Patient interface with eye mask and connector for eye mask

Abstract

A connector for connecting an eye mask to a headgear tube is described. The connector comprises a flexible member. A first end of the flexible member is configured to be releasably connected to another portion of the flexible member to form a sleeve. The flexible member further comprises a slit. An outer face of the flexible member comprises a portion of hook material or a portion of unbroken loop material.

Description

PATIENT INTERFACE WITH EYE MASK AND CONNECTOR FOREYE MASK1 BACKGROUND OF THE TECHNOLOGY1.1 FIELD OF THE TECHNOLOGY

[0001] 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.1.2 DESCRIPTION OF THE RELATED ART1.2.1 Human Respiratory System and its Disorders

[0002] The respiratory system of the body facilitates gas exchange. The nose and mouth form the entrance to the airways of a patient.

[0003] 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.

[0004] A range of respiratory disorders exist. Certain disorders may be characterised by particular events, e.g. apneas, hypopneas, and hyperpneas.

[0005] 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.1.2.2 Therapies

[0006] 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.A2578192 12.0 11.2.2.1 Respiratory pressure therapies

[0007] 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).1.2.3 Respiratory Therapy Systems

[0008] 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.

[0009] 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

[0010] 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 cmFFO 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 cmFFO. For flow 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.1.2.3.1.1 Seal-forming structure

[0011] 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.

[0012] 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. In one form of patient interface, a seal-forming structure may comprise a first sub-portion toA2578192 12.0 2form 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.

[0013] 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.

[0014] One form of nasal pillow is found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow, or nasal puff is the subject of US Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0015] ResMed Inc. has manufactured the following products that incorporate nasal pillows: SWIFT™ nasal pillows mask, SWIFT™ II nasal pillows mask, SWIFT™ LT nasal pillows mask, SWIFT™ FX nasal pillows mask and MIRAGE LIBERTY™ full-face mask. The following patent applications describe examples of nasal pillows masks: International Patent Application WO 2004 / 073778 (describing amongst other things aspects of the SWIFT™ nasal pillows mask), US Patent Application 2009 / 0044808 (describing amongst other things aspects of the SWIFT™ LT nasal pillows mask); International Patent Applications WO 2005 / 063328 and WO 2006 / 130903 (describing amongst other things aspects of the MIRAGE LIBERTY™ full-face mask); International Patent Application WO 2009 / 052560 (describing amongst other things aspects of the SWIFT™ FX nasal pillows mask). / .2.3.1.2 Positioning and Stabilising Structure

[0016] 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 andA2578192 12.0 3stabilising 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.

[0017] One technique is the use of adhesives, e.g. see US Patent Application Publication No. US 2010 / 0000534.

[0018] Another 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

[0019] 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. / .2.3.1.4 Pressurised Air Conduit used for Positioning / Stabilising the Seal- Forming Structure

[0020] 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 are 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 patient’s head.

[0021] 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, form an air-tight and stable seal with the patient’s face, while also able to fit a range of patient head shapes and sizes.A2578192 12.0 41.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0022] 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.1.2.3.3 Air circuit

[0023] 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.1.2.3.4 Humidifier

[0024] 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

[0025] 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.

[0026] 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.A2578192 12.0 5

[0027] 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

[0028] 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

[0029] 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 / monitoring of sleep disordered breathing.

[0030] 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.

[0031] 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.A2578192 12.0 61.2.5 Eye Masks

[0032] Respiratory therapies are often delivered while the patient is asleep (or is attempting to sleep). However, many patients find it more difficult to get to sleep while wearing a patient interface.

[0033] Eye masks with a light-blocking design which provides a condition of total darkness are known to help stimulate melatonin production and thus serve to promote a state of sleep, and so use of an eye mask when respiratory therapy is being delivered may assist with helping the patient sleep well during therapy.

[0034] However, many eye masks may be inconvenient to use in combination with a patient interface. For example, placing eye mask straps over a PAP system which uses conduits as a positioning and stabilising structure can lead to crushing of the conduits and consequent air restriction during treatment. Conversely, if the patient places the eye-mask on first, they subsequently have to place their PAP mask system on while partially or fully visually obstructed.2 BRIEF SUMMARY OF THE TECHNOLOGY

[0035] 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.

[0036] A first aspect of the present technology relates to apparatus used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of a respiratory disorder.

[0037] Another aspect of the present technology relates to methods used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of a respiratory disorder.

[0038] 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.

[0039] 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.A2578192 12.0 7

[0040] One form of the present technology comprises a patient interface comprising a plenum chamber, a seal-forming structure, and a positioning and stabilising structure.

[0041] One form of the present technology comprises patient interface comprising a plenum chamber pressurisable to a therapeutic pressure of at least 4 cmH20 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 seal-forming 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.

[0042] 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.

[0043] 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.

[0044] One form of the present technology comprises a connector for connecting an eye mask to a headgear tube. The connector comprises a flexible member. A first end of the flexible member is configured to be releasably connected to another portion of the flexible member to form a sleeve. The flexible member further comprises a slit. An outer face of the flexible member comprises a portion of hook material or a portion of unbroken loop material.

[0045] In examples: a. the flexible member comprises a first portion of unbroken loop material on a first side and a second portion of unbroken loop material on an opposite second side thereof;A2578192 12.0 8b. the first end of the flexible member includes a portion of hook material configured to engage the second portion of unbroken loop material when the flexible member is wrapped around the headgear tube; c. the flexible member has a second end and two side edges; d. the flexible member is rectangular; e. the slit is substantially parallel to the first end of the flexible member or a second end of the flexible member; f. the slit is substantially orthogonal to one of the side edges; g. the slit has a length between 35mm-65mm; and / or h. the connector is configured to remain connected to the headgear tube, in use, over multiple therapy cycles regardless of whether the eye mask is attached.

[0046] Another form of the technology comprises a connector for connecting an eye mask to a headgear tube. The connector comprises a flexible member comprising a first portion of unbroken loop material having loops on a first side of the flexible member and a second portion of unbroken loop material having loops on an opposite second side of the flexible member. The connector further comprises a portion of hook material connected to a first end of the flexible member for releasable connection to the second portion of unbroken loop material such that the flexible member forms a sleeve. The flexible member further comprises a slit which is generally parallel to the first end of the flexible member.

[0047] Another form of the present technology comprises a conduit headgear for a patient interface comprising a headgear tube, the headgear tube comprising a tab for connection to a headgear strap, the headgear further comprising a sleeve configured to releasably wrap around the headgear tube, the sleeve comprising a slit through which the tab protrudes, in use, wherein the sleeve has a patient facing side and a non patient facing side, and wherein the non patient facing side is provided with a portion of hook material or a portion of unbroken loop material.

[0048] Another form of the present technology comprises a system comprising a conduit headgear for a patient interface in combination with an eye mask, the conduit headgear comprising a headgear tube which has a tab for connection to a headgear strap, the headgear further comprising a flexible member, a first end of the flexibleA2578192 12.0 9member configured to be releasably connected to another portion of the flexible member to form a sleeve around the tube, the sleeve comprising a slit through which the tab protrudes, in use, wherein the sleeve has a patient facing side and a non patient facing side, and wherein the eye mask is releasably connectable to the sleeve by a hook and loop fastener.

[0049] In examples: a. the flexible member comprises a portion of loop material and a portion of hook material is connected to the first end of the flexible member; b. the slit is dimensioned to receive the tab such that the flexible member is prevented from sliding or rotating relative to the headgear tube in use; c. the eye mask includes lateral tab portions to facilitate engagement and disengagement of the eye mask with the sleeve; d. the flexible member is substantially rectangular when laid flat; e. the flexible member is configured to remain connected to the headgear tube over multiple therapy cycles; f. the system is configured to allow the eye mask, when in use, to be disengaged from the sleeve disturbing the position of the headgear tube; g. the eye mask comprises lateral portions of hook material which are positioned to allow engagement with a portion of unbroken loop material provided to the flexible member; and / or h. in use, no part of the eye mask is located between the patient’s face and the patient interface.

[0050] Another aspect of one form of the present technology is a patient interface that is moulded or otherwise constructed with a perimeter shape which is complementary to that of an intended wearer.

[0051] An aspect of one form of the present technology is a method of manufacturing apparatus.

[0052] Another aspect of one form of the present technology is a method of assembling a modular system comprising selecting a positioning and stabilising structure, and connecting the positioning and stabilising structure to either a first cushion or a second cushion.A2578192 12.0 10

[0053] 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.

[0054] 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.

[0055] 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.

[0056] 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.

[0057] 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.

[0058] 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

[0059] 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

[0060] 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 aA2578192 12.0 11humidifier 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.

[0061] Fig. IB shows 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.

[0062] 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 RESPIRATORY SYSTEM AND FACIAL ANATOMY

[0063] Fig. 2 shows an overview of a human respiratory system including the nasal and oral cavities, the larynx, vocal folds, oesophagus, trachea, bronchus, lung, alveolar sacs, heart and diaphragm.3.3 PATIENT INTERFACE

[0064] Fig. 3 A shows a patient interface in the form of a nasal mask in accordance with one form of the present technology.

[0065] Fig. 3A-1 shows forces acting on the patient interface of Fig. 3 A, while in use.

[0066] Fig. 3B shows a patient interface having conduit headgear, in accordance with one form of the present technology.

[0067] Fig. 3B-1 shows forces acting on the patient interface of Fig. 3B, while in use.3.4 RPT DEVICE

[0068] Fig. 4 shows an RPT device in accordance with one form of the present technology.3.5 HUMIDIFIER

[0069] Fig. 5A shows an isometric view of a humidifier in accordance with one form of the present technology.

[0070] Fig. 5B shows an isometric view of a humidifier in accordance with one form of the present technology, showing a humidifier reservoir 5110 removed from the humidifier reservoir dock 5130.A2578192 12.0 123.6 BREATHING WAVEFORMS

[0071] Fig. 6 shows a model typical breath waveform of a person while sleeping.3.7 MODULARITY

[0072] Fig. 7A shows a perspective view of a cushion of a patient interface configured to be worn by a patient and convey pressurized air to the patient’s nose and the patient’s mouth.

[0073] Fig. 7B shows a perspective view of a cushion of a patient interface configured to be worn by a patient and convey pressurized air to the patient’s nose.

[0074] Fig. 7C shows a perspective view of tubes usable with either the cushion of Fig. 7 A or the cushion of Fig. 7B.

[0075] Fig. 7D shows a perspective view of rigidiser arms usable with either the cushion of Fig. 7 A of the cushion of Fig. 7B.

[0076] Fig. 7E shows a perspective view of headgear straps usable with the cushion of Fig. 7 A.

[0077] Fig. 7F shows a perspective view of headgear straps usable with the cushion of Fig. 7B.

[0078] Fig. 7G shows a front view of a pair of sleeves that is removably fitted to either the tubes of Fig. 7C or the rigidiser arms of Fig. 7D.

[0079] Fig. 7H shows a front view of a full sleeve that is removably fitted to the rigidiser arms of Fig. 7D.

[0080] Fig. 71 shows a front perspective view of yet another alternate form of a full sleeve that is removably fitted to the rigidiser arms of Fig. 7D.

