the plenum chamber 3200 from the air circuit 4170. The tubes 3350 are configured to position and stabilise the seal-forming structure 3100 of the patient interface 3000 at the appropriate part of the patient’s face (for example, the nose and / or mouth) in use. This allows the conduit of air circuit 4170 providing the flow of pressurised air to connect to a connection port 3600 of the patient interface in a position other than in front of the patient’ s face, for example on top of the patient’s head.

[0165] The tubes 3350 may be formed from a flexible material, such as an elastomer, e.g. silicone or TPE, and / or from one or more textile and / or foam materials. The lubes 3350 may have a preformed shape and may be able to be bent or moved into another shape upon application of a force but may return to the original preformed shape in the absence of said force. The tubes 3350 may be generally arcuate or curved in a shape approximating the contours of a patient’s head between the top of the head and the nasal or oral region.4.3.3.1.2 Conduit headgear connection port

[0166] In certain forms of the present technology, the patient interface 3000 may comprise a connection port 3600 located proximal to a superior, lateral or posterior portion of a patient’s head. For example, in the form of the present technology illustrated in Fig 3, theconnection port 3600 is located on top of the patient’s head (e.g. at a superior location with respect to the patient’s head). In this example the patient interface 3000 comprises an elbow 3610 forming the connection port 3600. The elbow 3610 may be configured to fluidly connect with a conduit of an air circuit 4170. The elbow 3610 may be configured to swivel with respect to the positioning and stabilising structure 3300 to at least partially decouple the conduit from the positioning and stabilising structure 3300. In some examples the elbow 3610 may be configured to swivel by rotation about a substantially vertical axis and, in some particular examples, by rotation about two or more axes. In some examples the elbow may comprise or be connected to the tubes 3350 by a ball-and-socket joint. The connection portion 3600 may be located in the sagittal plane of the patient’s head in use.

[0167] Patient interfaces having a connection port that is not positioned anterior to the patient’s face may be advantageous as some patients may find a conduit that connects to a patient interface anterior to their face to be unsightly and / or obtrusive. For example, a conduit connecting to a patient interface anterior to the patient’s face may be prone to interference with bedclothes or bed linen, particularly if the conduit extends inferiorly from the patient interface in use. Forms of the present technology comprising a patient interface having a connection port positioned superiorly to the patient's head in use may make it easier or more comfortable for a patient to lie or sleep in one or more of the following positions: a sidesleeping position, a supine position (e.g. on their back, facing generally upwards) or in a prone position (e.g. on their front, facing generally downwards). Moreover, connecting a conduit to an anterior portion of a patient interface may exacerbate a problem known as tube drag in which the conduit exerts an undesired force upon the patient interface during movement of the patient’ s head or the conduit, thereby causing dislodgement away from the face. Tube drag may be less of a problem when force is received at a superior location of the patient's head than anterior to the patient’s face proximate to the seal-forming structure (where tube drag forces may be more likely to disrupt the seal).4.3.3.2 Headgear straps

[0168] In some forms, the positioning and stabilising structure 3300 may include headgear with al least one or more straps, for example 3302 in Fig. 2 or 3310 in Fig. 3, which may be worn by the patient in order to assist in properly orienting the seal-forming structure 3100 against the patient’s face (e.g., in order to limit or prevent leaks).

[0169] As described above, some forms of the headgear 3302, 3310 may be constructed from a textile material, which may be comfortable against the patient’s skin. The textile may be flexible in order to conform to a variety of facial contours. Although the textile may include rigidisers along a selected length, which may limit bending, flexing, and / or stretching of the headgear 3302, 3310.

[0170] In certain forms, the headgear 3302, 3310 may be at least partially extensible. For example, the headgear 3302, 3310 may include elastic, or a similar extensible material. For example, the entire headgear 3302, 3310 may be extensible or selected portions may be extensible (or more extensible than surrounding portions). This may allow the headgear 3302, 3310 to stretch while under tension, which may assist in providing a sealing force for the sealforming structure 3100.4.3.4 Vent

[0171] In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow for the washout of exhaled gases, e.g. carbon dioxide.

[0172] In certain forms the vent 3400 is configured to allow a continuous vent flow from an interior of the plenum chamber 3200 to ambient whilst the pressure within the plenum chamber is positive with respect to ambient. The vent 3400 is configured such that the vent flow rate has a magnitude sufficient to reduce rebreathing of exhaled CO2 by the patient while maintaining the therapeutic pressure in the plenum chamber in use.

[0173] One form of vent 3400 in accordance with the present technology comprises a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0174] The vent 3400 may be located in the plenum chamber 3200. Alternatively, the vent 3400 is located in a decoupling structure, e.g., a swivel.4.3.5 Decoupling structure(s)

[0175] In one form the patient interface 3000 includes at least one decoupling structure, for example, a swivel or a ball and socket.4.3.6 Connection port

[0176] Connection port 3600 allows for connection to the air circuit 4170 that may be created by assembling the different components together.4.4 RPT DEVICE

[0177] An RPT device 4000 in accordance with one aspect of the present technology comprises mechanical, pneumatic, and / or electrical components and is configured to execute one or more afgorithms 4300, such as any of the methods, in whole or in part, described herein. The RPT device 4000 may be configured to generate a flow of air for del ivery to a patient’s airways, such as to treat one or more of the respiratory conditions described elsewhere in the present document.4.5 AIR CIRCUIT

[0178] An air circuit, identified as 4170 in each of Figs. I A to I C, in accordance with an aspect of the present technology is a conduit or a tube of a suitable plastics material, such as a durable thermoplastic elastomer or thermoplastics polymer in non-limiting examples, constructed and arranged to allow, in use, a flow of air to travel between two componentssuch as RPT device 4000 and the patient interface 3000. It will be understood that with respect to the flow of air, the patient interface is downstream of the RPT device.

[0179] The air circuit 4170 may be configured with cuffs of a suitable plastics material, such as polycarbonate or reinforced nylon in non-limiting examples, connecting structures at the respective ends, these being configured to engage with the patient interface 3000 and the RPT device 4000. In some examples not shown here, the air circuit 4170 may be formed from two or more lengths of tubing.

[0180] As shown in Figs. 1 A to 1C, the air circuit 4170 is provided with an outer surface that is configured with a series of corrugations or ribs, arranged in a spiral formation, along its length. These provide some structure and form to the air circuit and help to minimise or eliminate the potential for formation of kinks. Such kinks may inhibit the flow of air through the air circuit. The corrugations may be provided to the tubing of the air circuit via over-moulding techniques or the like. In some examples, the corrugations also provide a means for integrating electrical wiring, such as may be used for heating circuits to warm the air passing through the air circuit, or for conducting of data signals, into the air circuit.

[0181] One example of a securing device 4172 for use with the air circuit 4170 of Figs. 1 A to 1C is shown in Fig. 4.

[0182] This securing device 4172 allows for the air circuit (not shown in Fig. 4) to be attached to an item of clothing, bedding or other article, such as the case may be. A useful aspect of the securing device 4172 is that it allows the patient to orientate at least a portion of the air circuit, and in particular the portion of the air circuit that is upstream of the securing device, i.e. between the securing device and the RPT device, away from their body when in use, so as to eliminate or at least reduce contact with same.

[0183] The securing device 4172 has a substantially tube-like body 4174, formed from a suitably robust plastics material, such as polypropylene, polycarbonate or reinforced nylon in non-limiting examples. Other plastic materials having the desired properties, w'hich will be apparent from the following discussion, may alternatively be used.

[0184] The body 4174 has a substantially C- or U-shaped cross-sectional profile, the interior of which defines a channel 4176 running therethrough along the longitudinal or length dimension of the body. This receives the air circuit, which may be inserted through the lengthways opening or slot 4178 provided to the body 4174. As will be appreciated, this requires the cross-sectional profile of the body 4174 to have some ability to slightly deform, temporarily increasing the w'idth of the opening 4178 to allow sufficient clearance for the air circuit to be inserted by the patient applying a gentle force to same. This configuration allows the patient to quickly engage and disengage the air circuit from the securing device 4172 as required.

[0185] In a further example not shown here, the body 4174 may alternatively be formed from two separate halves and fitted together in a snap-lock type arrangement. In another example, the two halves may be configured to connected to each other along a common hinging edge and snap-locked together on the opposing edges. Such examples may eliminate the need for an opening along the length of the body; instead, the two halves are assembled together around the air circuit. These examples may include detail features on the surfaces of the channel to complementarity engage with the corrugations or ribs provided to the exterior of the air circuit.

[0186] The body 4174, and therefore the channel 4176 therein, of the securing device 4172 has a first portion 4180 and a second portion 4182. The respective first and second portions are angled relative to each other.

[0187] In further examples not shown here, the body 4174 may be configured with three or more portions, each successive portion being angled relative to the preceding portion. The channel 4176 would similarly have three or more portions corresponding to those of the body. Such examples may provide the ability to progressively impart a relatively large angle between the first portion and the final portion that may be more easily conformed to by the air circuit.

[0188] Il will be appreciated that because of the angle of the second portion 4182 relative to the first portion 4180 of the body 4174, one side of the body 4174 has an inner curvature or inside angle; the opening 4178 is provided to this side of the body 4174. The opposing side of the body therefore has an outer curvature or outside angle. In an example, the second portion may be at a 5" to 25° angle relative to the first portion, i.e. the inner curvature of the body is at an angle at or between 155" to 175°, while the outer curvature of the body is at or between 185° to 205°. In other examples, the angle may be as much as 55° to 75° or more, i.e. the inner curvature of the body is at or between 105° to 125° or more, while the outer curvature of the body is at or between 235° to 255" or more.

[0189] The securing device 4172 includes a securing means 4184, by which it may be attached to the desired portion of the article (not shown in Fig. 4) with which the securing device 4172 is to be used. The article may be an item of clothing, the securing device 4172 being positioned at or proximate the neck portion of the clothing being worn by the patient. Alternatively, the article may be bedding or other material. Such articles are inserted into the mouth 4186 of the securing means 4184, allowing the securing device 4172 to hang from same.

[0190] In the illustrated example, the securing means 4184 is a clip which is integrally formed to the first portion 4180 of the body 4174, on the side corresponding to the outer curvature or angle, i.e. the side opposing the opening 4178 of the body 4174. Having thesecuring means 4184 integrally formed with the rest of the body 4174 of the securing device 4172 may be preferred for ease of manufacture and use.

[0191] As can be seen, the clip 4184 is a L-shaped structure, with a first arm 4184a attached to the first portion 4180 of the body 4174 at a first end and to a second arm 4184b at the other. The second arm 4184b, orientated substantially perpendicular to the first arm 4184a, extends away towards the second portion 4182 of the body 4174, in a cantilever arrangement. The second arm progressively angles towards the second portion to create a narrow mouth 4186, which in use receives the item of clothing or bedding.

[0192] Variations of the described securing device may be envisaged for simpler construction, and / or ease of use, and / or convenience or suitability for use with differing materials. In some examples, the user may be provided with a plurality of securing devices for their respiratory therapy system, with one or more of this plurality of securing devices being provided in a different size, and therefore dimension, to the other securing devices. Alternatively, one or more of the plurality of securing devices may vary in the manner of attachment to the clothing or bedding, i.e. the securing means may have differing configurations / architecture / dimensions. This provides the user with the ability to select an example of the securing device that best meets their needs at the time of using the respiratory therapy system. Some alternative and vari aliens of the securing device arc discussed below.

[0193] Referring to Fig. 5, one alternative example of the securing device 4172 is shown. The body 4174 is substantially as previously described in respect of Fig. 4, but the clip 4184 has a different configuration. In this instance, the clip 4184 is integrally formed to the second portion 4182 of the body 4174 on the side corresponding to the outer curvature or angle.

[0194] The first arm 4184a of the clip, arising from the second portion 4182 of the body 4174, is more centrally positioned relative to the second arm 4184b, with a lever portion 4184c extending in the same orientation as the first portion 4180 of the body 4174. Effectively, the second arm 4184b and lever portion 4184c, being unsupported at their respective ends takes a cantilever form. In use, the patient depresses the lever 4184c, thereby increasing the width of the opening of the mouth 4186. Although not visible in this view, a contoured or button-like surface may be provided for the user to place their finger or thumb when depressing the lever. The first arm 4184a is kinked at its midportion to better facilitate the ability of the lever 4184c to be depressed.

[0195] The second arm 4184b terminates in an upstanding tip 4184d, which between it and the end of the second portion 4182 of the body defi nes the mouth 4186. The use of the upstanding tip 4184d may help the patient in directing the fabric of the patient’s clothing or bedding into the mouth 4186 of the clip 4184.

[0196] The opposing surfaces of the second arm 4184b and the second portion 4182 of the body 4174 are provided with complementary protrusions 4184e and 4174a. In use, these serve as contact or gripping surfaces that cooperate to trap the fabric of the patient’ s clothing or bedding in between them. Although the illustrated example depicts the second arm 4184b as being configured with two bumps 4184e with a single bump 4174a provided to the body 4174, it should be appreciated that this arrangement may be reversed. Additionally, further bumps may be provided to increase the size of the contact surface of the clip.

[0197] A further alternative embodiment of the securing device 4172 is shown in Fig. 6. This embodiment has much similarity to that of Fig. 5, but a key difference from the previous embodiment is that the bumps provided to the gripping surface of the second arm 4184b are absent, which makes it a simpler moulding for manufacturing purposes. Instead, a small cutout 4184f is provided and in use, this corresponds with the bump 4174a forming the gripping surface of the body 4174 of the securing device.

[0198] The architecture of the securing means 4184 is such that unless force is applied to the lever portion 4184c, the bump 4174a partially occludes the cutout 4184f. Thus, depression of the lever portion creates clearance between the bump of the body 4174 and the cutout allowing a portion of the item of clothing or bedding (not shown) to be inserted into the mouth 4186. Release of the lever portion means that the material therein is held in an interference fit between the securing means and the body of the securing device 4172.

[0199] In other examples, such as that shown in Fig. 7, the securing means 4184 of the securing device 4172 may be configured from one or more separate component which is attached or otherwise provided to complementary fittings formed to the body 4174 in a snaplock type arrangement. In the illustrated example, the securing means is provided with a cliplike structure 4184g that is received in a complementary receptacle -like structure 4174b provided to the body. An advantage of having the securing means and the body of the securing device formed as separate components is that this may provide the ability to confer a high pre-loading of force when in an assembled state compared to that possible for a securing device where the securing means is integrally formed with the body (for example, the embodiment of Fig. 5). Effectively, the securing 4184 means may already be applying a degree of force against the body 4174 prior to the use of the securing device with an item of clothing or bedding. This may make a securing device so configured more suitable for use with lighter or thinner materials.