[0081] Fig. 7J is a front view of a patient wearing the cushion of Fig. 7A connected to the tubes of Fig. 7C, the headgear straps of Fig. 7E, and the sleeves of Fig. 7G.

[0082] Fig. 7K is a front view of a patient wearing the cushion of Fig. 7A connected to the rigidiser arms of Fig. 7D, the headgear straps of Fig. 7E, and the sleeve of Fig. 7H.

[0083] Fig. 7L is a front view of a patient wearing the cushion of Fig. 7B connected to the conduit headgear of Fig. 7C, and the headgear straps of Fig. 7F.

[0084] Fig. 7M is a front view of a patient wearing the cushion of Fig. 7B connected to the rigi disier arms of Fig. 7D, the headgear straps of Fig. 7F, and the sleeve of Fig. 71.

[0085] Fig. 7N is an isolated perspective view of the vent of Fig. 7L.A2578192 12.0 13

[0086] Fig. 70 is an isolated perspective view of a portion of the air circuit of Fig. 7M.

[0087] Fig. 7P is a schematic view illustrating the possible combinations of the patient interfaces.3.8 EYE MASK SYSTEM OF THE PRESENT TECHNOLOGY

[0088] Fig. 8 shows a perspective view of a patient wearing a patient interface and an eye mask according to one form of the present technology.

[0089] Fig. 9A shows a connector for connecting an eye mask to a headgear tube of a patient interface according to one form of the technology.

[0090] Fig. 9B shows a patient preparing to connect the connector of Fig. 9A to a headgear tube.

[0091] Fig. 9C shows the headgear connector and tube of Fig. 9B, with the headgear connector partially connected to the headgear tube, with an opening of the connector engaged with the headgear tube tab.

[0092] Fig. 9D shows another view of the headgear connector and tube of Fig.9B, with the connector partially connected to the tube.

[0093] Fig. 9E shows another view of the headgear connector and tube of Fig.9B, with the connector partially connected to the tube and the second portion of unbroken loop material being connected to the hook portion to secure the connector to the tube.

[0094] Fig. 9F shows the headgear connector and tube of Fig. 9B, with the connector fully engaged with the headgear tube, from the patient facing side of the connector and tube.

[0095] Fig. 9G shows the headgear connector and tube of Fig. 9B from the non patient facing side of the connector and tube.

[0096] Fig. 10A shows a headgear tube with the connector of Fig. 9A fully engaged, and a headgear strap attached to the tab of the tube.

[0097] Fig. 10B shows a patient interface with connectors of the present technology engaged with both headgear tubes.

[0098] Fig. 11 shows the patient interface of Fig.10B being worn by a patient.

[0099] Fig. 12 shows a posterior view of the eye mask shown in Fig. 8.A2578192 12.04 DETAILED DESCRIPTION OF EXAMPLES OF THETECHNOLOGY

[0100] 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.

[0101] 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

[0102] 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.

[0103] 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.

[0104] In certain examples of the present technology, mouth breathing is limited, restricted or prevented.4.2 RESPIRATORY THERAPY SYSTEMS

[0105] 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

[0106] A non-invasive patient interface 3000, such as that shown in Fig. 3A, 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 stabilising structure 3300, a vent 3400, one form of connection port 3600 for connection to air circuit 4170, and a forehead support 3700. In some forms a functional aspect may be provided by one or more physical components. In someA2578192 12.0 15forms, 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.

[0107] As shown in Fig. 3B, a non-invasive patient interface 3000 in accordance with another aspect of the present technology comprises the following functional aspects: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilising structure 3300, a vent 3400 and one form of connection port 3600 for connection to an air circuit (such as the air circuit 4170 shown in Figs. 1 A-1C). The plenum chamber 3200 may be formed of one or more modular components (e.g., a cushion module 3150 together with the seal -forming structure 3100) in the sense that it or they can be replaced with different components, for example components of a different size.

[0108] An unsealed patient interface 3800, in the form of a nasal cannula, includes nasal prongs 3810a, 3810b which can deliver air to respective nares of the patient 1000 via respective orifices in their tips. Such nasal prongs do not generally form a seal with the inner or outer skin surface of the nares. This type of interface results in one or more gaps that are present in use by design (intentional) but they are typically not fixed in size such that they may vary unpredictably by movement during use. This can present a complex pneumatic variable for a respiratory therapy system when pneumatic control and / or assessment is implemented, unlike other types of mask-based respiratory therapy systems. The air to the nasal prongs may be delivered by one or more air supply lumens 3820a, 3820b that are coupled with the nasal cannula-type unsealed patient interface 3800. The lumens 3820a, 3820b lead from the nasal cannula-type unsealed patient interface 3800 to a respiratory therapy device via an air circuit. The unsealed patient interface 3800 is particularly suitable for delivery of flow therapies, in which the RPT device generates the flow of air at controlled flow rates rather than controlled pressures. The “vent” or gap at the unsealed patient interface 3800, through which excess airflow escapes to ambient, is the passage between the end of the prongs 3810a and 3810b of the nasal cannula-type unsealed patient interface 3800 via the patient’s nares to atmosphere.A2578192 12.0 16

[0109] If a patient interface is unable to comfortably deliver a minimum level of positive pressure to the airways, the patient interface may be unsuitable for respiratory pressure therapy.

[0110] The patient interface 3000 in accordance with one form of the present technology is constructed and arranged to be able to provide a supply of air at a positive pressure above the ambient, for example at least 2, 4, 6, 10, or 20 cmH20 with respect to ambient.4.3.1 Seal-forming structure

[0111] 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.

[0112] In one form the target seal -forming region is located on an outside surface of the seal-forming structure 3100.

[0113] In certain forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material, e.g. silicone rubber.

[0114] A seal -forming structure 3100 in accordance with the present technology may be constructed from a soft, flexible, resilient material such as silicone.

[0115] 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

[0116] 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 assistedA2578192 12.0 17mechanism may act in conjunction with elastic tension in the positioning and stabilising structure.4.3.1.2 Nasal pillows

[0117] 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.4.3.1.3 Nose-only Masks

[0118] 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.

[0119] 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.

[0120] Another form of nose-only mask may seal around an inferior periphery of the patient’s nose without engaging the user’s nasal ridge. This type of patient interface 3000 may be identified as a “nasal cradle” mask and the seal-forming structure 3100 may be identified as a “nasal cradle cushion”, for example. In one form, for example as shown in Fig. 3B, the seal -forming structure 3100 is configured to form a seal in use with inferior surfaces of the nose around the nares. The sealforming structure 3100 may be configured to seal around the patient’s nares at an inferior periphery of the patient’s nose including to an inferior and / or anterior surfaceA2578192 12.0 18of a pronasale region of the patient’s nose and to the patient’s nasal alae. The sealforming structure 3100 may seal to the patient’s lip superior. The shape of the sealforming structure 3100 may be configured to match or closely follow the underside of the patient’s nose and may not contact a nasal bridge region of the patient’s nose or any portion of the patient’s nose superior to the pronasale. In one form of nasal cradle cushion, the seal-forming structure 3100 comprises a bridge portion dividing the opening into two orifices, each of which, in use, supplies air or breathable gas to a respective one of the patient’s nares. The bridge portion may be configured to contact or seal against the patient’s columella in use. Alternatively, the seal-forming structure 3100 may comprise a single opening to provide a flow or air or breathable gas to both of the patient’s nares.

[0121] In some forms, a nose-only mask may comprise nasal pillows, described above.4.3.1.4 Nose and Mouth Masks

[0122] 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.

[0123] 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 sealforming structure 3100 may be referred to as a “nose-and-mouth cushion”.

[0124] In another form the patient interface 3000 comprises a seal-forming structure 3100 that forms a seal in use on a patient’s chin region (which may includeA2578192 12.0 19the patient’s lip inferior and / or a region directly inferior to the lip inferior), to an inferior and / or an anterior surface of a pronasale portion of the patient’s nose, to the alae of the patient’s nose and to the patient’s face on each lateral side of the patient’s nose, for example proximate the nasolabial sulci. The seal-forming structure 3100 may also form a seal against a patient’s lip superior. A patient interface 3000 having this type of seal-forming structure may have a single opening configured to deliver a flow of air or breathable gas to both nares and mouth of a patient, may have an oral hole configured to provide air or breathable gas to the mouth and a nasal hole configured to provide air or breathable gas to the nares, or may have an oral hole for delivering air to the patient’s mouth and two nasal holes for delivering air to respective nares. This type of patient interface 3000 may have a nasal portion and an oral portion, the nasal portion sealing to the patient’s face at similar locations to a nasal cradle mask.

[0125] In a further form of nose and mouth mask, the patient interface 3000 may comprise a seal -forming structure 3100 having a nasal portion comprising nasal pillows and an oral portion configured to form a seal to the patient’s face around the patient’s mouth.

[0126] In some forms, the seal-forming structure 3100 may have a nasal portion that is separate and distinct from an oral portion. In other forms, a seal-forming structure 3100 may form a contiguous seal around the patient’s nose and mouth.

[0127] It is to be understood that the above examples of different forms of patient interface 3000 do not constitute an exhaustive list of possible configurations. In some forms a patient interface 3000 may comprise a combination of different features of the above described examples of nose-only and nose and mouth masks.4.3.2 Plenum chamber

[0128] 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.A2578192 12.0 20

[0129] 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 tend to be less obtrusive and / or more comfortable for the wearer, which can improve compliance with therapy.4.3.2.1 Multiple Openings

[0130] As shown in Figs. 7A and 7B, different plenum chambers 3200-1, 3200-2 may be formed as part of a multi -opening cushion 3050-1, 3050-2. In the illustrated examples, the cushions 3050-1, 3050-2 each include three openings, although an alternate cushion may be formed with greater or fewer openings.

[0131] In some forms, the different openings may serve different functions. For example, some openings may be exclusively inlet openings, while other openings may be exclusively outlet openings.

[0132] In other forms, at least one opening may serve two different functions. For example, one opening may operate as both an inlet and an outlet during the same breathing cycle.

[0133] The plurality of openings may allow for a variety of configurations of air delivery to the plenum chamber 3200-1, 3200-2. For example, depending on patient need and / or patient comfort, the patient may use a given cushion 3050-1, 3050-2 in a “tube-up” configuration (e.g., using conduit headgear - described below) or a “tubedown” configuration (e.g., using a single conduit in front of the patient’s face).4.3.2.1.1 Nose and Mouth Mask

[0134] As shown in Fig. 7A, the plenum chamber 3200-1 includes a pair of plenum chamber inlet ports 3254-1, which may be used to convey gas into and / or out of the plenum chamber 3200-1. The plenum chamber inlet ports 3254-1 may be disposed on opposite sides (e.g., left and right sides) of the plenum chamber 3200-1.

[0135] In some forms, the plenum chamber 3200-1 may also include at least one vent opening 3402-1 (see e.g., Fig. 7A). The vent opening 3402-1 may be disposed in a center of the plenum chamber 3200-1. For example, the vent opening 3402-1 may be disposed between the plenum chamber inlet ports 3254-1.