[0200] A further example of securing device 4172 is illustrated in Fig. 7A. As with the example illustrated in Fig. 7, securing device 4172 is formed from two separate components, body 4174 and securing means 4184 in the form of a clip-like structure.

[0201] The clip-like structure of securing means 4184 comprises a first arm 4184a and second arm 4184b. The first arm 4184a of the clip is connected at a first end 4184i to secondarm 4184b and at an opposing second end 4184j to a connection member 4240. The connection point of first arm 4184a at first end 4184i to second arm 4184b may be offset from the connection point of first arm 4184a at a second end 4184j to connection member 4240, the first end 4184i of first arm 4184a connecting to second arm 4184b off centre, closer to lever 4184c and further from tip 4184d . This offset enables tip 4184d of second arm 4184b to be biased towards body 4174, with mouth 4186 held in a closed position.

[0202] First arm 4184a may be formed as a flat, curved member, and may be the same or similar width as second arm 4184b, or may be slightly narrower. When the second arm is depressed by a user at 4184c, first arm 4184a acts as a fulcrum enabling the tip 4184d of second arm 4184 to be raised to receive clothing or similar. When lever 4184c is released, the tip 4184c is lowered, trapping the clothing between protrusions 4174h and 4184h. The first arm 4184a may include a kink or curve at its midportion to better facilitate the ability of the lever 4184c to be depressed.

[0203] Connection member 4240 is shaped to connect or at least partially to the the circumferential axis of body 4174, and in the example illustrated, is formed as a C-shaped clip with a curved central band 4241 terminating in opposing end portions 4242 and 4243 (not shown). End portions 4242 and 4243 of the C-shaped clip defining a space therebetween to receive body 4174. Central band 4241 is sized such that when connected to body 4174, the inner curvature of C-shaped central band 4241 substantially corresponds to or can flexibly correspond with the curvature of outer surface 4174k of body 4174, creating a flush connection between the two components. Central band 4241 also provides a connection point for second end 4184j of first arm 4184a, which in certain forms is integrally formed with the connection member 4240, second end 4184j of first arm 4184a connected to substantially the middle portion of central band 4241.

[0204] Connection member 4240 is preferably made of a resilient material, with opposing end portions 4242 and 4243 of connection means 4240 biased towards each other such that when opposing end portions 4242 and 4243 are pushed against the outer surface 4174k of the body, end portions 4242 and 4243 are forced away from each other to receive body 4174 within the inner curve of the C-shaped connection means. Once attached to body 4174, the biasing force between opposing end portions 4242 and 4243 urges these end portions towards each other, retaining the connection member 4240 on the outer surface 4174K of body 4174.

[0205] Connection member 4240 can be readily removed from body 4174 by providing a pulling force on central band 4241 , urging end portions 4242 and 4243 apart and releasing connection member 4240 from body 4174.

[0206] End portions 4242 and 4243 may be shaped to have a greater width then central band 4241 to provide an increased surface area at either end of central band 4241. Thisincreases the connection member surface area, and therefore the friction between the connection member 4240 and body 4174. In the example shown, connection member 4240 may be shaped as a curved capital “I”, with each end 4242 and 4243 forming the feet of the “I” shape.

[0207] The increase in surface area connection between the body 4174 and removably connected securing means 4184 distributes the load forces over a larger area, improving the ability of the components to withstand pressures applied during use and retain the connection.

[0208] Outer surface 4174k of body 4174 may include depressions, ridges or texture integrally formed with body 4174 to guide and / or hold connection member 4240 in a preferred position when connected to body 4174 to simplify and aid in fast and effective assembly. In some forms, the outer surface 4174k may include a depression corresponding to the shape of the connection member 4240, such that connection member 4240 is retained within the depression and prevented or discouraged from slipping or moving to a different position along body 4174 when in use.

[0209] In Fig. 7A, the opposing surfaces of the second arm 4184b and the second portion 4182 of the body 4174 are provided with complementary offset protrusions 4184h and 4174h. In use, these serve as contact or gripping surfaces that cooperate to trap the fabric of the patient’ s clothing or bedding in between them when mouth 4186 is in a closed position. Although the illustrated example depicts two sets of protrusions 4184h and 4174h, there may be any number of protrusions required to improve connection with clothing or fabric held between the protrusions. Further, the protrusions may be in a line, or may be spaced out across an area, but should be positioned such that any protrusions on opposing surfaces are offset from each other to allow the second arm 4184b to close against body 4174.

[0210] In some other examples, the one or more separate components may be a pair of jaws, or at least one half of a pair of jaws (the other half being provided to the body). In some of these examples, a biasing member, in the form of a spring or the like, may be provided such that the pair of jaws have to be levered open to receive the item of clothing and then released in order to fix the securing device 4172 in position. Some examples of this configuration are described later in this specification.[021 I] Referring now back to the examples shown in Figs. 4 and 5, to assist in the locating of the securing device 4172 with the portion of the air circuit with w'hich it is to be used, one or both sides of the opening 4178 to the channel 4176 may include a lip or flange 4188 which tapers inwardly, towards the interior of the channel 4176, to a point 4190. It should be appreciated that the air circuit may be positioned such that this point 4190 rests between adjacent corrugations or ribs. As such, once in place, it may be difficult for the securing device 4172 to inadvertently move along the length of the air circuit. The point 4190 may also demarcate the change in angle between the first portion 4180 and the second portion4182 of the body 4174. In some examples not shown here, rather than tapering inwardly, the interior surface of the point 4190, which forms part of the channel 4176 may be provided with a protrusion or similar, which in use may rest between the adjacent corrugations or ribs of the air circuit.

[0212] An important aspect of the securing device is the orientation of the mouth 4186 of the securing means 4184 and its placement on the outer curvature or angle of the body 4174. As can be seen in Figs. 4 and 5, the mouth 4186 faces the same direction as the end of the second portion 4182 of the body 4174.

[0213] It will be appreciated that when a patient assumes a certain posture, for example, being seated, the mouth 4186 of the securing means 4184 and the second portion 4182 of the body 4174 may be inferiorly orientated, i.e. facing downwards. The side of the securing device 4172 corresponding to the inner angle or inside curvature faces anteriorly, away from the patient while the side corresponding to the outer angle or outside curvature faces the patient. Because of the angle of the second portion 4182 of the body 4174 relative to the first portion 4180, this has the effect of projecting the air circuit, when fitted to the securing device 4172, away from the patient’s body. It will be understood that this projected portion of the air circuit is that leading to the RPT device; the portion of the air circuit extending from the first portion 4180 of the body is that leading to the patient interface, which is downstream from the RPT device. The greater the angle of the second portion 4182 away from the first portion 4180, the greater the air circuit may be projected away from the patient’ s body. This may help in reducing contact, and the associated weight of same, between the air circuit and the patient’s body.

[0214] In some examples, such as that shown in Fig. 4, the projection away from the patient’s body may also be assisted by the architecture of the clip 4184, and particularly the extent of the angle of the second arm 4184b of the clip 4184 relative to the first arm 4184a of the clip 4184. As will be appreciated, the second arm bears against the patient in use; depending on the extent of the angle of the second arm 4184b, this could be deliberately arranged to supplement the projection of the air circuit away from the patient’s body, without imparting any additional curvature directly on the air circuit itself.