[0136] In some forms, the plenum chamber 3200-1 may include a pair of grooves 3266-1. Each groove 3266-1 may be disposed proximate to one of the plenum chamber inlet ports 3254-1. Each groove 3266-1 may form a partially recessed surface.A2578192 12.0 214.3.2.1.2 Nose-only Mask

[0137] The plenum chamber 3200-2 of a nasal only cushion 3050-2 may be similar to the plenum chamber 3200-1 of the mouth and nose cushion 3050-1. Only some similarities and differences between the plenum chambers 3200-1, 3200-2 may be described below.

[0138] As shown in Fig. 7B, the plenum chamber 3200-2 includes a pair of plenum chamber inlet ports 3254-2, which may be used to convey gas into and / or out of the plenum chamber 3200-2. The plenum chamber inlet ports 3254-2 may be disposed on opposite sides (e.g., left and right sides) of the plenum chamber 3200-2.

[0139] In some forms, the plenum chamber 3200-2 may also include at least one vent opening 3402-2 (see e.g., Fig. 7B). The vent opening 3402-2 may be disposed in a center of the plenum chamber 3200-2. For example, the vent opening 3402-2 may be disposed between the plenum chamber inlet ports 3254-2.

[0140] In some forms, the plenum chamber 3200-2 may include a pair of grooves 3266-2. Each groove 3266-2 may be disposed proximate to one of the plenum chamber inlet ports 3254-2. Each groove 3266-2 may form a partially recessed surface.4.3.3 Positioning and stabilising structure

[0141] The seal-forming structure 3100 of the patient interface 3000 of the present technology may be held in sealing position in use by the positioning and stabilising structure 3300. 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. 3 A and 3A-1.

[0142] 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 chamber 3200 to lift off the face (i.e., Fpienum).

[0143] 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.

[0144] With continued reference to Fig. 3A-1, the positioning and stabilising structure 3300 provides a force Fpss that assists in maintaining the plenum chamber 3200 in the sealing position on the patient’s face. The positioning and stabilising forceA2578192 12.0 22Fpss may be the resultant force from the various forces of the different elements of the positioning and stabilising structure 3300. For example, headgear straps may individually provide a strap force Fstrap in order to hold the seal -forming structure 3100 against the patient’s face. The force Fstrap may also be directed at least partially in the superior direction in order to overcome the gravitational force Fg. The gravitational force Fgmay be specifically shown for the seal -forming structure 3100 and the plenum chamber 3200, but gravity would act on the entirely of the patient interface 3000 (i.e., in the same direction as the illustrated gravitational force Fg).

[0145] The gravitational force Fgmay be opposed by a frictional force Ff, which may act in a direction directly opposite of the gravitational force Fg. As gravity pulls the seal -forming structure 3100 and the plenum chamber 3200 in the inferior direction (as viewed in Fig. 3A-1), the frictional force Ff would act in the superior direction (e.g., against a patient’s face). For example, the patient may experience the frictional force Ff against his lip superior (and / or other surfaces of the patient’s face in contact with the seal-forming structure 3100) in order to oppose the motion in the inferior direction (which may help to stabilising the cushion in place). Although the frictional force Ff is shown specifically opposing the gravitational force Fgof the seal -forming structure 3100 and the plenum chamber 3200, components of an overall frictional force (not shown) would also oppose the gravitational force Fgassociated with the positioning and stabilising structure 3300 and any other portions of the patient interface 3000. A force of friction can act along any place where the patient interface 3000 contacts the patient’s skin (or hair). The frictional force Ff extends in the opposite direction of the gravitational force Fgand along the patient’s skin (or hair). In some forms the gravitiational force Fgmay also be countered by vertical components of the reaction force from the patient’s face acting on the seal -forming structure 3100, for example at the nose ridge and chin regions of the patient’s face, for example.

[0146] In some forms, the sum of the various forces may equal zero so that the patient interface 3000 is at equilibrium (e.g., not moving along the patient’s face while in use). Specifically, the gravitational force Fgand the blowout force Fpienumtend to move the seal -forming structure 3100 away from the desired sealing position. The positioning and stabilising force Fpss is applied in order to counteract the gravitational force Fgand the blowout force Fpienum (as well as any frictional forces Ff) and keep the seal-forming structure 3100 properly situated. Although the positioning andA2578192 12.0 23stabilising force Fpss may exceed the sum of the gravitational force Fgand the blowout force Fpienum (with any additional positioning and stabilising force Fpss being balanced by reaction force from the patient’s head acting on the portions of patient interface 3000) and still maintain the seal-forming structure 3100 in an appropriate sealing position, patient comfort may be sacrificed. Maximum patient comfort may be achieved when the net force on the patient interface 3000 is zero and the positioning and stabilising force Fpss is exactly strong enough to achieve this. In some examples the positioning and stabilising structure 3300 may be adjustable such that when fitted the positioning and stabilising force Fpss is greater than required to exactly balance the gravitational force Fgand the blowout force Fpienumto hold the patient interface 3000 against the patient’s head tightly enough that disruptive forces which may be experienced in use (such as tube drag or lateral shunting of the plenum chamber 3200 during side sleeping) do not disrupt the seal. As described below, various positions of the patient’s head while using the patient interface 3000 may determine the positioning and stabilising force Fpss necessary to achieve equilibrium.

[0147] In one form the positioning and stabilising structure 3300 provides a retention force as a safety margin to overcome the potential effect of disrupting forces on the patient interface 3000, such as from tube drag, or accidental interference with the patient interface.

[0148] 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.

[0149] 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.

[0150] 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.A2578192 12.0 24

[0151] 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 that when 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.

[0152] In one form of the present technology, a positioning and stabilising structure 3300 comprises a strap constructed from a laminate of a fabric patientcontacting 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.

[0153] 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 tie.

[0154] In one form of the present technology, the positioning and stabilising structure comprises a first tie, the first tie being constructed and arranged so that in use at least a portion of an inferior edge thereof passes superior to an otobasion superior of the patient’s head and overlays a portion of a parietal bone without overlaying the occipital bone.

[0155] In one form of the present technology suitable for a nasal-only mask or for a full-face mask, the positioning and stabilising structure includes a second tie, the second tie being constructed and arranged so that in use at least a portion of a superior edge thereof passes inferior to an otobasion inferior of the patient’s head and overlays or lies inferior to the occipital bone of the patient’s head.

[0156] In one form of the present technology suitable for a nasal-only mask or for a full-face mask, the positioning and stabilising structure includes a third tie that is constructed and arranged to interconnect the first tie and the second tie to reduce a tendency of the first tie and the second tie to move apart from one another.A2578192 12.0 25

[0157] In certain forms of the present technology, a positioning and stabilising structure 3300 comprises a strap that is bendable and e.g. non-rigid. An advantage of this aspect is that the strap is more comfortable for a patient to lie upon while the patient is sleeping.

[0158] In certain forms of the present technology, a positioning and stabilising structure 3300 comprises a strap constructed to be breathable to allow moisture vapour to be transmitted through the strap,

[0159] In certain forms of the present technology, a system is provided comprising more than one positioning and stabilising structure 3300, each being configured to provide a retaining force to correspond to a different size and / or shape range. For example the system may comprise one form of positioning and stabilising structure 3300 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.4.3.3.1 Conduit headgear4.3.3.1.1 Conduit headgear tubes

[0160] 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 part 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. 3B, 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.

[0161] In the form of the present technology illustrated in Fig. 3B, the positioning and stabilising structure 3300 comprises two tubes 3350, each tube 3350 being positioned in use on a different side of the patient’s head and extending across the respective cheek region, above the respective ear (superior to the otobasion superior on the patient’s head) to the elbow 3610 on top of the head of the patient 1000. This form of technology may be advantageous because, if a patient sleeps withA2578192 12.0 26their head on its side and one of the tubes 3350 is compressed to block or partially block the flow of gas along the tube 3350, the other tube 3350 remains open to supply pressurised gas to the patient. In other examples of the technology, the patient interface 3000 may comprise a different number of tubes, for example one tube, or two or more tubes.

[0162] In one example in which the patient interface has one tube 3350, the single tube 3350 is positioned on one side of the patient’s head in use (e.g. across one cheek region) and a strap forms part of the positioning and stabilising structure 3300 and is positioned on the other side of the patient’s head in use (e.g. across the other region) to assist in securing the patient interface 3000 on the patient’s head. For example, the tube 3350 and the strap may each be under tension in use in order to assist in maintaining the seal-forming structure 3100 in a sealing position.

[0163] In one form, the tube 3350 may be at least partially extensible so that the tube 3350 and the strap may adjust substantially equal lengths when worn by a patient. This may allow for substantially symmetrical adjustments between the tube 3350 and the strap so that the seal-forming structure remains substantially in the middle.

[0164] In the form of the technology shown in Fig. 3B, the two tubes 3350 are fluidly connected at superior ends to each other and to the connection port 3600. In some examples, the two tubes 3350 are integrally formed while in other examples the tubes 3350 are formed separately but are connected in use and may be disconnected, for example for cleaning or storage. Where separate tubes are used, they may be indirectly connected together, for example each may be connected to a T-shaped connector. The T-shaped connector may have two arms / branches each fluidly connectable to a respective one of the tubes 3350. Additionally, the T-shaped connector may have a third arm or opening providing the connection port 3600 for fluid connection to the air circuit 4170 in use. The opening may be an inlet 3332 (see e.g., 7C) for receiving the flow of pressurized air.

[0165] In some forms, the third arm of the T-shaped connector may be substantially perpendicular to each of the first two arms.

[0166] In some forms, the third arm of the T-shaped connector may be obliquely formed with respect to each of the first two arms.

[0167] In some forms, a Y-shaped connector may be used instead of the T-shaped connector. The first two arms may be oblique with respect to one another, and theA2578192 12.0 27third arm may be oblique with respect to the first two arms. The angled formation of the first two arms may be similar to the shape of the patient’s head in order to conform to the shape.

[0168] In some forms, at least one of the arms of the T-shaped connector (or Y- shaped connector) may be flexible. This may allow the connector to bend based on the shape of the patient’s head and / or a force in the positioning and stabilising structure 3300.

[0169] In some forms, at least one of the arms of the T-shaped connector (or Y- shaped connector) may be at least partially rigidised. This may assist in maintaining the shape of the connector so that bending of the connector does not close the airflow path.

[0170] 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 tubes 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.

[0171] In some examples, the one or more tubes 3350 are crush resistant to resist being blocked if crushed during use, for example if squashed between a patient’s head and pillow, especially if there is only one tube 3350. The tubes 3350 may be formed with a sufficient structural stiffness to resist crushing or may be as described in US Patent No. 6,044,844, the contents of which are incorporated herein by reference.

[0172] Each tube 3350 may be configured to receive a flow of air from the connection port 3600 on top of the patient’s head and to deliver the flow of air to the seal-forming structure 3100 at the entrance of the patient’s airways. In the example shown in Fig. 3B, each tube 3350 lies in use on a path extending from the plenum chamber 3200 across the patient’s cheek region and superior to the patient’s ear to the elbow 3610. For example, a portion of each tube 3350 proximate the plenum chamber 3200 may overlie a maxilla region of the patient’s head in use. Another portion of each tube 3350 may overlie a region of the patient’s head superior to an otobasion superior of the patient’s head. Each of the tubes 3350 may also lie over the patient’s sphenoid bone and / or temporal bone and either or both of the patient’s frontal bone and parietal bone. The elbow 3610 may be located in use over the patient’s parietalA2578192 12.0 28bone, over the frontal bone and / or over the junction therebetween (e.g. the coronal suture).

[0173] In certain forms of the present technology the patient interface 3000 is configured such that the connection port 3600 can be positioned in a range of positions across the top of the patient’s head so that the patient interface 3000 can be positioned as appropriate for the comfort or fit of an individual patient. In some examples, the headgear tubes 3350 are configured to allow movement of an upper portion of the patient interface 3000 (e.g. a connection port 3600) with respect to a lower portion of the patient interface 3000 (e.g. a plenum chamber 3200). That is, the connection port 3600 may be at least partially decoupled from the plenum chamber 3200. In this way, the seal-forming structure 3100 may form an effective seal with the patient’s face irrespective of the position of the connection port 3600 (at least within a predetermined range of positions) on the patient’s head.

[0174] As described above, in some examples of the present technology the patient interface 3000 comprises a seal-forming structure 3100 in the form of a cradle cushion which lies generally under the nose and seals to an inferior periphery of the nose (e.g. an under-the-nose cushion). The positioning and stabilising structure 3300, including the tubes 3350 may be structured and arranged to pull the seal-forming structure 3100 into the patient’s face under the nose with a sealing force in a posterior and superior direction (e.g. a posterosuperior direction). A sealing force with a posterosuperior direction may cause the seal -forming structure 3100 to form a good seal to both the inferior periphery of the patient’s nose and anterior-facing surfaces of the patient’s face, for example on either side of the patient’s nose and the patient’s lip superior.

[0175] Conduits forming part of the positioning and stabilising structure 3300, like headgear straps, may provide a force that contributes to the positioning and stabilising force Fpss. As illustrated in Fig. 3B-1, the positioning and stabilising force Fpss may be the resultant force from the various forces of the different elements of the positioning and stabilising structure 3300. For example, each conduit may provide a force Fconduit directed in the posterior and respective lateral direction in order to hold the seal -forming structure 3100 against the patient’s face (into the upper lip and sealing under the nose) and oppose the effect of the positive pressure in the plenum chamber 3200 to lift off the face (i.e., Fpienum). The force F conduit directed may also beA2578192 12.0 29directed at least partially in the superior direction in order to overcome the gravitational force Fg.

[0176] In some forms, the conduits may provide a force directed into the patient’s head when the conduits are filled with pressurized air. The force may assist in gripping the patient’s head. The force may be caused by the inflation of the conduits during normal use. In some forms, the force may provide a cushioning effect to the patient’s head. The conduits may be designed in order to limit expansion in order to prevent over-gripping the patient’s head.

[0177] The position of the patient’s head may also change the gripping force of the conduits. For example, if the patient is sleeping on his side, the weight of the patient’s head may compress one conduit, and the other conduit (e.g., the lateral portion not between the patient’s head and a sleeping surface, like a pillow) may additionally expand in order to keep substantially the same flow rate of pressurized air.

[0178] The gravitational force Fgmay be opposed by a frictional force Ff, which may act in a direction directly opposite of the gravitational force Fg. As gravity pulls the seal -forming structure 3100 and the plenum chamber 3200 in the inferior direction (as viewed in Fig. 3A-1), the frictional force Ff would act in the superior direction (e.g., against a patient’s face). For example, the patient may experience the frictional force Ff against his lip superior (and / or other surfaces of the patient’s face in contact with the seal-forming structure 3100) in order to oppose the motion in the inferior direction (which may help to stabilising the cushion in place). Although the frictional force Ff is shown specifically opposing the gravitational force Fgof the seal -forming structure 3100 and the plenum chamber 3200, components of an overall frictional force (not shown) would also oppose the gravitational force Fgassociated with the positioning and stabilising structure 3300 and any other portions of the patient interface 3000. A force of friction can act along any place where the patient interface 3000 contacts the patient’s skin (or hair). The frictional force Ff extends in the opposite direction of the gravitational force Fgand along the patient’s skin (or hair).

[0179] In some forms, the sum of the various forces may equal zero so that the patient interface 3000 is at equilibrium (e.g., not moving along the patient’s face while in use). Specifically, the gravitational force Fgand the blowout force Fpienumtend to move the seal -forming structure 3100 away from the desired sealing position. The positioning and stabilising force Fpss is applied in order to counteract the gravitationalA2578192 12.0 30force Fg and the blowout force Fpienum (as well as any frictional forces Ff) and keep the seal-forming structure 3100 properly situated. Although the positioning and stabilising force Fpss may exceed the sum of the gravitational force Fg and the blowout force Fpienum (with any additional positioning and stabilising force Fpss being balanced by reaction force from the patient’s head acting on the portions of patient interface 3000) and still maintain the seal-forming structure 3100 in an appropriate sealing position, patient comfort may be sacrificed. Maximum patient comfort may be achieved when the net force on the patient interface 3000 is zero and the positioning and stabilising force Fpss is exactly strong enough to achieve this. In some examples the positioning and stabilising structure 3300 may be adjustable such that when fitted the positioning and stabilising force Fpss is greater than required to exactly balance the gravitational force Fgand the blowout force Fpienum to hold the patient interface 3000 against the patient’s head tightly enough that disruptive forces which may be experienced in use (such as tube drag or lateral shunting of the plenum chamber 3200 during side sleeping) do not disrupt the seal. As described below, various positions of the patient’s head while using the patient interface 3000 may determine the positioning and stabilising force Fpss necessary to achieve equilibrium4.3.3.1.2 Extendable and non-extendable tube portions

[0180] In some examples of the present technology, one or both of the tubes 3350 are not extendable in length. However, in some forms, the tubes 3350 may comprise one or more extendable tube sections, for example formed by an extendable concertina structure. In some forms, the patient interface 3000 may comprise a positioning and stabilising structure 3300 including at least one gas delivery tube comprising a tube wall having an extendable concertina structure. The patient interface 3000 shown in Fig. 3B comprises tubes 3350, the superior portions of which comprise extendable tube sections each in the form of an extendable concertina structure 3362.

[0181] In some forms, the extendable concertina structure 3328 may be formed as a series of ridges and grooves on the surface of the tubes 3350. The concertina structure 3328 may be biased toward a retracted position, and may move to an expanded position when the patient dons the positioning and stabilising structure 3300. Because portions of the tubes 3350 may be substantially inextensible (e.g., non- extendable tube sections 3363), the concertina structures 3328 permit the positioning and stabilising structure 3300 to stretch in order to fit different sized heads. This mayA2578192 12.0 31allow a single sized tube 3350 to be used with multiple sized heads. For example, the positioning and stabilising structure 3300 may be “one-size-fits-all” as a result of the concertina structure 3328. Alternatively, the tubes 3350 may be manufactured in multiple sizes (e.g., small, medium, large). The patient may select a length that most closely conforms to their head, and the concertina structures 3328 may make small adjustments in order to tailor the fit to the individual patient.

[0182] In some forms, the inlet 3332 may be disposed in the middle of the conduit 6320. For example, the tubes 3350 may be symmetric about the inlet 3332 through at least one axis.

[0183] The cross-sectional shape of the non-extendable tube sections 3363 of the tubes 3350 may be circular, elliptical, oval, D-shaped or a rounded rectangle, for example as described in US Patent No. 6,044,844. A cross-sectional shape that presents a flattened surface of tube on the side that faces and contacts the patient’s face or other part of the head may be more comfortable to wear than, for example a tube with a circular cross-section.

[0184] In some examples of the present technology, the non-extendable tube sections 3363 connects to the plenum chamber 3200 from a low angle. The headgear tubes 3350 may extend inferiorly down the sides of the patient’s head and then curve anteriorly and medially to connect to the plenum chamber 3200 in front of the patient’s face. The tubes 3350, before connecting to the plenum chamber 3200, may extend to a location at the same vertical position as (or, in some examples, inferior to) the connection with the plenum chamber 3200. That is, the tubes 3350 may project in an at least partially superior direction before connecting with the plenum chamber 3200. A portion of the tubes 3350 may be located inferior to the plenum chamber 3200 and / or the seal forming structure 3100. The tubes 3350 may contact the patient’s face below the patient’s cheekbones, which may be more comfortable than contact on the patient’s cheekbones and may avoid excessively obscuring the patient’s peripheral vision.4.3.3.1.3 Conduit headgear connection port

[0185] 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 3B, the connection 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 theA2578192 12.0 32patient 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.

[0186] 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 side-sleeping 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).4.3.3.1.4 Headgear Tube Fluid Connections

[0187] The two tubes 3350 are fluidly connected at their inferior ends to the plenum chamber 3200. In certain forms of the technology, the connection between the tubes 3350 and the plenum chamber 3200 is achieved by connection of two rigid connectors. The tubes 3350 and plenum chamber 3200 may be configured to enable the patient to easily connect the two components together in a reliable manner. TheA2578192 12.0 33tubes 3350 and plenum chamber 3200 may be configured to provide tactile and / or audible feedback in the form of a ‘re-assuring click’ or a similar sound, so that the patient may easily know that each tube 3350 has been correctly connected to the plenum chamber 3200. In one form, the tubes 3350 are formed from a silicone or textile material and the inferior end of each of the silicone tubes 3350 is overmolded to a rigid connector made, for example, from polypropylene, polycarbonate, nylon or the like. The rigid connector on each tube 3350 may comprise a female mating feature configured to connect with a male mating feature on the plenum chamber 3200. Alternatively, the rigid connector on each tube 3350 may comprise a male mating feature configured to connect to a female mating feature on the plenum chamber 3200. In other examples the tubes 3350 may each comprise a male or female connector formed from a flexible material, such as silicone or TPE, for example the same material from which the tubes 3350 are formed.

[0188] In other examples a compression seal is used to connect each tube 3350 to the plenum chamber 3200. For example, a resiliently flexible (e.g. silicone) tube 3350 without a rigid connector may be configured to be squeezed to reduce its diameter so that it can be compressed into a port in the plenum chamber 3200 and the inherent resilience of the silicone pushes the tube 3350 outwards to seal the tube 3350 in the port in an air-tight manner. Alternatively, in a hard-to-hard type engagement between the tube 3350 and the plenum chamber 3200, each tube 3350 and / or plenum chamber 3200 may comprise a pressure activated seal, for example a peripheral sealing flange. When pressurised gas is supplied through the tubes 3350 the sealing flange may be urged against the join between the tubes and a circumferential surface around a port or connector of the plenum chamber 3200 to form or enhance a seal between the tube 3350 and plenum chamber 3200.4.3.3.1 Headgear straps

[0189] In some forms, the positioning and stabilising structure 3300 may include headgear 3302 with at least one strap 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).

[0190] As described above, some forms of the headgear 3302 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. AlthoughA2578192 12.0 34the textile may include rigi disers along a selected length, which may limit bending, flexing, and / or stretching of the headgear 3302.

[0191] In certain forms, the headgear 3302 may be at least partially extensible. For example, the headgear 3302 may include elastic, or a similar extensible material. For example, the entire headgear 3302 may be extensible or selected portions may be extensible (or more extensible than surrounding portions). This may allow the headgear 3302 to stretch while under tension, which may assist in providing a sealing force for the seal -forming structure 3100.