[0215] In use, the air circuit is inserted into the securing device 4172. The point of the tapered flange 4190 is disposed within adjacent corrugations of the air circuit, thereby anchoring the securing device 4172 in place, such that it is unlikely to slip or otherwise move incrementally up or down the length of the air circuit. The securing device 4172 is then in turn secured to the desired location (which typically is at or proximate the neck portion of the item of clothing being worn by the patient) through the use of the securing means 4184. Once in place, the upstream portion of the air circuit extending from the second portion 4182 of the securing device 4172 projects away from the desired location.

[0216] It will be appreciated that the materials of the item of clothing or bedding with which the securing device 4172 may be used will have differing thickness properties that may affect the interference fit of the securing means 4184. For example, some sleeping clothes may be comprised of relatively lightweight or thin materials, such as silk, while others may be comprised of relatively heavyweight materials, such as flannelette. Additionally, some clothes may be comprised of multiple layers of material; for example, the front or buttoned placket of a long-sleeved pyjama shirt may be folded over such that there are two layers of material as opposed to the single layer that forms the front panel of the shirt. There are similar considerations for bedding.

[0217] This may mean that a securing means 4184 that provides a good interference fit with heavy bedding material may perform poorly with lightweight sleeping clothes. To provide the user with some functionality to select a securing device 4172 suitable for their needs and usage, the securing means 4184 may take a variety of forms as will be understood from the following discussion. It should be note that aside from changes arisin g as a consequence of variations to the configuration of the securing means as discussed below, the body 4174 of the securing device is substantially as previously described.

[0218] Turning now to Fig. 8, this shows in an isometric view a securing device 4172 provided with a securing means 4184 having its first arm 4184a at the lar end of the first portion 4180 of the body 4174. The second arm 4184b extends substantially beyond the end of the second portion 4182, increasing the potential surface area available to engage with the material of the item of clothing or bedding (not shown) with which the securing device is to be used. First and second gripping surfaces 4185a, 4185b oppose each other and are provided to the second arm and body respectively. The gripping surfaces are contoured in a complementary arrangement intended to better trap the material of the clothing or bedding therebetween. A portion of the opposing surfaces may lack contouring; this may provide a gathering region 4185c in which the clothing or bedding material may be gathered in use. This surplus material may allow for some slippage in the event of inadvertent movement of the securing device as the user moves.

[0219] The securing device 4172 shown in an isometric view in Fig. 9 differs in that the gripping surface 4185a is provided to a third arm 4187 arising from the far end of the second portion 4182 of the body 4174. This third arm partially defines the mouth 4186 of the securing means 4184. Material may be secured between the gripping portion of the third arm and the gripping portion 4185b provided to the second arm 4184b. A gathering region 4185c for surplus material is formed between the third arm and the body.

[0220] An alternative configuration for the securing means 4184 of the securing device 4172 is shown in Figs. 10A and 10B; this arrangement may be preferred for thinner materials. In this example, the first arm 4184a arises from the far end of the first portion 4180 of thebody 4174, but the second arm 4184b is configured as a rectangular frame-like structure with a central opening 4189. This may be advantageous in increasing the overall width of the securing means, and therefore the available surface area for the user to hold while engaging the securing means with the item of clothing or bedding (not shown). The opening itself may allow for some gathering of the material of the clothing or bedding.[0221 J Additionally, the free end of the second arm 4184b is tilted away from the body to increase the width of the mouth 4186 of the securing means 4184. This may assist in the user when initially engaging the securing device 4172 with the item of clothing or bedding with which it is to be used.[0222J As best seen in Fig. 10B, a further advantage of the open frame-like structure is that it can place the gripping portion 4185a of the body 4174 quite close to the second arm 4184b with relatively minimal clearance between it and the body, when compared to the previous examples. It will be appreciated that the area dimensions of the gripping portion approximates those of the opening 4189 provided to the second arm.

[0223] It should be understood that from a manufacturing perspective, the manner of the extent of the interference fit between the gripping portion 4185a and the second arm 4184b, i.c. the extent and placement of force applied to the material placed therein, can be manipulated through appropriate reconfiguration of the securing means 4184.

[0224] For example, Fig. 11 shows a side view of a variant of the securing device 4172 described in Figs. 10A and 10B. As can be seen, the second arm 4184b of the securing means 4184 is slightly declined from the horizontal. In this configuration, the interference fit between in and the gripping portion 4185a of the body 4174, in use, is greatest towards the opening 4186 of the securing means. At the far end of the channel, proximate the first arm 4184a, there may be sufficient clearance for a gathering region 4185c.

[0225] Although not shown here, it will be appreciated that a similar effect may be achieved in the embodiment of Figs. 10A and 10B by angling the gripping portion 4185a relative to the body, i.e. declining it from the end proximate the mouth 4186 of the securing means towards the first arm 4184a. The same effect could be achieved by gradually decreasing the individual peaks forming the gripping portion.

[0226] Turning to Figs. I 2A and I2B, these shown in isometric views an embodiment of the securing device 4172 in which the securing means 4184 does not utilise a gripping portion that substantially bears against the body 4174 in use. Instead, as can be seen, the securing means is a unitary structure extending away from the body. The securing means is formed by a pair of supports 4191 a, 419 lb connected at their ends by a linking bar or span 4191 c. Depending from the first support 4191a and extending tow ards the second support 4191 b is a gripping tab 4192. This substantially fills the area defined by the first and second supports, linking bar and the body. The free end of the tab forms part of the mouth 4186 into which theitem of clothing or bedding is to be inserted, while support 4191b forms another part of the mouth. In use, the material of the item of clothing of bedding once secured may also bear against the linking bar on one side and the portion of the body that defines the opposing side to the linking bar. The tab’s rear face, visible in Fig. 12B, includes a thickened region 4192a to assist in applying and maintaining a securing force to material placed therein.

[0227] The embodiment of Figs. 12A and 12B may be advantageous for placement of the securing device 4172, and therefore the orientation of the air circuit (not shown), at certain locations or positions on the items of clothing worn by the user. For example, when the securing device is placed onto the front or buttoned placket of a long-sleeved pyjama shirt, this orientates the air circuit passing through the securing device substantially horizontally. This embodiment is also a relatively straightforward moulding, simplifying manufacture.

[0228] To provide greater flexibility with regard to orientation and placement of the air circuit to be secured relative to the item of clothing or bedding, the embodiment of the securing device 4172 shown in Figs. 13A and 13B is configured such that the securing means 4184 is rotatable with respect to the body 4174 of the securing device.

[0229] In this example, the securing means 4184 is formed as a frame 4193a defining an opening therein 4193b. A portion of the frame is configured with a contoured surface 4193c that may serve as a contact surface for the fingers of the user when manipulating the securing means. A gripping tab 4193d extends into the opening from an internal perimeter of the frame.

[0230] As best seen from the side of the securing device, shown in Fig. 13B, the plane of the gripping tab 4193c is generally substantially laterally displaced relative to the frame 4193a, although. At their respective far ends, the frame 4193a and gripping tab 4193d diverge away from each other, better defining and enhancing the size of the mouth 4186 of the securing means 4184.