[0192] Two forms of the headgear, four-point headgear 3302-1 and two-point headgear 3302-2, are discussed in more detail below as illustrative examples.4.3.3.2.1 Four-point connection

[0193] As shown in Fig. 7E, some forms of the headgear 3302-1 may be a four- point connection headgear. This means that the headgear 3302-1 may connect to four separate places on the plenum chamber 3200, on a frame connected to the plenum chamber 3200, and / or on arms connected to the plenum chamber 3200. The headgear 3302-1 may include four different straps providing a tensile force to help maintain the seal-forming structure 3100 in a sealing position. The positioning and stabilising structure 3300 of Fig. 3 A may also be considered a four-point connection headgear.

[0194] In some forms, the headgear 3302-1 may include inferior straps 3304-1, which may connect to an inferior portion of the cushion 3050-1. The inferior straps3304-1 may extend along the patient’s cheek toward a posterior region of the patient’s head. For example, the inferior straps 3304-1 may overlay the masseter muscle on either side of the patient’s face. The inferior straps 3304-1 may therefore contact the patient’s head below the patient’s ears. The inferior straps 3304-1 may meet at the posterior of the patient’s head, and may overlay the occipital bone and / or the trapezius muscle.

[0195] The headgear 3302-1 may also include superior straps 3305-1, which may overlay the temporal bones, parietal bone, and / or occipital bone. The superior straps3305-1 may also connect to the tubes 3350 (e.g., by interfacing with the tabs 3320).

[0196] A rear strap 3307-1 may extend between the superior straps 3305-1 and between the inferior straps 3304-1. The inferior and superior straps 3304-1, 3305-1 on a given side (e.g., left or right) may also be connected to the rear strap 3307-1 adjacent to one another. The height of the rear strap 3307-1 may therefore be approximately the combined height of the inferior and superior strap 3304-1, 3305-1.A2578192 12.0 35The rear strap 3307-1 may overlay the occipital bone and / or the pariental bone in use. This may allow the rear strap 3307-1 to assist in anchoring the headgear 3302-1 to the patient’s head.

[0197] In the illustrated example, the headgear 3302-1 may be formed with a substantially X-shape. The inferior and superior straps 3304-1, 3305-1 may be connected to a rear strap 3307-1 using stitching, ultrasonic welding, or any similar process.

[0198] In some forms, the inferior straps 3304-1 are connected to a magnetic member 3306-1. For example, each inferior straps 3304-1 may be threaded through a magnetic member 3306-1, so that a length of each inferior strap 3304-1 may be adjusted. The magnetic members 3306-1 may removably connect to the magnets 3370-1 (described below), so that the inferior straps 3304-1 may be disconnected from the plenum chamber 3200, but the length of the inferior straps 3304-1 may not be affected.

[0199] In some forms, the superior straps 3305-1 may be connected directly to the tabs 3320 of the tubes 3350. The superior straps 3305-1 may be threaded through the tabs 3320 in order to adjust the length and control the tensile force of each superior strap 3305-1.

[0200] In some forms, the headgear 3302-1 may be used only with the nose and mouth cushion 3050-1 (e.g., because the nose-only cushion 3050-1 does not have four connection points). However, the headgear 3302-1 may be used interchangeably with the tubes 3350 and the rigidiser arms 3340.4.3.3.2.2 Two-point connection

[0201] As shown in Fig. 7F, some forms of the headgear 3302-2 may be a two- point connection headgear. This means that the headgear 3302-2 may connect to two separate places.

[0202] In some forms, the headgear 3302-2 may be formed from a continuous piece of material. In other words, the headgear 3302-2 may not be formed from multiple straps connected (e.g., stitched) together. This may be comfortable for a patient as they will not be in contact with any seams or joints connecting different straps. In other forms, the headgear 3302-2 may be formed from multiple straps (e.g., two superior straps, a rear strap, etc.) that are connected together (e.g., with stitching, ultra-sonic welding, etc.).A2578192 12.0 36

[0203] In certain forms of the present technology, the positioning and stabilising structure 3300 comprises at least one headgear strap acting in addition to the tubes 3350 to position and stabilise the seal-forming structure 3100 at the entrance to the patient’s airways. As shown in Fig. 3B, the patient interface 3000 comprises a strap 3307-2 forming part of the positioning and stabilising structure 3300. The strap 3307- 2 may be known as a back strap or a rear headgear strap, for example. The rear strap 3307-2 may overlay the temporal bones, parietal bone, and / or occipital bone. In other examples of the present technology, one or more further straps may be provided. For example, patient interfaces 3000 according to examples of the present technology having a nose-and-mouth cushion may have a second, lower, strap configured to lie against the patient’s head proximate the patient’s neck and / or against posterior surfaces of the patient’s neck.

[0204] In the example shown in Fig. 3B, strap 3310 of the positioning and stabilising structure 3300 is connected between the two tubes 3350 positioned on each side of the patient’s head and passing around the back of the patient’s head, for example overlying or lying inferior to the occipital bone of the patient’s head in use. The strap 3310 connects to each tube above the patient’s ears. With reference to Fig. 3B, the positioning and stabilising structure 3300 comprises a pair of tabs 3320. In use a strap 3310 may be connected between the tabs 3320. The strap 3310 may be sufficiently flexible to pass around the back of the patient’s head and lie comfortably against the patient’s head, even when under tension in use.

[0205] As shown in Fig. 7F, some forms of the headgear 3302-2 may be at least partially bifurcated. For example, a rear strap 3307-2 of the headgear 3302-2 (e.g., configured to contact the posterior portion of the patient’s head) may be wider than the surrounding portions of the headgear 3302-2. An intermediate section 3308-2 of the rear strap 3307-2 may include a slit 3309-2. A superior section of the rear strap 3307-2 may therefore be movable relative to the inferior section as a result of the slit 3309-2. This may allow the patient to have a larger strap coverage on the posterior region of their head, which may assist in better anchoring the headgear 3302-2 to the patient’s head since there is no inferior strap (e.g., 3304-1).

[0206] In some forms, the headgear 3302-2 may be used only with the nasal cushion 3050-2 (e.g., because the nose and mouth cushion 3050-1 does not have four connection points). However, the headgear 3302-2 may be used interchangeably with the tubes 3350 and the rigidiser arms 3340.A2578192 12.0 374.3.3.3 Rigidiser Arm

[0207] As shown in Fig. 7D, a rigidiser arm 3340 may be an elongated, rigid member that assists in maintaining the cushion (e.g., the nose and mouth cushion 3050-1 or the nasal cushion 3050-2) in an operating position. The rigidiser arm 3340 may contact a side of the patient’s head and provide a force to limit slipping of the seal-forming structure 3100 from the patient’s nose and / or mouth.

[0208] In some forms, the rigidiser arm 3340 is constructed from a rigid material (e.g., plastic). The rigid material may not permit the rigidiser arm 3340 to stretch. Additionally, the rigidiser arm 3340 may be substantially inflexible and may be unable to bend. The rigidiser arm 3340 may be pre-molded into a desired shape in order to fit a patient’s head. For example, the rigidiser arms 3340 may be molded with a curved shape to substantially correspond to the shape of the side of the patient’s head (e.g., overlaying the masseter muscle and / or the temporal bone).

[0209] In certain forms, the rigidiser arm 3340 may be molded in order to conform to a specific patient’s head (e.g., the rigidiser arm 3340 is customized).

[0210] In some forms, the rigidiser arm 3340 may be flexible along at least one direction. For example, the rigidiser arm 3340 may be flexible about its width and may be inflexible along its length. In other words, the rigidiser arm 3340 may be bendable about an axis along the width of the rigidiser arm 3340, but may be unable to bend about an axis perpendicular to the rigidiser arm 3340. This may allow an individual patient to adjust the rigidiser arm 3340 in order to better fit their individual head.

[0211] In certain forms, the rigidiser arm 3340 may remain in the new position after being bent. This may allow a patient adjust the shape of the rigidiser arm 3340 for their specific head and then the rigidiser arm 3340 will keep the desired shape while in use in order to promote patient comfort.

[0212] In some forms, a first end 3342 of the rigidiser arm 3340 may be a free end and a second end 3344 (e.g., opposite of the first end 3342) of the rigidiser arm 3340 may be fixed. The first end 3342 may be curved in order to minimize sharp edges that could cause patient discomfort. The first end 3342 may also overlay the patient’s head proximate to the temporal bone, in use. The second end 3344 may be fixed to an arm connection structure 3504.

[0213] In some forms, the arm connection structure 3504 may be similar to the conduit connection structure 3500. For example, the arm connection structure 3504A2578192 12.0 38and the conduit connection structure 3500 may have substantially the same shape. This may allow either the conduit connection structure 3500 or the arm connection structure 3504 to fit into the groove (e.g., 3266-1 or 3266-2) and connect to the plenum chamber inlet port 3254. The arm connection structure 3504 may connect to the nose and mouth cushion 3050-1 or the nose-only cushion 3050-2 in substantially the same way as the conduit connection structure 3500 (e.g., via a snap fit, press fit, friction fit, etc.).

[0214] In some forms, the arm connection structure 3504 may act as a plug for the plenum chamber inlet port 3254 (e.g., either 3254-1 and / or 3254-2). Unlike the tubes 3350, the rigidiser arm 3340 does not convey pressurized air to the plenum chamber 3200. The rigidised arm 3340 may be used with a “tube down” configuration, where a hose is connected to the vent opening 3402 (e.g., either 3402-1 and / or 3402-2), and conveys air into the plenum chamber 3200 through the vent opening 3402. In this example, air does not need to travel into or out of the plenum chamber inlet openings 3254. Thus, the arm connection structure 3504 may form a seal with the plenum chamber inlet opening 3254 in order to limit airflow into or out of the plenum chamber 3200.4.3.4 Vent

[0215] 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.

[0216] 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.

[0217] 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.

[0218] 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.A2578192 12.0 39

[0219] As shown in Fig. 7N, a vent 3450 may be used with the patient interface 3000. The vent 3450 may have a substantially similar shape to the vent opening 3402-1 (e.g., a substantially circular shape).

[0220] The vent 3450 may be used with either the mouth and nose plenum chamber 3200-1 (e.g., illustrated in Figs. 7A) or the nose-only plenum chamber 3200-2 (e.g., illustrated in Figs. 7B).

[0221] With continued reference to Fig. 7A, the vent 3450 may include a vent housing 3404, which may be configured to engage with the vent opening 3402. The vent housing 3404 may be constructed from a rigid material or a semi-rigid material. For example, the vent housing 3404 may be constructed from plastic, metal, or any similar material. The vent housing 3404 may add rigidity to the patient interface 3000 (e.g., to limit unwanted bending that may affect the position of the seal-forming structure 3100 on the patient’s face).