[0231] The entire securing means 4184 is mounted to the body 4174 of the securing device via a pin 4193e arising from the body and passing through the gripping tab 4193b in a snap-fit arrangement. The tolerances between the pin and the gripping tab are such that the securing means is able to freely rotate. Although not seen here, in some examples the outer face of the gripping tab, i.e. the surface not facing the body 4174, may include contours to enhance the interference fit with the material of the item of clothing or bedding in use. Also, and as best seen in the isometric view of Fig. 13 A, the gripping tab may include a thickened region 4193f, proximate the mouth 4186 of the securing means, to assist in applying and maintaining a securing force to material placed therein.

[0232] Another securing device 4172 configured such that it is suitable for use with materials having differing thicknesses is depicted in a side view in Figure 14. In this embodiment, the securing means 4184 is a cantilever arrangement formed from a first arm4184a centrally located on the body 4174 and extending away from same. The second arm 4184b is arranged substantially perpendicular to the first arm and extends past the first portion 4180 and second portion 4182 of the body. As with the embodiment of Fig. 8, the opposing surfaces of the second arm and the body are contoured to provide gripping surfaces 4185a, 4185b.

[0233] Because the first arm 4184a intersects with the second arm 4184b substantially at the latter’s midpoint, this forms a securing means that has two mouths. Each mouth has a pair of gripping surfaces 4185 a, 4185b, but one pair is closer together than the other pair. The former can therefore be used with thinner items of clothing while the latter may be more suitable for use with thicker items of clothing or bedding.

[0234] It was previously noted that the securing means may be formed, at least partially, as a pair of jaws that is separate from the body of the securing device. An example of this is illustrated in Fig. 15, in which the body 4174 of the securing device 4172 is provided with a loop 4174c that receives a cord or string 4194. In Lun, the cord is connected to the securing means 4184 which is formed as a peg 4195 having a pair of jaws. This embodiment of the securing device places a distinct separation between the securing means and the body, holding the air circuit in use, which may be helpful in absorbing some inadvertent movement by the user before it affects the quality of the seal between the seal-forming structure (not shown) and the user’s face.

[0235] In other examples, the securing means may be in the form of a pair of j aws that are integrally formed with the body of the securing device. Referring to Fig. 16, this embodiment of the securing device 4172 has a pair of arms 4196, 4197, each arm provided to opposing sides of the body 4174 and extending perpendicularly to the length dimension of same. The arms are linked to their respective sides of the body by supports 4196a, 4197a. One end of each arm is configured as a gripping portion or teeth 4196b, 4197b which are complementary to those of the other arm; these form the jaws 4198 of the securing means 4184. The other end of each arm is configured as levers 4196c, 4197c which are operative to open the jaws, which are shown here in a closed state, in a manner similar to a clothing peg. When the levers are depressed, the jaws open and form the mouth (not visible) into which the material of the item of clothing or bedding may be placed. A gathering region 4185c may be provided for any excess material.

[0236] Another embodiment of a securing device 4172 with an integrally formed securing means 4184 is shown in Figs. 17A and 17B. The securing means is in the form of a peg-like structure, with a first gripping member 4199a and a second gripping member 4200a linked via a hinge structure 4201.

[0237] In this embodiment, the body 4174 is provided substantially midway along the first gripping member 4199a, with the opening 4178 to its channel 4176, which receives theair circuit in use, orientated outwards. The hinge structure 4201 is arranged such that the respective first gripping member and second gripping member 4200a face each other. The mouth 4186 of the securing means 4184 substantially opposes the hinge structure. The orientation of the first gripping member and the second gripping member is substantially perpendicular to the longitudinal dimension of the body.[0238J The first gripping member 4199a is configured with a receptacle 4199b that in use receives a bar 4200b of the second gripping member 4200a in a snap-lock arrangement. It will be appreciated that these complementary structures provide a gripping or contact surface between them. When in a closed configuration, the bar and receptacle trap material placed between the first gripping member and the second gripping member. The force required to place the securing device 4172 in the closed configuration may be applied by the user to the levers 4199c and 4200c of the respective gripping members.

[0239] To assist in structural integrity, particularly the forces that may be applied when closing the securing means 4184, bracing 4199d may be provided between the body 4174 and the first gripping member 4199a. To further assist in structural integrity, it will be noted, as best seen the side view of Fig. 17B, that the receptacle of the first gripping member is located, at least partially, atop and is integral with, the body of the securing device 4172. This provides additional robustness when force is applied during the closing of the securing device.

[0240] Referring to Fig. 18, this shows another form of the securing device 4172, in which an integrally formed securing member 4184 is configured to act in a peg- like manner. In contrast to the embodiment described above in respect of Figs. 17A and 17B, the orientation of the first gripping member 4199a and the second gripping member 4200a is substantially in line with the longitudinal dimension of the body 4174 of the securing device. In this example, because the orientation of the first gripping member is in line with the longitudinal dimension of the body, it is able to be substantially integral to the body.

[0241] As with the previous body described, the respective gripping members 4199a, 4200a are operatively linked via a hinge structure. The user actuates the levers 4199c, 4200c in order to open the mouth 4186 of the securing means. The gripping members have been provided with complementary interlocking features, hooks 4 l 99e, 4200d in this instance. Once these are engaged, by the user applying sufficient force to bring the hooks into proximity with each other, these act as the axis of movement for the members; an urging or biasing force is applied by the hinge structure which may be suitably pre-tensioned for this purpose.

[0242] Another embodiment of the securing device 4172 in which the securing means 4184 has two gripping members 4199a, 4200a linked by a hinge structure 4201 is shown inFigs. 19A and 19B in an isometric view and a side view respectively. In this instance, the hinge structure is a simple, thin structure with no inherent pretension moulded into it.

[0243] As depicted, the first gripping member 4199a is in the form of a box-like structure provided to the body 4174 of the securing device 4172. Disposed within the structure is an upright 4199f ; this co-operates with uprights 4200e provided to the second gripping member 4200a. It should be understood that there is clearance between all the uprights, both side to side and also at their tips. When the mouth 4186 of the securing means 4184 is open, the item of clothing or bedding is placed between the first and second gripping members. The securing means is then closed, trapping the material of the clothing or bedding between the uprights.

[0244] The free end of the second gripping member 4200a, which will be understood to form part of the mouth 4186 in use, is provided with an opening 4200f, closed off by a bar 4200h; this opening co-operates with a nub 4199g moulded to the corresponding portion of the first gripping member 4199a to lock the securing means in a closed configuration once the material has been appropriately located between the respective gripping members. To return the securing means to an open condition, the user applies a force to the bar, to urge or otherwise lever it away from the nub.

[0245] An alternative embodiment of the arrangement shown in Figs. 19A and 19B is depicted in Figs. 20A and 20B; this embodiment of the securing device 4172 differs in that the first gripping member 4199a of the securing means 4184 lacks the box-like structure previously described. Instead, a pair of uprights 4199f arises from a flat surface and interplays with a single upright 4200e provided to a flat surface of the second gripping member 4200a.

[0246] Additionally, the nub 4199g of the first gripping member is provided to a side of the first gripping member rather than at its end (as shown in the previous embodiment). Similarly, the bar 4200h that closes off the opening (not visible) is provided to the side of the second gripping member. This arrangement is useful since it places the locking arrangement (the nub, opening and bar) on a different orientation to the surfaces, from which the respective uprights 4199f, 4200e extend, that secures the material in use. Such an arrangement may be suitable for use on, for example, a shirt collar as the locking arrangement may be more accessible to the user being less obscured by the secured material.4.6 GLOSSARY

[0247] For the purposes of the present technology disclosure, in certain forms of the present technology, one or more of the following definitions may apply. In other forms of the present technology, alternative definitions may apply.4.6.1 General

[0248] Air: In certain forms of the present technology, air may be taken to mean atmospheric air, and in other forms of the present technology air may be taken to mean some other combination of breathable gases, e.g. oxygen enriched air.

[0249] Ambient: In certain forms of the present technology, the term ambient will be taken to mean (i) external of the treatment system or patient, and (ii) immediately surrounding the treatment system or patient.

[0250] For example, ambient humidity with respect to a humidifier may be the humidity of air immediately surrounding the humidifier, e.g. the humidity in the room where a patient is sleeping. Such ambient humidity may be different to the humidity outside the room where a patient is sleeping.

[0251] In another example, ambient pressure may be the pressure immediately surrounding or external to the body.

[0252] In certain forms, ambient (e.g., acoustic) noise may be considered to be the background noise level in the room where a patient is located, other than for example, noise generated by an RPT device or emanating from a mask or patient interface. Ambient noise may be generated by sources outside the room.

[0253] Automatic Positive Airway Pressure (APAP) therapy: CPAP therapy in which the treatment pressure is automatically adjustable, e.g. from breath to breath, between minimum and maximum limits, depending on the presence or absence of indications of SDB events.

[0254] Continuous Positive Airway Pressure (CPAP) therapy: Respiratory pressure therapy in which the treatment pressure is approximately constant through a respiratory cycle of a patient. In some forms, the pressure at the entrance to the airways will be slightly higher during exhalation, and slightly lower during inhalation. In some forms, the pressure will vary between different respiratory cycles of the patient, for example, being increased in response to detection of indications of partial upper airway obstruction, and decreased in the absence of indications of partial upper airway obstruction.

[0255] Flow rale: The volume (or mass) of air delivered per unit lime. Flow rale may refer to an instantaneous quantity. In some cases, a reference to flow rate will be a reference to a scalar quantity, namely a quantity having magnitude only. In other cases, a reference to flow rate will be a reference to a vector quantity, namely a quantity having both magnitude and direction. Flow rate may be given the symbol Q. ‘Flow rate’ is sometimes shortened to simply ‘flow’ or ‘airflow’.

[0256] In the example of patient respiration, a flow rate may be nominally positive for the inspiratory portion of a breathing cycle of a patient, and hence negative for the expiratory portion of the breathing cycle of a patient. Device flow rate, Qd, is the flow rate of air leavingthe RPT device. Total flow rate, Qt. is the flow rate of air and any supplementary gas reaching the patient interface via the air circuit. Vent flow rate, Qv, is the flow rate of air leaving a vent to allow washout of exhaled gases. Leak flow rate, QI, is the flow rate of leak from a patient interface system or elsewhere. Respiratory flow rate, Qr, is the flow rate of air that is received into the patient's respiratory system.

[0257] Flow therapy: Respiratory therapy comprising the delivery of a flow of air to an entrance to the airw'ays at a controlled flow rate referred to as the treatment flow rate that is typically positive throughout the patient’s breathing cycle.

[0258] Humidifier: The word humidifier will be taken to mean a humidifying apparatus constructed and arranged, or configured with a physical structure to be capable of providing a therapeutically beneficial amount of water (H2O) vapour to a flow' of air to ameliorate a medical respiratory condition of a patient.

[0259] Leak: The word leak will be taken to be an unintended flow' of air. In one example, leak may occur as the result of an incomplete seal between a mask and a patient’s face. In another example leak may occur in a swivel elbow to the ambient.

[0260] Noise, conducted (acoustic): Conducted noise in the present document refers to noise which is carried to the patient by the pneumatic path, such as the air circuit and the patient interface as w'ell as the air therein. In one form, conducted noise may be quantified by measuring sound pressure levels at the end of an air circuit.

[0261] Noise, radiated (acoustic): Radiated noise in the present document refers to noise which is carried to the patient by the ambient air. In one form, radiated noise may be quantified by measuring sound power / pressure levels of the object in question according to ISO 3744.

[0262] Noise, vent (acoustic): Vent noise in the present document refers to noise which is generated by the flow of air through any vents such as vent holes of the patient interface.

[0263] Oxygen enriched air: Air with a concentration of oxygen greater than that of atmospheric air (21%), for example at least about 50% oxygen, at least about 60% oxygen, at least about 70% oxygen, at least about 80% oxygen, at least about 90% oxygen, at least about 95% oxygen, at least about 98% oxygen, or at least about 99% oxygen. “Oxygen enriched air” is sometimes shortened to “oxygen”.

[0264] Medical Oxygen: Medical oxygen is defined as oxygen enriched air with an oxygen concentration of 80% or greater. Patient'. A person, w'hcthcr or not they arc suffering from a respiratory condition.

[0265] Pressure: Force per unit area. Pressure may be expressed in a range of units, including cm! I-O. g-f / cm2and hectopascal. 1 cmlLO is equal to 1 g-f / cm2and is approximately 0.98 hectopascal (1 hectopascal = 100 Pa = 100 N / nt1= 1 millibar - 0.001 atm). In this specification, unless otherwise stated, pressure is given in units of cm FLO.

[0266] The pressure in the patient interface is given the symbol Pm, while the treatment pressure, which represents a target value to be achieved by the interface pressure Pm at the current instant of time, is given the symbol Pt.

[0267] Respiratory Pressure Therapy: The application of a supply of air to an entrance to the airways at a treatment pressure that is typically positive with respect to atmosphere.

[0268] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.4.6.1.1 Materials & their properties

[0269] Hardness: Refers to durometer or indentation hardness, which is a material property measured by indentation of an indentor (e.g., as measured in accordance with ASTM D2240). i) ‘Soft’ materials may include silicone or thermo-plastic elastomer (TPE), and may, e.g. readily deform under finger pressure. ii) ‘Hard’ materials may include polycarbonate, polypropylene, and may not e.g. readily deform under finger pressure.

[0270] Silicone or Silicone Elastomer: A synthetic rubber. In this specification, a reference to silicone is a reference to liquid silicone rubber (LSR) or a compression moulded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the range of products sold under this trademark), manufactured by Dow Corning. Another manufacturer of LSR is Wacker. Unless otherwise specified to the contrary, an exemplary form of LSR has a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

[0271] Polycarbonate: a thermoplastic polymer of Bisphenol- A Carbonate.4.6.1.2 Mechanics

[0272] Axes: a) Neutral axis: An axis in the cross-section of a beam or plate along which there are no longitudinal stresses or strains. b) Longitudinal axis: An axis extending along the length of a shape. The axis generally passes through a center of the shape. c) Circumferential axis: An axis oriented perpendicularly with respect to the longitudinal axis. The axis may be specifically present in pipes, tubes, cylinders, or similar shapes with a circular and / or elliptical cross section.

[0273] Deformation: The process where the original geometry of a member changes when subjected to forces, e.g. a force in a direction with respect to an axis. The process may include stretching or compressing, bending and, twisting.

[0274] Elasticity: The ability of a material to return to its original geometry after deformation.

[0275] Floppy structure or component: A structure or component that will change shape, e.g. bend, when caused to support its own weight, within a relatively short period of time such as 1 second.

[0276] Resilience: Ability of a material to absorb energy when deformed elastically and to release the energy upon unloading.