[0222] The vent housing 3404 may include an anterior surface 3408, a posterior surface 3412, and a groove 3416. The anterior surface 3408 faces away from the patient’s face in use, and may be positioned outside the pressurized volume of the plenum chamber 3200. The posterior surface 3412 is disposed opposite to the anterior surface 3408. In use, the posterior surface 3412 may face the patient and may be disposed within the pressurized volume of the plenum chamber 3200. The groove 3416 may be formed between the anterior and posterior surfaces 3408, 3412. A portion of the plenum chamber 3200 may be received within the groove 3416 in order to retain the vent 3400 in position.

[0223] In some forms, a diffuser 3448 may be used with the vent housing 3404. The diffuser 3448 may assist with limiting the decibel output from any of the patient interface 3000 (or any other patient interface). Specifically, the diffuser 3448 may assist in limiting the decibel level associated with air output from the patient interface 3000 (e.g., exhaled air), although the diffuser 3448 may limit the decibel level of at any point in the patient interface.

[0224] In certain forms, the diffuser 3448 may diffuse, and therefore slow, the exhaust gas exiting the plenum chamber 3200 and passing through the vent housing 3404. The diffuser 3448 may assist in avoiding jetting and associated discomfort to the patient and / or bed partner (e.g., noise caused by jetting against a pillow, sheets, bedclothes, etc.).A2578192 12.0 40

[0225] In some forms, the diffuser may include an anterior surface 3456 that faces away from the patient in use. An outer diameter of the anterior surface 3456 may be less than an inner diameter of the vent housing 3404 proximate to the anterior surface 3408. This may form a gap 3464 through which air may travel.4.3.5 Decoupling structure(s)

[0226] 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

[0227] Connection port 3600 allows for connection to the air circuit 4170.4.3.7 Forehead support

[0228] In one form, the patient interface 3000 includes a forehead support 3700.4.3.8 Anti-asphyxia valve

[0229] In one form, the patient interface 3000 includes an anti-asphyxia valve.4.3.9 Ports

[0230] In one form of the present technology, a patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one form this allows a clinician to supply supplementary oxygen. In one form, this allows for the direct measurement of a property of gases within the plenum chamber 3200, such as the pressure.4.3.10 Modularity

[0231] As described above, the cushion, headgear, and sleeves may come in different styles, which may correspond to different uses (e.g., mouth breathing, nasal breathing, etc.). A patient or clinician may select certain combinations of cushions, headgear, and sleeves in order to optimize the effectiveness of the therapy and / or the individual patient’s comfort. An example of this sort of modular design is described in PCT / SG2022 / 050777 filed 28 October 2022, incorporated herein by reference in its entirety.

[0232] In some forms, the different styles of cushions, headgear, and sleeves may be used interchangeably with one another in order to form different combinations of patient interfaces. This may be beneficial from a manufacturing prospective because wider variety of patient interfaces may be created using fewer parts. Additionally or alternatively, the various combinations may allow a patient to change styles of patient interface without changing the every component.A2578192 12.0 41

[0233] Air may be delivered to the patient in one of two main ways. In one example, the patient may receive the flow of pressurized air through headgear tubes 3350 (see e.g., Fig. 3B). This may be referred to as a “tube up” configuration and may position a connection port at the top of the patient’s head. In other example, the patient may receive the flow of pressurized air through a conduit connected to the plenum chamber 3200, for example through the connection port 3600 (see e.g., Fig.3 A). This may be referred to a “tube down” configuration where the airflow conduit is positioned in front of the patient’s face. Different patients may be more comfortable with one style of air delivery over the other (e.g., because of the patient’s sleep style). Therefore, it may be beneficial to allow a single style of patient interface to be used in either the “tube up” or “tube down” configuration.

[0234] The patient interface may be part of a modular assembly with a variety of interchangeable components that may be swapped out by a patient and / or clinician for one or more components for a different style. The following description describes the various combinations that may be created by assembling the different components together.4.3.10.1 Sleeve

[0235] In some forms, to allow for modularity, a sleeve may be used with the tubes 3350 and / or the rigidisier arms 3340. The sleeve may at least partially surround the tubes 3350 and / or the rigidiser arms 3340. As shown in Figs. 7G to 71, different shapes of sleeves may be used, which may correspond to different types of positioning and stabilising structures 3300. In some forms, the configuration of the sleeve may be customized to fit a particular user’s face. For instance, the sleeves may be configured in a relatively more posterior region of the patient’s head.

[0236] In some forms, the sleeve may be constructed from a comfortable material. For example, the sleeve may be constructed from a textile material, a foam material, or a combination of the two. The comfortable material may contact the patient in use, and may feel soft against the patient’s skin in order to improve patient compliance.

[0237] The material may also be flexible in order to assist in donning or doffing the sleeve from the tube 3350 or the rigidiser arms 3340. For example, the material may allow the sleeve to bend in order to conform to the shape of the tubes or conduit headgear 3350 or the rigidiser arms 3340, which may change depending on the shape of an individual patient’s head.A2578192 12.0 42

[0238] In some forms, the sleeve may also be at least partially elastic (e.g., the material may allow the sleeve to stretch). The elastic material may help the sleeve stretch in order to fit around the tubes 3350 or the rigidiser arms 3340. The elastic material may then return to an initial position that is snug against the tubes 3350 or the rigidiser arms 3340 in order to limit the sleeve from sliding while in use.

[0239] As described in more detail below, some forms of the sleeves may be specific to a rigidising element (e.g., tubes 3350 and / or rigidiser arms 3340).However, the sleeves may assist the rigidising elements in connecting interchangeably with the version or styles of cushions (e.g., the mouth and nose cushion 3050-1, the nose-only cushion 3050-2, etc.).4.3.10.1.1 Conduit Sleeve

[0240] As shown in Fig. 7G, one example of a sleeve is a conduit sleeve 3351, which may be usable with the tubes 3350 described above.

[0241] As shown in Fig. 7G, the conduit sleeve 3351 may include a curved shape that may be similar to the shape of the tubes 3350 shown in Fig. 7C. The flexible material used to construct the conduit sleeve 3351 may allow the conduit sleeve 3351 to further curve in order to correspond to the shape of the tubes 3350 (e.g., when worn by the patient).

[0242] In some forms, the conduit sleeve 3351 may include a first or superior opening 3352. The superior opening 3352 may be disposed at one end of the conduit sleeve 3351. The superior opening 3352 may be an opening to a passage that extends along at least a portion of the conduit sleeve 3351.

[0243] As shown in Fig. 7G, some forms of the conduit sleeve 3351 may also include an inferior extension 3354. The inferior extension 3354 may be positioned on an opposite end of the conduit sleeve 3351 from the superior opening 3352. The conduit sleeve 3351 may be customized to fit a particular user’s face. For instance, the inferior extension 3354 of the conduit sleeve 3351 may be configured in a relatively more posterior region or anterior region of the patient’s head.

[0244] Some forms of the inferior extension 3354 may include a rigid or semirigid piece (e.g., within the sleeve 3351). The rigid or semi-rigid piece may be constructed from a plastic material, or a similar material. Alternatively, the inferior extension 3354 may be stiffened using a manufacturing process (e.g., stitching rigidised thread, flat knitting, using thicker material).A2578192 12.0 43

[0245] As shown in Fig. 7G, some forms of the inferior extension 3354 may include a connection member 3356. In the illustrated example, the connection member 3356 may be a magnet, although in other examples, the connection member 3356 may be a different type of connector (e.g., a mechanical fastener, an adhesive, hook and loop material, etc.). The connection member 3356 may also be positioned at an end of the inferior extension 3354, although the connection member 3356 could alternatively be positioned anywhere along the inferior extension 3354.

[0246] In some forms, the connection member 3356 (e.g., a magnet) may be removably connected to the magnets 3370-1 of the headgear 3302-1. For example, when the conduit sleeves 3351 are connected to the tubes 3350 (see e.g., Fig. 7J), the magnets 3370-1 connected to the inferior straps 3304-1 may be removably connected to the connection member 3356 in order to provide the tensile force.4.3.10.1.2 Four-point arm sleeve

[0247] As shown in Fig. 7H, another example of a sleeve is a four-point arm sleeve 3380, which may be usable with the rigidiser arms 3340 described above.

[0248] As shown in Fig. 7H, the four-point arm sleeve 3380 may include a curved shape that may be similar to the shape of the rigidiser arm 3340 shown in Fig. 7D. The flexible material used to construct the four-point arm sleeve 3380 may allow the four-point arm sleeve 3380 to further curve in order to correspond to the shape of the rigidiser arm 3340 (e.g., when worn by the patient and / or went bent by the patient).

[0249] As shown in Fig. 7H, some forms of the four-point arm sleeve 3380 may include an inferior extension 3384. The inferior extension 3384 may be positioned at an end of the four-point arm sleeve 3380.

[0250] In the illustrated example, the shape and / or structure of the inferior extension 3384 is substantially the same as the shape of the inferior extension 3354. For example, the inferior extension 3384 may be more rigid as compared to the rest of the four-point arm sleeve 3380 (e.g., as a result of rigidising thread or rigid material).

[0251] As shown in Fig. 7H, some forms of the inferior extension 3384 may include a connection member 3386. In the illustrated example, the connection member 3386 may be a magnet, although in other examples, the connection member 3386 may be a different type of connector (e.g., a mechanical fastener, an adhesive, hook and loop material, etc.). The connection member 3386 may also be positioned atA2578192 12.0 44an end of the inferior extension 3384, although the connection member 3386 could alternatively be positioned anywhere along the inferior extension 3384.

[0252] In some forms, the connection member 3386 (e.g., a magnet) may be removably connected to the magnets 3370-1 of the headgear 3302-1. For example, when the four-point arm sleeves 3380 are connected to the rigidiser arm 3340 (see e.g., Fig. 7K), the magnets 3370-1 connected to the inferior straps 3304-1 may be removably connected to the connection member 3386 in order to provide the tensile force.

[0253] As shown in Fig. 7H, the four-point arm sleeve 3380 may include a pair of tabs 3394, which may be similar to the tab 3320 on the tubes 3350. When the four- point arm sleeve 3380 is worn by the patient, the tabs 3394 may be positioned in substantially the same place on the patient’s head as where the tabs 3320 are positioned when the patient wears the tubes 3350.4.3.10.1.3 Two-point arm sleeve

[0254] As shown in Fig. 71, yet another example of a sleeve is a two-point arm sleeve 3380-1, which may be usable with the rigidiser arms 3340 described above.

[0255] In some forms, the two-point arm sleeve 3380-1 may be similar to the four-point arm sleeve 3380 described above. Only some similarities and differences may be described below.

[0256] As shown in Fig. 71, the two-point arm sleeve 3380-1 may include an inferior opening 3388-1 that is positioned at an end of the two-point arm sleeve 3380- 1. The inferior opening 3388-1 may form an opening to a passageway through the two-point arm sleeve 3380-1. In the illustrated example, the inferior opening 3388-1 may open into a surface of the conduit sleeve 3380-1.