[0277] Resilient: Will release substantially all of the energy when unloaded. Includes e.g. certain silicones, and thermoplastic elastomers.

[0278] Rigid structure or component: A structure or component that will not substantially change shape when subject to the loads typically encountered in use. An example of such a use may be setting up and maintaining a patient interface in sealing relationship with an entrance to a patient's airways, e.g. at a load of approximately 20 to 30 cmH2O pressure.

[0279] As an example, an I-beam may comprise a different bending stiffness (resistance to a bending load) in a first direction in comparison to a second, orthogonal direction. In another example, a structure or component may be floppy in a first direction and rigid in a second direction.

[0280] Stiffness (or rigidity) of a structure or component: The ability of the structure or component to resist deformation in response to an applied load. The load may be a force or a moment, e.g. compression, tension, bending or torsion. The structure or component may offer different resistances in different directions. The inverse of stiffness is flexibility.

[0281] Viscous: The ability of a material to resist flow.

[0282] Visco-elasticity: The ability of a material to display both elastic and viscous behaviour in deformation.

[0283] Yield: The situation when a material can no longer return back to its original geometry after deformation.4.6.1.3 Structural Elements

[0284] Compression member: A structural element that resists compression forces.

[0285] Elbow: An elbow is an example of a structure that directs an axis of flow of air travelling therethrough to change direction through an angle. In one form, the angle may be approximately 90 degrees. In another form, the angle may be more, or less than 90 degrees. The elbow may have an approximately circular cross-section. In another form the elbow may have an oval or a rectangular cross-section. In certain forms an elbow may be rotatable with respect to a mating component, e.g. about 360 degrees. In certain forms an elbow may be removable from a mating component, e.g. via a snap connection. Tn certain forms, an elbow may be assembled to a mating component via a one-time snap during manufacture, but not removable by a patient.

[0286] Frame: Frame will be taken to mean a mask structure that bears the load of tension between two or more points of connection with a headgear. A mask frame may be a non-airtight load bearing structure in the mask. However, some forms of mask frame may also be air-tight.

[0287] Membrane: Membrane will be taken to mean a typically thin element that has, preferably, substantially no resistance to bending, but has resistance to being stretched.

[0288] Tie (noun): A structure designed to resist tension.

[0289] Thin structures: a) Beams: A beam may be relatively long in one dimension compared to the other two dimensions such that the smaller dimensions are comparatively thin compared to the long dimension b) Membranes: Relatively long in two dimensions, with one thin dimension. Readily deforms in response to bending forces. Resists being stretched, (might also resist compression).

[0290] Plates & Shells: These may be relatively long in two directions, with one thin dimension. They may have bending, tensile, and / or compressive stiffness.

[0291] Thick structures: Solids

[0292] Seal: May be a noun form ("a seal") which refers to a structure, or a verb form (“to seal”) which refers to the effect. Two elements may be constructed and / or arranged to ‘seal’ or to effect ‘sealing’ therebetween without requiring a separate ‘seal’ element per se.

[0293] Shell: A shell will be taken to mean a curved, relatively thin structure having bending, tensile and compressive stiffness. For example, a curved structural wall of a mask may be a shell. In some forms, a shell may be faceted. In some forms a shell may be airtight. In some forms a shell may not be airtight.

[0294] Stiffener: A stiffener will be taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0295] Strut: A strut will be taken to be a structural component designed to increase the compression resistance of another component in at least one direction.

[0296] Swivel (noun): A subassembly of components configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the swivel may be constructed to rotate through an angle of at least 360 degrees. In another form, the swivel may be constructed to rotate through an angle less than 360 degrees. When used in the context of an air delivery conduit, the sub-assembly of components preferably comprises a matched pair of cylindrical conduits. There may be little or no leak flow of air from the swivel in use.4.6.2 Patient interface

[0297] Anti-asphyxia valve (AAV): The component or sub-assembly of a mask system that, by opening to atmosphere in a failsafe manner, reduces the risk of excessive CO2 rebreathing by a patient.

[0298] Headgear: Headgear will be taken to mean a form of positioning and stabilising structure designed to hold a device, e.g., a mask, on a head.

[0299] Plenum chamber: a mask plenum chamber will be taken to mean a portion of a patient interface having walls at least partially enclosing a volume of space, the volume having air therein pressurised above atmospheric pressure in use. A shell may form part of the walls of a mask plenum chamber.

[0300] Seal: May be a noun form ("a seal") which refers to a structure, or a verb form (“to seal”) which refers to the effect. Two elements may be constructed and / or arranged to ‘seal’ or to effect ‘scaling’ therebetween without requiring a separate ‘seal’ clement per sc.

[0301] Vent: (noun): A structure that allows a flow of air from an interior of the mask, or conduit, to ambient air for clinically effective washout of exhaled gases. For example, a clinically effective washout may involve a flow rate of about 10 litres per minute to about 100 litres per minute, depending on the mask design and treatment pressure.4.7 OTHER REMARKS

[0302] A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in Patent Office patent files or records, but otherwise reserves all copyright rights whatsoever.

[0303] Unless the context clearly dictates otherwise and where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit, between the upper and lower limit of that range, and any other stated or intervening value in that stated range is encompassed within the technology. The upper and lower limits of these intervening ranges, which may be independently included in the intervening ranges, are also encompassed within the technology, subject to any specifically excluded limit in the stated range. Where the staled range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the technology.

[0304] Furthermore, where a value or values are stated herein as being implemented as part of the technology, it is understood that such values may be approximated, unless otherwise stated, and such values may be utilized to any suitable significant digit to the extent that a practical technical implementation may permit or require it.

[0305] Furthermore, “approximately”, “substantially”, “about”, or any similar term used herein means + / - 5-10% of the recited value.

[0306] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present technology, a limited number of the exemplary methods and materials are described herein.

[0307] When a particular material is identified as being used to construct a component, obvious alternative materials with si mil ar properties may be used as a substitute. Furthermore, unless specified to the contrary, any and all components herein described are understood to be capable of being manufactured and, as such, may be manufactured together or separately.

[0308] It must be noted that as used herein and in the appended claims, the singular forms "a", "an", and "the" include their plural equivalents, unless the context clearly dictates otherwise.

[0309] All publications mentioned herein arc incorporated herein by reference in their entirety to disclose and describe the methods and / or materials which are the subject of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present technology is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates, which may need to be independently confirmed.

[0310] The terms "comprises" and "comprising" should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced.

[0311] The subject headings used in the detailed description are included only for the ease of reference of the reader and should not be used to limit the subject matter found throughout the disclosure or the claims. The subject headings should not be used in construing the scope of the claims or the claim limitations.

[0312] Although the technology herein has been described with reference to particular examples, it is to be understood that these examples are merely illustrative of the principles and applications of the technology. Tn some instances, the terminology and symbols may imply specific details that are not required to practice the technology. For example, although the terms "first" and "second" may be used, unless otherwise specified, they arc not intended to indicate any order but may be utilised to distinguish between distinct elements. Furthermore, although process steps in the methodologies may be described or illustrated in an order, such an ordering is not required. Those skilled in the art will recognize that such ordering may be modified and / or aspects thereof may be conducted concurrently or even synchronously.

[0313] It is therefore to be understood that numerous modifications may be made to the illustrative examples and that other arrangements may be devised without departing from the spirit and scope of the technology.4.8 REFERENCE SIGNS LIST patient 1000 bed partner 1 100 patient interface 3000 seal - forming structure 3100 cushion module 3150 plenum chamber 3200 positioning and stabilising structure 3300 headgear 3302 strap 3310 tab 3320 tube 3350 extendable tube sections 3362 non - extendable tube sections 3363 vent 3400 connection port 3600 elbow 3610 forehead support 3700RPT device 4000 air circuit 4170 securing device for air circuit 4172 body (of securing device) 4174 bump (of body) 4174a receptacle (for clip of securing means) 4174b loop (of body) 4174c protrusion (of body) 4174h outer curved surface (of body) 4174k channel (of securing device) 4176 opening (of channel) 4178 first portion (of body of securing device) 4180 second portion (of body of securing device) 4182 securing means 4184 first arm (of securing means) 4184a second arm (of securing means) 4184b lever (of securing means) 4184c tip (of securing means) 4184d bump (of securing means) 4184e cutout (of securing means) 4184f clip (of securing means) 4184g protrusion (of securing means) 4 l 84h first end of first arm (of securing means) 4184isecond end of first arm (of securing means) 4184j first gripping surface 4185a second gripping surface 4185b gathering region (of securing means) 4185c mouth (of securing means) 4186 third arm (of securing means) 4187 flange (of opening of channel) 4188 opening (of second arm of securing means) 4189 point (of flange) 4190 first support (of securing means) 4191a second support (of securing means) 4191b linking bar (of securing means) 4191c gripping tab (of securing means) 4192 frame (of securing means) 4193a opening of frame 4193b contoured surface of frame 4193c gripping tab 4193d pin for gripping Lab 4193e cord / string 4194 separate peg 4195 first arm (of securing means) 4196 support (of first arm) 4196a gripping portion (of first arm) 4196b lever (of first arm) 4196c second arm (of securing means) 4197 support (of second arm) 4197a gripping portion (of second arm) 4197b lever (of second arm) 4197c jaws (of securing means) 4198 first gripping member (of securing means) 4199a receptacle (of first gripping member) 4199b lever (of first gripping member) 4199c bracing (of first gripping member) 4199d hook (of first gripping member) 4199c upright (of first gripping member) 4199f nub (of first gripping member) 4199g second gripping member (of securing 4200a means) bar (of second gripping member) 4200b lever (of second gripping member) 4200c hook (of second gripping member) 4200d uprighlfs) (of second gripping member) 4200e opening (of second gripping member) 4200f bar (of second gripping member) 4200g hinge structure 4201

Claims

CLAIMS1. A securing device for an air circuit for a respiratory therapy system, the securing device including: a body configured with a channel therethrough, wherein the channel has a longitudinal length and wherein, in use, the channel receives a portion of a length of the air circuit, and wherein along its longitudinal length the channel has a first portion and a second portion, wherein the second portion is at an angle relative to the first portion, and wherein the body has a first side having an inner curvature and a second side having an outer curvature, and a securing means provided to the body.

2. The securing device as claimed in claim 1, wherein the securing means is provided to the second side of the body.

3. The securing device as claimed in claim 2, wherein the securing means is provided to the second side of one of the first portion of the body or the second portion of the body.

4. The securing device as claimed in any one of claims 1 to 3 wherein the body is integrally formed with the securing means.

5. The securing device as claimed in any one of claims 1 to 3, wherein the securing means is a separate component configured to be mounted or otherwise attached to the body.

6. The securing device of claim 5, wherein the securing means comprises a first arm and a second arm, and a connection member adapted for removably connecting the securing means to the body.

7. The securing device of claim 6, wherein the connection member is a C-shaped clip shaped to be received by the second side of the body, at least partially around the circumferential axis of the body.

8. The securing device of claim 6 or 7. wherein the second arm is connected to the connection member via the first arm.

9. The securing device as claimed in any one of claims 5 to 8, wherein the securing means is rotatably mounted to the body.

10. The securing device as claimed in claim 5, wherein the securing means is mounted to the body in a snap-lock arrangement.

11. The securing device as claimed in any one claims 1 to 10, wherein the securing means has a mouth leading to an opening or recess defined by a portion of a surface of the body and a portion of the surface of the securing means.

12. The securing device as claimed in any one of claims 1 to 10, wherein the securing means has a mouth leading to an opening or recess defined by a first surface of the securing means and a second surface of the securing means.

13. The securing device as claimed in claim 12, wherein the first surface and the second surface substantially oppose each other.

14. The securing device as claimed in claim 12 or claim 13, wherein the securing means has a second mouth leading to a second opening or recess defined by a third surface of the securing means and a fourth surface of the securing means.

15. The securing device as claimed in claim 14, wherein the third surface and the fourth surface substantially oppose each other.

16. The securing device as claimed in claim I I , wherein the mouth is configured with protrusions that interlock with complementary protrusions provided to a portion of the surface of the body.

17. The securing device as claimed in claim 12, wherein the mouth is configured with protrusions that interlock with complementary protrusions provided to a portion of a surface of the securing means.

18. The securing device as claimed in any one of claims 1 to 17, wherein the second portion of the channel is angled relative to the first portion of the channel at an angle ranging from between, and including, 5° to 75°.

19. The securing device as claimed in claim 18, wherein the second portion of the channel is angled relative to the first portion of the channel at an angle ranging from between, and including, 5° to 45°.

20. The securing device as claimed in any one of claims 1 to 19, wherein the body has a C-shaped cross-sectional profile with an opening to the channel defined by a slot along the length of the body.

21. The securing device as claimed in claim 20, wherein the slot is configured to allow a portion of a length of the air circuit to be forced therethrough to locate the air circuit in the channel of the body.

22. The securing device as claimed in either claim 20 or claim 21, wherein al least one side of the slot is configured with a flange or lip along its length.

23. The securing device as claimed in claim 22, wherein the flange or lip increases in width from its respective ends to form a point.

24. The securing device as claimed in any one of claims 20 to 23, wherein the slot is provided to the first side of the body.

25. The securing device as claimed in any one of claims 1 to 24, wherein the body is formed from a thermoplastic polymer.

26. The securing device as claimed in claim 5, wherein the securing means is formed from a thermoplastic polymer.

27. The securing device as claimed in claim 25 or claim 26, wherein the thermoplastic polymer is polypropylene.

28. An air circuit for a respiratory therapy system, the air circuit including: a tube configured and arranged to be connected to one or both of a respiratory therapy device or a patient interface; and a securing device as claimed in any one of claims 1 to 27.

29. A respiratory therapy system, the system including: a respiratory therapy device; a patient interface comprising a plenum chamber and a seal-forming structure, the patient interface also comprising a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on a patient’s head, wherein the seal-forming structure is constructed and arranged to form a seal with a region of the patient’s face surrounding an entrance to the patient’s airways for sealed delivery of a flow of air at a therapeutic pressure of at least 6 emH 'O above ambient air pressure throughout the patient’s respirator cycle in use; an air circuit; and a securing device as claimed in any one of claims 1 to 27.

30. The respiratory therapy system as claimed in claim 29, including a plurality of securing devices as claimed in any one of claims 1 to 27.

31. The respiratory therapy system as claimed in claim 30, wherein at least one of the plurality of securing devices is provided in a different dimension to at least one other of the plurality of securing devices.

32. The respiratory therapy system as claimed in claim 30 or claim 31, wherein at least one of the plurality of securing devices is provided with a securing means having a different configuration / architecture to at least one other of the plurality of securing devices.

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