[0257] As shown in Fig. 71, the two-point arm sleeve 3380-1 may include a pair of tabs 3394-1, which may be similar to the tab 3320 on the tubes 3350. When the two-point arm sleeve 3380-1 is worn by the patient, the tabs 3394-1 may be positioned in substantially the same place on the patient’s head as where the tabs 3320 are positioned when the patient wears the tubes 3350.4.3.10.2 Assembled Patient Interfaces

[0258] As illustrated in Figs. 7J to 7M, the various elements described above may be combined into four different patient interfaces. The different patient interfaces may allow patients to use different styles based on their individual comfort. The modularity of the different elements (e.g., the ability to be used in multiple styles ofA2578192 12.0 45patient interfaces) may simplify manufacturing and / or may allow a patient to more easily switch between styles of patient interfaces.4.3.10.2.1 Nose and Mouth Mask Tube Up Configuration

[0259] As illustrated in Fig. 7J, the patient may wear the cushion 3050-1 in a tube-up configuration with the tubes 3350 and the four-point headgear 3302-1. This assembly may form a tube up nose and mouth patient interface 3000-1.

[0260] In some forms, a conduit sleeve may be used with the tubes 3350 in order to enable a patient to experience the “tube up” air delivery style with the mouth and nose cushion 3050-1. As is described below, the conduit sleeve provides additional connection locations for connecting the four-point headgear 3302-1. However, other forms of connectors aside from or in addition to the conduit sleeve may be used.

[0261] In the illustrated example, the conduit sleeves may be connected to the tubes 3350 of the positioning and stabilising structure 3300. The tubes 3350 (via the conduit connection structure 3500), may be used to connect the tubes 3350 to the cushion 3050-1. The conduit sleeves provide the magnets in order to connect to the magnets 3370-1 (see e.g., Fig. 7E) of the four-point headgear 3302-1. Alternatively, a different connection form may be used.

[0262] As illustrated in Fig. 7J, the four-point headgear 3302-1 may connect in four separate locations in order to provide a tensile force that maintains the cushion 3050-1 in a sealing position on the patient’s head.

[0263] For example, the inferior straps 3304-1 (e.g., via the magnetic members 3306-1) may removably connect to the magnets of the conduit sleeves. In use, each inferior strap 3304-1 may contact the patient’s cheek (e.g., overlaying the masseter muscle). The inferior straps 3304-1 may also extend below the patient’s ears.4.3.10.2.2 Nose and Mouth Mask Tube Down Configuration

[0264] As illustrated in Fig. 7K, the patient may wear the cushion 3050-1 in a tube-down configuration with the rigidiser arms 3340 and the four-point headgear 3302-1. This assembly may form a tube down nose and mouth patient interface 3000- 2.

[0265] In some forms, a conduit sleeve may be used with the rigidiser arms 3340 in order to enable a patient to experience the “tube down” air delivery style with the mouth and nose cushion 3050-1. As is described below, the conduit sleeve provides additional connection locations for connecting the four-point headgear 3302-1.A2578192 12.0 46However, other forms of connectors aside from or in addition to the conduit sleeve may be used.

[0266] In the illustrated example, the conduit sleeves may be connected to the rigidiser arms 3340 of the positioning and stabilising structure 3300. The rigidiser arms 3340 (via the conduit connection structure 3504), may be used to connect the rigidiser arms 3340 to the cushion 3050-1. The conduit sleeves provide the magnets in order to connect to the magnets 3370-1 (see e.g., Fig. 7E) of the four-point headgear 3302-1. Alternatively, a different connection form may be used.

[0267] As illustrated in Fig. 7K, the four-point headgear 3302-1 may connect in four separate locations in order to provide a tensile force that maintains the cushion 3050-1 in a sealing position on the patient’s head.

[0268] For example, the inferior straps 3304-1 (e.g., via the magnetic members 3306-1) may removably connect to the magnets of the conduit sleeves. In use, each inferior strap 3304-1 may contact the patient’s cheek (e.g., overlaying the masseter muscle). The inferior straps 3304-1 may also extend below the patient’s ears.4.3.10.2.3 Nose Mask Tube Up Configuration

[0269] As illustrated in Fig. 7L, the patient may wear the cushion 3050-2 in a tube-up configuration with the tubes 3350 and the two-point headgear 3302-2. This assembly may form a tube up nose only patient interface 3000-3

[0270] A conduit sleeve may be used with the tubes 3350, and may provide additional comfort to the patient. The sleeve may not add additional connection points to connect the positioning and stabilising structure 3300 on the cushion 3050-2. In the illustrated example, the tubes 3350 of the positioning and stabilising structure 3300 may be connected directly to the cushion 3050-2.

[0271] As illustrated in Fig. 7L, the two-point headgear 3302-2 may connect to the tabs 3320 on the tubes 3350 in order to provide a tensile force that maintains the cushion 3050-2 in a sealing position on the patient’s head.4.3.10.2.4 Nose Mask Tube Down Configuration

[0272] As illustrated in Fig. 7M, the patient may wear the cushion 3050-2 in a tube-up configuration with the rigidiser arms 3340 and the two-point headgear 3302- 2. This assembly may form a tube down nose only patient interface 3000-4.

[0273] A conduit sleeve may be used with the rigidiser arms 3340, and may provide additional comfort to the patient. The sleeve may not add additional connection points to connect the positioning and stabilising structure 3300 on theA2578192 12.0 47cushion 3050-2. In the illustrated example, the rigidiser arms 3340 of the positioning and stabilising structure 3300 may be connected directly to the cushion 3050-2.

[0274] As illustrated in Fig. 7M, the two-point headgear 3302-2 may connect to the tabs 3320 on the sleeve in order to provide a tensile force that maintains the cushion 3050-2 in a sealing position on the patient’s head.4.3.10.2.5 Modularity of Elements

[0275] Fig. 7P illustrates how the different elements can be combined in order to form the four different patient interfaces described above. As illustrated, the different components may be reused for different styles of patient interfaces. This may allow for easier manufacturing and assembly, because a large number of the same components may be produced and used in a variety of styles. The only components not used in multiple styles may be the sleeves. However, the sleeves may be easier to manufacture. Fig. 70 shows a portion of air circuit 4170 that may interface with the patient interface, while Fig. 7N shows a vent 3404 that may interchangeably replace the air circuit shown in Fig. 70, depending on the style of the patient interface.4.4 EYE MASK AND CONNECTOR

[0276] Referring next to Fig. 8, a patient interface 3000 is shown being worn by a patient 1000. The patent interface 3000 comprises a positioning and stabilising structure 3300 comprising a pair of headgear tubes 3350. The patient interface 3000 further comprises an eye mask 8000 which is releasably connected to each of the headgear tubes 3350, as is described further below. The eye mask 8000 is connected to the outside of the patient interface 3000. In examples, no part of the eye mask 8000 is located, in use, between the patient’s face and the patient interface 3000.

[0277] Referring next to Fig. 9A-9G, a connector 9000 according to one form of the technology is shown. The connector 9000 allows connection of the eye mask 8000 to the tube(s) 3350.

[0278] The connector 9000 comprises a flexible member 9010 which is configured to form a sleeve around the tube 3350 (and around conduit sleeve 3351, 3380, 3380-1, if present), as best seen in Figs. 9F-10B. The flexible member 9010 is provided with releasable connector means to allow the flexible member 9010 to be releasably engaged with the tube 3350.

[0279] The flexible member 9010 may comprise first and second ends 9010A, 9010B and opposite side edges 9010C, 9010D. In examples, the flexible memberA2578192 12.0 489010 may be rectangular, although a strictly rectangular form is not essential. For example, in some examples the side edges 9010C, 9010D may converge. In examples one or more of the ends 9010 A, 9010B and side edges 9010C, 9010D may be arcuate. In some examples the first and second ends 9010 A, 9010B may be non-parallel. One or both of the first and second ends 9010 A, 9010B may not be orthogonal to the side edges 9010C, 9010D.

[0280] In the example shown the flexible member 9010 is made from two portions of unbroken loop material 9020. A first portion 9020A of the unbroken loop material is orientated so as to have its loops 9030A on a first side of the flexible member 9010. A second portion 9020B of the unbroken loop material is orientated so have to have its loops 9030B on an opposite second side of the flexible member 9010. In the form of the technology shown in Figs 9A-9G, the flexible member 9010 is substantially rectangular, although it is shown in Fig. 9A not completely flat. In one form of the technology both the first and second portions of unbroken loop material 9020 A, 9020B are also rectangular.

[0281] A portion of hook material 9040 (e.g. one half of a hook and loop fastening system) is provided to a first end 9050 of the first portion of unbroken loop material 9020A (e.g. the first end 9010A of the flexible member 9010). The hook material 9040 is orientated so as to be engageable with the loops 9030B of the second portion of unbroken loop material 9020B when the flexible member 9010 wraps around a headgear tube 3350, as shown in Figs. 9C-9F.

[0282] In some forms of the technology, the flexible member 9010 comprises an opening, for example a slit 9060. The slit 9060 may be dimensioned to so as to fit over a tab 3320 which is provided to the headgear tube 3350 for connection to a headgear strap, e.g. a back strap 3310. In some forms of the technology, the slit 9060 is dimensioned such that the flexible member 9010 fits securely around the tab 3320, with the tab 3320 preventing the flexible member 9010 from sliding or rotating on the tube 3350. In some forms the slit 9060 may have a length between 35mm-65mm, e.g. between 40mm-60mm, e.g. between 45mm-55mm. The slit 9060 may be orientated substantially parallel to first end 9010A, the second end 9010B and / or substantially orthogonal to one of the side edges 9010C, 9010C.

[0283] As best seen in Figs. 9G, 10B and 11, in use, the flexible member 9010 is connected to the tube 3350 such that the loops 9030A of the first portion of the unbroken loop material 9020A are on the non-patient facing side 9070 of the tubeA2578192 12.0 493350. The hook material 9040 is on the patient facing side 9080 of the tube 3350, and is covered by the second portion of the unbroken loop material 9020B and connected to loops 9030B.

[0284] As seen in Fig. 12, an eye mask 8000 for use as part of the system comprises lateral portions 8010 of hook material 9040 which are positioned to allow engagement with the first portion of the unbroken loop material 9020A to hold the eye mask 8000 in position on the patient's face, covering the patient’s eyes. The hook material 9040 may be provided to portions of the eye mask 8000 which are relatively flexible, to allow the eye mask 8000 to be disengaged from the connector 9000 by peeling the hook material 9040 of the mask 8000 away from the unbroken loop material of the connector 9000. Tab or flap portions 8020 may extend beyond the lateral hook portions 8010 for the patient to grasp when engaging or disengaging the eye mask 8000.

[0285] Once connected to the tube 3350, the connector 9000 may remained connected over multiple therapy cycles regardless of whether the eye mask 8000 is used. The engagement of the opening / slit 9060 with the tabs 3320 provided to the tube 3350 may ensure that the connector 9000 remains in the correct position on the tube 3350, without rotating or sliding relative to the tube 3350.

[0286] Connecting the eye mask 8000 to the tubes 3350 via the connector 9000 has no adverse effect on the performance of the tubes 3350 or the therapy in general. The connectors 9000 allow the patient to put the eye mask 8000 on after the patient interface 3000 has been correctly positioned for therapy. The eye mask 8000 can easily be removed and replaced without affecting the position or performance of the patient interface 3000.

[0287] The example described above has a flexible member 9010 formed entirely from portions of unbroken loop material 9020, in other forms of the technology the flexible member 9010 may comprise a substrate (for example a textile) with portions of unbroken loop material 9020 connected to the substrate in the orientations described above, or portions of other materials may be provided between the unbroken loop portions. In still other forms of the technology, alternative fasteners may be used to connect the ends of the flexible member 9010 together to form a sleeve, and the flexible member 9010 may comprise only a single portion of unbroken loop material on the non-patient facing side, for connection with the eye mask 8000. In other forms of the technology, the flexible member may comprise a hook materialA2578192 12.0 509040 on the non-patient facing side, and the eye mask 8000 may comprise unbroken loop material for connection to the hook material.4.5 RPT DEVICE

[0288] 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 algorithms, 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 delivery to a patient’s airways, such as to treat one or more of the respiratory conditions described elsewhere in the present document.

[0289] In one form, the RPT device 4000 is constructed and arranged to be capable of delivering a flow of air in a range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 4 cmH20, or at least 10cmH2O, or at least 20 cmH20.

[0290] In one form, the RPT device 4000 is constructed and arranged to be capable of delivering a flow of air in a range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH20, or at least 10cmH2O, or at least 20 cmH20.

[0291] The RPT device may have an external housing 4010, formed in two parts, an upper portion 4012 and a lower portion 4014. Furthermore, the external housing 4010 may include one or more panel(s) 4015. The RPT device 4000 comprises a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0292] The pneumatic path of the RPT device 4000 may comprise one or more air path items, e.g., filters such as an inlet air filter 4112 and outlet air filter, an inlet muffler, a pressure generator capable of supplying air at positive pressure (e.g., a blower 4142 comprising a motor), a muffler such as an outlet muffler and one or more transducers, such as pressure sensors and flow rate sensors.

[0293] One or more of the air path items may be located within a removable unitary structure which will be referred to as a pneumatic block 4020. The pneumatic block 4020 may be located within the external housing 4010. In one form a pneumatic block 4020 is supported by, or formed as part of the chassis 4016.

[0294] The RPT device 4000 may have an electrical power supply 4210, one or more input devices, a central controller, a therapy device controller, a pressure generator, one or more protection circuits, memory, transducers, data communicationA2578192 12.0 51interface and one or more output devices. Electrical components may be mounted on a single Printed Circuit Board Assembly (PCBA) 4202. In an alternative form, the RPT device 4000 may include more than one PCBA 4202.4.6 AIR CIRCUIT

[0295] An air circuit 4170 in accordance with an aspect of the present technology is a conduit or a tube constructed and arranged to allow, in use, a flow of air to travel between two components such as RPT device 4000 and the patient interface 3000 or 3800.4.7 HUMIDIFIER4.7.1 Humidifier overview

[0296] In one form of the present technology there is provided a humidifier 5000 (e.g. as shown in Fig. 5A) to change the absolute humidity of air or gas for delivery to a patient relative to ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity and increase the temperature of the flow of air (relative to ambient air) before delivery to the patient’s airways.

[0297] The humidifier 5000 may comprise a humidifier reservoir 5110, a humidifier inlet 5002 to receive a flow of air, and a humidifier outlet 5004 to deliver a humidified flow of air. In some forms, as shown in Fig. 5A and Fig. 5B, an inlet and an outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004 respectively. The humidifier 5000 may further comprise a humidifier base 5006, which may be adapted to receive the humidifier reservoir 5110 and comprise a heating element 5240.

[0298] In examples the humidifier reservoir further comprises a conductive portion 5120, a locking lever 5135 and a water level indicator 5150.

[0299] In one form of the present technology, an anti-spill back valve 4160 is located between the humidifier 5000 and the pneumatic block 4020.4.8 BREATHING WAVEFORMS

[0300] Fig. 6 shows a model typical breath waveform of a person while sleeping. The horizontal axis is time, and the vertical axis is respiratory flow rate. While the parameter values may vary, a typical breath may have the following approximate values: tidal volume Vt 0.5L, inhalation time Ti 1.6s, peak inspiratory flow rate Qpeak 0.4 L / s, exhalation time Te 2.4s, peak expiratory flow rate Qpeak -0.5 L / s. The total duration of the breath, Ttot, is about 4s. The person typically breathes at a rate ofA2578192 12.0 52about 15 breaths per minute (BPM), with Ventilation Vent about 7.5 L / min. A typical duty cycle, the ratio of Ti to 'Hot, is about 40%.4.9 RESPIRATORY THERAPY MODES

[0301] Various respiratory therapy modes may be implemented by the disclosed respiratory therapy system.4.10 GLOSSARY

[0302] 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.4.10.1 General

[0303] 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.

[0304] 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.4.10.1.1 Materials & their properties

[0305] 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).• ‘Soft’ materials may include silicone or thermo-plastic elastomer (TPE), and may, e.g. readily deform under finger pressure.• ‘Hard’ materials may include polycarbonate, polypropylene, and may not e.g. readily deform under finger pressure.

[0306] 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.

[0307] Polycarbonate', a thermoplastic polymer of Bisphenol-A Carbonate.A2578192 12.0 534.10.1.2 Mechanics

[0308] 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.

[0309] 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.

[0310] Elasticity '. The ability of a material to return to its original geometry after deformation.

[0311] 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.

[0312] Resilience'. Ability of a material to absorb energy when deformed elastically and to release the energy upon unloading.

[0313] Resilient'. Will release substantially all of the energy when unloaded. Includes e.g. certain silicones, and thermoplastic elastomers.

[0314] 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 cmH20 pressure.

[0315] 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.

[0316] 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. TheA2578192 12.0 54structure or component may offer different resistances in different directions. The inverse of stiffness is flexibility.

[0317] Viscous'. The ability of a material to resist flow.

[0318] Visco-elasticity : The ability of a material to display both elastic and viscous behaviour in deformation.

[0319] Yield: The situation when a material can no longer return back to its original geometry after deformation.4.10.1.3 Structural Elements

[0320] Compression member: A structural element that resists compression forces.

[0321] 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. In certain forms, an elbow may be assembled to a mating component via a one-time snap during manufacture, but not removable by a patient.

[0322] 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.

[0323] 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.

[0324] Tie (noun): A structure designed to resist tension.

[0325] Thin structures: a. Beams, i. 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,A2578192 12.0 55i. Relatively long in two dimensions, with one thin dimension. Readily deforms in response to bending forces. Resists being stretched, (might also resist compression). c. Plates & Shells i. These may be relatively long in two directions, with one thin dimension. They may have bending, tensile, and / or compressive stiffness.

[0326] Thick structures: Solids

[0327] 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.

[0328] 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.

[0329] 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.

[0330] 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.

[0331] 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.4.10.2 Patient interface

[0332] 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.A2578192 12.0 56

[0333] 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.

[0334] 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.

[0335] 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.

[0336] 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.4.11 OTHER REMARKS

[0337] 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.

[0338] 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 stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the technology.

[0339] 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 suitableA2578192 12.0 57significant digit to the extent that a practical technical implementation may permit or require it.

[0340] Furthermore, “approximately”, “substantially”, “about”, or any similar term used herein means + / - 5-10% of the recited value.

[0341] 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.

[0342] When a particular material is identified as being used to construct a component, obvious alternative materials with similar 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.

[0343] 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.

[0344] All publications mentioned herein are 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.

[0345] 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.

[0346] 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.A2578192 12.0 58

[0347] 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. In 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 are 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.

[0348] 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.4.12 REFERENCE SIGNS LISTA2578192 12.0 59A2578192 12.0 60A2578192 12.0 61A2578192 12.0 62

Claims

5 CLAIMS1. A connector for connecting an eye mask to a headgear tube, the connector comprising a flexible member, a first end of the flexible member configured to be releasably connected to another portion of the flexible member to form a sleeve, the flexible member further comprising a slit, wherein an outer face of the flexible member comprises a portion of hook material or a portion of unbroken loop material.

2. The connector of claim 1, wherein the flexible member comprises a first portion of unbroken loop material on a first side and a second portion of unbroken loop material on an opposite second side thereof.

3. The connector of claim 2, wherein the first end of the flexible member includes a portion of hook material configured to engage the second portion of unbroken loop material when the flexible member is wrapped around the headgear tube.

4. The connector any one of claims 1 to 3, wherein the flexible member has a second end and two side edges.

5. The connector of claim 4, wherein the flexible member is rectangular.

6. The connector of claim 4 or 5, wherein the slit is substantially parallel to the first end of the flexible member or a second end of the flexible member.

7. The connector of any one of claims 4, 5 or 6, wherein the slit is substantially orthogonal to one of the side edges.

8. The connector of any one of claims 1 to 7, wherein the slit has a length between 35mm-65mm.

9. The connector of any one of claims 1 to 8, wherein the connector is configured to remain connected to the headgear tube, in use, over multiple therapy cycles regardless of whether the eye mask is attached.A2578192 12.0 6310. A connector for connecting an eye mask to a headgear tube, the connector comprising a flexible member comprising a first portion of unbroken loop material having loops on a first side of the flexible member and a second portion of unbroken loop material having loops on an opposite second side of the flexible member, the connector comprising a portion of hook material connected to a first end of the flexible member for releasable connection to the second portion of unbroken loop material such that the flexible member forms a sleeve, the flexible member further comprising a slit which is generally parallel to the first end of the flexible member.

11. A conduit headgear for a patient interface comprising a headgear tube, the headgear tube comprising a tab for connection to a headgear strap, the headgear further comprising a sleeve configured to releasably wrap around the headgear tube, the sleeve comprising a slit through which the tab protrudes, in use, wherein the sleeve has a patient facing side and a non patient facing side, and wherein the non patient facing side is provided with a portion of hook material or a portion of unbroken loop material.

12. A system comprising a conduit headgear for a patient interface in combination with an eye mask, the conduit headgear comprising a headgear tube which has a tab for connection to a headgear strap, the headgear further comprising a flexible member, a first end of the flexible member configured to be releasably connected to another portion of the flexible member to form a sleeve around the tube, the sleeve comprising a slit through which the tab protrudes, in use, wherein the sleeve has a patient facing side and a non patient facing side, and wherein the eye mask is releasably connectable to the sleeve by a hook and loop fastener.

13. The system of claim 12, wherein the flexible member comprises a portion of loop material and a portion of hook material is connected to the first end of the flexible member.A2578192 12.0 6414. The system of claim 12 or 13, wherein the slit is dimensioned to receive the tab such that the flexible member is prevented from sliding or rotating relative to the headgear tube in use.

15. The system of any one of claims 12 to 14, wherein the eye mask includes lateral tab portions to facilitate engagement and disengagement of the eye mask with the sleeve.

16. The system of any one of claims 12 to 15, wherein the flexible member is substantially rectangular when laid flat.

17. The system of any one of claims 12 to 16, wherein the flexible member is configured to remain connected to the headgear tube over multiple therapy cycles.

18. The system of any one of claims 12 to 17, wherein the system is configured to allow the eye mask, when in use, to be disengaged from the sleeve disturbing the position of the headgear tube.

19. The system of any one of claims 12 to 18, wherein the eye mask comprises lateral portions of hook material which are positioned to allow engagement with a portion of unbroken loop material provided to the flexible member.

20. The system of any one of claims 12 to 19, wherein, in use, no part of the eye mask is located between the patient’s face and the patient interface.A2578192 12.0 65

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